Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
1 litre of solution for infusion contains:
Sodium chloride                        4.52 g/l
Sodium caprylate                       2.660 g/l (16 mmoles/l)
N-Acetyl-DL-Tryptophan                 3.940 g/l (16 mmoles/l)
Water for injections                   up to 1000 ml
Total concentration of sodium          123.5 – 136.5 mmoles/l

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

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage
Do not store the product above 30°C.
Keep the vial in the outer carton in order to protect from light.
Do not freeze.
The storage conditions must be strictly followed.
6.5   Nature and contents of container
A card box containing a glass vial, with pierceable rubber stopper.
50 ml type II glass vial, 100 ml type II glass vial

6.6   Special precautions for disposal and other handling
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 container 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.

7     Manufacturer:
Kedrion S.p.A., Barga, Lucca, Italy.