Description
FORMULATION
Active ingredient
200 g / L of plasma proteins containing at least 95% of human albumin.
List of excipients 1 litre of solution for infusion contains
Sodium Chloride 4.52 g/L
Sodium caprylate 2.660 g/L (16 mmol/L)
Acetyltryptophan 3.940 g/L (16 mmol/L)
Water for injections up to 1000 mL
Total concentration of sodium 123.5 – 136.5 mmol/L
THERAPEUTIC INDICATIONS
Albumin replacement in patients with major albumin deficiency.
SPECIAL PRECAUTIONS FOR USE
If allergic reactions occur, the infusion should be stopped immediately. If
allergic reactions persist, then appropriate treatment is recommended. In
anaphylactic
reactions, treatment should follow the current recommendations for shock
therapy.
The colloid-osmotic effect of human albumin 20% 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.
If the required volume of Human Albumin (Kedrialb) 20% exceeds 200 mL,
appropriate additional electrolyte solutions should be administered to maintain
normal fluid balance.
Alternatively, therapy may be continued with 5% human albumin solution.
If comparatively large volumes are to be replaced, controls of coagulation
and haematocrit are necessary. Care should be taken to ensure adequate
substitution of other blood constituents (coagulation factors, electrolytes,
platelets, and erythrocytes).
If haematocrit drops below 30%, packed red cells should be given in order to
maintain the oxygen transport capacity of the blood.
