MAR-OSELTAMIVIR CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

متاح من:

MARCAN PHARMACEUTICALS 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:

2020-03-18

خصائص المنتج

_MAR-OSELTAMIVIR_
_ _
_(Oseltamivir phosphate capsules) _
_Page 1 of 38 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-OSELTAMIVIR
Oseltamivir Phosphate Capsules
Capsules, 30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir
phosphate), Oral
USP
Antiviral Agent
Marcan Pharmaceuticals Inc.
2 Gurdwara Rd, Suite
112 Ottawa, Ontario
K2E 1A2
Date of Initial Authorization:
March 18, 2020
Date of Revision:
May 19, 2023
Submission Control Number: 270701
_MAR-OSELTAMIVIR_
_ _
_(Oseltamivir phosphate capsules) _
_ _
_Page 2 of 38 _
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
........................................................ 5
4.3
Reconstitution
..............................................