TEVA-CANDESARTAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CANDESARTAN CILEXETIL

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

C09CA06

INN (Nome Internazionale):

CANDESARTAN

Dosaggio:

8MG

Forma farmaceutica:

TABLET

Composizione:

CANDESARTAN CILEXETIL 8MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-02-10

Scheda tecnica

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
.......................................................