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

teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol vaginal inserts 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 vaginal inserts [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 are 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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

besins healthcare sa-nv - estradiol hemihydrate 0,775 mg/dose - eq. estradiol 0,75 mg/dose - transdermal gel - 0,75 mg/dose - estradiol hemihydrate 0.775 mg/dose - estradiol

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

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.1 mg in 1 g - 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:

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

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - 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 intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg is also in

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

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - estradiol transdermal system continuous delivery (once-weekly) is indicated for:     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.       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 continuous delivery (once-weekly) is contraindicated in women with any of the following conditions: estradiol transdermal system continuous delivery (once-weekly) is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system continuous delivery (once-weekly) 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

Israel - English - 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’).

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - estradiol hemihydrate estradiol hemihydrate norethisterone acetate - transdermal patch - 50/250 microgram/day

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - estradiol hemihydrate estradiol hemihydrate norethisterone acetate - transdermal patch - 50/250 microgram/day

Australia - English - 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).

Australia - English - 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 postmenopausal oestrogen deficiency (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, 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 kliogest 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. kliogest is for use in postmenopausal women with an intact uterus. in perimenopausal women treated with kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.