IXIARO suspension for injectionJapanese encephalitis vaccine (inactivated, adsorbed)

What IXIARO is

IXIARO is a vaccine against the Japanese encephalitis virus.

The vaccine causes the body to produce its own protection (antibodies) against this disease.

What IXIARO is used for

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.

IXIARO should be given to adults (18 years and older).

You must NOT receive IXIARO

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of IXIARO. The active substance and other ingredients are listed at the end of the leaflet (see Section 6 ?Further Information ?).
• if you have developed an allergic reaction after receiving a former dose of IXIARO. Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
• if you are ill with a high fever. In this case, your doctor will postpone the vaccination.

Take special care with IXIARO

IXIARO must not be injected into a blood vessel.
Primary immunization should be completed at least one week prior to potential exposure to JEV.

Tell your doctor:

• if you have experienced any health problems after previous administration of any vaccine.
• if you have any other known allergies.
• if you have a bleeding disorder (a disease that makes you bleed more than normal) or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia).
• if you are under 18. Since IXIARO has not been tested in people under 18 it is not recommended to be used in this group.
• if your immune system does not work properly (immunodeficiency) or you are taking medicines affecting your immune system(such as a medicine called cortisone or cancer medicine).

Your doctor will discuss with you the possible risks and benefits of receiving IXIARO.

Please note that:

• IXIARO cannot cause the disease it protects against.
• IXIARO will not prevent infections caused by other viruses than the Japanese encephalitis virus.
• You should take appropriate precautions to reduce mosquito bites (adequate clothing, use of repellents, mosquito nets) even after receiving IXIARO.

Using other medicines or vaccines
A study in humans to evaluate the effectiveness and safety of medicines (clinical trial) has shown that IXIARO can be given at the same time with hepatitis A vaccine.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.

Pregnancy and breast-feeding

There are limited amount of data from the use of IXIARO in pregnant or breast-feeding women. As a precautionary measure, the use of IXIARO during pregnancy or breast-feeding should be avoided. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effect of IXIARO on the ability to drive or use machines have been preformed.

Dosage for adults
You will receive a total of 2 injections:

• the first injection on Day 0
• the second injection 28 days after the first injection (Day 28).

Make sure you finish the complete vaccination course of 2 injections. The second injection should be given at least 1 week before you will be at risk of exposure to JE virus. If not, you may not be fully protected against the disease.

A booster dose can be given within the second year (i.e. 12 - 24 months) after the first dose of the recommended primary immunization. Your doctor will decide on requirement of booster.

Administration
IXIARO is injected into your upper arm muscle (deltoid muscle) by your doctor or a nurse. It must not be injected into a blood vessel. In case you 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 take IXIARO
If you miss a scheduled injection, talk to your doctor and arrange another visit for the second injection. Without the second injection you will not be fully protected against the disease. There is data that the second injection can be given up to 11 months after the first one.

Like all medicines, IXIARO can cause side effects, although not everybody gets them.

The frequency of the side effects are defined as follows Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known Frequency cannot be estimated from the available data

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 disappear within a few days.

Very common:

• headache
• muscle pain
• tiredness
• injection site reactions (pain, tenderness)

Common:

• fatigue
• nausea
• influenza like illness
• fever
• injection site reactions (redness, hardening, swelling, itching)

Uncommon:

• vomiting
• skin rash
• changes in the lymph-nodes
• migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light)
• dizziness
• vertigo (spinning sensation)
• diarrhoea
• belly pain
• itching
• chills
• runny or blocked nose
• inflammation of nose and throat
• general condition of feeling unwell
• musculoskeletal stiffness
• injection site reactions (bleeding, bruising)
• abnormal laboratory liver test results

Rare:

• palpitations
• rapid heart beat
• difficulty to breathe
• abnormal sensation of skin
• hives
• skin redness
• pain in leg or arm
• joint pain
• platelet deficiency
• nerve inflammation
• foot, leg and ankle swelling

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use IXIARO after the expiry date which is stated on the carton and label after ?EXP?. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C).
• Do not freeze. If the vaccine has been frozen it should not be used.
• Store in the original package in order to protect from light.
• Any unused product or waste material should be disposed of in accordance with local requirements.

