INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PRIMOBOLAN S TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PRIMOBOLAN S TABLETS

COMPOSITION
1 tablet Primobolan S contains
metenolone acetate (17beta-hydroxy-1-methyl-5alpha-androst-1-en-3-one acetate) 25 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 21.6 Anabolic steroids.

PHARMACOLOGICAL ACTION
In aplastic anaemias of various origins - both the idiopathic forms and those with exogenously damaged bone marrow - high doses of metenolone acetate may stimulate bone marrow function, particularly erythropoiesis. Metenolone acetate is a non-17alpha-alkylated anabolic steroid.

INDICATIONS
Aplastic anaemias.

CONTRA-INDICATIONS
Primobolan S is contra-indicated in pregnancy as the metenolone acetate contained in the preparation, like all anabolic agents, possesses some androgenic activity which may lead to signs of virilisation in the female newborn.
Because of this androgenic activity, Primobolan S is also contra-indicated in patients with prostatic carcinoma, since such substances may aggravate the disease.

DOSAGE AND DIRECTIONS FOR USE
The therapy may have to be continued for at least 3 months at a dosage of 2-3 mg/kg bodyweight per day, ie 4-6 tablets for a person weighing 50 kg. Since some patients only respond after several months, treatment must not be stopped too soon. After improvement of the clinical picture treatment should, as a general rule, be continued for a further few weeks. Deterioration of the blood count after discontinuation of therapy may be reversed by renewed administration of Primobolan S.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
In female patients, signs of virilisation (acne, hirsutism, hoarseness, possibly irreversible deepening of the voice) must be reckoned with; in sexually mature women menstrual irregularities may occur.
In adult males, spermatogenesis may be inhibited, in boys there may be signs of premature puberty.
Non-adult patients should be monitored for accelerated bone maturation by X-ray.
Impairment of liver function is less frequent than with a 17alpha-alkylated anabolic steroid.
In men, regular examinations of the prostate should be carried out prophylactically to exclude a malignant tumour.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The symptoms mentioned under "Side effects and special precautions" may occur. There is no specific antidote.

IDENTIFICATION
White, round, flat-sided tablets, scored on the upper side, and on the reverse bearing a hexagon with the letters BM.

PRESENTATION
50 tablets.

STORAGE INSTRUCTIONS
Store below 30°C. For shelf-life please refer to the imprint on the pack. Keep out of reach of children.

REGISTRATION NUMBER
D/21.6/202

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
16 February 1984

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry

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