IXCHIQ 0.5 ml Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

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

IXCHIQ powder and solvent for injectable solution

Vaccine against chikungunya (live)
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for information on
how to report adverse effects.

because it contains important information for you.

• If you have any doubts, ask your doctor, pharmacist or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 administered
• 4. Possible side effects
• 5. How to store IXCHIQ
• 6. Contents of the pack and other information

1. What is IXCHIQ and what is it used for

IXCHIQ is a vaccine that helps protect adults and adolescents starting from 12 years of age
from the disease caused by the chikungunya virus (CHIKV).
Chikungunya is a disease caused by the chikungunya virus (CHIKV), spread in the
subtropical regions of the Americas, Africa, Southeast Asia, India and the Pacific region. CHIKV is
spread to humans through the bite of an infected mosquito. Most 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 usually resolve within 7-10 days, but can last for months or years.
Talk to your doctor, pharmacist or nurse first to decide if this
vaccine is right for you.

How the vaccine works
IXCHIQ works by teaching the immune system (the body's natural defenses) to defend itself against
CHIKV. The vaccine contains a form of the virus that has been weakened in the laboratory so that it
cannot multiply. When the body encounters this weakened version of the virus, the immune system
recognizes it and produces antibodies to attack it. When a vaccinated person comes into
contact with the virus, their immune system recognizes it and is ready to defend the body against it.
This prevents you from getting sick.

2. What you need to know before you receive IXCHIQ

The vaccine should not be administered:

• If you are allergic to the active ingredient 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 if your immune system is weakened (immunocompromised) due to an illness 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, pharmacist or nurse before you receive IXCHIQ:

• If you have ever had a severe allergic reaction after another vaccine injection.
• If you suffer from anxiety about needles or injections or if you have ever fainted after an injection.
• If you have problems with bleeding or bruising or if you are taking a blood-thinning medicine (to prevent blood clots).
• If you have a recent onset of fever (body temperature higher than 38 °C). However, you may still receive the vaccination if you have a mild fever or an upper respiratory tract infection such as a cold.

Your doctor will carefully assess the benefits and risks before recommending the vaccine, taking into
account the risk of infection with the chikungunya virus in the regions where you live or where you intend
to stay. Serious reactions to the vaccine have been reported mainly in people 65 years of age and
older and in people with chronic medical conditions, such as hypertension, diabetes or heart disease.
Immediately inform your doctor or nurse if you experience a worsening of your overall health
or existing conditions (see section 4).
If you are unsure whether any of these conditions apply to you, talk to your doctor, pharmacist or
nurse before the vaccine is administered to you.
Do not donate blood for at least 4 weeks after being vaccinated with IXCHIQ.
Brain inflammation
Inflammation of the brain (encephalitis) has been observed after vaccination with IXCHIQ. The
symptoms may include confusion, drowsiness and convulsions accompanied by fever and headache. If you experience any of the above symptoms after vaccination, seek immediate
medical attention mentioning that you have recently received IXCHIQ (see Section 4).
Adverse reactions similar to chikungunya
IXCHIQ may cause undesirable effects similar to those of chikungunya, which may also be
serious or last longer (see Section 4).
IXCHIQ may not fully protect everyone who receives the vaccine.
IXCHIQ does not protect against other mosquito-borne diseases.
You will need to protect yourself from mosquito bites even after receiving the IXCHIQ vaccine. When
travelling to countries with the chikungunya virus, use an insect repellent, wear long trousers and
long-sleeved shirts and stay in air-conditioned places or with mosquito nets at windows and
doors.

Children and adolescents
IXCHIQ can be used in adolescents starting from 12 years of age. IXCHIQ has not been
fully tested 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, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before receiving this vaccine.
IXCHIQ has not been studied in pregnant or breastfeeding women.

Driving and operating machinery
Some of the side effects of IXCHIQ (see section 4) may temporarily affect your ability to drive
vehicles and operate machinery. Avoid driving vehicles or operating machinery if you do not feel well after vaccination. Wait until these
effects have disappeared before driving vehicles or operating machinery.

IXCHIQ contains sodium and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially "sodium-free".
This medicine contains potassium, less than 1 mmol (39 mg) per dose, that is to say essentially "potassium-free".

