DEca Durabolin Electronic Package Insert

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DECA-DURABOLIN® 25 mg
DECA-DURABOLIN® 50 mg

RUM 1220.041.006

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

DECA-DURABOLIN® 25 mg
DECA-DURABOLIN® 50 mg
injection

COMPOSITION
Deca-Durabolin contains 25 mg or 50 mg Nandrolone decanoate in 1 mL arachis oil containing 10% v/v benzyl alcohol

PHARMACOLOGICAL CLASSIFICATION
A 21.6 Anabolic Steroids

PHARMACOLOGICAL ACTION
Deca Durabolin® is an injectable anabolic preparation. After injection, nandrolone decanoate is gradually released from the intramuscular depot and subsequently hydrolysed into nandrolone.

INDICATIONS
As an anabolic steroid.
Certain cases of disseminated breast cancer in women.
Osteoporosis due to androgen deficiency in hypogonadal males.

CONTRA-INDICATIONS
Not intended for use in children.
Known or suspected prostatic carcinoma and mammary carcinoma in the male.
Not intended for use in female patients other than those with disseminated breast cancer.
Contraindicated in nephrosis or the nephrotic phase of nephritis, cardiac and renal failure, hypercalcaemia, oedema, jaundice, liver disease with impaired bilirubin excretion, testicular and hepatic carcinoma.

DOSAGE AND DIRECTIONS FOR USE
Deca-Durabolin should be administered by deep intramuscular injection.
Adult dose: 25-50 mg every 3 weeks.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
- Virilisation which appears in sensitive women as hoarseness, acne, hirsutism, and increased 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 a long-lasting, sometimes irreversible deepening of the voice.
Other adverse reactions may include:
- Oligospermia and decreased ejaculatory volume;
- Suppression of ovarian activity, atrophy of the breasts and endometrial tissue.
- Amenorrhoea and inhibition of spermatogenesis.
- Water and salt retention.
- Premature epiphyseal closure.
- If signs of virilisation develop, treatment should be discontinued.
- Increase in nitrogen retention and skeletal weight;
- Oedema;
- Increased vascularity of the skin;
- Increased growth of the bone;
- Elderly males may become over-stimulated.
Patients 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 induce salt and fluid retention;
- diabetes, since anabolic steroids may improve the glucose tolerance and decrease the need for insulin or other antidiabetic dugs;
- 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.
Interactions:
Liver-enzyme-inducing agents may reduce the effects of Deca-Durabolin® by enhancing its metabolism in the liver.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side-effects and special precautions”. Treatment is symptomatic and supportive.

CONDITIONS OF REGISTRATION
Product to be advertised to the professions only.

IDENTIFICATION
A clear oily solution.
25 mg/mL: Each ampoule neck is marked with a green and yellow ring.
50 mg/mL: Each ampoule neck is marked with a blue and green ring.

PRESENTATION
Deca-Durabolin 25 mg/mL: 1 mL clear ampoules – boxes of 6
Deca-Durabolin 50 mg/mL: 1 mL clear ampoules – boxes of 6

STORAGE INSTRUCTIONS
The syringes and ampoules should be protected from light and stored below 30°C.
Keep out of reach of children.

REFERENCE NUMBER
Deca-Durabolin® 25 mg/mL: G3183 (Act 101/1965)
Deca-Durabolin® 50 mg/mL: G3184 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
DONMED PHARMACEUTICALS (PTY) LIMITED
Donmed House, Cambridge Place
cnr Kirkby & Oxford Roads
Bedfordview 2007

DATE OF PUBLICATION OF THIS PACKAGE INSERT
9 June 1987

Under license of NV Organon, The Netherlands

Source: Pharmaceutical Industry

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DEca Durabolin Electronic Package Insert