AURO-CEFIXIME POWDER FOR SUSPENSION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFIXIME

Доступно од:

AURO PHARMA INC

АТЦ код:

J01DD08

INN (Међународно име):

CEFIXIME

Дозирање:

100MG

Фармацеутски облик:

POWDER FOR SUSPENSION

Састав:

CEFIXIME 100MG

Пут администрације:

ORAL

Јединице у пакету:

50ML/100ML

Тип рецептора:

Prescription

Терапеутска област:

THIRD GENERATION CEPHALOSPORINS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2017-10-11

Карактеристике производа

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