Daunoblastina Caution For Usage





Zuellig Pharma


Full Prescribing Info
Caution For Usage
Special precautions for disposal and other handling: Preparation of the solution: Daunorubicin hydrochloride powder for injection should be reconstituted by adding 4 mL of sterile Water for Injection. The vial content is under a negative pressure to minimize aerosol formation during reconstitution; particular care is needed when the needle is inserted: inhalation of any aerosol produced during reconstitution must be avoided. The vial should be gently shaken until the drug is completely dissolved. The resultant solution contains 5 mg of daunorubicin per mL. The reconstituted solution should be protected from light and is stable for 24 hours at room temperature or 48 hours at 4°C - 10°C.
Intravenous administration: The required dose of the reconstituted solution has to be withdrawn into a syringe containing 10 to 15 mL of 0.9% sodium chloride and slowly injected into the tubing of a freely flowing IV infusion of 0.9% sodium chloride or 5% dextrose to minimize the risk of drug extravasation and make sure that the vein is flushed after the administration of the drug.
Protective measures: The following protective recommendations are given due to the toxic nature of the compound: Personnel should be trained in good technique for reconstitution and handling;
Pregnant staff should be excluded from working with this drug;
Personnel handling daunorubicin should wear protective clothing: goggles, gowns and disposable gloves and masks;
A designated area should be defined for reconstitution (preferably under a laminar flow system). The work surface should be protected by disposable, plastic-backed, absorbent paper;
All items used for reconstitution, administration or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high-temperature incineration;
Spillage or leakage should be treated with diluted sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water;
All cleaning materials should be disposed of as indicated previously;
Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution; medical attention should be sought;
Always wash hands after removing gloves;
The drug should be used within 24 hours of first penetration of the rubber stopper. Discard any unused solution.
Incompatibilities: Daunorubicin has been reported to be incompatible with heparin sodium, which might cause the drug to precipitate in the solution, and with aluminum. Incompatibility has also been reported when a daunorubicin hydrochloride solution is mixed with a solution of dexamethasone sodium phosphate, aztreonam, allopurinol sodium, fludarabine, piperacillin/tazobactam and aminophylline. Daunorubicin can be used in combination with other antitumor agents, but it is not recommended that it be mixed with other drugs in the same syringe.
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