MYLAN-TRANDOLAPRIL CAPSULE

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

TRANDOLAPRIL

Доступна с:

MYLAN PHARMACEUTICALS ULC

код АТС:

C09AA10

ИНН (Международная Имя):

TRANDOLAPRIL

дозировка:

0.5MG

Фармацевтическая форма:

CAPSULE

состав:

TRANDOLAPRIL 0.5MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0131524001; AHFS:

Статус Авторизация:

CANCELLED PRE MARKET

Дата Авторизация:

2023-06-19

Характеристики продукта

_Mylan-Trandolapril Product Monograph _
_Page 1 of 43 _
_ _
PRODUCT MONOGRAPH
PR
MYLAN-TRANDOLAPRIL
Trandolapril Capsules
0.5 mg, 1 mg, 2 mg and 4 mg
Manufacturer’s Standard
Angiotensin-Converting Enzyme Inhibitor
_ _
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
January 21, 2020
Etobicoke, Ontario
M8Z 2S6
Submission Control No: 234994
_Mylan-Trandolapril Product Monograph _
_Page 2 of 43 _
_ _
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL INFORMATION
..........................................................................29
CLINICAL TRIALS
......................................................................