NTP-TELMISARTAN HCTZ TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TELMISARTAN (TELMISARTAN SODIUM); HYDROCHLOROTHIAZIDE

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

C09DA07

INN (Διεθνής Όνομα):

TELMISARTAN AND DIURETICS

Δοσολογία:

80.0MG; 12.5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TELMISARTAN (TELMISARTAN SODIUM) 80.0MG; HYDROCHLOROTHIAZIDE 12.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2017-06-13

Αρχείο Π.Χ.Π.

_ _
_NTP-TELMISARTAN HCTZ _
_Page 1 of 50_
PRODUCT MONOGRAPH
PR
NTP-TELMISARTAN HCTZ
Telmisartan (as Telmisartan Sodium) and Hydrochlorothiazide Tablets
80 mg/12.5 mg and 80 mg/25 mg
NTP standard
Angiotensin II AT
1
Receptor Blocker/Diuretic
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
September 23, 2013
Submission Control No: 167610
_ _
_NTP-TELMISARTAN HCTZ _
_Page 2 of 50_
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
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
...............................................................