New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - alanine 16 g/l;  ;  ;  ; arginine 11.3 g/l (l-arginine);  ;  ; aspartic acid 3.4 g/l (l-aspartic acid);  ;  ; cysteine 560 mg/l (l-cysteine); glutamic acid 5.6 g/l (l-glutamic acid);  ;  ; glycine 7.9 g/l (as aminoacetic acid);  ;  ;  ; histidine 6.8 g/l (l-histidine);  ;  ;  ; isoleucine 5.6 g/l (l-isoleucine);  ;  ;  ; leucine 7.9 g/l (l-leucine);  ;  ;  ; lysine acetate 12.7 g/l equivalent to 6 g/l lysine a;  ;  ; methionine 5.6 g/l (l-methionine);  ;  ; phenylalanine 7.9 g/l (l-phenylalanine);  ;  ;  ; proline 6.8 g/l (l-proline);  ; serine 4.5 g/l (l-serine);  ;  ;  ;  ; threonine 5.6 g/l (l-threonine);  ;  ;  ; tryptophan 1.9 g/l (l-tryptophan);  ; tyrosine 230 mg/l (l-tyrosine); valine 7.3 g/l (l-valine);  ;  ;   - solution for infusion - active: alanine 16 g/l       arginine 11.3 g/l (l-arginine)     aspartic acid 3.4 g/l (l-aspartic acid)     cysteine 560 mg/l (l-cysteine) glutamic acid 5.6 g/l (l-glutamic acid)     glycine 7.9 g/l (as aminoacetic acid)       histidine 6.8 g/l (l-histidine)       isoleucine 5.6 g/l (l-isoleucine)       leucine 7.9 g/l (l-leucine)       lysine acetate 12.7 g/l equivalent to 6 g/l lysine a     methionine 5.6 g/l (l-methionine)     phenylalanine 7.9 g/l (l-phenylalanine)       proline 6.8 g/l (l-proline)   serine 4.5 g/l (l-serine)         threonine 5.6 g/l (l-threonine)       tryptophan 1.9 g/l (l-tryptophan)   tyrosine 230 mg/l (l-tyrosine) valine 7.3 g/l (l-valine)       excipient: glacial acetic acid water for injection - intravenous supply of amino acids to patients with highly increased requirement who are unable to receive sufficient amounts of protein enterally. vamin 18 is also indicated where there is need to control the total amount of fluid being given to a patient. vamin 18 has been shown to reduce nitrogen loss in patients with major burns without sepsis.

Israel - English - Ministry of Health

baxter healthcare distribution ltd., israel - arginine; calcium chloride dihydrate; glycine; histidine; isoleucine; l- alanine; leucine; lysine hydrochloride; magnesium chloride hexahydrate; methionine; phenylalanine; proline; serine; sodium (s) - lactate; sodium chloride; threonine; tryptophan; tyrosine; valine - solution for peritoneal dialysis - tyrosine 0.3 g/l; tryptophan 0.27 g/l; phenylalanine 0.57 g/l; threonine 0.646 g/l; serine 0.51 g/l; proline 0595 g/l; glycine 0.51 g/l; l- alanine 0.951 g/l; valine 1.393 g/l; methionine 0.85 g/l; isoleucine 0.85 g/l; leucine 1.02 g/l; histidine 0.714 g/l; arginine 1.071 g/l; sodium chloride 5.38 g/l; lysine hydrochloride 0.955 g/l; calcium chloride dihydrate 0.184 g/l; magnesium chloride hexahydrate 0.051 g/l; sodium (s) - lactate 4.480 g/l - combinations of electrolytes - combinations of electrolytes - nutritional supplement for malnourished renal failure patients (albumin concentration lower then 35 g/liter) being maintained on peritoneal dialysis.

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

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

fresenius kabi australia pty ltd - alanine,arginine,aspartic acid,calcium chloride dihydrate,glucose monohydrate,glutamic acid,glycine,histidine,isoleucine,leucine,lysine hydrochloride,magnesium sulfate heptahydrate,methionine,phenylalanine,potassium chloride,proline,serine,sodium acetate trihydrate,sodium glycerophosphate,soya oil,threonine,tryptophan,tyrosine,valine -

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

nuscience pharmaceuticals (pg) sdn. bhd. - glycine max -

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

qatar pharma, qatar - glycine - irrigation solution - 1.5 %

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

dzr pharma manufacture sdn. bhd. - l-glycine -

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)

spectrumceuticals pty ltd - magnesium glycinate,magnesium oxide -