Pharmaceutical particulars : מידע רוקחי

6     Pharmaceutical particulars

6.1   List of excipients
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.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4   Special precautions for storage
Unopened: Do not store above 30 °C.
For storage conditions of the medicinal product after addition of an additive, see section 6.3.

6.5   Nature and contents of container
Plastic containers of low-density polyethylene, contents: Polyethylene containers containing 500 ml and 1000 ml available in packs of 10.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Handling:
Use only if the solution is clear, colourless and if the container is undamaged. The solution should be free of visible particles. The solution should not be administered if the container or its closure show visible signs of damage.
Containers are for single use only. Discard container and any unused contents after use. Do not re-connect partially used containers.
Any unused product or waste material should be disposed of in accordance with local requirements.
The equipment to be primed with the solution in order to prevent air entering the system.
In case of an adverse reaction, infusion must be stopped immediately