Package leaflet: Information for the patient ASPEN Artwork Panel
Deca‑Durabolin 50 mg/ml AW Version:
3
Page:
1 of 2
Solution for Injection New Item Code:
(Nandrolone decanoate)
N/A
èTell your doctor or pharmacist or nurse
Read all of this leaflet carefully before this if you have ever had, still have or are
medicine is administered because it contains Replacement:
suspected to have:
important information for you. • breast cancer which has spread to N/A
• Keep this leaflet. You may need to the bones;
read it again. • Kidney or lung cancer Market:
• If you have any further questions, ask your • heart disease UK
doctor or your pharmacist. • kidney disease
• This medicine has been prescribed for you • liver disease Product Name:
only. Do not pass it on to others. It may • high blood pressure Deca-durabolin 50mg/ml Injection
harm them, even if their signs of illness are • diabetes mellitus
the same as yours. • epilepsy Number of Colours:
• If you get any side effects talk to your • migraine
1
160 mm Measuring Bar
doctor or pharmacist or nurse. This
includes any possible side effects not listed Other medicines and Deca‑Durabolin
in this leaflet. Please tell your doctor or pharmacist or nurse
Black
if you are taking, have recently taken, or might
What is in this leaflet: take any other medicines-even those not
1. What Deca-Durabolin is and what it prescribed.
is used for Other medicines may affect how Deca‑Durabolin
2. What you need to know before works or Deca‑Durabolin may affect how they
Deca‑Durabolin is given to you
3. How Deca‑Durabolin is given to you
work. Therefore you must tell your doctor Manufacturing Site:
or pharmacist or nurse if you are using, or
4. Possible side effects about to use: Ever Pharma
5. How to store Deca‑Durabolin • Insulin and/or other medicines to control your
6. Contents of the pack and other information blood sugar levels. Drawing Ref. Number:
• Erythropoietin (medicine to reduce anemia); leaflet_148x420mm
1. WHAT DECA‑DURABOLIN IS AND WHAT IT • Medicines to reduce the clotting of your
IS USED FOR blood (anti-coagulants) Drawing Version:
PHARMA CODE N° xxxx
Deca‑Durabolin is a clear yellow oily solution The use of anabolic steroids like Deca‑Durabolin 01
for injection containing 50 mg/ml of the active may lead to a reduction of the doses of these
ingredient nandrolone decanoate. medicines. Originated by:
The active substance, nandrolone decanoate
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Also tell your doctor or pharmacist or nurse Aidan Collins
belongs to the group of medicines known as
if you are using or about to use the hormone
anabolic steroids that help to prevent bone loss. Originated at:
ACTH or corticosteroids (used to treat various
Deca‑Durabolin is used in osteoporosis, when conditions such as rheumatism, arthritis, allergic APTL
bones thin and become brittle, after the conditions and asthma). The use of anabolic
menopause. steroids like Deca‑Durabolin may increase the Originated on:
risk of water retention especially if your heart
2. WHAT YOU NEED TO KNOW BEFORE and liver are not working properly. 05 Nov 2015
DECA‑DURABOLIN IS GIVEN TO YOU
Do not receive Deca‑Durabolin:
Laboratory tests: Amended on:
Anabolic steroids may also affect the results
• If you are pregnant or think you may be of some laboratory tests (e.g. thyroid gland).
24 Nov 2015
pregnant (see section 2 “pregnancy, breast- Therefore, you must tell your doctor or the
feeding and fertility”). laboratory staff performing the tests that you
• If you are allergic (hypersensitive) to are using this medicine.
nandrolone decanoate or any of the
ingredients of this medicine (listed in section Using Deca‑Durabolin with food and drink
6 “What Deca‑Durabolin contains”). This medicine can be injected without taking
consideration of meals and drinks.
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• In children under the age of 3 years.
• If you have porphyria (an inherited èPlease tell your doctor or pharmacist or
blood disorder) nurse if you are taking or have recently taken Artwork Studio‘s Check:
If you are allergic to peanuts or soya (see any other medicines, including medicines
section 2 “Important information about some of obtained without a prescription.
the ingredients of Deca‑Durabolin").
Pregnancy, breast-feeding and fertility
Take special care with Deca‑Durabolin: This medicine must not be taken by women who Date Signature
If you notice any signs of masculinization (for are pregnant or think that they are pregnant, or
instance lowering of the voice or increase by women who are breast-feeding. Proof Reader‘s Check:
in body or facial hair), consult your doctor In women, treatment with Deca‑Durabolin can
immediately. lead to an irregular or absent menstrual cycle.
