ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Dostupno od:

ACCORD HEALTHCARE INC

ATC koda:

J05AH02

INN (International ime):

OSELTAMIVIR

Doziranje:

30MG

Farmaceutski oblik:

CAPSULE

Sastav:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0139501003; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2023-04-03

Svojstava lijeka

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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