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

baxter sa-nv - alanine 16 g/l; arginine 10,9 g/l; aspartic acid 3,2 g/l; glutamic acid 5,53 g/l; glycine 7,68 g/l; histidine 6,6 g/l; isoleucine 5,53 g/l; leucine 7,68 g/l; lysine acetate 12,2 g/l - eq. lysine 8,64 g/l; methionine 5,53 g/l; phenylalanine 7,68 g/l; proline 6,6 g/l; serine 4,38 g/l; threonine 5,53 g/l; tryptophan 1,85 g/l; tyrosine 0,28 g/l; valine 7,08 g/l - solution for infusion - alanine 16 g/l; arginine 10.9 g/l; aspartic acid 3.2 g/l; glutamic acid 5.53 g/l; glycine 7.68 g/l; histidine 6.6 g/l; isoleucine 5.53 g/l; leucine 7.68 g/l; lysine acetate 12.2 g/l; methionine 5.53 g/l; phenylalanine 7.68 g/l; proline 6.6 g/l; serine 4.38 g/l; threonine 5.53 g/l; tryptophan 1.85 g/l; tyrosine 0.28 g/l; valine 7.08 g/l - amino acids

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

baxter sa-nv - alanine 16 g/l; arginine 10,9 g/l; aspartic acid 3,2 g/l; glutamic acid 5,53 g/l; glycine 7,68 g/l; histidine 6,6 g/l; isoleucine 5,53 g/l; leucine 7,68 g/l; lysine acetate 12,2 g/l - eq. lysine 8,64 g/l; methionine 5,53 g/l; phenylalanine 7,68 g/l; proline 6,6 g/l; serine 4,38 g/l; threonine 5,53 g/l; tryptophan 1,85 g/l; tyrosine 0,28 g/l; valine 7,08 g/l - solution for infusion - amino acids

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

baxter healthcare pty ltd - threonine, quantity: 3.7 mg/ml; proline, quantity: 3 mg/ml; glycine, quantity: 4 mg/ml; arginine, quantity: 8.4 mg/ml; tyrosine, quantity: 0.45 mg/ml; valine, quantity: 7.6 mg/ml; leucine, quantity: 10 mg/ml; serine, quantity: 4 mg/ml; isoleucine, quantity: 6.7 mg/ml; cysteine, quantity: 1.89 mg/ml; taurine, quantity: 0.6 mg/ml; lysine, quantity: 11 mg/ml; ornithine monohydrochloride, quantity: 3.18 mg/ml; histidine, quantity: 3.8 mg/ml; alanine, quantity: 8 mg/ml; aspartic acid, quantity: 6 mg/ml; methionine, quantity: 2.4 mg/ml; glutamic acid, quantity: 10 mg/ml; tryptophan, quantity: 2 mg/ml; phenylalanine, quantity: 4.2 mg/ml - injection, intravenous infusion - excipient ingredients: malic acid; water for injections - primene 10% amino acid iv infusion is indicated in infants and neonates at term or premature, for short-term use, of normal or low birth-weight when oral or enteral nutrition is impossible, insufficient or contraindicated. it is used as an amino acid component in a composite admixture of total parenteral nutrition.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - l-isoleucine; l-leucine; l-valine; l-lysine; l-methionine; l-threonine; l-tryptophan; l-arginine; l-histidine; l-alanine; l-aspartic acid; cysteine; l-glutamic acid; glycine; l-proline; l-serine; l-tyrosine; ornithine hydrochloride; taurine; l-phenylalanine - solution for infusion - 10 percent - solutions for parenteral nutrition; amino acids

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - alanine; arginine ; aspartic acid; cysteine; glutamic acid ; glycine; histidine; isoleucine; leucine ; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; taurine - solution for infusion - 100 millilitre(s) - solutions for parenteral nutrition; amino acids

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

baxter healthcare corporation - leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), tyrosine (unii: 42hk56048u) (tyrosine - unii:42hk56048u), arginine (unii: 94zla3w45f) (arginine - unii:94zla3w45f), proline (unii: 9dlq4ciu6v) (proline - unii:9dlq4ciu6v), alanine (unii: of5p57n2zx) (alanine - unii:of5p57n2zx), glutamic acid (unii: 3kx376gy7l) (glutamic acid - unii:3kx376gy7l), serine (unii: 452vly9402) (serine - unii:452vly9402), glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c), aspartic acid (unii: 30kyc7miai) (aspartic acid - unii:30kyc7miai), taurine (unii: 1eqv5mly3d) (taurine - unii:1eqv5mly3d), cysteine hydrochloride (unii: zt934n0x4w) (cysteine - unii:k848jz4886) - leucine 1.4 g in 100 ml - premasol 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring tpn via either central or peripheral infusion routes. parenteral nutrition with premasol 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see dosage and administration). central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants, or those requiring long-term parenteral nutrition. for moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5-10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. premasol 10% injection is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids present in the solution.

