IXCHIQ – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine IXCHIQ, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start rece iving this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What IXCHIQ is and what it is used for
IXCHIQ is a vaccine that helps protect adults and adolescents aged 12 years and older against disease caused by the Chikungunya virus (CHIKV). It should be given to individuals who are at high risk of becoming infected with Chikungunya virus and after carefully weighing the benefits and risks (see section 2).
Chikungunya is a disease that is caused by the chikungunya virus ( CHIKV) , which is found in the sub- tropical regions of the Americas, Africa, Southeast Asia, India, and the Pacific Region. CHIKV is spread to humans by the bite of an infected mosquito . The majority of people infected with CHIKV develop a sudden fever and severe pain in multiple joints. Other symptoms may include headache, muscle pain, joint swelling, or rash. These symptoms typically resolve within 7 to 10 days, but symptoms may last for months or years .
Talk to your doctor, pharmacist or nurse first to decide if you should be given this vaccine.
How the vaccine works
IXCHIQ works by teaching the immune system (the body’s natural defences) to defend itself against CHIKV. The vaccine contains a form of the virus that has been weakened in the laboratory so it can not multiply. When the body encounters this weakened version of t he virus, the immune system will recognise it and produce antibodies to attack it. When a vaccinated person later comes into contact with the virus, their immune system will recognise it and be ready to defend the body against it. This helps protect them f rom getting sick.
⚠️ 2. What you need to know before you receive IXCHIQ
The vaccine must not be given:
- If you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).
- If your immune system has a reduced ability to fight infections and other diseases (immunodeficiency) or you have a weakened immune system (immunocompromised) because of a disease or a medicine (such as cancer and chemotherapy, use of medicines that weaken the immune system such as corticosteroids or immunosuppressants , inherited immune problems, or HIV infection).
Warnings and precautions
Talk to your doctor or , pharmacist or nurse before you receive IXCHIQ :
- If you have ever had a severe allergic reaction after any other vaccine injection.
- If you have anxiety related to needles or injections or if you have ever fainted following any injection .
- If you have a problem with bleeding or bruising , or if you are taking an anticoagulant medicine (to prevent blood clots) .
- If you have a recent onset of fever (body temperature over 38°C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold .
Your doctor will carefully weigh the benefits and risks before recommending the vaccine, taking into consideration the risk of infection with the chikungunya virus in the regions where you are living or going to stay. Serious reactions to the vaccine have been reported mostly in persons 65 years and older and in persons with chronic medical conditions, such as high blood pressure, diabetes or heart disease , but also in healthy young adults . Tell your doctor or nurse immediately if you experience worsening of your general health or existing diseases (see section 4).
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine .
Do not donate blood for at least 4 weeks after you have been vaccinated with IXCHIQ.
Inflammation of the brain Inflammation of the brain (encephalitis) has been observed following vaccination with IXCHIQ .
Symptoms may include confusion, sleepiness and seizures accompanied by fever and headache. If you experience any of the above symptoms after vaccination, seek medical attention immediately mentioning that you have recently received IXCHIQ (see Section 4).
Chikungunya -like adverse reactions IXCHIQ may cause side effects similar to chikungunya disease, which may also be severe or last longer (see Section 4).
IXCHIQ may not fully protect everyone who gets the vaccine.
IXCHIQ does not protect against other diseases transmitted by mosquitoes.
You should still protect yourself from mosquito bites even after you have received the IXCHIQ vaccine. When traveling to countries with chikungunya virus, use insect repellent , wear long- sleeved shirts and pants and stay in places with air conditioning or that use window and door screens.
Children and adolescents
IXCHIQ can be used in adolescents aged 12 years and older . IXCHIQ has not been tested fully in young people under 12 years of age . It should not be used in this age group.
Other medicines and IXCHIQ
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines .
Pregnancy , breast -feeding and fertility If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
IXCHIQ has not been studied in pregnant women or nursing mothers.
