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

baxter healthcare (malaysia) sdn. bhd. - alanine; arginine; aspartic acid; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate, trihydrate; sodium glycerophosphate, hydrated; potassium chloride; magnesium chloride, hexahydrate; glucose monohydrate; calcium chloride dihydrate; refined olive oil; soya bean oil refined -

Canada - English - Health Canada

hospira healthcare ulc - magnesium chloride; potassium phosphate dibasic; l-isoleucine; l-leucine; l-lysine (l-lysine acetate); methionine; l-phenylalanine; l-threonine; tryptophan; l-valine; l-alanine; l-arginine; l-aspartic acid; glutamic acid; glycine; histidine; l-proline; serine; n-acetyl-l-tyrosine; sodium chloride; potassium chloride - solution - 102mg; 522mg; 660mg; 1g; 1.05g; 172mg; 298mg; 400mg; 200mg; 500mg; 993mg; 1.018g; 700mg; 738mg; 500mg; 300mg; 722mg; 530mg; 270mg; 410mg; 45mg - magnesium chloride 102mg; potassium phosphate dibasic 522mg; l-isoleucine 660mg; l-leucine 1g; l-lysine (l-lysine acetate) 1.05g; methionine 172mg; l-phenylalanine 298mg; l-threonine 400mg; tryptophan 200mg; l-valine 500mg; l-alanine 993mg; l-arginine 1.018g; l-aspartic acid 700mg; glutamic acid 738mg; glycine 500mg; histidine 300mg; l-proline 722mg; serine 530mg; n-acetyl-l-tyrosine 270mg; sodium chloride 410mg; potassium chloride 45mg - caloric agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

fresenius kabi ltd - magnesium; sodium; chloride; l-alanine; l-arginine; l-aspartic acid; l-cysteine hydrochloride monohydrate; l-glutamic acid; glycine; l-isoleucine; l-leucine; l-lysine monohydrochloride; l-methionine; l-phenylalanine; l-proline; l-serine; l-tryptophan; l-tyrosine; l-valine; glucose; potassium; calcium; l-threonine; l-histidine - solution for injection - 15mmol/1litre ; 50mmol/1litre ; 50mmol/1litre ; 3mg/1ml ; 3.3mg/1ml ; 4.1mg/1ml ; 1.4mg/1ml ; 9mg/1ml ; 2.1mg/1ml ; 3.9mg/1ml ; 5.3mg/1ml ; 3.9mg/1ml ; 1.9mg/1ml ; 5.5mg/1ml ; 8.1mg/1ml ; 7.5mg/1ml ; 1mg/1ml ; 500microgram/1ml ; 4.3mg/1ml ; 100mg/1ml ; 20mmol/1litre ; 2.5mmol/1litre ; 3mg/1ml ; 2.4mg/1ml

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

fresenius kabi australia pty ltd - tryptophan, quantity: 1.9 g/l; arginine, quantity: 11.3 g/l; phenylalanine, quantity: 7.9 g/l; cysteine, quantity: 0.56 g/l; tyrosine, quantity: 0.23 g/l; glycine, quantity: 7.9 g/l; threonine, quantity: 5.6 g/l; methionine, quantity: 5.6 g/l; leucine, quantity: 7.9 g/l; alanine, quantity: 16 g/l; isoleucine, quantity: 5.6 g/l; aspartic acid, quantity: 3.4 g/l; lysine acetate, quantity: 12.7 g/l (equivalent: lysine, qty 9 g/l); serine, quantity: 4.5 g/l; histidine, quantity: 6.8 g/l; proline, quantity: 6.8 - injection, intravenous infusion - excipient ingredients: glacial acetic acid; water for injections - intravenous supply of amino acids specially to patients with highly increased requirement who are unable to receive sufficient amounts of protein enterally. vamin 18 is also indicated where there is a need to control the total amount of fluid being given to a patient.

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

fresenius kabi australia pty ltd - cysteine, quantity: 0.42 g/l; leucine, quantity: 5.9 g/l; tryptophan, quantity: 1.4 g/l; isoleucine, quantity: 4.2 g/l; alanine, quantity: 12 g/l; tyrosine, quantity: 0.17 g/l; histidine, quantity: 5.1 g/l; serine, quantity: 3.4 g/l; lysine acetate, quantity: 9.5 g/l (equivalent: lysine, qty 6.8 g/l); aspartic acid, quantity: 2.5 g/l; valine, quantity: 5.5 g/l; phenylalanine, quantity: 5.9 g/l; glycine, quantity: 5.9 g/l; methionine, quantity: 4.2 g/l; arginine, quantity: 8.4 g/l; threonine, quantity: 4.2 g - injection, intravenous infusion - excipient ingredients: water for injections; glacial acetic acid - intravenous supply of amino acids to patients with moderately increased requirement who are unable to receive sufficient amounts of protein enterally

