Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Potassium chloride; Calcium chloride dihydrate; Magnesium sulphate heptahydrate ; Sodium Glycerophosphate Hydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya Bean Oil, Refined Ph.Eur; Olive oil, refined; Medium chain triglycerides saturated; Fish oil, rich in omega-3 acids
Baxter Holding B.V.
B05BA; B05BA01
Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Potassium chloride; Calcium chloride dihydrate; Magnesium sulphate heptahydrate ; Sodium Glycerophosphate Hydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya Bean Oil, Refined Ph.Eur; Olive oil, refined; Medium chain triglycerides saturated; Fish oil, rich in omega-3 acids
42% +10 % + 20 percent
Emulsion for infusion
Solutions for parenteral nutrition; amino acids
Marketed
2019-07-19
Package leaflet : Information for the user G PER 1000 ML Tyrosine 0.20 Valine 2.95 Sodium acetate trihydrate 2.85 Potassium chloride 2.28 Calcium chloride dihydrate 0.38 Magnesium sulfate heptahydrate 1.25 Sodium glycerophosphate hydrated 3.01 Zinc sulphate heptahydrate 0.012 Glucose (as monohydrate) 139.5 Soya-bean oil, refined 11.40 Olive oil, refined 9.50 Medium-chain triglycerides 9.50 Fish oil, rich in omega-3-acids 7.60 G PER 1000 ML Alanine 10.52 Arginine 5.84 Glycine 5.23 Histidine 2.44 Isoleucine 3.05 Leucine 3.71 Lysine (as hydrochloride) 3.68 Methionine 2.03 Phenylalanine 2.84 Proline 3.45 Serine 2.54 Threonine 2.13 Tryptophan 0.91 ADDITIVE Nutryelt (Composition per vial: Zinc 153 µmol; Copper 4.7 µmol; Manganese 1.0 µmol; Fluorine 50 µmol; Iodine 1.0 µmol; Selenium 0.9 µmol; Molybdenum 0.21 µmol; Chromium 0.19 µmol; Iron 18 µmol) Cernevit (Composition per vial: Vit. A (as Retinol palmitate) 3500 IU, Vit. D3 (Cholecalciferol) 220 IU, Vit. E (Alpha- tocopherol) 11.2 IU, Vit. C (Ascorbic acid) 125 mg, Vit. B1 (Thiamine) 3.51 mg, Vit. B2 (Riboflavin) 4.14 mg, Vit. B6 (Pyridoxine) 4.53 mg, Vit. B12 (Cyanocobalamin) 6 µg, Vit. B9 (Folic acid) 414 µg, Vit. B5 (Pantothenic acid) 17.25 mg, Vit. B8 (Biotin) 69 µg, Vit. PP (Nicotinamide) 46mg) Sodium Potassium Magnesium Calcium Phosphate (organic such as sodium glycerophosphate) Or Phosphate (mineral such as potassium phosphate) Selenium Zinc a Volume of vial: 10mL concentrate solution b Volume of vial: 5 mL lyophilisate 2 vials a /bag 2 vials b /bag 138 mmol/L 138 mmol/L 5 mmol/L 4.6 mmol/L 18.5 mmol/L 5.5 mmol/L 7.6 µmol/L 0.31 mmol/L TOTAL CONTENT AFTER ADDITION FOR ALL BAG SIZES OF FINOMEL ACTIVE SUBSTANCE 1085 ML 1435 ML 1820 ML Fish oil, rich in omega-3-acids 8.24 g 10.92 g 13.84 g Olive oil, refined 10.30 g 13.65 g 17.30 g Soya-bean oil, refined 12.36 g 16.38 g 20.76 g Medium-chain triglycerides 10.30 g 13.65 g 17.30 g Alanine 11.41 g 15.09 g 19.13 g Arginine 6.34 g 8.38 g 10.63 g Glycine 5.68 g 7.51 g 9.52 g Histidine 2.64 g 3.50 g 4.44 g Is Citiți documentul complet
Health Products Regulatory Authority 05 January 2024 CRN00DGCS Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finomel Emulsion for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Finomel is presented in a 3-compartment plastic bag. Each bag contains a sterile non-pyrogenic combination of a 42% glucose solution, a 10% amino acid solution with electrolytes, and a 20% lipid emulsion. Composition of the reconstituted emulsion after mixing the content of the 3 compartments is provided in the table below: ACTIVE SUBSTANCE 1085 ML 1435 ML 1820 ML Fish oil, rich in omega-3-acids 8.24 g 10.92 g 13.84 g Olive oil, refined 10.30 g 13.65 g 17.30 g Soya-bean oil, refined 12.36 g 16.38 g 20.76 g Medium-chain triglycerides 10.30 g 13.65 g 17.30 g Alanine 11.41 g 15.09 g 19.13 g Arginine 6.34 g 8.38 g 10.63 g Glycine 5.68 g 7.51 g 9.52 g Histidine 2.64 g 3.50 g 4.44 g Isoleucine 3.31 g 4.37 g 5.54 g Leucine 4.02 g 5.32 g 6.75 g Lysine _(as Lysine hydrochloride)_ 3.20 g _(3.99 g)_ 4.23 g _(5.29 g)_ 5.36 g _(6.70 g)_ Methionine 2.20 g 2.92 g 3.70 g Phenylalanine 3.09 g 4.08 g 5.17 g Proline 3.75 g 4.96 g 6.28 g Serine 2.76 g 3.65 g 4.62 g Threonine 2.31 g 3.06 g 3.88 g Tryptophan 0.99 g 1.31 g 1.66 g Tyrosine 0.22 g 0.29 g 0.37 g Valine 3.20 g 4.23 g 5.36 g Sodium acetate trihydrate 3.10 g 4.10 g 5.19 g Potassium chloride 2.47 g 3.27 g 4.14 g Calcium chloride dihydrate 0.41 g 0.54 g 0.68 g Magnesium sulfate heptahydrate 1.36 g 1.80 g 2.28 g Sodium glycerophosphate, hydrated 3.26 g 4.32 g 5.47 g Zinc sulfate heptahydrate 0.013 g 0.017 g 0.021 g Glucose _(as Glucose monohydrate)_ 137.8 g _(151.5 g)_ 181.9 g _(200.0 g)_ 231.0 g _(254.1 g)_ Nutritional intakes of reconstituted emulsion, for each bag size: 1085 ML 1435 ML 1820 ML Nitrogen (g) 9.1 12.0 15.3 Amino acids (g) 55 73 92 Glucose (g) 138 182 231 Lipids a (g) 44 58 73 _ENERGY:_ Total calories (kcal) 1184 1567 1988 Non-protein calories (kcal) 964 1276 1619 Glucose calories (kcal) b 571 755 958 Lipid calories (kcal) c 393 521 661 Non-protein c Citiți documentul complet