Šalis: Airija
kalba: anglų
Šaltinis: 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
7g/L/1140kcal/L
Emulsion for infusion
Solutions for parenteral nutrition; combinations
Marketed
2010-04-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIOMEL 7 G/L NITROGEN 1140 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 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is and what it is used for 2. What you need to know before TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is administered 3. How TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion will be used 4. Possible side effects 5. How TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is stored 6. Contents of the pack and other information 1. WHAT TRIOMEL 7 G/L NITROGEN 1140 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 7 G/L NITROGEN 1140 KCAL/L, EMULSION FOR INFUSION IS ADMINISTERED TRIOMEL 7 G/L NITROGEN 1140 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. Perskaitykite visą dokumentą
Health Products Regulatory Authority 05 October 2020 CRN009CM8 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triomel 7g/L nitrogen 1140kcal/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 35 % Glucose solution (corresponding to 35 g/100 mL) 400 mL 600 mL 800 mL 11.1 % Amino acid solution (corresponding to 11.1 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 6.41 g 9.61 g 12.82 g Arginine 4.34 g 6.51 g 8.68 g Aspartic acid 1.28 g 1.92 g 2.56 g Glutamic acid 2.21 g 3.32 g 4.42 g Glycine 3.07 g 4.60 g 6.14 g Histidine 2.64 g 3.97 g 5.29 g Isoleucine 2.21 g 3.32 g 4.42 g Leucine 3.07 g 4.60 g 6.14 g Lysine (equivalent to lysine acetate) 3.48 g (4.88 g) 5.23 g (7.31 g) 6.97 g (9.75 g) Methionine 2.21 g 3.32 g 4.42 g Phenylalanine 3.07 g 4.60 g 6.14 g Proline 2.64 g 3.97 g 5.29 g Serine 1.75 g 2.62 g 3.50 g Threonine 2.21 g 3.32 g 4.42 g Tryptophan 0.74 g 1.10 g 1.47 g Tyrosine 0.11 g 0.17 g 0.22 g Valine 2.83 g 4.25 g 5.66 g Glucose (equivalent to glucose monohydrate) 140.00 g (154.00 g) 210.00 g (231.00 g) 280.00 g (308.00 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 44.3 g 66.4 g 88.6 g Nitrogen 7.0 g 10.5 g 14.0 g Glucose 140.0 g 210.0 g 280.0 g Health Products Regulatory Authority 05 October 2020 CRN009C Perskaitykite visą dokumentą