ONCASPAR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEGASPARGASE

Available from:

SERVIER CANADA INC

ATC code:

L01XX24

INN (International Name):

PEGASPARGASE

Dosage:

750UNIT

Pharmaceutical form:

SOLUTION

Composition:

PEGASPARGASE 750UNIT

Administration route:

INTRAMUSCULAR

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0131872001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-20

Summary of Product characteristics

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_Page 1 of 34_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ONCASPAR®
*
Pegaspargase Injection
Solution, 3,750 Units / 5 mL (750 Units / mL) for Injection/Infusion
Antineoplastic Agent
Servier Canada Inc.
3224 Avenue Jean-Béraud, bureau 270
Laval, Quebec H7T 2S4
Canada
www.servier.ca
Date of Initial Authorization:
FEB 24, 2017
Date of Revision:
JAN 30, 2023
Submission Control Number: 267580
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_Page 2 of 34_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration
.....................................................................................................5
5
OVERDOSAGE
...............................................................