LINEZOLID INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LINEZOLID

Предлага се от:

JAMP PHARMA CORPORATION

АТС код:

J01XX08

INN (Международно Name):

LINEZOLID

дозиране:

2MG

Лекарствена форма:

SOLUTION

Композиция:

LINEZOLID 2MG

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:

2018-09-28

Данни за продукта

_Linezolid Injection Product Monograph _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LINEZOLID INJECTION
Linezolid
Solution, 2 mg/mL, for intravenous infusion
Antibacterial Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
September 28, 2018
Date of Revision:
January 4, 2023
Submission Control No: 266289
_Linezolid Injection Product Monograph _
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_Page_
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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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATIO