STRENSIQ SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ASFOTASE ALFA

Disponibbli minn:

ALEXION PHARMA GMBH

Kodiċi ATC:

A16AB13

INN (Isem Internazzjonali):

ASFOTASE ALFA

Dożaġġ:

40MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

ASFOTASE ALFA 40MG

Rotta amministrattiva:

SUBCUTANEOUS

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ENZYMES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0157271001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2015-08-14

Karatteristiċi tal-prodott

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_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
.......