ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Sẵn có từ:

ACCORD HEALTHCARE INC

Mã ATC:

J05AH02

INN (Tên quốc tế):

OSELTAMIVIR

Liều dùng:

30MG

Dạng dược phẩm:

CAPSULE

Thành phần:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2023-04-03

Đặc tính sản phẩm

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
....................................................................................
4
1
INDICATIONS
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4
1.1
Pediatrics
...................................................................................................................................
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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