ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Boleh didapati daripada:

ACCORD HEALTHCARE INC

Kod ATC:

J05AH02

INN (Nama Antarabangsa):

OSELTAMIVIR

Dos:

75MG

Borang farmaseutikal:

CAPSULE

Komposisi:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2023-04-03

Ciri produk

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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