アメリカ合衆国 - 英語 - 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)] .

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - levonorgestrel 1.5mg - tablet - 1.5 mg - active: levonorgestrel 1.5mg excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose poloxamer 188

マルタ - 英語 - Medicines Authority

biogaran 15, boulevard charles de gaulle, colombes 92700, france - levonorgestrel, ethinylestradiol - coated tablet - levonorgestrel 0.15 mg ethinylestradiol 0.03 mg - sex hormones and modulators of the genital system

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel tablets, 0.75 mg are progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. to obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. the second tablet should be taken 12 hours later. levonorgestrel tablets, 0.75 mg are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. levonorgestrel tablets, 0.75 mg are not indicated for routine use as a contraceptive. levonorgestrel tablets, 0.75 mg are 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-marketing cases of decreased milk production have been reported. small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. use of levonorgestrel tablets, 0.75 mg emergency contraception before menarche is not indicated. this product is not intended for use in postmenopausal women. no formal studies have evaluated the effect of race. however, clinical trials demonstrated a higher pregnancy rate in chinese women with both levonorgestrel tablets, 0.75 mg and the yuzpe regimen (another form of emergency contraception). the reason for this apparent increase in the pregnancy rate with emergency contraceptives in chinese women is unknown. no formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg. no formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg. levonorgestrel is not a controlled substance. there is no information about dependence associated with the use of levonorgestrel tablets, 0.75 mg.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: lactose; hypromellose; microcrystalline cellulose; magnesium stearate; polysorbate 80; titanium dioxide; macrogol 400; allura red ac aluminium lake; brilliant blue fcf aluminium lake - seasonique is indicated for use as an oral contraceptive.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; maize starch; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400 - oral contraception

オーストラリア - 英語 - 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

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

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

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; poloxamer; magnesium stearate - emergency contraception within 72 hours of unprotected intercourse.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - levonorgestrel -