الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) -     ●estradiol is contraindicated in women with any of the following conditions: ● undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)]. ● breast cancer or a history of breast cancer [see warnings and precautions (5.3)]. ● estrogen-dependent neoplasia [see warnings and precautions (5.3)]. ● active dvt, pe, or history of these conditions [see warnings and precautions (5.2)]. ● active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)]. ● known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol [see warnings and precautions (5.16)] . hepatic impairment or disease. ● protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol vaginal inserts is not indicated for use in pregnancy. there are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol vaginal inserts and any potential adverse effects on the breastfed child from estradiol or from the underlying maternal condition. estradiol vaginal inserts are not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol vaginal inserts to determine whether those over 65 years of age differ from younger subjects in their response to estradiol vaginal inserts. 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 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 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)].

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

novo nordisk a/s - estradiol; estradiol; norethisterone acetate; estradiol - film-coated tablet - 2 2 1 1 mg/tablet - progestogens and estrogens, sequential preparations; norethisterone and estrogen

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

direct_rx - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.5 mg - - estradiol tablets usp are 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 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 osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (see clinical pharmacology, clinical studies.) the mainstays for decreasing the risk of postmenopausal ost

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of oestrogen deficiency associated with natural or artificial menopause (see dosage and administration and clinical trials).

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol transdermal system is indicated for: limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or a history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol transdermal system - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for estradiol transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition. in general, estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system. 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 clinical studies (14.3)] . 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 (14.3)] . 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 (5.3), and clinical studies (14.4)] . 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 (14.4)] .

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

pharmacia & upjohn company llc - estradiol cypionate (unii: 7e1dv054lo) (estradiol - unii:4ti98z838e) - estradiol cypionate 5 mg in 1 ml - depo-estradiol injection is indicated in the treatment of: estrogens should not be used in individuals with any of the following conditions: 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.) chlorobutanol anhydrous (chloral derivative) added as a preservative may be habit forming.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

physicians total care, inc. - estradiol cypionate (unii: 7e1dv054lo) (estradiol cypionate - unii:7e1dv054lo) - estradiol cypionate 5 mg in 1 ml - depo-estradiol injection is indicated in the treatment of: - moderate to severe vasomotor symptoms associated with the menopause. - hypoestrogenism due to hypogonadism. estrogens should not be used in individuals with any of the following conditions: - undiagnosed abnormal genital bleeding. - known or suspected cancer of the breast. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or 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. - depo-estradiol should not be used in patients with known hypersensitivity to its ingredients. - known or suspected pregnancy. there is no indication for depo-estradiol 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.) chlorobu

أستراليا - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol tablets are 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 prescribed 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 breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6.    prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (see clinical pharmacology, clinical studies .) the mainstays for decreasing the

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

proficient rx lp - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol tablets are 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 prescribed 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 breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6.    prevention of osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (see clinical pharmacology, clinical studies .) the mainstays for decreasing the