PMS-CANDESARTAN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CANDESARTAN CILEXETIL

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

C09CA06

INN (International Nazwa):

CANDESARTAN

Dawkowanie:

8MG

Forma farmaceutyczna:

TABLET

Skład:

CANDESARTAN CILEXETIL 8MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0135220002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-08-03

Charakterystyka produktu

_pms-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PMS-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
PHARMASCIENCE INC.
6111 Av. Royalmount, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
JULY 19, 2016
Submission Control No: 195306
_pms-CANDESARTAN Product Monograph_
_Page 2 of 38_
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
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24