Ixiaro

Package leaflet: Information for the user

IXIARO, injectable suspension

Japanese encephalitis vaccine (inactivated, adsorbed)
Please read all of this leaflet carefully before you or the child receive this vaccine as it contains
important information for you.

• Keep this leaflet. You or the child may need to read it again.
• If you have any questions, ask your doctor.
• This vaccine has been prescribed for you and/or the child personally. Do not give it to other people.
• If you and/or the child experience any adverse reactions, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What IXIARO is and what it is used for
2. What you need to know before you and/or the 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 that works against the Japanese encephalitis virus.
The vaccine stimulates the body to develop protection (antibodies) against this disease.
IXIARO is indicated for the prevention of Japanese encephalitis. The Japanese encephalitis virus (JEV) is
found predominantly in Asia and is transmitted to humans through mosquitoes that have bitten an infected animal (e.g. pigs).
In many individuals, the infection causes mild symptoms or is asymptomatic. In people who develop a severe form of the disease,
Japanese encephalitis begins as an influenza-like syndrome, with fever, chills, fatigue, headache, nausea, and vomiting.
In the early stage of the disease, the patient may also experience confusion and agitation.
IXIARO should only be administered to adults, adolescents, children, and infants from 2 months of age who are travelling to countries where Japanese encephalitis is locally common (endemic), or who are at risk of exposure due to their occupation.

2. What you should know before you and/or the child receive IXIARO

Do not use IXIARO

• if you and/or the child are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you and/or the child have had an allergic reaction after receiving a previous dose of IXIARO. Signs of an allergic reaction include itchy rash, difficulty breathing, and swelling of the face and tongue.
• if you and/or the child have a high fever; in this case, the doctor will postpone vaccination.

Warnings and precautions
IXIARO must not be administered intravenously or intra-arterially.
Primary immunization must be completed at least one week before potential exposure to the Japanese encephalitis virus.
Inform your doctor:

• if you and/or the child have had any health problems in the past after receiving a vaccine.
• if you and/or the child have any known allergies.
• if you and/or the child have a blood clotting disorder (a disease causing abnormal bleeding) or a low platelet count, a condition that increases the risk of bleeding or bruising (thrombocytopenia).
• if the child is younger than 2 months of age, since IXIARO has not been tested in infants under 2 months.
• if your immune system or that of the child is not functioning properly (immunodeficiency), or if you and/or the child are taking medicines that affect the immune system (e.g. a medicine called cortisone or anticancer drugs).

The doctor will discuss with you the potential risks and benefits of administering IXIARO.
Please note the following:

• IXIARO cannot cause the diseases it protects against.
• IXIARO does not prevent infections caused by viruses other than the Japanese encephalitis virus.
• As with any other vaccine, vaccination with IXIARO may not always lead to protection.
• Even after vaccination with IXIARO, you and/or the child should take necessary precautions to reduce mosquito bites (use of appropriate clothing, use of repellents, use of mosquito nets).

Other medicines and IXIARO
Clinical studies conducted in humans to evaluate the efficacy and safety of the medicine have shown that IXIARO can be administered concomitantly with the hepatitis A vaccine and the rabies vaccine. Inform your doctor if you and/or the child are currently taking, have recently taken, or might take any other medicines, including over-the-counter medicines, or if you have recently received any other vaccination.

Pregnancy, breastfeeding and fertility
There is only limited information available on the use of IXIARO in pregnant or breastfeeding women. As a precautionary measure, the use of IXIARO during pregnancy and breastfeeding should be avoided. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before receiving this vaccine.

Driving and using machines
IXIARO has no effect or negligible effect on the ability to drive vehicles or operate machinery.

IXIARO contains potassium and sodium
This medicine contains potassium, less than 1 mmol (39 mg) per 0.5 ml single dose, i.e. essentially "potassium-free", and contains less than 1 mmol (23 mg) of sodium per 0.5 ml single dose, i.e. essentially "sodium-free". This product may contain trace amounts of residual sodium metabisulfite below the limit of detection.

3. How to use IXIARO

The recommended dose for adults, adolescents, and children from 3 years of age is a total of 2 injections of
0.5 ml each:

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

Adults aged between 18 and ≤ 65 years may also be vaccinated according to the following schedule:

• the first dose on Day 0
• the second injection 7 days after the first dose (Day 7).

Newborns and children from 2 months to less than 3 years of age:
The recommended dose for newborns and children from 2 months to less than 3 years of age is a total of 2 injections of
0.25 ml each:

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

For instructions on how to prepare the 0.25 ml dose, see the end of this leaflet.
It is important that you and/or the child complete the 2-dose vaccination cycle. The second injection should be
administered at least 1 week before potential exposure to the Japanese encephalitis virus. Otherwise,
protection against the disease may be only partial for you and/or the child.
For adults, adolescents, children, and infants aged at least 1 year, a booster dose may be administered
within the second year (i.e., at 12–24 months) after the first dose of the recommended primary immunization.
In adults, a second booster may be given 10 years after the first. For elderly individuals (> 65 years), the first
booster dose may be given earlier. Your doctor will decide on the need and timing of booster doses.

