Clinpro 5000

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Sodium fluoride 1.12%;  

Διαθέσιμο από:

3M New Zealand Ltd

INN (Διεθνής Όνομα):

Sodium fluoride 1.12%

Δοσολογία:

1.12 %

Φαρμακοτεχνική μορφή:

Toothpaste

Σύνθεση:

Active: Sodium fluoride 1.12%   Excipient: Carmellose sodium Glycerol Hydrated silica as 13.92% Sident 9 + 6.5% Zeodent 165 Macrogol 600 Poloxamer 407 Purified water Saccharin sodium Sodium laurilsulfate Sorbitol TCP-SLS Titanium dioxide Vanilla mint flavour 661144

Τρόπος διάθεσης:

Restricted

Κατασκευάζεται από:

Sunlit Fluo & Chemical Co Ltd

Θεραπευτικές ενδείξεις:

Fluoride toothpaste for use after recommendation by a dental or medical professional, in the prevention of dental caries in high risk patients.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Tube, Aluminium barrier laminate tube with a HDPE tube head - 113 g - 36 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

2013-03-22

Αρχείο Π.Χ.Π.

NEW ZEALAND DATA SHEET
Clinpro 5000 DSv2 31Aug2018
Page 1 of 6
1 PRODUCT NAME
Clinpro 5000 anti-cavity toothpaste Vanilla Mint
Clinpro 5000 anti-cavity toothpaste Spearmint
Clinpro 5000 anti-cavity toothpaste Bubble Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Thick white paste containing sodium fluoride (5000 ppm F ion) 1.1% w/w
(0.63% w/v fluoride
ion).
Each gram contains 5 mg of fluoride ion in a neutral pH base
consisting of purified water,
sorbitol solution 70% non-crystallising, silicon dioxide, glycerol,
poloxamer, flavour (Vanilla
Mint, Spearmint or Bubble Gum), macrogol 600, sodium lauryl sulfate,
titanium dioxide,
carmellose sodium, saccharin sodium and TCP-SLS (modified calcium
phosphate).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
CLINPRO 5000 is a self-applied fluoride dentifrice presented as a
thick white paste for the
prevention of dental caries.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CLINPRO 5000 is a fluoride toothpaste for use after recommendation by
a dental or medical
professional, in the prevention of dental caries in high risk
patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
CLINPRO 5000 is recommended for adults and children 6 years of age and
older, as part of a
caries prevention program.
Use CLINPRO 5000 once daily in place of a conventional toothpaste
unless instructed
otherwise by a dentist or physician.
Apply a thin ribbon or pea-sized amount of CLINPRO 5000 to a
soft-bristled toothbrush and
brush teeth for at least two minutes.
After brushing, adults should expectorate. Children 6 to 16 years of
age should expectorate
and rinse mouth thoroughly with water.
For best results, do not eat or drink for 30 minutes after use.
Follow these instructions or use as directed by a dental professional.
4.3
CONTRAINDICATIONS
Known allergic reactions or hypersensitivity to any of the stated
ingredients.
Not recommended for use in children under 6 years of age.
NEW ZEALAND DATA SHEET
Clinpro 5000 DSv2 31Aug2018
Page 2 of 6
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR