DECA-DURABOLIN 50MG/ML INJECTION

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Package leaflet: Information for the patient

Deca‑Durabolin 50 mg/ml
Solution for Injection

AW Version:
3
New Item Code:
N/A

(Nandrolone decanoate)

1. WHAT DECA‑DURABOLIN IS AND WHAT IT
IS USED FOR
Deca‑Durabolin is a clear yellow oily solution
for injection containing 50 mg/ml of the active
ingredient nandrolone decanoate.
The active substance, nandrolone decanoate
belongs to the group of medicines known as
anabolic steroids that help to prevent bone loss.
Deca‑Durabolin is used in osteoporosis, when
bones thin and become brittle, after the
menopause.
2. WHAT YOU NEED TO KNOW BEFORE
DECA‑DURABOLIN IS GIVEN TO YOU
Do not receive Deca‑Durabolin:
• If you are pregnant or think you may be
pregnant (see section 2 “pregnancy, breast-
feeding and fertility”).
• If you are allergic (hypersensitive) to
nandrolone decanoate or any of the
ingredients of this medicine (listed in section
6 “What Deca‑Durabolin contains”).
• In children under the age of 3 years.
• If you have porphyria (an inherited
blood disorder)
If you are allergic to peanuts or soya (see
section 2 “Important information about some of
the ingredients of Deca‑Durabolin").
Take special care with Deca‑Durabolin:
If you notice any signs of masculinization (for
instance lowering of the voice or increase
in body or facial hair), consult your doctor
immediately.
Extra supervision by your doctor may be
necessary in some cases; particularly the
elderly. At regular intervals, blood tests will be
done to check the oxygen-carrying substance in
your red blood cells (haemoglobin). In very rare
cases the number of red blood cells will increase
too much leading to complications.
Medical checks may also be necessary in some
other conditions.

Market:
UK
Product Name:
Deca-durabolin 50mg/ml Injection
Number of Colours:
1
Black

Manufacturing Site:
Ever Pharma
Drawing Ref. Number:
leaflet_148x420mm
Drawing Version:
01
Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
05 Nov 2015
Amended on:
24 Nov 2015

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Deca‑Durabolin 50mg/ml for Injection
nandrolone decanoate

PHARMA CODE N° xxxx

Technical information for the healthcare
professional
The following information is intended for the
healthcare professional only:
This is an extract from the Summary of
Product Characteristics (SmPC) to assist in the
administration of Deca‑Durabolin 50mg/ml
solution for Injection.
The prescriber should be familiar with
the full SmPC in order to determine
the appropriateness of the use of the
product in a particular patient. The full
SmPC can be found on the electronic
Medicines Compendium (eMC) website:
http://www.‌medicines.org.‌uk/emc/.
The Patient Information Leaflet provided (see
the other half of this leaflet) should be given
to the patient.
Deca‑Durabolin 50mg/ml solution for injection
contains nandrolone decanoate.
Each vial contains 1 ml of solution. Each
1 ml of solution contains 50 mg nandrolone
decanoate.
PREPARATION AND OTHER HANDLING
INSTRUCTIONS
Deca‑Durabolin should be administered by deep
intramuscular injection.
DOSAGE AND ADMINISTRATION
Dosage
Post-menopausal women
50mg every three weeks.
The duration of treatment depends on the
clinical response and the possible occurrence of
side-effects.
We would recommend that the effectiveness
of therapy be monitored with the
appropriate methods for osteoporosis on
a 6-12 monthly basis.
CONTRAINDICATIONS
• Pregnancy (see section 4.6 of the full SmPC)
• Breast-feeding
• Porphyria
• Hypersensitivity to the active substance or
to any of the excipients, including arachis oil.
Deca‑Durabolin is therefore contraindicated
in patients allergic to peanuts or soya (see
section 4.4 of the full SmPC)

WARNINGS
Medical examination:
Physicians should consider monitoring patients
receiving Deca‑Durabolin before the start
of treatment, at quarterly intervals for the
first 12 months and yearly thereafter for the
following parameters:
• Hematocrit and hemoglobin to exclude
polycythemia.
Conditions that need supervision:
• Patients, especially the elderly, with the
following conditions should be monitored for:
– Tumours - Mammary carcinoma,
hypernephroma, bronchial
carcinoma and skeletal metastases.
In these patients hypercalcaemia
or hypercalciuria may develop
spontaneously, and also during
androgen therapy. Nevertheless, the
hypercalcaemia or hypercalciuria should
first be treated appropriately and after
restoration of normal calcium levels,
if judged necessary and taking into
account the risks and benefits on a case
by case basis, hormone therapy can be
resumed, with caution.
– Pre-existing conditions-In patients with
pre-existing cardiac, renal or hepatic
insufficiency/disease or epilepsy or
migraine anabolic steroid treatment
may cause complications characterized
by oedema with or without congestive
heart failure. In such cases treatment
must be stopped immediately. Patients
who experienced myocardial infarction,
cardiac-, hepatic- or renal insufficiency,
hypertension, epilepsy, or migraine
should be monitored due to the risk
of deterioration of or reoccurrence of
disease. In such cases treatment must
be stopped immediately.
– Diabetes mellitus - Deca‑Durabolin
can improve glucose tolerance in
diabetic patients (see section 4.5 of the
full SmPC).
– Anti-coagulant therapy - Deca‑Durabolin
can enhance the anti-coagulant action
of coumarin-type agents (see also
section 4.5 of the full SmPC).
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160 mm Measuring Bar

