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

Canada - English - Health Canada

baxter corporation - l-isoleucine; l-phenylalanine; histidine; l-threonine; l-cysteine; methionine; tryptophan; taurine; l-tyrosine; glutamic acid; l-arginine; l-alanine; l-aspartic acid; serine; glycine; l-proline; l-ornithine dihydrochloride; l-leucine; l-lysine; l-valine - liquid - 670mg; 420mg; 380mg; 370mg; 189mg; 240mg; 200mg; 60mg; 45mg; 1g; 840mg; 800mg; 600mg; 400mg; 400mg; 300mg; 318mg; 1g; 1.1g; 760mg - l-isoleucine 670mg; l-phenylalanine 420mg; histidine 380mg; l-threonine 370mg; l-cysteine 189mg; methionine 240mg; tryptophan 200mg; taurine 60mg; l-tyrosine 45mg; glutamic acid 1g; l-arginine 840mg; l-alanine 800mg; l-aspartic acid 600mg; serine 400mg; glycine 400mg; l-proline 300mg; l-ornithine dihydrochloride 318mg; l-leucine 1g; l-lysine 1.1g; l-valine 760mg - caloric agents

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

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

baxter healthcare ltd - l-ornithine hydrochloride; l-phenylalanine; l-proline; l-serine; taurine; l-threonine; l-tryptophan; l-tyrosine; l-valine; potassium acetate; calcium chloride dihydrate; magnesium acetate tetrahydrate; sodium glycerophosphate hydrate; glucose monohydrate; olive oil; soya oil; l-alanine; l-arginine; l-aspartic acid; l-cysteine; l-glutamic acid; glycine; l-histidine; l-isoleucine; l-leucine; l-lysine monohydrate; l-methionine - infusion - 1mg/1ml ; 1.3mg/1ml ; 933.33microgram/1ml ; 1.23mg/1ml ; 200microgram/1ml ; 1.17mg/1ml ; 633.33microgram/1ml ; 233.33microgram/1ml ; 2.37mg/1ml ; 2.03mg/1ml ; 1.83mg/1ml ; 333.33microgram/1ml ; 3.27mg/1ml ; 146.67mg/1ml ; 20mg/1ml ; 5mg/1ml ; 2.5mg/1ml ; 2.6mg/1ml ; 1.87mg/1ml ; 600microgram/1ml ; 3.1mg/1ml ; 1.23mg/1ml ; 1.17mg/1ml ; 2.07mg/1ml ; 3.1mg/1ml ; 3.83mg/1ml ; 733.33microgram/1ml

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

baxter sa-nv - cysteine 1,89 g/1000 ml; taurine 0,6 g/1000 ml; methionine 2,4 g/1000 ml; valine 7,6 g/1000 ml; tryptophan 2 g/1000 ml; phenylalanine 4,2 g/1000 ml; threonine 3,7 g/1000 ml; isoleucine 6,7 g/1000 ml; glycine 4 g/1000 ml; leucine 10 g/1000 ml; proline 3 g/1000 ml; lysine 11 g/1000 ml; glutamic acid 10 g/1000 ml; alanine 8 g/1000 ml; aspartic acid 6 g/1000 ml; serine 4 g/1000 ml; tyrosine 0,45 g/1000 ml; ornithine hydrochloride 3,18 g/1000 ml; arginine 8,4 g/1000 ml; histidine 3,8 g/1000 ml - solution for infusion - 10 % - cysteine hydrochloride 2.46 mg/ml; glycine 4 mg/ml; histidine 3.8 mg/ml; glutamic acid 10 mg/ml; methionine 2.4 mg/ml; isoleucine 6.7 mg/ml; leucine 10 mg/ml; lysine 11 mg/ml; proline 3 mg/ml; phenylalanine 4.2 mg/ml; ornithine 2.49 mg; tyrosine 0.45 mg/ml; tryptophan 2 mg/ml; threonine 3.7 mg/ml; taurine 0.6 mg/ml; serine 4 mg/ml; alanine 8 mg/ml; arginine 8.4 mg/ml; aspartic acid 6 mg/ml; valine 7.6 mg/ml - combinations

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

baxter healthcare pty ltd - taurine; leucine; tyrosine; arginine; lysine; ornithine monohydrochloride; methionine; phenylalanine; valine; isoleucine; serine; alanine; cysteine; glycine; aspartic acid; tryptophan; histidine; glutamic acid; proline; threonine -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

baxter sa. - alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil - emulsion for infusion - 1,83g+ 1,9g+ 1,37g+ 0,43g+ 2,29g+ 0,91g+ 0,87g+ 1,53g+ 2,29g+ 2,82g+ 0,55g+ 0,73g+ 0,96g+ 0,69g+ 0,91g+ 0,14g+ 0,85g+ 0,46g+ 0,18g+ 1,74g+ 1,79g+ 3,14g+ 0,56g+ 0,55g+ 2,21g+ 210,65+ 28,1g

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

baxter sa. - alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil - emulsion for infusion - 1,03g+ 1,08g+ 0,77g+ 0,24g+ 1,29g+ 0,51g+ 0,49g+ 0,86g+ 1,29g+ 1,59g+ 0,31g+ 0,41g+ 0,54g+ 0,39g+ 0,51g+ 0,08g+ 0,48g+ 0,26g+ 0,10g+ 0,98g+ 0,30g+ 1,12g+ 0,46g+ 0,33g+ 0,98g+ 85,25+ 15,5g (6) bags 500ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

baxter sa. - alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil - emulsion for infusion - 0,75g+ 0,78g+ 0,56g+ 0,18g+ 0,93g+ 0,37g+ 0,35g+ 0,62g+ 0,93g+ 1,15g+ 0,22g+ 0,30g+ 0,39g+ 0,28g+ 0,37g+ 0,06g+ 0,35g+ 0,19g+ 0,07g+ 0,71g+ 0,61g+ 0,55g+ 0,10g+ 0,98g+ 44g+ 7,5g