Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - zinc sulphate.; tyrosine.; calcium chloride.; taurine; magnesium sulphate.; tryptophan; histidine; sodium acetate.; methionine; sodium glycerophosphate; potassium chloride.; threonine; isoleucine; phenylalanine; valine; serine; lysine; leucine; glycine; proline,; arginine; fish oil; alanine; olive oil; glucose monohydrate; medium chain triglycerides; soya bean oil. -

Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - alanine; arginine; calcium chloride dihydrate; fish oil, rich in omega -3 acids; glucose monohydrate; glycine; histidine; isoleucine; leucine; lysine acetate; magnesium sulphate heptahydrate; methionine; olive oil, refined; phenylalanine; potassium chloride; proline; serine; sodium acetate trihydrate; sodium glycerophosphate anhydrous; soya bean oil, refined; taurine; threonine; triglycerides, medium chain; tryptophan; tyrosine; valine; zinc sulphate heptahydrate - injection, emulsion - 14.0g/1000ml - alanine 14.0g/1000ml; arginine 12.0g /1000ml; calcium chloride dihydrate 0.74g /1000ml; fish oil, rich in omega -3 acids 30g /1000ml; glucose monohydrate 462g /1000ml; glycine 11.0g /1000ml; histidine 3.0g /1000ml; isoleucine 5.0g /1000ml; leucine 7.4g /1000ml; lysine acetate 9.3g /1000ml; magnesium sulphate heptahydrate 2.47g /1000ml; methionine 4.3g /1000ml; olive oil, refined 50g /1000ml; phenylalanine 5.1g /1000ml; potassium chloride 4.48g /1000ml; proline 11.2g /1000ml; serine 6.5g /1000ml; sodium acetate trihydrate 5.62g /1000ml; sodium glycerophosphate anhydrous 4.18g /1000ml; soya bean oil, refined 60.0g /1000ml; taurine 1.0g /1000ml; threonine 4.4g /1000ml; triglycerides, medium chain 60g /1000ml; tryptophan 2.0g/1000ml; tyrosine 0.4g /1000ml; valine 6.2g /1000ml; zinc sulphate heptahydrate 0.023g /1000ml

Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - alanine; arginine; calcium chloride dihydrate; fish oil, rich in omega -3 acids; glucose monohydrate; glycine; histidine; isoleucine; leucine; lysine acetate; magnesium sulphate heptahydrate; methionine; olive oil, refined; phenylalanine; potassium chloride; proline; serine; sodium acetate trihydrate; sodium glycerophosphate anhydrous; soya bean oil, refined; taurine; threonine; triglycerides, medium chain; tryptophan; tyrosine; valine; zinc sulphate heptahydrate - injection, emulsion - 14.0g/1000ml - alanine 14.0g/1000ml; arginine 12.0g /1000ml; calcium chloride dihydrate 0.74g /1000ml; fish oil, rich in omega -3 acids 30g /1000ml; glucose monohydrate 143g /1000ml; glycine 11.0g /1000ml; histidine 3.0g /1000ml; isoleucine 5.0g /1000ml; leucine 7.4g /1000ml; lysine acetate 9.3g /1000ml; magnesium sulphate heptahydrate 2.47g /1000ml; methionine 4.3g /1000ml; olive oil, refined 50g /1000ml; phenylalanine 5.1g /1000ml; potassium chloride 4.48g /1000ml; proline 11.2g /1000ml; serine 6.5g /1000ml; sodium acetate trihydrate 5.62g /1000ml; sodium glycerophosphate anhydrous 4.18g /1000ml; soya bean oil, refined 60.0g /1000ml; taurine 1.0g /1000ml; threonine 4.4g /1000ml; triglycerides, medium chain 60g /1000ml; tryptophan 2.0g/1000ml; tyrosine 0.4g /1000ml; valine 6.2g /1000ml; zinc sulphate heptahydrate 0.023g /1000ml

European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - busulfan - hematopoietic stem cell transplantation - alkyl sulfonates - busulfan fresenius kabi followed by cyclophosphamide (bucy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (hpct) in adult patients when the combination is considered the best available option.busulfan fresenius kabi followed by cyclophosphamide (bucy4) or melphalan (bumel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed fresenius kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed fresenius kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed fresenius kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed fresenius kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

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

fresenius kabi usa, llc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion [see warnings and precautions (5.4)]. available data with sincalide for injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. however, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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 to 4% and 15 to 20%, respectively. data animal data there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. risk summary there are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sincalide for injection and any potential adverse effect on the breastfed infant from sincalide for injection or from the underlying condition. the safety and effectiveness in pediatric patients have not been established. clinical studies of sincalide for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - calcium chloride dihydrate eqv. calcium chloride; fish oil, rich in omega-3 acids; glucose monohydrate eqv. glucose; glycine; l-alanine; l-arginine; l-histidine; l-isoleucine; l-leucine; l-lysine acetate equv. l-lysine; l-methionine; l-phenylalanine; l-proline; l-serine; l-threonine; l-tryptophan; l-tyrosine; l-valine; magnesium sulfate heptahydrate as magnesium sulfate; olive oil, refined; potassium chloride; sodium acetate trihydrate as sodium acetate; sodium glycerophosphate hydrated as sodium glycerophosphate; soy-bean oil, refined; taurine; triglycerides, medium-chain; zinc sulfate heptahydrate as zinc sulfate - injection, emulsion - calcium chloride dihydrate eqv. calcium chloride 0.28g/1000ml; fish oil, rich in omega-3 acids 4.3g/1000ml; glucose monohydrate eqv. glucose 85g/1000ml; glycine 7.2g/1000ml; l-alanine 9.2g/1000ml; l-arginine 7.9g/1000ml; l-histidine 2g/1000ml; l-isoleucine 3.3g/1000ml; l-leucine 4.8g/1000ml; l-lysine acetate equv. l-lysine 4.3g/1000ml; l-methionine 2.8g/1000ml; l-phenylalanine 3.3g/1000ml; l-proline 7.3g/1000ml; l-serine 4.3g/1000ml; l-threonine 2.9g/1000ml; l-tryptophan 1.3g/1000ml; l-tyrosine 0.26g/1000ml; l-valine 4.1g/1000ml; magnesium sulfate heptahydrate as magnesium sulfate 0.61g/1000ml; olive oil, refined 7.2g/1000ml; potassium chloride 2.3g/1000ml; sodium acetate trihydrate as sodium acetate 1.6g/1000ml; sodium glycerophosphate hydrated as sodium glycerophosphate 2.3g/1000ml; soy-bean oil, refined 8.7g/1000ml; taurine 0.65g/1000ml; triglycerides, medium-chain 8.7g/1000ml; zinc sulfate heptahydrate as zinc sulfate 0.0066g/1000ml

Canada - English - Health Canada

fresenius kabi canada ltd - zinc (zinc sulfate) - solution - 1mg - zinc (zinc sulfate) 1mg

Canada - English - Health Canada

fresenius kabi canada ltd - zinc (zinc sulfate) - solution - 5mg - zinc (zinc sulfate) 5mg

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

fresenius kabi usa, llc - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6) ] risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, 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 to 4% and 15 to 20%, respectively. clinical considerations disea