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pfizer pfe pharmaceuticals israel ltd - medroxyprogesterone acetate - suspension for injection - medroxyprogesterone acetate 104 mg / 0.65 ml - medroxyprogesterone - medroxyprogesterone - * sayana is indicated for long-term female contraception. each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- 1 week). however, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year .since loss of bone mineral density may occur in females of all ages who use sayana long-term, a risk/benefit assessment, which also takes into consideration the decrease in bone mineral density that occurs during pregnancy and/or lactation, should be considered.* use in adolescents (12-18 years)in adolescents, use of sayana is only indicated when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with sayana during the critical period of bone accretion.sayana has not been studied in women under the age of 18 years but data is available for intramuscular medroxyprogesterone acetate in this population.

英国 - 英文 - MHRA (Medicines & Healthcare Products Regulatory Agency)

sayana press 104mg/0.65 ml suspension for injection pre-filled disposable devices

pfizer ltd - medroxyprogesterone acetate - suspension for injection - 160mg/1ml

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

sayana medroxyprogesterone acetate 104 mg/0.65 ml suspension for injection syringe

pfizer australia pty ltd - medroxyprogesterone acetate, quantity: 104 mg - suspension - excipient ingredients: methyl hydroxybenzoate; propyl hydroxybenzoate; sodium chloride; macrogol 3350; polysorbate 80; monobasic sodium phosphate monohydrate; dibasic sodium phosphate dodecahydrate; methionine; povidone; sodium hydroxide; hydrochloric acid; water for injections - endometriosis: for use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contra- indicated or has been unsuccessful. contraception (ovulation suppression): for long-term prevention of pregnancy in women when administered at 3-month intervals. since loss of bone mineral density (bmd) may occur in pre-menopausal women who use sayana long-term (greater than 2 years), women should be assessed, before starting treatment for contraception or endometriosis, regarding the risk of osteoporosis. women under the age of 18 years may be at risk of failing to achieve their predicted peak bone mineral density (see precautions).