FOSINOPRIL TABLETS

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FOSINOPRIL SODIUM

Dostępny od:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

C09AA09

INN (International Nazwa):

FOSINOPRIL

Dawkowanie:

20MG

Forma farmaceutyczna:

TABLET

Skład:

FOSINOPRIL SODIUM 20MG

Droga podania:

ORAL

Sztuk w opakowaniu:

90/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0122777002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-08-24

Charakterystyka produktu

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_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
FOSINOPRIL Tablets
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 Preparation:
August 20, 2009
Submission Control No: 132105
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_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND
STABILITY.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL
INFORMATION.........................................................................
21
CLINICAL
TRIALS.........................................................................................................
21
DETAILED
PHARMACOLOGY...........................