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T. H. Osaki, M. H. Osaki, T. H. Osaki, A. E. Sant'Anna, A. Hofling-Lima, M. C. Zorat, R. Belfort, Jr.; Analysis of Microbial Growth in Reconstituted Botulinum Toxin - A Vials. Invest. Ophthalmol. Vis. Sci. 2009;50(13):663.
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The purpose of this study was to analyze microbial growth in reconstituted Botulinum toxin - A solutions from vials stored in refrigerator for one month after use.
Seventy eight consecutive 100-U vials of Botulinum toxin-A (Botox®) were reconstituted with 3.0 mL each of normal saline without preservative and were used in aseptic conditions in blepharospasm and hemifacial spasm patients. The Botulinum toxin-A solution was used to treat one or two patients in the same day. The same needle was used for aspiration (just the syringes were replaced and each patient had his own needle for application). After the applications, each vial was stored in a multiuse medication refrigerator. Four weeks later, the vials were sent to microbiological analysis. The contents of the vials were plated by microbiologists using standard techniques on blood agar, chocolate agar, Sauboraud agar and thioglycolate broth.
Sterility analysis with blood agar, chocolate agar, Sauboraud agar and thioglycolate broth detected no bacterial growth from the 78 vials of reconstituted Botulinum toxin-A solutions. There was not fungus growth either.
Even though manufacturers advocate that Botulinum toxin-A shoud be used within 4 hours after reconstitution, refrigerator storage of medication vials containing reconstituted botulinum toxin (applied following aseptic precautions), did not result in microbial contamination of the contents. Therefore, the results of this study suggest that reconstituted Botulinum toxin-A can be safely stored in refrigerator for at least 1 month.
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