TARO-CEFPROZIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Commercializzato da:

SUN PHARMA CANADA INC

Codice ATC:

J01DC10

INN (Nome Internazionale):

CEFPROZIL

Dosaggio:

500MG

Forma farmaceutica:

TABLET

Composizione:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 500MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

SECOND GENERATION CEPHALOSPORINS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-01-06

Scheda tecnica

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PRODUCT MONOGRAPH
PR
TARO-CEFPROZIL
CEFPROZIL TABLETS
(250 MG AND 500 MG OF CEFPROZIL AS CEFPROZIL MONOHYDRATE)
USP
ANTIBIOTIC
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
September 18, 2020
CONTROL NO: 242660
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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
........................................................................................................
9
DOSAGE AND ADMINISTRATION
..................................................................................
10
OVERDOSAGE
....................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 11
STORAGE AND STABILITY
..............................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL INFORMATION
..............................................................................
13
CLINICAL TRIALS
..............................................................................................................
14
MICROBIOLOGY
....................