What IXIARO contains

6 micrograms31 dose 0.5 ml of IXIARO contains Japanese encephalitis virus strain SA1,214-14-2 inactivatedcorresponding to a potency of 460 ng ED5

12 produced in Vero cells adsorbed on aluminium hydroxide, hydrated 0.25 milligrams Al33 total protein content

Aluminium hydroxide is included in this vaccine as an adjuvant.

The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections

What IXIARO looks like and contents of the pack

IXIARO is a suspension for injection (0.5 ml in a glass syringe with or without a separate needle, pack size of 1).

IXIARO is a white and slightly milky sterile suspension which becomes homogenous on shaking.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Intercell AG
Campus Vienna Biocenter 3
A-1030 Vienna
Austria

Manufacturer:
Intercell Biomedical Ltd.
Oakbank Park Road,
Livingston EH53 0TG, Scotland,
United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Vaccines and Diagnostics Ltd TélTel 44 0 845 745 1500 LuxembourgLuxemburg Novartis Vaccines and Diagnostics Ltd TélTel 44 0 845 745 1500

Bulgaria Novartis Vaccines and Diagnostics Ltd Te. 44 0 845 745 1500 MagyarországHungary Novartis Vaccines and Diagnostics Ltd TélTel 44 0 845 745 1500

eská republikaCzech Republic Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 Danmark SBL Vaccin AB Tlf 46 08 735 10 00 Malta Novartis Vaccines and Diagnostics Ltd Tel. 44 0 845 745 1500 Nederland Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500

NorgeNorway SBL Vaccin AB Tlf 46 08 735 10 00 Deutschland Novartis Vaccines and Diagnostics GmbH Co. KG Emil -von-Behring-Str. 76 D-35041 Marburg Tel 49 0 6421 39-15

EestiEstonia Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 ÖsterreichAustria Novartis Pharma GmbH Brunner Strasse 59 A-1235 Wien Tel 43 186 6570

Greece Novartis Vaccines and Diagnostics Ltd 44 0 845 745 1500 PolskaPoland Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500

Portugal Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 EspañaSpain Novartis Vaccines and Diagnostics, S.L. B-58564808 Gran Vía de les Corts Catalanes 764 08013 Barcelona Tel 34 93 306 42 00

România Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 France Novartis Vaccines and Diagnostics SAS 10, rue Chevreul F-92150 Suresnes Tél 33 1 4138 7400

Ireland Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 SlovenijaSlovenia Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500

ÍslandIceland Novartis Vaccines and Diagnostics Ltd Sími 44 0 845 745 1500 Slovenská republikaSlovakia Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500

SuomiFinland SBL Vaccin AB PuhTel 46 0 8 735 10 00 Italia Novartis Vaccines and Diagnostics Srl Via Florentina 1 I-53100 Siena Tel 8000 16888 39 0577 243111

Cyprus Novartis Vaccines and Diagnostics Ltd 44 0 845 745 1500 SverigeSweden SBL Vaccin AB SE-105 21 Stockholm Tel 46 08 735 10 00

LatvijaLatvia Novartis Vaccines and Diagnostics Ltd Tel 44 0 845 745 1500 United Kingdom Novartis Vaccines and Diagnostics Ltd Gaskill Road Speke Liverpool L24 9GR Tel 44 0 845 745 1500

Lietuva/Lithuania
Novartis Vaccines and Diagnostics Ltd
Tel: +44 (0) 845 745 1500

This leaflet was last approved in 03/2010.

The following information is intended for medical or healthcare professionals only: The vaccine should be well shaken before administration to obtain a homogenous suspension. The pre-filled syringe is for single use only and should not be used for more than 1 person. The entire content of a syringe has to be injected.