Amerikas Savienotās Valstis - angļu - 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)] .

Malta - angļu - Malta Medicines Authority

mylan products limited - dydrogesterone; estradiol - film-coated tablet - dydrogesterone 10 mg; estradiol 2 mg - sex hormones and modulators of the genital system

Izraēla - angļu - Ministry of Health

abbott medical laboratories ltd, israel - dydrogesterone; estradiol; estradiol - film coated tablets - dydrogesterone 10 mg; estradiol 1 mg; estradiol 1 mg - dydrogesterone and estrogen - hormone replacement therapy (hrt) for estrogen deficiency symptoms in menopausal women at least 6 months since last menses.prevention of osteoporosis in postmenopausal women at high risk of future fractures. femoston 1/10 should only be used in patients who are intolerant of other products, approved for the prevention of osteoporosis or for whom these products are contra-indicated.femoston is indicated for women with an intact uterusexperience with treatment of women older than 65 years is limited.

Malta - angļu - Malta Medicines Authority

mylan products limited - dydrogesterone; estradiol - film-coated tablet - dydrogesterone 10 mg; estradiol 1 mg - sex hormones and modulators of the genital system

Malta - angļu - Malta Medicines Authority

mylan products limited - dydrogesterone; estradiol - film-coated tablet - dydrogesterone 5 mg; estradiol 1 mg - sex hormones and modulators of the genital system

Izraēla - angļu - Ministry of Health

abbott medical laboratories ltd, israel - dydrogesterone; estradiol as hemihydrate - film coated tablets - dydrogesterone 2.5 mg; estradiol as hemihydrate 0.5 mg - dydrogesterone and estrogen - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women at least 12 months since last menses.femoston is indicated for women with an intact uterus

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

alvogen, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d -     when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.     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. the estradiol transdermal system is contraindicated in women with any of the following conditions: the estradiol transdermal system 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 oral contraceptives inadvertently during early pregnancy. the estradiol transdermal system 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 b

Īrija - angļu - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - estradiol; dydrogesterone - film-coated tablet - 0.5/2.5 milligram(s) - progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Īrija - angļu - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - estradiol; dydrogesterone - film-coated tablet - 1mg/5mg milligram(s) - progestogens and estrogens, fixed combinations; dydrogesterone and estrogen

Īrija - angļu - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - dydrogesterone; estradiol - film-coated tablet - 1 mg/5 milligram(s) - progestogens and estrogens, fixed combinations; dydrogesterone and estrogen