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

exeltis usa, inc. - cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), iron (unii: e1uol152h7) (iron - unii:e1uol152h7), iodine (unii: 9679tc07x4) (iodine - unii:9679tc07x4) - cholecalciferol 1000 [iu] - vitafol ® -nano 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 therapy 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).

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

exeltis usa, inc - vitamin a (unii: 81g40h8b0t) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), vitamin d (unii: 9vu1ki44gp) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol (unii: h4n855pnz1) (.alpha.-tocopherol - unii:h4n855pnz1), thiamine mononitrate (unii: 8k0i04919x) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacin (unii: 2679mf687a) (niacin - unii:2679mf687a), pyridoxine hydrochloride (unii: 68y4cf58bv) - vitamin a 2700 [iu] - vitafol ® -ob+dha is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* vitafol ® -ob+dha does not contain fish, fish oils, fish proteins or fish byproducts. vitafol ® -ob+dha 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 therapy 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 cyanocobalam

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

exeltis usa dermatology, llc - econazole nitrate (unii: h438wyn10e) (econazole - unii:6z1y2v4a7m) - econazole nitrate 10 mg in 1 g - ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by trichophyton rubrum, trichophyton mentagrophytes, and epidermophyton floccosum in patients 12 years of age and older. none. pregnancy category c there are no adequate and well-controlled trials with ecoza topical foam in pregnant women. ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. fetotoxic or embryotoxic effects were observed in segment i oral studies with rats receiving 10 to 40 times the human dermal dose. similar effects were observed in segment ii or segment iii studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. it is not known whether econazole nitrate is excreted in human milk. because many drugs are excreted in human milk, caution shou

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

exeltis usa, inc. - benznidazole (unii: yc42nrj1zd) (benznidazole - unii:yc42nrj1zd) - benznidazole 100 mg - benznidazole tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of chagas disease (american trypanosomiasis) caused by trypanosoma cruzi . this indication is approved under accelerated approval based on the number of treated patients who became immunoglobulin g (igg) antibody negative against the recombinant antigens of t. cruzi [see clinical studies ( 14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. benznidazole tablets are contraindicated in patients with a history of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives. reactions have included severe skin and soft tissue reactions [see adverse reactions ( 6.1)] . benznidazole tablets are contraindicated in patients who have taken disulfiram within the last two weeks. psychotic reactions may occur in patients

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

exeltis usa, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 65 mg in 5 g - nuvessa is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. nuvessa is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives. psychotic reactions have been reported with co-administration of disulfiram and oral metronidazole. do not administer concurrently with or within 2 weeks of disulfiram. disulfiram-like reactions to alcohol have been reported with co-administration of oral metronidazole; do not consume ethanol or propylene glycol, during and for at least 24 hours following treatment. risk summary there are no data available on the use of nuvessa in pregnant women. metronidazole usage in pregnancy has been associated with certain congenital anomalies (see data) . in animal reproduction studies, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally, during organogenesis to pregnant rats and rabbits at up to 30 times

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

exeltis usa, inc. - vitamin a (unii: 81g40h8b0t) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), vitamin d (unii: 9vu1ki44gp) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol (unii: h4n855pnz1) (.alpha.-tocopherol - unii:h4n855pnz1), thiamine mononitrate (unii: 8k0i04919x) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacin (unii: 2679mf687a) (niacin - unii:2679mf687a), pyridoxine hydrochloride (unii: 68y4cf58bv) - 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).

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

exeltis usa, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - slynd is a progestin indicated for use by females of reproductive potential to prevent pregnancy. slynd is contraindicated in females with the following conditions: - renal impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] - adrenal insufficiency [see warnings and precautions (5.1)] - presence or history of cervical cancer or progestin sensitive cancers [see warnings and precautions (5.4)] - liver tumors, benign or malignant, or hepatic impairment [see warnings and precautions (5.5) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] risk summary based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral

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

exeltis usa, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - tyblume is indicated for use by females of reproductive potential to prevent pregnancy. tyblume is contraindicated in females who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include females who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have current or history of deep vein thrombosis or pulmonary embolism [see warnings and precautions (5.1) ] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disea