IXCHIQ contains sorbitol
This medicine contains 25 mg of sorbitol in each 0.5 mL dose, which is equivalent to 0.036 mg of
sorbitol/kg/0.5 mL. The additive effect of co-administration of products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be considered.

3. How IXCHIQ is administered

IXCHIQ is administered as a single injection of 0.5 mL into the muscle of the upper arm by a doctor, pharmacist or nurse.
The dose for adolescents aged between 12 and 18 years is the same as for adults.
If you have any doubts about the use of this vaccine, please contact 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
Seek urgent medical attention if you experience symptoms of a severe allergic reaction. These reactions
may include a combination of the following symptoms:

• difficulty breathing
• hoarseness or wheezing
• hives or skin rash
• swelling of the lips, face or throat
• dizziness
• weakness
• fast heartbeat

In post-marketing experience, serious but rare reactions to the vaccine have been observed, especially in
elderly people (65 years of age or older) with multiple long-term medical conditions. These side
effects included worsening of general health or chronic medical conditions and
inflammation of the brain, leading to falls, hospitalisation or death (see section 2). Immediately inform
your doctor or nurse if you experience a worsening of your general health
or existing illnesses.
The following serious side effects have been reported (frequency not known – cannot be estimated
from available data):

• Inflammation of the brain (encephalitis)
• General brain dysfunction, which can be caused by various factors (encephalopathy)
• Inflammation of the membranes surrounding the brain and spinal cord (meningitis)

If you experience symptoms suggesting these side effects, such as confusion, drowsiness, fever,
headache, convulsions or stiff neck, seek immediate medical attention mentioning
that you recently received IXCHIQ.
Side effects similar to chikungunya
IXCHIQ can cause side effects similar to chikungunya (fever ≥ 38 °C together with joint pain, muscle pain, headache, fatigue or some symptoms related to the nervous system, the
heart or the eyes). Symptoms usually start about 3 days after vaccination and disappear within
4 days. In some rare cases (about 4 out of 1,000 people), these side effects may last more than
30 days. Chikungunya-like side effects are mostly mild, but some adults
may develop more serious symptoms (about 2 out of 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
• nausea
• fatigue
• muscle pain (myalgia)
• joint pain (arthralgia)
• fever
• tenderness, pain, redness (erythema), hardening or swelling at the injection site
• low levels of white blood cells
• elevated liver enzymes, measured with 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):

• tingling, a burning or prickling sensation usually felt in the hands, arms, legs or feet (paresthesia)
• dilation and redness of the palpebral vessels
• ringing or buzzing in the ears (tinnitus)
• shortness of breath (dyspnea)
• excessive sweating (hyperhidrosis)
• physical weakness (asthenia)
• swelling in the lower legs or hands (peripheral edema)
• low levels of platelets in the blood which may lead to bleeding and bruising
• fainting (syncope)
• decreased appetite
• feeling generally unwell (not feeling well)

Rare (may affect up to 1 in 1,000 people):

• low amounts of water and sodium in the blood (hypovolemic hyponatremia)
• confusion.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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.
The doctor, pharmacist or nurse are responsible for the storage of the medicine and for the
correct disposal of unused product. The following information is intended for healthcare
professionals.
Do not use this medicine after the expiry date indicated on the packaging, vial and
syringe after the wording "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
Store in the outer packaging to protect from light.
The stability of the reconstituted vaccine has been demonstrated for 2 hours if stored in a refrigerator (2 °C – 8
°C) or at room temperature (15 °C – 25 °C). After this period, the reconstituted vaccine must
be discarded.
From a microbiological point of view, after first opening, the vaccine must be used
immediately. If it is not used immediately, the storage times and conditions are the responsibility of the user.
Do not dispose of any vaccine in wastewater or household waste. The doctor or nurse
will dispose of the vaccine. These measures will help protect the environment.

6. Contents of the pack and other information

What IXCHIQ contains
After reconstitution, 1 dose (0.5 mL) contains the chikungunya virus strain Δ5nsP3 (live,
attenuated)*, not less than 3.0 log TCID **.
* Produced in Vero cells
** 50% of the tissue culture infectious dose
This product contains genetically modified organisms (GMOs).
The other ingredients are:
Powder: Sucrose, D-sorbitol, L-methionine, trisodium citrate dihydrate, magnesium chloride, potassium
dihydrogen phosphate, dipotassium 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".

