Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Caprylic acid
N-Acetyltryptophan
Water for Injection
Total sodium content:                   100 – 130 mmol/l

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products (except the recommended diluents mentioned in section 6.6), whole blood and packed red cells. Further human albumin should not be mixed with protein hydrolysates (e.g. parenteral nutrition) or solutions containing alcohol since these combinations may cause the proteins to precipitate.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials 
After opening the product should be used immediately.

6.4   Special precautions for storage
Do not store above 25°C.
Do not freeze.
Store in the original package in order to protect from light.

6.5   Nature and contents of container

50 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper – pack size of 1 or 70.
100 ml of solution in a vial (type II glass) with a bromobutyl rubber stopper – pack size of 1 or 56.

Not all pack sizes may be marketed.

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.

Do not use unless seal is intact. If leaks are found, discard.

Once the container has been opened, the contents should be used immediately. Any unused medicinal product or waste meterial should be disposed of in accordance with local requirements.


7.    MARKETING AUTHORISATION HOLDER
Takeda Israel Ltd.
25 Efal st.,
P.O.B 4140
Petach Tikva 4951125