Foclivia

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)

Saatavilla:

Seqirus S.r.l. 

ATC-koodi:

J07BB02

INN (Kansainvälinen yleisnimi):

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

Terapeuttinen ryhmä:

Influenza vaccines

Terapeuttinen alue:

Influenza, Human; Immunization; Disease Outbreaks

Käyttöaiheet:

Prophylaxis of influenza in an officially declared pandemic situation.Pandemic influenza vaccine should be used in accordance with official guidance.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-10-18

Pakkausseloste

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOCLIVIA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Pandemic 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 Foclivia is and what it is used for
2.
What you need to know before you receive Foclivia
3.
How Foclivia is given
4.
Possible side effects
5.
How to store Foclivia
6.
Contents of the pack and other information
1.
WHAT FOCLIVIA IS AND WHAT IT IS USED FOR
Foclivia is a vaccine intended to be given to prevent influenza (flu)
in an officially declared pandemic.
Pandemic flu is a type of influenza that happens at intervals that
vary from less than 10 years to many
decades. It spreads rapidly around the world. The signs of pandemic
flu are similar to those of
ordinary flu but may be more serious.
It is for use in to prevent flu caused by the H5N1 type of the virus.
When a person is given the vaccine, the body’s natural defence
system (immune system) produces its
own protection (antibodies) against the disease. None of the
ingredients in the vaccine can cause flu.
As with all vaccines, Foclivia may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FOCLIVIA
FOCLIVIA SHOULD NOT BE GIVEN IF YOU:
-
have experienced serious allergic reaction (i.e. life-threatening) to
any of the constituents of Foclivia,
-
are allergic (hypersensitive) to influenza vaccines or any of the
ingredients of Foclivia,
-
are allergic to eggs, chicken protein, ovalbumin,
-
are allergic to kanamycin sulphate and neomycin sulphate
(antibiotics), formaldehyde,
hydrocortisone, cetyltrimethylammonium bromide (

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Foclivia suspension for injection in pre-filled syringe
Pandemic influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*
of strain:
A/Vietnam/1194/2004 (H5N1)
7.5 micrograms**
per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
expressed in micrograms haemagglutinin.
Adjuvant MF59C.1 containing:
Squalene
9.75 milligrams
Polysorbate 80
1.175 milligrams
Sorbitan trioleate
1.175 milligrams
Sodium citrate
0.66 milligrams
Citric acid
0.04 milligrams
This vaccine complies with the WHO recommendations and EU decision for
the pandemic.
Foclivia may contain trace residues of egg and chicken proteins,
ovalbumin, kanamycin sulphate,
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
Prophylaxis of influenza in an officially declared pandemic situation.
Foclivia should be used in accordance with Official Guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals 6 months of age and older: administer two doses (0.5 ml
each), 21 days apart.
Data on a third dose (booster) administered 6 months after the first
dose are limited
(see sections 4.8 and 5.1).
Paediatric population
3
No data are available in children aged less than 6 months.
Method of administration
The vaccine is administered by intramuscular injection, preferably in
the anterolateral aspect of the
thigh in infants or in the deltoid muscle region of the upper arm in
older individuals.
4.3
CONTRAINDICATIONS
History of an anaphylactic (i.e. life-threatening) reaction to any of
the constituents or trace residues
(eggs, chicken protein