Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.03 mg - blisovi fe 1.5/30 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from ra hatcher et al, reference 7. 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 - cerebral vascular or coronary artery disease - known or suspected carcinoma of the breast - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

afaxys pharma, llc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 0.02 mg - tarina fe 1/20 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from ra hatcher et al, reference 7. * the authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. ** this term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

a-s medication solutions - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate and ethinyl estradiol tablets are 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table 1 lowest expected and typical failure rates during the first year of continuous use of a method % of women experiencing an unintended pregnancy in the first year of continuous use method lowest expected* typical** (no contraception) (85) (85) oral contraceptives 3 combined 0.1 n/a*** progestin only 0.5 n/a*** diaphragm with spermicidal cream or jelly 6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 vaginal sponge nulliparous 9 20 parous 20 40 implant 0.05 0.05 injection: depot medroxyprogesterone acetate 0.3 0.3 iud progesterone t 1.5 2 copper t 380a 0.6 0.8 lng 20 0.1 0.1 condom without spermicides female 5 21 male 3 14 cervical cap with spermicidal cream or jelly nulliparous 9 20 parous 26 40 periodic abstinence (all methods) 1 to 9 25 withdrawal 4 19 female sterilization 0.5 0.5 male sterilization 0.1 0.15 adapted from ra hatcher et al, reference 7. *the authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. **this term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ***n/a-data not available. oral contraceptives are contrainditaded in women who currently have the following conditions:

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

actavis pharma, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - na/ee and fe is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of na/ee and fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. na/ee and fe 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 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

proficient rx lp - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1.5 mg - junel ® 21 and junel ® fe 28 are 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 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, 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 in the first year of continuous use method lowest expected* typical† (no contraception) (85) (85) oral contraceptives combined progestin only 0.1 0.5 3 n/a‡ n/a‡ diaphragm with spermicidal cream or jelly 6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 vaginal sponge nulliparous parous 9 20 20 40 implant 0.05 0.05 injection: depot medroxyprogesterone acetate 0.3 0.3 iud progeste

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

northstar rx llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1.5 mg - larintm fe 1.5/30 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 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, 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 in the first year of continuous use method lowest expected* typical** (no contraception) (85) (85) oral contraceptives combined progestin only 0.1 0.5 3 n/a*** n/a*** diaphragm with spermicidal cream or jelly 6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 vaginal sponge nulliparous parous 9 20 20 40 implant 0.05 0.05 injection: depot medroxyprogesterone acetate 0.3 0.3 iud progesterone t copp

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

aurobindo pharma limited - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - aurovela 1/20 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. - oral contraceptives are contraindicated in women who currently have 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 of, or history of, breast cancer, which may be hormone sensitive - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

aurobindo pharma limited - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1.5 mg - aurovela 1.5/30 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates.  - oral contraceptives are contraindicated in women who currently have 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 of, or history of, breast cancer, which may be hormone sensitive - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy o

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - taytulla is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of taytulla in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. taytulla 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 warnings and precautions (5.4) ] • have diabetes mellitus with vascular disease [see warnings and precautions (5.6) ] • have headaches with focal neurological symptoms or have migraine headaches with aura       • women over age 35 with any migraine headaches [see warnings and precautions (5.7) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [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) ] - 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, taytulla should be discontinued during pregnancy. 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 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 breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see  dosage and administration (2.2) ] . the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for taytulla and any potential adverse effects on the breast-fed child from taytulla or from the underlying maternal condition. safety and efficacy of taytulla have been established in women of reproductive age. efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. taytulla has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of taytulla has not been studied in subjects with renal impairment [ see clinical pharmacology (12.3) ] .  the pharmacokinetics of taytulla has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded [ s ee contraindications (4) and warnings and precautions (5.2) ] . the safety and efficacy of taytulla in women with a body mass index (bmi) >35 kg/m2 has not been evaluated [ s ee clinical studies (14) ] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

aurobindo pharma limited - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1.5 mg - aurovela fe 1.5/30 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 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, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. - oral contraceptives are contraindicated in women who currently have 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 of, or history of, breast cancer, which may be hormone sensitive - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of preg