Ribomustin Caution For Usage

Incompatibilities: This medicinal product should not be mixed with other medicinal products except those mentioned in Instructions for Use and Handling and Disposal as follows.
Instructions for Use and Handling: When handling Ribomustin, inhalation, skin contact or contact with mucous membranes should be avoided (wear gloves and protective clothes). Contaminated body parts should be carefully rinsed with water and soap, the eye should be rinsed with physiological saline solution. If possible, it is recommended to work on special safety workbenches (laminar flow) with liquid impermeable, absorbing disposable foil. Pregnant personnel should be excluded from handling cytostatics.
The powder for concentrate for solution for infusion has to be reconstituted with water for injection, diluted with sodium chloride 9 mg/mL (0.9%) solution for injection and then administered by intravenous infusion. Aseptic technique is to be used.
1. Reconstitution: Reconstitute each vial of Ribomustin containing 25 mg bendamustine hydrochloride in 10 mL water for injection by shaking.
Reconstitute each vial of Ribomustin containing 100 mg bendamustine hydrochloride in 40 mL water for injection by shaking.
The reconstituted concentrate contains 2.5 mg bendamustine hydrochloride per mL and appears as a clear colorless solution.
2. Dilution: As soon as a clear solution is obtained (usually after 5-10 minutes) dilute the total recommended dose of Ribomustin immediately with 0.9% NaCl solution to produce a final volume of about 500 mL.
Ribomustin must be diluted with 0.9% NaCl solution and not with any other injectable solution.
3. Administration: The solution is administered by intravenous infusion over 30-60 min. The vials are for single use only.
Instructions for Disposal: Any unused product or waste material should be disposed of in accordance with local requirements.