BUPIVACAINE INJECTION BP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

EUGIA PHARMA INC.

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

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-07-21

Summary of Product characteristics

BUPIVACAINE INJECTION BP
PAGE 1 OF 32
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BUPIVACAINE INJECTION BP
Bupivacaine Injection
Solution, 2.5 mg / mL and 5 mg / mL bupivacaine hydrochloride,
Parenteral – Epidural Block / Infiltration
BP
Local Anesthetic
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Initial Authorization:
JUL 21, 2023
Date of Revision:
FEB 20, 2024
Submission Control Number: 283295
BUPIVACAINE INJECTION BP
PAGE 2 OF 32
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, GENERAL,
HEPATIC/BILIARY/PANCREATIC
02/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
...........................................................................................................................
4
1.2
Geriatrics
...........................................................................................................................
4
2 CONTRAINDICATIONS
.......................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4 DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1 Dosing Considerations
.....................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................. 6
4.3 Reconstitution
................................