Prevora 100mg/ml Dental Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORHEXIDINE DIACETATE

Available from:

CHX Technologies Europe Limited

ATC code:

A01AB; A01AB03

INN (International Name):

CHLORHEXIDINE DIACETATE

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Dental solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives and antiseptics for local oral treatment; chlorhexidine

Authorization status:

Not marketed

Authorization date:

2006-05-05

Patient Information leaflet

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

Summary of Product characteristics

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