APO-TELMISARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TELMISARTAN

Tersedia dari:

APOTEX INC

Kode ATC:

C09CA07

INN (Nama Internasional):

TELMISARTAN

Dosis:

80MG

Bentuk farmasi:

TABLET

Komposisi:

TELMISARTAN 80MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/500

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0138223002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-01-24

Karakteristik produk

_APO-TELMISARTAN Product Monograph_
Page 1 of 30
PRODUCT MONOGRAPH
Pr APO-TELMISARTAN
(TELMISARTAN TABLETS, USP)
40 MG AND 80 MG
ANGIOTENSIN II AT1 RECEPTOR BLOCKER
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
JANUARY 24, 2014
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 149368
_APO-TELMISARTAN Product Monograph_
Page 2 of 30
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
.....................................................................................15
OVERDOSAGE
...................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
......................................................................16
STORAGE AND
STABILITY................................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................18
PART II: SCIENTIFIC INFORMATION
...................................................................................20
PHARMACEUTICAL INFORMATION
..................................................................................20
CLINICAL TRIALS
........................................................................