AG-OSELTAMIVIR CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
29-08-2023
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ingredients actius:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Disponible des:
ANGITA PHARMA 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
Área terapéutica:
NEURAMINIDASE INHIBITORS
Resumen del producto:
Active ingredient group (AIG) number: 0139501001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2021-01-07
Fitxa tècnica
AG-Oseltamivir (oseltamivir phosphate)
Page1 of43
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AG-Oseltamivir
Oseltamivir PhosphateCapsules
Capsule, 30 mg,45mgand75 mg oseltamivir (asoseltamivir phosphate),oral
USP
Antiviral Agent
Angita Pharma Inc.
1310 rueNobel
Boucherville,Quebec
J4B 5H3,Canada
SubmissionControl Number: 277564
Dateofinitial Authorization:
JAN 07,2021
DateofRevision:
AUG29,2023
AG-Oseltamivir (oseltamivir phosphate)
Page2 of43
RECENT MAJORLABELCHANGES
4Dosage and Administration
08/2023
7Warnings and Precautions,7.1.1 PregnantWomen
08/2023
TABLE OF CONTENTS
Sections or subsections that arenot applicable at thetimeof
authorization arenot
listed.
RECENT
MAJORLABELCHANGES....................................................................................
2
TABLE OF
CONTENTS......................................................................................................
2
PART I:HEALTH
PROFESSIONALINFORMATION..............................................................
4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
...........................................................................................................5
1.2
Geriatrics............................................................................................................5
2
CONTRAINDICATIONS
.........................................................................................
5
4
DOSAGE AND
ADMINISTRATION.........................................................................
5
4.1
DosingConsiderations
.......................................................................................5
4.2
RecommendedDose and
DosageAdjustment..................................................6
4.4
Administration
.................................................................................................11
4.5
Missed
Dose.....................................................................................................
1
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