Extra supervision by your doctor may be If you are pregnant or breast-feeding, think
necessary in some cases; particularly the you may be pregnant or are planning to have
Date Signature
elderly. At regular intervals, blood tests will be a baby, ask your doctor or pharmacist or nurse
done to check the oxygen-carrying substance in for advice before taking any medicine.
Technical Site Check:
your red blood cells (haemoglobin). In very rare Driving and using machines
cases the number of red blood cells will increase As far as is known Deca‑Durabolin has no
too much leading to complications. influence on driving and using machines.
Medical checks may also be necessary in some
other conditions. Date Signature
Market Approval:
Deca‑Durabolin 50mg/ml for Injection
nandrolone decanoate Date Signature
WARNINGS
Technical information for the healthcare Medical examination:
professional Physicians should consider monitoring patients
The following information is intended for the receiving Deca‑Durabolin before the start
healthcare professional only: of treatment, at quarterly intervals for the
This is an extract from the Summary of first 12 months and yearly thereafter for the
Product Characteristics (SmPC) to assist in the following parameters:
administration of Deca‑Durabolin 50mg/ml • Hematocrit and hemoglobin to exclude
PHARMA CODE N° xxxx
solution for Injection. polycythemia.
The prescriber should be familiar with Conditions that need supervision:
the full SmPC in order to determine • Patients, especially the elderly, with the
the appropriateness of the use of the following conditions should be monitored for:
product in a particular patient. The full – Tumours - Mammary carcinoma,
SmPC can be found on the electronic hypernephroma, bronchial
Medicines Compendium (eMC) website: carcinoma and skeletal metastases.
http://www.medicines.org.uk/emc/. In these patients hypercalcaemia
The Patient Information Leaflet provided (see or hypercalciuria may develop
the other half of this leaflet) should be given spontaneously, and also during
to the patient. androgen therapy. Nevertheless, the
hypercalcaemia or hypercalciuria should
Deca‑Durabolin 50mg/ml solution for injection first be treated appropriately and after
contains nandrolone decanoate. restoration of normal calcium levels,
Each vial contains 1 ml of solution. Each if judged necessary and taking into
1 ml of solution contains 50 mg nandrolone account the risks and benefits on a case
decanoate. by case basis, hormone therapy can be
resumed, with caution.
PREPARATION AND OTHER HANDLING
INSTRUCTIONS – Pre-existing conditions-In patients with
Deca‑Durabolin should be administered by deep pre-existing cardiac, renal or hepatic
intramuscular injection. insufficiency/disease or epilepsy or
migraine anabolic steroid treatment
DOSAGE AND ADMINISTRATION may cause complications characterized
Dosage by oedema with or without congestive
Post-menopausal women heart failure. In such cases treatment
50mg every three weeks. must be stopped immediately. Patients
The duration of treatment depends on the who experienced myocardial infarction,
clinical response and the possible occurrence of cardiac-, hepatic- or renal insufficiency,
side-effects. hypertension, epilepsy, or migraine
We would recommend that the effectiveness should be monitored due to the risk
of therapy be monitored with the of deterioration of or reoccurrence of
appropriate methods for osteoporosis on disease. In such cases treatment must
a 6-12 monthly basis. be stopped immediately.
CONTRAINDICATIONS – Diabetes mellitus - Deca‑Durabolin
• Pregnancy (see section 4.6 of the full SmPC) can improve glucose tolerance in
• Breast-feeding diabetic patients (see section 4.5 of the
• Porphyria full SmPC).
• Hypersensitivity to the active substance or – Anti-coagulant therapy - Deca‑Durabolin
to any of the excipients, including arachis oil. can enhance the anti-coagulant action
Deca‑Durabolin is therefore contraindicated of coumarin-type agents (see also
in patients allergic to peanuts or soya (see section 4.5 of the full SmPC).
section 4.4 of the full SmPC)
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Important information about some of the • Masculinization ASPEN Artwork Panel
ingredients of Deca‑Durabolin • Abnormal blood tests
This medicine also contains: Deca‑Durabolin may affect some liver tests or AW Version: Page:
• Arachis oil (peanut oil) - If you are allergic may cause liver tumours, although very rarely.