Driving and using machines
Some of the side effects of IXCHIQ (see section 4 ) may temporarily affect your ability to drive and use machines. Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.
IXCHIQ contains sodium and potassium
This medicine contains less than 1 mmol sodium (23 mg) per dose , that is to say essentially ‘sodium – free’.
This medicine contains potassium, less than 1 mmol (39 mg) per dose , i.e. essentially ‘potassium – free’.
IXCHIQ contains sorbitol
This medicine contains 25 mg Sorbitol in each 0.5 mL dose which is equivalent to 0.036 mg Sorbitol/kg/0.5 mL. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should b e taken into account.
💊 3. How IXCHIQ is given
IXCHIQ is given as a single injection of 0.5 mL into the muscle of your upper arm by a doctor , pharmacist or nurse .
The dose for adolescents aged 12 to <18 years is the same as for adults.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Serious side effects
Get urgent medical attention if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms:
- difficulty breathing
- hoarseness or wheezing
- hives or rash
- swelling of your lips, face or throat
- dizziness
- weakness
- fast heartbeat In the post -marketing setting, severe but rare reactions to the vaccine have been seen, especially in elderly persons (65 years or older) with multiple long- term medical conditions. These side effects included worsening of the general health or of chronic medical conditions and inflammation of the brain, leading to falls, hospitalisation or death (see section 2). Tell your doctor or nurse immediately if you experience worsening of your general health or existing diseases.
The following serious side effects have been reported (frequency not known – cannot be estimated from the available data):
- Inflammation of the brain (encephalitis)
- General dysfunction of the brain, which may be caused by various factors (encephalopathy)
- Inflammation of the membranes that surround the brain and spinal cord (meningitis) If you experience symptoms suggestive of these side effects, such as confusion, sleepiness, fever, headache, seizures or neck stiffness, seek medical attention immediately mentioning that you have recently received IXCHIQ.
Side effects similar to chikungunya disease IXCHIQ may cause side effects similar to chikungunya disease (fever ≥ 38°C together with joint pain, muscle pain, headache, fatigue, or certain symptoms pertaining to the nervous system, the heart or the eyes). The symptoms usually start about 3 days after vaccination and disappear within 4 days. In some uncommon cases (about 4 in 1000 people), these side effects may last longer than 30 days. Side effects similar to chikungunya disease are most often mild but some adults may develop more severe symptoms (ab out 2 in 100 people).
Other side effects
The following side effects may also occur after receiving this vaccine.
Very common (may affect more than 1 in 10 people)
- headache
- feeling sick (nausea )
- tiredness (fatigue)
- muscle pain (myalgia)
- joint pain (arthralgia)
- fever
- tenderness, pain, redness (erythema ), hardening (induration) , or swelling where the injection is given
- low levels of white blood cells
- high levels of liver enzymes, as measured in blood tests
Common (may affect up to 1 in 10 people)
- swollen lymph nodes (lymphadenopathy)
- skin rash
- chills
- back pain
- dizziness
- diarrhoea
- vomiting
- eye pain
Uncommon (may affect up to 1 in 100 people)
- pins and needles, a burning or prickling sensation that is usually felt in the hands, arms, legs, or feet (paraesthesia)
- dilation and redness of the eyelid vessels
- ringing or buzzing in the ears (tinnitus ),
- shortness of breath (dyspnoea)
- excessive sweating (hyperhidrosis)
- physical weakness (asthenia)
- swelling of lower legs or hands (peripheral oedema)
- low levels of blood platelets which can lead to bleeding and bruising
- fainting (syncope)
- decreased appetite
- feeling generally unwell (malaise)
Rare (may affect up to 1 in 1 000 people)
- low amounts of water and sodium in the blood (hypovolaemic hyponatraemia)
- confusion.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V .* By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store IXCHIQ
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton , vial and syringe after “EXP” . The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C to 8 °C ). Do not freeze.
Store in the outer carton in order to protect from light.
