ID: Medicinal product (Registration number 6031118.00.00)

TOXAVIT. Dental Paste Composition: 1 g paste contains active ingredients: 460 mg paraformaldehyde, 370 mg lidocaine hydrochloride 1 H2 O and 45 mg metacresol (Ph.Eur.) List of excipients: Eugenol, glycerol and carbon fibres Therapeutic indications: TOXAVIT is used to devitalise dental pulp in particular cases where endodontic surgical measures (e.g. vital extirpation) are not possible. Prior to use, it should be checked whether successful treatment might be able to be achieved using other, aldehyde-free procedures (e.g. anaesthesia or bleeding control). Prior to using the preparation, the patient should be informed about the eventual risks associated with treatment as well as about alternative forms of treatment. Contraindications: Allergy to formaldehyde, lidocaine, metacresol or eugenol. Undesirable effects: Following application to the exposed pulp cavity, more or less severe pulpitis-like complaints occur. These are relieved through the addition of the local anaesthetic lidocaine hydrochloride to the paste. Upon extirpation of the pulp, occasional bleeding occurs at the apical site of detachment despite devitalisation. In the event of insufficient diffusion or inadequate release of formaldehyde, vital tissue fragments can remain in the canal and cause considerable pain. If formaldehyde extravasates from the apex or the furcation area or side canals or leaking filling edges, inflammation or necrosis of periapical tissue, surrounding bone or the gums may result. When used on milk-teeth, damage to the dental germ of the subsequent adult tooth may occur during the early stages of development (before mineralisation is complete) in extremely rare cases. Systemic effects cannot be ruled out. There are no findings on this method of application and local carcinogenicity. Local and systemic allergic reactions are possible. Date of current information: 01/2011