Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE DL-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE AMINOACETIC ACID ALANINE PROLINE ASPARTIC ACID ASPARGINE MONOHYDRATE ACETYLCYSTEINE GLUTAMIC ACID ORNITHINE HYDROCHLORIDE SERINE TYROSINE SODIUM ACETATE TRIHYDRATE POTASSIUM ACETATE MAGNESIUM ACETATE TETRAHYDRATE SODIUM PHOSPHATE MONOBASIC MALIC ACID N-ACETYLTYROSINE PH. EUR.
B. Braun Medical Limited
10 %w/v
Solution for Infusion
1987-04-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aminoplasmal 10% E without Carbohydrates Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _1000 ml of solution contains_ Isoleucine 5.10 g Leucine 8.90 g Lysine Hydrochloride 7.00 g _(equivalent to lysine 5.60 g)_ Methionine 3.80 g Phenylalanine 5.10 g Threonine 4.10g Tryptophan 1.80g Valine 4.80g Arginine 9.20 g Histidine 5.20 g Glycine 7.90 g Alanine 13.70 g Proline 8.90 g Aspartic Acid 1.30 g Asparagine Monohydrate 3.72 g _(equivalent to asparagine 3.27 g)_ Acetylcysteine 0.68 g _(equivalent to cysteine 0.50 g)_ Glutamic Acid 4.60 g Ornithine Hydrochloride 3.20 g _(equivalent to ornithine 2.51 g)_ Serine 2.40 g Tyrosine 0.30 g Acetyltyrosine 1.23 g _(equivalent to tyrosine 1.0 g)_ Sodium Acetate Trihydrate 3.95 g Potassium Acetate 2.45 g Magnesium Acetate Tetrahydrate 0.56 g Sodium Dihydrogen Phosphate Dihydrate 1.40 g Sodium hydroxide 0.20 g Malic Acid 1.01 g Electrolyte concentrations: Sodium 43.0 mmol/l Potassium 25.0 mmol/l Magnesium 2.6 mmol/l Acetate 59.0 mmol/l Chloride 57.0 mmol/l Dihydrogen phosphate 9.0 mmol/l L-Malate 7.5 mmol/l IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/11/2008_ _CRN 2058214_ _page number: 1_ For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion A clear, colourless or faintly straw-coloured aqueous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supply of amino acids as a substrate for protein synthesis in parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. In parenteral nutrition, amino acid infusions should always be combined with adequate calorie supply, e. g. in the form of carbohydrate solutions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dos Les hele dokumentet