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

aurobindo pharma limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - lo simpessetm (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. lo simpesse 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

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

aurobindo pharma limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - simpesse® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. simpesse 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

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.02 mg - levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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. contraceptive hormones and/or metabolites are present in human milk. cocs can red

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 0.1 mg - loseasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe loseasonique to women 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 have deep vein thrombosis or pulmonary embolism, now or in the past have cerebrovascular disease have coronary artery disease have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) have hypercoagulopathies have uncontrolled hypertension have diabetes with vascular disease have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 - smoke, if over age 35 - have deep vein thrombosis or pulmonary embolism, now or in the past - have cerebrovascular disease - have coronary artery disease - have thrombogenic valvular

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 - seasonique® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe seasonique to women who are known to have the following: - 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 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 (5.4)] . have diabetes with vascular

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 0.1 mg - aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 2  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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year 3 method (1) typical use 1 (2) perfect use 2 (3) (4) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63      calendar 9      ovulation method 3      sympto-thermal 6 2      post-ovulation 1 cap 7      parous women 40 26 42      nulliparous women 20 9 56 sponge      parous women 40 20 42      nulliparous women 20 9 56

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 0.050 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. table i: 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 2.0              copper t 380a 0.6 0.8 condom (male) without spermicide 3 14 (female) without sp

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

proficient rx lp - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - aviane (levonorgestrel and ethinyl estradiol tablets usp) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table ii 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, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year * method (1) typical use † (2) perfect use ‡ (3) (4) chance § 85 85 spermicides ¶ 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal # 2 post-ovulation 1 capÞ parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm Þ 20 6 56 withdrawal 19 4

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

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 100 microgram; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: maize starch; gelatin; magnesium stearate; hypromellose; macrogol 4000; titanium dioxide; iron oxide red; lactose monohydrate - oral contraception

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

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: gelatin; hypromellose; iron oxide yellow; titanium dioxide; magnesium stearate; lactose monohydrate; maize starch; macrogol 4000 - oral contraception