Pharmaceutical particulars : מידע רוקחי

6         PHARMACEUTICAL PARTICULARS

6.1       List of excipients
Sodium chloride                 7.7 g/l
N-acetyl-DL-tryptophan          1 g/l
Caprylic acid                   0.6 g/l
Water for injections            ad 1000 ml

Electrolytes
Sodium                          144-160 mmol/l

6.2       Incompatibilities
Human albumin solution must not be mixed with other medicinal products, whole blood, packed red cells and water for injections.

6.3       Shelf life
3 years
After the vial has been opened, the content should be used immediately.

6.4       Special precautions for storage
Do not store above +25 °C.
Store in the original container in order to protect from light.
Do not freeze.
6.5       Nature and contents of container
- 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.

6.6       Special precautions for disposal and other handling

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.

7.     MARKETING AUTHORISATION HOLDER
Dover medical & Scientific Equipment Ltd.,
11 Hamaalot St.,
Herzliya 46583, Israel

8.     MARKETING AUTHORISATION NUMBER(S)
[150-27-33710]