BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Available from:

NOVOCOL PHARMACEUTICAL OF CANADA INC

ATC code:

N01BB51

INN (International Name):

BUPIVACAINE, COMBINATIONS

Dosage:

5MG; 0.0091MG

Pharmaceutical form:

SOLUTION

Composition:

BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG

Administration route:

BLOCK/INFILTRATION

Units in package:

1.8ML

Prescription type:

Ethical

Therapeutic area:

LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0231290002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-04-16

Summary of Product characteristics

_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
...........