Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
B. Braun Melsungen AG
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
10% %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-12-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hemohes 10% w/v solution for infusion, Ecobag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for Infusion Clear colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hemohes 10% is used as a colloidal plasma volume substitute in the following situations: 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Total dosage, duration and rate of infusion will depend upon the amount of blood or plasma lost and the condition of the patient, and will need to be adjusted as necessary by monitoring the usual circulatory parameters (_e.g. _blood pressure). The risk of circulatory overload by too-rapid infusion or inappropriately large doses must be borne in mind especially with Hemohes 10%, which is hyperoncotic. In order to detect the occurrence of an anaphylactoid reaction as early as possible, the first 20-30 ml of Hemohes should be infused slowly and under careful observation. 1000ML OF SOLUTION CONTAINS: Poly(0-2-hydroxyethyl) starch (HES) 100.0 g Sodium Chloride 9.0 g For excipients, see section 6.1. PHYSICO-CHEMICAL PROPERTIES: Weight average molecular weight (Mw; Dalton) 200,000 Number average molecular weight (Mn, Dalton) ~80,000 Molar substitution (MS) 0.5 (0.45-0.55) Theoretical osmolarity 310 mOsm/l pH 4.0 – 7.0 Electrolytes: Sodium 154.0 mmol/litre Chloride 154.0 mmol/litre - Prevention and treatment of hypovolaemia (e.g., following shock due to haemorrhage or trauma, peri-operative blood loss, burns, sepsis). - Prevention of hypotension (e.g., in connection with induction of general, spinal or peridural anaesthesia). - Haemodilution. - Extra-corporeal circulation. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _D Perskaitykite visą dokumentą