AG-OSELTAMIVIR CAPSULE
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
29-08-2023
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Fáanlegur frá:
ANGITA PHARMA INC.
ATC númer:
J05AH02
INN (Alþjóðlegt nafn):
OSELTAMIVIR
Skammtar:
75MG
Lyfjaform:
CAPSULE
Samsetning:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
NEURAMINIDASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0139501001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-01-07
Vara einkenni
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)
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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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