AURO-CEFIXIME POWDER FOR SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CEFIXIME

Pieejams no:

AURO PHARMA INC

ATĶ kods:

J01DD08

SNN (starptautisko nepatentēto nosaukumu):

CEFIXIME

Deva:

100MG

Zāļu forma:

POWDER FOR SUSPENSION

Kompozīcija:

CEFIXIME 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

50ML/100ML

Receptes veids:

Prescription

Ārstniecības joma:

THIRD GENERATION CEPHALOSPORINS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-10-11

Produkta apraksts

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