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

fresenius kabi australia pty ltd - cysteine, quantity: 0.42 g/l; lysine acetate, quantity: 9.5 g/l (equivalent: lysine, qty 6.8 g/l); threonine, quantity: 4.2 g/l; proline, quantity: 5.1 g/l; serine, quantity: 3.4 g/l; glutamic acid, quantity: 4.2 g/l; isoleucine, quantity: 4.2 g/l; arginine, quantity: 8.4 g/l; methionine, quantity: 4.2 g/l; phenylalanine, quantity: 5.9 g/l; glycine, quantity: 5.9 g/l; histidine, quantity: 5.1 g/l; alanine, quantity: 12 g/l; tyrosine, quantity: 0.17 g/l; tryptophan, quantity: 1.4 g/l; aspartic acid, quantity - injection, intravenous infusion - excipient ingredients: water for injections; glacial acetic acid - intravenous supply of amino acids to patients with moderately increased requirement who are unable to receive sufficient amounts of protein enterally

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

fresenius kabi australia pty ltd - valine, quantity: 7.3 g/l; leucine, quantity: 7.9 g/l; lysine acetate, quantity: 12.7 g/l (equivalent: lysine, qty 9 g/l); glutamic acid, quantity: 5.6 g/l; threonine, quantity: 5.6 g/l; glycine, quantity: 7.9 g/l; aspartic acid, quantity: 3.4 g/l; tyrosine, quantity: 0.23 g/l; phenylalanine, quantity: 7.9 g/l; isoleucine, quantity: 5.6 g/l; arginine, quantity: 11.3 g/l; alanine, quantity: 16 g/l; serine, quantity: 4.5 g/l; proline, quantity: 6.8 g/l; cysteine, quantity: 0.56 g/l; histidine, quantity: 6.8 g - injection, intravenous infusion - excipient ingredients: glacial acetic acid; water for injections - intravenous supply of amino acids specially to patients with highly increased requirement who are unable to receive sufficient amounts of protein enterally. vamin 18 is also indicated where there is a need to control the total amount of fluid being given to a patient.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter - alanine; arginine; aspartic acid; cysteine; glutamic acid; glycine; isoleucine; histidine; leucine; lysine monohydrate; methionine; ornithine hydrochloride; phenylalanine; proline; serine; taurine; threonine; tryptophan; tyrosine; valine; potassium acetate; calcium chloride dihydrate; magnesium acetate tetrahydrate; sodium glycerophosphate hydrate; glucose monohydrate; soyabean oil + olive oil - emulsion for infusion - alanine 2.5 mg/ml; arginine 2.6 mg/ml; aspartic acid 1.867 mg/ml; cysteine 0.6 mg/ml; glutamic acid 3.1 mg/ml; glycine 1.233 mg/ml; isoleucine 2.067 mg/ml; histidine 1.167 mg/ml; leucine 3.1 mg/ml; lysine monohydrate 3.833 mg/ml; methionine 0.733 mg/ml; ornithine hydrochloride 1 mg/ml; phenylalanine 1.3 mg/ml; proline 0.933 mg/ml; serine 1.233 mg/ml; taurine 0.2 mg/ml; threonine 1.167 mg/ml; tryptophan 0.633 mg/ml; tyrosine 0.233 mg/ml; valine 2.367 mg/ml; potassium acetate 2.033 mg/ml; calcium chloride dihydrate 1.833 mg/ml; magnesium acetate tetrahydrate 0.333 mg/ml; sodium glycerophosphate hydrate 3.267 mg/ml; glucose monohydrate 146.667 mg/ml; soyabean oil + olive oil 25 mg/ml - combinations

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, phenylalanine, potassium chloride, histidine, arginine, aspartic acid, olive oil, threonine, tryptophan, tyrosine, valine, glucose monohydrate, glutamic acid, glycine, methionine, isoleucine, lysine, magnesium chloride, hexahydrate, serine, proline, sodium acetate, trihydrate, sodium glycerophosphate, soybean oil - emulsion for infusion - tryptophan tyrosine valine glucose monohydrate glutamic acid glycine methionine isoleucine lysine magnesium chloride hexahydrate serine proline sodium acetate trihydrate sodium glycerophosphate soybean oil calcium chloride dihydrate phenylalanine potassium chloride histidine arginine aspartic acid olive oil alanine threonine - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, phenylalanine, potassium chloride, histidine, arginine, aspartic acid, olive oil, threonine, tyrosine, valine, glucose monohydrate, glutamic acid, glycine, methionine, isoleucine, tryptophan, lysine, magnesium chloride, hexahydrate, serine, proline, sodium acetate, trihydrate, sodium glycerophosphate, soybean oil - emulsion for infusion - calcium chloride dihydrate phenylalanine potassium chloride histidine arginine aspartic acid olive oil threonine tyrosine valine glucose monohydrate glutamic acid glycine methionine isoleucine l-tryptophan lysine magnesium chloride hexahydrate serine proline sodium acetate trihydrate sodium glycerophosphate soybean oil - blood substitutes and perfusion solutions