FLUMIST QUADRIVALENT SPRAY

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

INFLUENZA VIRUS TYPE A (H1N1); INFLUENZA VIRUS TYPE A (H3N2); INFLUENZA VIRUS TYPE B (VICTORIA); INFLUENZA VIRUS TYPE B (YAMAGATA)

متاح من:

ASTRAZENECA CANADA INC

ATC رمز:

J07BB03

INN (الاسم الدولي):

INFLUENZA, LIVE ATTENUATED

جرعة:

32000000FFU; 32000000FFU; 32000000FFU; 32000000FFU

الشكل الصيدلاني:

SPRAY

تركيب:

INFLUENZA VIRUS TYPE A (H1N1) 32000000FFU; INFLUENZA VIRUS TYPE A (H3N2) 32000000FFU; INFLUENZA VIRUS TYPE B (VICTORIA) 32000000FFU; INFLUENZA VIRUS TYPE B (YAMAGATA) 32000000FFU

طريقة التعاطي:

NASAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Schedule D

المجال العلاجي:

VACCINES

ملخص المنتج:

Active ingredient group (AIG) number: 0455811001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2014-06-20

خصائص المنتج

FLUMIST
®
QUADRIVALENT_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FLUMIST
® QUADRIVALENT
Influenza Vaccine (live, attenuated)
Nasal spray, suspension
Each 0.2 mL dose contains 10
6.5-7.5
fluorescent focus units of Influenza Virus Type A (H1N1),
Type A (H3N2), Type B (Victoria) and Type B (Yamagata) strains
Nasal Use
Active Immunizing Agent
ATC Code: J07BB03
AstraZeneca Canada
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
JUN 20, 2014
Date of Revision:
May 4, 2023
Submission Control Number: 274796
FLUMIST
®
is a registered trademark of MedImmune, LLC, used under license by
AstraZeneca Canada Inc.
© AstraZeneca Canada Inc. 2023
_ _
FLUMIST
®
QUADRIVALENT_ _
_Page 2 of 33_
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
........................................................................................2
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics
................................................................................................................4
1.2
Geriatrics
................................................................................................................4
2
CONTRAINDICATIONS
..................................................................................................4
4
DOSAGE AND ADMINISTRATION
.................................................................................4
4.2
Recommended Dose and Dosage Adjustment
......................................................4
4.4
Administration
...............................