Ticovac

Package leaflet: Information for the user

TICOVAC

0.25 ml for paediatric use
Injectable suspension in a pre-filled syringe
Vaccine (whole virus, inactivated) against tick-borne encephalitis
Please read all of this leaflet carefully before you or your child is given this vaccine, as it contains important information for you and your child.

1. Keep this leaflet. You may need to read it again.
2. If you have any questions, ask your doctor, pharmacist or nurse.
3. This vaccine has been prescribed only for you or your child. Do not give it to others.
4. If you or your child experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What TICOVAC 0.25 ml for paediatric use is and what it is used for
2. What you need to know before you or your child is given TICOVAC 0.25 ml for paediatric use
3. How to use TICOVAC 0.25 ml for paediatric use
4. Possible side effects
5. How to store TICOVAC 0.25 ml for paediatric use
6. Contents of the pack and other information

1. What TICOVAC 0.25 ml for pediatric use is and what it is used for

TICOVAC 0.25 ml for pediatric use is a vaccine used to prevent disease caused by the tick-borne encephalitis (TBE) virus. It is indicated for children aged between 1 and 15 years.

• The vaccine stimulates the body to produce adequate protection (antibodies) against the virus.
• It does not protect against other viruses and bacteria (some of which are transmitted by tick bites) that may cause similar symptoms.

The tick-borne encephalitis virus can cause severe infections of the brain or spinal cord and their coverings. These infections often begin with headache and fever. In some individuals and in more severe forms, they may progress to loss of consciousness, coma, and death.
The virus can be carried by ticks and is transmitted to humans through tick bites.
The risk of being bitten by ticks carrying the virus is very high in large parts of Europe, as well as in Central and Eastern Asia. People living in or travelling to these areas are at risk of contracting tick-borne encephalitis. Ticks are not always visible on the skin, and bites may go unnoticed.

• As with all vaccines, this vaccine may not fully protect all vaccinated individuals.
• A single dose of the vaccine is unlikely to be sufficient to protect you or your child against infection. Three doses should be administered (see section 3 for further information) to achieve optimal protection.
• Protection does not last for life. Regular booster doses are required (see section 3 for further information).
• There are no data available on post-exposure prophylaxis (vaccination after tick bite).

2. What you should know before you or your child receives TICOVAC 0.25 ml for paediatric use

Do not use TICOVAC 0.25 ml for paediatric use:

• If you or your child are allergic to the active substance, to any of the other ingredients (listed in section 6), formaldehyde or protamine sulfate (used during the manufacturing process), or to antibiotics such as neomycin and gentamicin. For example, if you or your child have experienced skin rash, facial or throat swelling, difficulty breathing, bluish discoloration of the tongue or lips, low blood pressure, or collapse.
• If you or your child have had a severe allergic reaction after eating eggs or chicken.
• If you or your child have an acute illness with or without fever, you should wait before receiving TICOVAC 0.25 ml for paediatric use. The doctor may ask you or your child to delay the injection until you or your child feel better.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before vaccination if you or your child:

• has a bleeding disorder or bruises easily
• has an autoimmune disease (e.g. rheumatoid arthritis or multiple sclerosis)
• has a weakened immune system (so that you or your child cannot effectively fight infections)
• does not produce antibodies effectively
• is taking medicines for cancer
• is taking medicines called corticosteroids (which reduce inflammation)
• has any brain disease
• has neurological disorders or epilepsy

The vaccine may not be suitable if any of the above conditions apply to you or your child. Alternatively, the doctor may still administer the vaccine. The doctor may ask you to have a blood test to check whether the vaccine has worked.

Other medicines and TICOVAC 0.25 ml for paediatric use

Tell your doctor, pharmacist, or nurse if you or your child are taking or have recently taken any other medicines, including those without a prescription. The doctor will tell you whether you or your child can receive TICOVAC 0.25 ml for paediatric use at the same time as other vaccines. If you or your child have recently received another vaccine, the doctor will decide where and when to administer TICOVAC 0.25 ml for paediatric use.

TICOVAC 0.25 ml for paediatric use may not provide complete protection if you or your child are receiving immunosuppressive treatment.

