In rare cases, some people may have an allergic reaction
It is not approved by the TGA or any regulatory body for human or animal consumption, therapeutic use, or clinical application
Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes
More severe side effects are rare but can include an allergic reaction or the development of blood clots
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Stable for approximately 28 days after reconstitution when stored properly and prepared with bacteriostatic water