Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
N-acetyltryptophanate (16 mmol/l), Sodium chloride (63 mmol/l), Sodium caprylate (16 mmol/l), water for injections.

6.2   Incompatibilities

Human albumin must not be mixed with other medicinal products (except those mentioned in section 6.6), whole blood and packed red blood cells.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage


Store below 25 °C. Do not freeze.
Keep the container in the outer carton in order to protect from light.
6.5   Nature and contents of container

50 ml or 100 ml of a solution in a vial (Type II glass) with a grey rubber stopper (bromobutyl) and a cap (aluminium) – pack size of one vial.
6.6   Special precautions for disposal and other handling

The solution can be directly administered by the intravenous route, or it can be diluted in an isotonic solution (e.g. 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.
The solution should be clear or slightly opalescent.
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 contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.