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

sandoz sa-nv - levonorgestrel 1,5 mg - tablet - 1,5 mg - levonorgestrel 1.5 mg - levonorgestrel

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

ceres pharma sa-nv - levonorgestrel 1,5 mg - tablet - 1,5 mg - levonorgestrel 1.5 mg - levonorgestrel

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets 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 warning 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 (5.4)] . have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see warnings and precautions (5.7)] . - smoke, if over age 35 [see boxed warning 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 (5.4)] . - have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or 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 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 (5.3) ]. risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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 female 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 levonorgestrel and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets or the underlying maternal condition. safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated. levonorgestrel and ethinyl estradiol tablet has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of levonorgestrel and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. however, cocs may be poorly metabolized in patients with hepatic impairment. levonorgestrel and ethinyl estradiol tablets is contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2)] .

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

gavis pharmaceuticals, llc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 1.5 mg - my way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. to obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse. my way is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. my way is not indicated for routine use as a contraceptive. my way is contraindicated for use in the case of known or suspected pregnancy. many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. the few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. in general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. however, isolated post-ma

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

par pharmaceutical - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.05 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use myzilra® tablets 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. depending on method (calendar, ovulation, symptothermal, post-ovulation) adapted from hatcher ra et al, contraceptive technology: 17th revised edition. ny, ny: ardent media, inc., 1998. 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. known or suspected carcinoma of the breast. carcinoma of

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

physicians total care, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - jolessa™ tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. in a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of jolessa™ during which no backup contraception was utilized. this represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use. oral contraceptives are highly effective for pregnancy prevention. table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® implant system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic dis

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

teva pharmaceuticals usa, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - camrese®  is indicated for use by females of reproductive potential to prevent pregnancy. camrese 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 warning 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)]. hav

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

teva women's health llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - seasonique® is indicated for use by females of reproductive potential to prevent pregnancy. seasonique 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 warning 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 )].

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

northstar rx llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.05 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. *depending on method (calendar, ovulation, symptothermal, post-ovulation) adapted from hatcher ra et al, contraceptive technology : 17t h revised edition . ny, ny: ardent media, inc., 1998 levonest™ 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

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

sandoz inc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 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 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 1: percentage of women experiencing an unintended pregnancy during the first year of use of a contraceptive method method perfect use typical use levonorgestrel implants 0.05 0.05 male sterilization 0.1 0.15 female sterilization 0.5 0.5 depo-provera® (injectable progestogen) 0.3 0.3 oral contraceptives 5 combined 0.1 na progestin only 0.5 na iud progesterone 1.5 2 copper t 380a 0.6 0.8 condom (male) without spermicide 3 14 (female) without spermicide 5 21 cervical cap nulliparous women 9 20 par