MYLAN-CILAZAPRIL TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Доступно од:

MYLAN PHARMACEUTICALS ULC

АТЦ код:

C09AA08

INN (Међународно име):

CILAZAPRIL

Дозирање:

1MG

Фармацеутски облик:

TABLET

Састав:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 1MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2009-07-10

Карактеристике производа

_ _
_ _
_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
_ _
_ _
_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..........................................