CLEXANE 60MG/0.6ML SYRINGES
Active substance(s): ENOXAPARIN SODIUM / SODIUM ENOXAPARIN
PACKAGE LEAFLET:
INFORMATION FOR THE USER
®
Clexane 60mg/0.6ml Syringes
(enoxaparin sodium)
Read all of this leaflet carefully before you
start using this medicine
Keep this leaflet. You may need to read it
again
If you have any further questions, ask your
doctor or pharmacist
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
Please note that the leaflet also contains
information about other strengths, Clexane
20mg, 40mg, 80mg and 100mg Syringes.
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is
used for
The name of your medicine is Clexane
60mg/0.6ml Syringes but it will be referred as
Clexane throughout this leaflet. Clexane
contains a medicine called enoxaparin sodium.
This belongs to a group of medicines called
Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.
1
7
1
5
6
6
0
4
Clexane can be used to:
Treat blood clots that are in your blood
Stop blood clots forming in your blood in the
following situations:
Unstable angina (where not enough
blood gets to your heart)
After an operation or long periods of
bed rest due to illness
After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with
kidney problems)
Take special care with Clexane
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding
caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your
eyes or brain
You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by
diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist or nurse
before using Clexane.
2. Before you use Clexane
Do not have this medicine and tell your
doctor, pharmacist or nurse if:
You are allergic (hypersensitive) to
enoxaparin sodium or any of the other
ingredients of Clexane (listed in Section 6:
‘Further information’)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
You are allergic to heparin or other Low
Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin to
treat blood clots
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Clexane.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Clexane® 60mg0.6/ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (2,000IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5mg/kg (150IU/kg).
Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is
established.
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Clexane can affect
the way some other medicines work. Also some
medicines can affect the way Clexane works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
Warfarin - used for thinning the blood
Aspirin, dipyridamole, clopidogrel or other
medicines – used to stop blood clots
forming
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
1 NAME OF THE MEDICINAL PRODUCT
Clexane® 60mg/0.6ml Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000IU anti-Xa activity) in 0.6ml Water for
Injections
For full list of excipients, see section 6.1
Taking or using other medicines
Dose (mg)
Injection
volume (ml)
120mg / 0.8ml
105 od
0.70
120mg / 0.8ml
112.5 od
0.76
80
120mg / 0.8ml
120 od
0.80
85
150mg / 1ml
127.5 od
0.86
90
150mg / 1ml
135 od
0.90
95
150mg / 1ml
142.5 od
0.96
100
150mg/ 1ml
150 od
1.00
Kg
Syringe label
70
75
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1mg/kg Clexane every 12 hours by subcutaneous injection, administered
concurrently with oral aspirin (100 to 325mg once daily). Treatment with Clexane in these patients
should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual
duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
60mg / 0.6ml
60 od
0.60
45
80mg / 0.8ml
67.5 od
0.675
50
80mg / 0.8ml
75 od
0.75
55
100mg / 1ml
82.5 od
0.825
60
100mg / 1ml
90 od
0.90
65
100mg / 1ml
97.5 od
0.975
100mg/ml
Solution for
Injection
CLEXANE
syringes
Dextran injection - used as a blood replacer
Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and swelling
in arthritis and other illnesses
Prednisolone, dexamethasone or other
medicines – used to treat asthma,
rheumatoid arthritis and other conditions
Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Clexane
Your doctor may change one of your medicines
or take regular blood tests to check that taking
these medicines with Clexane is not causing
you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are
using Clexane. Tell also your doctor if you have
any problem with your spine or if you have ever
had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine
if you are pregnant, might become pregnant, or
think you may be pregnant.
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
You should not breast-feed whilst using
Clexane. If you are planning to breast-feed, talk
to your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
When you go home you may need to
continue to use Clexane and give it to
yourself (see below instructions on how to
do this)
Clexane is usually given by injection
underneath the skin (subcutaneous)
Do not inject Clexane into a muscle
(intramuscular)
If you are not sure why you are receiving
Clexane or have any questions about how
much Clexane is being given to you, speak to
your doctor, pharmacist or nurse.
How much will be given to you
Your doctor will decide how much to give
you. The amount of Clexane given to you
will depend on the reason it is being used
1)
2)
a)
b)
3. How to use Clexane
Having this medicine
Before you use Clexane your doctor or
nurse may carry out a blood test
While you are in hospital your doctor or
nurse will normally give you Clexane. This is
because it needs to be given as an injection
1
7
1
5
6
6
0
4
If you have problems with your kidneys, you
may be given a smaller amount of Clexane
Treating blood clots that are in your blood
The usual dose is 1.5mg for every kilogram
of your weight, each day
Clexane will usually be given for at least 5
days
Stopping blood clots forming in your
blood in the following situations:
Unstable angina
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take
aspirin as well
After an operation or long periods of
bedrest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot
If you have a low to medium risk of getting a
clot, you will be given 20mg of Clexane each
day for 7 to 10 days. If you are going to have
an operation, your first injection will usually
be given 2 hours before your operation
If you have a higher risk of getting a clot,
you will be given 40mg each day for 7 to 28
days. If you are going to have an operation,
your first injection will usually be given 12
hours before your operation
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
115
120mg / 0.8ml
115 bd
0.78
120
120mg / 0.8ml
120 bd
0.80
125
150mg / 1ml
125 bd
0.84
130
150mg / 1ml
130 bd
0.88
135
150mg / 1ml
135 bd
0.90
140
150mg / 1ml
140 bd
145
150mg / 1ml
150
150mg / 1ml
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml (1)
105 bd (1)
0.70 (1)
110
120mg / 0.8ml (1)
110 bd (1)
0.74 (1)
115
120mg / 0.8ml (1)
115 bd (1)
0.78 (1)
120
120mg / 0.8ml (1)
120 bd (1)
0.80 (1)
125
150mg / 1ml (1)
125 bd (1)
0.84 (1)
130
150mg / 1ml (1)
130 bd (1)
0.88 (1)
0.94
135
150mg / 1ml (1)
135 bd (1)
0.90 (1)
145 bd
0.98
140
150mg / 1ml (1)
140 bd (1)
0.94 (1)
150 bd
1.00
145
150mg / 1ml (1)
145 bd (1)
0.98 (1)
150
150mg / 1ml (1)
150 bd (1)
1.00 (1)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
‘Posology and method of administration: Elderly’.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
If you are bedridden due to illness, you will
be normally be given 40mg of Clexane each
day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of
heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will
depend on your age and the kind of heart attack
you have had.
i) NSTEMI type of heart attack
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
30mg of Clexane will be given as an
injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
At the same time, you will also be given
Clexane as an injection under your skin
(subcutaneous injection). The usual dose is
1mg for every kilogram of your weight.
Then you will be given 1mg for every kilogram of
your weight every 12 hours
The maximum amount of Clexane given for
the first two injections is 100mg
The injections will normally be given for up
to 8 days
If you are aged 75 years or older
Your doctor or nurse will give you injections
of Clexane under your skin (subcutaneous
injection)
The usual dose is 0.75mg for every kilogram
of your weight, every 12 hours
The maximum amount of Clexane given for
the first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
Depending on when you were last given
Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI
operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or
60, 80 or 100mg Pre-filled syringes)
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed.
