ACT CANDESARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Boleh didapati daripada:

ACTAVIS PHARMA COMPANY

Kod ATC:

C09CA06

INN (Nama Antarabangsa):

CANDESARTAN

Dos:

16MG

Borang farmaseutikal:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 16MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220003; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-08-13

Ciri produk

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_ACT CANDESARTAN Product Monograph _
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_ Page 1 of 35 _
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PRODUCT MONOGRAPH
Pr
ACT CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
May 3, 2016
Submission Control No: 194118
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_ACT CANDESARTAN Product Monograph _
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_ Page 2 of 35 _
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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
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
............