AlbuRx Special Precautions

In the event of allergic or anaphylactic type reactions the infusion must be discontinued immediately and appropriate treatment must be instituted. In case of anaphylactic shock, the current medical guidelines for shock should be followed.
Albumin should be used with caution in all conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are: congestive cardiac failure, hypertension, oesophageal varices, pulmonary oedema, hemorrhagic diathesis, severe anaemia, renal or postrenal anuria.
When albumin is given, the electrolyte status of the patient should be monitored and appropriate steps taken to restore or maintain the electrolyte balance.
If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
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 in the event of increased blood pressure, raised central venous pressure or pulmonary oedema, the infusion must be stopped immediately and the patient's haemodynamic parameters must be carefully monitored.
AlbuRx contains approximately 3.2 mg sodium per ml of solution (140 mmol/l). That should be taken into consideration for patients on a controlled sodium diet.
AlbuRx 20 & AlbuRx25: The colloid-osmotic effect of human albumin 200-250 g/l is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.
200-250 g/l human albumin solutions are relatively low in electrolytes compared to the 40-50 g/l albumin solutions.
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in patients.
Information on safety in regard to transmissible agents: 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.
Albumin manufactured to European Pharmacopoeia specifications is regarded as having reliable viral safety.
It is recommended that every time AlbuRx is administered to a patient, the name and batch number of the product should be recorded in order to create a link between the patient and the batch of the product.
Effect on the ability to drive and use machines: There is no evidence of adverse effects affecting the ability to drive or use machines.