Fluad Tetra

Negara: Uni Eropa

Bahasa: Inggris

Sumber: EMA (European Medicines Agency)

Bahan aktif:

A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26)

Tersedia dari:

Seqirus Netherlands B.V.

Kode ATC:

J07BB02

INN (Nama Internasional):

influenza vaccine (surface antigen, inactivated, adjuvanted)

Kelompok Terapi:

Vaccines

Area terapi:

Influenza, Human

Indikasi Terapi:

Prophylaxis of influenza in the elderly (65 years of age and older).Fluad Tetra should be used in accordance with official recommendations.

Ringkasan produk:

Revision: 7

Status otorisasi:

Authorised

Tanggal Otorisasi:

2020-05-20

Selebaran informasi

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUAD TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated, adjuvanted)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluad Tetra is and what it is used for
2.
What you need to know before you receive Fluad Tetra
3.
How Fluad Tetra is given
4.
Possible side effects
5.
How to store Fluad Tetra
6.
Contents of the pack and other information
1.
WHAT FLUAD TETRA IS AND WHAT IT IS USED FOR
Fluad Tetra is a vaccine against flu (influenza).
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection against the influenza virus. None of the
ingredients in the vaccine can
cause flu.
Fluad Tetra is used to prevent flu in adults 50 years of age and
older.
The vaccine targets four strains of influenza virus following the
recommendations by the World
Health Organisation for the 2023/2024 season.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FLUAD TETRA
YOU SHOULD NOT RECEIVE FLUAD TETRA
-
if you are allergic to
•
the active substances or any of the other ingredients of this medicine
(listed in section 6)
•
egg or chicken proteins (such as ovalbumin), kanamycin and neomycin
sulphate, formaldehyde,
cetyltrimethylammonium bromide (CTAB) and hydrocortisone, which are
trace residues from
the manufacturing process.
-
If you have had a severe allergic

Karakteristik produk

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Fluad Tetra, suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase),
inactivated, of the following
strains*:
PER 0.5 ML DOSE
A/Victoria/4897/2022 (H1N1)pdm09-like strain
(
A/Victoria/4897/2022
IVR-238)
15 micrograms HA
**
A/Darwin/9/2021 (H3N2) -like strain
(A/Darwin/6/2021 IVR-227)
15 micrograms HA
**
B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021 BVR-26)
15 micrograms HA
**
B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013 BVR‐1B)
15 micrograms HA
**
*propagated in fertilised hens’ eggs from healthy chicken flocks and
adjuvanted with MF59C.1
**haemagglutinin
Adjuvant MF59C.1 containing per 0.5 ml dose: squalene (9.75 mg),
polysorbate 80 (1.175 mg),
sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric
acid (0.04 mg).
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU
recommendation for the 2023/2024 season.
Fluad Tetra may contain traces of eggs such as ovalbumin or chicken
proteins, kanamycin and
neomycin sulphate, formaldehyde, hydrocortisone,
cetyltrimethylammonium bromide (CTAB) which
are used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe (injection).
Milky-white suspension.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in adults 50 years of age and older.
Fluad Tetra should be used in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One 0.5 ml dose.
_Paediatr