Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
PRIMOGYN DEPOT 10 mg SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): PRIMOGYN DEPOT 10 mg For intramuscular estrogen therapy (oily solution) COMPOSITION 1 mL contains estradiol valerate (estra-1,3,5(10)-triene-3,17beta-diol 17-valerate) 10,0 mg in an oily solution. PHARMACOLOGICAL CLASSIFICATION A. 21.8.1 Estrogens. PHARMACOLOGICAL ACTION Primogyn Depot 10 mg is an estrogen preparation which contains the n-valeric-acid ester of the naturally occurring estrogen, estradiol. Following intramuscular injection estradiol valerate provides a depot effect of about two weeks. With suitable dosage it is possible to induce proliferative changes in the endometrium and, in combination with progestogens, to imitate a physiological course of the menstrual cycle. Estradiol valerate is suitable for replacement therapy in all pathological conditions caused by estrogen deficiency. INDICATIONS Primary and secondary amenorrhoea, uterine hypoplasia, deficiency symptoms in young women after oophorectomy or radiological castration for non-carcinomatous diseases, gynaecological operations, dysfunctional bleeding. CONTRA-INDICATIONS Pregnancy; existing or suspected hormone-dependent tumours of the uterus or mammae, endometriosis. DOSAGE AND DIRECTIONS FOR USE Before starting the use of Primogyn Depot 10 mg a thorough general medical and gynaecological examination (including the breasts) should be carried out and pregnancy must be excluded. Like all oily solutions Primogyn Depot 10 mg must be injected intramuscularly • Primary and secondary amenorrhoea In the case of secondary amenorrhoea hormone treatment is to be given at the earliest 8 weeks after the last menstrual period. In addition to Primogyn Depot 10 mg, the administration of a progestogen (hydroxyprogesterone hexanoate injections or norethistero Read the complete document