Appearance of IXCHIQ and contents of the pack
IXCHIQ is a powder and solvent for injectable solution. The powder is from white to
slightly yellowish in colour. The solution is a clear, colourless liquid.
Each pack of IXCHIQ contains:

• 1 vial containing the IXCHIQ component in powder form for 1 dose, ranging from white to slightly yellowish powder.
• 1 pre-filled syringe containing the solvent for 1 dose of sterile water component in a clear solution.

The contents of the two components (vial and syringe) must be mixed before vaccination,
providing a dose of 0.5 mL.

Marketing authorisation holder and manufacturer
Valneva Austria GmbH
Campus Vienna Biocenter 3
1030 Vienna
Austria
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines
Agency website http://www.ema.europa.eu
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The following information is intended for healthcare professionals only:
The vaccine must only be reconstituted with the supplied solvent before administration.
A needle (22-25G) of appropriate length, preferably
at least 40 mm (1 1/2"), should be used for vaccine reconstitution.
The syringe is for single use only.
The reconstituted vaccine is a clear, transparent liquid, from colourless to slightly yellowish. The
vaccine should be visually inspected for the presence of particulate matter and
discoloration before administration, where the container and solution allow. If any of these conditions
exist, do not administer the vaccine.

Figure 1

• 1) After removing the syringe cap, attach a needle to the syringe luer lock.

Figure 2

• 2) Clean the vial stopper. Slowly transfer the entire contents of the pre-filled syringe (solvent) into the vial (powder).

Figure 3

• 3) Gently rotate the vial to dissolve the powder. Do not shake or invert the vial.
• 4) After rotating, wait at least one minute for complete vaccine reconstitution.

Figure 4

• 5) After reconstitution, slightly tilt the vial and draw the entire contents (0.5 mL) of the reconstituted vaccine into the same syringe. Do not invert the vial to ensure complete withdrawal of the reconstituted volume.

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 must be disposed of in accordance with local guidelines for pharmaceutical
waste. Any spills must be cleaned up immediately and disinfected according to
local policies. Dispose of used syringes and needles in a sharps container, such as a
closeable, puncture-resistant container

Annex IV
Scientific conclusions
Scientific conclusions
Since January 2025, the French overseas departments of the European Union (EU) have been affected by a
large outbreak of chikungunya, which has led to a vaccination campaign for people over 65 years of age with comorbidities at risk of severe illness. The campaign was subsequently
extended to all people aged 18 years and over. As of April 25, 2025, more than
44,000 confirmed cases of chikungunya had been reported in the French overseas territories of Réunion, including at least
9 fatal cases.
As of April 30, 2025, the marketing authorisation holder had reported 15 cases
of serious adverse events following vaccination with Ixchiq, both within and outside the EU.
Of the 9 serious cases reported within the EU, 4 involved people over 80 years of age
with multiple underlying comorbidities requiring hospitalisation. Two (2) of
these cases involved severe neurological complications in 84-year-olds; one patient was
deceased as a result of these complications, while the other was recovering in hospital. In both
subjects, the vaccine strain of the chikungunya virus was identified in body fluids by
polymerase chain reaction (PCR) method. Consequently, the French public health authority (Haute Autorité de Santé) recommended a temporary suspension of vaccination
with Ixchiq for subjects aged 65 years and over, pending completion of the necessary
investigations. The 6 cases reported in the United States of America were associated with serious neurological or cardiac adverse events after vaccination in travellers aged 67 years and over (source:
Vaccine Adverse Event Reporting System, VAERS). Five (5) of these subjects had been
hospitalised and all had recovered. All 6 patients had existing comorbidities.
Although the marketing authorisation holder has not determined a
causal relationship, the association of vaccination with serious adverse events was considered
plausible by at least one expert from the Clinical Immunization Safety Assessment (CISA) project. For
this reason, at the meeting of April 16, the Advisory Committee on Immunization Practices (ACIP)
of the Centers for Disease Control and Prevention (CDC) of the United States recommended
caution in vaccinating people aged 65 years and over depending on the risk of
exposure. Subsequently, in May, the US Food and Drug Administration (FDA) and
CDC jointly issued a safety communication recommending a pause
in the use of the vaccine for subjects aged 60 years and over.
On May 7, 2025, the PRAC recommended, as a temporary measure, a contraindication of Ixchiq
for subjects aged 65 years and over during the review and conduct of a thorough assessment
of all available data.