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

afaxys pharma, llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - tarina fe 1/20 eq 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 pregnan

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

rpk pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - 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

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

rpk pharmaceuticals, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - microgestin and microgestin fe 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 i: 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 lowest method 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 spe

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

rpk pharmaceuticals, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - microgestin and microgestin fe 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. 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 pregnancy or jaundice with prior pill u

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

glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - hailey 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 1 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 inj

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

afaxys pharma, llc - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) -  tarina 24 fe is indicated for use by women to prevent pregnancy [see clinical studies (14)] . the efficacy of tarina 24 fe in women with a body mass index (bmi) of greater than 35 kg/m2 has not been evaluated. tarina 24 fe 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 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 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 [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - 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 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 [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - 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, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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 chcs 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. data human data 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 chcs before conception or during early pregnancy. risk summary contraceptive hormones and/or metabolites are present in human milk. chcs 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 (2.2).] the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and any potential adverse effects on the breastfed child from norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets or from the underlying maternal condition. safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets have 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 [see contraindications (4) and warnings and precautions (5.2)]. the pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets have not been studied in women with renal impairment. the safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) greater than 35 kg/m2 has not been evaluated [see clinical studies (14)] . tarina® 24 fe   (norethindrone acetate and ethinyl estradiol tablets usp and ferrous fumarate tablets) important information about taking tarina 24 fe - take 1 pill every day at the same time. take the pills in the order directed on your blister 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 tarina 24 fe, talk to your healthcare provider.  - when you first start taking tarina 24 fe,  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 tarina 24 fe. 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 tarina 24 fe  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 tarina 24 fe  according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking tarina 24 fe.  - if you have vomiting or diarrhea within 3 to 4 hours of taking a light yellow to yellow active pill, take another light yellow to yellow pill from your extra blister pack. if you do not have an extra blister pack, take the next light yellow to yellow pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister 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 and a spermicide, until you check with your healthcare provider.   - stop taking tarina 24 fe  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 and spermicide) during this time period. before you start taking tarina 24 fe: - 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 blister pack.  - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.   when should i start taking tarina 24 fe? if you start taking tarina 24 fe  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 and spermicide for the first 7 days that you take tarina 24 fe. you do not need back-up contraception if you use the day 1 start.   if you start taking tarina 24 fe  and you are switching from another birth control pill:   - start your new tarina 24 fe  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 pack.   if you start taking tarina 24 fe  and previously used a vaginal ring or transdermal patch:   - start using tarina 24 fe  on the day you would have reapplied the next ring or patch. if you start taking tarina 24 fe  and you are switching from a progestin-only method such as an implant or injection:    - start taking tarina 24 fe  on the day of removal of your implant or on the day when you would have had your next injection.  if you start taking tarina 24 fe  and you are switching from an intrauterine device or system (iud or ius):    - start taking tarina 24 fe  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 and spermicide for the first 7 days that you take tarina 24 fe.  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 tarina 24 fe? ” above. follow these instructions for either a sunday start or a day 1 start . 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.    - 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 blister pack at the same time each day for 28 days.   - after taking the last pill on day 28 from the blister pack, 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 and spermicide for the first 7 days of the first cycle that you take tarina 24 fe.  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 blister pack, at the same time each day, for 28 days.   - after taking the last pill on day 28 from the blister pack, 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.  instructions for using your blister pack:   the tarina 24 fe  blister pack has 24 "active" light yellow to yellow pills (with hormones) to be taken for 24 days, followed by 4 "reminder" brown pills (without hormones) to be taken for the next 4 days. look for: - where on the pack to start taking pills - in what order to take the pills. follow the arrows shown in figure a . - the week numbers as shown in figure a.   what if should i do if i miss any tarina 24 fe  light yellow to yellow pills? if you miss 1 light yellow to yellow 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 light yellow to yellow pills in a row 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 and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 light yellow to yellow pills in a row in week 3 or week 4, or you miss 3 or more light yellow to yellow pills in a row at any time, 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.  - throw out the rest of the pill pack and start a new pack that same day.  - 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.   - 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.   - 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 and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.   if you miss any of the 4 brown “reminder” pills in week 4 , throw away the pills you missed and keep taking 1 pill each day until the pack is empty. you do not need to use a back-up method of birth control. 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 has been approved by the u.s. food and drug administration. manufactured for: afaxys pharma, llc charleston, sc, 29403, usa. manufactured by: aurobindo pharma limited unit-vii (sez) mahaboob nagar (dt)-509302, india revised: 11/2023

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - blisovi 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. 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 p

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - 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 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 or jaundice with prior pill use - hepatic adenomas or carcinomas - are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ) .

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - blisovi™ 24 fe is indicated for use by women to prevent pregnancy [see clinical studies (14)]. the efficacy of blisovi 24 fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. blisovi 24 fe 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 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 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 [see warnings and precautions (5.7)] - 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 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 [see warnings and precautions (5.7)] ■    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, blisovi 24 fe 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 chcs 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. data human data 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 chcs before conception or during early pregnancy. risk summary contraceptive hormones and/or metabolites are present in human milk. chcs 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 (2.2)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for blisovi 24 fe and any potential adverse effects on the breastfed child from blisovi 24 fe or from the underlying maternal condition. safety and efficacy of blisovi 24 fe 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. blisovi 24 fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of blisovi 24 fe 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 [see contraindications (4) and warnings and precautions (5.2)]. the pharmacokinetics of blisovi 24 fe has not been studied in women with renal impairment. the safety and efficacy of blisovi 24 fe in women with a body mass index (bmi) > 35 kg/m2 has not been evaluated [see clinical studies (14)].

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

exeltis usa, inc. - doconexent (unii: zad9okh9jc) (doconexent - unii:zad9okh9jc), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), .alpha.-tocopherol acetate, dl- (unii: wr1wpi7ew8) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), beta carotene (unii: 01yae03m7j) (beta carotene - unii:01yae03m7j), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), thiamine mononitrate (unii: 8k0i04919x) (thiamine ion - unii:4abt0j945j), r - vitafol ® fe + prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives. folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. iron supplementation is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin b12).