Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
DEXTRAN 40 SODIUM CHLORIDE
Baxter Healthcare Limited
10/0.9 %w/v %w/v
Solution for Infusion
1983-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gentran 40 (Dextran 40 Intravenous Infusion BP 10% w/v in Sodium Chloride Intravenous Infusion BP 0.9% w/v). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1000 ml contains: For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Infusion. A clear, colourless, sterile, aqueous solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the treatment of hypovolaemic shock. Prophylaxis of thromboembolic episodes in surgery. As a diluent in the pump oxygenator during extra-corporeal circulation. To improve blood flow and tissue function in burns and conditions associated with local ischaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE The dosage is dependent upon the age, weight and clinical condition of the patient. HYPOVOLAEMIC SHOCK _Adults_ Usual dose is 500 to 1500ml, depending on individual response. This dose should not be exceeded except in unusual circumstances. _Paediatric Patients_ Children 10ml/kg - Babies 5ml/kg. PROPHYLAXIS OF THROMBOEMBOLIC EPISODES 500 -1000ml daily commencing on day of surgery and continuing for 2-5 days post operatively. AS DILUENT IN PUMP OXYGENATOR 10 to 20ml/kg. The dextran concentration should never exceed 3%. Dextran 40 (Dextran 40 for Injection) 100 g Sodium Chloride 9 g IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/11/2007_ _CRN 2043478_ _page number: 1_ TO IMPROVE BLOOD FLOW AND TISSUE FUNCTION IN BURNS/ISCHAEMIA Usual dose is 500ml prior to surgery and 500ml during surgery. Dosage depends on individual patient’s circumstances and response. ADMINISTRATION Intravenous. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to dextrans. Use in Izlasiet visu dokumentu