If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of
0.3mg/kg of enoxaparin sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high
risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or
0.75 mg/kg (75 IU/kg) for single vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of
age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg
for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
impaired (see also section 4.2 ‘Posology and method of administration: Renal impairment;’ section 4.4
‘Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and
Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
3) Stopping blood clots forming in the tubes
of your dialysis machine
The usual dose is 1mg for every kilogram of your
weight
Clexane is added to the tube leaving the
body (arterial line) at the start of the dialysis
session
This amount is usually enough for a 4 hour
session. However, your doctor may give you a
further dose of 0.5 to 1mg for every kilogram
of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your
doctor or nurse will show you how to do this. Do
not try to inject yourself if you have not been
trained how to do so. If you are not sure what to
do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
Check the expiry date on the medicine. Do
not use if the date has passed
Check the syringe is not damaged and the
medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are
going to inject
Check your abdomen to see if the last
injection caused any redness, change in
skin colour, swelling, oozing or is still painful,
if so talk to your doctor or nurse
Decide where you are going to inject the
medicine. Change the place where you
inject each time from the right to the left side
of your stomach. Clexane should be injected
just under the skin on your stomach, but not
too near the belly button or any scar tissue
(at least 5 cm away from these)
Instructions on injecting yourself with
Clexane:
1) Wash your hands and the area that you
will inject with soap and water. Dry them.
1
7
1
5
6
6
0
4
2) Sit or lie in a
comfortable position
so you are relaxed.
Make sure you can
see the place you are
going to inject. A
lounge chair, recliner,
or bed propped up with pillows is ideal.
6) Hold the syringe so that the needle is pointing
downwards (vertically at a 90º angle). Insert the
full length of the needle into the skin fold.
7) Press down on the plunger with your thumb.
This will send the medication into the fatty
tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
3) Choose an area on the right or left side of
your stomach. This should be at least 5
centimetres away from your belly button and
out towards your sides.
Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right
sides of your stomach, depending on the
area you were last injected.
8) Remove the needle by pulling it straight out.
You can now let go of the skin fold. To avoid
bruising, do not rub the injection site after
you have injected yourself.
9) Drop the used syringe into the sharps bin
provided. Close the container lid tightly and
place the container out of reach of children.
When the container is full, give it to your
doctor or home care nurse for disposal. Do
not put it in the household rubbish.
4) Carefully pull off the needle cap from the
Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
If you have too much or too little Clexane
If you think that you have used too much or too
little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no
signs of a problem. If a child accidentally injects
or swallows Clexane, take them to a hospital
casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as
soon as you remember. Do not give yourself a
double dose on the same day to make up for a
forgotten dose. Keeping a diary will help to
make sure you do not miss a dose
If you stop using Clexane
It is important for you to keep having Clexane
injections until your doctor decides to stop
them. If you stop, you could get a blood clot
which can be very dangerous.
Blood Tests
Using Clexane may affect the results of some
blood tests. If you are going to have a blood
test, it is important to tell your doctor you are
having Clexane.
Do not press on the plunger before injecting
yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have
removed the cap, do not allow the needle to
touch anything. This is to make sure the needle
stays clean (sterile).
5) Hold the syringe in the hand you write with (like
a pencil) and with your other hand, gently pinch
the cleaned area of your abdomen between
your forefinger and thumb to make a fold in the
skin
Make sure you hold the skin fold throughout
the injection.
Dosage chart for 0.75mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
Kg
Syringe label
Dosage adjustments for therapeutic dosage range
(elderly patients aged ≥75 years only)
0.75mg/kg Dose
(mg)
Adjusted
dosing (mg)
Injection
volume (ml)
Standard dosing
Severe renal impairment
1mg/kg SC twice daily
1mg/kg SC once daily
1.5mg/kg SC once daily
1mg/kg SC once daily
40
60mg / 0.6ml
30 bd
30 bd
0.30
45
60mg / 0.6ml
33.75 bd
35 bd
0.35
50
60mg / 0.6ml
37.5 bd
37.5 bd
0.375
55
60mg / 0.6ml
41.25 bd
42.5 bd
0.425
60
60mg / 0.6ml
45 bd
45 bd
0.45
65
60mg / 0.6ml
48.75 bd
50 bd
0.5
70
60mg / 0.6ml
52.5 bd
52.5 bd
0.525
75
60mg / 0.6ml
56.25 bd
57.5 bd
0.575
80
60mg / 0.6ml
60 bd
60 bd
0.60
85
80mg / 0.8ml
63.75 bd
65 bd
0.65
90
80mg / 0.8ml
67.5 bd
67.5 bd
0.675
95
80mg / 0.8ml
71.25 bd
72.5 bd
0.725
100
80mg / 0.8ml
75 bd
75 bd
0.75
105
80mg / 0.8ml
78.75 bd (1)
80 bd (1)
0.80 (1)
110
100mg / 1ml
82.5 bd (1)
82.5 bd (1)
0.825 (1)
115
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
0.875 (1)
120
100mg / 1ml
90 bd (1)
90 bd (1)
0.90 (1)
125
100mg / 1ml
93.75 bd (1)
95 bd (1)
0.95 (1)
130
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
0.975 (1)
135
120mg / 0.8ml
101.25 bd (1)
102 bd (1)
0.68 (1)
140
120mg / 0.8ml
105 bd (1)
105 bd (1)
0.7 (1)
145
150
120mg / 0.8ml
120mg / 0.8ml
108.75 bd (1)
112.5 bd (1)
111 bd (1)
114 bd (1)
0.74 (1)
0.76 (1)
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 ‘Special warnings and precautions for use: Renal impairment
and Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment
(creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin sodium
exposure is significantly increased in this patient population:
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a
30mg-single IV bolus plus a 1mg/kg SC dose
1mg/kg SC dose followed by
followed by 1mg/kg twice daily.
1mg/kg once daily
(Max 100mg for first SC dose
(Max 100mg for each of the first two SC doses)
only)
For treatment of acute STEMI in elderly patients ≥75 years of age
1mg/kg SC once daily without
0.75mg/kg SC twice daily without initial bolus.
initial bolus.
(Max 100mg for first SC dose
(Max 75mg for each of the first two SC doses)
only)
Dosage adjustments for prophylactic dosage ranges
Standard dosing
Severe renal impairment
40mg SC once daily
20mg SC once daily
20mg SC once daily
20mg SC once daily
The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min),
careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
precautions for use:’ Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
‘Special warnings and precautions for use: ‘Low body weight and Monitoring’, section 5.2
‘Pharmacokinetic properties’).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial
line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation
during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for
the initial dose of acute STEMI indication and before PCI when needed. It must not be
administered by the intramuscular route.
4. Possible side effects
Like all medicines, Clexane can cause side
effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital
straight away if you notice any of the
following side effects:
Very common (affects more than 1 in 10
people)
Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
A painful rash of dark red spots under the
skin which do not go away when you put
pressure on them. You may also notice pink
patches on your skin. These are more likely
to appear in the area you have been injected
with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
Sudden severe headache. This could be a
sign of bleeding in the brain.
