Albumini humani solutio

Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. If an allergic or anaphylactic-type reaction is suspected, the infusion must be stopped immediately. In the event of shock, treatment should follow standard guidelines for the management of shock. Albumin should be used with caution in conditions in which hypervolaemia and its consequences or haemodilution could pose a particular risk to the patient. Examples of such conditions include: Decompensated cardiac failure Hypertension Oesophageal varices Pulmonary oedema Haemorrhagic diathesis Severe anaemia Renal and post-renal anuria In a follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality than resuscitation with saline. Although the mechanism underlying this difference in mortality is not fully understood, caution is required 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. Patients should be carefully monitored to guard against circulatory overload and hyperhydration. Human albumin solutions of 200–250 g/l have a relatively low electrolyte content compared with 40–50 g/l solutions. When albumin is administered, the patient's electrolyte status should be monitored (see section 4.2) and appropriate measures taken to restore or maintain electrolyte balance. Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in the recipient. If a relatively large volume is to be replaced, monitoring of coagulation and haematocrit is required. Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and erythrocytes) must be ensured. Hypervolaemia may occur if the dose and rate of infusion are not adjusted to the patient's circulatory status. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion) or raised blood pressure, raised venous pressure and pulmonary oedema, the infusion must be stopped immediately. This medicinal product contains 331–368 mg of sodium per 100 ml of albumin solution, equivalent to up to 18.4% of the WHO-recommended maximum daily dietary intake of 2 g of sodium 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, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/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 to European Pharmacopoeia specifications by established processes. It is strongly recommended that every 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 product.