ACH-OSELTAMIVIR PHOSPHATE CAPSULE
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
31-03-2023
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Fáanlegur frá:
ACCORD HEALTHCARE INC
ATC númer:
J05AH02
INN (Alþjóðlegt nafn):
OSELTAMIVIR
Skammtar:
30MG
Lyfjaform:
CAPSULE
Samsetning:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0139501003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-04-03
Vara einkenni
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
............................................................................................................................
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
..........................................................................
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