A feeling of tenderness and swelling in your
stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
If you have an allergic reaction. The signs
may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue.
Frequency unknown
If you have had a spinal puncture or a spinal
anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the
lower part of your body. Also if you lose
control over your bladder or bowel (so you
cannot control when you go to the toilet).
Tell a nurse or doctor as soon as possible if
you notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
You bruise more easily than usual. This
could be because of a blood problem
(thrombocytopenia).
You have pain, swelling or irritation in the
area you have been injected with Clexane.
This normally gets better after a few days.
1
7
1
5
6
6
0
4
Rare (affects less than 1 in a 1000 people)
If you have a mechanical heart valve,
treatment with Clexane might not be
sufficient to prevent blood clots. You may
notice that you have difficulty breathing,
tiredness or difficulty exercising, chest pain,
numbness, feeling sick or loss of
consciousness. This could be due to a blood
clot on the heart valve
5. How to store Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date which
is stated on the carton and blister label after
‘Exp’. The expiry date refers to the last day of
that month.
Do not store above 25°C.
Do not refrigerate. Do not freeze.
Medicines should not be disposed of via
wastewater or household waste. If you are
using this medicine at home you will be given a
container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused
syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to
protect the environment.
Frequency unknown
Feeling tired, faint, dizzy, having pale skin.
These could be symptoms of anaemia.
You notice yellowing of your skin or eyes
and your urine becomes darker in colour.
This could be a liver problem.
Other side effects that you should discuss
with your nurse or doctor if you are
concerned about them:
6. Further Information
What Clexane contains
The active ingredient in clexane is enoxaparin
sodium. Each pre-filled syringe contains 60mg
enoxaparin sodium (equivalent to 6,000 IU antiXa activity) in 0.6ml water for injections.
The other inactive ingredient is water for
injections.
What Clexane looks like and contents of the
pack
Clexane clear, colourless to pale yellow solution
for injection in a glass pre-filled syringe fitted
with an injection needle and needle cap. It is
supplied in packs of 10 syringes.
Manufactured by: Sanofi Winthrop Industrie,
180 rue Jean-Jaures, 94702 Maisons Alfort
France. Or
Sanofi Winthrop Industrie, Boulevard Industriel,
76580 Le Trait, France.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®
Clexane 60mg/0.6ml Syringes
PL 18799/2375
POM
Leaflet date: 12.02.2016
Clexane is a registered trade mark of
sanofi-aventis.
Very common (affects more than 1 in 10
people)
Changes in the results of blood tests done to
check how your liver is working. These
usually go back to normal after you stop
having Clexane.
Rare (affects less than 1 in a 1000 people)
Changes in the potassium levels in your
blood. This is more likely to happen in
people with kidney problems or diabetes.
Your doctor will be able to check this by
carrying out a blood test.
Frequency unknown
If Clexane is used for a long period of time
(more than 3 months), it may increase the
risk of you getting a condition called
‘osteoporosis’. This is when your bones are
more likely to break
Headache
Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine.
Subcutaneous injection technique
The pre-filled disposable syringe is ready for immediate use. Clexane should be administered when
the patient is lying down by deep subcutaneous injection. The administration should be alternated
between the left and right anterolateral or posterolateral abdominal wall. The whole length of the
needle should be introduced vertically into a skin fold held between the thumb and index finger. The
skin fold should not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects
the used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Weight
Required
dose
(0.3mg/kg)
Volume to inject
when diluted to a
final
concentration of
3mg/ml
Weight
Required dose
(0.3mg/kg)
Volume to inject
when diluted to a
final
concentration of
3mg/ml
(Kg)
(mg)
(ml)
(Kg)
(mg)
(ml)
45
13.5
4.5
100
30
10
50
15
5
105
31.5
10.5
55
16.5
5.5
110
33
11
60
18
6
115
34.5
11.5
65
19.5
6.5
120
36
12
70
21
7
125
37.5
12.5
Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated pre-filled syringe (60, 80 or
100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mg dose can
then be directly injected into an injection site in the intravenous line.
75
22.5
7.5
130
39
13
80
24
8
135
40.5
13.5
85
25.5
8.5
140
42
14
Additional bolus for PCI when last SC administration was given more than 8 hours
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus
of 0.3mg/kg is to be administered if last SC administration was given more than 8 hours before
balloon inflation (see section 4.2 ‘Posology and method of administration’: ‘Treatment of acute STsegment Elevation Myocardial Infarction’).
90
27
9
145
43.5
14.5
95
28.5
9.5
150
45
15
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg pre-filled syringes can
be used. Enoxaparin sodium should be administered through an intravenous line. It should not be
mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin
sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient
amount of saline or dextrose solution prior to and following the intravenous bolus administration of
enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with
normal saline solution (0.9%) or 5% dextrose in water.
6 PHARMACEUTICAL PARTICULARS
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the
drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium pre-filled syringe, it is recommended
to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water)
as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete
contents of the 60mg enoxaparin sodium pre-filled syringe into the 20ml remaining in the bag.
Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe
for administration into the intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use. Volume to be injected through intravenous line after dilution is completed
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in
water.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
Solution for injection in Type I glass pre-filled syringe in pack of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
7 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8 DATE OF REVISION OF THE TEXT: 12.02.2016
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Enoxaparin sodium 60mg/0.6ml
Syringes
Read all of this leaflet carefully before you
start using this medicine
Keep this leaflet. You may need to read it
again
If you have any further questions, ask your
doctor or pharmacist
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
Please note that the leaflet also contains
information about other strengths, Enoxaparin
sodium 20mg, 40mg and 80mg and 100mg
Syringes.
In this leaflet:
1. What Enoxaparin sodium is and what it is
used for
2. Before you use Enoxaparin sodium
3. How to use Enoxaparin sodium
4. Possible side effects
5. How to store Enoxaparin sodium
6. Further information
1. What Enoxaparin sodium is
and what it is used for
The name of your medicine is Enoxaparin
sodium 60mg/0.6ml Syringes but it will be
referred as Enoxaparin sodium throughout this
leaflet. Enoxaparin sodium contains a medicine
called enoxaparin sodium. This belongs to a
group of medicines called Low Molecular
Weight Heparins.
Enoxaparin sodium works in two ways.
1) Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.
1
7
1
5
6
6
0
4
Enoxaparin sodium can be used to:
Treat blood clots that are in your blood
Stop blood clots forming in your blood in the
following situations:
Unstable angina (where not enough
blood gets to your heart)
After an operation or long periods of
bed rest due to illness
After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with
kidney problems)
Take special care with Enoxaparin
sodium
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding
caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your
eyes or brain
You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by
diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist or nurse
before using Enoxaparin sodium.
