MYLAN-TELMISARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TELMISARTAN

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C09CA07

INN (Nama Internasional):

TELMISARTAN

Dosis:

80MG

Bentuk farmasi:

TABLET

Komposisi:

TELMISARTAN 80MG

Rute administrasi :

ORAL

Unit dalam paket:

28/100/500

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-08-15

Karakteristik produk

_ MYLAN-TELMISARTAN Product Monograph _
_Page 1 of 33 _
PRODUCT MONOGRAPH
PR
MYLAN-TELMISARTAN
Telmisartan Tablets
40 mg and 80 mg
USP
Angiotensin II AT
1
Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 162814
Date of Revision: May 27, 2013
_ MYLAN-TELMISARTAN Product Monograph _
_Page 2 of 33 _
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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
..........................................................................
18
OVERDOSAGE
................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ....................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.......................................................................................................
25
DETAILED PHARMACOLOGY
..................................