IXIARO 6 MCG Инъекционная суспензия

Содержание инструкции

1. What is IXIARO and what is it used for
2. What you need to know before you and/or your child receive IXIARO
3. How to use IXIARO
4. Possible side effects
5. How to store IXIARO
6. Package Contents and Other Information

IXIARO, injectable suspension
Japanese encephalitis vaccine (inactivated adsorbed)

Read this leaflet carefully before you or your child receive this vaccine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This vaccine has been prescribed for you personally and/or for your child. Do not give it to other people.
• If you and/or your child experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What IXIARO is and what it is used for
• 2. What you need to know before you and/or your child receive IXIARO
• 3. How IXIARO is administered
• 4. Possible side effects
• 5. How to store IXIARO
• 6. Contents of the pack and other information

1. What is IXIARO and what is it used for

IXIARO is a vaccine that acts against the Japanese encephalitis virus.
The vaccine stimulates the body to develop protection (antibodies) against this disease.
IXIARO is indicated in the prevention of Japanese encephalitis. The Japanese encephalitis virus (JEV) is
mainly found in Asia and is transmitted to humans by mosquitoes that have bitten an infected animal (e.g. pigs). In many individuals, the infection causes mild symptoms or is asymptomatic. In people who
develop a severe form of the disease, Japanese encephalitis begins as a flu-like syndrome, with fever, chills, fatigue, headache, nausea and vomiting. In the early stages of the disease, the
patient may also show confusion and agitation.
IXIARO should only be administered to adults, adolescents, children and infants from 2 months of age
who travel to countries where Japanese encephalitis is common (endemic), or who are at risk of
exposure due to their work.

2. What you need to know before you and/or your child receive IXIARO

Do not use IXIARO

• if you and/or your child are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• if you and/or your child have developed an allergic reaction following administration of a previous dose of IXIARO. Signs of an allergic reaction include: itchy rash, difficulty breathing and swelling of the face and tongue.
• if you and/or your child are ill with a high fever; in this case, the doctor will postpone the vaccination.

Warnings and precautions
IXIARO must not be administered intravenously or intra-arterially.
Primary immunization must be completed at least one week before any potential exposure
to the Japanese encephalitis virus.
Inform your doctor:

• if you and/or your child have health problems of any kind, which you have had in the past following the administration of a vaccine.
• if you and/or your child have any other known allergies.
• if you and/or your child have a bleeding disorder (a condition that causes abnormal bleeding) or a decrease in platelets (thrombocytopenia), a condition that increases the risk of bleeding or bruising.
• if the child is under 2 months of age, as IXIARO has not been tested in infants under 2 months of age.
• if your or the child's immune system is not functioning properly (immunodeficiency) or if you and/or your child are taking medicines that affect the immune system (e.g. a medicine called cortisone or anticancer drugs).

The doctor will discuss the potential risks and benefits of administering
IXIARO with the patient.
Note that:

• IXIARO cannot cause the diseases it protects against.
• IXIARO does not prevent infections caused by viruses other than the Japanese encephalitis virus.
• As with any other vaccine, vaccination with IXIARO may not always generate protection.
• Even after vaccination with IXIARO, you and/or your child must take the necessary precautions to limit mosquito bites (use of appropriate clothing, use of repellents, use of mosquito nets). Other medicines and IXIAROStudies conducted in humans to evaluate the efficacy and safety of the medicine (clinical studies) have shown that IXIARO can be administered concurrently with the hepatitis A vaccine and the rabies vaccine. Inform your doctor if you and/or your child are taking, have recently taken or may take any other medicines, including over-the-counter medicines, or if you have recently been vaccinated. Pregnancy, breastfeeding and fertilityThere is limited information regarding the use of IXIARO in pregnant or breastfeeding women. The use of IXIARO during pregnancy and breastfeeding should be avoided as a precautionary measure. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before receiving this vaccine. Driving and using machinesIXIARO does not or negligibly alters the ability to drive vehicles or use machines.

IXIARO contains potassium and sodium
This medicine contains potassium, less than 1 mmol (39 mg) per single dose of 0.5 ml, i.e.
essentially “potassium-free” and contains less than 1 mmol (23 mg) of sodium per single dose of 0.5 ml, i.e.
essentially “sodium-free”. This product may contain traces of residual sodium metabisulfite below
the limit of detectability.

3. How to use IXIARO

The recommended dose for adults, adolescents and children from 3 years of age is a total of 2 injections of
0.5 ml each:

• a first dose by injection on Day 0
• a second dose 28 days after the first injection (Day 28).

Adults aged between 18 and ≤ 65 years can also be vaccinated according to the following schedule:

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

Infants and children from 2 months to less than 3 years of age:
The recommended dose for infants and children from 2 months to less than 3 years of age is a total of 2 injections of
0.25 ml each:

• a first dose by injection on Day 0
• a second dose 28 days after the first injection (Day 28).

