NPLATE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROMIPLOSTIM

Available from:

AMGEN CANADA INC

ATC code:

B02BX04

INN (International Name):

ROMIPLOSTIM

Dosage:

500MCG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ROMIPLOSTIM 500MCG

Administration route:

SUBCUTANEOUS

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

HEMATOPOIETIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152535004; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-02-19

Summary of Product characteristics

_NPLATE Product Monograph _
_Page 1 of 77_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NPLATE
®
romiplostim for injection
Lyophilized Powder for Solution
250 mcg/0.5 mL and 500 mcg/1 mL
Professed Standard
Thrombopoiesis-Stimulating Protein
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4
Date of Initial Authorization:
FEB 19, 2009
Date of Revision:
AUG 4, 2021
Submission Control No: 243699

2009-2021 Amgen Canada Inc., All rights reserved
_NPLATE Product Monograph _
_Page 2 of 77_
RECENT MAJOR LABEL CHANGES
INDICATIONS (1)
XX/2021
WARNING AND PRECAUTIONS (7)
XX/2021
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
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing
Considerations.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.3
Reconstitution
...............................