PATIENT INFORMATION LEAFLET

IXIARO injectable suspension

Japanese encephalitis inactivated, adsorbed vaccine

Read this leaflet carefully before you or your child start using this vaccine, as it contains important information for you.

• Keep this leaflet, as you and your child may need to read it again.
• If you have any questions, consult your doctor.
• This vaccine has been prescribed only for you and/or your child. Do not give it to other people.
• If you and/or your child experience any adverse effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

IXIARO is a vaccine against Japanese encephalitis virus.

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

IXIARO is indicated to prevent infection by the Japanese encephalitis virus (JEV). This virus is mainly found in Asia and is transmitted to humans through mosquitoes that have bitten an infected animal (for example, a pig). Many infected individuals present mild symptoms or have no symptoms. In people who contract a severe form of the disease, JE usually starts similarly to the flu, with fever, chills, fatigue, headache, nausea, and vomiting. In the initial stages of the disease, confusion and agitation also appear.

IXIARO should only be administered to adults, adolescents, children, or babies over 2 months old who are traveling to countries where JE is endemic or who, due to their work, are exposed to the risk of contracting it.

Do not use IXIARO:

• If you or your child are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• If you or your child have experienced an allergic reaction after receiving a previous dose of IXIARO. Symptoms of an allergic reaction may include a skin rash with itching, difficulty breathing, and swelling of the face and tongue.
• If you or your child have a disease that is accompanied by high fever. In this case, your doctor will postpone the vaccination.

Warnings and precautions

IXIARO should not be injected into a blood vessel.

The primary vaccination should be completed at least one week before possible exposure to JE.

Inform your doctor:

• • If you or your child have experienced any health problems after receiving a previous vaccine;
• If you or your child have any other known allergy;
• If you suffer from a bleeding disorder (a disease that makes you or your child bleed more than normal) or present a decrease in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia);
• If your child is less than 2 months old, as IXIARO has not been tested in babies under 2 months;
• If your immune system (yours or your child's) does not function correctly (immunodeficiency) or if you or your child are taking medications that affect your immune system (such as a medication called cortisone or cancer medications).

Your doctor will explain the possible risks and benefits of receiving IXIARO.

Take note of the following:

• IXIARO cannot cause the disease it protects against.
• IXIARO will not prevent infections caused by other viruses distinct from the Japanese encephalitis virus.
• Like any other vaccine, the vaccination with IXIARO may not provide protection in all cases.
• You should take necessary precautions to avoid mosquito bites (use of suitable clothing, repellents, mosquito nets) even after being vaccinated with IXIARO.

Use of IXIARO with other medications

Studies conducted in humans to evaluate the efficacy and safety of medications (clinical trials) have shown that IXIARO can beaministered at the same time as the hepatitis A vaccine and the rabies vaccine.

Inform your doctor if you or your child are using, have used recently, or may take other medications, even those obtained without a prescription, or if you have received a recent vaccine.

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of IXIARO in pregnant women or breastfeeding women.

As a precaution, IXIARO should not be used during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this vaccine.

Driving and operating machinery

IXIARO has no influence or its influence is insignificant on the ability to drive and operate machinery.

IXIARO contains potassium and sodium

This medication contains potassium, less than 1 mmol (39 mg) per 0.5 ml single dose, which is essentially “potassium-free”) and less than 1 mmol of sodium (23 mg) per 0.5 ml single dose, which is essentially “sodium-free”). This medication may contain residual sodium metabisulfite below the detection limit

The recommended dose for adults, adolescents, and children over 3 years old is 2 injections of 0.5 ml each:

• The first injection, on day 0
• The second injection, 28 days after the first (day 28)

Adults aged 18 to ≤ 65 years may also be vaccinated in the following way:

• The first injection on day 0
• The second injection 7 days after the first injection (day 7).

Babies and children aged between 2 months and <3 years

The recommended dose for babies and children aged between 2 months and <3 years

• The first injection, on day 0
• The second injection, 28 days after the first (day 28)

To obtain instructions on how to prepare the 0.25 ml dose, see the end of this leaflet.

Make sure you and/or your child complete the full vaccination program of 2 injections. The second injection must be administered at least one week before possible exposure to the Japanese encephalitis virus. Otherwise, you and/or your child may not be fully protected against the disease.

For adults, adolescents, children, and infants aged 1 year or older, a booster dose may be administered during the second year (i.e., 12 to 24 months) after the first dose of the primary recommended immunization. For adults, a second booster dose may be administered 10 years after the first booster dose. For older adults (> 65 years), the first booster dose may be administered earlier. Your doctor will decide on the need and timing of booster doses.

Administration

Your doctor or nurse will inject IXIARO into your arm muscle (deltoid). IXIARO must not be injected into a blood vessel. If you and/or your child experience a bleeding disorder, your doctor may decide to administer the vaccine under the skin (subcutaneously).

