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

perrigo company - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 20 mg in 1 ml - estradiol valerate injection is indicated in the: 1.    treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. 3.    treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection should not be used in women with any of the following conditions: 1.    undiagnosed abnormal genital bleeding. 2.    known, suspected, or history of cancer of the breast. 3.    known or suspected estrogen-dependent neoplasia. 4.    active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.    active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial i

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

sandoz inc - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - estradiol valerate and estradiol valerate/dienogest is indicated for use by women to prevent pregnancy. the efficacy of estradiol valerate and estradiol valerate/dienogest in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. estradiol valerate and estradiol valerate/dienogest is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. do not prescribe estradiol valerate and estradiol valerate/dienogest to women who are known to have the following: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce w

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

american regent, inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate injection is indicated in the: 1.    treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. 3.    treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection should not be used in women with any of the following conditions: 1.    undiagnosed abnormal genital bleeding. 2.    known, suspected, or history of cancer of the breast. 3.    known or suspected estrogen-dependent neoplasia. 4.    active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.    active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial i

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

xiromed, llc - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate injection, usp is indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - 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. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection, usp 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 dysfu

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

hikma pharmaceuticals usa inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate injection, usp is indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - 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. - treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection should not be used in women with any of the following conditions: 1.  undiagnosed abnormal genital bleeding. 2.  known, suspected, or history of cancer of the breast. 3.  known or suspected estrogen-dependent neoplasia. 4.  active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.  active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial   infarction). 6.  live

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

par pharmaceutical, inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 10 mg in 1 ml - delestrogen (estradiol valerate injection, usp) is indicated in the: 1. treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. 3. treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). delestrogen should not be used in women with any of the following conditions: 1. undiagnosed abnormal genital bleeding. 2. known, suspected, or history of cancer of the breast. 3. known or suspected estrogen-dependent neoplasia. 4. active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5. active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. liver dysfunction or disease. 7. delestrogen should not be used in patients with known hypersensitivity to its ingredients. 8. known or suspected pregnancy. there is no indication for delestrogen in pregnancy. there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy [see precautions ].

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

physicians total care, inc. - estradiol valerate (unii: okg364o896) (estradiol valerate - unii:okg364o896) - estradiol valerate 3 mg - natazia™ is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. do not prescribe natazia to women who are known to have the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1 )] have cerebrovascular disease [see warnings and precautions (5.1 )] have coronary artery disease [see warnings and precautions (5.1 )] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1 )] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1 )] have uncontrolled hypertension [see warnings and precautions (5.

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

bayer healthcare pharmaceuticals inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - natazia® is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. natazia is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. wo

Israel - English - Ministry of Health

bayer israel ltd - dienogest; dienogest; estradiol valerate; estradiol valerate; estradiol valerate - film coated tablets - estradiol valerate 1 mg; estradiol valerate 3 mg; dienogest 2 mg; dienogest 3 mg; estradiol valerate 2 mg - estradiol - estradiol - oral contraception.treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.

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

bayer australia ltd - estradiol valerate, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; povidone; purified talc; maize starch - oral contraception. treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.