Tell your doctor if you or your child have ever been infected with, or vaccinated against, yellow fever, Japanese encephalitis, or dengue virus. This is because you or your child may have antibodies in the blood that could react with the tick-borne encephalitis (TBE) virus used in tests to measure your antibody levels. These tests may therefore give incorrect results.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this vaccine.

The doctor will discuss the potential risks and benefits with you. The effect of TICOVAC 0.25 ml for paediatric use during pregnancy or breastfeeding is unknown. However, it may still be administered if the risk of infection is high.

Driving and using machines

It is unlikely that the vaccine will affect the ability to drive or use machinery (such as playing in the street or riding a bicycle). However, you may experience vision problems or dizziness.

TICOVAC 0.25 ml for paediatric use contains potassium and sodium

Potassium and sodium are present at levels less than 1 mmol per dose; therefore, the product is essentially “sodium- and potassium-free”.

3. How to use TICOVAC 0.25 ml for paediatric use

This vaccine is usually injected into the muscle of the upper arm. In children under 18 months of age, the vaccine may be injected into the thigh. It must not be injected into a blood vessel. Only in exceptional cases (if you or your child has a bleeding disorder or is taking blood-thinning medicines called anticoagulants), the vaccine may be administered under the skin (subcutaneously).
This vaccine must not be administered to individuals aged 16 years or older. For this age group, the TBE vaccine for adults is recommended. Vaccination must be documented by the doctor, who will record the batch number.

Primary vaccination schedule
The primary vaccination course consists of three doses of TICOVAC 0.25 ml for paediatric use:

1. Your doctor will decide when to administer the first dose.
2. The second dose should be given 1 to 3 months after the first. However, if rapid protection is required, the second dose may be administered as early as two weeks after the first dose.
3. The third dose should be given 5 to 12 months after the second dose.

• It is preferable that the first and second doses are administered during the winter season, since ticks become active in spring. This will allow you to develop adequate protection before the start of tick season.

• The third dose completes the primary vaccination course. The vaccination schedule should ideally be completed with the third dose within the same tick season or at least before the beginning of the next tick season.

• Provides protection for up to three years.

• If too much time passes between the three doses, you may not achieve full protection against infection.

Booster vaccinations
The first booster dose should be administered 3 years after the third dose. Further booster doses should be administered every 5 years.

Catch-up dose
If too much time passes between one vaccine dose and the next, you may not be protected against TBE. However, a single catch-up dose with TICOVAC is sufficient to continue the vaccination schedule if you have previously received at least two vaccinations. It is not necessary to restart the entire vaccination cycle. Consult your doctor for further information.
Data regarding catch-up doses in children under 6 years of age are not available.

Children with a weakened immune system (including those undergoing immunosuppressive therapy)
Your doctor may decide to measure the antibodies present in the blood four weeks after the second dose and to administer an additional dose if there are no signs of an immune response at that point. The same applies to each of the subsequent doses.

If you use more TICOVAC 0.25 ml pediatric use than you should
An overdose is highly unlikely, as the injection is administered by a healthcare professional using a single-dose pre-filled syringe.
If you have any doubts about the use of this vaccine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

As with all vaccines, severe allergic reactions may occur. These are very rare, but appropriate treatment and medical supervision must always be readily available. Symptoms of severe allergic reactions include:

• swelling of the lips, mouth, or throat (which may make swallowing and breathing difficult),
• a rash or swelling of the hands, feet, and ankles,
• loss of consciousness due to a drop in blood pressure.

These signs or symptoms usually occur very rapidly after injection, while the person is still at the clinic or medical office. If you experience any of these symptoms after leaving the place where the injection was given, seek medical attention IMMEDIATELY.

