CLINICAL PHARMACOLOGY
In aplastic anemias 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.

INDICATIONS AND USAGE
Aplastic anemias. The therapy may have to be continued for at least 3 months at a dosage of 2-3 mg/kg bodyweight per day, or 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 Primabolan-LA®

CONTRAINDICATIONS
Primabolan-LA® 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, Primabolan-LA® is also contra-indicated in patients with prostatic carcinoma, since such substances may aggravate the disease.

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.

HOW SUPPLIED
Primabolan-LA® Tablets, round, are available in the 25 mg strengths and white colors:
Bottles of 30 tablets
Store at controlled room temperature below 30°C .
For shelf-life please refer to the imprint on the pack. Keep out of reach of children.
Rχ only
Manufactured by: LA Pharma S.r.l.