NRA-TELMISARTAN HCTZ TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Inapatikana kutoka:

NORA PHARMA INC

ATC kanuni:

C09DA07

INN (Jina la Kimataifa):

TELMISARTAN AND DIURETICS

Kipimo:

80MG; 12.5MG

Dawa fomu:

TABLET

Tungo:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-08-25

Tabia za bidhaa

_NRA-Telmisartan - Product Monograph _
_1 of 31 _
PRODUCT MONOGRAPH
PR
NRA-TELMISARTAN
Telmisartan Tablets
40 mg and 80 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Québec
J3X 1P7 Canada
SUBMISSION CONTROL NO.:
266032
Date of
Revision:
August 9, 2022
_NRA-Telmisartan - Product Monograph _
_2 of 31 _
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
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
..............