Ország: Kanada
Nyelv: angol
Forrás: Health Canada
IDURSULFASE
TAKEDA CANADA INC
A16AB09
IDURSULFASE
2MG
SOLUTION
IDURSULFASE 2MG
INTRAVENOUS
3ML
Prescription
ENZYMES
Active ingredient group (AIG) number: 0152221001; AHFS:
APPROVED
2021-02-11
_ELAPRASE_ _®_ _ Product Monograph _ _Page 1 of 31_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ELAPRASE ® idursulfase for injection 2 mg/mL concentrate for solution for intravenous infusion Enzyme Replacement Therapy Takeda Canada Inc. 22 Adelaide Street West, Suite 3800 Toronto Ontario M5H 4E3 Date of Initial Approval: June 13, 2007 Date of Revision: February 11, 2021 Submission Control No: 243289 ELAPRASE ® and the ELAPRASE Logo ® are registered trademarks of Shire Human Genetic Therapies, Inc. TAKEDA™ and the TAKEDA Logo ® are trademarks of Takeda Pharmaceutical Company Limited, used under license. _ELAPRASE_ _®_ _ Product Monograph _ _Page 2 of 31_ RECENT MAJOR LABEL CHANGES None. TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS ................................................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 4 4.1 Dosing Considerations ........................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment ....................................................... 4 4.3 Administration ........................................................................................................ 4 5 OVERDOSAGE ............................................................................................................... 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 6 8 WARNINGS AND PRECAUTIONS .................................................................. Olvassa el a teljes dokumentumot