DECA-DURABOLIN Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Deca-Durabolin 50mg/ml.
Qualitative and quantitative composition
Each ampoule contains 1 ml of 50 mg/ml nandrolone decanoate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, yellow, oily solution.
Therapeutic indications
For use in osteoporosis in post-menopausal women. Established osteoporosis should have been diagnosed by the following parameters: crush or wedge fractures of the vertebrae other osteoporotic fractures ...
Posology and method of administration
Posology <u>Post-menopausal women:</u> 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 ...
Contraindications
Pregnancy (see section 4.6). Breast-feeding. Porphyria. Hypersensitivity to the active substance or to any of the excipients, including arachis oil. Deca-Durabolin is therefore contraindicated in patients ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase nandrolone levels. Therefore, adjustment of the dose of Deca-Durabolin may be required. Insulin and other anti-diabetic medicines ...
Fertility, pregnancy and lactation
Deca-Durabolin is contra-indicated in women who are pregnant (see section 4.3). Pregnancy There are no adequate data for the use of Deca-Durabolin in pregnant women. In view of the risk of virilisation ...
Effects on ability to drive and use machines
Deca-Durabolin has no influence on the ability to drive and use machines.
Undesirable effects
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. Deca-Durabolin at the recommended ...
Overdose
The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute overdosage with Deca-Durabolin in the human.
Pharmacodynamic properties
Pharmacotherapeutic group: Anabolic steroids ATC code: A14AB01 Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity. In humans Deca-Durabolin has ...
Pharmacokinetic properties
Absorption Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days. Distribution The ester is rapidly hydrolysed to nandrolone in the blood with a half-life ...
Preclinical safety data
Toxicity studies in animals after repeated dosing did not indicate a safety risk for humans. No formal studies to assess reproduction toxicity, genotoxicity and carcinogenicity have been conducted by the ...
List of excipients
Benzyl alcohol Arachis oil
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Store below 30°C. Do not refrigerate or freeze. Store in the original package in order to protect from light.
Nature and contents of container
Deca-Durabolin 50 mg/ml solution for injection: 1 ml type I ampoules sold in packs of 1, 3 or 6 ampoules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0055
Date of first authorization / renewal of the authorization
Date of first authorisation: 27/09/1988 Date of latest renewal: 26/04/2005
Date of revision of the text
April 2019
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