Review
Published · Updated · 1 min read
Clotrimazole: routine pharmacovigilance in the risk management plan for Klofan vaginal suppositories
What it means for practice
The plan provides for routine collection and analysis of reports of adverse reactions to clotrimazole. The absence of listed risks in the summary should not be interpreted as an absence of possible adverse reactions.
Summary
The supplied abstract describes the risk management plan for Klofan, vaginal suppositories containing clotrimazole. The document title specifies a strength of 100 mg and the manufacturer, KUSUM LLC, Ukraine. The medicine is used to treat fungal infections and bacterial superinfections caused by organisms sensitive to clotrimazole.
Safety information
According to the abstract, the plan lists no identified or potential risks. The document describes safety information and risk minimization measures. Current safety information is consistent with data for the reference medicinal product; no additional post-registration studies are required.
Pharmacovigilance and limits of interpretation
The plan provides for routine pharmacovigilance activities, including collecting and analyzing adverse reaction reports. Thus, the absence of listed risks does not mean that safety monitoring stops. The supplied abstract provides no population size, adverse reaction frequencies, or quantitative risk estimates. This description of the plan therefore does not allow quantitative assessment of safety or comparison with other medicines.
Source
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Клофан, супозиторії вагінальні 100 мг, ТОВ “КУСУМ”, Україна.
Reviewed by: DrugCard editorial team ·
This article does not replace clinical judgement. Disclaimer
