Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Disodium phosphate dihydrate,
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

As packaged for sale:
The expiry date of the product is indicated on the packaging materials.
Shelf life after dilution:
Infusion solutions detailed in section 6.6 are physically and chemically stable for at least 28 days when stored in a refrigerator (2°C - 8°C) with protection from light and at room temperature (20°C - 25°C) with and without protection from light.

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 would normally no be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

As packaged for sale:
Store in a refrigerator (2°C – 8°C).
For storage condition after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Colorless type I glass vial with grey fluoropolymer coated chlorobutyl rubber stopper.
Pack sizes: 1 x 2 ml vial.
6.6   Special precautions for disposal and other handling

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 of sodium chloride 9 mg/ml (0.9%) solution for injection. Alternatively, for infusion, the required dose may be diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or in 100 to 125 ml of glucose 5% solution and infused over approximately 30 minutes.

Inspection prior to use
Only clear and colourless solutions without particles should be used. The product should not be used in case of a defective container.

Handling and disposal
Pregnant women should be excluded from handling fludarabine phosphate. The Regulations concerning proper handling and disposal must be followed considering guidelines for proper handling and disposal of cytotoxic medicinal products. Any spilled or unused material may be eliminated by incineration.

Caution should be exercised during handling and preparation of fludarabine phosphate solution. The use of protective gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution comes in contact with skin or mucous membranes, the affected area should be cleaned thoroughly with soap and water.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.