APO-CEFPROZIL TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Lataa Valmisteyhteenveto (SPC)
03-06-2020

Aktiivinen ainesosa:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Saatavilla:

APOTEX INC

ATC-koodi:

J01DC10

INN (Kansainvälinen yleisnimi):

CEFPROZIL

Annos:

250MG

Lääkemuoto:

TABLET

Koostumus:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SECOND GENERATION CEPHALOSPORINS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0127613003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2007-03-09

Valmisteyhteenveto

                                Page 1 of 27
PRODUCT MONOGRAPH
PR
APO-CEFPROZIL
Cefprozil Tablets
(cefprozil as cefprozil monohydrate)
250 mg and 500 mg cefprozil (on anhydrous basis)
USP
Antibiotic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
DATE OF REVISION:
M9L 1T9
June 3, 2020
_Control Number: _235587
_ _
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
.........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................
8
OVERDOSAGE
........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL TRIALS
...............................................................................................................
13
MIC
                                
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