Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glacial acetic acid, water for injection.

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After the first opening: for immediate further dilution.

After dilution with 0.9 % sodium chloride or 5% glucose: Chemical and physical in-use stability after dilution before use has been demonstrated for 18 hours at room temperature or 24 hours at 2 °C – 8 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4   Special precautions for storage
Store refrigerated (2°C – 8°C). Do not freeze.
Keep out of reach of children.

For storage conditions after first opening and dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Clear hydrolytic class I glass 1 ml ampoule with breaking ring. 10 ampoules per carton.

6.6   Special precautions for disposal and other handling

Vasopressin Farmak concentrate must not be administered without dilution.
The solution should be checked for visible particles and discolouration prior to the use. Only clear and colourless solutions should be used.

Single use ampoules, discard any remaining solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.