MYLAN-CILAZAPRIL TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C09AA08

INN (Nama Antarabangsa):

CILAZAPRIL

Dos:

1MG

Borang farmaseutikal:

TABLET

Komposisi:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0122806001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2009-07-10

Ciri produk

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_Page 1_
PRODUCT MONOGRAPH
PR MYLAN-CILAZAPRIL
Cilazapril
Monohydrate Tablets
1 mg, 2.5 mg, 5 mg
Angiotensin Converting Enzyme Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission
Control No.: 257402
Date of Revision:
November 16, 2021
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_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE
REACTIONS............................................................................................12
DRUG INTERACTIONS
............................................................................................19
DOSAGE AND ADMINISTRATION
.........................................................................23
OVERDOSAGE
.........................................................................................................26
ACTION AND CLINICAL
PHARMACOLOGY.........................................................27
STORAGE AND STABILITY
....................................................................................30
SPECIAL HANDLING INSTRUCTIONS
...................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................30
PART II: SCIENTIFIC INFORMATION
..........................................................................
32
PHARMACEUTICAL INFORMATION
.....................................................................32
CLINICAL TRIALS
...................................................................................................33
DETAILED
PHARMACOLOGY..........................................