It is important that you and/or the child complete the 2-injection vaccination schedule. It is recommended to
administer the second injection at least 1 week before exposure to the risk of contracting the Japanese encephalitis virus. Otherwise, protection against the disease for you and/or the child may
be only partial.
For adults, adolescents, children and infants at least one year old, a booster dose may be
administered within the second year (i.e. 12 - 24 months) from the first dose of the recommended primary immunization
schedule. In adults, a second booster can be given 10 years after the first. For the
elderly (> 65 years) the first booster dose may be given earlier. The doctor will decide on the
need and timing of booster doses.
Administration
IXIARO is administered to you and/or the child by a doctor or nurse by injection into the
arm muscle (deltoid muscle). IXIARO must not be injected into a blood vessel.
In the event that you and/or the child suffer from a coagulation disorder, the doctor may decide
to administer the vaccine under the skin (subcutaneously).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you forget to receive IXIARO
If you and/or the child miss a scheduled injection, it is recommended to contact your doctor and
book a second appointment for the second injection.
Without the second injection, you and/or the child will not be fully protected from the disease. Based on
some data, the second injection can be given up to 11 months after the first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects listed below have been observed during clinical studies. These
reactions usually occur within the first three days after vaccination, are generally
mild and disappear within a few days.

Very common (affects more than 1 in 10 people):
headache, muscle pain, pain at the injection site, tenderness at the injection site,
fatigue

Common (affects 1 to 10 in 100 people):
Nausea, flu-like illness, fever, other reactions at the injection site (e.g. redness,
hardening, swelling, itching)

Uncommon (affects 1 to 10 in 1000 people):
vomiting, skin rash, changes in lymph nodes, migraine (throbbing headache often accompanied by
nausea and vomiting and sensitivity to light), dizziness, vertigo (a sensation of spinning), diarrhea, pain
abdominal, excessive sweating, itching, chills, general feeling of discomfort, musculoskeletal
stiffness, joint pain, weakness, abnormal laboratory tests for the liver (increased
liver enzymes)

Rare (affects 1 to 10 in 10000 people):
palpitations, fast heartbeat, difficulty breathing, abnormal skin sensation (e.g.
tingling), urticaria, skin redness, pain in the legs or arms, thrombocytopenia,
nerve inflammation, swelling of the limbs and ankles, altered taste, eyelid swelling,
fainting

Further side effects in children aged between 2 months and less than 3 years
In children from 2 months to less than 3 years of age, the following adverse events have been observed with
more frequency compared to children aged between 3 and less than 12 years, adolescents and adults:

Very common:fever (28.9%), diarrhea (11.8%), flu-like illness (11.2%), irritability (11.0%)

Common:loss of appetite, vomiting, skin rash

Uncommon:cough

Reporting of side effects
If you and/or the child experience any side effects, including those not listed in this
the national reporting system as reported in Annex V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store IXIARO

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package 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 must not be used.
• Store in the original package to protect the medicine from light.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What IXIARO contains
1 dose (0.5 ml) of IXIARO contains:
SA -14-2 strain of Japanese encephalitis virus (inactivated) 6 UA
corresponding to a potency of ≤ 460 ng ED
cultivated on Vero cells
adsorbed on hydrated aluminum hydroxide (approximately 0.25 milligrams Al)
antigen units
This vaccine contains aluminum hydroxide as an adjuvant.
The other components are: sodium chloride, dipotassium hydrogen phosphate, disodium hydrogen phosphate, water for
injections

Description of the appearance of IXIARO and package contents
IXIARO is an injectable suspension (0.5 ml in a glass syringe with or without a separate needle, pack
of 1).
IXIARO is a sterile, white to slightly opalescent suspension, which becomes homogeneous after being
shaken.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Valneva Austria GmbH
Campus Vienna Biocenter 3
A-1030 Vienna
Austria
E-mail: [email protected]
Manufacturer:
Valneva Austria GmbH
Campus Vienna Biocenter 3
A-1030 Vienna
Austria
For further information on this medicinal product, contact the marketing authorisation holder at the following e-mail address:
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu. This leaflet is available in all languages of the European
Union/European Economic Area on the European Medicines Agency website.

--------------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
The pre-filled syringe is for single use only and must not be used for more than one person. The pre-filled syringe
is ready for use. If the package does not contain needles, use a sterile needle.
Do not use if the blister pack protective film is damaged or if the package is damaged.
Following storage, a slight white deposit with a clear, colorless supernatant may be observed.
Before administration, shake the syringe well to obtain a white, opaque and homogeneous suspension. Do not proceed with administration if, after shaking the syringe, particulate matter remains, or if
discoloration is observed, or if the syringe appears materially damaged.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with
current local regulations.
Information on administering a dose of 0.5 ml of IXIARO to subjects from 3 years of age
To administer the full dose of 0.5 ml, proceed as follows:

• 1. Shake the syringe to obtain a homogeneous suspension.
• 2. Remove the cap from the syringe tip by twisting it gently. Do not attempt to remove it by snapping or pulling, otherwise there is a risk of damaging the syringe.
• 3. Attach a needle to the pre-filled syringe.

Information on preparing a dose of 0.25 ml of IXIARO, for use in children under 3
years of age
To administer a dose of 0.25 ml to children between 2 months and under 3 years of age, proceed as follows:

• 1. Shake the syringe to obtain a homogeneous suspension.
• 2. Remove the cap from the syringe tip by twisting it gently. Do not attempt to remove it by snapping or pulling, otherwise there is a risk of damaging the syringe.
• 3. Attach a needle to the pre-filled syringe.
• 4. Hold the syringe in a vertical position.
• 5. Press the syringe plunger up to the edge of the red line marked on the syringe body, indicated by a red arrow (see Figure 1)*, to expel the excess volume.
• 6. Attach a new sterile needle before injecting the remaining volume.

* If the syringe plunger has been pressed beyond the red line, it is not possible to guarantee the
administration of a 0.25 ml dose and a new syringe should be used.

Figure 1: Preparation for administering a 0.25 ml dose