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SPC, UK: DECA-DURABOLIN Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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 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 ...

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

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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