ONCASPAR SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PEGASPARGASE

Disponibbli minn:

SERVIER CANADA INC

Kodiċi ATC:

L01XX24

INN (Isem Internazzjonali):

PEGASPARGASE

Dożaġġ:

750UNIT

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

PEGASPARGASE 750UNIT

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

5ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2018-04-20

Karatteristiċi tal-prodott

_ _
_ _
_ _
_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
_ _
_ _
_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
...............................................................