MERIOFERT 150 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Meriofert 75 IU
Meriofert 150 IU

powder and solvent for solution
for injection

FI/158 (UK) xxxxx Ed. I/04.17

Menotrophin

This medicine is subject to additional
monitoring. This will allow quick identification
of new safety information. You can help by
reporting any side effects you may get. See
the end of section 4 for how to report side
effects.

This medicinal product must be used under
the supervision of your doctor.

There is a slightly increased risk of extrauterine pregnancy (an ectopic pregnancy) in
women with damaged fallopian tubes.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE MERIOFERT

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
-- Keep this leaflet. You may need to read it
again.
-- If you have any further questions, please ask
your doctor or pharmacist.
-- This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
-- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
-- In this leaflet Meriofert 75 IU powder
and solvent for solution for injection and
Meriofert 150 IU powder and solvent for
solution for injection are called Meriofert.

You and your partner’s fertility will be
evaluated before your treatment is started.
Do not use Meriofert if you have any of the
following:
-- Enlarged ovaries or cysts not caused by
a hormonal disorder (polycystic ovarian
disease).
-- Bleeding of unknown cause.
-- Cancer of the ovaries, uterus or breast.
-- Abnormal swelling (tumour) of the pituitary
gland or hypothalamus (brain).
-- Hypersensitivity (allergy) to Menotrophin or
any of the ingredients in Meriofert

Multiple pregnancies and characteristics of
the parents undergoing fertility treatments
(e.g. maternal age, sperm characteristics) may
be associated with an increased risk of birth
defects.

What is in this leaflet:
1. What Meriofert is and what it is used for
2. What you need to know before you use
Meriofert
3. How to use Meriofert
4. Possible side-effects
5. How to store Meriofert
6. Contents of the pack and other information
1. WHAT MERIOFERT IS AND WHAT IT IS
USED FOR
-- Meriofert is used to promote ovulation in
women who are not ovulating and who
have not responded to other treatment
(clomiphene citrate).
-- Meriofert is used to bring about the
development of several follicles (and
therefore several eggs) in women receiving
fertility treatment.
Meriofert is a highly purified human
menopausal gonadotrophin, belonging to a
group of medicines called gonadotrophins.
Each freeze-dried vial contains 75 IU human
follicle stimulating hormone activity (FSH) and
75 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a
hormone naturally present in urine of pregnant
women, is added to contribute to the total LH
activity.
Each freeze-dried vial contains 150 IU human
follicle stimulating hormone activity (FSH) and
150 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a
hormone naturally present in urine of pregnant
women, is added to contribute to the total LH
activity.

This medicine should not be used if you
have an early menopause, a malformation of
the sexual organs or certain tumours of the
womb that would make a normal pregnancy
impossible.
Warnings and Precautions
Although no allergic reactions to Meriofert
have yet been reported, you should tell your
doctor if you have an allergic reaction to
similar medicines.
This treatment increases your risk of developing
a condition known as ovarian hyperstimulation
syndrome (OHSS) (see Possible side effects).
If ovarian hyperstimulation occurs then your
treatment will be stopped and pregnancy
will be avoided. The first signs of ovarian
hyperstimulation are pain in the lower
abdominal region as well as nausea (feeling
sick), vomiting and weight gain. If these
symptoms occur you should be examined by
your doctor as soon as possible. In serious, but
rare cases, the ovaries can become enlarged
and fluid can build up in the abdomen or chest.
The drug used to bring about the final
release of mature eggs (containing human
chorionic gonadotrophin-hCG) can increase
the likelihood of OHSS. It is therefore not
advisable to use hCG in cases where OHSS is
developing and you should not have sexual
intercourse even if using a barrier method of
contraception for at least 4 days.
It should be noted that women with fertility
problems have a higher rate of miscarriages
than the normal population.
In patients having treatment to help ovulation,
the occurrence of multiple pregnancies
and births is increased compared to natural
conception. However, this risk can be
minimised by using the recommended dose.

