APO-CANDESARTAN TABLET
Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
Karakteristik produk
(SPC)
29-01-2019
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Bahan aktif:
CANDESARTAN CILEXETIL
Tersedia dari:
APOTEX INC
Kode ATC:
C09CA06
INN (Nama Internasional):
CANDESARTAN
Dosis:
4MG
Bentuk farmasi:
TABLET
Komposisi:
CANDESARTAN CILEXETIL 4MG
Rute administrasi :
ORAL
Unit dalam paket:
10/100
Jenis Resep:
Prescription
Area terapi:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Ringkasan produk:
Active ingredient group (AIG) number: 0135220001; AHFS:
Status otorisasi:
APPROVED
Tanggal Otorisasi:
2011-04-26
Karakteristik produk
_APO-CANDESARTAN Tablets Product Monograph_
Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-CANDESARTAN
CANDESARTAN CILEXETIL TABLETS USP
4 MG, 8 MG, 16 MG AND 32 MG
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JANUARY 29, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 222632
_APO-CANDESARTAN Tablets Product Monograph_
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
_SUMMARY PRODUCT INFORMATION
.................................................................................................
3_
_INDICATIONS AND CLINICAL USE
.......................................................................................................
3_
_CONTRAINDICATIONS
...........................................................................................................................
3_
_WARNINGS AND
PRECAUTIONS..........................................................................................................
4_
_ADVERSE REACTIONS
..........................................................................................................................
7_
_DRUG INTERACTIONS
.........................................................................................................................
13_
_DOSAGE AND ADMINISTRATION
.......................................................................................................
16_
_OVERDOSAGE
.....................................................................................................................................
18_
_ACTION AND CLINICAL PHARMACOLOGY
........................................................................................
18_
_STORAGE AND STABILITY
..................................................................................................................
21_
_DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................................
21_
PART II: SCIENTIFIC INFORMATION
..................
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