OSELTAMIVIR PHOSPHATE CAPSULES

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

متاح من:

STRIDES PHARMA CANADA INC

ATC رمز:

J05AH02

INN (الاسم الدولي):

OSELTAMIVIR

جرعة:

30MG

الشكل الصيدلاني:

CAPSULE

تركيب:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 30MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

250ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

NEURAMINIDASE INHIBITORS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2020-08-24

خصائص المنتج

_Pr_
_Oseltamivir Phosphate Capsules (oseltamivir phosphate)_
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OSELTAMIVIR PHOSPHATE CAPSULES
Capsules, 30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir
phosphate), Oral
USP
Antiviral Agent
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, Quebec
Canada J3X 1P7
Date of Initial Authorization:
AUG 24, 2020
Date of Revision:
MAY 31, 2023
Submission Control Number: 270536
_Pr_
_Oseltamivir Phosphate Capsules (oseltamivir phosphate)_
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
05/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
05/2023
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 Adjustment
.............................................................. 6
4.3
Recon