PREVORA Dental solution Ref.[50410] Active ingredients: Chlorhexidine

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 Solution and thereafter is applied to the tooth surfaces (Figure 1).

Figure 1. Application of Prevora Stage 1 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.

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.

18 months.

Discard any remaining solution immediately after use.

Store in refrigerator (2° to 8°C).

Prevora 100 mg/ml Dental Solution contains:

Stage 1 chlorhexidine coating:

Chlorhexidine diacetate
Sumatra benzoin (benzoic acid)
Ethanol

Stage 2 sealant coating:

Ammonio methacrylate copolymer dispersion, Type B
Triethyl citrate

One treatment box of Prevora Dental solution contains 6 Type 1 glass vials of Stage 1 chlorhexidine coating along with 6 Type 1 glass vials of Stage 2 sealant coating.

Each vial contains 1 ml of Stage 1 chlorhexidine coating or Stage 2 sealant coating.

Step #1. Preparation: Ensure that the dentition contains no opencaries lesions or restorations with imperfect margins. Prepare for theapplication with a tray (Figure 2), consisting of cotton rolls, cotton pelletsor fine brushes, forceps, air syringe,and a vial of Stage 1 chlorhexidine coating and a vial of Stage 2 sealant coating.

Figure 2. Tray set up for Stage. One Stage 1 chlorhexidine coating and Stage 2 sealant coating treatments.:

Step #2. Prophylaxis: Give a rubber cup prophylaxis using flour ofpumice and water. Avoid using a non-oil based prophylactic paste.

Step #3. Floss: Thoroughly rinse and floss the patient’steeth with un-waxed floss to remove pumice and residual dental plaque. Ensurethe cleanliness of the distal surface of the last tooth in each arch by wipingit with a cotton pellet held in a pair of forceps.

Step #4. Isolate onequadrant: Isolate one quadrant of the dentitionwith cotton rolls and a saliva ejector.

Step #5. Dry teeth: Dry all teeth in that quadrant with an airsyringe.

Step #6. Apply Stage 1 chlorhexidine coatinginter-proximally: Using a cotton pellet held in forceps, or a fine brushsuitable for reaching inter-proximal areas, apply Stage 1 Chlorhexidine coatingto the inter-proximal areas of all posterior teeth in the quadrant, ensuringnot to apply the coating to the soft tissues. Then dry these tooth surfaces with an air syringe.

Figure 3. Apply Prevora Stage 1 chlorhexidinecoating with a fine brush to the gingival margin, followed by Prevora Stage 2sealant coating using the same techniques.:

Step #7. Apply Stage1 chlorhexidine coating to other tooth surfaces: Apply this coating to all other tooth surfaces (Figure 3) in this samequadrant, and then air dry. Be careful to avoid applying Stage 1 chlorhexidine coating to the soft tissues asthe patient may experience stinging or burning of the gums or tongue.

Step #8. Apply Stage2 sealant coating: Apply this second coating (with white cap),using a second cotton pellet or with another fine brush, to this same quadrant.Then dry this second coating with an air syringe.

Step #9. Repeatcoating of other quadrants: Repeat steps 4 through 8 in the remainingquadrants of the dentition.

Step #10. Advise the patient:

Instruct the patient:

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

Step #11. Schedule repeat treatments: Repeat this initial Prevora application everyweek for 3 more weeks after the initial application, followed by a singleapplication at six months and thereafter according to clinical judgment. Instruments and clothing incontact with Stage 1 chlorhexidine coating may be cleaned with alcohol.Instruments and clothing in contact with Stage 2 sealant coating may be cleanedwith water.

Any unused product or waste material should be disposed of in accordance with local requirements.