MYLAN-TELMISARTAN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TELMISARTAN

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

C09CA07

INN (Internationale Bezeichnung):

TELMISARTAN

Dosierung:

40MG

Darreichungsform:

TABLET

Zusammensetzung:

TELMISARTAN 40MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

28/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0138223001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2018-08-15

Fachinformation

_ 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
..................................