Pays: Canada
Langue: anglais
Source: Health Canada
LIDOCAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)
ASTRAZENECA CANADA INC
N01BB52
LIDOCAINE, COMBINATIONS
20MG; 0.01MG
LIQUID
LIDOCAINE HYDROCHLORIDE 20MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01MG
BLOCK/INFILTRATION
10X20ML,10X50ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0201284005; AHFS:
CANCELLED POST MARKET
2012-09-12
COPYRIGHT 1954, 2008 ASTRAZENECA CANADA INC. Page 1 of 31 PRESCRIBING INFORMATION XYLOCAINE ® PARENTERAL SOLUTIONS Lidocaine Hydrochloride Injection USP 0.5%, 1%, and 2% Lidocaine Hydrochloride and Epinephrine Injection USP 1%, 1.5% and 2% (lidocaine hydrochloride with epinephrine 1:200,000 and 1:100,000) Local Anesthetic AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca DATE OF REVISION: SEPTEMBER 7, 2011 SUBMISSION CONTROL NO: 144224, 144225 XYLOCAINE ® is a registered trademark of the AstraZeneca group of companies. COPYRIGHT 1954, 2008 ASTRAZENECA CANADA INC. Page 2 of 31 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................3 SUMMARY PRODUCT INFORMATION......................................................................3 INDICATIONS AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS.................................................................................................4 WARNINGS AND PRECAUTIONS ...............................................................................5 ADVERSE REACTIONS ...............................................................................................12 DRUG INTERACTIONS................................................................................................14 DOSAGE AND ADMINISTRATION ...........................................................................16 OVERDOSAGE..............................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY..........................................................22 STORAGE AND STABILITY .......................................................................................24 SPECIAL HANDLING INSTRUCTIONS.....................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING...........................................25 PART II: SCIENTIFIC INFORMA Lire le document complet