ACT REPAGLINIDE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
03-04-2020
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:
REPAGLINIDE
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
A10BX02
INN (Alþjóðlegt nafn):
REPAGLINIDE
Skammtar:
2MG
Lyfjaform:
TABLET
Samsetning:
REPAGLINIDE 2MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MEGLITINIDES
Vörulýsing:
Active ingredient group (AIG) number: 0137035003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2014-06-05
Vara einkenni
_ _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
Pr
ACT REPAGLINIDE
Repaglinide Tablets, USP
0.5 mg, 1 mg, and 2 mg
Oral Antidiabetic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No.: 237126
Date of Revision:
April 3, 2020
_ _
_ _
_Page 2 of 39_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
..........................................................................
Lestu allt skjalið
