Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Soya bean oil; Glucose anhydrous; Alanine; Arginine; Aspartic acid; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride; Sodium glycerophosphate anhydrous; Magnesium sulfate; Potassium chloride; Sodium acetate
Fresenius Kabi Limited
B05BA; B05BA10
Soya bean oil; Glucose anhydrous; Alanine; Arginine; Aspartic acid; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride; Sodium glycerophosphate anhydrous; Magnesium sulfate; Potassium chloride; Sodium acetate
percent weight/volume
Emulsion for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; combinations
Marketed
2006-07-28
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KABIVEN PERIPHERAL, EMULSION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If you get any side effects, talk to your doctore, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Kabiven Peripheral is and what it is used for 2. What you need to know before you are given Kabiven Peripheral 3. How you are given Kabiven Peripheral 4. Possible side effects 5. How to store Kabiven Peripheral 6. Contents of the pack and otherinformation 1. WHAT KABIVEN PERIPHERAL IS AND WHAT IT IS USED FOR Kabiven Peripheral comes in a three chamber bag in an overpouch. Kabiven Peripheral contains the following medicines: amino acids (components used to build proteins), fat, glucose and electrolyte solutions. It provides energy (as sugar and fat) and amino acids into your bloodstream when you cannot eat normally. It is used as part of a balanced intravenous diet, together with salts, trace elements and vitamins which together provide your complete nutritional needs. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KABIVEN PERIPHERAL YOU SHOULD NOT RECEIVE KABIVEN PERIPHERAL: • if you are ALLERGIC to any of the active substances or any of the other ingredients of this medicine (listen in section 6). • if you are allergic to products containing EGG, SOYA OR PEANUT • if you have TOO MUCH FATTY SUBSTANCES (like cholesterol) in your blood • if you have seriously reduced LIVER function • if you suffer from ACUTE SHOCK (resulting from heavy blood loss or allergic reaction) • if you have a DEFECT IN YOUR BLOOD CLOTTING SYSTEM (haemophagocytotic syndrome) or if your BLOOD IS NOT CLOTTING PROPERLY • if you have a condition where your body has problems using proteins or amino acids • if Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kabiven Peripheral emulsion for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Kabiven Peripheral is available in a three chamber bag system. Each bag contains the following different volumes depending on the pack size. This corresponds to the following total compositions: 2400 ML 1920 ML 1440 ML Glucose (Glucose 11%) 1475 ml 1180 ml 885 ml Amino acids and electrolytes (Vamin 18 Novum) 500 ml 400 ml 300 ml Fat emulsion (Intralipid 20%) 425 ml 340 ml 255 ml ACTIVE INGREDIENTS 2400 ML 1920 ML 1440 ML Purified soybean oil 85.0 g 68.0 g 51.0 g Glucose monohydrate Corresponding to Glucose (anhydrous) 178.0 g 162.0 g 143.0 g 130.0 g 107.0 g 97.0 g Alanine 8.0 g 6.4 g 4.8 g Arginine 5.6 g 4.5 g 3.4 g Aspartic acid 1.7 g 1.4 g 1.0 g Glutamic acid 2.8 g 2.2 g 1.7 g Glycine 4.0 g 3.2 g 2.4 g Histidine 3.4 g 2.7 g 2.0 g Isoleucine 2.8 g 2.2 g 1.7 g Leucine 4.0 g 3.2 g 2.4 g Lysine hydrochloride 5.6 g 4.5 g 3.4 g Corresponding to Lysine 4.5 g 3.6 g 2.7 g Methionine 2.8 g 2.2 g 1.7 g Phenylalanine 4.0 g 3.2 g 2.4 g Proline 3.4 g 2.7 g 2.0 g Serine 2.2 g 1.8 g 1.4 g Threonine 2.8 g 2.2 g 1.7 g Tryptophan 0.95 g 0.76 g 0.57 g Tyrosine 0.12 g 0.092 g 0.069 g Valine 3.6 g 2.9 g 2.2 g ACTIVE INGREDIENTS 2400ML 1920ML 1440ML Calcium chloride 2 H 2 O 0.49 g 0.39 g 0.29 g Corresponding to Calcium chloride 0.37 g 0.30 g 0.22 g Sodium glycerophosphate (anhydrous) 2.5 g 2.0 g 1.5 g Magnesium sulphate 7H 2 O Corresponding to Magnesium 1.6 g 1.3 g 0.99 g H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lestu allt skjalið