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

elanco australasia pty ltd - iron dextran complex; vitamin a palmitate; vitamin d3 = cholecalciferol; tocopheryl acetate (vitamin e) - parenteral liquid/solution/suspension - iron dextran complex mineral-iron active 100.0 mg/ml; vitamin a palmitate vitamin-a active 100000.0 iu/ml; vitamin d3 = cholecalciferol vitamin-d3 active 1000.0 iu/ml; tocopheryl acetate (vitamin e) vitamin-e active 10.0 mg/ml - nutrition & metabolism - pig - piglet | neonatal piglet | new born pig | sucker pig - iron & haemopoietic agent | anaemia | haemopoietic agents | hematinic | iron deficiency

Israeli - Kiingereza - Ministry of Health

lapidot medical import and marketing ltd - iron sucrose - solution for injection - iron sucrose 20 mg/ml - iron-sorbitol-citric acid complex - iron-sorbitol-citric acid complex - ferrovin is indicated for the treatment of iron deficiency in the following indications:• where there is a clinical need for a rapid iron supply,• in patients who cannot tolerate oral iron therapy or who are non-compliant,• in active inflammatory bowel disease where oral iron preparations are ineffective,• in chronic kidney disease when oral iron preparations are less effective.the diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. hb (haemoglobin),serum ferritin, tsat (transferrin saturation), serum iron, etc.).

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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.

Malesia - Kiingereza - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

f.e. venture sdn. bhd. - iron dextran -

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - iron sucrose 540 mg/ml equivalent to iron 20 mg/ml - solution for injection - 20 mg/ml - active: iron sucrose 540 mg/ml equivalent to iron 20 mg/ml excipient: water for injection - venofer is indicated for the treatment of iron deficiency in the following indications: · where there is a clinical need for a rapid iron supply, · in patients who cannot tolerate oral iron therapy or who are non-compliant, · in active inflammatory bowel disease where oral iron preparations are ineffective.

Marekani - Kiingereza - 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.

Kenya - Kiingereza - Pharmacy and Poisons Board

dawa limited p.o box 16633-00620 nairobi, kenya - iron dextran - injection - iron dextran equiv. to iron 100mg per ml - antianemic preparations - iron preparations: iron

Marekani - Kiingereza - NLM (National Library of Medicine)

alaven pharmaceutical llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), heme iron polypeptide (unii: 31vdo12cjy) (heme iron polypeptide - unii:31vdo12cjy), iron dextran (unii: 95hr524n2m) (iron dextran - unii:95hr524n2m), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - folic acid 1 mg - biferarx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients. hemochromatosis and hemosiderosis are contraindications to iron therapy.

Marekani - Kiingereza - NLM (National Library of Medicine)

redpharm drug, inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual du