FLUORIDE 5000 ppm Toothpaste (2015)
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Περιεχόμενα
Name of the medicinal product
Fluoride 5000 ppm Toothpaste.
Qualitative and quantitative composition
1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride, sodium fluoride 1.1% w/w. Excipient(s) with known effect: Sodium benzoate Sorbitol solution (non-crystallising) ...
Pharmaceutical form
Toothpaste. For dental use. Smooth, blue coloured translucent paste with the odour and taste of spearmint.
Therapeutic indications
Fluoride 5000 ppm Toothpaste is indicated in adults and adolescents aged 16 years and over. Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries ...
Posology and method of administration
Paediatric population Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents aged under 16 years, see section 4.3. Adult and adolescents and children aged 16 years or more To be used ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use by children and adolescents aged under sixteen years, see section 4.2.
Special warnings and precautions for use
This toothpaste has a high fluoride content. Therefore, the opinion of a dental specialist must be sought before the product is used. An increased number of potential fluoride sources may lead to fluorosis. ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in pregnant women. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very ...
Effects on ability to drive and use machines
Fluoride 5000 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Gastrointestinal disorders Frequency not known (cannot be estimated from the available data): burning oral sensation Immune system disorders Rare (>1/10,000, <1/1,000): hypersensitivity reactions Reporting ...
Overdose
Acute Intoxication The toxic dose, i.e the lowest dose at which symptoms of intoxication can be induced, is 5 mg fluoride per Kg body weight. Such intoxication appears in the form of digestive problems: ...
Pharmacodynamic properties
Pharmacotherapeutic group: caries prophylactic agents ATC code: A01AA01 The primary mode of the caries preventative action of fluoride is post-eruptive, i.e topical action. Systemic fluoride supplements ...
Pharmacokinetic properties
Fluoride 5000 ppm Toothpaste has a local, topical action on the teeth and so the route taken within the body does not apply. However, the following information has been included in case any toothpaste ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Sorbitol solution (non-crystallising), E420 Dental type silica (precipitated), E551 Macrogol 600, E1521 Tetrapotassium pyrophosphate, E340 Xanthan gum, E415 Sodium benzoate, E211 Sodium laurilsulphate ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: Thirty six (36) months unopened. 6 months after opening.
Special precautions for storage
This product requires no special storage conditions.
Nature and contents of container
Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. 51g.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, United Kingdom
Marketing authorization number(s)
PL 20117/0240
Date of first authorization / renewal of the authorization
10/12/2014
Date of revision of the text
22/07/2015
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