Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Japanese encephalitis vaccine (inactivated, adsorbed) may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR IXIARO is a vaccine against the Japanese encephalitis virus. The vaccine causes the body to produce its own protection (antibodies) against this disease. 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 of disease. IXIARO should be given only to adults, adolescents, children and infants aged 2 months and older travelling to countries, where JE is endemic or who are at risk through work.
2. WHAT YOU NEED TO KNOW BEFORE YOU AND/OR YOUR CHILD RECEIVE IXIARO Do not use IXIARO:
the active substance or any of the other ingredients of this medicine (listed in section 6). If you and/or your child 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 and/or your child are ill with a high fever. In this case, your doctor will postpone the vaccination.
Warnings and precautions 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 and/or your child have experienced any health problems after previous administration of any vaccine. If you and/or your child have any other known allergies.
• •
Black
(a disease that makes you bleed more than normal) or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia). If your child is younger than 2 months of age, since IXIARO has not been tested in infants younger than 2 months of age. If your or your child's immune system does not work properly (immunodeficiency) or you and/or your child 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. As with any other vaccine, vaccination with IXIARO may not result in protection in all cases. You should take appropriate precautions for you and your child to reduce mosquito bites (adequate clothing, use of repellents, mosquito nets) even after receiving IXIARO.
• • • •
Other medicines and IXIARO Studies in humans to evaluate the effectiveness and safety of medicines (clinical trials) have shown that IXIARO can be given at the same time with hepatitis A vaccine and rabies vaccine. Tell your doctor if you and/or your child are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Pregnancy and breast-feeding and fertility 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this vaccine.
Driving and using machines IXIARO has no or negligible influence on the ability to drive and use machines.
IXIARO contains potassium and sodium This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml single dosage i.e. essentially 'pot assium-free' and less than 1 mmol sodium (23 mg) per 0.5 ml single dosage, that is to say essentially 'sodium- free'. This product might contain traces of residual sodium metabisulfite which is below detection limit.
IXIARO 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).
• •
PANTONE 639 CVU
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. In adults, a second booster can be given 10 years after the first booster. For elderly persons (>65 years) the first booster dose may be given earlier. Your doctor will decide on the requirement and timing for booster doses.
Administration IXIARO is injected into your or your child's upper arm muscle (deltoid muscle) by your doctor or a nurse. It must not be injected into a blood vessel. In case you and/or your child 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 get IXIARO If you and/or your child miss a scheduled injection, talk to your doctor and arrange another visit for the second injection. Without the second injection you and/or your child will not be fully protected against the disease. There is data showing that the second injection can be given up to 11 months after the first one.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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 (affects more than 1 user in 10): headache, muscle pain, injection site pain, injection site tenderness, tiredness
Format: 210 mm × 297 mm
Common (affects 1 to 10 users in 100): Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)
Uncommon (affects 1 to 10 users in 1,000): 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, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased)
IXIARO
Rare (affects 1 to 10 users in 10,000): palpitations, rapid heartbeat, difficulty to breathe, abnormal sensation of skin (for example pins and needles), hives, skin redness, pain in leg or arm, platelet deficiency, nerve inflammation, limb swelling and ankle swelling, taste disturbance, swelling of eyelid, fainting
Additional side effects in children aged 2 months to <3 years In children aged 2 months to <3 years, the following side effects have been observed more frequently compared to children aged 3 years to <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, skin rash Uncommon: cough
Reporting of side effects If you and/or your child get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you and/or your child no longer use. These measures will help protect the environment.
What IXIARO contains 1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3 corresponding to a potency of ≤ 460 ng ED50
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria Email: [email protected] Manufacturer: Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria For any information about this medicine, please contact the Marketing Authorization Holder by the following e-mail address: [email protected] This leaflet was last revised in May 2021.
produced in Vero cells adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+) 3 Antigen Units 1 2
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.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Information on the administration of a 0.5 ml dose of IXIARO for persons 3 years of age and above For administration of the full 0.5 ml dose follow the steps below:
Information on the preparation of a 0.25 ml dose of IXIARO for use in children below 3 years of age For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below: 1. Shake the syringe to obtain a homogeneous suspension. 2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off 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 stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, to discard excess volume. 6. Attach a new sterile needle prior to injection of the remaining volume.
