PREVORA 100 MG / ML DENTAL SOLUTION - summary of medicine characteristics

Summary of medicine characteristics - PREVORA 100 MG / ML DENTAL SOLUTION

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Prevora 100mg/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 only by dental professionals.

4.2 Posology and method of administration

Posology

An individual dosing in adults is between 300 ^l and 600 ^l 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 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 solution and thereafter is applied to the tooth surfaces (Figure 1).

Figure 1 Application of Prevora 100 mg/ml Dental Solution

Dip cotton pellet or fine brush in vial and then apply pellet or brush to tooth surfaces.

The patient should be instructed that:

The dried Prevora coating will begin coming off the teeth during the next meal.

They should avoid eating hard foods (e.g. meat, apples) for at least 4 hours after treatment

Do not chew gum for at least 24 hours.

Do not brush his/her teeth for 24 hours after treatment. Then to resume brushing with a new brush 2 to 3 times daily with fluoride tooth paste.

Do not floss for 3 days after treatment. Then to resume flossing daily. If dentures are worn, clean and disinfect these dentures regularly prior to use. Disinfect using soap and warm water.

4.3 Contraindications

Known hypersensitivity to chlorhexidine, Sumatra benzoin (benzoic acid) or ethanol, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)

4.4 Special warnings and precautions for use

Prevora 100 mg/ml Dental Solution contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be rare. Prevora 100 mg/ml Dental Solution should not be administered to anyone with a potential history of an allergic reaction to chlorhexidine-containing compound (see sections 4.3 and 4.8)

For external (oral) topical use only – keep out of the eyes and ears. If the drug product comes into contact with the eyes, wash out promptly and thoroughly with water. Avoid application of Prevora 100 mg/ml Dental Solution to the soft tissues. Failure to do so can result in temporary stinging or mild inflammation of the soft tissues.

Prevora 100 mg/ml Dental Solution should be used with caution in patients with a history of asthma or eczema.

This medicine contains 420 mg of ethanol in each dose, equivalent to 700 mg/ml. It may cause burning sensation on damaged skin.

This medicine contains 49.2 mg benzoic acid in each dose, equivalent to 82 mg/ml. It may cause local irritation.

4.5 Interaction with other medicinal products and other forms of interaction

Prevora 100 mg/ml Dental Solution should not be applied immediately following use of an oil-based prophylactic paste or up to 3 days following application of a fluoride dental varnish.

Chlorhexidine is incompatible with anionic agents.

4.6 Fertility, pregnancy and lactation

There are no or limited amount of data from the use of chlorhexidine diacetate in pregnant women. Prevora 100 mg/ml Dental Solution is not recommended during pregnancy.

It is unknown whether chlorhexidine diacetate/metabolites are excreted in human milk. Prevora 100 mg/ml Dental Solution should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Uncommon (>1/1,000 to

<1/100)

Not known (cannot be estimated from the available data)

Skin and subcutaneous tissues disorders

Redness and/or temporary stinging sensation of the oral mucosa

Objectionable, bitter taste when Prevora 100 mg/ml Dental Solution comes into contact with the saliva or oral

mucosa

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation and blisters.

Immediate hypersensitivity reactions to chlorhexidine (urticaria or anaphylaxis)

General disorders and administration site conditions

Immune Disorders: Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4)

Transient tooth sensitivity and loss of taste

Discoloration of the teeth and silicate or composite restorations

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9 Overdose

There is no experience with over-dosage with Prevora 100 mg/ml Dental Solution. Consequently, the signs and symptoms have not been identified. If overdose should occur, treat symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: A01AB Anti-infectives and antiseptics for local oral treatment.

ATC Code: A01AB03 chlorhexidine.

Chlorhexidine is effective against a wide range of important oral microorganisms associated with dental caries. Chlorhexidine in the drug product has been found at bactericidal levels to Streptococcus mutans for between 24 hours and 48 hours on the surface of adult dental patients after its application, as measured by HPLC.

There have been no published reports of permanent resistance by Streptococcus mutans to the repeated use of chlorhexidine for up to 2 years and no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans were observed after treatment with Prevora over one year in adult patients. The cumulative monthly mean dose of chlorhexidine delivered by Prevora 100 mg/ml Dental Solution is approximately equal to that of 1.0% w/w chlorhexidine dental gel and approximately half that of 0.2% w/v chlorhexidine oral rinse.

5.2 Pharmacokinetic properties

Chlorhexidine binds strongly to the oral mucosa and the dentition and thus has very poor systemic absorption. No detectable blood levels of chlorhexidine have been found after oral use.

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Stage 1 chlorhexidine coating:

Sumatra benzoin (benzoic acid)

Ethanol

Stage 2 sealant coating:

Ammonio methacrylate copolymer dispersion, Type B

Triethyl citrate

6.2 Incompatibilities

In the absence of compatibility studies, this topical medicinal product must not be mixed with other topical medicinal products.

6.3 Shelf life

18 months.

Discard any remaining solution immediately after use.

6.4 Special precautions for storage

Store in refrigerator (2° to 8°C)

6.5 Nature and contents of container

Prevora 100 mg/ml Dental Solution contains: