BYETTA SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

EXENATIDE

থেকে পাওয়া:

ASTRAZENECA CANADA INC

এটিসি কোড:

A10BJ01

INN (আন্তর্জাতিক নাম):

EXENATIDE

ডোজ:

10MCG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

EXENATIDE 10MCG

প্রশাসন রুট:

SUBCUTANEOUS

প্যাকেজ ইউনিট:

2.4ML PREFILLED PEN.

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

INCRETIN MIMETICS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2022-02-01

পণ্য বৈশিষ্ট্য

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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
.........................