Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
ROMIPLOSTIM
AMGEN CANADA INC
B02BX04
ROMIPLOSTIM
250MCG
POWDER FOR SOLUTION
ROMIPLOSTIM 250MCG
SUBCUTANEOUS
0.5ML
Prescription
HEMATOPOIETIC AGENTS
Active ingredient group (AIG) number: 0152535003; AHFS:
APPROVED
2009-02-19
_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 ............................... Izlasiet visu dokumentu