MYLAN-CILAZAPRIL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

C09AA08

INN (Internationale Bezeichnung):

CILAZAPRIL

Dosierung:

1MG

Darreichungsform:

TABLET

Zusammensetzung:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-07-10

Fachinformation

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