Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - 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. jinteli is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions ( 5.2)]. - breast cancer or a history of breast cancer [see warnings and pr ecautions (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 and mi), or a history of these conditions [see warnings and precautions (5.1)]. - known anaphylactic reaction, angioedema, or hypersensitivity to jinteli - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders.  risk summary jinteli is not indicated for use in pregnancy. there are no data with the use of jinteli 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 (estrogens and progestins) product 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 plus progestogens are present in human milk and can reduce milk production in breastfeeding women. this reduction can occur at any time but is less likely to occur once breastfeeding is well-established. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for jinteli and any potential adverse effects on the breastfed child from jinteli or from the underlying maternal condition. jinteli is 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 jinteli to determine whether those over 65 years of age differ from younger subjects in their response to jinteli. the women’s health initiative studies 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 (14.5)] . 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 (14.5)] . 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 plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.6)] . 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 (14.6)] .

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - vagifem 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 deep vein thrombosis, pulmonary embolism or history of these conditions - active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions - known liver dysfunction or disease - known or suspected pregnancy vagifem 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. vagifem should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk. detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen. caution should be

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

physicians total care, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - jintelitm (norethindrone acetate and ethinyl estradiol tablets, usp) are indicated in women with an intact uterus for the: - treatment of moderate to severe vasomotor symptoms associated with the 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. 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. risk factors for osteoporosis include low bone mineral dens

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1.0 mg in 1 g - divigel® (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause. estrogen products, including divigel® (estradiol gel) 0.1%, 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 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. - known hypersensitivity to the ingredients of divigel® . - known or suspected pregnancy. there is no indication for divigel® 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 .)

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

physicians total care, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 100 mg - prometrium capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. prometrium capsules should not be used in women with any of the following conditions: - prometrium capsules should not be used in patients with known hypersensitivity to its ingredients. prometrium capsules contain peanut oil and should never be used by patients allergic to peanuts. - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast. - 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. - known or suspected pregnancy. there is no indication for prometrium capsules in pregnancy. there appears to be little or no increased risk of birth defects in chi

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

remedyrepack inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 1 mg - estradiol tablets 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 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 to 800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estrogens should not be used in individuals with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. - 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. - estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. estradiol tablets 2 mg contain fd&c yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. although the overall incidence of fd&c yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. - known or suspected pregnancy. there is no indication for estradiol tablets 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 .)

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

remedyrepack inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 2 mg - estradiol tablets 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 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 to 800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estrogens should not be used in individuals with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. - 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. - estradiol tablets should not be used in patients with known hypersensitivity to its ingredients. estradiol tablets 2 mg contain fd&c yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. although the overall incidence of fd&c yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. - known or suspected pregnancy. there is no indication for estradiol tablets 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 .)

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - estradiol, quantity: 1 mg/g - gel - excipient ingredients: purified water; propylene glycol; carbomer 934p; ethanol; trolamine - short-term treatment of climacteric symptoms after natural or surgical menopause. whenever possible the lowest effective dose should be used. review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see section 5.1 pharmacodynamic properties - clinical trials and section 4.4 special warnings and precautions for use). sandrena should only be continued for as long as the benefit outweighs the risks

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of 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 future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 3.09 mg (equivalent: estradiol, qty 3 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of 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 future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing( see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.