LINEZOLID INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LINEZOLID

Предлага се от:

PHARMARIS CANADA INC

АТС код:

J01XX08

INN (Международно Name):

LINEZOLID

дозиране:

2MG

Лекарствена форма:

SOLUTION

Композиция:

LINEZOLID 2MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

600ML

Вид предписание :

Prescription

Терапевтична област:

OXAZOLIDINONES

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2022-07-15

Данни за продукта

_ _
_PR_
_LINEZOLID INJECTION (linezolid) _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LINEZOLID INJECTION
Solution, 2 mg/mL, for intravenous infusion
Antibacterial Agent
Pharmaris Canada Inc.
8310-130 Street, Suite 102
Surrey, British Columbia
Canada, V3W 8J9
Submission Control Number: 260665
Date of Initial Authorization:
July 6, 2022
_ _
_PR_
_LINEZOLID INJECTION (linezolid) _
_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.2 Breastfeeding
07/2022
7 Warning and Precautions, Renal
07/2022
_ _
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..............................................................................................................4
1.2
Geriatrics
..............................................................................................................4
2
CONTRAINDICATIONS
......................................................................................................5
4
DOSAGE AND
ADMINISTRATION........................................................................................5
4.1
Dosing
considerations.............................................................................................5
4.2
Recommended Dose and Dosage Adjustment
............................................................6
4.3
Reconstitution
.......................................................................................................6
4.4
Adminis