High temperature (fever) may occur in children. In young children (aged between 1 and 2 years), one in three develops fever after the first injection. In children aged between 3 and 15 years, fewer than one in ten develop fever. Fever usually lasts only 1–2 days. Fever occurs less frequently after the second, third injection, or after booster doses. If necessary, your doctor may recommend a treatment to prevent or treat fever.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• Pain at the injection site

Common (may affect up to 1 in 10 people):

• Headache
• Swelling, hardening, and redness at the injection site
• Nausea or vomiting, decreased appetite
• Feeling tired or unwell
• Restlessness and insomnia (in younger children)
• Muscle pain
• Fever (see above)

Uncommon (may affect up to 1 in 100 people):

• Swollen lymph nodes
• Stomach pain
• Joint pain
• Chills

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

• Itching at the injection site
• Abnormal or reduced sensation such as tingling or numbness along multiple nerves
• Dizziness
• Vertigo
• Diarrhea
• Indigestion
• Hives (urticaria)

The following additional side effects have also been reported from post-marketing surveillance,
with rare frequency:

• Allergic reactions
• Brain inflammation, signs of meningeal irritation such as neck stiffness
• Neurological symptoms such as facial paralysis, paralysis, nerve inflammation
• A condition characterized by muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body (Guillain-Barré syndrome)
• Visual disturbances, increased sensitivity to light, eye pain
• Ringing sensation in the ears
• Shortness of breath
• Skin reactions (skin rash and/or itching), skin redness, increased sweating
• Musculoskeletal and neck stiffness, pain in arms and legs
• Influenza-like illness, weakness, skin swelling, unsteady gait
• Seizures with or without fever

In a small comparative study on immune response after intramuscular and subcutaneous administration of TICOVAC in healthy adults, the subcutaneous route led to higher local reactions at the injection site (e.g., redness, swelling, itching, and pain), particularly in women.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store TICOVAC 0.25 ml for paediatric use

• Store in a refrigerator (2°C - 8°C). Keep the syringe in the outer packaging to protect the medicinal product from light. Do not freeze. Do not use this vaccine if there are any visible signs of foreign particles or leakage.
• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
• Do not dispose of any vaccine via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TICOVAC 0.25 ml for paediatric use contains
The active substance is: tick-borne encephalitis virus (Neudörfl strain)
One dose (0.25 millilitres) of the vaccine contains 1.2 micrograms of inactivated tick-borne
encephalitis virus (Neudörfl strain), produced in chicken embryo cells.
The other components are: human albumin, sodium chloride, disodium phosphate dihydrate,
potassium dihydrogen phosphate, sucrose and water for injections. Aluminium hydroxide
(hydrated) is included in this vaccine as an adsorbent. Adsorbents are substances included in
certain vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

Description of the appearance of TICOVAC 0.25 ml for paediatric use and contents of the pack
TICOVAC 0.25 ml for paediatric use is an injectable suspension supplied in a 0.25 millilitre pre-filled syringe (one dose). The pack may not contain the needle or may contain 1 separate needle per syringe. The needles are sterile and for single use only. Packs containing 1 or 10 pre-filled syringes are available. Not all pack sizes may be marketed. After shaking, the suspension is whitish and milky in appearance.
Each pre-filled syringe is packaged in a blister. The opening in the blister seal is intentional and allows for humidity equilibration during warming, which is recommended prior to administration of the vaccine. To remove the syringe, open the blister by peeling off the lid. Do not press the syringe against the blister.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pfizer S.r.L.
Via Isonzo, 71 - 04100 Latina
Italy
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
België/Belgique/Belgien, Deutschland, FSME-IMMUN 0.25 ml Junior
Luxembourg/Luxemburg, Nederland, Polska,
Portugal
България FSME-IMMUN 0.25 ml Junior
Česká republika FSME-IMMUN
Danmark, Suomi/Finland, Norge, Ísland, TicoVac Junior
Ελλάδα, Κύπρος
Eesti TicoVac 0.25 ml
Hrvatska FSME-IMMUN 0.25 ml Junior, suspension for injection in pre-filled syringe, tick-borne encephalitis vaccine, inactivated
Magyarország FSME-IMMUN Junior vaccine in pre-filled syringe
Malta TicoVac Junior 0.25 ml Suspension for injection in pre-filled syringe
Österreich FSME-IMMUN 0.25 ml Junior Injektionssuspension in einer Fertigspritze
France TicoVac Enfant 0.25 ml
Ireland, United Kingdom (Northern Ireland) TicoVac Junior 0.25 ml
Sverige FSME-IMMUN Junior
Italia TicoVac 0.25 ml for paediatric use
Latvija, Lietuva TicoVac 0.25 ml
România FSME-IMMUN 0.25 ml Junior suspensie injectabila in seringa preumpluta
Slovenija FSME-IMMUN 0.25 ml za otroke
Slovenská republika FSME-IMMUN 0.25 ml Junior Injekčná suspenzia

Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia italiana del farmaco), https://www.aifa.gov.it.

