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

gedeon richter australia pty ltd - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: potato starch; maize starch; purified talc; lactose monohydrate; colloidal anhydrous silica; magnesium stearate - emergency contraception within 72 hours of unprotected intercourse.

Yhdysvallat - englanti - 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)] .

Uusi-Seelanti - englanti - 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

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

aspen pharmacare australia pty ltd - atovaquone, quantity: 150 mg/ml - oral liquid, suspension - excipient ingredients: poloxamer; saccharin sodium; benzyl alcohol; purified water; xanthan gum; flavour - wellvone suspension is indicated for: acute treatment of mild to moderate pneumocystis carinii pneumonia (pcp) (difference of alveolar and arterial oxygen tensions [(a-a)do2]<=45mmhg(6kpa) and oxygen tension in arterial blood (pa02)>=60mmhg(8kpa) breathing room air) in adult patients with aids who are intolerant of trimethoprim/sulphamethoxazole therapy.

Kanada - englanti - Health Canada

teva canada limited - levonorgestrel - tablet - 0.75mg - levonorgestrel 0.75mg - contraceptives

Yhdysvallat - englanti - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - larissia 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 typical use1 perfect use2 (1) (2) (3) (4) chance4 spermicides5 periodic abstinence calendar ovulation method sympto-thermal6 post-ovulation cap7 parous women nulliparous women sponge parous women nulliparous women diaphragm7 withdrawal condom8 female (reality) male pill progestin only combined iud progesterone t copper t380a lng 20 depo-provera® levonorgestrel impl

Yhdysvallat - englanti - 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 - afirmelle 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: hatch

Yhdysvallat - englanti - NLM (National Library of Medicine)

sandoz inc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - vienvatm (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 c

Yhdysvallat - englanti - NLM (National Library of Medicine)

allergan, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel 52 mg - liletta is indicated for prevention of pregnancy for up to 8 years.  liletta is indicated for the treatment of heavy menstrual bleeding for up to 5 years in patients who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed. liletta is contraindicated when one or more of the following conditions exist: pregnancy [see use in specific populations ( 8.1 ) ] for use as post-coital contraception (emergency contraception)  congenital or acquired uterine anomaly, including leiomyomas, that distorts the uterine cavity and would be incompatible with correct ius placement [see warnings and precautions ( 5.10 )] acute pelvic inflammatory disease (pid) [see warnings and precautions ( 5.4 )] postpartum endometritis or infected abortion in the past 3 months [see warnings and precautions ( 5.2 , 5.4 )] known or suspected uterine or cervical malignancy known or suspected breast cancer or other hormone-s

Yhdysvallat - englanti - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 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 copper t 380a 0.6 0.8 condom (male) without spermicide 3 14 (female) without spermicide 5 21 cervical cap nulliparous women 9 20 par