Treatment with Meriofert, just as pregnancy
itself, may increase the chance of having
thrombosis. Thrombosis is the formation of a
blood clot in a blood vessel, most often in the
veins of the legs or the lungs.
Please discuss this with your doctor, before
starting treatment, especially:
-- If you already know you have an increased
chance of having thrombosis.
-- If you, or anyone in your immediate family,
have ever had a thrombosis.
-- If you are severely overweight.
Children and Adolescents
The product is not intended to be used by
children or adolescents.
Other medicines and Meriofert
Tell your doctor or pharmacist if you are
taking or have recently taken or might take
any other medicines.
Pregnancy, breast-feeding and fertility
Meriofert should not be used if you are
pregnant or breast-feeding.
Driving and using machines
Meriofert has no or negligible influence on the
ability to drive and use of machinery. However,
no studies on the effect on ability to drive and
use machines have been performed.
3. HOW TO USE MERIOFERT
Dosage and duration of the treatment:
Always use this medicine exactly as your
doctor has told you. Check with your doctor if
you are not sure.
Women who are not ovulating and are
having irregular periods or no periods at all:
As a general rule, the first injection of one
Meriofert 75 IU vial is given during the first
week of the cycle after spontaneous or
induced menses.
Subsequently, Meriofert is injected daily at
the dosage prescribed by the physician and
the treatment will continue until one or more
ripe follicle have developed in the ovary. Your
physician will adjust the Meriofert dosage
depending on the ovarian response, which is
determined by clinical examinations.
As soon as one follicle reaches the required
development stage, the Meriofert treatment
will be withheld and ovulation will be

triggered with another hormone (chorionic
gonadotropin, hCG).
Ovulation generally takes place after 32 to 48
hours.
In this phase of the treatment, fertilization is
possible. You will be advised to have sexual
intercourse every day starting from the day
preceding the administration of hCG. If
pregnancy is not achieved in spite of ovulation,
the treatment can be repeated.

Meriofert must only be reconstituted with the
solvent provided in the package.

Women undergoing ovarian stimulation
for multiple follicular development prior
to in vitro fertilisation or other assisted
reproductive techniques:

-- two cotton wool alcohol swabs (not
provided),
-- one vial containing Meriofert powder,
-- one solvent in ampoule,
-- one syringe (not provided),
-- one needle for preparing the injection (not
provided),
-- a fine bore needle for subcutaneous
injection (not provided).

The aim of this method is to obtain concomitant
multiple follicular development. The treatment
will start on the 2nd or 3rd day of the cycle
with injections of 150-300 IU of Meriofert
(1-2 vials of Meriofert 150 IU). Your physician
may decide to administer higher dosages if
required. The injected dosage of Meriofert
is higher than in the method used for natural
fertilization. The continuation of the treatment
is adjusted individually by the physician.
As soon as a sufficient number of follicles has
developed, the treatment with Meriofert is
withheld and ovulation is triggered by injecting
another hormone (chorionic gonadotropin,
hCG).
How Meriofert should be given:
Meriofert is given by injection under your
skin (by the subcutaneous route) or into your
muscle (intramuscular injection).
Each vial should be used only once and
the injection should be used as soon as it is
prepared.
After suitable advice and training your doctor
may ask you to inject Meriofert yourself.
For the first time, your doctor must:
-- let you practise giving yourself a
subcutaneous injection,
-- have shown you the possible places where
you can inject yourself,
-- have shown you how to prepare the solution
for injection,
-- have explained how to prepare the right
dose of injection.
Before injecting Meriofert yourself, read the
following instructions carefully.
How to prepare and inject Meriofert using 1
vial of powder:
The solution must be prepared just before
injection. One vial is for single use only. The
medicinal product must be reconstituted
under aseptic conditions.

Prepare a clean surface and wash your hands
before the solution is reconstituted. It is
important that your hands and the items you
use are as clean as possible.
Set out all the following items on the clean
surface:

Reconstitution of the solution for injection
using 1 vial of powder
Prepare the solution for injection:
1.
The ampoule
neck is specifically
designed to break
more easily below
the coloured dot.
Gently flick the top
of the ampoule to dislodge any liquid
remaining in the tip. Hold the ampoule with
the coloured dot facing away from you and
snap off the top of the ampoule as shown
in the picture. Using a cloth or ampoulesnapper to hold the ampoule will help
protect your fingers.
Carefully place the opened ampoule upright
on the cleaned surface.
Remove the protective cap
of the needle. Attach the
reconstitution needle (large
needle) to the syringe.
With the syringe in one hand,
pick up the opened solvent
ampoule, insert the needle and draw up all
the solvent into the syringe.
Attach the protective cap of the needle.
Carefully set the syringe down on the surface.
2.
Remove the coloured plastic
cap (75 IU light green, 150 IU
dark green) from the powder
vial by gently pushing it
upwards.
Disinfect the top of the rubber stopper by
wiping it with an alcohol swab and allow to
dry.

