Bufatas Caution For Usage

INCOMPATIBILITIES: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal as follows.
Do not use polycarbonate syringes with Busulfan concentrate for solution for infusion.
SPECIAL PRECAUTIONS FOR DISPOSAL: Preparation of Busulfan Injection: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
As with other cytotoxic compounds, caution should be exercised in handling and preparing the busulfan solution: The use of gloves and protective clothing is recommended; If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Calculation of the quantity of Busulfan concentrate for solution for infusion to be diluted and of the diluent: Busulfan Injection must be diluted prior to use with either sodium chloride 9 mg/mL (0.9%) solution for injection or glucose solution for injection 5%.
The quantity of the diluent must be 10 times the volume of Busulfan Injection ensuring the final concentration of busulfan remains at approximately 0.5 mg/mL.
By example: The amount of Busulfan Injection and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight: See equation.

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Preparation of the solution for infusion: Busulfan Injection must be prepared by a healthcare professional using sterile transfer techniques. Using a non polycarbonate syringe fitted with a needle: the calculated volume of Busulfan Injection must be removed from the vial; the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent. Busulfan Injection must always be added to the diluent, not the diluent to Busulfan Injection. Busulfan Injection must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
The diluted solution must be mixed thoroughly by inverting several times.
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Diluted Busulfan Injection is a clear colourless solution.
Instruction for use: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of busulfan has not been tested and is not recommended.
The entire prescribed Busulfan Injection dose should be delivered over two or three hours depending of the conditioning regimen.
Small volumes may be administered over 2 hours using electric syringes. In this case infusion sets with minimal priming space should be used (i.e 0.3-0.6 mL), primed with medicinal product solution prior to beginning the actual Busulfan concentrate for solution for infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Busulfan Injection must not be infused concomitantly with another intravenous solution.
Polycarbonate syringes must not be used with Busulfan Injection.
For single use only. Only a clear solution without any particles should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.