Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, POTASSIUM CHLORIDE, HISTIDINE, ARGININE, ASPARTIC ACID, OLIVE OIL, THREONINE, TYROSINE, VALINE, GLUCOSE MONOHYDRATE, GLUTAMIC ACID, GLYCINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, LYSINE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SERINE, PROLINE, SODIUM ACETATE, TRIHYDRATE, SODIUM GLYCEROPHOSPHATE, SOYBEAN OIL
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05BA10
CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE SOYBEAN OIL
EMULSION FOR INFUSION
CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE SOYBEAN OIL
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2009-12-11
Page 1 of 17 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIOMEL 5 G/L NITROGEN 990 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 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion is and what it is used for 2. What you need to know before TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion is administered 3. How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion will be used 4. Possible side effects 5. How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion is stored 6. Contents of the pack and other information 1. WHAT TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION IS AND WHAT IT IS USED FOR TRIOMEL 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 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 must only be used under medical supervision. 2. WHAT YOU NEED TO KNOW BEFORE TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION IS ADMINISTERED TRIOMEL 5 G/L NITROGEN 990 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 (allergic) to egg, soybean, peanut proteins, or corn/corn products (see also section “Warnings and precautions” below), o Leggi il documento completo
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRIOMEL 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 1,500 ML 2,000 ML 2,500 ML 28.75 % Glucose solution (corresponding to 28.75 g/100 mL) 600 mL 800 mL 1000 mL 8.2 % Amino acid solution (corresponding to 8.2 g/100 mL) 600 mL 800 mL 1000 mL 20 % Lipid emulsion (corresponding to 20 g/100 mL) 300 mL 400 mL 500 mL Composition of the reconstituted emulsion after mixing the contents of the 3 compartments: ACTIVE SUBSTANCES 1,500 ML 2,000 ML 2,500 ML Refined olive oil+ refined soya-bean oil a 60.00 g 80.00 g 100.00 g Alanine 7.14 g 9.52 g 11.90 g Arginine 4.84 g 6.45 g 8.06 g Aspartic acid 1.43 g 1.90 g 2.38 g Glutamic acid 2.47 g 3.29 g 4.11 g Glycine 3.42 g 4.56 g 5.70 g Histidine 2.95 g 3.93 g 4.91 g Isoleucine 2.47 g 3.29 g 4.11 g Leucine 3.42 g 4.56 g 5.70 g Lysine (equivalent to lysine acetate) 3.88 g (5.48 g) 5.18 g (7.30 g) 6.47 g (9.13 g) Methionine 2.47 g 3.29 g 4.11 g Phenylalanine 3.42 g 4.56 g 5.70 g Proline 2.95 g 3.93 g 4.91 g Serine 1.95 g 2.60 g 3.25 g Threonine 2.47 g 3.29 g 4.11 g Tryptophan 0.82 g 1.10 g 1.37 g Tyrosine 0.13 g 0.17 g 0.21 g Valine 3.16 g 4.21 g 5.26 g Sodium acetate, trihydrate 2.24 g 2.99 g 3.74 g Sodium glycerophosphate, hydrated 5.51 g 7.34 g 9.18 g Potassium chloride 3.35 g 4.47 g 5.59 g Magnesium chloride, hexahydrate 1.22 g 1.62 g 2.03 g Calcium chloride, dihydrate 0.77 g 1.03 g 1.29 g Glucose (equivalent to glucose monohydrate) 172.50 g (189.75 g) 230.00 g (253.00 g) 287.50 g (316.25 g) Page 2 of 17 a: Mixture of refined olive oil (approximately 80%) and refined soya-bean oil (approximately 20%) corresponding to a ratio essential fatty acids / total fatty acids of 20%. For the full list of excipients, see section 6.1. Nutritional intakes of Leggi il documento completo