Ország: Kanada
Nyelv: angol
Forrás: Health Canada
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
NOVOCOL PHARMACEUTICAL OF CANADA INC
N01BB51
BUPIVACAINE, COMBINATIONS
5MG; 0.0091MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG
BLOCK/INFILTRATION
1.8ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0231290002; AHFS:
APPROVED
2012-04-16
_Novocol Pharmaceutical of Canada, Inc._ Page 1 of 24 PRODUCT MONOGRAPH BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION USP) _ _ _ _ _ _ _Local Anaesthetic for Dental Use _ Sponsor/Manufacturer: Novocol Pharmaceutical of Canada, Inc. 25 Wolseley Court, Cambridge, Ontario, N1R 6X3 Date of Preparation: March 15, 2012 Submission Control No: 153985 _Novocol Pharmaceutical of Canada, Inc._ Page 2 of 24 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................................3 SUMMARY PRODUCT INFORMATION ....................................................................................................3 INDICATIONS AND CLINICAL USE..........................................................................................................3 CONTRAINDICATIONS ...............................................................................................................................4 WARNINGS AND PRECAUTIONS..............................................................................................................4 ADVERSE REACTIONS ...............................................................................................................................7 DRUG INTERACTIONS................................................................................................................................8 DOSAGE AND ADMINISTRATION..........................................................................................................10 OVERDOSAGE ............................................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ........................................................................................13 STORAGE AND STABILITY .....................................................................................................................15 SPECIAL HANDLING INSTRUCTIONS ........... Olvassa el a teljes dokumentumot