LISINOPRIL TABLETS
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-08-2009
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Aktiv bestanddel:
LISINOPRIL (LISINOPRIL DIHYDRATE)
Tilgængelig fra:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kode:
C09AA03
INN (International Name):
LISINOPRIL
Dosering:
20MG
Lægemiddelform:
TABLET
Sammensætning:
LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0121550002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2009-08-20
Produktets egenskaber
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
LISINOPRIL TABLETS
(LISINOPRIL)
5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate
USP
Angiotensin Converting Enzyme Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd East, Suite 200
Mississauga, Ontario
L4W 0A5
Date of Preparation:
August 17, 2009
Submission Control No: 131981
_ _
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_Page 2 of 41_
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.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND
STABILITY.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.........................................................................................................
26
DETAILED
PHARMACOLOGY
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