TEVA-CANDESARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

C09CA06

INN (Nama Internasional):

CANDESARTAN

Dosis:

8MG

Bentuk farmasi:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 8MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-02-10

Karakteristik produk

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