Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Albumin 200 g/L (Albumin ex NZ)
CSL Behring (NZ) Ltd
Albumin 200 g/L (Albumin ex NZ)
20% w/v
Solution for infusion
Active: Albumin 200 g/L (Albumin ex NZ) Excipient: Octanoate ions Sodium Water for injection
Vial, glass, bottle, 10 mL
General sale
General sale
CSL Behring (Australia) Pty Ltd
Hypoproteinaemia in the acutely ill patient; Albumex® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.
Package - Contents - Shelf Life: Vial, glass, bottle - 10 mL - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, bottle - 100 mL - 48 months from date of manufacture stored at or below 30°C protect from light
1995-08-25
NEW ZEALAND DATA SHEET Albumex 20 NZ DS 16.00 Page 1 of 12 1 PRODUCT NAME Albumex ® 20 (20%) solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin It is a 20% w/v human albumin solution. Albumex ® 20 is manufactured from human plasma donated by New Zealand’s voluntary and non-remunerated donors. It is prepared by a combination of the Cohn cold-ethanol fractionation process and chromatographic techniques. The composition of Albumex ® 20 is as follows: Human Albumin 200 g/L Sodium 48 to 100 mmol/L Octanoate 32 mmol/L Albumex ® contains no preservatives. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for intravenous infusion. Albumex ® 20 is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. It has a nominal osmolality of 130 mOsm/kg, is hypotonic and the pH is 6.7 to 7.3. It is hyperoncotic and hypo-osmotic compared to human serum. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPOPROTEINAEMIA IN THE ACUTELY ILL PATIENT Albumex ® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. SHOCK Albumex ® 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4% human albumin is preferred when available. BURNS Extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins resulting in hypovolaemic shock and circulatory failure. NEW ZEALAND DATA SHEET Albumex 20 NZ DS 16.00 Page 2 of 12 Initially (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. Large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of Albumex ® 20 are required to maintain adequate plasma volume and colloid osmotic pressure. ADULT RESPIRATORY DISTRESS SYNDROME The c Preberite celoten dokument