NAT-OSELTAMIVIR CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

から入手可能:

NATCO PHARMA (CANADA) INC

ATCコード:

J05AH02

INN（国際名）:

OSELTAMIVIR

投薬量:

30MG

医薬品形態:

CAPSULE

構図:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

NEURAMINIDASE INHIBITORS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2018-02-05

製品の特徴

PR
_NAT-OSELTAMIVIR (Oseltamivir phosphate) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-OSELTAMIVIR
Oseltamivir Phosphate Capsules
Capsules, 30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir
phosphate), Oral
USP
oseltamivir powder for oral suspension
Powder for Suspension, 6 mg/mL oseltamivir (as oseltamivir phosphate)
when reconstituted, Oral
Antiviral Agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
SEP 23, 2016
Date of Revision:
SEP 19, 2023
Submission Control Number: 274076
_ _
PR
_NAT-OSELTAMIVIR (Oseltamivir phosphate) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
09/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
09/2023
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 Ad