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Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock must be implemented.
Albumin must 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.
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 must 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 human albumin solutions. When albumin is given, the electrolytes status of the patients must 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.
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).
If the haematocrit drops below 30%, packed red cells should be given in order to maintain the oxygen transport capacity of the blood.
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.
Viral safety: 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 transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that UMAN ALBUMIN 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.
Effects on ability to drive and use machines: UMAN ALBUMIN has no or negligible influence on the ability to drive and use machines.
Fertility: No animal reproduction studies have been conducted with UMAN ALBUMIN.
However human albumin is a normal constituent of human blood.
Use in Children: Although no specific data are available for paediatric population, the clinical experience on the use of Human Albumin in children suggests that no differences between adults and children are to be expected, provided that a careful attention to the dosage has been observed in order to avoid circulatory overload.
