Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Refined olive oil + refined soybean oil; Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate; Glucose monohydrate
Baxter Holding B.V.
B05BA; B05BA10
Refined olive oil + refined soybean oil; Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate; Glucose monohydrate
5g/L/ 990kcal/L
Emulsion for infusion
Solutions for parenteral nutrition; combinations
Marketed
2010-04-09
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), or to any othe Preberite celoten dokument
Health Products Regulatory Authority 14 October 2020 CRN009ZK9 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triomel 5g/L nitrogen 990kcal/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) 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 o Preberite celoten dokument