Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: CHX Technologies Europe Limited, Guiness Enterprise Centre, Taylors Lane, Dublin 8, Ireland
Prevora 100 mg/ml Dental Solution.
| 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. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Chlorhexidine |
Chlorhexidine is an antimicrobial agent, active against a broad spectrum of Gram-positive and Gram-negative organisms, yeasts, fungi, opportunistic anaerobes and aerobes. Chlorhexidine is mainly a “membrane-acting” agent that destroys the outer membrane of the bacteria. It is inactive on bacterial spores unless the temperatures are high. |
| List of Excipients |
|---|
|
Stage 1 chlorhexidine coating: Sumatra benzoin (benzoic acid) Stage 2 sealant coating: Ammonio methacrylate copolymer dispersion, Type B |
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.
CHX Technologies Europe Limited, Guiness Enterprise Centre, Taylor’s Lane, Dublin 8, Ireland
PA1205/001/001
Date of First Authorisation: 5th May 2006
Date of last renewal: 4th May 2011
| Drug | Countries | |
|---|---|---|
| PREVORA | Canada, Ireland |
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