RAN-FOSINOPRIL TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FOSINOPRIL SODIUM

Предлага се от:

RANBAXY PHARMACEUTICALS CANADA INC.

АТС код:

C09AA09

INN (Международно Name):

FOSINOPRIL

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

FOSINOPRIL SODIUM 10MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0122777001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2007-05-03

Данни за продукта

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_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
RAN-FOSINOPRIL
Fosinopril Sodium Tablets USP
10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
Date of Revision:
April 27, 2009
Submission Control No: 127034
_ _
_ _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND
STABILITY.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL
INFORMATION.........................................................................
21
CLINICAL
TRIALS.........................................................................................................
21
DETAILED
PHARMACOLOGY...................................