MYLAN-CILAZAPRIL TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

C09AA08

INN (Kansainvälinen yleisnimi):

CILAZAPRIL

Annos:

1MG

Lääkemuoto:

TABLET

Koostumus:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2009-07-10

Valmisteyhteenveto

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