Deca Durabolin 50mg/ml

Each ml of Deca Durabolin contains 50mg nandrolone decanoate.

Solution for injection.

For use in osteoporosis in post-menopausal women.

Established osteoporosis should have been diagnosed by the following parameters:

i) crush or wedge fractures of the vertebrae

ii) other osteoporotic fractures

iii) established reduction in bone mineral content as measured by accepted BMC measurements.

Dosage

Post-menopausal women

50 mg 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.

Children

There are no recommendations for use in children.

Administration

Deep intramuscular injection

Pregnancy

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)

Known or suspected carcinoma of prostate or mammary carcinoma in the male

If signs of virilisation develop, discontinuation of the treatment should be considered.

Patients, especially the elderly, with the following conditions should be monitored:

• latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since anabolic steroids may occasionally induce sodium and water retention;

• incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure;

• skeletal metastases, since anabolic steroids may induce hypercalcaemia and hypercalciuria in these patients;

• 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.

• diabetes mellitus

Deca Durabolin 50mg/ml contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old.

Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other anti-diabetic drugs in diabetics.

Anabolic steroids have been reported to increase the activity of oral anticoagulants. Patients receiving oral anticoagulants require close monitoring, especially at the beginning or end of androgen therapy. Increased monitoring of the prothrombin time, and INR determinations, are recommended.

Deca-Durabolin is contra-indicated during pregnancy because of possible masculinisation of the foetus. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm to the infant or a possible influence on milk production.

None known.

Deca-Durabolin at the recommended dosages is unlikely to produce virilising effects. High dosages, prolonged treatment and/or too frequent administration may cause:

• Virilisation which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in long-lasting, sometimes irreversible deepening of the voice;

• Amenorrhoea and inhibition of spermatogenesis;

• Premature epiphyseal closure;

• Sodium and water retention.

Abnormal liver function tests have been reported in patients treated with (high doses) of Deca-Durabolin.

Liver tumours have been reported occasionally on prolonged treatment with orally active C17-alpha alkylated anabolic steroids. A relationship between liver tumours and non-C17-alkylated injectable steroids, such as nandrolone esters, appears to be highly unlikely, but cannot be absolutely excluded.

The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute overdosage with Deca-Durabolin in the human.

Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity.

In humans Deca-Durabolin has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis.

Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.

Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days. The ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis of nandrolone decanoate and of distribution and elimination of nandrolone is 4.3 hours.

Nandrolone is metabolised by the liver. 19-norandrosterone, 19-noretiocholanolone and 19-norepiandrosterone have been identified as metabolites in the urine. It is not known whether these metabolites display a pharmacological action.

Not applicable.

Benzyl alcohol

Arachis oil

None known

1 ml ampoule 60 months.

Do not store above 30°C

Do not refrigerate or freeze.

Keep in the container in the outer carton.

1 x 1ml ampoules

3 x 1ml ampoules

6 x 1ml ampoules

Not applicable.

Organon Laboratories Limited,

Cambridge Science Park,

Milton Road,

Cambridge, CB4 0FL

PL 0065/5063R

28/2/73 / 27/04/05

29 December 2011

Prescription Only Medicine

RA 1235 GB SPC 9 (REF 8.0)

DecaDurabolin/SPC/UK/12-11/03