Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Sodium citrate
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

6.3. Shelf-life

The expiry date of the product is indicated on the packaging materials.
Use for injection
It should be administered immediately after opening (see section 6.6).


Use in solution for infusion:
Dexamethasone solutions for intravenous infusion are physically and chemically stable for 24 hours when stored below 25°C.

From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
6.4. Special precautions for storage

Dexamethasone Kern Pharma is sensitive to heat and, therefore, should not be autoclaved.

Store below 25°C. Do not freeze.
Store in the original package to protect it from light.
For storage conditions after dilution of the medicinal product, see section 6.3.


6.5. Nature and contents of container
Ampoules of Dexamethasone Kern Pharma 4 mg/1 ml:
Pack of three type-I glass ampoules containing 1 ml of solution for injection.

Ampoules of Dexamethasone Kern Pharma 20 mg/5 ml:
Pack of five type-I glass ampoules containing 5 ml of solution for injection.

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 Kern Pharma solution for injection is compatible with the following solutions for infusion (250 ml each) and must be used within 24 hours: 
• 0.9% sodium chloride
• 5% dextrose 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.

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