ALBUNORM Solution for infusion Ref.[27722] Active ingredients: Albumin

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient´s individual requirements.

Posology

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

Paediatric population

Data on the use of Albunorm 5% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks.

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-rate should be adjusted to the rate of removal.

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.

3 years.

After the vial has been opened, the content should be used immediately.

Do not store above +25°C.

Store in the original container in order to protect from light.

Do not freeze.

• 100 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

• 250 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

• 500 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack of 1.

Not all pack sizes may be marketed in all countries.

The solution can be directly administered by the intravenous route.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room or body temperature before use.

Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated.

Once the container has been opened the content should be used immediately.

Any unused product should be disposed of in accordance with local requirements.