Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Water for Injection

6.2    Incompatibilities

None known.
6.3    Shelf life

Unopened

The expiry date of the product is indicated on the packaging materials.
After first opening the container

Not applicable. See also section 6.6.

After dilution
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Under normal circumstances, dilutions should not be stored for longer than 24 hours at 2°C–8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Do not store above 25°C.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Low-density polyethylene (LDPE) ampoules, contents: 10mL,
20 mL,available in packs of 20 × 10 mL, 20 x 20 mL.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Dilution
Suitable vehicle solutions are, for example, a 5% or 10% glucose solution, isotonic saline solution, Ringer's lactate solution or balanced electrolyte solutions.
Potassium Chloride 14.9% may only be added immediately before setting up the infusion, thereby observing a strictly aseptic technique. The infusion container should then be shaken gently.

The containers are intended for single use only. Discard any unused contents.

Only use if the solution is clear, colourless and practically free from visible particles and the container and seal are intact.