Ixiaro
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-04-2021
Fachinformation
(SPC)
12-04-2021
Öffentlichen Beurteilungsberichts
(PAR)
15-03-2019
Wirkstoff:
Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
Verfügbar ab:
Valneva Austria GmbH
ATC-Code:
J07BA02
INN (Internationale Bezeichnung):
Japanese encephalitis vaccine (inactivated, adsorbed)
Therapiegruppe:
Vaccines
Therapiebereich:
Encephalitis, Japanese; Immunization
Anwendungsgebiete:
Ixiaro is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged two months and older.Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
Produktbesonderheiten:
Revision: 17
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2009-03-31
Gebrauchsinformation
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
IXIARO SUSPENSION FOR INJECTION
Japanese encephalitis vaccine (inactivated, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
THIS VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You and your child may need to read it again.
•
If you have any further questions, ask your doctor.
•
This vaccine has been prescribed for you and/or your child only. Do
not pass it on to others.
•
If you and/or your child get any side effects, talk to your doctor.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What IXIARO is and what it is used for
2. What you need to know before you and/or your child receive IXIARO
3. How IXIARO is given
4. Possible side effects
5. How to store IXIARO
6. Contents of the pack and other information
1.
WHAT IXIARO IS AND WHAT IT IS USED FOR
IXIARO is a vaccine against the Japanese encephalitis virus.
The vaccine causes the body to produce its own protection (antibodies)
against this disease.
IXIARO is used to prevent infection with the Japanese encephalitis
virus (JEV). This virus is mainly found
in Asia and is transmitted to humans by mosquitoes that have bitten an
infected animal (like pigs). Many
infected people develop mild symptoms or no symptoms at all. In people
who develop severe disease, JE
usually starts as a flu-like illness, with fever, chills, tiredness,
headache, nausea, and vomiting. Confusion
and agitation also occur in the early stage of disease.
IXIARO should be given only to adults, adolescents, children and
infants aged 2 months and older travelling
to countries, where JE is endemic or who are at risk through work.
2.
WHAT YOU NEED TO KNOW BEFORE YOU AND/OR YOUR CHILD RECEIVE IXIARO
DO NOT USE
IXIARO:
•
If you and/or your child are allergic (hypersensitive) to the active
substance or any of the other
ingredients of this medicine (listed in section 6).
•
If you and/or your child have deve
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IXIARO suspension for injection
Japanese encephalitis vaccine (inactivated, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) of IXIARO contains:
Japanese encephalitis virus strain SA
14
-14-2 (inactivated)
1,2
6 AU
3
corresponding to a potency of ≤ 460 ng ED50
1
produced in Vero cells
2
adsorbed on aluminium hydroxide, hydrated (approximately 0.25
milligrams Al
3+
)
3
Antigen Units
Excipients with known effect:
This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml
single dosage i.e. essentially
‘potassium-free’ and less than 1 mmol sodium (23 mg) per 0.5 ml
single dosage, that is to say essentially
‘sodium-free’. This product might contain traces of residual
sodium metabisulfite which is below detection
limit.
Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline
composition:
NaCl – 9mg/mL
KH2PO4 – 0.144 mg/mL
Na2HPO4 – 0.795 mg/mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with a white precipitate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IXIARO is indicated for active immunisation against Japanese
encephalitis in adults, adolescents, children
and infants aged 2 months and older.
IXIARO should be considered for use in individuals at risk of exposure
through travel or in the course of
their occupation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
ADULTS (18 TO
≤
65 YEARS OF AGE)
The primary vaccination series consists of two separate doses of 0.5
ml each, according to the following
conventional schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
Rapid schedule
Persons aged 18 to ≤ 65 years can be vaccinated in a rapid schedule
as follows:
3
First dose at Day 0.
Second dose: 7 days after first dose.
With both schedules, primary immunisation should be completed at least
one week prior to potential
exposure to Japanese encephalitis virus (JEV) (see section 4.4).
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