Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
HETASTARCH SODIUM CHLORIDE
Baxter Healthcare Limited
6 %w/v
Solution for Infusion
1998-01-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 6% w/v Hetastarch in 0.9% w/v Sodium Chloride Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each one litre of solution contains: For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion A clear almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a plasma volume expander for the treatment of hypovolaemia and shock. The solution is not to be used as a substitute for either blood or plasma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION a) Plasma Volume Expansion The dose and rate of infusion will depend upon the clinical condition of the patient, the amount of blood lost and the resultant haemoconcentration in the individual patient. Care should be exercised in keeping the dose and rate to the lowest effective level and due to the risk of anaphylactic reactions occurring the initial 10-20ml of 6% w/v Hetastarch in 0.9% w/v Sodium Chloride Solution for Infusion should be infused slowly, whilst the patient is kept under careful observation. When administering 6% Hetastarch in 0.9% Sodium Chloride Solution for Infusion it should be appreciated that the effective increase in plasma volume exceeds that of the volume infused (refer to Section 5.1). In adults the amounts usually administered is 500ml to 1000ml. Total dosage does not usually exceed 1500ml per day or 20ml per kg of body weight per day for a typical 70kg patient, but in common with other colloids the limiting dose will depend on circulating volume and haematocrit; in patients without cardiovascular or pulmonary risks the solution should only be used when the haematocrit is greater than 30%. An initial administration rate of not greater than 15 ml/kg/hr is recommended. The total Olvassa el a teljes dokumentumot