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; Glucose monohydrate; Sodium acetate trihydrate ; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate
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; Glucose monohydrate; Sodium acetate trihydrate ; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate
9g/L / 1070kcal/L
Emulsion for infusion
Solutions for parenteral nutrition; combinations
Marketed
2010-04-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIOMEL 9 G/L NITROGEN 1070 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 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion is and what it is used for 2. What you need to know before TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion is administered 3. How TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion will be used 4. Possible side effects 5. How TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for infusion is stored 6. Contents of the pack and other information 1. WHAT TRIOMEL 9 G/L NITROGEN 1070 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 9 G/L NITROGEN 1070 KCAL/L WITH ELECTROLYTES, EMULSION FOR INFUSION IS ADMINISTERED TRIOMEL 9 G/L NITROGEN 1070 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 Preberite celoten dokument
Health Products Regulatory Authority 05 October 2020 CRN009CM8 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triomel 9g/L nitrogen 1070kcal/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 1,000 ML 1,500 ML 2,000 ML 27.5 % Glucose solution (corresponding to 27.5 g/100 mL) 400 mL 600 mL 800 mL 14.2 % Amino acid solution (corresponding to 14.2 g/100 mL) 400 mL 600 mL 800 mL 20 % Lipid emulsion (corresponding to 20 g/100 mL) 200 mL 300 mL 400 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 Refined olive oil+ refined soya-bean oil a 40.00 g 60.00 g 80.00 g Alanine 8.24 g 12.36 g 16.48 g Arginine 5.58 g 8.37 g 11.16 g Aspartic acid 1.65 g 2.47 g 3.30 g Glutamic acid 2.84 g 4.27 g 5.69 g Glycine 3.95 g 5.92 g 7.90 g Histidine 3.40 g 5.09 g 6.79 g Isoleucine 2.84 g 4.27 g 5.69 g Leucine 3.95 g 5.92 g 7.90 g Lysine (equivalent to lysine acetate) 4.48 g (6.32 g) 6.72 g (9.48 g) 8.96 g (12.64 g) Methionine 2.84 g 4.27 g 5.69 g Phenylalanine 3.95 g 5.92 g 7.90 g Proline 3.40 g 5.09 g 6.79 g Serine 2.25 g 3.37 g 4.50 g Threonine 2.84 g 4.27 g 5.69 g Tryptophan 0.95 g 1.42 g 1.90 g Tyrosine 0.15 g 0.22 g 0.30 g Valine 3.64 g 5.47 g 7.29 g Sodium acetate, trihydrate 1.50 g 2.24 g 2.99 g Sodium glycerophosphate, hydrated 3.67 g 5.51 g 7.34 g Potassium chloride 2.24 g 3.35 g 4.47 g Magnesium chloride, hexahydrate 0.81 g 1.22 g 1.62 g Calcium chloride, dihydrate 0.52 g 0.77 g 1.03 g Glucose (equivalent to glucose monohydrate) 110.00 g (121.00 g) 165.00 g (181.50 g) 220.00 g (242.00 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