Fluad, Suspension for injection in pre-filled syringeInfluenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59C.1(20

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

A/MICHIGAN/45/2015 (H1N1) PDM09 - LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180A); A/SINGAPORE/IMFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016,NIB-104); B/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE)(B/MARYLAND/15/2016,NYMC BX-69A)

Mevcut itibaren:

Seqirus S.r.l.

ATC kodu:

J07BB; J07BB02

INN (International Adı):

A/MICHIGAN/45/2015 (H1N1) PDM09 - LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180A); A/SINGAPORE/IMFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016,NIB-104); B/COLORADO/06/2017-LIKE STRAIN (B/VICTORIA/2/87 LINEAGE)(B/MARYLAND/15/2016,NYMC BX-69A)

Doz:

0.5 millilitre(s)

Farmasötik formu:

Suspension for injection in pre-filled syringe

Uygulama yolu:

Intramuscular injection

Paketteki üniteler:

Pack of 1 or 10 with or without needle

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik grubu:

Influenza vaccine

Terapötik alanı:

Influenza vaccines; influenza, inactivated, split virus or surface antigen

Terapötik endikasyonlar:

Active immunisation against influenza in the elderly (65 years of age and over. Refer to SPC for detailed information.

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2000-08-18

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUAD 2020/2021, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Influenza vaccine surface antigen, inactivated, adjuvanted with
MF59C.1
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE
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 or pharmacist.
-
This vaccine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fluad is and what it is used for
2.
What you need to know before you use Fluad
3.
How to use Fluad
4.
Possible side effects
5.
How to store Fluad
6.
Contents of the pack and other information
1.
WHAT FLUAD IS AND WHAT IT IS USED FOR
Fluad is a vaccine. This vaccine helps to protect you against
influenza (flu). It is used as active
immunisation in the elderly (of 65 years of age and over),
particularly in people with an increased risk
of associated complications.
Fluad should be used in accordance with the official recommendations.
Through vaccination with Fluad, the immune system (the body’s
natural defence system) is stimulated
to produce its own protection (antibodies) against the illness. None
of the ingredients of this vaccine
can by itself cause flu.
Flu is a disease that can spread rapidly and is caused by different
types of strains that can change
every year. Therefore, this is why you might need to be vaccinated
every year. The greatest risk of
catching flu is during the cold months between October and March. If
you were not vaccinated in the
autumn, it is still sensible to be vaccinated up until the spring
since you run the risk of catching flu
until then. Your doctor will be able to recommend the best time to be
vaccinated.
Fluad will protect you against the three strains of

Ürün özellikleri

Health Products Regulatory Authority
11 August 2020
CRN009T5R
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluad, Suspension for injection in pre-filled syringeInfluenza
Vaccine, Surface Antigen, Inactivated, Adjuvanted with
MF59C.1(2020/2021 SEASON)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase),
of strains*:
A/Guandong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain
(A/Victoria/2454/2019 IVR-207)
15 micrograms HA**
A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019
IVR-208)
15 micrograms HA**
B/Washington/02/2019-like strain (B/Victoria/705/2018 BVR-11)
15 micrograms HA**
*propagated in fertilized hens' eggs from healthy chicken flocks and
adjuvanted with MF59C.1
**haemagglutinin
Adjuvant: MF59C.1 which is an exclusive adjuvant: 9.75 mg squalene,
1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, 0.66
mg sodium citrate, 0.04 mg citric acid, water for injections.
For one dose of 0.5 ml
This vaccine complies with the World Health Organisation
(WHO)recommendations (northern hemisphere) and EU
recommendation for the 2020/2021 season.
Fluad may contain traces of eggs such as ovalbumin or chicken
proteins, kanamycin and neomycin sulphate, formaldehyde,
cetyltrimethylammonium bromide (CTAB) and hydrocortisone, 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.
The vaccine appears as a milky-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation against influenza in the elderly (65 years of age
and over), especially for those with an increased risk of
associated complications.
The use of Fluad should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single 0.5 ml dose should be administered by intramuscular injection
into the deltoid muscle. Due to the presence of the
adjuvant, the injection should be ca