AURO-CEFIXIME POWDER FOR SUSPENSION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CEFIXIME

Доступна з:

AURO PHARMA INC

Код атс:

J01DD08

ІПН (Міжнародна Ім'я):

CEFIXIME

Дозування:

100MG

Фармацевтична форма:

POWDER FOR SUSPENSION

Склад:

CEFIXIME 100MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

50ML/100ML

Тип рецепту:

Prescription

Терапевтична области:

THIRD GENERATION CEPHALOSPORINS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2017-10-11

Характеристики продукта

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