Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric acid (for pH adjustment)
Water for injections

6.2 Incompatibilities
This medicine must not be mixed with other medicinal products except those mentioned in section 6.6 due to possible incompatibilities.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

Following dilution:
Mixtures of NaCl solution 0.9% and Ringer's solution with Dipyrone Kalceks 500 mg/ml solution for injection should be applied within 6 hours at room temperature. Mixtures of glucose 5% solution and Dipyrone Kalceks 500 mg/ml solution for injection should be applied within 20 minutes.

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.
6.4 Special precautions for storage
Store below 25ºC. Store in the original package in order to protect from light. Do not freeze.


6.5 Nature and contents of container
Type I hydrolytic resistant class brown glass ampoules of 2 ml or 5 ml in the PVC liner.
Liners are placed into a cardboard box.
Pack size: 10 x 2 ml, 100 x 2 ml, 5 x 5 ml, 100 x 5 ml.
Not all pack sizes may be marketed.


6.6 Special precautions for disposal and other handling
The solution for injection may be diluted using 5% glucose solution, 0.9% sodium chloride solution or Ringer's solution. For further information please refer to section 6.3.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.