ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Commercializzato da:

ACCORD HEALTHCARE INC

Codice ATC:

J05AH02

INN (Nome Internazionale):

OSELTAMIVIR

Dosaggio:

75MG

Forma farmaceutica:

CAPSULE

Composizione:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0139501001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-04-03

Scheda tecnica

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