ACH-OSELTAMIVIR PHOSPHATE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-03-2023
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Active ingredient:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
Available from:
ACCORD HEALTHCARE INC
ATC code:
J05AH02
INN (International Name):
OSELTAMIVIR
Dosage:
75MG
Pharmaceutical form:
CAPSULE
Composition:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0139501001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-04-03
Summary of Product characteristics
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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