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you forgot to receive IXIARO

If you and/or your child miss one of the scheduled injections, consult your doctor and request another appointment for the second injection. Without the second injection, you and/or your child will not be fully protected against the disease. There is information indicating that the second injection may be administered up to 11 months after the first.

Like all medicines, this product may cause side effects, although not everyone will experience them.

During clinical trials, the majority of the following side effects were observed, which usually occur within three days after vaccination, are generally mild and disappear within a few days.

Very common (affects more than 1 in 10 users):

Headache, muscle pain, pain at the injection site, hypersensitivity at the injection site, fatigue

Common (affects between 1 and 10 users in 100):

Nausea, flu-like illness, fever, other reactions at the injection site (e.g., redness, hardness, swelling, itching)

Uncommon (affects between 1 and 10 users in 1,000):

Vomiting, skin rash, changes in lymph nodes, migraine (pulsating headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (sensation of spinning), diarrhea, abdominal pain, excessive sweating, itching, chills, general feeling of discomfort, muscle and skeletal stiffness, joint pain, weakness, abnormal liver test results (elevated liver enzymes)

Rare (affects between 1 and 10 users in 10,000):

Palpitations, rapid heart rate, difficulty breathing, abnormal skin sensation (e.g., pinpricks), hives, skin redness, pain in the legs or arms, platelet deficiency, nerve inflammation, swelling of the extremities and ankles, altered taste, swelling of the eyelids, fainting

Other side effects in children aged 2 months to <3 years

Among children aged 2 months to <3 years

Very common:Fever (28.9%), diarrhea (11.8%), flu-like illness (11.2%), irritability (11.0%)

Common:Loss of appetite, vomiting, exanthema

Uncommon:Cough

Reporting of side effects

If you and/or your child experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• • Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
• Store in the refrigerator (between 2 °C and 8 °C).
• Do not freeze. If the vaccine has frozen, it should not be used.
• Store in the original packaging to protect it from light.
• Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the medications that you and/or your child no longer need. This will help protect the environment.

Composition of IXIARO

A dose (0.5 ml) of IXIARO contains:

6 Units of the inactivated SA14-14-2 (Japanese encephalitis virus) strain3

equivalent to a potency ≤ 460 ng DE50

1. produced in Vero cells
2. adsorbed on hydrated aluminum hydroxide(approximately 0.25 milligrams Al3+)
3. Antigen units

Aluminum hydroxide is added to this vaccine as an adjuvant.

The other components are: sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injection

Appearance of the product and contents of the pack

IXIARO is an injectable suspension (0.5 ml in a glass syringe with or without a needle supplied separately, pack with 1 syringe).

IXIARO is a sterile white or slightly milky suspension that becomes homogeneous when shaken.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Valneva Austria GmbH

Campus Vienna Biocenter 3

A-1030 Vienna

Austria

Email:[email protected]

Manufacturer:

Valneva Scotland Ltd.

Oakbank Park Road,

Livingston EH53 0TG

United Kingdom

Valneva Austria GmbH

Campus Vienna Biocenter 3

A-1030 Vienna

Austria

For any information about this product, please contact the marketing authorization holder at the following address:

[email protected]

Last review date of this leaflet.

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/. On the website of the European Medicines Agency, this leaflet can be found in all languages of the European Union/European Economic Area.

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This information is intended solely for healthcare professionals:

The pre-filled syringe is for single use only and should not be used on more than one person. The pre-filled syringe is ready for use. If no needle is supplied, use a sterile needle.

Do not use if the blister foil is not intact or if the pack is damaged.

During storage, a slight white deposit with a colourless and transparent supernatant may form.

Before administration, shake the syringe well to obtain a white, opaque and homogeneous suspension. Do not administer if particles or colour changes are observed after shaking or if the syringe shows physical damage.

The disposal of unused medicinal product and any waste materials derived from the use of such product should be in accordance with local requirements.

Information about the administration of a 0.5 ml dose of IXIARO to individuals over 3 years old

For the administration of a full dose of 0.5 ml, follow these steps:

1. Shake the syringe until a homogeneous suspension is obtained.

1. Remove the cap from the syringe tip by turning it gently. Do not attempt to break or pull the tip as this may damage the syringe.
2. Attach a needle to the pre-filled syringe.

Information about the preparation of a 0.25 ml dose of IXIARO for use in children under 3 years old

For the administration of a 0.25 ml dose to children aged between 2 months and <3>

1. Shake the syringe until a homogeneous suspension is obtained.
2. Remove the cap from the syringe tip by turning it gently. Do not attempt to break or pull the tip as this may damage the syringe.
3. Attach a needle to the pre-filled syringe.
4. Hold the syringe in a vertical position.
5. Push the plunger stopper to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)* to discard the excess volume
6. Attach a new sterile needle before injecting the remaining volume.

*If the plunger stopper is pushed beyond the red line, the 0.25 ml dose is not guaranteed and a new syringe should be used.