Zoonotic Influenza Vaccine Seqirus

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

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)

Disponible depuis:

Seqirus S.r.l. 

DCI (Dénomination commune internationale):

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

Groupe thérapeutique:

Vaccines

Domaine thérapeutique:

Influenza A Virus, H5N1 Subtype

indications thérapeutiques:

Active immunisation against H5 subtype of Influenza A virus

Statut de autorisation:

Authorised

Notice patient

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOONOTIC INFLUENZA VACCINE SEQIRUS
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Zoonotic influenza vaccine (H5N1) (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 receive 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 onwards, intended to be
given in the context of outbreaks of zoonotic influenza viruses
(coming from birds) with pandemic
potential to prevent flu caused by viruses similar to the vaccine
strain reported in section 6.
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.
As with all vaccine

Résumé des caractéristiques du produit

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 (H5N1) (surface antigen, inactivated,
adjuvanted).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*
of strain:
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 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:
squalene
9.75 milligrams per 0.5 ml
polysorbate 80
1.175 milligrams per 0.5 ml
sorbitan trioleate
1.175 milligrams per 0.5 ml
sodium citrate
0.66 milligrams per 0.5 ml
citric acid
0.04 milligrams per 0.5 ml
Excipient with known effect:
The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams
of potassium per 0.5 ml dose.
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).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects
from the age of 18 years
onwards following administration of two doses of the vaccine
containing H5N1 subtype strain (see
sections 4.4 and 5.1).
Zoonotic Influenza Vaccine Seqirus should be used in accordance with
official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly (18 years of age and above)_
One dose of 0.5 ml.
3
A second dose of 0.5 ml should be given after an interval of at least
3 weeks.
Zoonotic Influenza Vaccine Seqirus has been evaluated in healthy
adults (18-60 years of age) and
hea