ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Kúpte ho teraz

Aktívna zložka:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Dostupné z:

ACCORD HEALTHCARE INC

ATC kód:

J05AH02

INN (Medzinárodný Name):

OSELTAMIVIR

Dávkovanie:

45MG

Forma lieku:

CAPSULE

Zloženie:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 45MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0139501004; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2023-04-03

Súhrn charakteristických

                                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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