Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ISOLEUCINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; MEDIUM CHAIN TRIGLYCERIDES; GLYCINE; GLUCOSE MONOHYDRATE; FISH OIL; OLIVE OIL; TAURINE; Tyrosine.; Soya Bean Oil, Refined Ph. Eur; L-Alanine; Proline,
FRESENIUS KABI MALAYSIA SDN. BHD
ISOLEUCINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; MEDIUM CHAIN TRIGLYCERIDES; GLYCINE; GLUCOSE MONOHYDRATE; FISH OIL; OLIVE OIL; TAURINE; Tyrosine.; Soya Bean Oil, Refined Ph. Eur; L-Alanine; Proline,
986ml mL; 1970ml mL; 2463ml mL; 1477ml mL; 1970ml2Units mL; 1970 ml 4 Units mL; 2463 ml 3 Units mL; 2463ml2Units mL; 986ml4Units mL; 1477ml4Units mL
FRESENIUS KABI AB
Leafl et no SMOFKABIVEN EF LEAFL ET (ersätter) Tryckspecifi kation Format: 630 x 210 mm Färger: PMS svart Utskrift: anpassat till A3 12:e korr 08-04-21 Johanna Eriksson, 018 64 40 46 xxx xxx _SMOFKABIVEN ELECTROLYTE FREE_ Emulsion for infusion The other ingredients are: glycerol, purifi ed egg phospholipids, all-rac- α -tocopherol, sodium hydroxide (pH-adjustment), sodium oleate, acetic acid (pH-adjustment), hydrochloric acid (pH- adjustment) and water for injections. _What SmofKabiven Electrolyte Free looks like and contents _ _of the pack_ Glucose- and amino acid solutions are clear, colourless or slightly yellow and free from particles. The lipidemulsion is white and homogenous. _Pack sizes:_ 1 x 986 ml, 4 x 986 ml 1 x 1477 ml, 4 x 1477 ml 1 x 1970 ml, 2 x 1970 ml 1 x 2463 ml, 2 x 2463 ml Marketing Authorisation Holder and Manufacturer Manufacturer: Fresenius Kabi AB, SE-751 74 Uppsala, Sweden To be completed nationally Marketing authorisation holder: Fresenius Kabi (country specifi c name and address will be added) This leafl et was last approved in {MM/YYYY} To be completed nationally ----------------------------------------------------------------------------- _The following information is intended for medical or health _ _care professionals only:_ Warnings and precautions for use To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination especially during catheter insertion. Serum glucose, electrolytes and osmolarity as well as fl uid balance, acid-base status and liver and enzyme tests should be monitored. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion. SmofKabiven Electrolyte Free should not be given simultaneously with blood in the same infusi Lees het volledige document
Page 1 of 8 PI83190542000 Package Insert _SmofKabiven Electrolyte Free _ Emulsion for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven Electrolyte Free consists of a three chamber bag system. Each bag contains the following partial volumes depending on the five pack sizes 493 ml 986 ml 1477 ml 1970 ml 2463 ml Per 1000 ml Amino acid solution 250ml 500 ml 750 ml 1000 ml 1250 ml 508 ml Glucose 42% 149 ml 298 ml 446 ml 595 ml 744 ml 302 ml Lipid emulsion 94 ml 188 ml 281 ml 375 ml 469 ml 190 ml This corresponds to the following total compositions: Active ingredients 493 ml 986 ml 1477 ml 1970 ml 2463 ml Per 1000 ml Alanine 3.5 g 7.0 g 10.5 g 14.0 g 17.5 g 7.1 g Arginine 3.0 g 6.0 g 9.0 g 12.0 g 15.0 g 6.1 g Glycine 2.8 g 5.5 g 8.2 g 11.0 g 13.8 g 5.6 g Histidine 0.8 g 1.5 g 2.2 g 3.0 g 3.7 g 1.5 g Isoleucine 1.3 g 2.5 g 3.8 g 5.0 g 6.2 g 2.5 g Leucine 1,9 g 3.7 g 5.6 g 7.4 g 9.4 g 3.8 g Lysine (as acetate) 1.7 g 3.3 g 5.0 g 6.6 g 8.4 g 3.4 g Methionine 1.1 g 2.2 g 3.2 g 4.3 g 5.4 g 2.2 g Phenylalanine 1.3 g 2.6 g 3.8 g 5.1 g 6.4 g 2.6 g Proline 2.8 g 5.6 g 8.4 g 11.2 g 14.0 g 5.7 g Serine 1.6 g 3.2 g 4.9 g 6.5 g 8.1 g 3.3 g Taurine 0.25 g 0.50 g 0.75 g 1.0 g 1.2 g 0.5 g Threonine 1.1 g 2.2 g 3.3 g 4.4 g 5.4 g 2.2 g Tryptophan 0.5 g 1.0 g 1.5 g 2.0 g 2.5 g 1.0 g Tyrosine 0.10 g 0.20 g 0.30 g 0.40 g 0.49 g 0.20 g Valine 1.6 g 3.1 g 4.6 g 6.2 g 7.6 g 3.1 g Glucose (as monohydrate) 63 g 125 g 187 g 250 g 313 g 127 g Soya-bean oil, refined 5.6 g 11.3 g 16.9 g 22.5 g 28.1 g 11.4 g Medium-chain triglycerides 5.6 g 11.3 g 16.9 g 22.5 g 28.1 g 11.4 g Olive oil, refined 4.7 g 9.4 g 14.1 g 18.8 g 23.4 g 9.5 g Fish oil, rich in omega 3-acids 2.8 g 5.6 g 8.4 g 11.3 g 14.0 g 5.7 g Corresponding to 493 ml 986 ml 1477 ml 1970 ml 2463 ml Per 1000 ml • Amino acids 25 g 50 g 75 g 100 g 125 g 51 g • Nitrogen 4 g 8 g 12 g 16 g 20 g 8 g Page 2 of 8 PI83190542000 • Carbohydrates - Glucose (anhydrous) 63 g 125 g 187 g 250 g 313 g 127 g • Lipids 19 g 38 g 56 g 75 g 94 g 38 g • Acetate 1) 37 mmol 73 mmol 110 mmol 147 mm Lees het volledige document