Other medicines and Deca‑Durabolin
Please tell your doctor or pharmacist or nurse
if you are taking, have recently taken, or might
take any other medicines-even those not
prescribed.
Other medicines may affect how Deca‑Durabolin
works or Deca‑Durabolin may affect how they
work. Therefore you must tell your doctor
or pharmacist or nurse if you are using, or
about to use:
• Insulin and/or other medicines to control your
blood sugar levels.
• Erythropoietin (medicine to reduce anemia);
• Medicines to reduce the clotting of your
blood (anti-coagulants)
The use of anabolic steroids like Deca‑Durabolin
may lead to a reduction of the doses of these
medicines.
Also tell your doctor or pharmacist or nurse
if you are using or about to use the hormone
ACTH or corticosteroids (used to treat various
conditions such as rheumatism, arthritis, allergic
conditions and asthma). The use of anabolic
steroids like Deca‑Durabolin may increase the
risk of water retention especially if your heart
and liver are not working properly.
Laboratory tests:
Anabolic steroids may also affect the results
of some laboratory tests (e.g. thyroid gland).
Therefore, you must tell your doctor or the
laboratory staff performing the tests that you
are using this medicine.
Using Deca‑Durabolin with food and drink
This medicine can be injected without taking
consideration of meals and drinks.
èPlease tell your doctor or pharmacist or
nurse if you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.
Pregnancy, breast-feeding and fertility
This medicine must not be taken by women who
are pregnant or think that they are pregnant, or
by women who are breast-feeding.
In women, treatment with Deca‑Durabolin can
lead to an irregular or absent menstrual cycle.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist or nurse
for advice before taking any medicine.
Driving and using machines
As far as is known Deca‑Durabolin has no
influence on driving and using machines.

Replacement:
N/A

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Signature

ASPEN Artwork Panel • May 2013 • Version 5

What is in this leaflet:
1. What Deca-Durabolin is and what it
is used for
2. What you need to know before
Deca‑Durabolin is given to you
3. How Deca‑Durabolin is given to you
4. Possible side effects
5. How to store Deca‑Durabolin
6. Contents of the pack and other information

èTell your doctor or pharmacist or nurse
if you have ever had, still have or are
suspected to have:
• breast cancer which has spread to
the bones;
• Kidney or lung cancer
• heart disease
• kidney disease
• liver disease
• high blood pressure
• diabetes mellitus
• epilepsy
• migraine

PHARMA CODE N° xxxx

Read all of this leaflet carefully before this
medicine is administered because it contains
important information for you.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask your
doctor or your 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 or nurse. This
includes any possible side effects not listed
in this leaflet.

Page:
1 of 2

4. POSSIBLE SIDE EFFECTS
Like all medicines Deca‑Durabolin can cause
side effects, although not everybody gets them.
Dependent on the dose, frequency and total
period of administration of Deca‑Durabolin the
following undesirable effects may occur:
• Fluid retention in the tissues, usually marked
by swelling of the ankles or feet or increased
blood pressure
• An increase in male characteristics in women;
your voice may get deeper and you may
notice some hair growth or acne
• Acne
• Increased sexual desire
• Nausea
• Itching
• Increased haemoglobin
• Changes in blood lipids
• Abnormal liver function
• Liver anatomy changes
• Hoarseness
• Change of the voice
• Increased body or facial hair
• Enlargement of the clitoris

AW Version:
3
New Item Code:
N/A

èIf you get any side effects talk to your doctor
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.

