Канада - английский - Health Canada

apotex inc - alendronic acid (alendronate sodium); vitamin d3 (cholecalciferol) - tablet - 70mg; 2800unit - alendronic acid (alendronate sodium) 70mg; vitamin d3 (cholecalciferol) 2800unit - vitamin d

Канада - английский - Health Canada

apotex inc - alendronic acid (alendronate sodium); vitamin d3 (cholecalciferol) - tablet - 70mg; 5600unit - alendronic acid (alendronate sodium) 70mg; vitamin d3 (cholecalciferol) 5600unit - vitamin d

Соединенные Штаты - английский - NLM (National Library of Medicine)

fresenius medical care holdings, inc. - iron sucrose (unii: fz7nyf5n8l) (ferric cation - unii:91o4lml611) - ferric cation 20 mg in 1 ml - venofer is indicated for the treatment of iron deficiency anemia (ida) in patients with chronic kidney disease (ckd). - known hypersensitivity to venofer risk summary published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see data) . available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. there are risks to the mother and fetus associated with untreated ida in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations) . animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see data). the estimated background risk of major birth defects and

Соединенные Штаты - английский - NLM (National Library of Medicine)

american regent, inc. - iron sucrose (unii: fz7nyf5n8l) (ferric cation - unii:91o4lml611) - ferric cation 20 mg in 1 ml - venofer is indicated for the treatment of iron deficiency anemia (ida) in patients with chronic kidney disease (ckd). - known hypersensitivity to venofer. risk summary published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see data) . available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. there are risks to the mother and fetus associated with untreated ida in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations) . animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see data). the estimated background risk of major birth defects and

Соединенные Штаты - английский - NLM (National Library of Medicine)

general injectables & vaccines, inc - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - ferric cation 50 mg in 1 ml - intravenous or intramuscular injections of infed are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. hypersensitivity to the product. all anemias not associated with iron deficiency.

Соединенные Штаты - английский - NLM (National Library of Medicine)

actavis pharma, inc. - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - ferric cation 50 mg in 1 ml - infed is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see warnings and precautions ( 5.1 ) ] . risk summary   parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see clinical considerations). advise pregnant persons of the potential risk to the fetus. available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. there are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see clinical considerations). iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbi

Соединенные Штаты - английский - NLM (National Library of Medicine)

allergan, inc. - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - ferric cation 50 mg in 1 ml - infed is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see warnings and precautions ( 5.1 ) ] . risk summary   parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see clinical considerations). advise pregnant persons of the potential risk to the fetus. available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. there are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see clinical considerations). iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations   disease-associated maternal and/or embryo/fetal risk    untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. fetal /neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. data animal data no consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. the animals used in these tests were not iron deficient. risk summary trace amounts of unmetabolized iron dextran are present in human milk. there are no data on the effects of iron dextran in breastfed infants or effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. infed is not recommended for use in infants under 4 months of age [s ee dosage and administration ( 2.2 ) ]. reports in the literature from countries outside the united states (in particular, new zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to e. coli.

Малайзия - английский - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - iron (iii) hydroxide polymaltose complex -

Малайзия - английский - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - iron (iii) hydroxide polymaltose complex -

Малайзия - английский - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbott laboratories (m) sdn. bhd. - folic acid; calcium pantothenate; ascorbic acid; riboflavine; niacinamide; ferrous sulfate; thiamine mononitrate; vitamin b12; pyridoxine hcl -