MYLAN-TELMISARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TELMISARTAN

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

C09CA07

INN (Medzinárodný Name):

TELMISARTAN

Dávkovanie:

40MG

Forma lieku:

TABLET

Zloženie:

TELMISARTAN 40MG

Spôsob podávania:

ORAL

Počet v balení:

28/100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-08-15

Súhrn charakteristických

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