Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
ASFOTASE ALFA
ALEXION PHARMA GMBH
A16AB13
ASFOTASE ALFA
40MG
SOLUTION
ASFOTASE ALFA 40MG
SUBCUTANEOUS
15G/50G
Prescription
ENZYMES
Active ingredient group (AIG) number: 0157271001; AHFS:
APPROVED
2015-08-14
_ _ _Draft_08APR2021 Alexion STRENSIQ_ _® _ _(asfotase alfa) _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr STRENSIQ ® (asfotase alfa) Solution for Injection 40 mg/mL & 100 mg/mL Enzyme Replacement Therapy Alexion Pharma GmbH Giesshübelstrasse 30 CH - 8045 Zürich, Switzerland Date of Initial Authorization: August 14, 2015 Date of Revision: August 25, 2021 Submission Control Number: 251587 _ _ _Draft_08APR2021 Alexion STRENSIQ_ _® _ _(asfotase alfa) _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Immune 05/2020 14 Clinical Trials 05/2020 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 4 DOSAGE AND ADMINISTRATION................................................................................. 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 4 4.3 Reconstitution ................................................................................................... 4 4.4 Administration................................................................................................... 4 4.5 Missed Dose ....... Aqra d-dokument sħiħ