Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
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 individual patient, based on official recommendations.
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:
The posology in children and adolescents (0-18 years) should be adjusted to the patient’s individual requirements.
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.
Hypervolaemia may occur if the dosage and infusion rate 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.
Do not store above 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
50 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).
100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).
1 vial per pack (10 g/50 ml, 20 g/100 ml).
Not all pack sizes may be marketed.
The solution 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).
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 vial has been opened, the contents should be used immediately.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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