2. Before you use Enoxaparin sodium
Do not have this medicine and tell your
doctor, pharmacist or nurse if:
You are allergic (hypersensitive) to
enoxaparin sodium or any of the other
ingredients of Enoxaparin sodium (listed in
Section 6: ‘Further information’)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
You are allergic to heparin or other Low
Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin to
treat blood clots
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Enoxaparin sodium.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Enoxaparin sodium 60mg/0.6ml Syringes
1 NAME OF THE MEDICINAL PRODUCT
Enoxaparin sodium 60mg/0.6ml Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6ml Water for
Injections
For full list of excipients, see section 6.1
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (2,000IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Enoxaparin sodium should be administered subcutaneously as a single daily injection of 1.5mg/kg
(150IU/kg). Enoxaparin sodium treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Enoxaparin sodium
can affect the way some other medicines work.
Also some medicines can affect the way
Enoxaparin sodium works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
Warfarin - used for thinning the blood
Aspirin, dipyridamole, clopidogrel or other
medicines – used to stop blood clots
forming
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin sodium Syringes
Taking or using other medicines
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
70
120mg / 0.8ml
105 od
0.70
75
120mg / 0.8ml
112.5 od
0.76
80
120mg / 0.8ml
120 od
0.80
85
150mg / 1ml
127.5 od
0.86
90
150mg / 1ml
135 od
0.90
95
150mg / 1ml
142.5 od
0.96
100
150mg/ 1ml
150 od
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1mg/kg Enoxaparin sodium every 12 hours by subcutaneous injection,
administered concurrently with oral aspirin (100 to 325mg once daily). Treatment with Enoxaparin
sodium in these patients should be prescribed for a minimum of 2 days and continued until clinical
stabilisation. The usual duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
Injection
ENOXAPARIN SODIUM
syringes
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
60mg / 0.6ml
60 od
0.60
45
80mg / 0.8ml
67.5 od
0.675
50
80mg / 0.8ml
75 od
0.75
55
100mg / 1ml
82.5 od
0.825
60
100mg / 1ml
90 od
0.90
65
100mg / 1ml
97.5 od
0.975
100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes
Dextran injection - used as a blood replacer
Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and swelling
in arthritis and other illnesses
Prednisolone, dexamethasone or other
medicines – used to treat asthma,
rheumatoid arthritis and other conditions
Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Enoxaparin
sodium
Your doctor may change one of your medicines
or take regular blood tests to check that taking
these medicines with Enoxaparin sodium is not
causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are
using Enoxaparin sodium. Tell also your doctor
if you have any problem with your spine or if
you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine
if you are pregnant, might become pregnant, or
think you may be pregnant.
When you go home you may need to
continue to use Enoxaparin sodium and give
it to yourself (see below instructions on how
to do this)
Enoxaparin sodium is usually given by
injection underneath the skin
(subcutaneous)
Do not inject Enoxaparin sodium into a
muscle (intramuscular)
If you are not sure why you are receiving
Enoxaparin sodium or have any questions
about how much Enoxaparin sodium is being
given to you, speak to your doctor, pharmacist
or nurse.
How much will be given to you
Your doctor will decide how much to give
you. The amount of Enoxaparin sodium
given to you will depend on the reason it is
being used
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
2)
You should not breast-feed whilst using
Enoxaparin sodium. If you are planning to
breast-feed, talk to your doctor, pharmacist or
nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
1)
a)
b)
3. How to use Enoxaparin sodium
Having this medicine
Before you use Enoxaparin sodium your
doctor or nurse may carry out a blood test
While you are in hospital your doctor or
nurse will normally give you Enoxaparin
sodium. This is because it needs to be given
as an injection
1
7
1
5
6
6
0
4
If you have problems with your kidneys, you
may be given a smaller amount of
Enoxaparin sodium
Treating blood clots that are in your blood
The usual dose is 1.5mg for every kilogram
of your weight, each day
Enoxaparin sodium will usually be given for
at least 5 days
Stopping blood clots forming in your
blood in the following situations:
Unstable angina
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Enoxaparin sodium will usually be given for
2 to 8 days. Your doctor will normally ask
you to take aspirin as well
After an operation or long periods of
bedrest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot
If you have a low to medium risk of getting a
clot, you will be given 20mg of Enoxaparin
sodium each day for 7 to 10 days. If you are
going to have an operation, your first
injection will usually be given 2 hours before
your operation
If you have a higher risk of getting a clot,
you will be given 40mg each day for 7 to 28
days. If you are going to have an operation,
your first injection will usually be given 12
hours before your operation
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
115
120mg / 0.8ml
115 bd
0.78
120
120mg / 0.8ml
120 bd
0.80
125
150mg / 1ml
125 bd
0.84
130
150mg / 1ml
130 bd
0.88
135
150mg / 1ml
135 bd
0.90
140
150mg / 1ml
140 bd
0.94
145
150mg / 1ml
145 bd
150
150mg / 1ml
150 bd
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml (1)
105 bd (1)
0.70 (1)
110
120mg / 0.8ml (1)
110 bd (1)
0.74 (1)
115
120mg / 0.8ml (1)
115 bd (1)
0.78 (1)
120
120mg / 0.8ml (1)
120 bd (1)
0.80 (1)
125
150mg / 1ml (1)
125 bd (1)
0.84 (1)
130
150mg / 1ml (1)
130 bd (1)
0.88 (1)
135
150mg / 1ml (1)
135 bd (1)
0.90 (1)
0.98
140
150mg / 1ml (1)
140 bd (1)
0.94 (1)
1.00
145
150mg / 1ml (1)
145 bd (1)
0.98 (1)
150
150mg / 1ml (1)
150 bd (1)
1.00 (1)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
‘Posology and method of administration: Elderly’.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes
If you are bedridden due to illness, you will
be normally be given 40mg of Enoxaparin
sodium each day for 6 to 14 days
c) After you have had a heart attack
Enoxaparin sodium can be used for two
different types of heart attack called NSTEMI or
STEMI.
The amount of Enoxaparin sodium given to you
will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Enoxaparin sodium will usually be given for
2 to 8 days. Your doctor will normally ask
you to take aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
30mg of Enoxaparin sodium will be given as
an injection into your vein (intravenous
injection using Enoxaparin sodium Multidose
Vial or 60, 80 or 100mg Pre-filled syringes)
At the same time, you will also be given
Enoxaparin sodium as an injection under
your skin (subcutaneous injection). The
usual dose is 1mg for every kilogram of your
weight.
Then you will be given 1mg for every kilogram of
your weight every 12 hours
The maximum amount of Enoxaparin
sodium given for the first two injections is
100mg
The injections will normally be given for up
to 8 days
If you are aged 75 years or older
Your doctor or nurse will give you injections
of Enoxaparin sodium under your skin
(subcutaneous injection)
The usual dose is 0.75mg for every kilogram
of your weight, every 12 hours
The maximum amount of Enoxaparin
sodium given for the first two injections is
75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
Depending on when you were last given
Enoxaparin sodium, your doctor may decide
to give an additional dose of Enoxaparin
sodium before a PCI operation. This is by
injection into your vein (intravenous using
Enoxaparin sodium Multidose Vial or 60, 80
or 100mg Pre-filled syringes)
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Patient
weight
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation
INFORMATION FOR THE USER
®
Clexane 60mg/0.6ml Syringes
(enoxaparin sodium)
Read all of this leaflet carefully before you
start using this medicine
Keep this leaflet. You may need to read it
again
If you have any further questions, ask your
doctor or pharmacist
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
Please note that the leaflet also contains
information about other strengths, Clexane
20mg, 40mg, 80mg and 100mg Syringes.
