Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
SODIUM FLUORIDE
Colgate-Palmolive (U.K.) Ltd
SODIUM FLUORIDE
0.619 %w/w
Toothpaste
Withdrawn
2008-09-25
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duraphat 2800ppm Fluoride Toothpaste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tube contains sodium fluoride 0.619 %w/w (2800 ppm fluoride). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Toothpaste Smooth white paste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of dental caries and demineralisation in adults and children over 16 years, who are at high risk of developing caries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 16 years old: Use daily instead of the normal toothpaste. The usual dosage is to apply a line of paste (about 1g) across the head of a toothbrush and brush the teeth thoroughly for one minute morning and evening. Spit out after use; for best results do not eat, drink or rinse for 30 minutes. Children under 16 years: not recommended. Elderly: use as for adults. 4.3 CONTRAINDICATIONS None known. Individuals with known hypersensitivity should consult their dentist before using. Not to be used in children under 16 years old. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not to be swallowed. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/07/2006_ _CRN 2025856_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Not applicable. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES When used as recommended there are no side effects. 4.8 UNDESIRABLE EFFECTS Not applicable. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES This product is a toothpaste in which the active ingredient is Sodium Fluoride present at a level of 0.619 Olvassa el a teljes dokumentumot