3.
Pick up the syringe, remove
the needle shield and slowly
inject the solvent into the
powder vial through the
middle of the top of the

rubber stopper.
Press the plunger down firmly to squirt all the
solution onto the powder.
DO NOT SHAKE, but gently roll the vial
between the hands until the powder is
completely dissolved, taking care to avoid
creating foam
4.
Once the powder is dissolved
(which, in general, occurs
immediately), slowly draw the
solution into the syringe:
• With the needle still
inserted, turn the vial
upside down.
• Make sure the needle tip is underneath the
level of the liquid.
• Gently pull the plunger to draw all the
solution up into the syringe.
• Check that the reconstituted solution is
clear and colourless.
Preparation of higher doses, using more
than 1 vial of powder
If your doctor has recommended higher doses
for you, this can be achieved by using more
than one vial powder with one ampoule of
solvent.
When reconstituting more than 1 vial of
Meriofert , at the end of step 4 above, draw
the reconstituted contents of the first vial back
into the syringe and slowly inject into a second
vial. Repeat steps 2 to 4 for the second and
subsequent vials, and until the contents of
the required number of vials equivalent to
the prescribed dosage are dissolved (within
the limit of the maximum total dosage of 450
IU, corresponding to a maximum of 6 vials of
Meriofert 75 IU or 3 vials of Meriofert 150 IU).
Your doctor may increase your dose by 37.5 IU
which represents half a vial of Meriofert 75 IU.
For this you should reconstitute the contents
of the 75 IU vial according to steps 2 to
3 described above and draw half of this
reconstituted solution (0.5 ml) back into the
syringe according to step 4.
In that situation you will have two preparations
to be injected: the first preparation
reconstituted in 1 ml and the second containing
37.5 IU in 0.5 ml.
Both preparations will be injected with their
own syringe according to the following steps.
The solution must be clear and colourless.

Injecting your medicine subcutaneously:
• When the syringe contains
the described dose, attach
the protective cap of the
needle. Remove the needle
from the syringe and replace
it with the fine bore needle
for subcutaneous injection
including its protective cap.
• Push the fine bore needle
firmly onto the syringe
barrel, then twist it slightly
to ensure it is fully screwed
on and to create a firm seal.
• Remove the protective cap of
the needle. Hold the syringe
with the needle pointing upwards and
gently tap the side of the syringe to force
any air bubbles up to the top;
• Push the plunger until a bead of liquid
appears at the tip of the needle.
• Do not use if it contains any particles or is
cloudy.
The injection site:
• Your doctor or nurse will have already
advised you where on your body to inject
your medicine. The usual places are the
thigh or the lower abdominal wall below the
navel.
• Wipe the injection site with an alcohol swab.
Inserting the needle:
• Firmly pinch the skin
together. With the other
hand, insert the needle with
a dart-like motion at an
angle of 45° or 90°.
Injecting the solution:
• Inject under the skin as you were shown.
Do not inject directly into a vein. Push the
plunger slowly and steadily, so the solution
is correctly injected and the skin tissues are
not damaged.
Take as much time as you need to inject the
volume of solution prescribed. As described
for the preparation of the solution, depending
on the dosage prescribed by your doctor, you
may not use the entire volume of the solution.
Removing the needle:
• Pull the syringe out quickly and apply
pressure to the injection site with a swab
containing disinfectant. A gentle massage
of the site – while still maintaining pressure
– helps disperse the Meriofert solution and
relieve any discomfort.
Injecting your medicine intramuscularly:
For intramuscular injections your healthcare
provider will prepare and then inject Meriofert
into the side of your thigh or buttock.

Dispose of all used items:
Once you have finished your injection, all
the needles and empty syringes should be
disposed of in an appropriate container. Any
unused solution or waste material should
be disposed of in accordance with local
requirements.
If you use more Meriofert than you should:
The effects of an overdose of Meriofert are
unknown, nevertheless, one could expect
ovarian hyperstimulation syndrome to occur
(see Possible side effects). If you use more
Meriofert than you should, speak to your
doctor or pharmacist.
If you forget to use Meriofert :
Take it at the next normal time for an injection.
Do not take double dose to make up for a
forgotten dose.
If you stop using Meriofert :
Do not stop on your own initiative: Always
consult your doctor if you are considering
stopping this medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meriofert can cause side
effects, although not everybody gets them.
The following side effect is important and will
require immediate action if you experience
it. You should stop taking Meriofert and
see your doctor immediately if the following
occurs:
Common, affects 1 to 10 users in 100:
• Ovarian
Hyperstimulation
Syndrome
(symptoms include ovarian cyst formation or
enlargement of existing cysts, lower stomach
pain, feeling thirsty and sick, and sometimes
being sick, passing reduced quantities of
concentrated urine and weight gain) (see
Section 2 for additional information).

• Tiredness
• Feeling generally unwell
• Injection site reaction such as pain and
inflammation (frequency higher with IM than
SC).
Rare, (likely to affect between 1 in 10,000 and
1 in 1000 users):
• Ovarian torsion (twisting of the ovary which
causes extreme pain in the lower abdomen)
Very rare, (likely to affect between 1 in
100,000 and 1 in 10,000 users):
• Thromboembolism (formation of a clot in a
blood vessel that breaks loose and is carried
by the blood stream to block another vessel).
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme www.mhra.gov.uk/
yellowcard. By reporting side effects you can
help provide more information on the safety
of this medicine.

Human Chorionic Gonadotrophin (hCG), an
hormone naturally present in urine of pregnant
women, is added to contribute to the total LH
activity.
Each freeze-dried vial contains 150 IU human
follicle stimulating hormone activity (FSH) and
150 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), an
hormone naturally present in urine of pregnant
women, is added to contribute to the total LH
activity.
If multiple vials of powder are used, the
amount of menotrophin contained in 1 ml of
reconstituted solution will be as follows:
Meriofert 75 IU
powder and solvent for solution for
injection
Number of
vials used

Total amount of
menotrophin in 1 ml of
solution

1

75 IU

5. HOW TO STORE MERIOFERT

2

150 IU

Keep this medicine out of the sight and reach
of children.

3

225 IU

4

300 IU

5

375 IU

6

450 IU

Do not store above 25° C. Keep the vial and
the ampoule of solvent in the outer carton in
order to protect from light.
Do not use this medicine after the expiry date
which is stated on the outer carton, the vial
and the ampoule of solvent. The expiry date
refers to the last day of the month.
Use immediately after reconstitution.

Meriofert 150 IU
powder and solvent for solution for
injection

Do not use Meriofert if you notice the solution
does not look clear. After reconstitution the
solution must be clear and colourless.

Number of
vials used

Total amount of
menotrophin in 1 ml of
solution

The following side-effects have also been
reported:
Very Common (likely to affect up to 1 in 10
users):
• Headache
• Swollen or bloated stomach

Do not throw away any medicines via
wastewater. Ask your pharmacist how
to throw away medicines you no longer
use. These measures will help protect the
environment.

1

150 IU

2

300 IU

3

450 IU

Common (likely to affect between 1 in 100
and 1 in 10 users):
• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Sensation of heaviness
• Breast discomfort
• Dizziness
• Hot flushes
• Thirst
• Feeling sick

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Meriofert contains
The active substance is menotrophin.
Each freeze-dried vial contains 75 IU human
follicle stimulating hormone activity (FSH) and
75 IU human luteinising hormone activity (LH).

The other excipients are
For the powder: lactose monohydrate.
For the solvent: sodium chloride and water for
injections.
What Meriofert looks like and contents of
the pack
Powder: white to almost white lyophilized
powder
Solvent: clear and colourless solution.

Meriofert is presented as a powder and
solvent for solution for injection.
1 set contains the following:
• One vial containing a white to almost white
powder
• One ampoule (1 ml) containing a clear and
colourless solution
It comes in pack sizes of 1, 5 or 10 sets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi – Italy
Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi – Italy
This medicinal product is authorized in
the Member States of the EEA under
the following names: (The strength and
pharmaceutical form are identical in all
countries, only the trade name changes)
Austria: Meriofert
Belgium: Fertinorm
Bulgaria: Meriofert
Cyprus: Meriofert
Czech Republic: Eigenorm
Denmark: Meriofert
Greece: Meriofert
Hungary: Meriofert
Luxembourg: Fertinorm
Romania: Meriofert
Slovakia: Meriofert
The Netherlands: Meriofert
This leaflet was last revised in April 2017