Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Triamcinolone acetonide; Triamcinolone acetonide; Demeclocycline hydrochloride; Demeclocycline hydrochloride
Henry Schein UK Holdings Limited
A01AC; A01AC01
Triamcinolone acetonide; Triamcinolone acetonide; Demeclocycline hydrochloride; Demeclocycline hydrochloride
3 percent volume/volume
Dental solution
Product subject to prescription which may not be renewed (A)
Corticosteroids for local oral treatment; triamcinolone
Not marketed
1983-04-01
REVISION: 1.6 DATE: 21/11/2018 PRINTED COLOURS (3 COLOUR) JOB: LEDERMIX COMBINATION KIT LABEL CODE: 14016_12 SIZE: 320MM X 105MM DATE: 03/09/2015 Pantone 116 Pantone 5255 Black Cutting Form (Not Printed) FONTS USED BODY COPY HELVETICA CONDENSED: SAMPLE Sample SIZE: 9pt HEADING/SUB HEADING COPY HELVETICA BOLD CONDENSED: SAMPLE Sample SIZE: 10pt Sample 12ly Sample Only 1 2 Please read all of this leaflet carefully before you receive the medicine. Keep the leaflet as you may want to read it again. If you have any further questions please ask your dentist. If you experience any troublesome side effects or any effects not listed in this leaflet tell your dentist or doctor. In this leaflet: 1. What LEDERMIX is and what it is used for 2. Before you receive LEDERMIX 3. How LEDERMIX is used 4. Possible side effects 5. How to store LEDERMIX 6. Further information 1. What LEDERMIX is and what it is used for cement LEDERMIX is a combination kit which contains a dental paste, a dental powder and two dental liquids (slow and fast setting hardeners). LEDERMIX dental paste contains the active ingredients demeclocycline calcium and triamcinolone acetonide. LEDERMIX dental cement powder contains the active ingredients demeclocycline hydrochloride and triamcinolone acetonide. Demeclocycline hydrochloride is one of a group of antibiotics called tetracyclines which is used to treat or prevent infections. Triamcinolone acetonide is a corticosteroid used to reduce swelling or inflammation. LEDERMIX is used by dentists to treat deep and possibly painful cavities (holes in the teeth) which are close to the nerve or involve the nerve in the tooth, and as a dressing during the treatment of the root canal. 2. Before you receive LEDERMIX You should not receive this medicine if: you are allergic to any tetracycline antibiotic (e.g. oxytetracycline, tetracycline, chlortetracycline, demeclocycline, doxycycline or minocycline) or any of the ingredients in this medicine (see section 6 for more details) you have badly infected dental pulp This med Leggi il documento completo
Health Products Regulatory Authority 27 March 2019 CRN008SGQ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ledermix for Dental Use 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1. Ledermix 30 mg/g + 10 mg/g Dental Paste. Each gram contains: Demeclocycline calcium equivalent to Demeclocycline hydrochloride 30mg. Triamcinolone acetonide 10mg. 2. Ledermix 20 mg/g + 6.7 mg/g Dental Cement Powder. Each gram contains: Demeclocycline hydrochloride 20mg. Triamcinolone acetonide 6.7mg. For use with Ledermix Hardener ‘F’ Dental Liquid and Ledermix Hardener ‘S’ Dental Liqud. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Ledermix for Dental Use is a combination pack consisting of 4 separate unit containers as follows: 1. Ledermix Dental Paste is a greyish yellow smooth paste, free from gritty particles. 2. Ledermix Dental Cement Powder is a fine cream coloured powder. 3. Ledermix Hardener ‘F’ Dental Liquid is a clear colourless to yellow liquid with an odour of oil of cloves. 4. Ledermix Hardener ‘S’ Dental Liquid is a clear colourless to yellow liquid with an odour of oil of cloves. Each of the units is also supplied separately. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A topical dental preparation with antibiotic and corticosteroid properties. LEDERMIX is indicated in pulpitis (except total purulent pulpitis) and periodontitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: PULPITIS: LEDERMIX Dental Paste is applied with a small cotton pledget to the dentine adjacent to the pulp or to the exposed pulp. The cavity is then closed with a temporary dressing. Approximately three to six days later the vitality of the tooth is determined, the cavity is re-opened and the cotton pledget is removed. The dentine close to the pulp, or the wound in the pulp, is covered with LEDERMIX Dental Cement prepared in the following manner: To one drop of the Hardener (no more) add sufficient LEDERMIX Dental Cement Powder to obtain an homogeneous mixture of cream-lik Leggi il documento completo