to peanut or soya, you should not be Due to the nature of Deca‑Durabolin side effects
3 2 of 2
given this medicine (see “Do not receive cannot be quickly reversed by discontinuing
Deca‑Durabolin”). medication. Injectables in general, may cause New Item Code:
• Benzyl alcohol (100 mg per ml solution) local reaction at the injection site. N/A
- Products containing benzyl alcohol
must not be given to premature babies or èIf you get any side effects talk to your doctor Replacement:
neonates. Benzyl alcohol may cause toxic or pharmacist or nurse. This includes any N/A
reactions and allergic reactions in infants possible side effects not listed in this leaflet.
and children up to 3 years old. 5. HOW TO STORE DECA‑DURABOLIN Market:
Improper use Keep this medicine out of the reach and sight UK
Nandrolone is classified as a prohibited of children.
substance under the Olympic Movement Anti- Do not use this medicine after the expiry date Product Name:
doping Code (OMAC 1999). The misuse of this
medicine to enhance ability in sports carries
stated on the carton or label after the term Deca-durabolin 50mg/ml Injection
“exp.” (expiry date). The expiry date refers to
serious health risks and is to be discouraged. the last day of that month. Number of Colours:
Store below 30ºC. 1
160 mm Measuring Bar
3. HOW DECA‑DURABOLIN IS GIVEN TO YOU
Do not refrigerate or freeze.
This medicine should only be given by a doctor Store in the original package in order to protect
or a nurse. The injections are given deeply into from light. Do not throw away medicines via Black
a muscle (for instance in the buttock, upper leg wastewater or household waste. Ask your
or upper arm.) pharmacist how to dispose of medicines no
The dose depends on your illness and how bad longer required. These measures will help to
it is. Your doctor will decide the dose. protect the environment.
If you receive more Deca‑Durabolin than
you should: 6. CONTENTS OF THE PACK AND OTHER Manufacturing Site:
Your doctor or nurse will inject this medicine into INFORMATION
Ever Pharma
you. If you have the impression that the effect What Deca‑Durabolin contains
of this medicine is too strong then please talk to • The active substance is Nandrolone
your doctor or nurse immediately.
Drawing Ref. Number:
decanoate, 50 mg per ml fluid.
• The other ingredients are: 100mg/ml benzyl leaflet_148x420mm
If you forgot to get your injection of
Deca‑Durabolin: alcohol and Arachis oil.
Drawing Version:
PHARMA CODE N° xxxx
Your doctor or nurse will inject this medicine into What Deca‑Durabolin looks like and contents
you. Should you miss a scheduled injection of the pack 01
then please talk to your doctor or nurse as soon Deca‑Durabolin 50 mg solution for injection is
as possible. No double dose should be injected a slightly yellow, oily solution filled in a 1ml Originated by:
ASPEN Artwork Panel • May 2013 • Version 5
to make up for forgotten individual doses. clear glass ampoule and sold in packs of 1, 3 or Aidan Collins
Effects when treatment with Deca‑Durabolin 6 ampoules.
is stopped: Marketing Authorisation Holder Originated at:
The effects of this medicine do not stop Aspen Pharma Trading Limited, APTL
immediately after discontinuation, but 3016 Lake Drive,
gradually subside. Citywest Business Campus, Originated on:
When treatment with this medicine is stopped, Dublin 24, 05 Nov 2015
complaints such as those experienced before Ireland.
treatment may re-occur within a few weeks. Manufacturer: Amended on:
If you have any further questions on the Ever Pharma Jena GmbH, 24 Nov 2015
use of this medicine, ask your doctor or Otto-Schott-Str. 15, 07745, Germany
pharmacist or nurse.
This leaflet was last updated in November 2015
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
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period of administration of Deca‑Durabolin the
following undesirable effects may occur: Artwork Studio‘s Check:
• 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; Date Signature
your voice may get deeper and you may
notice some hair growth or acne Proof Reader‘s Check:
• Acne
• Increased sexual desire
• Nausea
• Itching
• Increased haemoglobin Date Signature
• Changes in blood lipids
• Abnormal liver function Technical Site Check:
• Liver anatomy changes
• Hoarseness
• Change of the voice
• Increased body or facial hair
• Enlargement of the clitoris Date Signature
Market Approval:
– Liver dysfunction - caution should be Marketing Authorisation Holder
used in patients with severe hepatic Aspen Pharma Trading Limited,
impairment and Deca‑Durabolin 3016 Lake Drive, Date Signature
50mg/ml should only be used if the Citywest Business Campus,
benefits outweigh the risks. Dublin 24,
Adverse events: Ireland
If anabolic steroid-associated adverse This leaflet was last revised in November 2015
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:
PHARMA CODE N° xxxx
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.
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