FLUMIST QUADRIVALENT

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

A/DARWIN/9/2021 (H3N2)-LIKE VIRUS; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS; B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS

MAH:

ASTRAZENECA (ISRAEL) LTD

ATC_code:

J07BB02

pharmaceutical_form:

NASAL SPRAY, SUSPENSION

composition:

B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; A/DARWIN/9/2021 (H3N2)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS 7 ±0.5 LOG10 FFU^A / 0.2 ML

administration_route:

INTRANASAL

prescription_type:

Required

manufactured_by:

MEDIMMUNE LLC, USA

therapeutic_group:

INFLUENZA, PURIFIED ANTIGEN

therapeutic_area:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

therapeutic_indication:

FluMist quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses ad type B viruses contained in the vaccine. FluMist Quadrivalent is approved for use in persons 2 through 49 years of age.

authorization_date:

2018-09-30

PIL

BODY TEXT SIZE
7.0 pt
SMALLEST TEXT SIZE
7.0 pt
Profile
Technical Info
N/A
7003400
MGI-22x20-4pc-v1
7003400
04-04-2023
108485405/403240037 0113
FLUMIST Leaflet combined 0.2ML-1X10 IL
SGK is a Matthews International Corporation
Black
FLUMIST
®
QUADRIVALENT
11.2
Nursing Mothers
Risk Summary
FluMist is not absorbed systemically by the mother following
intranasal administration and breastfeeding is not expected to result
in exposure of the child to FluMist.
11.3
Pediatric Use
Safety and effectiveness of FluMist Quadrivalent in children 24 months
of age and older is based on data from FluMist clinical
studies and a comparison of post-vaccination antibody titers between
persons who received FluMist Quadrivalent and those who
received FluMist [see _Clinical Studies (15.2 ,15.1)_]. FluMist
Quadrivalent is not approved for use in children younger than 24
months
of age because use of FluMist in children 6 through 23 months has been
associated with increased risks of hospitalization and
wheezing in clinical trials [see _Warnings and Precautions (8)_ and
_Adverse Reactions (9)_].
11.4
Geriatric Use
FluMist Quadrivalent is not approved for use in persons 65 years of
age and older because in a clinical study (AV009), effectiveness
of FluMist to prevent febrile illness was not demonstrated in adults
50 through 64 years of age [see _Clinical Studies (15.3)_]. In this
study, solicited events among individuals 50 through 64 years of age
were similar in type and frequency to those reported in younger
adults. In a clinical study of FluMist in persons 65 years of age and
older, subjects with underlying high-risk medical conditions
(N = 200) were studied for safety. Compared to controls, FluMist
recipients had a higher rate of sore throat.
12.
DESCRIPTION
FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is a live
quadrivalent vaccine for administration by intranasal spray. FluMist
Quadrivalent contains four vaccine virus strains: an A/H1N1 strain, an
A/H3N2 strain and two B strains. FluMist Quadrivalent
contains B strains fr

SPC

PRESCRIBING INFORMATION
_ _
1.
NAME OF THE MEDICINAL PRODUCT
FLUMIST
® QUADRIVALENT
INTRANASAL SPRAY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled refrigerated FluMist Quadrivalent sprayer contains a
single 0.2 mL dose. Each 0.2 mL
dose contains 10
7.0±0.5
FFU (fluorescent focus units) of live attenuated influenza virus
reassortants of
each of the four strains:
A/Victoria/4897/2022 (H1N1)pdm09 - like strain (A/Norway/31694/2022)
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021)
B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021)
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013)
3. PHARMACEUTICAL FORM
NASAL SPRAY
4. THERAPEUTIC INDICATIONS
FluMist
®
Quadrivalent is a vaccine indicated for active immunization for the
prevention of influenza
disease caused by influenza A subtype viruses and type B viruses
contained in the vaccine [see
_Description (12)_].
FluMist Quadrivalent is approved for use in persons 2 through 49 years
of age.
5
.
DOSAGE AND ADMINISTRATION
FOR INTRANASAL ADMINISTRATION BY A HEALTHCARE PROVIDER.
5.1
DOSING INFORMATION
Administer FluMist Quadrivalent according to the following schedule:
AGE
DOSE
SCHEDULE
2 years through 8 years
1 or 2 doses
a
,
0.2 mL
b
each
If 2 doses, administer at least
1 month apart
9 years through 49 years
1 dose, 0.2 mL
b
-
“-” indicates information is not applicable
a
1 or 2 doses depends on vaccination history as per Advisory Committee
on Immunization Practices annual
recommendations on prevention and control of influenza with vaccines.
b
Administer as 0.1 mL per nostril.
5.2
ADMINISTRATION INSTRUCTIONS
Each sprayer contains a single dose (0.2 mL) of FluMist Quadrivalent;
administer approximately one half
of the contents of the single-dose intranasal sprayer into each
nostril (each sprayer contains 0.2 mL of
vaccine). Refer to Figure 1 for step-by-step administration
instructions. Following administration, dispose
of the sprayer according to the standard procedures for medical waste
(e.g., sharps container or
biohazard containe