CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Доступна с:

SANDOZ CANADA INCORPORATED

код АТС:

J01DD04

ИНН (Международная Имя):

CEFTRIAXONE

дозировка:

250MG

Фармацевтическая форма:

POWDER FOR SOLUTION

состав:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG

Администрация маршрут:

INTRAMUSCULAR

Штук в упаковке:

1ML(IM)-2.5ML(IV)

Тип рецепта:

Prescription

Терапевтические области:

THIRD GENERATION CEPHALOSPORINS

Обзор продуктов:

Active ingredient group (AIG) number: 0117292001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2018-03-15

Характеристики продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CEFTRIAXONE SODIUM FOR INJECTION BP
Sterile Powder for Solution, 250 mg, 1 g, 2 g and 10 g ceftriaxone per
vial
Intravenous or Intramuscular
BP
Antibiotic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
August 17, 2006
Date of Revision:
January 6, 2022
Submission Control Number: 255080
Ceftriaxone Sodium for Injection BP
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1
INDICATIONS.....................................................................................................................
4
1.1
P
EDIATRICS
.........................................................................................................................
5
1.2
G
ERIATRICS
.........................................................................................................................
5
2
CONTRAINDICATIONS
........................................................................................................
5
4
DOSAGE AND
ADMINISTRATION..........................................................................................
5
4.1
D
OSING
C
ONSIDERATI ONS
.......................................................................................................
5
4.2
R
ECOMMENDED
D
OSE AND
D
OSAGE
A
DJUSTMENT
...........................................................................
6
4.3
R
ECONSTI TUTI ON
..................................................................................................................
7
4.4
A
DMINISTRATION
.....................................................................................