NRA-TELMISARTAN HCTZ TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Disponibil de la:

NORA PHARMA INC

Codul ATC:

C09DA07

INN (nume internaţional):

TELMISARTAN AND DIURETICS

Dozare:

80MG; 12.5MG

Forma farmaceutică:

TABLET

Compoziție:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-08-25

Caracteristicilor produsului

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