IXIARO Suspension for Injection 0.5ml in pre-filled syringe

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

JAPANESE ENCEPHALITIS VIRUS STRAIN SA₁₄-14-2 (INACTIVATED)

Verfügbar ab:

AENON PHARMACEUTICALS SEA PTE. LTD.

ATC-Code:

J07BA02

Dosierung:

6 μg/0.5 mL

Darreichungsform:

INJECTION, SUSPENSION

Zusammensetzung:

JAPANESE ENCEPHALITIS VIRUS STRAIN SA₁₄-14-2 (INACTIVATED) 6 μg/0.5 mL

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

Prescription Only

Hergestellt von:

Valneva Scotland Ltd.

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2012-02-16

Gebrauchsinformation

aged 2 months to < 3 years is a total of 2 injections
of 0.25 ml each:
•
The first injection on Day 0
•
The second injection 28 days after the first injection
(Day 28).
For instruction on the preparation of the 0.25 ml dose,
please refer to the end of this package leaflet.
Make sure you and/or your child finish the complete
vaccination course of 2 injections. The second injection
should be given at least 1 week before you and/or your
child will be at risk of exposure to JE virus. If not, you
and/or your child may not be fully protected against
the disease.
For adults, adolescents, children and infants aged
1 year and older a booster dose can be given within
the second year (i.e. 12 - 24 months) after the first dose
of the recommended primary immunization. In adults,
a second booster can be given 10 years after the first
booster. For elderly persons (≥65 years) the first booster
dose may be given earlier. Your doctor will decide on
the requirement and timing for booster doses.
ADMINISTRATION
IXIARO is injected into your or your child’s upper arm
muscle (deltoid muscle) by your doctor or a nurse. It
must not be injected into a blood vessel. In case you
and/or your child suffer from a bleeding disorder, your
doctor may decide to administer the vaccine under the
skin (subcutaneously).
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
IF YOU FORGET TO GET IXIARO
If you and/or your child miss a scheduled injection,
talk to your doctor and arrange another visit for the
second injection.
Without the second injection you and/or your child
will not be fully protected against the disease.
There is data showing that the second injection can
be given up to 11 months after the first one.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The majority of the side effects listed below have been
observed during clinical trials. They usually occur within
the first 3 days after vaccination, are usually mild and
disap

Fachinformation

1
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 ED
50
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/dose and sodium,
less than 1mmol/dose.
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 immunization 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
ADULT_s _
(18 – 65 years of age)
2
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 18-65 years can be vaccinated in a rapid schedule as
follows:
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).
It is recommended that vaccinees who received the first dose of IXIARO
complete the primary 2-dose
vaccination course with IXIARO.
If the primary immunization of two injections is not completed, full
protection against the disease might
not be achieved. There is data that a second injection