Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
PRIMODIAN DEPOT SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): PRIMODIAN DEPOT Combined intramuscular estrogen-androgen preparation (oily solution) COMPOSITION 1 mL contains estradiol valerate (estra-1,3,5(10)-triene-3,17beta-diol17-valerate) 4,0 mg and testosterone enantate (17beta-hydroxyandrost-4-en-3-one heptanoate) 90,3 mg in oily solution. PHARMACOLOGICAL CLASSIFICATION A. 21.9 Androgen-estrogen combinations. PHARMACOLOGICAL ACTION Primodian Depot contains long-acting esters of the naturally occurring estrogen, estradiol, and the naturally occurring androgen, testosterone. Estrogens and androgens have partly synergistic and partly antagonistic actions in the organism. Their proportion in Primodian Depot has been especially selected so that their desirable effects are brought to the fore, and the undesirable effects are to a large extent suppressed. Primodian Depot has a favourable influence especially on the severe deficiency symptoms of the female climacteric. Above all psychic complaints respond very well to treatment. Furthermore, Primodian Depot has proved effective in the treatment of osteoporosis during the climacteric. The effect of Primodian Depot usually begins to show a few days after the injection and lasts on the average 3-6 weeks or even longer. INDICATIONS Typical deficiency symptoms of the female climacteric or following oophorectomy or radiological castration for non- carcinomatous diseases (eg hot flushes, bouts of perspiration, sleep disturbances, depressive moods, irritability, headaches, dizziness). Furthermore, Primodian Depot has a favourable influence on bladder irritation - a not infrequent occurrence in the climacteric - signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age, and on osteoporotic Read the complete document