RATIO-GLIMEPIRIDE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GLIMEPIRIDE

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

A10BB12

INN (Nama Internasional):

GLIMEPIRIDE

Dosis:

2MG

Bentuk farmasi:

TABLET

Komposisi:

GLIMEPIRIDE 2MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

SULFONYLUREAS

Ringkasan produk:

Active ingredient group (AIG) number: 0146247002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-04-04

Karakteristik produk

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_Page 1 of 49_
PRODUCT MONOGRAPH PR
RATIO-GLIMEPIRIDE
glimepiride
Tablets 1, 2 and 4 mg
Teva Standard
Oral Hypoglycemic (Sulfonylurea)
TEVA CANADA LIMITED
30 NOVOPHARM COURT
TORONTO, ONTARIO
CANADA, M1B 2K9
DATE OF REVISION:
NOVEMBER 6, 2014
Submission Control No.: 178528
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_Page 2 of 49_
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
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
18
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
......................................................................
23
CLINICAL TRIALS
......................................................................................................
24
DETAILED PHARMACOLOGY
.................................................................................
29