מדינה: אירלנד
שפה: אנגלית
מקור: 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
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
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 , 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, 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, emulsion for infusion is administered 3. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion will be used 4. Possible side effects 5. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is stored 6. Contents of the pack and other information 1. WHAT TRIOMEL 9 G/L NITROGEN 1070 KCAL/L, 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, the second one contains a lipid emulsion and the third one contains an amino acid solution. 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, EMULSION FOR INFUSION IS ADMINISTERED TRIOMEL 9 G/L NITROGEN 1070 KCAL/L, 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 other ingredient of this medicine (listed in section 6). • If your body has problems using certain amino acids. • If you have an especially high level of fats in your blood קרא את המסמך השלם
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 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, a lipid emulsion and an amino acid solution. 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 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 of excipients, see section 6.1. Nutritional intakes of reconstituted emulsion for each of the bag sizes: 1,000 ML 1,500 ML 2,000 ML Lipids 40 g 60 g 80 g Amino acids 56.9 g 85.4 g 113.9 g Nitrogen 9.0 g 13.5 g 18.0 g Glucose 110.0 g 165.0 g 220.0 g Health Products Regulatory Authority 05 October 2020 קרא את המסמך השלם