ACH-OSELTAMIVIR PHOSPHATE CAPSULE
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
31-03-2023
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有效成分:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)
可用日期:
ACCORD HEALTHCARE INC
ATC代码:
J05AH02
INN（国际名称）:
OSELTAMIVIR
剂量:
75MG
药物剂型:
CAPSULE
组成:
OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG
给药途径:
ORAL
每包单位数:
100
处方类型:
Prescription
產品總結:
Active ingredient group (AIG) number: 0139501001; AHFS:
授权状态:
APPROVED
授权日期:
2023-04-03
产品特点
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
..............................................................................................................................
4
1.1
Pediatrics
...................................................................................................................................
5
1.2
Geriatrics
...................................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................................
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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