AURO-CEFIXIME POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-11-2020
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Active ingredient:
CEFIXIME
Available from:
AURO PHARMA INC
ATC code:
J01DD08
INN (International Name):
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
Product summary:
Active ingredient group (AIG) number: 0122105001; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-10-11
Summary of Product characteristics
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
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