NeutraFluor 5000 Sensitive

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Potassium nitrate 5%{relative};  ;  ;  ; Sodium fluoride 1.105%{relative} equivalent to 5000 ppm Fluoride;  

Dostupné z:

Colgate-Palmolive Limited (NZ)

INN (Medzinárodný Name):

Potassium nitrate 5% w/w

Forma lieku:

Toothpaste

Zloženie:

Active: Potassium nitrate 5%{relative}       Sodium fluoride 1.105%{relative} equivalent to 5000 ppm Fluoride   Excipient: Brilliant blue FCF Cocamidopropyl betaine Colloidal silicon dioxide Carageenan concentrate Macrogol 600 Mica/Titanium dioxide sparkle Peppermint flavour PVS K91-6287 Poloxamer Purified water Quinoline yellow Saccharin sodium Sodium hydroxide Sodium laurilsulfate Sorbitol

Počet v balení:

Bottle, plastic, White PET bottle with white PP flip top, 115 g

Trieda:

Restricted

Typ predpisu:

Restricted

Výrobca:

Mallinckrodt Baker Inc

Terapeutické indikácie:

Dental caries prevention for individuals at high risk for caries, when used as part of a preventative regimen recommended by a dental professional or doctor.

Prehľad produktov:

Package - Contents - Shelf Life: Bottle, plastic, White PET bottle with white PP flip top - 115 g - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2010-02-17

Súhrn charakteristických

Neutrafluor Sensitive 120220
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NeutraFluor 5000 Sensitive
5000ppm Fluoride Professional Toothpaste
11.05 mg/g Neutral Sodium Fluoride, 5 mg/g Potassium Nitrate plus a
mild cleaning system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS:
Sodium Fluoride 11.05 mg/g
Potassium Nitrate 5 mg/g
EXCIPIENTS: Water, Silicon Dioxide, Sorbitol, Macrogol 600, Sodium
lauryl sulphate, Carrageenan,
Flavour, Poloxamer, Cocamidopropyl betaine, sodium saccharin, Mica,
Sodium hydroxide, Titanium
dioxide, Brilliant blue FCF, Quinoline yellow.
3.
PHARMACEUTICAL FORM
Toothpaste
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Self-applied topical 11.05 mg/g neutral sodium fluoride toothpaste
with 5 mg/g potassium nitrate for use
as a dental caries preventive in individuals with sensitive teeth who
are at high risk for caries. To be used
as part of a preventive regimen recommended by a dental professional
or doctor.
In individuals at high risk for caries, the use of a high
concentration fluoride toothpaste as part of a
preventive regimen prescribed by a dental professional is a rational
approach to caries control. 1.1%
sodium fluoride was first reported to provide significant protection
against dental caries in the 1960’s
when it was applied in a mouth tray daily to school children
1-2
. Neutrafluor 5000 Sensitive toothpaste is
easily applied on a toothbrush and should be used daily in place of
regular fluoride toothpaste unless
otherwise instructed by a dental professional. More recent studies
have shown its effectiveness in
preventing dental caries in children with high caries experience,
adults with root caries and patients with
xerostomia
3-6
. As Neutrafluor 5000 Sensitive toothpaste delivers fluoride topically
to teeth and is
intended for erupted teeth in adults and children over the age of
twelve, the increased fluoride dose should
not contribute to fluorosis provided it is not used in an unsupervised
manner in children under six years of
age.
REFERENCES:
1.
Englander HR, K