AURO-CEFIXIME POWDER FOR SUSPENSION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-11-2020
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Aktiva substanser:
CEFIXIME
Tillgänglig från:
AURO PHARMA INC
ATC-kod:
J01DD08
INN (International namn):
CEFIXIME
Dos:
100MG
Läkemedelsform:
POWDER FOR SUSPENSION
Sammansättning:
CEFIXIME 100MG
Administreringssätt:
ORAL
Enheter i paketet:
50ML/100ML
Receptbelagda typ:
Prescription
Terapiområde:
THIRD GENERATION CEPHALOSPORINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0122105001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2017-10-11
Produktens egenskaper
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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