Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
FOSTAMATINIB (FOSTAMATINIB DISODIUM)
MEDISON PHARMA CANADA INC.
B02BX09
FOSTAMATINIB
150MG
TABLET
FOSTAMATINIB (FOSTAMATINIB DISODIUM) 150MG
ORAL
15G/50G
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0162598001; AHFS:
APPROVED
2021-07-15
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TAVALISSE ® Fostamatinib tablets 100 mg, 150 mg fostamatinib (as fostamatinib disodium hexahydrate) Antihemorrhagics (ATC Code: B02BX09) Date of Initial Approval: November 17, 2020 Date of Revision: July 12, 2021 Submission Control No.: 253525 TAVALISSE ® is a registered trademark of Rigel Pharmaceuticals Inc. used under license by Medison Pharma Canada Inc. Medison Pharma Canada Inc. 2-1176 Mount Pleasant Road Toronto, Ontario M4N 2T2 _ _ _ _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES Not applicable. TABLE OF CONTENTS 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 ....................................................... 4 4.3 Administration ........................................................................................................ 7 4.4 Reconstitution ........................................................................................................ 7 4.5 Missed Dose .......................................................................................................... 7 5 OVERDOSAGE ............................................................................................................... 7 6 DOSAG Perskaitykite visą dokumentą