Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Human Albumin
CSL BEHRING PTE. LTD.
B05AA01
200g/L
INFUSION, SOLUTION
Human Albumin 200g/L
INTRAVENOUS DRIP
Prescription Only
CSL Behring GmbH
ACTIVE
2012-01-20
1. NAME OF THE MEDICINAL PRODUCT Human Albumin solution for infusion 20 % Behring 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin solution for infusion 20 % Behring is a solution containing 200 g/l of total protein of which at least 96 % is human albumin. 100 ml contain at least 19.2 g of human albumin. 50 ml contain at least 9.6 g of human albumin. The solution is hyperoncotic. 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 infusionrate 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 – urine output – electrolyte – haematocrit/haemoglobin METHOD OF ADMINISTRATION Human albumin can be administered by the intravenous route, either undiluted or after dilution in an isotonic solution (e.g. 5 % glucose or 0.9 % sodium chloride). See section 3 "Pharmaceutical Form" and 6.6 "Special precautions for disposal and other handling". The infusionrate should be adjusted according to the individual circumstances and Olvassa el a teljes dokumentumot
1. NAME OF THE MEDICINAL PRODUCT Human Albumin solution for infusion 20 % Behring 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin solution for infusion 20 % Behring is a solution containing 200 g/l of total protein of which at least 96 % is human albumin. 100 ml contain at least 19.2 g of human albumin. 50 ml contain at least 9.6 g of human albumin. The solution is hyperoncotic. 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 infusionrate 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 – urine output – electrolyte – haematocrit/haemoglobin METHOD OF ADMINISTRATION Human albumin can be administered by the intravenous route, either undiluted or after dilution in an isotonic solution (e.g. 5 % glucose or 0.9 % sodium chloride). See section 3 "Pharmaceutical Form" and 6.6 "Special precautions for disposal and other handling". The infusionrate should be adjusted according to the individual circumstances and the indication. In plasma exchange the in Olvassa el a teljes dokumentumot