ארצות הברית - אנגלית - NLM (National Library of Medicine)

bryant ranch prepack - estradiol hemihydrate (unii: cxy7b3q98z) (estradiol - unii:4ti98z838e) - estradiol vaginal cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estradiol vaginal cream 0.01% 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 dvt, pe or history of these conditions. - active arterial thromboembolic disease (for example, stroke, mi) or a history of these conditions. - known anaphylactic reaction or angioedema to estradiol vaginal cream 0.01%. - known liver dysfunction or disease. - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. - known or suspected pregnancy.

ישראל - אנגלית - Ministry of Health

novo nordisk ltd., israel - estradiol hemihydrate - film coated tablets - estradiol hemihydrate 10 mcg - estradiol - estradiol - treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.the experience treating women older than 65 years is limited.שינוי משטר מינון: 1/7/2019שינויים בעלון לרופא בסעיף posology:4.2 posology and method of administrationvagifem is administered intravaginally as a local oestrogen therapy by use of an applicator. initial dose: one vaginal tablet daily for two weeks. maintenance dose: one vaginal tablet twice a week.treatment may be started on any convenient day.if a dose is forgotten, it should be taken as soon as the patient remembers. a double dose should be avoided.for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as vagifem, it is not recommended to add a progestagen (but see section 4.4, ‘special warnings and precautions for use’, ‘endometrial hyperplasia and carcinoma’).

סינגפור - אנגלית - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - estradiol hemihydrate 1.03 mg eqv estradiol anhydrous - tablet, film coated - 1 mg - estradiol hemihydrate 1.03 mg eqv estradiol anhydrous 1 mg

סינגפור - אנגלית - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - estradiol hemihydrate 2.07 mg eqv estradiol anhydrous - tablet, film coated - 2 mg - estradiol hemihydrate 2.07 mg eqv estradiol anhydrous 2 mg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol vaginal inserts 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 history of these conditions - active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions - known anaphylactic reaction or angioedema to estradiol vaginal inserts - known liver impairment or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy estradiol 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. estradiol 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 estradiol is administered to a nursing woman. estradiol 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 estradiol to determine whether those over 65 years of age differ from younger subjects in their response to estradiol. 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)] . the effect of renal impairment on the pharmacokinetics of estradiol has not been studied. the effect of hepatic impairment on the pharmacokinetics of estradiol has not been studied.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

bryant ranch prepack - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol vaginal inserts 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 history of these conditions - active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions - known anaphylactic reaction or angioedema to estradiol vaginal inserts - known liver impairment or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy estradiol 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. estradiol 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 estradiol is administered to a nursing woman. estradiol 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 estradiol to determine whether those over 65 years of age differ from younger subjects in their response to estradiol. 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)] . the effect of renal impairment on the pharmacokinetics of estradiol has not been studied. the effect of hepatic impairment on the pharmacokinetics of estradiol has not been studied.

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

sun pharmaceutical industries europe b.v. - estradiol - vaginal tablet - 10 microgram(s) - estradiol

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

les laboratoires servier - estradiol hemihydrate - nasal spray solution - 150 microgram

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

merck serono limited - estradiol hemihydrate - transdermal patch - 1.5 milligram

קנדה - אנגלית - Health Canada

lupin pharma canada limited - estradiol (estradiol hemihydrate) - tablet - 0.5mg - estradiol (estradiol hemihydrate) 0.5mg - estrogens