LINEZOLID INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LINEZOLID

Предлага се от:

AURO PHARMA INC

АТС код:

J01XX08

INN (Международно Name):

LINEZOLID

дозиране:

600MG

Лекарствена форма:

SOLUTION

Композиция:

LINEZOLID 600MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

300ML

Вид предписание :

Prescription

Терапевтична област:

OXAZOLIDINONES

Каталог на резюме:

Active ingredient group (AIG) number: 0143501003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2017-10-26

Данни за продукта

LINEZOLID INJECTION PRODUCT MONOGRAPH
PAGE 1 OF 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LINEZOLID INJECTION
Solution, 2 mg / mL, for intravenous infusion
Antibacterial Agent
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
April 2, 2001
Date of Revision:
January 16, 2023
Submission Control Number: 267159
LINEZOLID INJECTION PRODUCT MONOGRAPH
PAGE 2 OF 44
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.2 Breastfeeding
01/2023
7 Warning and Precautions, 7.1.5
Patients with Phenylketonuria
01/2023
7 Warning and Precautions, Renal
01/2023
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
01/2023
4 Dosage and Administration, 4.1 Dosing Considerations
01/2023
7 Warnings and Precautions, Hematologic/Hepatic/Renal
01/2023
7 Warnings and Precautions, Monitoring and Laboratory Tests
01/2023
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS ...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4
1 INDICATIONS
........................................................................................................................
4
1.1 Pediatrics
..................................................................................................................
5
1.2 Geriatrics
..................................................................................................................
5
2 CONTRAINDICATIONS ..........................................................................................................
5
4 DOSAGE AND ADMINISTRATION ........................................