Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
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 Read the complete document