Replacement:
N/A

5. HOW TO STORE DECA‑DURABOLIN
Keep this medicine out of the reach and sight
of children.
Do not use this medicine after the expiry date
stated on the carton or label after the term
“exp.” (expiry date). The expiry date refers to
the last day of that month.
Store below 30ºC.
Do not refrigerate or freeze.
Store in the original package in order to protect
from light. Do not throw away medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Market:
UK
Product Name:
Deca-durabolin 50mg/ml Injection
Number of Colours:
1
Black

Manufacturing Site:
Ever Pharma
Drawing Ref. Number:
leaflet_148x420mm
Drawing Version:
01
Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
05 Nov 2015
Amended on:
24 Nov 2015

This leaflet was last updated in November 2015

ASPEN Signature Panel
Artwork Studio‘s Check:

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Signature

Proof Reader‘s Check:

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Technical Site Check:

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Market Approval:
–

PHARMA CODE N° xxxx

Liver dysfunction - caution should be
used in patients with severe hepatic
impairment and Deca‑Durabolin
50mg/ml should only be used if the
benefits outweigh the risks.
Adverse events:
If anabolic steroid-associated adverse
reactions occur (see section 4.8 of the full
SmPC), treatment with Deca‑Durabolin should
be discontinued and, upon resolution of
complaints, treatment can be resumed.
Virilisation:
Patients should be informed about the potential
occurrence of signs of virilisation. In particular,
singers and women with speech professions
should be informed about the risk of deepening
of the voice.
If signs of virilisation develop, the risk/benefit
ratio has to be newly assessed with the
individual patient.
(Mis) use in sports:
Nandrolone is classified as a prohibited
substance under the Olympic Movement
Anti- doping Code (OMAC 1999). The misuse
of Nandrolone and other anabolic steroids to
enhance ability in sports carries serious health
risks and is to be discouraged.
Excipients:
Deca‑Durabolin contains arachis oil (peanut oil)
and should not be taken/applied by patients
known to be allergic to peanut. As there is
a possible relationship between allergy to
peanut and allergy to soya, patients with soya
allergy should also avoid Deca‑Durabolin (see
section 4.3 of the full SmPC).
OVERDOSE
The acute toxicity of nandrolone decanoate
in animals is very low. There are no reports
of acute over dosage with Deca‑Durabolin in
the human.
STORAGE
Store below 30°C
Do not refrigerate or freeze.
Store in the original package in order to protect
from light.

Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
This leaflet was last revised in November 2015

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160 mm Measuring Bar

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Deca‑Durabolin contains
• The active substance is Nandrolone
decanoate, 50 mg per ml fluid.
• The other ingredients are: 100mg/ml benzyl
alcohol and Arachis oil.
What Deca‑Durabolin looks like and contents
of the pack
Deca‑Durabolin 50 mg solution for injection is
a slightly yellow, oily solution filled in a 1ml
clear glass ampoule and sold in packs of 1, 3 or
6 ampoules.
Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland.
Manufacturer:
Ever Pharma Jena GmbH,
Otto-Schott-Str. 15, 07745, Germany

Page:
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ASPEN Artwork Panel • May 2013 • Version 5

3. HOW DECA‑DURABOLIN IS GIVEN TO YOU
This medicine should only be given by a doctor
or a nurse. The injections are given deeply into
a muscle (for instance in the buttock, upper leg
or upper arm.)
The dose depends on your illness and how bad
it is. Your doctor will decide the dose.
If you receive more Deca‑Durabolin than
you should:
Your doctor or nurse will inject this medicine into
you. If you have the impression that the effect
of this medicine is too strong then please talk to
your doctor or nurse immediately.
If you forgot to get your injection of
Deca‑Durabolin:
Your doctor or nurse will inject this medicine into
you. Should you miss a scheduled injection
then please talk to your doctor or nurse as soon
as possible. No double dose should be injected
to make up for forgotten individual doses.
Effects when treatment with Deca‑Durabolin
is stopped:
The effects of this medicine do not stop
immediately after discontinuation, but
gradually subside.
When treatment with this medicine is stopped,
complaints such as those experienced before
treatment may re-occur within a few weeks.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist or nurse.

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• Masculinization
• Abnormal blood tests
Deca‑Durabolin may affect some liver tests or
may cause liver tumours, although very rarely.
Due to the nature of Deca‑Durabolin side effects
cannot be quickly reversed by discontinuing
medication. Injectables in general, may cause
local reaction at the injection site.

PHARMA CODE N° xxxx

Important information about some of the
ingredients of Deca‑Durabolin
This medicine also contains:
• Arachis oil (peanut oil) - If you are allergic
to peanut or soya, you should not be
given this medicine (see “Do not receive
Deca‑Durabolin”).
• Benzyl alcohol (100 mg per ml solution)
- Products containing benzyl alcohol
must not be given to premature babies or
neonates. Benzyl alcohol may cause toxic
reactions and allergic reactions in infants
and children up to 3 years old.
Improper use
Nandrolone is classified as a prohibited
substance under the Olympic Movement Antidoping Code (OMAC 1999). The misuse of this
medicine to enhance ability in sports carries
serious health risks and is to be discouraged.