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is
used for
The name of your medicine is Clexane
60mg/0.6ml Syringes but it will be referred as
Clexane throughout this leaflet. Clexane
contains a medicine called enoxaparin sodium.
This belongs to a group of medicines called
Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.
1
7
1
5
6
6
0
4
Clexane can be used to:
Treat blood clots that are in your blood
Stop blood clots forming in your blood in the
following situations:
Unstable angina (where not enough
blood gets to your heart)
After an operation or long periods of
bed rest due to illness
After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with
kidney problems)
Take special care with Clexane
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding
caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your
eyes or brain
You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by
diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist or nurse
before using Clexane.
2. Before you use Clexane
Do not have this medicine and tell your
doctor, pharmacist or nurse if:
You are allergic (hypersensitive) to
enoxaparin sodium or any of the other
ingredients of Clexane (listed in Section 6:
‘Further information’)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
You are allergic to heparin or other Low
Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin to
treat blood clots
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Clexane.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Clexane® 60mg0.6/ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (2,000IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5mg/kg (150IU/kg).
Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is
established.
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Clexane can affect
the way some other medicines work. Also some
medicines can affect the way Clexane works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
Warfarin - used for thinning the blood
Aspirin, dipyridamole, clopidogrel or other
medicines – used to stop blood clots
forming
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
1 NAME OF THE MEDICINAL PRODUCT
Clexane® 60mg/0.6ml Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000IU anti-Xa activity) in 0.6ml Water for
Injections
For full list of excipients, see section 6.1
Taking or using other medicines
Dose (mg)
Injection
volume (ml)
120mg / 0.8ml
105 od
0.70
120mg / 0.8ml
112.5 od
0.76
80
120mg / 0.8ml
120 od
0.80
85
150mg / 1ml
127.5 od
0.86
90
150mg / 1ml
135 od
0.90
95
150mg / 1ml
142.5 od
0.96
100
150mg/ 1ml
150 od
1.00
Kg
Syringe label
70
75
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1mg/kg Clexane every 12 hours by subcutaneous injection, administered
concurrently with oral aspirin (100 to 325mg once daily). Treatment with Clexane in these patients
should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual
duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
60mg / 0.6ml
60 od
0.60
45
80mg / 0.8ml
67.5 od
0.675
50
80mg / 0.8ml
75 od
0.75
55
100mg / 1ml
82.5 od
0.825
60
100mg / 1ml
90 od
0.90
65
100mg / 1ml
97.5 od
0.975
100mg/ml
Solution for
Injection
CLEXANE
syringes
Dextran injection - used as a blood replacer
Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and swelling
in arthritis and other illnesses
Prednisolone, dexamethasone or other
medicines – used to treat asthma,
rheumatoid arthritis and other conditions
Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Clexane
Your doctor may change one of your medicines
or take regular blood tests to check that taking
these medicines with Clexane is not causing
you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are
using Clexane. Tell also your doctor if you have
any problem with your spine or if you have ever
had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine
if you are pregnant, might become pregnant, or
think you may be pregnant.
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
You should not breast-feed whilst using
Clexane. If you are planning to breast-feed, talk
to your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
When you go home you may need to
continue to use Clexane and give it to
yourself (see below instructions on how to
do this)
Clexane is usually given by injection
underneath the skin (subcutaneous)
Do not inject Clexane into a muscle
(intramuscular)
If you are not sure why you are receiving
Clexane or have any questions about how
much Clexane is being given to you, speak to
your doctor, pharmacist or nurse.
How much will be given to you
Your doctor will decide how much to give
you. The amount of Clexane given to you
will depend on the reason it is being used
1)
2)
a)
b)
3. How to use Clexane
Having this medicine
Before you use Clexane your doctor or
nurse may carry out a blood test
While you are in hospital your doctor or
nurse will normally give you Clexane. This is
because it needs to be given as an injection
1
7
1
5
6
6
0
4
If you have problems with your kidneys, you
may be given a smaller amount of Clexane
Treating blood clots that are in your blood
The usual dose is 1.5mg for every kilogram
of your weight, each day
Clexane will usually be given for at least 5
days
Stopping blood clots forming in your
blood in the following situations:
Unstable angina
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take
aspirin as well
After an operation or long periods of
bedrest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot
If you have a low to medium risk of getting a
clot, you will be given 20mg of Clexane each
day for 7 to 10 days. If you are going to have
an operation, your first injection will usually
be given 2 hours before your operation
If you have a higher risk of getting a clot,
you will be given 40mg each day for 7 to 28
days. If you are going to have an operation,
your first injection will usually be given 12
hours before your operation
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
115
120mg / 0.8ml
115 bd
0.78
120
120mg / 0.8ml
120 bd
0.80
125
150mg / 1ml
125 bd
0.84
130
150mg / 1ml
130 bd
0.88
135
150mg / 1ml
135 bd
0.90
140
150mg / 1ml
140 bd
145
150mg / 1ml
150
150mg / 1ml
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml (1)
105 bd (1)
0.70 (1)
110
120mg / 0.8ml (1)
110 bd (1)
0.74 (1)
115
120mg / 0.8ml (1)
115 bd (1)
0.78 (1)
120
120mg / 0.8ml (1)
120 bd (1)
0.80 (1)
125
150mg / 1ml (1)
125 bd (1)
0.84 (1)
130
150mg / 1ml (1)
130 bd (1)
0.88 (1)
0.94
135
150mg / 1ml (1)
135 bd (1)
0.90 (1)
145 bd
0.98
140
150mg / 1ml (1)
140 bd (1)
0.94 (1)
150 bd
1.00
145
150mg / 1ml (1)
145 bd (1)
0.98 (1)
150
150mg / 1ml (1)
150 bd (1)
1.00 (1)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
‘Posology and method of administration: Elderly’.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
If you are bedridden due to illness, you will
be normally be given 40mg of Clexane each
day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of
heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will
depend on your age and the kind of heart attack
you have had.
i) NSTEMI type of heart attack
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
30mg of Clexane will be given as an
injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
At the same time, you will also be given
Clexane as an injection under your skin
(subcutaneous injection). The usual dose is
1mg for every kilogram of your weight.
Then you will be given 1mg for every kilogram of
your weight every 12 hours
The maximum amount of Clexane given for
the first two injections is 100mg
The injections will normally be given for up
to 8 days
If you are aged 75 years or older
Your doctor or nurse will give you injections
of Clexane under your skin (subcutaneous
injection)
The usual dose is 0.75mg for every kilogram
of your weight, every 12 hours
The maximum amount of Clexane given for
the first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
Depending on when you were last given
Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI
operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or
60, 80 or 100mg Pre-filled syringes)
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed.
