ALEMBIC-TELMISARTAN/HCTZ TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

HYDROCHLOROTHIAZIDE; TELMISARTAN

Beszerezhető a:

ALEMBIC PHARMACEUTICALS LIMITED

ATC-kód:

C09DA07

INN (nemzetközi neve):

TELMISARTAN AND DIURETICS

Adagolás:

12.5MG; 80MG

Gyógyszerészeti forma:

TABLET

Összetétel:

HYDROCHLOROTHIAZIDE 12.5MG; TELMISARTAN 80MG

Az alkalmazás módja:

ORAL

db csomag:

(10X10)/30/1000

Recept típusa:

Prescription

Terápiás terület:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0244783001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2018-08-09

Termékjellemzők

_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 1 of 57 _
_ _
PRODUCT MONOGRAPH
PR
ALEMBIC-TELMISARTAN/HCTZ
Telmisartan and Hydrochlorothiazide Tablets, USP
80 mg/12.5 mg
80 mg/25 mg
(telmisartan/hydrochlorothiazide)
Angiotensin II AT
1
Receptor Blocker/Diuretic
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road,
Vadodara 390003,
Gujarat, India
IMPORTED AND DISTRIBUTED BY:
Alembic Pharmaceuticals Canada Ltd.
225 Gibraltar Road, Unit 5
Vaughan, Ontario
L4H 4P9, Canada
CONTROL NUMBER:
256615
DATE OF PREPARATION:
March 30, 2022
_ _
_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 2 of 57_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................