AURO-CEFIXIME POWDER FOR SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CEFIXIME

から入手可能:

AURO PHARMA INC

ATCコード:

J01DD08

INN（国際名）:

CEFIXIME

投薬量:

100MG

医薬品形態:

POWDER FOR SUSPENSION

構図:

CEFIXIME 100MG

投与経路:

ORAL

パッケージ内のユニット:

50ML/100ML

処方タイプ:

Prescription

治療領域:

THIRD GENERATION CEPHALOSPORINS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2017-10-11

製品の特徴

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