MYLAN-CILAZAPRIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

C09AA08

DCI (Dénomination commune internationale):

CILAZAPRIL

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-07-10

Résumé des caractéristiques du produit

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