If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of
0.3mg/kg of enoxaparin sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high
risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or
0.75 mg/kg (75 IU/kg) for single vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of
age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg
for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
impaired (see also section 4.2 ‘Posology and method of administration: Renal impairment;’ section 4.4
‘Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and
Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
3) Stopping blood clots forming in the tubes
of your dialysis machine
The usual dose is 1mg for every kilogram of your
weight
Clexane is added to the tube leaving the
body (arterial line) at the start of the dialysis
session
This amount is usually enough for a 4 hour
session. However, your doctor may give you a
further dose of 0.5 to 1mg for every kilogram
of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your
doctor or nurse will show you how to do this. Do
not try to inject yourself if you have not been
trained how to do so. If you are not sure what to
do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
Check the expiry date on the medicine. Do
not use if the date has passed
Check the syringe is not damaged and the
medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are
going to inject
Check your abdomen to see if the last
injection caused any redness, change in
skin colour, swelling, oozing or is still painful,
if so talk to your doctor or nurse
Decide where you are going to inject the
medicine. Change the place where you
inject each time from the right to the left side
of your stomach. Clexane should be injected
just under the skin on your stomach, but not
too near the belly button or any scar tissue
(at least 5 cm away from these)
Instructions on injecting yourself with
Clexane:
1) Wash your hands and the area that you
will inject with soap and water. Dry them.
1
7
1
5
6
6
0
4
2) Sit or lie in a
comfortable position
so you are relaxed.
Make sure you can
see the place you are
going to inject. A
lounge chair, recliner,
or bed propped up with pillows is ideal.
6) Hold the syringe so that the needle is pointing
downwards (vertically at a 90º angle). Insert the
full length of the needle into the skin fold.
7) Press down on the plunger with your thumb.
This will send the medication into the fatty
tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
3) Choose an area on the right or left side of
your stomach. This should be at least 5
centimetres away from your belly button and
out towards your sides.
Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right
sides of your stomach, depending on the
area you were last injected.
8) Remove the needle by pulling it straight out.
You can now let go of the skin fold. To avoid
bruising, do not rub the injection site after
you have injected yourself.
9) Drop the used syringe into the sharps bin
provided. Close the container lid tightly and
place the container out of reach of children.
When the container is full, give it to your
doctor or home care nurse for disposal. Do
not put it in the household rubbish.
4) Carefully pull off the needle cap from the
Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
If you have too much or too little Clexane
If you think that you have used too much or too
little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no
signs of a problem. If a child accidentally injects
or swallows Clexane, take them to a hospital
casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as
soon as you remember. Do not give yourself a
double dose on the same day to make up for a
forgotten dose. Keeping a diary will help to
make sure you do not miss a dose
If you stop using Clexane
It is important for you to keep having Clexane
injections until your doctor decides to stop
them. If you stop, you could get a blood clot
which can be very dangerous.
Blood Tests
Using Clexane may affect the results of some
blood tests. If you are going to have a blood
test, it is important to tell your doctor you are
having Clexane.
Do not press on the plunger before injecting
yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have
removed the cap, do not allow the needle to
touch anything. This is to make sure the needle
stays clean (sterile).
5) Hold the syringe in the hand you write with (like
a pencil) and with your other hand, gently pinch
the cleaned area of your abdomen between
your forefinger and thumb to make a fold in the
skin
Make sure you hold the skin fold throughout
the injection.
Dosage chart for 0.75mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes
Kg
Syringe label
Dosage adjustments for therapeutic dosage range
(elderly patients aged ≥75 years only)
0.75mg/kg Dose
(mg)
Adjusted
dosing (mg)
Injection
volume (ml)
Standard dosing
Severe renal impairment
1mg/kg SC twice daily
1mg/kg SC once daily
1.5mg/kg SC once daily
1mg/kg SC once daily
40
60mg / 0.6ml
30 bd
30 bd
0.30
45
60mg / 0.6ml
33.75 bd
35 bd
0.35
50
60mg / 0.6ml
37.5 bd
37.5 bd
0.375
55
60mg / 0.6ml
41.25 bd
42.5 bd
0.425
60
60mg / 0.6ml
45 bd
45 bd
0.45
65
60mg / 0.6ml
48.75 bd
50 bd
0.5
70
60mg / 0.6ml
52.5 bd
52.5 bd
0.525
75
60mg / 0.6ml
56.25 bd
57.5 bd
0.575
80
60mg / 0.6ml
60 bd
60 bd
0.60
85
80mg / 0.8ml
63.75 bd
65 bd
0.65
90
80mg / 0.8ml
67.5 bd
67.5 bd
0.675
95
80mg / 0.8ml
71.25 bd
72.5 bd
0.725
100
80mg / 0.8ml
75 bd
75 bd
0.75
105
80mg / 0.8ml
78.75 bd (1)
80 bd (1)
0.80 (1)
110
100mg / 1ml
82.5 bd (1)
82.5 bd (1)
0.825 (1)
115
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
0.875 (1)
120
100mg / 1ml
90 bd (1)
90 bd (1)
0.90 (1)
125
100mg / 1ml
93.75 bd (1)
95 bd (1)
0.95 (1)
130
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
0.975 (1)
135
120mg / 0.8ml
101.25 bd (1)
102 bd (1)
0.68 (1)
140
120mg / 0.8ml
105 bd (1)
105 bd (1)
0.7 (1)
145
150
120mg / 0.8ml
120mg / 0.8ml
108.75 bd (1)
112.5 bd (1)
111 bd (1)
114 bd (1)
0.74 (1)
0.76 (1)
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 ‘Special warnings and precautions for use: Renal impairment
and Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment
(creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin sodium
exposure is significantly increased in this patient population:
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a
30mg-single IV bolus plus a 1mg/kg SC dose
1mg/kg SC dose followed by
followed by 1mg/kg twice daily.
1mg/kg once daily
(Max 100mg for first SC dose
(Max 100mg for each of the first two SC doses)
only)
For treatment of acute STEMI in elderly patients ≥75 years of age
1mg/kg SC once daily without
0.75mg/kg SC twice daily without initial bolus.
initial bolus.
(Max 100mg for first SC dose
(Max 75mg for each of the first two SC doses)
only)
Dosage adjustments for prophylactic dosage ranges
Standard dosing
Severe renal impairment
40mg SC once daily
20mg SC once daily
20mg SC once daily
20mg SC once daily
The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min),
careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
precautions for use:’ Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
‘Special warnings and precautions for use: ‘Low body weight and Monitoring’, section 5.2
‘Pharmacokinetic properties’).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial
line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation
during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for
the initial dose of acute STEMI indication and before PCI when needed. It must not be
administered by the intramuscular route.
4. Possible side effects
Like all medicines, Clexane can cause side
effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital
straight away if you notice any of the
following side effects:
Very common (affects more than 1 in 10
people)
Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
A painful rash of dark red spots under the
skin which do not go away when you put
pressure on them. You may also notice pink
patches on your skin. These are more likely
to appear in the area you have been injected
with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
Sudden severe headache. This could be a
sign of bleeding in the brain.
A feeling of tenderness and swelling in your
stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
If you have an allergic reaction. The signs
may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue.
