New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - conjugated estrogens 0.3mg;  ; conjugated estrogens 0.3mg (includes 3% overage); conjugated estrogens 0.3mg - tablet - 0.3 mg - active: conjugated estrogens 0.3mg   excipient: calcium sulfate carnauba wax glyceryl mono-oleate lactose monohydrate macrogol 20000 magnesium stearate methylcellulose microcrystalline cellulose opaglos clear 98z19173 opalux green shellac stearic acid sucrose titanium dioxide active: conjugated estrogens 0.3mg (includes 3% overage) excipient: calcium sulfate carnauba wax glyceryl mono-oleate lactose monohydrate macrogol 20000 magnesium stearate methylcellulose microcrystalline cellulose opacode white s-8-28905 opalux green shellac stearic acid sucrose titanium dioxide active: conjugated estrogens 0.3mg excipient: carnauba wax hyprolose hypromellose     lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose   opacode white ns-78-18011 opadry green 15b21511 sucrose

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - conjugated estrogens 0.625mg;  ; conjugated estrogens 0.625mg (includes 3% overage); conjugated estrogens 0.625mg - tablet - 0.625 mg - active: conjugated estrogens 0.625mg   excipient: calcium sulfate carnauba wax glyceryl mono-oleate lactose monohydrate macrogol 20000 magnesium stearate methylcellulose microcrystalline cellulose opaglos clear 98z19173 shellac stearic acid sucrose titanium dioxide urethane dimethacrylate luting resin active: conjugated estrogens 0.625mg (includes 3% overage) excipient: calcium sulfate carnauba wax glyceryl mono-oleate lactose monohydrate macrogol 20000 magnesium stearate methylcellulose microcrystalline cellulose opacode opalux maroon as-3910 shellac stearic acid sucrose titanium dioxide active: conjugated estrogens 0.625mg excipient: carnauba wax hyprolose hypromellose     lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose   opacode white ns-78-18011 opadry maroon 03b16083 sucrose

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - oestrogens conjugated, bazedoxifene - postmenopause - conjugated estrogens and bazedoxifene - duavive is indicated for:treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.the experience treating women older than 65 years is limited.

United States - English - 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.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg in 1 g -             premarin vaginal cream therapy should not be used in women with any of the following conditions: premarin vaginal cream 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. premarin vaginal cream 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 estrogens have been identified in the breast milk of women receiving estrogen therapy. caution should be exercised when premarin vaginal cream is administered to a nursing woman. premarin vaginal cream is 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 premarin vaginal cream to determine whether those over 65 years of age differ from younger subjects in their response to premarin vaginal cream. the women's health initiative studies 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 warnings and precautions (5.2), and clinical studies (14.2)] . 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 warnings and precautions (5.2, 5.3), and clinical studies (14.2)] . 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-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.4), and clinical studies (14.3)] . 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 (5.4), and clinical studies (14.3)] . the effect of renal impairment on the pharmacokinetics of premarin vaginal cream has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin vaginal cream has not been studied.

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

avera mckennan hospital - 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: - undiagnosed abnormal genital bleeding - known, suspected, or history of breast cancer - known or suspected estrogen-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 prempro/premphase - known liver dysfunction or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy 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 t

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

u.s. pharmaceuticals - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: - use duavee for the shortest duration consistent with treatment goals and risks for the individual woman. postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. - when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. duavee is contraindicated in women with any of the following conditions: - undiagnosed abnormal uterine bleeding - known, suspected, or past history of breast cancer - known or suspected estrogen-dependent neoplasia - active deep venous thrombosis, pulmonary embolism, or history of these conditions - active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions - hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients -

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

physicians total care, inc. - estrogens, conjugated synthetic a (unii: jm2621p2ls) (estrogens, conjugated synthetic a - unii:jm2621p2ls) - estrogens, conjugated synthetic a 0.45 mg - cenestin therapy is indicated for the: 1. treatment of moderate-to-severe vasomotor symptoms associated with the menopause. - 0.45 mg cenestin - 0.625 mg cenestin - 0.9 mg cenestin - 1.25 mg cenestin 2. treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - 0.3 mg cenestin cenestin should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or a history of these conditions. - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - liver dysfunction or disease. - cenestin therapy should not be used in patients with known hypersensitivity to its ingredients. - known or su

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

physicians total care, inc. - estrogens, conjugated synthetic b (unii: 8l6lak9btr) (estrogens, conjugated synthetic b - unii:8l6lak9btr) - estrogens, conjugated synthetic b 0.9 mg - enjuvia tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. when prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. enjuvia tablets should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or a history of these conditions. - active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - liver dysfunction or disease. - known hypersensitivity to the ingredients of enjuvia tablets. - known or suspected pregnancy. there is no indication for enjuvia in pregnancy

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

aphena pharma solutions - tennessee, inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg - premarin therapy is indicated in the: - treatment of moderate to severe vasomotor symptoms due to menopause. - treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin d in