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DECA-DURABOLIN 50MG/ML INJECTION

Active substance: NANDROLONE DECANOATE

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Package leaflet: Information for the patient
Deca-Durabolin 50 mg/ml Solution for Injection
(Nandrolone decanoate)
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.

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

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, breastfeeding 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.
→Tell 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

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.
→Please 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.
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 Anti-doping
Code (OMAC 1999). The misuse of this medicine to enhance ability in sports carries serious
health risks and is to be discouraged.

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.

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
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.
→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.

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.

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 vial and sold in packs of 1, 3 or 6 vials.
Marketing Authorisation Holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland.
Manufacturer:
N.V. Organon, Kloosterstraat 6 5349 AB Oss, The Netherlands
This leaflet was last updated in July 2014.
___________________________________________________________________________
Deca-Durabolin 50mg/ml for Injection
nandrolone decanoate

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 sideeffects.
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. DecaDurabolin 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).
− 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 July 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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