ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Mevcut itibaren:

ACCORD HEALTHCARE INC

ATC kodu:

J05AH02

INN (International Adı):

OSELTAMIVIR

Doz:

45MG

Farmasötik formu:

CAPSULE

Kompozisyon:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 45MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Ürün özeti:

Active ingredient group (AIG) number: 0139501004; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2023-04-03

Ürün özellikleri

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