ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Доступна з:

ACCORD HEALTHCARE INC

Код атс:

J05AH02

ІПН (Міжнародна Ім'я):

OSELTAMIVIR

Дозування:

30MG

Фармацевтична форма:

CAPSULE

Склад:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2023-04-03

Характеристики 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
............................................................................................................................
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
................................................................................................
5
4.1
Dosing Considerations
...............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................................................................
6
4.3
Reconstitution
..........................................................................