ACH-OSELTAMIVIR PHOSPHATE CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Disponible desde:

ACCORD HEALTHCARE INC

Código ATC:

J05AH02

Designación común internacional (DCI):

OSELTAMIVIR

Dosis:

75MG

formulario farmacéutico:

CAPSULE

Composición:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2023-04-03

Ficha técnica

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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6
4.3
Reconstitution
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