Israel - English - Ministry of Health

remedix care ltd - glycine; l- alanine; l- aspartic acid; l- cysteine; l- glutamic acid; l- isoleucine; l- leucine; l- lysine; l- methionine; l- ornithine hydrochloride; l- phenylalanine; l- proline; l- serine; l- threonine; l- tryptophan; l- tyrosine; l- valine; l-arginine; l-histidine; taurine - solution for infusion - l- valine 0.76 g / 100 ml; l- tyrosine 0.045 g / 100 ml; l- tryptophan 0.2 g / 100 ml; l- threonine 0.37 g / 100 ml; taurine 0.06 g / 100 ml; l- serine 0.4 g / 100 ml; l- proline 0.3 g / 100 ml; l- phenylalanine 0.42 g / 100 ml; l- ornithine hydrochloride 0.318 g / 100 ml; l- methionine 0.24 g / 100 ml; l- lysine 1.1 g / 100 ml; l- leucine 1.0 g / 100 ml; l- isoleucine 0.67 g / 100 ml; l-histidine 0.38 g / 100 ml; glycine 0.4 g / 100 ml; l- glutamic acid 1.0 g / 100 ml; l- cysteine 0.189 g / 100 ml; l- aspartic acid 0.6 g / 100 ml; l-arginine 0.84 g / 100 ml; l- alanine 0.8 g / 100 ml - lysine - lysine - primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.משטר מינון: 3/7/2019 שינוי בפרק 4.2 בעלון ללא שינוי ברשיון הנמוקים לבקשה: בהתאם לעלון רפרנס spc-uk ו-clinical overview

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

fresenius kabi australia pty ltd - alanine, quantity: 16 g/l; glycylglutamine monohydrate, quantity: 30.27 g/l (equivalent: glutamine, qty 20 g); histidine, quantity: 6.8 g/l; methionine, quantity: 5.6 g/l; tryptophan, quantity: 1.9 g/l; threonine, quantity: 5.6 g/l; lysine acetate, quantity: 12.7 g/l (equivalent: glycine, qty 10.27 g; equivalent: lysine, qty 9 g); valine, quantity: 7.3 g/l; arginine, quantity: 11.3 g/l; glycyltyrosine dihydrate, quantity: 3.45 g/l (equivalent: tyrosine, qty 2.28 g; equivalent: glycine, qty 0.94 g); serine, quantity: 4.5 g/l; proline, quantity: 6.8 g/l; glutamic acid, quantity: 5.6 g/l; leucine, quantity: 7.9 g/l; isoleucine, quantity: 5.6 g/l; aspartic acid, quantity: 3.4 g/l; phenylalanine, quantity: 5.85 g/l - injection, intravenous infusion - excipient ingredients: water for injections; citric acid - glamin provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate or severe catabolic status.

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

fresenius kabi australia pty ltd - proline, quantity: 6.8 g/l; isoleucine, quantity: 5.6 g/l; methionine, quantity: 5.6 g/l; lysine acetate, quantity: 12.7 g/l (equivalent: lysine, qty 9 g; equivalent: glycine, qty 10.27 g); serine, quantity: 4.5 g/l; glycylglutamine monohydrate, quantity: 30.27 g/l (equivalent: glycine, qty 10.27 g; equivalent: glutamine, qty 20 g); alanine, quantity: 16 g/l; histidine, quantity: 6.8 g/l; glutamic acid, quantity: 5.6 g/l; tryptophan, quantity: 1.9 g/l; leucine, quantity: 7.9 g/l; valine, quantity: 7.3 g/l; aspartic acid, quantity: 3.4 g/l; phenylalanine, quantity: 5.85 g/l; glycyltyrosine dihydrate, quantity: 3.45 g/l (equivalent: tyrosine, qty 2.28 g; equivalent: glycine, qty 0.94 g); arginine, quantity: 11.3 g/l; threonine, quantity: 5.6 g/l - injection, intravenous infusion - excipient ingredients: citric acid; water for injections - glamin provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate or severe catabolic status.

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

fresenius kabi australia pty ltd - glycyltyrosine dihydrate, quantity: 3.45 g/l (equivalent: tyrosine, qty 2.28 g; equivalent: glycine, qty 0.94 g); histidine, quantity: 6.8 g/l; alanine, quantity: 16 g/l; lysine acetate, quantity: 12.7 g/l (equivalent: lysine, qty 9 g; equivalent: glycine, qty 10.27 g); glycylglutamine monohydrate, quantity: 30.27 g/l (equivalent: glutamine, qty 20 g; equivalent: glycine, qty 10.27 g); glutamic acid, quantity: 5.6 g/l; phenylalanine, quantity: 5.85 g/l; valine, quantity: 7.3 g/l; leucine, quantity: 7.9 g/l; tryptophan, quantity: 1.9 g/l; methionine, quantity: 5.6 g/l; isoleucine, quantity: 5.6 g/l; serine, quantity: 4.5 g/l; proline, quantity: 6.8 g/l; arginine, quantity: 11.3 g/l; threonine, quantity: 5.6 g/l; aspartic acid, quantity: 3.4 g/l - injection, intravenous infusion - excipient ingredients: citric acid; water for injections - glamin provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate or severe catabolic status.