Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
L-Leucine; L-Isoleucine; L-Valine; L-Lysine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; Sodium acetate; Dipotassium hydrogen phosphate; Sodium chloride; Magnesium chloride; L-Phenylalanine; L-Histidine; L-Methionine
Baxter Healthcare Ltd
B05BA01
L-Leucine; L-Isoleucine; L-Valine; L-Lysine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; Sodium acetate; Dipotassium hydrogen phosphate; Sodium chloride; Magnesium chloride; L-Phenylalanine; L-Histidine; L-Methionine
7.3gram/1litre ; 6gram/1litre ; 5.8gram/1litre ; 5.8gram/1litre ; 4.2gram/1litre ; 1.8gram/1litre ; 20.7gram/1litre ; 11.5gram/1litre ; 10.3gram/1litre ; 6.8gram/1litre ; 5gram/1litre ; 400mg/1litre ; 6.8gram/1litre ; 5.2gram/1litre ; 1.17gram/1litre ; 1.02gram/1litre ; 5.6gram/1litre ; 4.8gram/1litre ; 4gram/1litre
Infusion
Intravenous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09030000; GTIN: 55413760019340 05413760019345
OBJECT 1 SYNTHAMIN 17, 10% AMINO ACID INTRAVENOUS INFUSION Summary of Product Characteristics Updated 08-Jul-2015 | Baxter Healthcare Ltd 1. Name of the medicinal product Synthamin 17, 10% Amino Acid Intravenous Infusion 2. Qualitative and quantitative composition L-Leucine Ph. Eur 0.730% w/v L-Isoleucine Ph. Eur 0.600% w/v L-Lysine (as hydrochloride salt) Ph. Eur 0.580% w/v L-Valine Ph. Eur 0.580% w/v L-Phenylalanine Ph. Eur 0.560% w/v L-Histidine Ph. Eur 0.480% w/v L-Threonine Ph. Eur 0.420% w/v L-Methionine Ph. Eur 0.400% w/v L-Tryptophan Ph. Eur 0.180% w/v L-Alanine Ph. Eur 2.070% w/v L-Arginine Ph. Eur 1.150% w/v Amino acetic acid (glycine) Ph. Eur 1.030% w/v L-Proline Ph. Eur 0.680% w/v L-Serine Ph. Eur 0.500% w/v L-Tyrosine Ph. Eur 0.040% w/v Sodium acetate Ph. Eur. 0.680% w/v Dibasic potassium phosphate Ph. Eur. 0.522% w/v Sodium chloride Ph. Eur. 0.117% w/v Magnesium chloride Ph. Eur. 0.102% w/v 3. Pharmaceutical form The product is a sterile aqueous solution of amino acids and electrolytes for intravenous infusion to human beings. 4. Clinical particulars 4.1 Therapeutic indications Synthamin 17, 10% Amino Acid Intravenous Infusion provides a biologically available source of nitrogen (L-amino acids) for amino acids synthesis. When administered with an adequate source of energy such as concentrated carbohydrate solutions, minerals and vitamins, the mixture provides (with the exception of essential fatty acids) sufficient parenteral nutrition for patients unable to absorb adequate oral nutrition. 4.2 Posology and method of administration The solution is for administration by intravenous infusion through a central venous catheter with the tip located in the central vena cava. The total daily dose of the solution depends upon the patient's metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements. In addition to meeting nitrogen needs, the rate of ad Přečtěte si celý dokument