ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Disponible depuis:

ACCORD HEALTHCARE INC

Code ATC:

J05AH02

DCI (Dénomination commune internationale):

OSELTAMIVIR

Dosage:

75MG

forme pharmaceutique:

CAPSULE

Composition:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-04-03

Résumé des caractéristiques du produit

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