ROPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROPIVACAINE HYDROCHLORIDE

Available from:

PFIZER CANADA ULC

ATC code:

N01BB09

INN (International Name):

ROPIVACAINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ROPIVACAINE HYDROCHLORIDE 10MG

Administration route:

EPIDURAL

Units in package:

10ML/20ML

Prescription type:

Ethical

Therapeutic area:

LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0133273005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-10-01

Summary of Product characteristics

_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROPIVACAINE HYDROCHLORIDE INJECTION USP
Parenteral sterile solution
2 mg / mL ropivacaine hydrochloride per flexible container
5 mg / mL and 10 mg / mL ropivacaine hydrochloride per vial
Local Anaesthetic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
May 19, 2020
Submission Control No: 236564
_ _
_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions (6)
10/2018
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
DOSAGE AND ADMINISTRATION
................................................................................
5
3.1
Dosing Considerations
...........................................................................................
5
3.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4
OVERDOSAGE
...............................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 9
6