APO-GLIMEPIRIDE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
17-10-2018
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:
GLIMEPIRIDE
Fáanlegur frá:
APOTEX INC
ATC númer:
A10BB12
INN (Alþjóðlegt nafn):
GLIMEPIRIDE
Skammtar:
4MG
Lyfjaform:
TABLET
Samsetning:
GLIMEPIRIDE 4MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SULFONYLUREAS
Vörulýsing:
Active ingredient group (AIG) number: 0146247003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2007-05-16
Vara einkenni
Page 1 of 51
PRODUCT MONOGRAPH
PR
APO-GLIMEPIRIDE
GLIMEPIRIDE TABLETS USP
1 MG, 2 MG AND 4 MG
ORAL HYPOGLYCEMIC (SULFONYLUREA)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
CANADA M9L 1T9
_ _
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SUBMISSION CONTROL NO.: 219952
Page 2 of 51
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
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLINICAL TRIALS
...............................................................................................................
25
DETAILED PHARMACOLOGY
..
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