Marekani - Kiingereza - NLM (National Library of Medicine)

ohm laboratories inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - delyla 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. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraception.10 source: trussell j, contraceptive efficacy. in: hatcher ra

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

xiromed, llc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - vienva (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 year3 method (1) typical use1 (2) perfect use2 (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 cap7 parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm7 20 6 56 withdrawal 19 4 cond

Marekani - Kiingereza - NLM (National Library of Medicine)

a-s medication solutions - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - ashlyna is indicated for use by females of reproductive potential to prevent pregnancy. ashlyna is 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. 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition. safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets before menarche is not indicated. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. however, steroid hormones may be poorly metabolized in patients with impaired liver function. levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see contraindications (4) and warnings and precautions (5.2)].

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

lupin australia pty limited - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone; colloidal anhydrous silica - emergency contraception within 72 hours of unprotected intercourse.

Marekani - Kiingereza - NLM (National Library of Medicine)

watson pharma, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - ethinyl estradiol 0.01 mg

Marekani - Kiingereza - NLM (National Library of Medicine)

actavis pharma, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 0.1 mg

Marekani - Kiingereza - NLM (National Library of Medicine)

prasco laboratories - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring 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 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 warnin

Marekani - Kiingereza - 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 - introvaletm (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. do not prescribe introvaletm (levonorgestrel and ethinyl estradiol tablets) 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 [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 inherited or acquired hypercoagulopathies [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 rythym diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have