JAMP-BUPIVACAINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

JAMP PHARMA CORPORATION

ATC code:

N01BB01

INN (International Name):

BUPIVACAINE

Dosage:

2.5MG

Pharmaceutical form:

SOLUTION

Composition:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Administration route:

BLOCK/INFILTRATION

Units in package:

100

Prescription type:

Ethical

Therapeutic area:

LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0108896001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2023-07-12

Summary of Product characteristics

_Product Monograph – JAMP-Bupivacaine _
_Page 1 of 32 _
PRODUCT MONOGRAPH
JAMP-Bupivacaine
Bupivacaine Hydrochloride Injection USP
2.5 mg/mL and 5 mg/mL Bupivacaine Hydrochloride
(as bupivacaine hydrochloride monohydrate)
Sterile Solution
Local Anesthetic
JAMP Pharma Corporation
1380-203 newton
Boucherville, Québec
J4B 5H2
Control No. : 178342
Date of Preparation :
October 21, 2014
_Product Monograph – JAMP-Bupivacaine _
_Page 2 of 32 _
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
.......................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
........................