Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
•   Monobasic Potassium phosphate

•   Sodium hydroxide
•   Hydrochloric acid (for pH adjustment)

•   Water for injection

7. INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

8. SHELF LIFE
Unopened vial
The expiry date of the product is indicated on the packaging materials.

Reconstituted and diluted solution
Within 15 minutes of reconstitution, the concentrate (in 10 ml of sterile water for injection) must be further diluted with cold (2˚C to 8˚C) infusion fluids. This prepared diluted solution for intravenous infusion can be stored at 2˚C to 8˚C for up to maximum of 3 hours, followed by up to 1 hour at room temperature (20˚C to 25˚C) before administration.
From a microbiological point of view, the product should be used within the time period recommended above.
It is the responsibility of the user to follow the recommended storage times and conditions and ensures that reconstitution has taken place in aseptic conditions.

9. SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
For storage conditions of the reconstituted and diluted medicinal product see Section 6.3.


9.1 NATURE AND CONTENTS OF CONTAINER
20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine.
Pack size: 1 vial.



9.2 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
The powder should be aseptically reconstituted with 10 ml of water for injections. Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3. Within 15 minutes of reconstitution, the solution must be further diluted with cold infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml. For the shelf-life and the precaution for storage after reconstitution, see section 6.3.
Dacogen 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

10. MARKETING AUTHORIZATION NUMBER