TARO-CEFPROZIL TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Dostupné s:

SUN PHARMA CANADA INC

ATC kód:

J01DC10

INN (Mezinárodní Name):

CEFPROZIL

Dávkování:

250MG

Léková forma:

TABLET

Složení:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

SECOND GENERATION CEPHALOSPORINS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2020-01-06

Charakteristika produktu

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