Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
•   Potassium dihydrogen phosphate
•   Sodium hydroxide
•   Water for injection
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Unopened vial

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

Reconstituted and diluted solution
For reconstitution and dilution procedures refer to section 6.6.
Temperature of the diluent depends on the time of administration after preparation.

For Administration Within 15 Minutes of Preparation
Dilute the reconstituted solution with room temperature solvent.

For Delayed Administration
Dilute the reconstituted solution with cold infusion fluid. Chemical and physical in-use stability after dilution has been demonstrated for 4 hours when stored at 2°C to 8°C. From a microbiological point of view, the product should be used immediately after dilution.
6.4 Special precautions for storage
Do not store above 25°C.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

6.5 Nature and contents of container
20 ml clear Type I glass vial with 20mm igloo grey rubber stopper sealed with 20mm aluminum flip-off seal having blue color polypropylene disc.
Pack size: 1 vial.




6.6 Special precautions for disposal and other handling
Recommendations for safe handling
Skin contact with the solution should be avoided and protective gloves must be worn. Standard procedures for dealing with cytotoxic medicinal products should be adopted.
Reconstitution procedure
Aseptically reconstitute Decitabine Medomie with room temperature 10 mL of Sterile Water for Injection.
Upon reconstitution, the final concentration of the reconstituted Decitabine Medomie solution is 5 mg/mL.
You must dilute the reconstituted solution with 0.9% Sodium Chloride Injection or 5% Dextrose Injection prior to administration to a final concentration of 0.1 mg/mL to 1 mg/mL. For the shelf-life and the precaution for storage after reconstitution, see section 6.3.

Decitabine Medomie should not be infused through the same intravenous access/line with other medicinal products. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.

Disposal
This medicinal product is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements