ALBUNORM 200G/L Solution for infusion

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. If allergic or anaphylactic-type reactions are suspected, the infusion must be stopped immediately.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ In the event of shock, treatment should be in accordance with standard guidelines for the management of shock. Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are: Decompensated cardiac failure Hypertension Oesophageal varices Pulmonary oedema Haemorrhagic diathesis Severe anaemia Renal and post-renal anuria In a subsequent study in critically ill patients with traumatic brain injury, resuscitation with albumin was associated with higher mortality than resuscitation with normal saline. Although the mechanism underlying this difference in mortality is not fully understood, caution is advised when using albumin in patients with severe traumatic brain injury. The colloid-osmotic effect of human albumin 200 or 250 g/l is approximately four times that of human plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. The patient should be carefully monitored to prevent circulatory overload and hyperhydration. Human albumin solutions of 200–250 g/l have a relatively low electrolyte content compared with solutions of 40–50 g/l. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain electrolyte balance. Albumin solutions must not be diluted with water for injection, as this may cause haemolysis in recipients. If comparatively large volumes are to be replaced, monitoring of coagulation and haematocrit is necessary. Adequate substitution of other blood components (coagulation factors, electrolytes, platelets and red blood cells) must be ensured. Hypervolaemia may occur if the dosage and infusion rate 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, increased central venous pressure and pulmonary oedema, the infusion must be stopped immediately. This medicinal product contains 331–368 mg sodium per 100 ml of albumin solution, equivalent to up to 18.4% of the WHO recommended maximum daily sodium intake of 2 g for an adult. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, testing of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation and removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmission with albumin manufactured by established processes in accordance with the specifications of the European Pharmacopoeia. It is strongly recommended that each time Albunorm is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.