ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Доступно од:

ACCORD HEALTHCARE INC

АТЦ код:

J05AH02

INN (Међународно име):

OSELTAMIVIR

Дозирање:

30MG

Фармацеутски облик:

CAPSULE

Састав:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2023-04-03

Карактеристике производа

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
..........................................................................