USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.035 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. reproduced with permission of the population council from j. trussell, et al: contraceptive failure in the united states: an update. studies in family planning, 21(1), january-february 1990. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebrovascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of th

USA - engelsk - NLM (National Library of Medicine)

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.035 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. reproduced with permission of the population council from j. trussell, et al: contraceptive failure in the united states: an update. studies in family planning, 21(1), january-february 1990. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebrovascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of th

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - daysee™ is indicated for use by females of reproductive potential to prevent pregnancy. daysee is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include females who are known to: - smoke, if over age 35 [see boxed warnings and warnings and precautions (5.1)]. - have current or history of deep vein thrombosis or pulmonary embolism [see warnings and precautions (5.1)]. - have cerebrovascular disease [see warnings and precautions (5.1)] - have coronary artery disease [see warnings and precautions (5.1)]. - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)]. - have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]. - have uncontrolled hypertension or hypertension with vascular disease [see warnings and precautions (5.3)]. - have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see warnings and precautions (5.7)]. - have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see warnings and precautions (5.8)]. - current diagnosis of, or history of, breast cancer, which may be hormone sensitive [see warnings and precautions (5.11)]. - liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see warnings and warnings and precautions (5.2) and use in specific populations (8.6)]. - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.4)]. risk summary there is no use for contraception in pregnancy; therefore, daysee should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to cocs 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 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breastfeeding females. this reduction can occur at any time but is less likely to occur once breastfeeding is well-established. when possible, advise the nursing woman to use other methods of contraception until she discontinues breastfeeding [see dosage and administration (2.1]. the developmental and health benefits of breastfeeding should be  considered along with the mother's clinical need for daysee and any potential adverse effects on the breastfed child from daysee or the underlying maternal condition. safety and efficacy of daysee have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. use of daysee before menarche is not indicated. daysee has not been studied in postmenopausal women and is not indicated in this population. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of daysee. however, steroid hormones may be poorly metabolized in patients with impaired liver function. daysee is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2 )].

USA - engelsk - NLM (National Library of Medicine)

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary artery disease. thrombogenic valvulopathies. thrombogenic rhythm disorders. diabetes with vascular involvement. uncontrolled hypertension. known or suspected carcinoma of the breast. carcinoma of the endometrium or other known or suspected estrogen-dependent

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - kurvelo is indicated for use by females of reproductive potential to prevent pregnancy. kurvelo is contraindicated in females who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings (1)]. have current or history of deep vein thrombosis or pulmonary embolism [see warnings (1)]. have cerebrovascular disease [see warnings (1)]. have coronary artery disease [see warnings (1)]. have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings (1)]. have inherited or acquired hypercoagulopathies [see (1)]. have uncontrolled hypertension or hypertension with vascular disease [see warnings (3)]. have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years

USA - engelsk - NLM (National Library of Medicine)

mayne pharma inc - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - amethia tablets are indicated for use by women to prevent pregnancy. amethia tablets are contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: ­smoke, if over age 35 [see boxed warningand warnings and precautions (5.1)] . ­have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] . ­have cerebrovascular disease [see warnings and precautions (5.1)]. ­have coronary artery disease [see warnings and precautions (5.1)] . ­have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] . ­ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] . ­ have uncontrolled hypertension [see warnings and precautions (5.5)] . ­have diabetes with vascular disease [see warnings and precautions (5.7)] . ­have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.8)] . - ­smoke, if over age 35 [see boxed warningand warnings and precautions (5.1)] . - ­have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] . - ­have cerebrovascular disease [see warnings and precautions (5.1)]. - ­have coronary artery disease [see warnings and precautions (5.1)] . - ­have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] . - ­ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] . - ­ have uncontrolled hypertension [see warnings and precautions (5.5)] . - ­have diabetes with vascular disease [see warnings and precautions (5.7)] . - ­have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.8)] . - undiagnosed abnormal genital bleeding [see warnings and precautions (5.9)] . - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.2)] . - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3)and use in specific populations (8.6)] . - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.10)and use in specific populations (8.1)] . - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.4)]. there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. women who do not breastfeed may start cocs no earlier than four to six weeks postpartum. when possible, advise the nursing mother to use other forms of contraception until she has weaned her child. estrogen-containing cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of amethia tablets have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. use of amethia tablets before menarche is not indicated. amethia tablets have not been studied in women who have reached menopause and is not indicated in this population. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of amethia tablets. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal. [see contraindications (4)and warnings and precautions (5.3)]. no studies have been conducted to evaluate the effect of renal disease on the disposition of amethia tablets.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ethinylestradiol, quantity: 30 microgram; drospirenone, quantity: 3 mg - tablet - excipient ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table i: percentage of women experiencing an unintended pregnancy during the first year of use of a contraceptive method na - not available levonorgestrel and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: thrombophlebitis or thromboembolic disorders a past history of deep-vein-thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. current diagnosis or history of breast cancer, which may be hormone sensitive. undiagnosed abnormal genital bleeding. cholestatic jaundice of pregnancy or jaundice with prior pill use. hepatic adenomas and carcinomas. known or suspected pregnancy. women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - bella is indicated for use:,? as an oral contraceptive.,? for the treatment of moderate acne vulgaris in women who seek oral contraception.,? for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of ethinylestradiol/drospirenone 20 microgram/3 mg tablets for pmdd was not assessed beyond 3 cycles. ethinylestradiol/drospirenone 20 microgram/3 mg tablets have not been evaluated for treatment of pms (premenstrual syndrome) (see section 5.1 pharmacodynamic properties ? clinical trials).

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400 - ethinylestradiol/ drospirenone tablet is indicated for use as:,?an oral contraceptive.,?treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of ethinylestradiol/ drospirenone tablet for pmdd was not assessed beyond 3 cycles. ethinylestradiol/ drospirenone tablet has not been evaluated for treatment of pms (premenstrual syndrome).