NIVESTYM SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FILGRASTIM

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

L03AA02

INN (Internationale Bezeichnung):

FILGRASTIM

Dosierung:

480MCG

Darreichungsform:

SOLUTION

Zusammensetzung:

FILGRASTIM 480MCG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

HEMATOPOIETIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0123525003; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2020-04-16

Fachinformation

_Nivestym_
_®_
_ Product Monograph _
_ _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NIVESTYM
®
filgrastim injection
Sterile Solution
300 mcg/0.5 mL and 480 mcg/0.8 mL in a single-use prefilled syringe
300 mcg/1 mL and 480 mcg/1.6 mL in a single-use vial
(Subcutaneous or Intravenous Use Only)
Hematopoietic Agent
Granulocyte Colony-Stimulating Factor
ATC: L03AA02
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec H9J 2M5
Date of Initial Approval:
April 16, 2020
Date of Revision:
October 27, 2023
https://www.pfizer.ca/
Submission Control No: 275858
_ _
_Nivestym_
_®_
_ Product Monograph _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and
Mutagenesis
09/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2023
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
2
CONTRAINDICATIONS
.......................................................................................
5
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
.................................................................................................
8
4.4 Administration
...........................................................