New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - medroxyprogesterone acetate 150 mg/ml - injection (depot) - 150 mg/ml - active: medroxyprogesterone acetate 150 mg/ml excipient: hydrochloric acid macrogol 3350 methyl hydroxybenzoate polysorbate 80 propyl hydroxybenzoate sodium chloride sodium hydroxide - adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - medroxyprogesterone acetate, quantity: 150 mg/ml - injection, suspension - excipient ingredients: propyl hydroxybenzoate; methyl hydroxybenzoate; water for injections; sodium chloride; macrogol 3350; polysorbate 80 - carcinoma: palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. 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 depo-provera 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 warnings). the 50 mg/1ml vial is not approved for the indication of contraception (ovulation suppression). the injection, depo-provera 1

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - medroxyprogesterone acetate 150 mg/ml - suspension for injection - 150 mg/ml - medroxyprogesterone acetate 150 mg/ml - medroxyprogesterone

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - medroxyprogesterone acetate 150 mg/ml - suspension for injection - 150 mg/ml - medroxyprogesterone acetate 150 mg/ml - medroxyprogesterone

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - medroxyprogesterone acetate, quantity: 150 mg/ml - injection, suspension - excipient ingredients: propyl hydroxybenzoate; methyl hydroxybenzoate; water for injections; sodium chloride; macrogol 3350; polysorbate 80 - carcinoma: palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. 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 depo-provera 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 warnings). the 50 mg/1ml vial is not approved for the indication of contraception (ovulation suppression). the injection, depo-provera 150 mg/1ml, should be used for contraception.

United States - English - NLM (National Library of Medicine)

amphastar pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate long-term [see warnings and precautions (5.1)] . the use of medroxyprogesterone acetate is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)]. - known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.6)]. - undiagnosed vaginal bleeding

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 5 mg - medroxyprogesterone acetate tablets usp are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. medroxyprogesterone acetate is contraindicated in women with any of the following conditions:

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 10 mg - medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. they are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. mpa tablets is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen- or progesterone-dependent neoplasia. - active dvt, pe, or a history of these conditions. - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. - known anaphylactic reaction or angioedema to mpa. - known liver impairment or disease. - known or suspected pregnancy.

United States - English - NLM (National Library of Medicine)

greenstone llc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate (mpa) injectable suspension, usp is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use : the use of mpa injectable suspension, usp is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)]. the use of mpa injectable suspension, usp is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)] . - known hypersensitivity to mpa injectable suspension, usp (medroxyprogesterone acetate) or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and precautions (5.7)]

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate (mpa) injectable suspension, usp is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use mpa injectable suspension, usp long-term [see warnings and precautions (5.1)] . the use of mpa injectable suspension, usp is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)] . - known hypersensitivity to mpa injecta