Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
Fresenius Kabi Limited
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
%v/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-05-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT HyperHAES Soution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution for infusion contain: Poly(O-20hydroxyethyl) starch 60.0 g (Molar substitution 0.43-0.55) (Mean molecular weight 200,000 Da) Sodium chloride 72.0 g Na + 1232 mmol/l Cl - 1232 mmol/l Theoretical osmolarity 2464 mosml/l pH 3.5 – 6.0 Titratable acidity < 1.0 mmol NaoH/l For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion A clear to slightly opalescent solution, colourless to slightly yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Initial_, _single dose treatment of acute hypovolaemia and shock (“small volume resuscitation”) The solution is intended for blood volume replacement and is not to be used as a substitute for either blood or plasma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Maximum dose: HyperHAES is to be administered as a single intravenous bolus dose (approximately 4 ml/kg bodyweight = 250 ml for a patient with a body weight of 60-70 kg). Mode of administration: HyperHAES should be given as a single intravenous bolus dose or pressure-infusion (a full dose within two to five minutes). Although the osmolarity of HyperHAES is very high, the product can be administered via peripheral venous route. If available, central venous route is preferred, but not mandatory. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2010_ _CRN 2069896_ _page number: 1_ Duration of treatment: HyperHAES is intended for _single _administration only. Repeated infusions are not recommended. Treatment with HyperHAES should be immediately followed by a standard volume therapy (e.g. electrolytes and colloids), dosed adequately to Lire le document complet