Spojené štáty - angličtina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - 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 na - not available levonorgestrel and ethinyl estradiol tablet is contraindicated in females who are known to have or develop 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 or history of breast cancer, which may be hormone sensitive. undiagnosed abnormal genital bleeding. cholestatic jaundice of pregnancy or jaundice with prior pill use. hepatic adenomas and carcinomas. known or suspected pregnancy. women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Spojené štáty - angličtina - NLM (National Library of Medicine)

lotus pharmaceutical co., ltd. nantou plant - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - levonorgestrel tablets are a 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 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 are not indicated for routine use as a contraceptive. levonorgestrel tablets 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 ha

Spojené štáty - angličtina - NLM (National Library of Medicine)

acella pharmaceuticals - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel and ethinyl estradiol tablets, usp and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets, usp and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic disease. 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 rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warning

Spojené štáty - angličtina - NLM (National Library of Medicine)

actavis pharma, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 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 for pregnancy prevention. table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and implants, depend 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 sour

Spojené štáty - angličtina - NLM (National Library of Medicine)

naari pte limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. levonorgestrel and ethinyl estradiol tablets are contraindicated in females 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 (1)]. - have current or history of deep vein thrombosis or pulmonary embolism [see warnings (1)]. - have cerebrovascular disease [see warnings (1)]. - have coronary artery disease [see warnings (1)]. - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings (1)]. - have inherited or acquired hypercoagulopathies [see (1)]. - have uncontrolled hypertension or hypertension with vascular disease [see warnings (4)]. - have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see warnings (8)]. - have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see warnings (9)]. - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive. - liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see warnings (2)]. - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings (6)]. - undiagnosed abnormal uterine bleeding [see warnings (10)]. [lee-voe-nor-jes-trel and eh-thih-nill-ess-tra-dye-ole] important information about taking levonorgestrel and ethinyl estradiol tablets - take 1 pill every day at the same time. take the pills in the order directed on your pill pack. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take levonorgestrel and ethinyl estradiol tablets, talk to your healthcare provider. - when you first start taking levonorgestrel and ethinyl estradiol tablets, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking levonorgestrel and ethinyl estradiol tablets. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see what should i do if i miss any levonorgestrel and ethinyl estradiol pills? below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken levonorgestrel and ethinyl estradiol tablets according to directions, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking levonorgestrel and ethinyl estradiol tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking a light-orange pill, take another light-orange pill as soon as possible. continue taking all your remaining pills in order. start the first pill of your next pill pack the day after finishing your current pill pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider. - stop taking levonorgestrel and ethinyl estradiol tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms or spermicide) during this time period. before you start taking levonorgestrel and ethinyl estradiol tablets: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your pill pack. - look at your pill pack. your pill pack consists of 1 card that holds 28 individually sealed pills. the 28 pills consist of 21 light-orange pills (3 rows of 7 pills) and 7 pink pills (1 row of 7 pills). see figure a. - also find: where on the card to start taking pills (upper left corner) and in what order to take the pills (follow the weeks) - where on the card to start taking pills (upper left corner) and - in what order to take the pills (follow the weeks) - be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills. when should i start taking levonorgestrel and ethinyl estradiol tablets? if you start taking levonorgestrel and ethinyl estradiol tablets and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take levonorgestrel and ethinyl estradiol tablets. you do not need back-up contraception if you use the day 1 start. if you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from another birth control pill: - start your new levonorgestrel and ethinyl estradiol tablets pack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pill pack. if you start taking levonorgestrel and ethinyl estradiol tablets and previously used a vaginal ring: - start using levonorgestrel and ethinyl estradiol tablets on the day you would have started the next ring. if you start taking levonorgestrel and ethinyl estradiol tablets and previously used a transdermal patch: - start using levonorgestrel and ethinyl estradiol tablets on the day you would have started a new cycle (first patch application). if you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from a progestin-only method such as an implant or injection: - start taking levonorgestrel and ethinyl estradiol tablets on the day of removal of your implant, or on the day when you would have had your next injection. if you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from an intrauterine device or system (iud or ius): - start taking levonorgestrel and ethinyl estradiol tablets on the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take levonorgestrel and ethinyl estradiol tablets. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, “ when should i start taking levonorgestrel and ethinyl estradiol tablets? ?” above. follow these instructions for either a sunday start or a day 1 start . instructions for using your levonorgestrel and ethinyl estradiol tablets pill dispenser: sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts . to remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. - if your period starts on a sunday, take pill " 1 " that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the pill dispenser at the same time each day for 28 days. - after taking the last pill on day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take levonorgestrel and ethinyl estradiol tablets. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period . - take 1 pill every day in the order of the pill dispenser, at the same time each day, for 28 days. to remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. - after taking the last pill on day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. what should i do if i miss any levonorgestrel and ethinyl estradiol tablets pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps: - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: throw out the rest of the pill pack and start a new pack that same day. you may not have your period this month, but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - throw out the rest of the pill pack and start a new pack that same day. - you may not have your period this month, but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - if you are a sunday starter: keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured for: naari pte limited 36 robinson road, #13-06 city house, singapore 068877 issued december 2021

Spojené štáty - angličtina - NLM (National Library of Medicine)

naari pte limited - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 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 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, trussell j, stewart f, cates w, stewart gk, kowel d, guest f. contraceptive technology: seventeenth revised edition. new york ny: irvington publishers; 1998. - among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. - among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. - among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. - the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. - foams, creams, gels, vaginal suppositories, and vaginal film. - cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. - with spermicidal cream or jelly. - without spermicides. - the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the fda has declared the following dosage regimens of oral-contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. - however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. in a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. this represents an overall pregnancy rate of 0.84 per 100 woman-years. this rate includes patients who did not take the drug correctly. one or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. contraindications combination oral-contraceptives should not be used in women with any of the following conditions: - thrombophlebitis or thromboembolic disorders thrombophlebitis or thromboembolic disorders - a history of deep-vein thrombophlebitis or thromboembolic disorders a history of deep-vein thrombophlebitis or thromboembolic disorders - cerebrovascular or coronary artery disease (current or past history) cerebrovascular or coronary artery disease (current or past history) - valvular heart disease with thrombogenic complications valvular heart disease with thrombogenic complications - thrombogenic rhythm disorders thrombogenic rhythm disorders - hereditary or acquired thrombophilias hereditary or acquired thrombophilias - major surgery with prolonged immobilization major surgery with prolonged immobilization - diabetes with vascular involvement diabetes with vascular involvement - headaches with focal neurological symptoms headaches with focal neurological symptoms - uncontrolled hypertension uncontrolled hypertension - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive 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 carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy or jaundice with prior pill use cholestatic jaundice of pregnancy or jaundice with prior pill use - hepatic adenomas or carcinomas, or active liver disease hepatic adenomas or carcinomas, or active liver disease - known or suspected pregnancy known or suspected pregnancy - hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Kanada - angličtina - Health Canada

lupin limited - levonorgestrel - tablet - 0.75mg - levonorgestrel 0.75mg - contraceptives

Európska únia - angličtina - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

famy care europe ltd - levonorgestrel ethinylestradiol - coated tablets - 100/20 microgram

Spojené štáty - angličtina - NLM (National Library of Medicine)

actavis pharma, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.15 mg - quasense® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. do not prescribe quasense 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 rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1) ]. have uncontrolled hypertension [see warnings