FOSINOPRIL TABLETS

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

FOSINOPRIL SODIUM

Disponibbli minn:

RANBAXY PHARMACEUTICALS CANADA INC.

Kodiċi ATC:

C09AA09

INN (Isem Internazzjonali):

FOSINOPRIL

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

FOSINOPRIL SODIUM 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

90/1000

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2009-08-24

Karatteristiċi tal-prodott

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