AURO-CEFPROZIL TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CEFPROZIL

Pieejams no:

AURO PHARMA INC

ATĶ kods:

J01DC10

SNN (starptautisko nepatentēto nosaukumu):

CEFPROZIL

Deva:

500MG

Zāļu forma:

TABLET

Kompozīcija:

CEFPROZIL 500MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

SECOND GENERATION CEPHALOSPORINS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-04-09

Produkta apraksts

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