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Information Letter on Octenident antiseptic (octenidine dihydrochloride): Reducing drug and application risks

Active substance: octenidine dihydrochloride

For the newly approved medicinal product Octenident antiseptic (active ingredient octenidine dihydrochloride), prior to its market launch and in agreement with the Federal Institute for Drugs and Medical Devices (BfArM), information was provided in issue 7/2023 (01.04.2023) of the "Zahnärztliche Mitteilungen" on special safety instructions for use. The medicinal product must not be used for rinsing periodontal pockets, root canals or wound cavities, e.g. by means of a syringe and blunt cannula.

Persistent oedematous swelling, subcutaneous tissue damage and tissue necrosis cannot be excluded by such non-intended use.

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