MINT-CEFPROZIL TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Доступно од:

MINT PHARMACEUTICALS INC

АТЦ код:

J01DC10

INN (Међународно име):

CEFPROZIL

Дозирање:

500MG

Фармацеутски облик:

TABLET

Састав:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 500MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

SECOND GENERATION CEPHALOSPORINS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2012-08-02

Карактеристике производа

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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
............................