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

organon pharma pty ltd - ethinylestradiol, quantity: 2.7 mg; etonogestrel, quantity: 11.7 mg - drug delivery system, vaginal - excipient ingredients: magnesium stearate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer; ethylene distearamide - nuvaring is for use for contraception.

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

organon pharma pty ltd - ethinylestradiol, quantity: 2.7 mg; etonogestrel, quantity: 11.7 mg - drug delivery system, vaginal - excipient ingredients: magnesium stearate; vinyl acetate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; isododecane; ethylene/vinyl acetate copolymer - nuvaring is for use for contraception.

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

physicians total care, inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - etonogestrel 11.7 mg - nuvaring® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. like oral contraceptives, nuvaring® is highly effective if used as recommended in this label. in three large clinical trials of 13 cycles of nuvaring® use, pregnancy rates were between one and two per 100 women-years of use. table iii lists the pregnancy rates for users of various contraceptive methods. nuvaring® 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 (current or history) - valvular heart disease with thrombogenic complications - severe hypertension - diabetes with vascular involvement - headaches with focal neurological symptoms - major surgery with prolonged immobilization - known or suspected carcinoma of the breast or personal history of breast cancer - carcinoma of the endometriu

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

organon usa inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - etonogestrel 0.12 mg in 1 d - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe nuvaring to women who are known to have or use 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 (5.5)] have diabetes mellitus with vascular disease [see wa

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

central texas community health centers - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - etonogestrel 0.12 mg in 1 d - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe nuvaring 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 mellitus with vascular diseas

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

organon llc - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. nuvaring 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 (5.5)] have diabetes mellitus with vascu

Israel - English - Ministry of Health

organon pharma israel ltd., israel - ethinylestradiol; etonogestrel - vaginal ring - ethinylestradiol 2.7 mg; etonogestrel 11.7 mg - ethinylestradiol - ethinylestradiol - contraception. the safety and efficacy has been established in women aged 18 to 40 years.

Israel - English - Ministry of Health

organon pharma israel ltd., israel - ethinylestradiol; etonogestrel - vaginal ring - ethinylestradiol 2.7 mg; etonogestrel 11.7 mg - ethinylestradiol - contraception. the safety and efficacy has been established in women aged 18 to 40 years.

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

a-s medication solutions - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - etonogestrel 0.12 mg in 1 d - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe nuvaring to women who are known to have or use 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 (5.5)] have diabetes mellitus with vascular disease [see wa

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

a-s medication solutions - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. nuvaring 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 (5.5)] have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - 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 (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of nuvaring [see warnings and precautions (5.6) and adverse reactions (6)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] risk summary nuvaring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue nuvaring use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs 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. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nuvaring and any potential adverse effects on the breastfed child from nuvaring or from the underlying maternal condition. safety and efficacy of nuvaring have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. nuvaring has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of nuvaring has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal. [see contraindications (4) and warnings and precautions (5.3).] the effect of renal impairment on the pharmacokinetics of nuvaring has not been studied.