Frequency unknown
If you have had a spinal puncture or a spinal
anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the
lower part of your body. Also if you lose
control over your bladder or bowel (so you
cannot control when you go to the toilet).
Tell a nurse or doctor as soon as possible if
you notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
You bruise more easily than usual. This
could be because of a blood problem
(thrombocytopenia).
You have pain, swelling or irritation in the
area you have been injected with Clexane.
This normally gets better after a few days.
1
7
1
5
6
6
0
4
Rare (affects less than 1 in a 1000 people)
If you have a mechanical heart valve,
treatment with Clexane might not be
sufficient to prevent blood clots. You may
notice that you have difficulty breathing,
tiredness or difficulty exercising, chest pain,
numbness, feeling sick or loss of
consciousness. This could be due to a blood
clot on the heart valve
5. How to store Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date which
is stated on the carton and blister label after
‘Exp’. The expiry date refers to the last day of
that month.
Do not store above 25°C.
Do not refrigerate. Do not freeze.
Medicines should not be disposed of via
wastewater or household waste. If you are
using this medicine at home you will be given a
container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused
syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to
protect the environment.
Frequency unknown
Feeling tired, faint, dizzy, having pale skin.
These could be symptoms of anaemia.
You notice yellowing of your skin or eyes
and your urine becomes darker in colour.
This could be a liver problem.
Other side effects that you should discuss
with your nurse or doctor if you are
concerned about them:
6. Further Information
What Clexane contains
The active ingredient in clexane is enoxaparin
sodium. Each pre-filled syringe contains 60mg
enoxaparin sodium (equivalent to 6,000 IU antiXa activity) in 0.6ml water for injections.
The other inactive ingredient is water for
injections.
What Clexane looks like and contents of the
pack
Clexane clear, colourless to pale yellow solution
for injection in a glass pre-filled syringe fitted
with an injection needle and needle cap. It is
supplied in packs of 10 syringes.
Manufactured by: Sanofi Winthrop Industrie,
180 rue Jean-Jaures, 94702 Maisons Alfort
France. Or
Sanofi Winthrop Industrie, Boulevard Industriel,
76580 Le Trait, France.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®
Clexane 60mg/0.6ml Syringes
PL 18799/2375
POM
Leaflet date: 12.02.2016
Clexane is a registered trade mark of
sanofi-aventis.
Very common (affects more than 1 in 10
people)
Changes in the results of blood tests done to
check how your liver is working. These
usually go back to normal after you stop
having Clexane.
Rare (affects less than 1 in a 1000 people)
Changes in the potassium levels in your
blood. This is more likely to happen in
people with kidney problems or diabetes.
Your doctor will be able to check this by
carrying out a blood test.
Frequency unknown
If Clexane is used for a long period of time
(more than 3 months), it may increase the
risk of you getting a condition called
‘osteoporosis’. This is when your bones are
more likely to break
Headache
Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine.
Subcutaneous injection technique
The pre-filled disposable syringe is ready for immediate use. Clexane should be administered when
the patient is lying down by deep subcutaneous injection. The administration should be alternated
between the left and right anterolateral or posterolateral abdominal wall. The whole length of the
needle should be introduced vertically into a skin fold held between the thumb and index finger. The
skin fold should not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects
the used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Weight
Required
dose
(0.3mg/kg)
Volume to inject
when diluted to a
final
concentration of
3mg/ml
Weight
Required dose
(0.3mg/kg)
Volume to inject
when diluted to a
final
concentration of
3mg/ml
(Kg)
(mg)
(ml)
(Kg)
(mg)
(ml)
45
13.5
4.5
100
30
10
50
15
5
105
31.5
10.5
55
16.5
5.5
110
33
11
60
18
6
115
34.5
11.5
65
19.5
6.5
120
36
12
70
21
7
125
37.5
12.5
Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated pre-filled syringe (60, 80 or
100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mg dose can
then be directly injected into an injection site in the intravenous line.
75
22.5
7.5
130
39
13
80
24
8
135
40.5
13.5
85
25.5
8.5
140
42
14
Additional bolus for PCI when last SC administration was given more than 8 hours
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus
of 0.3mg/kg is to be administered if last SC administration was given more than 8 hours before
balloon inflation (see section 4.2 ‘Posology and method of administration’: ‘Treatment of acute STsegment Elevation Myocardial Infarction’).
90
27
9
145
43.5
14.5
95
28.5
9.5
150
45
15
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg pre-filled syringes can
be used. Enoxaparin sodium should be administered through an intravenous line. It should not be
mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin
sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient
amount of saline or dextrose solution prior to and following the intravenous bolus administration of
enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with
normal saline solution (0.9%) or 5% dextrose in water.
6 PHARMACEUTICAL PARTICULARS
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the
drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium pre-filled syringe, it is recommended
to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water)
as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete
contents of the 60mg enoxaparin sodium pre-filled syringe into the 20ml remaining in the bag.
Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe
for administration into the intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use. Volume to be injected through intravenous line after dilution is completed
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in
water.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
Solution for injection in Type I glass pre-filled syringe in pack of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
7 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8 DATE OF REVISION OF THE TEXT: 12.02.2016
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Enoxaparin sodium 60mg/0.6ml
Syringes
Read all of this leaflet carefully before you
start using this medicine
Keep this leaflet. You may need to read it
again
If you have any further questions, ask your
doctor or pharmacist
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
Please note that the leaflet also contains
information about other strengths, Enoxaparin
sodium 20mg, 40mg and 80mg and 100mg
Syringes.
In this leaflet:
1. What Enoxaparin sodium is and what it is
used for
2. Before you use Enoxaparin sodium
3. How to use Enoxaparin sodium
4. Possible side effects
5. How to store Enoxaparin sodium
6. Further information
1. What Enoxaparin sodium is
and what it is used for
The name of your medicine is Enoxaparin
sodium 60mg/0.6ml Syringes but it will be
referred as Enoxaparin sodium throughout this
leaflet. Enoxaparin sodium contains a medicine
called enoxaparin sodium. This belongs to a
group of medicines called Low Molecular
Weight Heparins.
Enoxaparin sodium works in two ways.
1) Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.
1
7
1
5
6
6
0
4
Enoxaparin sodium can be used to:
Treat blood clots that are in your blood
Stop blood clots forming in your blood in the
following situations:
Unstable angina (where not enough
blood gets to your heart)
After an operation or long periods of
bed rest due to illness
After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with
kidney problems)
Take special care with Enoxaparin
sodium
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding
caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your
eyes or brain
You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by
diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist or nurse
before using Enoxaparin sodium.
2. Before you use Enoxaparin sodium
Do not have this medicine and tell your
doctor, pharmacist or nurse if:
You are allergic (hypersensitive) to
enoxaparin sodium or any of the other
ingredients of Enoxaparin sodium (listed in
Section 6: ‘Further information’)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
You are allergic to heparin or other Low
Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin to
treat blood clots
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Enoxaparin sodium.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Enoxaparin sodium 60mg/0.6ml Syringes
1 NAME OF THE MEDICINAL PRODUCT
Enoxaparin sodium 60mg/0.6ml Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6ml Water for
Injections
For full list of excipients, see section 6.1
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (2,000IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Enoxaparin sodium should be administered subcutaneously as a single daily injection of 1.5mg/kg
(150IU/kg). Enoxaparin sodium treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Enoxaparin sodium
can affect the way some other medicines work.
