ID: Medicinal product (Registration number 6031118.00.00)

TOXAVIT. Dental Paste. Active substances: paraformaldehyde, lidocaine hydrochloride 1 H2O and metacresol (Ph.Eur.). 1 g paste contains active ingredients: 460 mg paraformaldehyde, 370 mg lidocaine hydrochloride 1 H2O 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). Contraindications: Allergy to any of the active ingredients or any of the other ingredients. Undesirable effects: Uncommon: Upon extirpation of the pulp, occasional bleeding occurs at the apical site of detachment despite devitalisation. Very rare: 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. Frequency not known: 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. 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. 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: 12/2021. lege artis Pharma GmbH + Co. KG, P. O. Box 60, D-72132 Dettenhausen.