Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Excipients: Sodium hydroxide solution 10N, Hydrochloric acid 20% w/w, Water for injections.

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

Unopened
The expiry date of the product is indicated on the packaging materials.

After first opening
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.
6.4   Special precautions for storage

Store below 25 °C. Do not freeze.

Keep out of the reach of children.
Handling instructions
Use only if the container is undamaged and the solution is clear. For single use only. Discard any leftover solution. If there is an Ecobag container, do not remove the outer packaging until just before use.
When using Gelaspan 4% B.Braun as a pressure infusion in an emergency situation (pressure cuff, infusion pump), it should be heated to body temperature first.



6.5   Nature and contents of container

Pack sizes:
“Ecoflac Plus” bottles: 10 x 500 ml
“Ecobag” bags: 20 x 500 ml
Not all pack sizes may be marketed.