Zenalb 4.5

/ Kamada

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements.
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:
– arterial blood pressure and pulse rate
– central venous pressure
– pulmonary artery wedge pressure
– urine output
– electrolyte
– haematocrit/haemoglobin
Method of administration: Human albumin can be directly administered by the
intravenous route.
The infusion rate should be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion should be adjusted to the rate of removal.

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the patient, based on official recommendations.

Hypersensitivity to albumin preparations or to any of the excipients.

If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately and appropriate treatment instituted. If comparatively large volumes are to be replaced, controls of coagulation and hematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). If the hematocrit falls below 30%, packed red cells should be given. Hypervolemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary edema, the infusion is to be stopped immediately. Special care should be taken when administering albumin in pathological states where capillary permeability may be increased.
Pediatric use: Physiological plasma volume is age dependent. This fact must be taken into account when determining dose volumes.

Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and appropriate treatment should be initiated.

No specific interactions of human albumin with other medicinal products are known.

The safety of Zenalb® 4.5 for use in human pregnancy has not been established in controlled clinical trials.
However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected.