AURO-CEFPROZIL TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CEFPROZIL

Saadav alates:

AURO PHARMA INC

ATC kood:

J01DC10

INN (Rahvusvaheline Nimetus):

CEFPROZIL

Annus:

250MG

Ravimvorm:

TABLET

Koostis:

CEFPROZIL 250MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

SECOND GENERATION CEPHALOSPORINS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2010-04-09

Toote omadused

Page 1 of 28
PRODUCT MONOGRAPH
PR
AURO-CEFPROZIL
(Cefprozil)
Tablets 250 mg & 500 mg
USP
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision:
September 22, 2020
Submission control No.: 243286
Page 2 of 28
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
..............................................................................
12
CLINICAL TRIALS
..............................................................................................................
13
MICROBIOLOGY
............