ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Предлага се от:

ACCORD HEALTHCARE INC

АТС код:

J05AH02

INN (Международно Name):

OSELTAMIVIR

дозиране:

30MG

Лекарствена форма:

CAPSULE

Композиция:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0139501003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-04-03

Данни за продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate Capsules
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
USP
Antiviral Agent
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
March 31, 2023
Submission Control Number: 247245
ACH-OSELTAMIVIR PHOSPHATE (oseltamivir phosphate)
Page 2 of 41
RECENT MAJOR LABEL CHANGES
Not applicable
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
..............................................................................................................................
4
1.1
Pediatrics
...................................................................................................................................
5
1.2
Geriatrics
...................................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................................
5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
...............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................................................................
6
4.3
Reconstitution
..........................................................................