Land: Irland
Sprog: engelsk
Kilde: 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
13 %+ 10 % +20 percent
Emulsion for infusion
Solutions for parenteral nutrition; amino acids
Marketed
2019-07-19
G PER 1000 ML Tyrosine 0.13 Valine 1.83 Sodium acetate trihydrate 1.77 Potassium chloride 1.41 Calcium chloride dihydrate 0.23 Magnesium sulfate heptahydrate 0.78 Sodium glycerophosphate hydrated 1.87 Zinc sulphate heptahydrate 0.007 Glucose (as monohydrate) 77.8 Soya-bean oil, refined 8.46 Olive oil, refined 7.05 Medium-chain triglycerides 7.05 Fish oil, rich in omega-3-acids 5.64 G PER 1000 ML Alanine 6.52 Arginine 3.62 Glycine 3.24 Histidine 1.51 Isoleucine 1.89 Leucine 2.30 Lysine (as hydrochloride) 2.28 Methionine 1.26 Phenylalanine 1.76 Proline 2.14 Serine 1.58 Threonine 1.32 Tryptophan 0.57 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: of 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 9.2 mmol/L 7.6 µmol/L 0.31 mmol/L TOTAL CONTENT AFTER ADDITION FOR ALL BAG SIZES OF FINOMEL PERI ACTIVE SUBSTANCE 1085 ML 1450 ML 2020 ML Fish oil, rich in omega-3-acids 6.12 g 8.16 g 11.40 g Olive oil, refined 7.65 g 10.20 g 14.25 g Soya-bean oil, refined 9.18 g 12.24 g 17.10 g Medium-chain triglycerides 7.65 g 10.20 g 14.25 g Alanine 7.08 g 9.46 g 13.17 g Arginine 3.93 g 5.26 g 7.31 g Glycine 3.52 g 4.71 g 6.55 g Histidine 1.64 g 2.19 g 3.05 g Isoleucine 2.05 g 2.74 g 3.82 g Leucine 2.50 g Læs hele dokumentet
Health Products Regulatory Authority 05 January 2024 CRN00DGCS Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finomel Peri Emulsion for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Finomel Peri is presented in a 3-compartment plastic bag. Each bag contains a sterile non-pyrogenic combination of a 13% 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 1450 ML 2020 ML Fish oil, rich in omega-3-acids 6.12 g 8.16 g 11.40 g Olive oil, refined 7.65 g 10.20 g 14.25 g Soya-bean oil, refined 9.18 g 12.24 g 17.10 g Medium-chain triglycerides 7.65 g 10.20 g 14.25 g Alanine 7.08 g 9.46 g 13.17 g Arginine 3.93 g 5.26 g 7.31 g Glycine 3.52 g 4.71 g 6.55 g Histidine 1.64 g 2.19 g 3.05 g Isoleucine 2.05 g 2.74 g 3.82 g Leucine 2.50 g 3.34 g 4.64 g Lysine _(as Lysine hydrochloride)_ 1.98 g _(2.48 g)_ 2.65 g _(3.31 g)_ 3.69 g _(4.61 g)_ Methionine 1.37 g 1.83 g 2.54 g Phenylalanine 1.92 g 2.56 g 3.56 g Proline 2.33 g 3.11 g 4.32 g Serine 1.71 g 2.29 g 3.18 g Threonine 1.44 g 1.92 g 2.67 g Tryptophan 0.62 g 0.82 g 1.14 g Tyrosine 0.14 g 0.18 g 0.25 g Valine 1.98 g 2.65 g 3.69 g Sodium acetate trihydrate 1.92 g 2.57 g 3.57 g Potassium chloride 1.53 g 2.05 g 2.85 g Calcium chloride dihydrate 0.25 g 0.34 g 0.47 g Magnesium sulfate heptahydrate 0.84 g 1.13 g 1.57 g Sodium glycerophosphate, hydrated 2.03 g 2.71 g 3.77 g Zinc sulfate heptahydrate 0.008 g 0.011 g 0.015 g Glucose _(as Glucose monohydrate)_ 76.7 g _(84.4 g)_ 102.6 g _(112.8 g)_ 142.9 g _(157.2 g)_ Nutritional intakes of reconstituted emulsion, for each bag size: 1085 ML 1450 ML 2020 ML Nitrogen (g) 5.6 7.5 10.5 Amino acids (g) 34 46 64 Glucose (g) 77 103 143 Lipids a (g) 32 43 60 _ENERGY:_ Total calories (kcal) 751 1003 1398 Non-protein calories (kcal) 614 820 1144 Glucose calories (kcal) b 322 431 600 Lipid calories (kcal) c 292 389 544 Non-protein calo Læs hele dokumentet