Human Albumin Solution (Burns)

SOURCE: UK SPC (eMC) for albunorm 20%, 200 g/l, solution for infusion, section 4.2 (https://www.medicines.org.uk/emc/product/421/smpc). The SPC posology contains NO numeric regimen at all - no g/kg, no mL/kg, no mL/hour, no burns-resuscitation formula and no maximum daily dose; the whole of section 4.2 is the individualisation and monitoring text quoted above, so any burns-specific volume or timing (for example a colloid component of a burns resuscitation formula) must come from a local burns protocol and has not been inferred here. MONITORING required when human albumin is administered - haemodynamic performance should be monitored regularly, which may include arterial blood pressure and pulse rate, central venous pressure, pulmonary artery wedge pressure, urine output, electrolytes and haematocrit/haemoglobin. SECTION 4.4 CAUTIONS DIRECTLY AFFECTING DOSE AND RATE: albumin should be used with caution where hypervolaemia and its consequences, or haemodilution, could represent a special risk - decompensated cardiac insufficiency, hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, severe anaemia, and renal and post-renal anuria. The colloid-osmotic effect of human albumin 200 or 250 g/l is approximately four times that of blood plasma, so when concentrated albumin is administered care must be taken to assure adequate hydration, and patients must be monitored carefully to guard against circulatory overload and hyperhydration. Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation; at the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure or pulmonary oedema, the infusion must be stopped immediately. 200-250 g/l solutions are relatively low in electrolytes compared with 40-50 g/l solutions, so electrolyte status should be monitored and corrected. If comparatively large volumes are replaced, coagulation and haematocrit must be checked and adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes) ensured. In a post-hoc follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality than resuscitation with saline, so caution is advised in severe traumatic brain injury. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. Each 100 mL of albumin solution contains 331-368 mg sodium (up to 18.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult). Traceability: the name and batch number of the administered product should be clearly recorded. PAEDIATRIC (section 4.2, verbatim): 'Data on the use of Albunorm 20% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks.' No paediatric dose is stated - verify against a children's formulary. Note that section 4.4 was truncated at the source-fetch limit in this bundle (the viral-safety paragraph is incomplete); section 4.2 itself appears complete. No openFDA (US) labelling was fetched in this bundle.