0.25 ml Dose
Upon storage, a fine white deposit with a clear colourless supernatant can be observed. Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension. Do not administer if particulate matter remains following shaking or if discoloration is observed or if the syringe appears to be physically damaged.
Discard
Do not use if the blister foil is not intact or packaging is damaged.
1. Shake the syringe to obtain a homogeneous suspension. 2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe. 3. Attach a needle to the pre-filled syringe.
Expel
The pre-filled syringe is for single use only and should not be used for more than one person. The pre-filled syringe is ready to use. If a needle is not provided, use a sterile needle.
Figure 1: Preparation for Administration of 0.25 ml Dose
IXIARO suspension for injection – Japanese encephalitis vaccine (inactivated, adsorbed) comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in IXIARO suspension for injection – Japanese encephalitis vaccine (inactivated, adsorbed) is japanese encephalitis vaccine (inactivated, adsorbed).
This leaflet reproduces the patient information leaflet approved for IXIARO suspension for injection – Japanese encephalitis vaccine (inactivated, adsorbed), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
IXIARO is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older.
IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
Posology
Adults (18 to ≤ 65 years of age)
The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
Rapid schedule
Persons aged 18 to ≤ 65 years can be vaccinated in a rapid schedule as follows:
First dose at Day 0.
Second dose: 7 days after first dose.
With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
If the primary immunization of two injections is not completed, full protection against the disease might not be achieved. There is data that a second injection given up to 11 months after the first dose results in high seroconversion rates (see section 5.1).
Booster dose
A booster dose (third dose) should be given within the second year (i.e. 12 - 24 months) after primary immunization, prior to potential re-exposure to JEV.
Persons at continuous risk for acquiring Japanese encephalitis (laboratory personnel or persons residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1).
Long-term seroprotection data following a first booster dose administered 12 - 24 months after primary immunization suggest that a second booster should be given 10 years after the first booster dose, prior to potential exposure to JEV.
Elderly (>65 years of age)
The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
If the primary immunization of two injections is not completed, full protection against the disease might not be achieved. There is data that a second injection given up to 11 months after the first dose results in high seroconversion rates (see section 5.1).
Booster dose
As with many vaccines, the immune response in elderly persons to IXIARO is lower than in younger adults. Duration of protection is uncertain in elderly persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus. Long-term seroprotection following a booster-dose is not known.
Paediatric Population
Children and adolescents from 3 years to < 18 years of age
The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
Children from 2 months to < 3 years of age
The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years.
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
Booster dose (Children and adolescents)
A booster dose (third dose) should be given within the second year (i.e. 12 - 24 months) after primary immunization, prior to potential re-exposure to JEV.
Children and adolescents at continuous risk for acquiring Japanese encephalitis (residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1).
Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose. Children from 14 months to < 3 years of age should receive a single 0.25 ml booster dose.
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years.
No long-term seroprotection data beyond two years after a first booster administered 1 year after primary immunization has been generated in children.
Children below 2 months of age
The safety and efficacy of IXIARO in children younger than 2 months has not been established. No data are available.
Method of administration
The vaccine should be administered by intramuscular injection into the deltoid muscle. In infants, the anterolateral aspect of the thigh may be used as injection site. IXIARO should never be injected intravascularly.
When IXIARO is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites.
Exceptionally, IXIARO can also be administered subcutaneously to patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration. Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4). However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite (see section 2.), host cell protein.
Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.
Administration must be postponed in persons with acute severe febrile conditions.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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.
Under no circumstances should IXIARO be administered intravascularly.
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 micro-organisms.
Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, haemophilia or other bleeding disorders (see section 4.2).
In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m. vaccination, and 97.3% one week after the second i.m. vaccination in the conventional schedule. After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m. vaccination. Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV).
Protection against Japanese Encephalitis is not ensured until the second dose has been received.
Concomitant administration of IXIARO with other vaccines:
Concomitant administration of IXIARO with inactivated hepatitis A vaccine and with inactivated rabies vaccine in two different schedules has been evaluated in clinical studies. There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section 5.1).
The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly.
In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained.
Paediatric population
No interaction studies have been performed in children and adolescents.
Pregnancy
There are limited amount of data from the use of IXIARO in pregnant women.
