Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     LIST OF EXCIPIENTS
•    Potassium Phosphate Monobasic
•    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 9.2.

8. SHELF LIFE
Unopened vial

The expiry date of the product is indicated on the packaging materials.
Reconstituted and diluted solution
Reconstitute with - room temperature (20°C to 25°C) 10 mL of Sterile Water for Injection USP.
Dilution with:
For Immediate Administration Within 15 Minutes of Preparation: room temperature (20°C - 25°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg/mL - 1 mg/mL.
For Delayed Administration up to 4 hours: cold (2°C - 8°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg/mL - 1 mg/mL .

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
Store below 25°C.
For storage conditions of the reconstituted and diluted medicinal product see Section 8 and 9.2.

9.1     NATURE AND CONTENTS OF CONTAINER
20 ml clear colourless Type I glass vial sealed with FluroTec coated grey rubber stopper and an aluminium red flip-off, tear of butten 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
Decitabine for Injection is aseptically reconstituted with 10 mL of Sterile Water for Injection USP, resulting in a drug concentration of 5 mg/mL at pH of 6.7-7.3. This solution is further diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final drug concentration of 0.1 mg/mL to 1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted drug product solution must be prepared using cold (2-8°C) infusion fluids and stored at 2-8°C for up to a maximum of 4 hours until administration.
For the shelf-life and the precaution for storage after reconstitution, see section 8.
Decitabine S.K. 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