Also some medicines can affect the way
Enoxaparin sodium works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
Warfarin - used for thinning the blood
Aspirin, dipyridamole, clopidogrel or other
medicines – used to stop blood clots
forming
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin sodium Syringes
Taking or using other medicines
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
70
120mg / 0.8ml
105 od
0.70
75
120mg / 0.8ml
112.5 od
0.76
80
120mg / 0.8ml
120 od
0.80
85
150mg / 1ml
127.5 od
0.86
90
150mg / 1ml
135 od
0.90
95
150mg / 1ml
142.5 od
0.96
100
150mg/ 1ml
150 od
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1mg/kg Enoxaparin sodium every 12 hours by subcutaneous injection,
administered concurrently with oral aspirin (100 to 325mg once daily). Treatment with Enoxaparin
sodium in these patients should be prescribed for a minimum of 2 days and continued until clinical
stabilisation. The usual duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
Injection
ENOXAPARIN SODIUM
syringes
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
60mg / 0.6ml
60 od
0.60
45
80mg / 0.8ml
67.5 od
0.675
50
80mg / 0.8ml
75 od
0.75
55
100mg / 1ml
82.5 od
0.825
60
100mg / 1ml
90 od
0.90
65
100mg / 1ml
97.5 od
0.975
100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes
Dextran injection - used as a blood replacer
Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and swelling
in arthritis and other illnesses
Prednisolone, dexamethasone or other
medicines – used to treat asthma,
rheumatoid arthritis and other conditions
Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Enoxaparin
sodium
Your doctor may change one of your medicines
or take regular blood tests to check that taking
these medicines with Enoxaparin sodium is not
causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are
using Enoxaparin sodium. Tell also your doctor
if you have any problem with your spine or if
you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine
if you are pregnant, might become pregnant, or
think you may be pregnant.
When you go home you may need to
continue to use Enoxaparin sodium and give
it to yourself (see below instructions on how
to do this)
Enoxaparin sodium is usually given by
injection underneath the skin
(subcutaneous)
Do not inject Enoxaparin sodium into a
muscle (intramuscular)
If you are not sure why you are receiving
Enoxaparin sodium or have any questions
about how much Enoxaparin sodium is being
given to you, speak to your doctor, pharmacist
or nurse.
How much will be given to you
Your doctor will decide how much to give
you. The amount of Enoxaparin sodium
given to you will depend on the reason it is
being used
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
2)
You should not breast-feed whilst using
Enoxaparin sodium. If you are planning to
breast-feed, talk to your doctor, pharmacist or
nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
1)
a)
b)
3. How to use Enoxaparin sodium
Having this medicine
Before you use Enoxaparin sodium your
doctor or nurse may carry out a blood test
While you are in hospital your doctor or
nurse will normally give you Enoxaparin
sodium. This is because it needs to be given
as an injection
1
7
1
5
6
6
0
4
If you have problems with your kidneys, you
may be given a smaller amount of
Enoxaparin sodium
Treating blood clots that are in your blood
The usual dose is 1.5mg for every kilogram
of your weight, each day
Enoxaparin sodium will usually be given for
at least 5 days
Stopping blood clots forming in your
blood in the following situations:
Unstable angina
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Enoxaparin sodium will usually be given for
2 to 8 days. Your doctor will normally ask
you to take aspirin as well
After an operation or long periods of
bedrest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot
If you have a low to medium risk of getting a
clot, you will be given 20mg of Enoxaparin
sodium each day for 7 to 10 days. If you are
going to have an operation, your first
injection will usually be given 2 hours before
your operation
If you have a higher risk of getting a clot,
you will be given 40mg each day for 7 to 28
days. If you are going to have an operation,
your first injection will usually be given 12
hours before your operation
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
115
120mg / 0.8ml
115 bd
0.78
120
120mg / 0.8ml
120 bd
0.80
125
150mg / 1ml
125 bd
0.84
130
150mg / 1ml
130 bd
0.88
135
150mg / 1ml
135 bd
0.90
140
150mg / 1ml
140 bd
0.94
145
150mg / 1ml
145 bd
150
150mg / 1ml
150 bd
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
105
120mg / 0.8ml (1)
105 bd (1)
0.70 (1)
110
120mg / 0.8ml (1)
110 bd (1)
0.74 (1)
115
120mg / 0.8ml (1)
115 bd (1)
0.78 (1)
120
120mg / 0.8ml (1)
120 bd (1)
0.80 (1)
125
150mg / 1ml (1)
125 bd (1)
0.84 (1)
130
150mg / 1ml (1)
130 bd (1)
0.88 (1)
135
150mg / 1ml (1)
135 bd (1)
0.90 (1)
0.98
140
150mg / 1ml (1)
140 bd (1)
0.94 (1)
1.00
145
150mg / 1ml (1)
145 bd (1)
0.98 (1)
150
150mg / 1ml (1)
150 bd (1)
1.00 (1)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
‘Posology and method of administration: Elderly’.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight
100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes
If you are bedridden due to illness, you will
be normally be given 40mg of Enoxaparin
sodium each day for 6 to 14 days
c) After you have had a heart attack
Enoxaparin sodium can be used for two
different types of heart attack called NSTEMI or
STEMI.
The amount of Enoxaparin sodium given to you
will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
The usual amount is 1mg for every kilogram
of weight, every 12 hours
Enoxaparin sodium will usually be given for
2 to 8 days. Your doctor will normally ask
you to take aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
30mg of Enoxaparin sodium will be given as
an injection into your vein (intravenous
injection using Enoxaparin sodium Multidose
Vial or 60, 80 or 100mg Pre-filled syringes)
At the same time, you will also be given
Enoxaparin sodium as an injection under
your skin (subcutaneous injection). The
usual dose is 1mg for every kilogram of your
weight.
Then you will be given 1mg for every kilogram of
your weight every 12 hours
The maximum amount of Enoxaparin
sodium given for the first two injections is
100mg
The injections will normally be given for up
to 8 days
If you are aged 75 years or older
Your doctor or nurse will give you injections
of Enoxaparin sodium under your skin
(subcutaneous injection)
The usual dose is 0.75mg for every kilogram
of your weight, every 12 hours
The maximum amount of Enoxaparin
sodium given for the first two injections is
75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
Depending on when you were last given
Enoxaparin sodium, your doctor may decide
to give an additional dose of Enoxaparin
sodium before a PCI operation. This is by
injection into your vein (intravenous using
Enoxaparin sodium Multidose Vial or 60, 80
or 100mg Pre-filled syringes)
Kg
Syringe label
Dose (mg)
Injection
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
65
80mg / 0.8ml
65 bd
0.65
70
80mg / 0.8ml
70 bd
0.70
75
80mg / 0.8ml
75 bd
0.75
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
Patient
weight
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation
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