Pharmaceutical particulars : מידע רוקחי

6.   Pharmaceutical particulars

6.1 List of excipients
Sodium acetate trihydrate
Water for injections


6.2 Incompatibilities

Tramadol-Kalceks should not be mixed with solutions for injection or infusion containing diclofenac, indomethacin, phenylbutazone, diazepam, midazolam, flunitrazepam and glyceryl trinitrate.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Once the ampoule has been opened, the product should be used immediately.

Chemical and physical in-use stability has been demonstrated for 48 hours at      25°C with 0.9% sodium chloride and 5% glucose solution. From a microbiological point of view, unless the method of opening/dilution 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

Store below 25°C. Do not refrigerate or freeze.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

The solution for injection/infusion is filled in 2 ml type I hydrolytic class colourless borosilicate glass ampoules with one point cut.

5 ampoules are packed in a PVC liner.

1, 2 or 20 liners are placed in a cardboard box.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

For single use only.
Tramadol-Kalceks is physically and chemically compatible with 0.9% sodium chloride or 5% glucose solution for infusion.

For shelf-life after dilution please refer to section 6.3.

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