Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN
Baxter Healthcare Limited
200 g/l
Solution for Infusion
2007-08-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flexbumin 200 g/l solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flexbumin 200 g/l is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A bag of 100 ml contains 20 g of human albumin. A bag of 50 ml contains 10 g of human albumin The solution is hyperoncotic Excipients: Sodium 130-160 mmol/l For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements. _Posology_ The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure (PCW-pressure) - urine output - electrolyte - haematocrit/haemoglobin - clinical signs of cardiac/respiratory failure (e.g.dyspnoea) IRISH MEDICINES BOARD ___________________________________________________________________ Read the complete document