FLUMIST SPRAY

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

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

Beszerezhető a:

ASTRAZENECA CANADA INC

ATC-kód:

J07BB03

INN (nemzetközi neve):

INFLUENZA, LIVE ATTENUATED

Adagolás:

10000000FFU; 10000000FFU; 10000000FFU

Gyógyszerészeti forma:

SPRAY

Összetétel:

INFLUENZA VIRUS TYPE A (H1N1) 10000000FFU; INFLUENZA VIRUS TYPE A (H3N2) 10000000FFU; INFLUENZA VIRUS TYPE B 10000000FFU

Az alkalmazás módja:

NASAL

db csomag:

5X0.2ML SPRAYER

Recept típusa:

Schedule D

Terápiás terület:

VACCINES

Termék összefoglaló:

Active ingredient group (AIG) number: 0352747002; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2015-11-04

Termékjellemzők

COPYRIGHT 2010, 2013, 2014 ASTRAZENECA CANADA INC.
_ _
Page 1 of 25
PRODUCT MONOGRAPH
FLUMIST
®
Influenza Vaccine (live, attenuated)
Intranasal spray
(ATC Code: J07BB03)
AstraZeneca Canada
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Manufactured by MedImmune, LLC
Submission Control Number: 173815
Date of Approval: 30 April 2014
FLUMIST
®
is a registered trademark of MedImmune licensed to AstraZeneca.
COPYRIGHT 2010, 2013, 2014 ASTRAZENECA CANADA INC.
_ _
Page 2 of 25
TABLE OF CONTENTS
PAGE
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
DESCRIPTION
..........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................... 3
CONTRAINDICATIONS..........................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................
4
ADVERSE REACTIONS
..........................................................................................
5
DRUG INTERACTIONS
........................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................
10
OVERDOSAGE
.......................................................................................................
12
ACTION AND CLINICAL
PHARMACOLOGY................................................... 12
STORAGE AND STABILITY
................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 13
PART II: SCIENTIFIC INFORMATION
....................................