TARO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
11-03-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
GLICLAZIDE
Fáanlegur frá:
SUN PHARMA CANADA INC
ATC númer:
A10BB09
INN (Alþjóðlegt nafn):
GLICLAZIDE
Skammtar:
30MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
GLICLAZIDE 30MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SULFONYLUREAS
Vörulýsing:
Active ingredient group (AIG) number: 0119934002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2017-05-04
Vara einkenni
_Pr_
_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
TARO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 11, 2020
Submission Control No.: 236213
_Pr_
_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
_ _
_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
8
DRUG INTERACTIONS
...............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
..............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 18
STORAGE AND STABILITY
.......................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
...................
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