RAN-FOSINOPRIL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
03-06-2009
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Aktiv bestanddel:
FOSINOPRIL SODIUM
Tilgængelig fra:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kode:
C09AA09
INN (International Name):
FOSINOPRIL
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
FOSINOPRIL SODIUM 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0122777001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2007-05-03
Produktets egenskaber
_ _
_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...................................
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