AURO-CEFIXIME POWDER FOR SUSPENSION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CEFIXIME

MAH:

AURO PHARMA INC

ATC_code:

J01DD08

INN:

CEFIXIME

dosage:

100MG

pharmaceutical_form:

POWDER FOR SUSPENSION

composition:

CEFIXIME 100MG

administration_route:

ORAL

units_in_package:

50ML/100ML

prescription_type:

Prescription

therapeutic_area:

THIRD GENERATION CEPHALOSPORINS

leaflet_short:

Active ingredient group (AIG) number: 0122105001; AHFS:

authorization_status:

APPROVED

authorization_date:

2017-10-11

SPC

Page 1 of 33
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CEFIXIME
CEFIXIME FOR ORAL SUSPENSION, HOUSE STANDARD
100 MG / 5 ML, WHEN RECONSTITUTED
(as cefixime trihydrate)
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision
:
November 5, 2020.
Submission Control No: 239750
Page 2 of 33
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
............................................................................................................8
DRUG INTERACTIONS
..........................................................................................................10
DOSAGE AND ADMINISTRATION
......................................................................................11
OVERDOSAGE
.........................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................13
STORAGE AND STABILITY
..................................................................................................15
SPECIAL HANDLING INSTRUCTIONS
................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATI