Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Sodium citrate
Creatinine
Disodium edetate
Sodium hydroxide solution 1M (for pH adjustment)
Water for injections

6.2. Incompatibilities

Dexamethasone sodium phosphate is physically incompatible with daunorubicin, doxorubicin, vancomycin, diphenhydramine (with lorazepam and metoclopramide) and metaraminol bitartrate and should not be admixed with solutions containing these drugs.
Different types of incompatibilities have been also reported in the mixture of different concentrations of dexamethasone with the following drugs: amikacin, chlorpromazine, gallium nitrate, hydromorphone, ondansetron, prochlorperazine. It is also incompatible with doxapram and glycopyrrolate in syringe and with ciprofloxacin, idarubicin and midazolam in Y-site injections (1:1 mixture).

6.3. Shelf-life

The expiry date of the product is indicated on the packaging materials.
After first opening: use immediately.
After dilution: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored below 25°C protected from light.
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 25°C. Store in the original package.


6.5. Nature and contents of container
Box with 10 ampoules of glass type I, brown; each ampoule contains 1 ml of solution for injection.
Box with 25 ampoules of glass type I, brown; each ampoule contains 1 ml of solution for injection.

Box with 100 ampoules of glass type I, brown; each ampoule contains 1 ml of solution for injection.
Box with 10 ampoules of glass type I, brown; each ampoule contains 2 ml of solution for injection.
Box with 25 ampoules of glass type I, brown; each ampoule contains 2 ml of solution for injection.
Box with 100 ampoules of glass type I, brown; each ampoule contains 2 ml of solution for injection.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling
Dexamethasone solution for injection can be diluted with the following infusion fluids: Sodium Chloride 0.9% infusion
Glucose 5% Infusion
Ringer’s Solution for injection

For single use only. Discard any unused solution after use. The product should only be used when the solution is clear and particle free.
Any unused product or waste material should be disposed of in accordance with local requirements.