Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients

Sodium citrate
Creatinine
Disodium edetate
Sodium hydroxide
Water for injections

6.2. Incompatibilities
Different types of incompatibilities have been described in the mixture of different concentrations of dexamethasone with the following drugs:
Amikacin
Chlorpromazine
Daunorubicin
Diphenhydramine
Doxapram
Doxorubicin
Gallium nitrate
Glycopyrrolate
Hydromorphone
Idarubicin
Lorazepam
Metaraminol
Ondansetron
Prochlorperazine
Vancomycin


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.

After opening the ampoule: Once opened, the medicinal product should be used immediately.

Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C (protected from light) and 2 to 8 °C.

From a microbiological point of view, the diluted 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, unless dilution has taken place in controlled and validated aseptic conditions.


6.4. Special precautions for storage
Dexamethasone Kalceks is sensitive to heat and, therefore, should not be autoclaved.

Do not store above 30 °C.

Keep the ampoules in the outer carton in order to protect from light.
For storage conditions after opening of the ampoule, see section 6.3.


6.5. Nature and contents of container
The solution is filled in 1 ml or 2 ml Type I clear colourless glass ampoules with one point cut.
Ampoules are marked with a specific colour ring code.

Ampoules are packed in liners. Liners are packed in outer cartons.

Pack sizes:
10 ampoules of 1 ml
10 ampoules of 2 ml

6.6. Special precautions for disposal and other handling

Preferably, this medicinal product should be administered directly intravenously or injected into an infusion line.
However, Dexamethasone Kalceks solution for injection/infusion is compatible with the following solutions for infusion (250 ml and 500 ml):
•   0.9% sodium chloride
•   5% dextrose solution
•   Ringer's solution

This medication is for single use only and any unused portion should be discarded.
Only clear solutions that remain free of cloudiness and precipitates should be used.


When combining with solutions for infusion, information from the respective manufacturers on their solutions for infusion, including data on compatibility, contraindications, undesirable effects and interaction, must be taken into account.


Disposal of unused medication and all materials that have been in contact with it will be done in accordance with local regulations.