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) - 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)

puretek corporation - chromium nicotinate (unii: a150ay412v) (chromic cation - unii:x1n4508kf1), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), calcium carbonate (unii: h0g - vitranol fe is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. also for treatment of condition in which iron deficiency and vitamin c deficiency occur together, along with a deficient intake or increased need for b-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence. this product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

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

puretek corporation - chromium nicotinate (unii: a150ay412v) (chromic cation - unii:x1n4508kf1), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), calcium carbonate (unii: h0g - venexa fe is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. also for treatment of condition in which iron deficiency and vitamin c deficiency occur together, along with a deficient intake or increased need for b-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence. this product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - kaitlib™ fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. the efficacy of kaitlib fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. kaitlib fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable 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 women who are known to:     o    smoke, if over age 35 [see  boxed  warning , and  warnings  and  precautions  (5.1.)]     o     have deep vein thrombosis or pulmonary embolism, now or in the past [see  warnings  and  precautions  (5.1)]     o    have cerebrovascular disease [see  warnings  and  precautions  (5.1)]     o    have coronary artery disease [see  warnings  and  precautions  (5.1)]     o    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)]     o    have inherited or acquired hypercoagulopathies [see  warnings  and  precautions  (5.1)]     o    have uncontrolled hypertension [see  warnings  and  precautions  (5.5)]     o    have diabetes with vascular disease [see  warnings  and  precautions  (5.7)]     o    have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see  warnings  and  precautions  (5.8)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.2)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3) , use in specific populations (8.7) , and clinical pharmacology (12.3)] - 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 (5.4)] risk summary there is no use for contraception in pregnancy; therefore, kaitlib 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 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 breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see dosage and administration (2.2) ]. the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for kaitlib fe and any potential adverse effects on the breast-fed child from kaitlib fe or from the underlying maternal condition. safety and efficacy of kaitlib 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. kaitlib fe have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of kaitlib fe has not been studied in subjects with renal impairment. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of kaitlib fe. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal [see  contraindications  (4) , and  warnings  and  precautions  (5.3)]. the safety and efficacy of kaitlib fe in women with a bmi > 35 kg/m2 have not been evaluated.

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

a-s medication solutions - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - lo loestrin® fe is indicated for use by women to prevent pregnancy [ see clinical studies (14) ] .   the efficacy of lo loestrin fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. lo loestrin 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 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 [see warnings and precautions (5.5) ] • have diabetes mellitus with vascular disease [see warnings and precautions (5.7) ] • have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.8) ] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.2) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3) ] - 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 (5.4) ] . risk summary there is no use for contraception in pregnancy; therefore, lo loestrin 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 combined hormonal contraceptives (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 also dosage and administration (2.2) .] the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lo loestrin fe and any potential adverse effects on the breastfed child from lo loestrin fe or from the underlying maternal condition. safety and efficacy of lo loestrin fe have been established in women of reproductive age. safety and efficacy are 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. lo loestrin fe has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of lo loestrin fe has not been studied in subjects with renal impairment.  no studies have been conducted to evaluate the effect of hepatic impairment on the disposition of lo loestrin fe. however, steroid hormones may be poorly metabolized in patients with impaired liver function. 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 [ s ee contraindications (4)   and  warnings and precautions (5.3) ] . the safety and efficacy of lo loestrin fe in women with a body mass index (bmi) >35 kg/m2 has not been evaluated [ s ee clinical studies (14) ] .  

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

akron pharma - ferrous sulfate (unii: 39r4tan1vt) (ferrous cation - unii:gw89581owr) -

Philippines - English - FDA (Food And Drug Administration)

jickstar pharma inc.; distributor: jickstar pharma inc. - thiamine hydrochloride (vitamin b1) , pyridoxine hydrochloride (vitamin b6) , cyanocobalamin (vitamin b12) , elemental iron (iron dextran) (vet.) - sterile solution for injection - 2mg/ 1.5mg/ 100mcg/ 100mg per ml

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

puretek corporation - chromium nicotinate (unii: a150ay412v) (chromic cation - unii:x1n4508kf1), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), calcium carbonate (unii: h0g - ventrixyl™ fe is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. also for the treatment of conditions in which iron deficiency and vitamin c deficiency occur together, along with a deficient intake or increased need for b-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence. this product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

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

preferred pharmaceuticals inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - junel 21 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.   % 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 nulliparous parous   9 20   20 40   implant   0.05   0.05   injection: depot

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

a-s medication solutions - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - 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. % 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 nulliparous parous 9 20 20 40 implant 0.05 0.05 injection: depot medroxyprogesterone acetate 0.3 0.3 iud progesterone t copper t 380a lng 20 1.5 0.6 0.1 2 0.8 0.1 condom without spermicides female male 5 3 21 14 cervical cap with spermicidal cream or jelly nulliparous parous 9 26 20 40 periodic abstinence (all methods) 1 to 9 25 withdrawal 4 19 female sterilization 0.5 0.5 male sterilization 0.10 0.15 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 for any other reason. *** n/a-data not available. 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 ).