BYDUREON POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

EXENATIDE

Saadav alates:

ASTRAZENECA CANADA INC

ATC kood:

A10BJ01

INN (Rahvusvaheline Nimetus):

EXENATIDE

Annus:

2MG

Ravimvorm:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Koostis:

EXENATIDE 2MG

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

INCRETIN MIMETICS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0152872002; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2022-04-01

Toote omadused

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