India - English - Central Drugs Standard Control Organization

saga lab - ferric amm.cit.,folic acid,vit.b12,l-lysine monohdrt. - syr - 60mg,1mg,5mcg,70mg - 200ml

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

coopersurgical, inc. - ferric subsulfate (unii: 3qj8ws6v8h) (ferric cation - unii:91o4lml611) - ferric cation 259 mg in 1 g - ferric subsulfate, aqueous, is a stypic agent used for achieving local hemostasis. in punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 one method of applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edge of the wound and stretching the skin. the wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds. 2

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

pharmacosmos therapeutics inc. - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components (see warnings and precautions (5.1), description (11)) . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see data) . there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see clinical considerations) . iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. the findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (mrhd) of 1000 mg, respectively, based on body surface area ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 includes 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 women with parenteral iron products (such as monoferric) which may cause fetal bradycardia, especially during the second and third trimester. data animal data iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. the highest recommended dose in human clinical use is 20 mg iron/kg body weight. in a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (gd) 17 at doses of 3, 11, and 32 mg fe/kg/day. the doses of 11 and 32 mg fe/kg/day (approximately 0.1 and 0.3 times the mrhd of 1000 mg, based on body surface area (bsa)) resulted in an increase in the incidence of skeletal developmental delays. ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from gd7 to gd20, at doses of 11, 25 and 43 mg fe/kg/day. the dose of 43 mg fe/kg/day (approximately 0.8 times the mrhd of 1000 mg, based on bsa) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). fetal malformations and reduced fetal weights were also noted in the 25 mg fe/kg/day group (approximately 0.5 times the mrhd based on bsa). risk summary the available data on the use of monoferric in lactating women demonstrate that iron is present in breast milk. however, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monoferric in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea). safety and effectiveness have not been established in pediatric patients. of the 3934 patients in clinical studies of monoferric, 29% were 65 years and over, while 13% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

pharmacosmos a/s - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components [see warnings and precautions (5.1), description (11)] . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to ass

Canada - English - Health Canada

p.v.u., division of vÉtoquinol n.-a. inc. - vitamin b12; ferric ammonium citrate; soluble liver extract; cobalt gluconate; copper gluconate; thiamine hydrochloride; vitamin b2; pyridoxine hydrochloride; nicotinamide; dexpanthenol - liquid - 100mcg; 15mg; 27mg; .7mg; .2mg; 75mg; 2mg; 5mg; 100mg; 20mg - vitamin b12 100mcg; ferric ammonium citrate 15mg; soluble liver extract 27mg; cobalt gluconate .7mg; copper gluconate .2mg; thiamine hydrochloride 75mg; vitamin b2 2mg; pyridoxine hydrochloride 5mg; nicotinamide 100mg; dexpanthenol 20mg - vitamin b-complex with minerals - cattle; horses; sheep; swine (pigs)

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline philippines, inc. - vitamin b-complex , lysine , iron - syrup - each 5ml contains; thiamine hydrochloride (vitamin b1) - 10mg pyridoxine hydrochloride (vitamin b6)-5mg cyanocobalamin (vitamin b12)-25mcg l-lysine hydrochloride-300mg iron(as ferric pyrophospate soluble) - 30mg (equivalent to 250mg ferric pyrophosphate soluble) - l-lysine hcl and ferric pyrophosphate (equivalent to elemental iron). it also includes b-complex vitamins such as b 1 , b 6 and b 12 . this product also contains alcohol 0.95% v/v subcomponent. - this product is indicated for the treatment and prevention of vitamin b complex deficiency and iron deficiency anemia (ida).

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

vifor pharma pty ltd - ferric carboxymaltose, quantity: 1800 mg (equivalent: iron, qty 500 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - ferinject is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,the diagnosis of iron deficiency must be based on laboratory tests.,ferinject is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,the diagnosis of iron deficiency anaemia must be based on laboratory tests.

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

vifor pharma pty ltd - ferric carboxymaltose, quantity: 360 mg (equivalent: iron, qty 100 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - ferinject is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,the diagnosis of iron deficiency must be based on laboratory tests.,ferinject is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,the diagnosis of iron deficiency anaemia must be based on laboratory tests.

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

ceva animal health pty ltd - lysine-l hydrochloride; copper sulfate; ammonium ferric citrate; vitamin b2 = riboflavin; glycine; methionine-dl; biotin - vitamin h; choline bitartrate; inositol; vitamin b12 = cyanocobalamin; vitamin b3 = nicotinamide; pantothenol-d = panthenol-d; vitamin b6 hydrochloride = pyridoxine hydrochloride - parenteral liquid/solution/suspension - lysine-l hydrochloride amino acid-lysine-l active 20.0 mg/ml; copper sulfate mineral-copper active 70.0 ug/ml; ammonium ferric citrate mineral-iron active 15.0 mg/ml; vitamin b2 = riboflavin vitamin-b2 active 10.0 mg/ml; glycine amino acid-glycine other 20.0 mg/ml; methionine-dl amino acid-methionine-dl other 20.0 mg/ml; biotin - vitamin h vitamin-b complex other 10.0 ug/ml; choline bitartrate vitamin-b complex other 10.0 mg/ml; inositol vitamin-b complex other 10.0 mg/ml; vitamin b12 = cyanocobalamin vitamin-b12 other 150.0 ug/ml; vitamin b3 = nicotinamide vitamin-b3 other 100.0 mg/ml; pantothenol-d = panthenol-d vitamin-b5 other 15.0 mg/ml; vitamin b6 hydrochloride = pyridoxine hydrochloride vitamin-b6 other 10.0 mg/ml - nutrition & metabolism - cattle | dog | horse | beef | bitch | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | castrate | colt | co - mineral and nutritional additive | acetonaemia | actinobacillosis | amino acid supplement | amino acids | bone fragility | bone growth | calcium supplement | cartilage strength | copper deficiency | egg shell | fatty acid deficiency | fatty liver | glucose | grass tetany | hepatotoxic drugs | hypocalcaemia | hypomagnesaemia | ileitis | iodine deficiencies | lactating | laxative | l-carnitine supplement | liver abscess | liver damage | lysine deficiencies | milk fever | mineral additive | myopathies | myositis syndrome | pangamic acid | phosphorous supplement | rickets | selenium deficiency | shell strength | soft bone disease | vitamin b12 | vitamin d supplement | vitamin e deficiencies | zinc deficiencies

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

gm pharmaceuticals, inc - vitamin a palmitate (unii: 1d1k0n0vvc) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, d- (unii: a7e6112e4n) (.alpha.-tocopherol, d- - unii:n9pr3490h9), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacin (unii: 2679mf687a) (niacin - unii:2679mf687a), pyridoxine hydro - vitamin a 1500 [iu] in 1 ml - supplementation of the diet with nine essential vitamins and iron, and supplementation of the diet with fluoride for caries prophylaxis. the american academy of pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.2 escavite® lq multi-vitamin with iron and fluoride 0.25 mg provides fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3 each 1.0 ml supplies sodium fluoride (0.25 mg fluoride per 1 ml) plus nine essential vitamins and iron. escavite® lq multi-vitamin with iron and fluoride 0.25 mg supplies significant amounts of vitamins a,c,d,e, thiamin, riboflavin, niacin, vitamin b6, vitamin b12, and iron to supplement the diet, and to help assure the deficiencies of these nutrients will