Država: Kanada
Jezik: engleski
Izvor: Health Canada
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
CARESTREAM HEALTH CANADA COMPANY
N01BB51
BUPIVACAINE, COMBINATIONS
5MG; 0.0091MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG
BLOCK/INFILTRATION
50X1.8ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0231290002; AHFS:
CANCELLED POST MARKET
2018-09-06
_Novocol Pharmaceutical of Canada, Inc._ Page 1 of 23 PRODUCT MONOGRAPH MARCAINE® (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION USP) BUPIVACAINE HYDROCHLORIDE 0.5% AND EPINEPHRINE 1:200,000 _Local Anaesthetic for Dental Use _ Sponsor: Manufacturer: Carestream Health Canada Company Novocol Pharmaceutical of Canada,Inc. 8800 Dufferin Street 25 Wolseley Court, Suite 201 Cambridge, Ontario, Vaughan ON L4K 0C5 N1R 6X3 Date of Revision: December 2, 2011 Submission Control No: 150074 _Novocol Pharmaceutical of Canada, Inc._ Page 2 of 23 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................................3 SUMMARY PRODUCT INFORMATION ....................................................................................................3 INDICATIONS AND CLINICAL USE..........................................................................................................3 CONTRAINDICATIONS ...............................................................................................................................3 WARNINGS AND PRECAUTIONS..............................................................................................................4 ADVERSE REACTIONS ...............................................................................................................................7 DRUG INTERACTIONS................................................................................................................................8 DOSAGE AND ADMINISTRATION............................................................................................................9 OVERDOSAGE ............................................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ........................................................................................13 STORAGE AND STABILITY ........................................................... Pročitajte cijeli dokument