Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sodium Chloride Ph Eur; magnesium chloride hexahydrate PhEur; Potassium Chloride Ph Eur; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.
FRESENIUS KABI MALAYSIA SDN. BHD
Sodium Chloride Ph Eur; magnesium chloride hexahydrate PhEur; Potassium Chloride Ph Eur; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.
250ml mL; 500ml mL; 250ml mL; 500ml mL; 250ml mL; 500ml mL; 250ml mL; 500ml mL
FRESENIUS KABI DEUTSCHLAND GMBH
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PIK86752100 VOLULYTE 6% SOLUTION FOR INFUSION Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1000mL contains: Active constituents Poly (O-2-hydroxyethyl) starch 60.00g - Molar substitution 0.38 – 0.45 - Mean molecular weight (Mw): 130,000Da (manufactured from waxy maize starch) Sodium Acetate trihydrate 4.63g Sodium Chloride 6.02g Potassium Chloride 0.30g Magnesium Chloride hexahydrate 0.30g Electrolytes: Na + 137.0 mmol/L K + 4.0 mmol/L Mg ++ 1.5 mmol/L Cl - 110.0 mmol/L CH3COO - 34.0 mmol/L Theoretical osmolarity: 286.5 mosm/L Titratable acidity: < 2.5 mmol NaOH/L pH: 5.7 – 6.5 Other ingredients: Sodium Hydroxide, hydrochloric acid, water for injections. DESCRIPTION A clear to slightly opalescent solution, colourless to slightly yellow. PHARMACODYNAMICS Volulyte is an artificial colloid for volume replacement whose effect on intravascular volume expansion and haemodilution depends on the molar substitution by hydroxyethyl groups (0.4), the mean molecular weight (130,000 Da), the concentration (6%) as well as the dosage and infusion rate. Hydroxyethyl starch (130/0.4) contained in Volulyte is derived from waxy maize starch and has a substitution pattern (C 2 /C 6 ratio) of approximately 9:1. Infusion of 500ml of a similar product containing HES 130/0.4 (6%) in 0.9% sodium chloride solution in 30 minutes in volunteers results in a plateau-like non-expansive volume increase of approximately 100% of the infused volume which lasts for approximately 4 to 6 hours. Isovolaemic exchange of blood with HES 130/0.4 in 0.9% sodium chloride solution maintains blood volume for at least 6 hours. PIK86752100 Volulyte contains the electrolytes sodium (Na + ), potassium (K + ), Magnesium (Mg ++ ), Chloride (Cl - ) and acetate (CH 3 COO - ) in an isotonic composition. Acetate is a metabolisable anion which is oxidised in different organs and has an alkalising effect. Volulyte contains a reduced amount of chloride and therefore counteracts the development of Lire le document complet