Zenalb 20

/ Kamada

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, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).
The infusion rate should be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion rate 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.

Hypersensitivity to albumin preparations or to any of the excipients.

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.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived human albumin solutions.
It is strongly recommended that every time that this medical product 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.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In the 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
The colloid-osmotic effect of human albumin 200 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.
Human albumin solutions with concentrations of 200-250 g/l contain relatively low levels of electrolytes compared to those with 40-50 g/l. Therefore, when administering albumin, it’s important to monitor the patient’s electrolyte status and take necessary measures to restore or maintain 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).
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient’s 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.
For full details see prescribing information.

Summary of the safety profile
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.
For full details see prescribing information.

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

Pregnancy: The safety of this medical product 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.

Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient’s haemodynamic parameters carefully monitored.