ACH-OSELTAMIVIR PHOSPHATE CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
31-03-2023
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ingredients actius:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Disponible des:
ACCORD HEALTHCARE INC
Codi ATC:
J05AH02
Designació comuna 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:
Estat d'Autorització:
APPROVED
Data d'autorització:
2023-04-03
Fitxa tècnica
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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