USA - engelsk - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.625 mg - prempro or premphase therapy should not be used in women with any of the following conditions: prempro and premphase should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. prempro and premphase should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving these drugs. caution should be exercised when prempro or premphase is administered to a nursing woman. prempro and premphase are not indicated in children. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing prempro or premphase to determine whether those over 65 years of age differ from younger subjects in their response to prempro or premphase. the women's health initiative studies in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.6)] . in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.6)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.7)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.7)] . the effects of renal impairment on the pharmacokinetics of prempro or premphase have not been studied. the effects of hepatic impairment on the pharmacokinetics of prempro or premphase have not been studied.

Canada - engelsk - Health Canada

pharmascience inc - conjugated estrogens - tablet - 0.625mg - conjugated estrogens 0.625mg - estrogens

Canada - engelsk - Health Canada

pharmascience inc - conjugated estrogens - tablet - 1.25mg - conjugated estrogens 1.25mg - estrogens

Canada - engelsk - Health Canada

pharmascience inc - conjugated estrogens - tablet - 0.3mg - conjugated estrogens 0.3mg - estrogens

Canada - engelsk - Health Canada

pharmascience inc - conjugated estrogens - tablet - 0.9mg - conjugated estrogens 0.9mg - estrogens

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

pfizer australia pty ltd - conjugated estrogens, quantity: 0.625 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; carnauba wax; sucrose; hypromellose; lactose monohydrate; macrogol 400; hyprolose; calcium phosphate; powdered cellulose; titanium dioxide; propylene glycol; purified water; isopropyl alcohol; allura red ac aluminium lake; indigo carmine aluminium lake - oestrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 premarin is indicated as replacement therapy for oestrogen deficiency states associated with climacteric manifested by: a) moderate to severe vasomotor symptoms associated with oestrogen deficiency in natural and surgical menopause (sweating, hot flushes). periodic re-evaluation with a view to short term treatment is recommended. b) atrophic vaginitis. when prescribing solely for the treatment of symptoms of vaginal atrophy, topical vaginal products should be considered. there is no evidence that oestrogens are effective for anxiety or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. 2. premarin is indicated for the prevention of postmenopausal osteoporosis in select patients. when prescribed solely for the prevention of postmenopausal osteoporosis, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of premarin should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. (see precautions and dosage and administration). 3. hypoestrogenic states e.g. female hypogonadism, primary ovarian failure or female castration. see boxed warning, particularly when considering premarin for long-term usage.

USA - engelsk - 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:

USA - engelsk - NLM (National Library of Medicine)

redpharm drug, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 10 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: 1. undiagnosed abnormal genital bleeding. 2. known, suspected, or history of breast cancer. 3. known or suspected estrogen- or progesterone-dependent neoplasia. 4. active dvt, pe, or a history of these conditions 5. active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions. 6. known anaphylactic reaction or angioedema to medroxyprogesterone acetate. 7. known liver impairment or disease. 8. known

USA - engelsk - NLM (National Library of Medicine)

proficient rx lp - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 10 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:

USA - engelsk - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 10 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: - 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 medroxyprogesterone acetate. - known liver impairment or disease. - known or suspected pregnancy.