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Reconstitution, storage and disposal Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis. Azzalure® has to be reconstituted with a sodium chloride 9 mg/ml (0.9%) solution for injection. As per the dilution table below, the requested amount of sodium chloride 9 mg/ml (0.9%) solution for
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Reconstitution, storage and disposal Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis. Azzalure® has to be reconstituted with a sodium chloride 9 mg/ml (0.9%) solution for injection. As per the dilution table below, the requested amount of sodium chloride 9 mg/ml (0.9%) solution for injection has to be drawn up into a syringe in order to obtain a reconstituted clear solution at a concentration of 10 U/0.05 ml; The accurate measurement of 0.63ml can be achieved using 1ml syringes, graduated in 0.1 ml and 0.01 ml increments. The stopper of the Azzalure vial should be cleaned with alcohol and then the solvent introduced slowly into the vial. The vial should be mixed gently to dissolve the vial’s contents. This provides a clear solution containing 125 Speywood Units of active substance at a concentration of 10 Speywood U per 0.05ml of reconstituted solution. Chemical and physical in-use stability has been demonstrated for 24 hours between 2-8°C. From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Azzalure should not be frozen. Once reconstituted, Azzalure should only be used to treat a single patient, during a single Amount of solvent added (0.9% sodium chloride solution) to a 125 U vial = 0.63ml Resulting dose (Units per 0.05 ml) = 10U
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