In animal studies findings of unclear clinical relevance have been identified (see section 5.3). As a precautionary measure, the use of IXIARO during pregnancy should be avoided.
Breast-feeding
It is unknown whether IXIARO is excreted in human milk.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible. However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided.
Fertility
A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.
IXIARO has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries).
Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions. They usually occur within the first three days after vaccination, are usually mild and resolve within a few days. No increase in the number of adverse reactions was noted between first and second doses or following a booster dose in adults.
Most commonly reported adverse reactions in adults included headache (20% of subjects), myalgia (13%), injection site pain (33%), injection site tenderness (33%) and fatigue (12.9%).
Most commonly reported adverse reactions in children and adolescents included pyrexia, diarrhoea, influenza like illness, irritability, injection site pain, injection site tenderness, and injection site redness (see table 1).
Adverse reactions are listed according to the following frequencies:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥1/1,000 to < 1/100
Rare: ≥1/10,000 to < 1/1,000
Adult and older adults (>65 years) population
Blood and lymphatic system disorders
Uncommon: lymphadenopathy
Rare: thrombocytopenia
Nervous system disorders
Very common: headache
Uncommon: migraine, dizziness
Rare: paraesthesia, neuritis, dysgeusia, syncope*
Eye disorders
Rare: eyelid oedema
Ear and labyrinth disorders
Uncommon: vertigo
Cardiac disorders
Rare: palpitations, tachycardia
Respiratory, thoracic and mediastinal disorders
Rare: dyspnoea
Gastrointestinal disorders
Common: nausea
Uncommon: vomiting, diarrhoea, abdominal pain
Skin and subcutaneous tissue disorders
Uncommon: rash, pruritus, hyperhidrosis
Rare: urticaria, erythema
Musculoskeletal and connective tissue disorders
Very common: myalgia
Uncommon: musculoskeletal stiffness, arthralgia
Rare: pain in extremity
General disorders and administration site conditions
Very common: injection site pain, injection site tenderness, fatigue
Common: influenza like illness, pyrexia, other injection site reactions e.g. redness, hardening, swelling, itching
Uncommon: chills, malaise, asthenia
Rare: oedema peripheral
Investigations
Uncommon: hepatic enzymes increased
*reported also from post-marketing experience
Paediatric population (2 months to <18 years of age)
Table 1: Frequency of adverse reactions observed in children given the 0.25 ml dose (2 months to <3 years of age) and in children and adolescents given the 0.5 ml dose (3 years to <18 years of age)
Frequency of adverse reactions(%) by dose/age
System Organ Class
Preferred Term
0.25 ml
N=783
2 months to <3 years
0.5 ml
N=628
3 to <18 years
Blood and Lymphatic System Disorders
Lymphadenopathy
0.1
0.0
Metabolism and Nutrition Disorders
Decreased appetite
8.2
1.9
Nervous System Disorders
Headache
2.9
6.1
Respiratory, Thoracic and Medistinal Disorders
Cough
0.5
0.3
Gastrointestinal Disorders
Diarrhoea
11.9
1.4
Vomiting
7.3
1.9
Nausea
3.9
1.9
Abdominal pain
0.1
0.0
Skin and Subcutaneous Tissue Disorders
Rash
6.3
1.4
Musculoskeletal and Connective Tissue Disorders
Myalgia
3.0
7.1
General Disorders and Administration Site Conditions
Pyrexia
28.5
10.4
Influenza like illness
10.9
2.9
Irritability
10.9
1.9
Fatigue
3.5
3.5
Injection site redness
10.0
4.1
Injection site pain
6.1
14.1
Injection site tenderness
4.2
14.7
Injection site swelling
3.6
2.2
Injection site hardening
1.2
1.9
Injection site itching
0.6
1.6
Investigations
Hepatic enzymes increased
0.5
0.2
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
No symptoms related to overdose were reported.
Paediatric population:
No case of overdose has been reported in the paediatric population. Inadvertent administration of an 0.5 ml dose of IXIARO in children aged 1 to <3 years does not pose any safety concerns (section 5.1.).
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Japanese encephalitis vaccine (inactivated, adsorbed). The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about IXIARO suspension for injection – Japanese encephalitis vaccine (inactivated, adsorbed). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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