Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
Serumwerk Bernburg AG
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
6 Per Cent
Solution for Infusion
Withdrawn
2007-02-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Infukoll ® 6 % solution for infusion, bag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of hypovolaemia and shock. Normovolaemic haemodilution. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION HES must be administered intravenously. Total dosage, duration and rate of infusion will depend upon the amount of blood lost and/or the haemodynamic status and general clinical condition of the patient. Dosage 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 rate of infusion or inappropriately large doses must be borne in mind. Due to the risk for occurrence of an anaphylactic reaction, the first 10 ml - 20 ml of Infukoll ® 6 % should be infused slowly and under careful observation of the patient. 1000 ml contains: Poly (O-2-hydroxyethyl)starch 60.0 g (Molar substitution 0.45-0.55) (Average molecular weight: 200 000 Da) Sodium chloride 9.00 g Na + 154 mmol Cl - 154 mmol Theoretical osmolarity 309 mosmol/l pH 5.0-7.0 For excipients, see 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/03/2006_ _CRN 2021077_ _page number: 1_ _Maximum infusion rate:_ The maximum rate of infusion should be adjusted to the clinical situation. _Patients with acute haemorrhagic shock:_ Up to 20 ml/kg bodyweight/hour (equivalent to 0.33 ml/kg BW/min). _In life-threatening situations: _500 ml as a rapid infusion (under pressure). The rates of infusion selected for perioperative indications and for burns and septic shock patients will usually be lower. _Maximum daily dosage:_ Lestu allt skjalið