Страна: Мальта
мова: англійська
Джерело: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, POTASSIUM CHLORIDE, HISTIDINE, ARGININE, ASPARTIC ACID, OLIVE OIL, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, GLUCOSE MONOHYDRATE, GLUTAMIC ACID, GLYCINE, METHIONINE, ISOLEUCINE, LYSINE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SERINE, PROLINE, SODIUM ACETATE, TRIHYDRATE, SODIUM GLYCEROPHOSPHATE, SOYBEAN OIL
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05BA10
TRYPTOPHAN TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE SOYBEAN OIL CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL ALANINE THREONINE
EMULSION FOR INFUSION
TRYPTOPHAN TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE SOYBEAN OIL CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL ALANINE THREONINE
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2009-12-11
Page 1 of 15 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED 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 or nurse. • If you get any side effect, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion is and what it is used for 2. What you need to know before TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion is administered 3. How TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion will be used 4. Possible side effects 5. How TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion is stored 6. Contents of the pack and other information 1. WHAT TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION IS AND WHAT IT IS USED FOR TRIOMEL Peripheral is an emulsion for infusion. It is presented in a bag with 3 chambers. One chamber contains a glucose solution with calcium, the second one contains a lipid emulsion and the third one contains an amino acid solution with other electrolytes. TRIOMEL Peripheral is used to provide nutrition to adults and children greater than 2 years of age by a tube into a vein when normal feeding by mouth is not suitable. TRIOMEL Peripheral must only be used under medical supervision. 2. WHAT YOU NEED TO KNOW BEFORE TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION IS ADMINISTERED TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION MUST NOT BE USED: • In premature neonates, infants, and children less than 2 years old. • If you are hypersensitive (all Прочитайте повний документ
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TRIOMEL PERIPHERAL 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRIOMEL PERIPHERAL is presented in the form of a 3-compartment bag. Each bag contains a glucose solution with calcium, a lipid emulsion and an amino acid solution with other electrolytes. CONTENTS PER BAG 1,000 ML 1,500 ML 2,000 ML 2,500 ML 18.75 % Glucose solution (corresponding to 18.75 g/100 mL) 400 mL 600 mL 800 mL 1000 mL 6.3 % Amino acid solution (corresponding to 6.3 g/100 mL) 400 mL 600 mL 800 mL 1000 mL 15 % Lipid emulsion (corresponding to 15 g/100 mL) 200 mL 300 mL 400 mL 500 mL Composition of the reconstituted emulsion after mixing the contents of the 3 compartments: ACTIVE SUBSTANCES 1,000 ML 1,500 ML 2,000 ML 2,500 ML Refined olive oil + refined soya-bean oil a 30.00 g 45.00 g 60.00 g 75.00 g Alanine 3.66 g 5.50 g 7.33 g 9.16 g Arginine 2.48 g 3.72 g 4.96 g 6.20 g Aspartic acid 0.73 g 1.10 g 1.46 g 1.83 g Glutamic acid 1.26 g 1.90 g 2.53 g 3.16 g Glycine 1.76 g 2.63 g 3.51 g 4.39 g Histidine 1.51 g 2.26 g 3.02 g 3.77 g Isoleucine 1.26 g 1.90 g 2.53 g 3.16 g Leucine 1.76 g 2.63 g 3.51 g 4.39 g Lysine (equivalent to lysine acetate) 1.99 g (2.81 g) 2.99 g (4.21 g) 3.98 g (5.62 g) 4.98 g (7.02 g) Methionine 1.26 g 1.90 g 2.53 g 3.16 g Phenylalanine 1.76 g 2.63 g 3.51 g 4.39 g Proline 1.51 g 2.26 g 3.02 g 3.77 g Serine 1.00 g 1.50 g 2.00 g 2.50 g Threonine 1.26 g 1.90 g 2.53 g 3.16 g Tryptophan 0.42 g 0.64 g 0.85 g 1.06 g Tyrosine 0.06 g 0.10 g 0.13 g 0.16 g Valine 1.62 g 2.43 g 3.24 g 4.05 g Sodium acetate, trihydrate 1.16 g 1.73 g 2.31 g 2.89 g Sodium glycerophosphate, hydrated 1.91 g 2.87 g 3.82 g 4.78 g Potassium chloride 1.19 g 1.79 g 2.38 g 2.98 g Magnesium chloride, hexahydrate 0.45 g 0.67 g 0.90 g 1.12 g Calcium chloride, dihydrate 0.30 g 0.44 g 0.59 g 0.74 g Glucose (equivalent to glucose monohydrate) 75.00 g (82.50 g) 112.50 g (123.75 g) 150.00 g (165.00 g) 187.50 g (206.25 g) Page 2 of Прочитайте повний документ