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IV Busulfex

IV Busulfex Caution For Usage

busulfan

Manufacturer:

Otsuka (Philippines)

Distributor:

Zuellig

Marketer:

Otsuka (Philippines)
Full Prescribing Info
Caution For Usage
Preparation and Administration Precautions: DUE TO INCOMPATIBILITY, DO NOT USE ANY INFUSION COMPONENTS CONTAINING POLYCARBONATE WITH BUSULFAN (IV BUSULFEX).
Use an administration set with minimal residual hold-up volume (2-5 cc) for product administration.
Busulfan (IV Busulfex) is a cytotoxic drug. Follow applicable special handling and disposal procedures. Skin reactions may occur with accidental exposure. Use gloves when preparing Busulfan (IV Busulfex). If Busulfan (IV Busulfex) or diluted Busulfan (IV Busulfex) solution contacts the skin or mucosa, wash the skin or mucosa thoroughly with water.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use if particulate matter is seen in the Busulfan (IV Busulfex) vial.
Preparation for Intravenous Administration: Busulfan (IV Busulfex) must be diluted prior to intravenous infusion with either 0.9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). The diluent quantity should be 10 times the volume of Busulfan (IV Busulfex), so that the final concentration of busulfan is approximately 0.5 mg per mL. Calculation of the dose for a 70 kg patient would be performed as follows:
(70 kg patient) x (0.8 mg per kg) ÷ (6 mg per mL) =9.3 mL Busulfan (IV Busulfex) (56 mg total dose).
To prepare the final solution for infusion, add 9.3 mL of Busulfan (IV Busulfex) to 93 mL of diluent (normal saline or D5W) as calculated as follows: (9.3 mL Busulfan (IV Busulfex)) x (10) =93 mL of either diluent plus the 9.3 mL of Busulfan (IV Busulfex) to yield a final concentration of busulfan of 0.54 mg per mL (9.3 mL x 6 mg per mL ÷ 102.3 mL =0.54 mg per mL).
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood while wearing gloves and protective clothing.
Always add the Busulfan (IV Busulfex) to the diluent, not the diluent to the Busulfan (IV Busulfex). Mix thoroughly by inverting several times. Discard unused portion.
Infusion pumps should be used to administer the diluted Busulfan (IV Busulfex) solution. Set the flow rate of the pump to deliver the entire prescribed Busulfan (IV Busulfex) dose over two hours. Prior to and following each infusion, flush the indwelling catheter line with approximately 5 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. DO NOT infuse concomitantly with another intravenous solution of unknown compatibility. WARNING: RAPID INFUSION OF Busulfan (IV Busulfex) HAS NOT BEEN TESTED AND IS NOT RECOMMENDED.
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