MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

GLICLAZIDE

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

A10BB09

INN (International Name):

GLICLAZIDE

ডোজ:

30MG

ফার্মাসিউটিকাল ফর্ম:

TABLET (EXTENDED-RELEASE)

রচনা:

GLICLAZIDE 30MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

60/100

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

SULFONYLUREAS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0119934002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2015-03-17

পণ্য বৈশিষ্ট্য

_MYLAN-GLICLAZIDE MR (Gliclazide) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-GLICLAZIDE MR
Gliclazide
Modified Release Tablets
30 mg
Modified Release Breakable Tablets
60 mg
Hypoglycemic sulfonylurea
Oral antidiabetic agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
MAR 17, 2015
Date of Revision:
MAR 08, 2024
Submission Control No. 280151
_MYLAN-GLICLAZIDE MR (Gliclazide) _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
Not Applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORISATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics (< 18 years of age)
................................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
..............................................................................................
4
4.1
Dosing Considerations
..........................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.....................................................................
5
4.4
Administration
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