Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
POLYGELINE
Piramal Healthcare UK Limited
POLYGELINE
17.5g/500m Millilitre
Solution for Infusion
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Haemaccel 3.5% w/v solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion (infusion) Clear colourless to slightly yellow solution for infusion. Ph 7.3 ± 0.3 Osmolarity 301 mosm/L (293 mosm/kg) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an immediate short term measure in plasma volume restoration in hypovolaemia due to blood or plasma loss, dehydration or peri-operative loss of circulating fluid. 2. Extra Corporeal circulation. 3. Isolated organ perfusion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Haemaccel should be administered intravenously. Dosage volume and ratio of administration depends on individual patient circumstances and response. In common with all intravenous infusion solutions Haemaccel should, if possible, be warmed to body temperature before use. However, in emergencies it may be infused at ambient temperatures. For technical reasons there is a residual air volume in the container. Thus, pressure infusions with the plastic infusion bottle must be carried out under controlled conditions only, as the risk of air embolism cannot be excluded. _Infusion rate: _The rate of infusion is determined by the condition of the patient. Normally 500 ml will be infused in not less than 60 minutes, but in emergencies Haemaccel can be rapidly infused. Losses of up to 25% of the blood volume can be replaced by Haemaccel alone. _Plastic infusion bottle: _It is advisable to disinfect the bottle top and then pull out the plastic ring. A hole will be exposed through which the piercing needle of an infusion set can be pushed. _Hypovolaemic shock: _500-1,000 ml Haemaccel should be infused intravenously Przeczytaj cały dokument