In-use stability of the reconstituted vaccine has been demonstrated for 2 hours when stored either refrigerated at (2°C – 8°C) or at room temperature (15°C – 25°C). After this time, the reconstituted vaccine must be discarded.
From a microbiological point of view, after first opening the vaccine should be used immediately. If not used immediately, in- use storage times and conditions are the responsibility of the user.
Do not throw away any vaccines via wastewater or household waste. Your doctor or nurse will dispose of this vaccine .These measures will help protect the environment.
📦 6. Contents of the pack and other information
What IXCHIQ contains
After reconstitution, o ne dose (0.5 mL) contains Chikungunya virus Δ5nsP3 strain (live, attenuated) *, not less than 3.0 log 10 TCID 50**.
- Produced in Vero cells ** 50% tissue c ulture infectious d ose
This product contains genetically modified organisms (GMOs).
The other ingredients are :
Powder: Sucrose, D -Sorbitol, L -Methionine , Trisodium Citrate D i-Hydrate , Magnesium Chloride, Di- Potassium – Hydrogen Phosphate , Potassium -Di- Hydrogen- Phosphate and recombinant Human Albumin (rHA produced in yeast (Saccharomyces cerevisiae) ).
Solvent: Sterile water for injections See Section 2 “the vaccine contains sodium and potassium”.
What IXCHIQ looks like and contents of the pack
IXCHIQ is a powder and solvent for solution for injection. The powder is white to slightly yellowish.
The solution is a clear colourless liquid .
Each pack of IXCHIQ contains :
- 1 vial containing the IXCHIQ c omponent powder for 1 dose as a white to slightly yellowish powder.
- 1 pre -filled syringe containing the solvent for 1 dose sterile water component as a clear solution.
The contents of the two components (vial and syringe ) are to be mixed prior to vaccination providing one dose of 0.5 mL.
Marketing Authorisation Holder and Manufacturer
Valneva Austria GmbH Campus Vienna Biocenter 3 1030 Vienna Austria infoixchiq @valneva.com
This leaflet was last revised i n
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu <————————————————————————————————————————>
🩺 Information intended for healthcare professionals only
The vaccine must be reconstituted only with the solvent provided prior to administration.
A needle (22 -25G) with appropriate length of preferably at least 40 mm (1 1/2″) should be used for reconstitution of the vaccine.
The syringe is for one -time use only .
The reconstituted vaccine is a clear, colorless to slightly yellowish liquid solution. The vaccine should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, do not administer the vaccine.
Figure 1 1) After removing the syringe cap, attach a needle on the luer lock of the syringe.
Figure 2 2) Cleanse the vial stopper. Slowly transfer the entire contents of the prefilled syringe (solvent ) into the vial (powder) .
Figure 3 3) Gently swirl the vial to dissolve the powder . Do not shake or invert the vial.
4) After swirling, wait for at least one minute for complete reconstitution of the vaccine.
After reconstitution, administer IXCHIQ intramuscularly within 2 hours. If not used within 2 hours, discard the reconstituted vaccine.
Disposal This product contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in compliance with the local guidance for pharmaceutical waste. Potential spills should be cleaned up immediately and disinfected according to local policies. Dispose of the used syringe and needle in a sharps container such as a closeable, puncture resistant container Figure 4 5) After reconstitution, slightly tilt the vial and withdraw the entire contents (0.5mL) of the reconstituted vaccine into the same syringe. Do not invert the vial in order to ensure complete withdrawal of the reconstituted volume .
ANNEX I V SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S) Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for chikungunya vaccine (live), the scientific conclusions of PRAC are as follows:
In view of available data on serious adverse reactions from spontaneous reports and in view of a plausible mechanism of action, the PRAC considers a restriction of the indication is warranted. The PRAC concluded that the product information of products con taining chikungunya vaccine (live) should be amended accordingly.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for chikungunya vaccine (live) the CHMP is of the opinion that the benefit -risk balance of the medicinal product(s) containing chikungunya vaccine (live) is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information IXCHIQ (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1828).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.