BUPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

STERIMAX INC

ATC code:

N01BB01

INN (International Name):

BUPIVACAINE

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

BUPIVACAINE HYDROCHLORIDE 5MG

Administration route:

BLOCK/INFILTRATION

Units in package:

100

Prescription type:

Ethical

Therapeutic area:

LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0108896004; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-11

Summary of Product characteristics

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PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
2.5 mg/mL,
5 mg
/mL and 7.5 mg/mL Bupivacaine Hydrochloride, USP
Sterile Solution
Local Anesthetic
STERIMAX INC.
Oakville, Ontario
2770 Portland Drive
L6H 6R4
Date of Preparation:
September 8, 2020
Submission Control No: 238228
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_Bupivacaine Hydrochloride Injection, USP Product Monograph Page 2 of
35_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.................................