FOSINOPRIL TABLETS

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FOSINOPRIL SODIUM

Dostopno od:

RANBAXY PHARMACEUTICALS CANADA INC.

Koda artikla:

C09AA09

INN (mednarodno ime):

FOSINOPRIL

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

FOSINOPRIL SODIUM 10MG

Pot uporabe:

ORAL

Enote v paketu:

90/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2009-08-24

Lastnosti izdelka

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