Aflunov
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
03-10-2022
Vara einkenni
(SPC)
03-10-2022
Opinber matsskýrsla
(PAR)
05-08-2019
Virkt innihaldsefni:
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)
Fáanlegur frá:
Seqirus S.r.l.
ATC númer:
J07BB02
INN (Alþjóðlegt nafn):
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Meðferðarhópur:
Vaccines
Lækningarsvæði:
Influenza, Human; Immunization; Disease Outbreaks
Ábendingar:
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 A/turkey/Turkey/1/05 (H5N1)-like strain.Aflunov should be used in accordance with official recommendations.
Vörulýsing:
Revision: 15
Leyfisstaða:
Authorised
Leyfisdagur:
2010-11-28
Upplýsingar fylgiseðill
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
AFLUNOV 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 AFLUNOV is and what it is used for
2.
What you need to know before you receive AFLUNOV
3.
How AFLUNOV is given
4.
Possible side effects
5.
How to store AFLUNOV
6.
Contents of the pack and other information
1.
WHAT AFLUNOV IS AND WHAT IT IS USED FOR
AFLUNOV 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 H5N1 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.
AFLUNOV 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 vaccines, AFLUNOV may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE AFLUNOV
YOU SHOULD NOT RECEIVE AFLUNOV:
•
if you have previously had a sudden life-threatening aller
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AFLUNOV 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 microgram haemagglutinin.
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.
AFLUNOV 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 in pre-filled syringe.
Milky-white liquid.
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
A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
AFLUNOV 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 at an elected date.
A second dose of 0.5 ml should be given after an interval of at least
3 weeks.
3
AFLUNOV has been evaluated in healthy adults (18-60 years of age) and
healthy elderly
(over 60 years of age) followin
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