País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE DIACETATE
CHX Technologies Europe Limited
A01AB; A01AB03
CHLORHEXIDINE DIACETATE
100 milligram(s)/millilitre
Dental solution
Product subject to prescription which may not be renewed (A)
Antiinfectives and antiseptics for local oral treatment; chlorhexidine
Not marketed
2006-05-05
PACKAGE LEAFLET: INFORMATION FOR THE USER : INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your dental professional. This coating has been recommended for your teeth by your dental professional and will be applied to your teeth by your dental professional on several occasions. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your dental professional. IN THIS LEAFLET 1. What Prevora is and what it is used for 2. What you need to know before you are treated with Prevora 3. How you are treated with Prevora 4. Possible side effects 5. How to store Prevora 6. Contents of the pack and other information 1. WHAT PREVORA IS AND WHAT IT IS USED FOR This dental coating is a topical treatment for the prevention of cavities on the crown and the root of the tooth of adult patients at high-risk of tooth decay (e.g. dry mouth sufferers or those with a number of cavities when you visit the dental professional). This coating temporarily covers your teeth to reduce the bacteria on your teeth which cause tooth decay. Oral hygiene and sugar intake: If you have poor oral hygiene and/or you frequently consume sugars you need to make sure you brush your teeth with fluoridated tooth paste and control your sugar intake, as they are important contributors to the overall success of Prevora. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH PREVORA DO NOT USE PREVORA if you are allergic (hypersensitive) to chlorhexidine diacetate, Sumatra benzoin or ethanol (see section 6). if you are allergic to the ingredients of the Stage 2 sealant, which is a secondary coating applied immediately over Stage 1. The ingredients of this second coating are methacrylate, triethyl citrate and purified water. if you have been treated with a fluoride dental varnish in the past 3 days. PACKAGE LEAFLET: INFORMATION FOR THE USER P Leia o documento completo
Health Products Regulatory Authority 26 October 2021 CRN00CFKC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prevora 100 mg/ml Dental Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Prevora Dental Solution (Stage 1 chlorhexidine coating) contains chlorhexidine diacetate 100 mg. Excipients with known effect: Ethanol 700 mg/ml Benzoic acid 82 mg/ml For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Dental Solution Stage 1 chlorhexidine coating A clear, slightly brownish solution with a characteristic odour, free of visible particulate matter. Stage 2 sealant coating A milky-white liquid of low viscosity with a faint characteristic odour, free of visible particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of CORONAL AND ROOT caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers OR THOSE WITH 3 OR MORE CARIES AT THE START OF THE TREATMENT PLAN). To be used in dental offices only by dental professionals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Health Products Regulatory Authority 26 October 2021 CRN00CFKC Page 2 of 6 Posology An individual dosing in adults is between 300 µl and 600 µl of Prevora 100 mg/ml Dental Solution. The patient is to receive 5 treatments in the initial year of treatment, of which 4 are administered one week apart in the first month, and the final dose is administered at 6 months. Treatment of the dental patient thereafter is according to professional clinical judgment of the risk of dental caries. Method of administration External (oral) topical use in the dental office by a dental professional. This product is not intended to be swallowed. Prevora 100 mg/ml Dental Solution is administered topically to the entire dentition of the patient using a cotton pellet or fine brush. The cotton pellet or brush is dipped into the Prevora 100 mg/ml Dental S Leia o documento completo