Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PRILOCAINE HYDROCHLORIDE
Dentsply Limited
40mg/ml Per Cent
Unknown
2000-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citanest Plain Dental, Prilocaine Hydrochloride 4% w/v Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Prilocaine Hydrochloride 40mg, (88mg per 2.2ml cartridge). For list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. 2.2ml glass cartridge containing a sterile clear aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Citanest Plain Dental is a local anaesthetic for use in dental infiltration anaesthesia and dental nerve block techniques. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION o Injections should always be made slowly with careful aspiration before and intermittently during injection to avoid inadvertent intravascular injection, which may have toxic effects. o The lowest dose that results in effective anaesthesia should be used. The dose will also depend on the area of oral cavity to be anaesthetised, the vascularity of the oral tissues and technique of anaesthesia. The total dose must be adjusted to the age, size and physical status of the patient. o For effective local anaesthesia in most dental procedures, an adequate dose of Citanest Plain Dental solution injected into the tissue is: In normally healthy adults: 1-2 ml (=40-80 mg prilocaine hydrochloride). Children under 10 years of age: ~1 ml (=~ 40 mg prilocaine hydrochloride). o Due to the specific need for bone penetration, dental local anaesthetics contain high concentrations of the active agent (e.g. 40 mg/ml for Citanest Plain Dental). A combination of a high pressure induced by the use of a dental cartridge system and a rapid rate of injection may lead to complications (_see section 4.9. Overdose_) even after the injection of small amounts of local anaes Läs hela dokumentet