Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
FILGRASTIM
PFIZER CANADA ULC
L03AA02
FILGRASTIM
300MCG
SOLUTION
FILGRASTIM 300MCG
INTRAVENOUS
15G/50G
Prescription
HEMATOPOIETIC AGENTS
Active ingredient group (AIG) number: 0123525001; AHFS:
APPROVED
2020-04-16
_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 ........................................................... Aqra d-dokument sħiħ