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Ixiaro suspension for injection (Japanese Encephalitis Vaccine)

What Ixiaro is and what it is used for

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 (18yearsand older).

Before you receive Ixiaro

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.

Asa 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

How Ixiaro is given Dosage for adults

You will receive a total of 2 injections:

  1. the first injection on Day
  2. the second injection at least 28 days after the first injection (Day 28, or later).

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

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.

Possible side effects

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

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, injection site reactions (pain, tenderness)

Common:

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

Uncommon:

  • abnormal laboratory liver test results, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), pain in the throat and voice box, diarrhoea, vomiting, inflammation of nose and throat, runny or blocked nose, chills, injection site reactions (bruising, bleeding)

Rare:

  • inflammation of the lymph-nodes, itching

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.

How to store Ixiaro

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 notfreeze. If the vaccine has beenfrozen 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.

Further information

What Ixiaro contains

1 dose (0.5 ml) of Ixiaro contains:

Japanese encephalitis virus strain SA,4-14-2 (inactivated)u6 microgram53 corresponding to a potency of < 460 ng ED50

1 produced inVero cells

2 adsorbed on aluminium hydroxide, hydrated0.25 milligrams AI3+

3 total protein content

Aluminium hydroxide is included in this vaccine as an adjuvant. The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, di sodium 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.

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