MINT-CEFPROZIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Tilgjengelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

J01DC10

INN (International Name):

CEFPROZIL

Dosering :

500MG

Legemiddelform:

TABLET

Sammensetning:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 500MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

SECOND GENERATION CEPHALOSPORINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0127613002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2012-08-02

Preparatomtale

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_Page 1 of 27_
PRODUCT MONOGRAPH
PR
MINT-CEFPROZIL
CEFPROZIL TABLETS
(250 MG AND 500 MG OF CEFPROZIL AS CEFPROZIL MONOHYDRATE)
USP
ANTIBIOTIC
Mint Pharmaceuticals Canada Inc.
1 First Canadian Place, Suite 5600
100 King Street West
Toronto, Ontario
M5X 1E2
Date of Preparation:
September 29, 2008
CONTROL NO: 124995
_ _
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_Page 2 of 27_
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...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND
ADMINISTRATION...............................................................................
9
OVERDOSAGE
.................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 10
STORAGE AND
STABILITY.........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 11
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL
INFORMATION.........................................................................
13
CLINICAL
TRIALS.........................................................................................................
13
MICROBIOLOGY
............................