Land: Israel
Språk: engelsk
Kilde: Ministry of Health
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
HENRY SCHEIN SHVADENT (2009 ) LTD
N01BB08
SOLUTION FOR INJECTION
EPINEPHRINE BITARTRATE 0.031 MG / 1.7 ML; ARTICAINE HYDROCHLORIDE 68 MG / 1.7 ML
DENTAL NERVE BLOCK, DENTAL INFILTRATION INJ.
Required
NOVOCOL PHARMACEUTICAL OF CANADA INC.
ARTICAINE
For infiltration anaesthesia and nerve block anaesthesia in clinical dentistry.
2021-10-31
PHYSICIAN’S PRESCRIBING INFORMATION 1) NAME OF THE MEDICINAL PRODUCTS: Articaine HCl 4% and Epinephrine 1:200,000 Articaine HCl 4% and Epinephrine 1:100,000 2) QUALITATIVE AND QUANTITATIVE COMPOSITION: Articaine HCl 4% and Epinephrine 1:200,000: 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 5 micrograms of epinephrine (as epinephrine bitartrate). Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 8.5 micrograms of epinephrine (as epinephrine bitartrate). Articaine HCl 4% and Epinephrine 1:100,000: 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 10 micrograms of epinephrine (as epinephrine bitartrate). Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 17 micrograms of epinephrine (as epinephrine bitartrate). Excipient(s) with known effect: sodium metabisulfite For the full list of excipients, see section 6.1. 3) PHARMACEUTICAL FORM: Solution for Injection. Clear and colourless solution, practically free from particles. 4) CLINICAL PARTICULARS: 4.1) THERAPEUTIC INDICATIONS: for infiltration anaesthesia and nerve block anaesthesia in clinical dentistry. 4.2) POSOLOGY AND METHOD OF ADMINISTRATION: As with all local anaesthetics the dosage varies and depends upon the area to be anaesthetized, the vascularity of the tissues, the number of numeral segments to be blocked, individual tolerance and the technique of anaesthesia. ADULTS: • For most common operations, one infiltration with 1.7 ml Articaine HCl 4% and Epinephrine 1: 200,000 or Articaine HCl 4% and Epinephrine 1: 100,000 is sufficient. In all cases, the injection must be administered slowly (About 1 ml/min). • For an infiltration in the interdental septum, a quantity of 0.3 to 0.5 ml is indicated as generally sufficient. Do not exceed the equivalent of 7 mg/kg articaine hydrochloride body weight which corresponds, for a subject weighing 60 Kg, to 6 standard 1.7 ml cartridges. The duration of anaesthesia d Les hele dokumentet