פלומיסט קואדריוואלנט

Země: Izrael

Jazyk: hebrejština

Zdroj: Ministry of Health

Aktivní složka:

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

Dostupné s:

ASTRAZENECA (ISRAEL) LTD

ATC kód:

J07BB02

Léková forma:

ספריי לאף

Složení:

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

Podání:

תוך-אפי

Druh předpisu:

מרשם נדרש

Výrobce:

MEDIMMUNE LLC, USA

Terapeutické skupiny:

INFLUENZA, PURIFIED ANTIGEN

Terapeutické oblasti:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Terapeutické indikace:

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.

Datum autorizace:

2018-09-30

Informace pro uživatele

BODY TEXT SIZE
7.0 pt
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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
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 (eac