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 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. 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 use ● hepatic

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

amneal pharmaceuticals ny llc - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. zenchent 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)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9)  and use in specific populations (8.1)] . - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - hypersensitivity to any of the components. - 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)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early 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 low dose cocs prior to conception or during early pregnancy. do not use cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs 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. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of zenchent fe have been established in women of reproductive age. efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. zenchent fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of zenchent fe has not been studied in women 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 zenchent fe has not been studied in women with renal impairment. zenchent fe norethindrone and ethinyl estradiol tablets and ferrous fumarate tablets   important information about taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - both the light yellow pills and the brown pills may be swallowed whole or chewed and swallowed. if the pill is chewed, drink a full glass (8 ounces) of liquid immediately after swallowing. - 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets, talk to your healthcare provider. when you first start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 and spermicide) during this time period. before you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets? if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 and spermicide for the first 7 days that you take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. you do not need back-up contraception if you use the day 1 start. if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from another birth control pill: - start your new zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 pack. if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and previously used a vaginal ring or transdermal patch: - start using zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day you would have reapplied the next ring or patch.  if you start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from a progestin-only method such as an implant or injection: - start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets and you are switching from an intrauterine device or system (iud or ius): - start taking zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 and spermicide for the first 7 days that you take zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets? ” 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 zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 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 pill pack: step 1. look at your zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pill pack. see figure a. the zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets pill pack has: - 21 light yellow (active) pills with hormone for week 1 through week 3. - 7 brown (inactive) pills without hormones for week 4. figure a step 2. find: - where on your pack to start taking pills - in what order to take your pills (follow the arrows) - the week numbers step 3. remove the light yellow pill by pressing the pill through the foil in the bottom of the pill pack. see figure b. continue taking the light yellow pills for 21 days. figure b step 4. on the first day of week 4 start taking the brown pills. take the brown pill for 7 days. your period should start during this time. step 5. when you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the light yellow pills. - for a day 1 start: begin your next pill pack on the same day of the week as your first cycle pill pack. begin your next pill pack on the same day of the week as your first cycle pill pack. - for a sunday start: begin your next pill pack on sunday. begin your next pill pack on sunday. what should i do if i miss any zenchent fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate 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 and 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. - 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 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. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 revised: 05-2022-03

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

direct_rx - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - junel21 and junel fe 28 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 method lowest expected* typical** (no contraception) (85) (85) oral contraceptives combined progestin only 0.1 0.5 3 n/a*** n/a*** diaphragm with spermicidal cream or jelly 6 20 spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 vaginal sponge nullipa

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

international animal health products pty ltd - cobalt as cobalt (ii) sulfate; copper (cu) present as copper sulfate; iron as ammonium ferric citrate; vitamin m = folic acid = pga - oral solution/suspension - cobalt as cobalt (ii) sulfate mineral-cobalt active 36.0 mg/l; copper (cu) present as copper sulfate mineral-copper active 1.0 g/l; iron as ammonium ferric citrate mineral-iron active 10.0 g/l; vitamin m = folic acid = pga vitamin-m active 300.0 mg/l - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - anaemia

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmacosmos a/s - iron dextran - solution for injection - 20 %w/v - iron trivalent, parenteral preparations - porcine - vitamins & minerals

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmacosmos a/ s - iron dextran - solution for injection - 20 percent weight/volume - iron, parenteral preparations - pigs - vitamins and minerals

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

fit-bioceuticals limited - ascorbic acid,arthrospira platensis,beta vulgaris,cupric citrate,iron (ii) glycinate,levomefolate calcium,mecobalamin (co-methylcobalamin),pyridoxal 5-phosphate monohydrate,retinol acetate -

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

rn labs pty ltd - iron (ii) glycinate,leucine -

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

fit-bioceuticals pty ltd - iron (ii) glycinate, quantity: 88.8 mg (equivalent: iron, qty 24 mg); cupric citrate, quantity: 545.4 microgram (equivalent: copper, qty 200 microgram); levomefolate calcium, quantity: 250 microgram (equivalent: levomefolic acid, qty 230.875 microgram); mecobalamin, quantity: 250 microgram; beta vulgaris, quantity: 30 mg (equivalent: beta vulgaris, qty 240 mg); betacarotene, quantity: 2.7 mg (equivalent: vitamin a, qty 450 re/microgram); ascorbic acid, quantity: 200 mg; pyridoxal 5-phosphate monohydrate, quantity: 24.59 mg (equivalent: pyridoxine, qty 15 mg); arthrospira platensis, quantity: 100 mg - tablet, film coated - excipient ingredients: maltodextrin; hypromellose; citric acid; starch sodium octenyl succinate; vegetable oil; maize starch; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; dl-alpha-tocopherol; stearic acid; magnesium stearate; calcium hydrogen phosphate; croscarmellose sodium; silicon dioxide; potable water; sodium ascorbate; glycerol - maintain/support energy levels ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; aid/assist healthy red blood cell production ; helps maintain/support transport of oxygen in the body ; helps maintain/support haemoglobin formation/synthesis ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support nervous system health ; maintain/support nervous system function

Singapore - English - HSA (Health Sciences Authority)

beckman coulter singapore pte. ltd. - clinical chemistry - fe reagent, when used in conjunction with synchron lx® system(s), unicel® dxc 600/800 system(s) and synchron® systems fe/ibct calibrator kit, is intended for the quantitative determination of iron in human serum or heparinized plasma