BYDUREON POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-12-2019
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Aktiv bestanddel:
EXENATIDE
Tilgængelig fra:
ASTRAZENECA CANADA INC
ATC-kode:
A10BJ01
INN (International Name):
EXENATIDE
Dosering:
2MG
Lægemiddelform:
POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Sammensætning:
EXENATIDE 2MG
Indgivelsesvej:
SUBCUTANEOUS
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
INCRETIN MIMETICS
Produkt oversigt:
Active ingredient group (AIG) number: 0152872002; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2022-04-01
Produktets egenskaber
COPYRIGHT 2015-2019 ASTRAZENECA CANADA INC.
Page 1 of 55
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BYDUREON
®
exenatide for extended-release injectable suspension
2 mg/dose once weekly_ _
ATC CODE: A10BJ01
Glucagon-like peptide-1 (GLP-1) analogues
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
December 18, 2019
Submission Control No: 233114
BYDUREON
®
is a registered trademark of Amylin Pharmaceuticals LLC used under
license by AstraZeneca
Canada Inc.
COPYRIGHT 2015-2019 ASTRAZENECA CANADA INC.
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
18
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND STABILITY
.........................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 26
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