Administration
IXIARO is administered to you and/or the child by a doctor or nurse as an injection into the muscle of the arm
(deltoid muscle). IXIARO must not be injected into a blood vessel.
If you and/or the child suffer from a coagulation disorder, the doctor may decide to administer the vaccine
under the skin (subcutaneous route).

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to receive IXIARO
If you and/or the child miss a scheduled injection, it is recommended to contact your doctor and schedule a
second appointment for the second injection.
Without the second injection, you and/or the child will not be fully protected against the disease. According to
some data, the second injection may be administered up to 11 months after the first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects listed below were observed during clinical studies. These reactions usually occur within the first three days after vaccination, are generally mild in severity, and resolve within a few days.

Very common (affects more than 1 in 10 people):
headache, muscle pain, pain at the injection site, tenderness at the injection site, fatigue

Common (affects from 1 to 10 in 100 people):
nausea, influenza-like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)

Uncommon (affects from 1 to 10 in 1,000 people):
vomiting, rash, lymph node abnormalities, migraine (pulsating headache often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (sensation of spinning), diarrhoea, abdominal pain, excessive sweating, itching, chills, general malaise, musculoskeletal stiffness, joint pain, weakness, abnormal liver laboratory tests (increased liver enzymes)

Rare (affects from 1 to 10 in 10,000 people):
palpitations, increased heart rate, breathing difficulties, abnormal skin sensations (e.g. tingling), urticaria, skin redness, pain in arms or legs, thrombocytopenia (low platelet count), nerve inflammation, swelling of limbs and ankles, taste disturbance, eyelid swelling, fainting

Additional side effects in children aged from 2 months to less than 3 years
In children aged from 2 months to less than 3 years, the following adverse events have been observed more frequently compared to children aged from 3 to less than 12 years, adolescents, and adults:

Very common: fever (28.9%), diarrhoea (11.8%), influenza-like illness (11.2%), irritability (11.0%)
Common: loss of appetite, vomiting, rash
Uncommon: cough

Reporting of side effects
If you and/or the child experience any side effect, including those not listed in this leaflet, please consult your doctor. You may also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store IXIARO

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date 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 must not be used.
• Keep in the original packaging to protect from light.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What IXIARO contains
1 dose (0.5 ml) of IXIARO contains:
inactivated Japanese encephalitis virus strain SA-14-2 6 IU
corresponding to a potency of ≤ 460 ng ED
grown on Vero cells
adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al)
antigen units
This vaccine contains aluminium hydroxide as an adjuvant.
The other components are: sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for
injections

Description of the appearance of IXIARO and contents of the pack
IXIARO is an injectable suspension (0.5 ml in a glass syringe with or without a separate needle, pack size: 1).
IXIARO is a sterile, white, slightly opalescent suspension which becomes homogeneous after shaking.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Valneva Austria GmbH
Campus Vienna Biocenter 3
A-1030 Vienna
Austria
E-mail: [email protected]

Manufacturer:
Valneva Austria GmbH
Campus Vienna Biocenter 3
A-1030 Vienna
Austria

For further information on this medicinal product, please contact the Marketing Authorisation Holder at the following e-mail address:
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

The pre-filled syringe is for single use only and must not be used for more than one person. The pre-filled syringe
is ready for use. If the package does not contain needles, use a sterile needle.
Do not use if the protective blister film is not intact or if the packaging is damaged.
After storage, a slight white deposit with a clear, colorless supernatant may be observed.
Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension.
Do not administer if particulate matter remains after shaking, or if discoloration is observed, or if the syringe appears physically damaged.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Information on administration of a 0.5 ml dose of IXIARO to subjects aged 3 years and older
To administer the full 0.5 ml dose, proceed as follows:

1. Shake the syringe to obtain a homogeneous suspension.
2. Remove the cap from the tip of the syringe by gently twisting it. Do not attempt to remove it by snapping or pulling, as this may damage the syringe.
3. Attach a needle to the pre-filled syringe.

Information on preparation of a 0.25 ml dose of IXIARO for use in children under 3 years of age
To administer a 0.25 ml dose to children aged 2 months to less than 3 years, proceed as follows:

1. Shake the syringe to obtain a homogeneous suspension.
2. Remove the cap from the tip of the syringe by gently twisting it. Do not attempt to remove it by snapping or pulling, as this may damage the syringe.
3. Attach a needle to the pre-filled syringe.
4. Hold the syringe in an upright position.
5. Push the plunger of the syringe down to the edge of the red line marked on the syringe barrel, indicated by a red arrow (see Figure 1)*, to expel the excess volume.
6. Attach a new sterile needle before injecting the remaining volume.

* If the syringe plunger has been pushed beyond the red line, it is not possible to ensure administration of a 0.25 ml dose, and a new syringe must be used.

Figure 1: Preparation for administration of a 0.25 ml dose