APO-CEFPROZIL POWDER FOR SUSPENSION

Land: Kanada

Språk: engelska

Källa: Health Canada

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Ladda ner Produktens egenskaper (SPC)
03-06-2020

Aktiva substanser:

CEFPROZIL

Tillgänglig från:

APOTEX INC

ATC-kod:

J01DC10

INN (International namn):

CEFPROZIL

Dos:

125MG

Läkemedelsform:

POWDER FOR SUSPENSION

Sammansättning:

CEFPROZIL 125MG

Administreringssätt:

ORAL

Enheter i paketet:

75ML/100ML

Receptbelagda typ:

Prescription

Terapiområde:

SECOND GENERATION CEPHALOSPORINS

Produktsammanfattning:

Active ingredient group (AIG) number: 0127613001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2007-04-19

Produktens egenskaper

                                Page 1 of 27
PRODUCT MONOGRAPH
PR
APO-CEFPROZIL
Cefprozil for Oral Suspension, USP
125 mg and 250 mg Cefprozil (on anhydrous basis) / 5 mL
Antibiotic
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
June 3, 2020
Toronto, Ontario
M9L 1T9
Control No: 235590
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
.................................................................................................................................
7
DOSAGE AND ADMINISTRATION
.............................................................................................................
8
OVERDOSAGE
................................................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................................
10
STORAGE AND STABILITY
.......................................................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................................................
11
PART II: SCIENTIFIC INFORMATION
.......................................................
                                
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