Albunorm Special Precautions

Albunorm 5%: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
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 insufficiency; Hypertension; Oesophageal varices; Pulmonary oedema; Haemorrhagic diathesis; Severe anaemia; Renal and post-renal anuria.
In a post-hoc follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality rates than was resuscitation with saline. While the mechanisms underlying this observed difference in mortality are not clear, caution is advised in the use of albumin in patients with severe traumatic brain injury.
200-250 g/l human albumin solutions are relatively low in electrolytes compared to 40-50 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see Dosage & Administration) 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 rate of infusion are not adjusted to the patients circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
This medicinal product contains 14.4-16 mmol/36-40 mmol/72-80 mmol sodium per one bottle of 100 ml/250 ml/500 ml albumin solution, this has to be taken into consideration by patients on a controlled sodium diet.
This medicine contains maximum 1.25 mmol potassium per one bottle of 500 ml albumin solution, this has to be taken into consideration for patients with reduced kidney function or patients on a controlled potassium diet.
Standard measure 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 transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that Albunorm 5% 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.
Albunorm 20%: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
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 insufficiency; Hypertension; Oesophageal varices; Pulmonary oedema; Haemorrhagic diathesis; Severe anaemia; Renal and post-renal anuria.
In a post-hoc follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality rates than was resuscitation with saline. While the mechanisms underlying this observed difference in mortality are not clear, caution is advised in the use of 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 blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure 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 40-50 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see Dosage & Administration) and appropriate steps taken to restore or maintain the electrolyte balance.
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patients circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
This medicinal product contains 7.2-8 mmol /14.4-16 mmol sodium per one bottle of 50 ml/100 ml albumin solution, this has to be taken into consideration by patients on a controlled sodium diet.
This medicine contains maximum 1mmol potassium per one bottle of 100 ml albumin solution, this has to be taken into consideration for patients with reduced kidney function or patients on a controlled potassium diet.
Standard measure 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 transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that Albunorm 20% 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.
Effect on ability to drive and use machines: No effects on ability to drive and use machines have been observed.