Bifluorid 12 Suspension 60mg/G
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bifluorid 12R
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Bifluorid 12R contains:
Active ingredients Sodium fluoride 60mg Calcium fluoride 60mg
3 PHARMACEUTICAL FORM
Suspension for topical application to teeth
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Bifluorid 12R is applied for
i. ) Treatment of hypersensitive dentine
ii. ) General caries prophylaxis (remineralisation)
iii. ) Following dental treatment, a single application to desensitise the
teeth/necks/ crown edges and against secondary caries
4.2 Posology and method of administration
Topical application to teeth
- Surfaces to be treated are cleaned (remove plaque) and thoroughly dried with air.
- Bifluorid 12R must be shaken well before use. Solid particles must be well dispersed. Two metal balls facilitate proper agitation. The suspension must be liquid in a way that it easily runs out of the dropper after agitation.
Attention: Layers which are too thick separate too easily!
- Drop Bifluorid 12R onto a brush, cotton tip or Pele Tim foam pellet and thinly paint the surfaces to be treated.
- Allow the fluoride varnish to be absorbed for 10 - 20 seconds and dry with air.
Dosage
a) for caries prophylaxis with complete painting of the whole dentition, application is done with
- approx. 0.5 ml respectively 30 mg sodium fluoride/30 mg calcium fluoride in case of deciduous teeth,
- approx. 0.5 ml-1.0 ml respectively 30-60 mg sodium fluoride/30 -60mg calcium fluoride in case of permanent teeth,
b) for prophylaxis after fillings have been inserted and for treatment of hypersensitive teeth approx. 0.02 ml per tooth, respectively approx. 0.98 mg sodium fluoride and calcium fluoride each are applied.
Duration of treatment
Treatment of dentine hypersensitivity:
- Single application
- In cases of intense dentine hypersensitivity (persistent after the first application) treatment should be repeated two or three times at weekly intervals.
Prophylaxis:
- for prophylaxis after treatments single application. For general prophylaxis twice a year.
4.3 Contraindications
Don't use if teeth are mottled (fluoride level of > 2 mg/day). Allergic reactions to the constituents cannot be excluded.
4.4 Special warnings and precautions for use
In case of unforeseen contact to the eyes rinse immediately with plenty of water. Avoid oral hygiene procedures (tooth brushing) until 24 hours after application.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known interactions with other products.
4.6 Pregnancy and lactation
Safety in pregnancy and lactation has not been established; however the product has been in use for more than seven years.
4.7 Effects on ability to drive and use machines
No restrictions.
4.8 Undesirable effects
No undesirable effects have been reported during seven years of use (on the market since 07/1986).
4.9 Overdose
In cases where more than 125 mg sodium fluoride (more than 2.0 ml Bifluorid 12R) has been absorbed, nausea, sickness and diarrhoea may occur.
In case of a daily absorption of more than 2 mg of fluorides in total during the stage of dental development, stains may appear (enamel or dental fluorosis) as a consequence of mineralisation disturbances of the enamel. However, up to now there are no secured findings regarding fluorosis as a consequence of a short-time increase of the fluoride serum concentration after topical application of fluorides. Therefore, the absorption of larger quantities of fluorides before the 8th year of life should be avoided.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The protective effect of fluorides against caries is due to three factors:
The increase of the tooth substance’s resistance to acid
The prevention of the breaking down of sugar by acid-producing
microorganisms in the dental plaques
The promotion of remineralisation of initial carious lesions
Long-lasting success is only secured in case of a lifelong administration of fluoride in therapeutically effective dosages.
Depending on the form of application, retention capacity of the dentition, material properties and individual factors, the fluoride quantities retained in the oral cavity after topical application will be absorbed, swallowed and resorbed in different amounts. However, it can be stated that in case of proper application, any toxic concentrations in the serum will not occur.
Calcium fluoride increases the accumulation of fluoride in the dentine tremendously in comparison with pure sodium fluoride varnish. This effect is additive and takes place only with slight interactions. A structural change of the dentine surface takes place in such a way that it inhibits the mobility of the dentinal fluid (precipitations on the dentine surface and within the tubuli). Painful sensations by movement of the dentinal fluid are reduced by this.
5.2 Pharmacokinetic properties
The profiles of fluoride concentration in the serum after topical application of varnishes containing fluorides fundamentally differ from those which can be proven after swallowing (oral administration).
The application of a varnish (with doses up to approx. 1g) the highest serum concentration exceed the 0.1 ppm mark slightly. A plateau concentration lasting about 30-120 min. is observed instead of a peak. The base line (between 0.01 and 0.02 ppm F) is reached again 24h after administration.
It is obvious that the different serum concentrations very likely result from the fact, that flakes of the varnish are gradually released from the teeth surfaces and swallowed. The urine F concentration rise from 0.2 mg F /24 h to about
1.0 mg F-/24h. Normal values are observed on the second day after treatment. In children the highest plasma fluoride concentrations between 0.06 and 0.12 ppm F- are measured within 2h after varnish application. Plasma fluoride concentrations rapidly decrease during the next 2h. A slower decrease follows until the base line is reached (about after 24 h).
The pretreatment urine fluoride concentration ranges from 50 to 200qg F-/12h. During the 12h period following application fluoride excretion is about 550-1,100qg F-/12h. During the subsequent 12h period still elevated fluoride concentrations are observed.
5.3 Preclinical safety data
The toxicological data of the ingredients were compiled and did not reveal any indications neither of an acute or chronic toxicity nor mutagenicity or carcinogenicity as regards the intended dosage and frequency of application.
The determination of the acute toxicity of Bifluorid 12 furnished a value of 3.47 g/kg body weight (rat, oral) and is thus far above the quantity of application.
The slight to moderate local toxicity (cytotoxicity) shows a dependence on the dosage, which is mainly due to the solvent contained. However, the influence of the solvent is only very short during application.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethylacetate Pyroxylin Fumed silica Clove oil
6.2 Incompatibilities
There are no known incompatibilities.
6.3 Shelf life
Bifluorid 12R should not be used after the expiry date indicated on the package (shelf life is 3 years).
After first opening the bottle Bifluorid 12 should not be used after one year (if the bottle is suitably reclosed).
6.4 Special precautions for storage
Reclose bottle of Bifluorid 12R after use and store at room temperature (max. 25°C) and under protection from direct sunlight.
6.5 Nature and contents of container
Original pack: with 4 g Bifluorid 12R, 10 ml 4g and l0ml solvent for the cleaning of instruments and Pele Tim foam pellets for application:
- glass bottle 5ml brown,
- 2 balls made of stainless steel
- dropper plug, polyethylene, natural
- screw cap, polypropylene, white Refill pack with 10g Bifluorid l2R:
- glass bottle 10ml brown,
- 2 balls made of stainless steel
- dropper plug, polyethylene, natural
- screw cap, polypropylene, white
6.6 Special precautions for disposal
Bifluorid 12R is a suspension with partly sedimentation of solid substances. It must be shaken well before use to get a homogeneous suspension again. Solid particles must be well dispersed. Two metal balls facilitate proper agitation. The suspension must be liquid in a way that it easily runs out of the dropper after agitation.
To avoid evaporation please reclose the bottle of Bifluorid 12R well after use.
7 MARKETING AUTHORISATION HOLDER
VOCO GmbH
P.O Box 767
27457 Cuxhaven/R.F.A
Germany
8 MARKETING AUTHORISATION NUMBER
PL 11807/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/09/1995 / 16/08/2006
10 DATE OF REVISION OF THE TEXT
28/07/2010