IXCHIQ 1 vial/1 pack Powder and solvent for solution for injection

• 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.

1. What IXCHIQ is and what it is used for
2. What you need to know before you receive IXCHIQ
3. How IXCHIQ is given
4. Possible side effects
5. How to store IXCHIQ
6. Contents of the pack and other information

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 the 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 from getting sick.

• 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, IgA deficiency, history of thymus disorder, thymectomy).
• If you have:
  Diabetes
  Cardiovascular Disease
  Chronic Kidney Disease
  Hypertension

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 chronic kidney disease (CKD) or heart disease. 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.

IXCHIQ has not been tested fully in young people under 18 years of age. It should not be used in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

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.

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’.

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 be taken into account.

If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.

After reconstitution, one dose (0.5 mL) contains Chikungunya virus Δ5nsP3 strain (live, attenuated)*, not less than 3.0 log¹⁰ TCID⁵⁰**.

* Produced in Vero cells

** 50% tissue culture infectious dose

This product contains genetically modified organisms (GMOs).

The other ingredients are:

Powder: Sucrose, D-Sorbitol, L-Methionine, Trisodium Citrate Di-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”.

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 component 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.