MINT-LISINOPRIL TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

C09AA03

INN (Kansainvälinen yleisnimi):

LISINOPRIL

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0121550002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2012-08-02

Valmisteyhteenveto

_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
MINT-LISINOPRIL
lisinopril tablets
5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate
USP
Angiotensin Converting Enzyme Inhibitor
Manufactured for:
Mint Pharmaceuticals Canada Inc.,
1 First Canadian Place, Suite 5600
100 King Street West
Toronto, Ontario
M5X 1E2
Date of Preparation:
September 29, 2008
Submission Control No: 124991
_ _
_ _
_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...........................................................................................