ACH-OSELTAMIVIR PHOSPHATE CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

제공처:

ACCORD HEALTHCARE INC

ATC 코드:

J05AH02

INN (국제 이름):

OSELTAMIVIR

복용량:

30MG

약제 형태:

CAPSULE

구성:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-04-03

제품 특성 요약

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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