BYETTA SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EXENATIDE

Tersedia dari:

ASTRAZENECA CANADA INC

Kode ATC:

A10BJ01

INN (Nama Internasional):

EXENATIDE

Dosis:

10MCG

Bentuk farmasi:

SOLUTION

Komposisi:

EXENATIDE 10MCG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

2.4ML PREFILLED PEN.

Jenis Resep:

Prescription

Area terapi:

INCRETIN MIMETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0152872004; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2022-02-01

Karakteristik produk

_ _
COPYRIGHT 2014 - 2019 ASTRAZENECA CANADA INC.
Page 1 of 47
PRODUCT MONOGRAPH
BYETTA
®
exenatide injection
250 µg/mL
1.2 mL prefilled pen (60 doses of 5 µg/dose)
and
2.4 mL prefilled pen (60 doses of 10 µg/dose)
ANTIHYPERGLYCEMIC AGENT
Glucagon-Like Peptide-1 (GLP-1) receptor agonist
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
December 18, 2019
Submission Control No: 233128
BYETTA
®
is a registered trademark of Amylin Pharmaceuticals LLC used under
license by AstraZeneca Canada
Inc
.
_ _
COPYRIGHT 2014 - 2019 ASTRAZENECA CANADA INC.
Page 2 of 47
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................