Regulatory
Published · Updated · 1 min read
DEC: dequalinium chloride risks in the Granzofen risk management plan summary
What it means for practice
When using dequalinium chloride vaginal tablets, consider the risk of vaginal epithelial ulcers and potential allergic reactions. Safety data are absent for patients over 55 years of age and for repeated use.
Summary
According to the abstract attached to the link, the Granzofen document hosted by the State Expert Centre of the Ministry of Health of Ukraine (DEC) is a risk management plan summary. The product contains dequalinium chloride as vaginal tablets and is used to treat bacterial and fungal vaginal infections. The document describes safety concerns and risk minimisation measures.
Main safety concerns
- Important identified risk: vaginal epithelial ulcers.
- Potential risk: allergic reactions.
- Missing information: safety data for patients over 55 years of age and for repeated use.
Risk minimisation and monitoring
Routine risk minimisation measures include information in the instructions for medical use and on the packaging. Ongoing pharmacovigilance activities are also described for monitoring and managing these risks.
The available abstract does not provide reaction frequencies, severity, or a quantitative risk estimate. Nor does it report a new DEC decision restricting use or changing the product information. Document on the DEC website.
Source
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dec.gov.ua. Гранзофен, таблетки вагінальні, ТОВ “КУСУМ”, Україна.
Reviewed by: DrugCard editorial team ·
This article does not replace clinical judgement. Disclaimer
