Consumer Information for: IXIARO

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

IXIARO* is a vaccine against the virus which causes Japanese encephalitis (encephalitis – is infection of the brain).
Japanese encephalitis is caused by the Japanese encephalitis virus that is found across Asia, including many tourist destinations, as well as in northern Australia. The virus is transmitted to humans by the bite of infected mosquitoes.

What it does

IXIARO* is used for vaccination (active immunization) against Japanese encephalitis virus in persons 2 months of age and older,

  • who plan to reside in or travel to areas where Japanese encephalitis is common (endemic) or seasonal (epidemic) particularly during the transmission season. Depending on your outdoor activities in rural areas your doctor will explain your individual risk of catching the disease.
  • who work with Japanese encephalitis virus both in laboratories as well as in industry.
What the medicinal ingredient is

What the non-medicinal ingredients are

Adjuvant: Aluminium hydroxide
Phosphate Buffered Saline:
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Sodium chloride
Water for injection

What dosage form it comes in

0.5 mL suspension for injection, having a potency of ≤ 460 ng ED50/dose

When it should not be used

Individuals with the following conditions should discuss vaccination with their physician, who will be able to advise on safe vaccination or alternative preventative measures to avoid infection with JEV:

  • Pregnant or breast feeding women
  • Persons with bleeding disorder, or abnormal bruising
  • Persons with fever (temperature above 37.8°C)
  • Immunosuppressed persons or individuals on cancer treatment
Warnings and precautions

Serious Warnings and Precautions

As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.

  • IXIARO* must never be injected into a vein or any blood vessel.
  • As with any other vaccine, vaccination with IXIARO* may not result in protection in all cases.
  • IXIARO* will not protect against encephalitis caused by other organisms.
  • Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, hemophilia or other bleeding disorders.
  • 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), protection may not be as expected.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you get IXIARO*. Talk about any health conditions or problems you may have, including 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).
  • you are or think you are pregnant or if you are breast feeding.
  • you have any known allergies.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Proper use of this medication

Usual dose

The recommended dosage for adults, adolescents and children aged 3 years of age and older is a total of 2 injections of 0.5 mL each:

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

In the event the usual dosing schedule (Day 0 and Day 28) cannot be completed due to time constraints, adults aged 18 to 65 years can also be vaccinated as follows:

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

Babies and children aged 2 months to < 3 years of age:
The recommended dosage for babies and children 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. For elderly persons (≥65 years) the first booster dose may be given earlier.

In adults, a second booster can be given 10 years after the first booster.

Your doctor will decide on the requirement and timing for booster doses.

Overdose

Few cases of overdose have been reported during post-marketing surveillance. None of them was associated with any specific or serious important clinical symptoms.

Side effects and what to do about them

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

Anaphylactic shock is a rare but very serious event. An allergic reaction causes symptoms in many parts of the body, often starting with tingling or swelling around the mouth and lips. The face and neck may swell and breathing may become difficult. Heartbeat is fast and may be irregular. A rash, hives or redness of the skin may occur and there may be diarrhea. If these symptoms occur, contact your physician or call your emergency services immediately.

The majority of the adverse reactions listed below have been observed during clinical trials. They usually occur within the first three days after vaccination, are usually mild and disappear within a few days.

Very common (in one or more than 1 in 10 of those who are vaccinated):
Headache, muscle pain, injection site reactions (pain, tenderness), tiredness

Common (in one or more than 1 in 100 of those who are vaccinated):
Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)

Uncommon (in one or more than 1 in 1,000):
Vomiting, skin rash, changes in lymph nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results

Rare (in one or more than 1 in 10,000):
Platelet deficiency, nerve inflammation, foot, leg and ankle swelling, palpitations, rapid heartbeat, difficulty to breathe, abnormal sensation of skin, hives, pain in leg or arm, joint pain, skin redness, taste disturbance, swelling of eyelid

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

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. Keep out of reach and sight of children.

Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Reporting Suspected Side Effects

For the general public: Should you experience a side effect following immunization, please report it to your doctor, nurse, or pharmacist.

Should you require information related to the management of the side effect, please contact your healthcare provider. The Public Health Agency of Canada, Health Canada and <Sponsor Name> cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit.

More information
  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.valneva.ca, or by calling Medical Information at Valneva Canada Inc. at 1-855-356-0831. Business hours: 9:00 a.m. to 5:00 p.m. Eastern Time, Monday to Friday.

This leaflet was prepared by Valneva Austria GmbH.

Last Revised: March 2018

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