AURO-CEFPROZIL TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

CEFPROZIL

Tillgänglig från:

AURO PHARMA INC

ATC-kod:

J01DC10

INN (International namn):

CEFPROZIL

Dos:

500MG

Läkemedelsform:

TABLET

Sammansättning:

CEFPROZIL 500MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

SECOND GENERATION CEPHALOSPORINS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2010-04-09

Produktens egenskaper

Page 1 of 31
PRODUCT MONOGRAPH
PR
AURO-CEFPROZIL
(Cefprozil)
Cefprozil Tablets, USP
250 mg and 500 mg of cefprozil (as cefprozil monohydrate), Oral
Cefprozil for Oral Suspension, USP
125 mg and 250 mg of cefprozil (as cefprozil monohydrate) per 5 mL,
Oral
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision:
February 22, 2023
Submission control No.: 270128
Page 2 of 31
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
.......................................................................