Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
L-Leucine; L-Isoleucine; L-Lysine; L-Valine; L-Histidine; L-Threonine; L-Alanine; Tryptophan; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; L-Phenylalanine; L-Methionine
Baxter Healthcare Ltd
B05BA01
L-Leucine; L-Isoleucine; L-Lysine; L-Valine; L-Histidine; L-Threonine; L-Alanine; Tryptophan; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; L-Phenylalanine; L-Methionine
4.02gram/1litre ; 3.3gram/1litre ; 3.19gram/1litre ; 3.19gram/1litre ; 2.64gram/1litre ; 2.31gram/1litre ; 11.38gram/1litre ; 990mg/1litre ; 6.32gram/1litre ; 5.66gram/1litre ; 3.74gram/1litre ; 2.75gram/1litre ; 220mg/1litre ; 3.08gram/1litre ; 2.2gram/1litre
Infusion
Intravenous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09030000; GTIN: 55413760141928 05413760141923
OBJECT 1 SYNTHAMIN 9, 5.5% AMINO ACID INTRAVENOUS INFUSION WITHOUT ELECTROLYTES Summary of Product Characteristics Updated 08-Jul-2015 | Baxter Healthcare Ltd 1. Name of the medicinal product Synthamin 9, 5.5% Amino Acid Intravenous Infusion without Electrolytes. 2. Qualitative and quantitative composition L-Leucine L-Isoleucine L-Lysine (as hydrochloride salt) L-Valine L-Phenylalanine L-Histidine L-Threonine L-Methionine L-Tryptophan L-Alanine L-Arginine Amino acetic acid L-Proline L-Serine L-Tyrosine Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. Ph. Eur. 0.402% w/v 0.330% w/v 0.319% w/v 0.319% w/v 0.308% w/v 0.264% w/v 0.231% w/v 0.220% w/v 0.099% w/v 1.138% w/v 0.632% w/v 0.566% w/v 0.374% w/v 0.275% w/v 0.022% w/v 3. Pharmaceutical form The product is a clear, or slightly coloured sterile non-pyrogenic solution of amino acids for intravenous infusion to human beings. 4. Clinical particulars 4.1 Therapeutic indications Synthamin 9, 5.5% Amino Acid Intravenous Infusion without Electrolytes 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 administration is governed, especially during the first few days of therap Přečtěte si celý dokument