Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS


6.1   List of excipients
Mannitol

Sodium hydroxide (to adjust the pH to 7.7).

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

Unopened vial: 3 years.

Reconstituted and diluted solution
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 and should not be longer than 24 hours at 2°C to 8 °C or 8 hours at room temperature.


6.4   Special precautions for storage
Store at room temperature, below 300C.

For storage conditions of the reconstituted or diluted medicinal product, see section 6.3.

6.5   Nature and contents of container

10 ml colorless Type I glass vials containing 50 mg fludarabine phosphate.

Pack size: 5 vials per carton.

6.6   Special precautions for disposal

Reconstitution
Fludara should be prepared for parenteral use by aseptically adding sterile water for injection. When reconstituted with 2 ml of sterile water for injection, the powder should fully dissolve in 15 seconds or less. Each ml of the resulting solution will contain 25 mg of fludarabine phosphate, 25 mg of mannitol, and sodium hydroxide (to adjust the pH to 7.7). The pH range for the final product is 7.2 - 8.2.

Dilution

The required dose (calculated on the basis of the patient's body surface) is drawn up into a syringe.
For intravenous bolus injection this dose is further diluted in 10 ml sodium chloride 9mg/ml (0.9%). Alternatively, for infusion, the required dose may be diluted in 100 ml sodium chloride 9mg/ml (0.9%) and infused over approximately 30 minutes.

In clinical studies, the product has been diluted in 100 ml or 125 ml of 5 % dextrose injection or sodium chloride 9mg/ml (0.9%).
Inspection prior to use

The reconstituted solution is clear and colourless. It should be visually inspected before use.

Only clear and colourless solutions without particles should be used. Fludara should not be used in case of a defective container.


•   Handling and disposal

Fludara should not be handled by pregnant staff.
Procedures for proper handling should be followed according to local requirements for cytotoxic drugs.

Caution should be exercised in the handling and preparation of the Fludara solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution comes into contact with the skin or mucous membranes, the area should be washed thoroughly with soap and water. In the event of contact with the eyes, rinse them thoroughly with copious amounts of water.
Exposure by inhalation should be avoided.

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