Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
L-alanine; L-arginine; GLYCINE; L-histidine; L-isoleucine; L-leucine; L-lysine; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-valine; Calcium chloride; Sodium glycerophophate hydrate; Magnesium sulphate heptahydrate; Potassium chloride; Sodium acetate trihydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya bean oil, refined; Triglycerides, medium chain; Olive oil, refined; Fish oil, rich in omega-3 acids
Fresenius Kabi Limited
B05BA; B05BA10
L-alanine; L-arginine; GLYCINE; L-histidine; L-isoleucine; L-leucine; L-lysine; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-valine; Calcium chloride; Sodium glycerophophate hydrate; Magnesium sulpha
0 gram(s)
Emulsion for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; combinations
Marketed
2009-08-28
V003/GZ _SMOFKABIVEN CENTRAL_ Emulsion for infusion PACKAGE LEAFLET: INFORMATION FOR THE USER Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven Central will be given to you by a healthcare professional. If you use more SmofKabiven Central than you should It is unlikely that you will receive too much medicine as SmofKabiven Central is given to you by a healthcare professional. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (may affect up to 1 in 10 people): a slightly raised body temperature. Uncommon (may affect up to 1 in 100 people): high blood (plasma) levels of compounds from the liver, lack of appetite, nausea, vomiting, chills, dizziness and headache. Rare (may affect up to 1 in 1,000 people): low or high blood pressure, difficulty in breathing, fast heart beat (tachycardia). Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised red areas), flushing, headache). Sensations of hot and cold. Paleness. Light blue coloured lips and skin (because of too less oxygen in the blood). Pain in the neck, back, bones, chest and loins. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard For Ireland - You can report directly via; HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store SmofKabiven Central Keep this medicine out of the sight and reach of children. Store in overpouch. Do not store above 25°C. Do not freeze. Read all of this leaflet carefully before you start using this medicine because it Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SmofKabiven Central emulsion for infusion, Excel bags 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven consists of a three chamber bag system. Each bag contains the following partial volumes depending on the five pack sizes. This corresponds to the following total compositions: 493 ML 986 ML 1477 ML 1970 ML 2463 ML PER 1000 ML Amino acid solution with electrolytes 250 ml 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 ACTIVE INGREDIENTS 493 ML 986 ML 1477ML 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 Calcium chloride (as dihydrate) 0.14 g 0.28 g 0.42 g 0.56 g 0.69 g 0.28 g Sodium glycerophosphate (as hydrate) 1.1 g 2.1 g 3.1 g 4.2 g 5.2 g 2.1 g Magnesium sulphate (as heptahydrate) 0.30 g 0.60 g 0.90 g 1.2 g 1.5 g 0.61 g Potassium chloride 1.1 g 2.2 g 3.4 g 4.5 g 5.7 g 2.3 g Sodium acetate (as trihydrate) 0.9 g 1.7 g 2.6 g 3.4 g 4.2 g 1.7 g Zinc sulphate (as heptahydrate) 0.0033 g 0.0065 g 0.0097 g 0.013 g 0.016 g 0.0066 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 H E A L T H Les hele dokumentet