ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Saadav alates:

ACCORD HEALTHCARE INC

ATC kood:

J05AH02

INN (Rahvusvaheline Nimetus):

OSELTAMIVIR

Annus:

75MG

Ravimvorm:

CAPSULE

Koostis:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-04-03

Toote omadused

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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