Zoonotic Influenza Vaccine Seqirus

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

Saatavilla:

Seqirus S.r.l. 

INN (Kansainvälinen yleisnimi):

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

Influenza A Virus, H5N1 Subtype

Käyttöaiheet:

Active immunisation against H5 subtype of Influenza A virus

Valtuutuksen tilan:

Authorised

Pakkausseloste

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOONOTIC INFLUENZA VACCINE SEQIRUS SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated,
adjuvanted)
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoonotic Influenza Vaccine Seqirus is and what it is used for
2.
What you need to know before you are given Zoonotic Influenza Vaccine
Seqirus
3.
How Zoonotic Influenza Vaccine Seqirus is given
4.
Possible side effects
5.
How to store Zoonotic Influenza Vaccine Seqirus
6.
Contents of the pack and other information
1.
WHAT ZOONOTIC INFLUENZA VACCINE SEQIRUS IS AND WHAT IT IS USED FOR
Zoonotic Influenza Vaccine Seqirus is a vaccine for use in adults from
18 years onwards, intended to
be given in the context of risk of outbreaks of zoonotic influenza
(coming from birds) to prevent flu
caused by H5 subtype influenza A viruses.
Zoonotic influenza viruses occasionally infect humans, and can cause
disease ranging from mild upper
respiratory infection (fever and cough) to rapid progression to severe
pneumonia, acute respiratory
distress syndrome, shock and even death. Human infections are
primarily caused by contact with
infected animals, but do not spread easily between people.
Zoonotic Influenza Vaccine Seqirus is intended also to be given when
there is anticipation of a
possible pandemic due to the same or a similar strain.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection (antibodies) against the disease. None of
the ingredients in the vaccine
can cause flu.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOONOTIC INFLUENZA

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoonotic Influenza Vaccine Seqirus suspension for injection in
pre-filled syringe
Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated,
adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*
of strain:
A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b)
7.5 micrograms**
per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
expressed in micrograms haemagglutinin (HA).
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).
Zoonotic Influenza Vaccine Seqirus may contain trace residues of egg
and chicken proteins,
ovalbumin, kanamycin, neomycin sulphate, formaldehyde,_
_hydrocortisone and
cetyltrimethylammonium bromide 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 (injection).
The vaccine is a milky-white liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active
immunisation against H5 subtype
influenza A viruses in adults 18 years of age and above (see sections
4.4 and 5.1).
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and elderly (18 years of age and above) _
Zoonotic Influenza Vaccine Seqirus H5N8 is administered
intramuscularly as a course of 2 doses of
0.5 ml each.
The second dose should be administered at least 3 weeks after the
first dose.
_Paediatric population _
The safety and efficacy of Zoonotic Influenza Vaccine Seqirus H5N8 in
subjects under 18 years of age
have not yet been established.
Currently available data with Zoonotic influenza vaccine H5N1 in
subjects aged 6 months to below
18 years of age are