Carmustine medac

The medicinal product contains no preservative and is not intended as multiple dose vial.​‍​​​​​‍​‍‍‍‍​‍‍ Reconstitution and further dilutions should be carried out under aseptic conditions. The storage of carmustine at 27°C or higher temperature can lead to liquefaction of the substance, since carmustine has a low melting point (ca. 30.5°C to 32.0°C). An indication of the decomposition is the appearance of an oil film at the bottom of the vial, visible when the vial is held in bright light. This medicine should not be used any further. There can be physical appearances of sharp flakes in the unopened vial as far as rigid mass, however without any decomposition of carmustine. Reconstitution and dilution for each vial of the powder for concentrate for solution for infusion Dissolve carmustine (100 mg powder) with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging. Carmustine must be completely dissolved in ethanol before sterile water for injection is added. The dissolution of the powder could take up to 2 minutes. Then aseptically add 27 ml of sterile water for injection to the alcohol solution. The 30 ml stock solution needs to be mixed thoroughly. Each ml of the reconstituted stock solution will contain 3.3 mg of carmustine in 10 % ethanol and have a pH of 4.0 to 6.8. Reconstitution, as recommended, results in a clear colourless to yellowish solution. The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection, or 500 ml 5 % glucose solution for injection. The ready-to-use solution should be administered over 1-2 hours. Infusion of Carmustine in less than one hour may produce intense pain and burning at the site of injection (see section 4.2). Guidelines for the safe handling and disposal of antineoplastic agents must be observed. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.