Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Sodium fluoride 5%{relative}; ;
Colgate-Palmolive Limited (NZ)
Sodium fluoride 5% w/v
5% w/v
Oral solution
Active: Sodium fluoride 5%{relative} Excipient: Colophony Ethanol Mastic Raspberry flavour 73562 Saccharin Shellac White beeswax
Tube, aluminium, 1 x 10ml, Al tube with white plastic screw cap & sealing plug, 10 mL
General sale
Prescription
Sunlit Fluo & Chemical Co Ltd
Latest Regulatory Activity
Package - Contents - Shelf Life: Tube, aluminium, 1 x 10ml, Al tube with white plastic screw cap & sealing plug - 10 mL - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, 5 x 30ml, Al tube with white plastic screw cap & sealing plug - 150 mL - 36 months from date of manufacture stored at or below 25°C
1978-04-13
NEW ZEALAND DATA SHEET Duraphat DS 17122021 Page 1 of 6 1. PRODUCT NAME Duraphat 50 mg/mL Dental Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL suspension contains 50 mg sodium fluoride (5% w/v), equivalent to 22,600 ppm fluoride ion (22.6 mg of fluoride) in an alcoholic solution of natural resins. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dental Suspension Brown/yellow, opaque suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caries prevention by deep penetration with fluoride. Desensitisation of sensitive teeth. 4.2 DOSE AND METHOD OF ADMINISTRATION Duraphat 50 mg/mL Dental Suspension is to be applied by the dental professional and not for self medication by the patient. For best results, remove excess plaque and dry teeth before applying Duraphat. Duraphat is applied as a thin layer to the most susceptible areas of dentition using a brush, probe or applicator. Refer to Section 6.6 for further pre-application recommendations. RECOMMENDED DOSAGE FOR SINGLE APPLICATION: For primary teeth: up to 0.25 mL (= 5.65 mg fluoride) For mixed dentition: up to 0.40 mL (= 9.04 mg fluoride) For permanent dentition: up to 0.75 mL (= 16.95 mg fluoride) For caries prevention: the application is usually repeated every 6 months but more frequent applications (every 3 months) may be made. For hypersensitivity: 2 or 3 applications should be made within a few days. The patient should not brush the teeth or chew food for 4 hours after treatment. Method of administration: For dental use. NEW ZEALAND DATA SHEET Duraphat DS 17122021 Page 2 of 6 4.3 CONTRAINDICATIONS Hypersensitivity to any ingredients of Duraphat. Ulcerative gingivitis. Stomatitis. Bronchial asthma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Application of Duraphat 50 mg/mL Dental Suspension to the whole dentition should not be carried out on an empty stomach. On the day when Duraphat has been applied, no high dose fluoride preparations, such as fluoride gels, should be used. The administration of fluoride suppleme Preberite celoten dokument