TEVA-CANDESARTAN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CANDESARTAN CILEXETIL

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C09CA06

INN (International Nazwa):

CANDESARTAN

Dawkowanie:

32MG

Forma farmaceutyczna:

TABLET

Skład:

CANDESARTAN CILEXETIL 32MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0135220004; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-02-10

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
TEVA-CANDESARTAN
Candesartan cilexetil Tablets
8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 194121
Date of Revision:
May 2, 2016
2
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
.....................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................. 15
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
............................................................. 22
CLINICAL TRIALS
.............................................................................................
23
DETAILED PHARMACOLOGY
........................................................................
26
TOXICOLOGY
....................................................................................................
26
REFERENCES
.......................................................