MYLAN-TELMISARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

TELMISARTAN

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C09CA07

INN (Nama Antarabangsa):

TELMISARTAN

Dos:

80MG

Borang farmaseutikal:

TABLET

Komposisi:

TELMISARTAN 80MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

28/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-08-15

Ciri 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
..................................