国家: 以色列
语言: 英文
来源: Ministry of Health
EPINEPHRINE AS BITARTRATE; LIDOCAINE AS MONOHYDRATE
HENRY SCHEIN SHVADENT (2009 ) LTD
N01BB02
SOLUTION FOR INJECTION
LIDOCAINE AS MONOHYDRATE 20 MG/ML; EPINEPHRINE AS BITARTRATE 10 MCG/ML
DENTAL NERVE BLOCK, DENTAL INFILTRATION INJ.
Required
NOVOCOL PHARMACEUTICAL OF CANADA INC.
LIDOCAINE
LIDOCAINE
Production of local anesthesia by nerve block or infiltration technique.
2014-09-30
2612-3 FPO Physician’s Prescribing Information Lidocaine HCL 2% and Epinephrine 1:100,000 1. NAME OF THE MEDICINAL PRODUCT: Lidocaine HCL 2% and Epinephrine 1:100,000 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: 1 ml of solution for injection contains 20 mg of lidocaine HCL (as monohydrate) and 10 micrograms (1:100,000) of epinephrine (as bitartrate). Epinephrine bitartrate is also called adrenaline tartrate. Both names are synonyms. One cartridge of 1.8 ml of solution for injection contains 36 mg of lidocaine hydrochloride (as monohydrate) and 18 micrograms of epinephrine (as bitartrate). Excipient(s) with known effect: This medicinal product contains 1.20 mg/ml potassium metabisulfite [equivalent to 0.422 mg/ml potassium (0.0108 mmol/ml)]. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM: Solution for injection. Clear and colourless solution, practically free from particles. The pH of the solution is adjusted to USP limits with sodium hydroxide. 4. CLINICAL PARTICULARS: 4.1) Therapeutic indications: For the production of local anaesthesia by nerve block or infiltration technique. Dental infiltration injection, dental nerve block. 4.2) Posology and method of administration: Lidocaine HCL 2% and Epinephrine 1:100,000 is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and is administered parenterally by injection. The dosage of Lidocaine HCL 2% and Epinephrine 1:100,000 depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks. Dosage requirements should be determined on an individu 阅读完整的文件