Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. LIST OF EXCIPIENTS
Citric acid monohydrate, mannitol.

6.2. INCOMPATIBILITIES

Dacarbazine-solution is chemically incompatible with heparin, hydrocortisone, L-cysteine and sodium hydrogen carbonate.

6.3. SHELF LIFE

The expiry date of the product is indicated on the packaging materials.
6.4. Reconstitution & Dilution of the product

Shelf life and storage conditions after reconstitution:

The reconstituted solution for injection does not contain any preservative. Chemical and physical in-use stability has been demonstrated for 8 hours at room temperature and under light protection and for 5 days at 2 to 8°C and under light protection. From a microbiological point of view, the reconstituted solution should be used immediately. If the reconstituted solution is 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 in a refrigerator (2 to 8°C) and protected from light, unless the reconstitution has taken place under controlled and validated aseptic conditions.
Shelf life and storage conditions after dilution:

The diluted solution for infusion does not contain any preservatives.
Chemical and physical in-use stability has been demonstrated for 8 hours at room temperature and under light protection and for 5 days at 2 to 8°C and under light protection. From a microbiological point of view, the diluted solution for infusion should be used immediately. If the diluted solution is 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 in a refrigerator (2 to 8°C) and protected from light, unless the reconstitution and dilution have taken place under controlled and validated aseptic conditions.

Once prepared, solutions must be stored in light proof containers and administered using a light proof delivery system (such as a non-transparent, light proof delivery tube (use of aluminium foil).

6.5. Special Precautions for Storage

DACARBAZINE-DACIN must be stored in its original packaging, protected from light and below 25 °C.
It should be kept out of the reach of children.

6.6. Handling of cytostatic agents

When handling DACARBAZINE-DACIN, preparing the solution for injection/infusion or when disposing of any remaining solution, the standard procedures for handling cytostatic agents are to be followed.

6.7. PACKAGE
Presentations: 10 and 12 brown glass vials (Type I).
Not all the presentations are marketed in the country.