Fludalym Caution For Usage

Instructions for Use, Handling and Disposal: ANTINEOPLASTIC AGENT: A crossover from initial treatment with fludarabine phosphate to chlorambucil for non responders to fludarabine phosphate should be avoided because most patients who have been resistant to fludarabine phosphate have shown resistance to chlorambucil.
Instructions for use: Reconstitution: Fludalym 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 of 0.9% sodium chloride. Alternatively, for infusion, the required dose may be diluted in 100 ml of 0.9% sodium chloride and infused over approximately 30 minutes.
Fludarabine phosphate must not be mixed with other drugs.
Storage after reconstitution: The physicochemical stability of the drug product after reconstitution in water for injections has been demonstrated for 8 hours at 25°C ± 2°C/ 60% ± 5% RH and for 7 days at 5°C ± 3°C.
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.
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. Fludalym should not be used in case of a defective container.
Handling and disposal: Fludalym 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 Fludalym 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 product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.