MINT-LISINOPRIL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Mevcut itibaren:

MINT PHARMACEUTICALS INC

ATC kodu:

C09AA03

INN (International Adı):

LISINOPRIL

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

LISINOPRIL (LISINOPRIL DIHYDRATE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0121550001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2012-08-02

Ürün özellikleri

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