---

The following information is intended exclusively for healthcare professionals:
The vaccine should be brought to room temperature before administration. Shake well before use to ensure the vaccine suspension is thoroughly mixed. After shaking, TICOVAC 0.25 ml for paediatric use appears as a homogeneous, opalescent, whitish suspension.
Before administration, the vaccine should be inspected visually for any foreign particles and/or changes in physical appearance. If any such changes are observed, do not use the vaccine.
After removing the syringe cap, immediately attach the needle and remove the needle cap before administration. Once the needle is attached, the vaccine should be administered immediately. In exceptional cases where subcutaneous administration is required, an appropriate needle must be used.
Any unused product and waste material derived from this product should be disposed of in accordance with local regulations.

Package leaflet: Information for the user

TICOVAC

0.5 ml
Injectable suspension in a pre-filled syringe
Whole virus inactivated vaccine against tick-borne encephalitis
Please read this leaflet carefully before this vaccine is administered to you or your child, as it contains important information for you or your child.

1. Keep this leaflet. You may need to read it again.
2. If you have any questions, ask your doctor, pharmacist or nurse.
3. This vaccine has been prescribed only for you or your child. Do not give it to others.
4. If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What TICOVAC 0.5 ml is and what it is used for
2. What you need to know before you or your child are given TICOVAC 0.5 ml
3. How to use TICOVAC 0.5 ml
4. Possible side effects
5. How to store TICOVAC 0.5 ml
6. Contents of the pack and other information

1. What TICOVAC 0.5 ml is and what it is used for

TICOVAC 0.5 ml is a vaccine used to prevent disease caused by the tick-borne encephalitis (TBE) virus. It is indicated for individuals aged 16 years and older.

• The vaccine stimulates the body to produce adequate protection (antibodies) against the virus.
• It does not protect against other viruses and bacteria (some of which are transmitted by tick bites) that may cause similar symptoms.

The tick-borne encephalitis virus can cause severe infections of the brain or spinal cord and their surrounding membranes. These infections often begin with headache and high fever. In some individuals, particularly in more severe forms, they may progress to loss of consciousness, coma, and death.
The virus can be carried by ticks and is transmitted to humans through tick bites.
The risk of being bitten by ticks carrying the virus is high in large parts of Europe, as well as in central and eastern Asia. People living in or travelling to these areas are at risk of contracting tick-borne encephalitis. Ticks are not always visible on the skin, and bites may go unnoticed.

• As with all vaccines, this vaccine may not fully protect all vaccinated individuals.
• A single dose of the vaccine is unlikely to provide sufficient protection for you or your child. Three doses must be administered (see section 3 for further information) to achieve optimal protection.
• Protection does not last a lifetime. Regular booster doses are required (see section 3 for further information).
• There are no data available on post-exposure prophylaxis (vaccination after a tick bite).

2. What you should know before you or your child receives TICOVAC 0.5 ml

Do not use TICOVAC 0.5 ml:

• If you or your child are allergic to the active substance, to any of the other ingredients (listed in section 6), formaldehyde or protamine sulfate (used during the manufacturing process), or to antibiotics such as neomycin and gentamicin. For example, if you or your child have experienced skin rash, swelling of the face and throat, difficulty breathing, blue discoloration of the tongue or lips, low blood pressure, or collapse.
• If you or your child have had a severe allergic reaction after eating eggs or chicken.
• If you or your child have an acute illness with or without fever, you should wait before receiving TICOVAC 0.5 ml. The doctor may ask you or your child to delay the injection until you or your child feel better.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before vaccination if you or your child:

• has a bleeding disorder or bruises easily
• has an autoimmune disease (e.g. rheumatoid arthritis or multiple sclerosis)
• has a weakened immune system (so that you or your child cannot effectively fight infections)
• does not produce antibodies effectively
• is taking medicines for cancer
• is taking medicines called corticosteroids (which reduce inflammation)
• has any brain disease
• has neurological disorders or epilepsy

The vaccine may not be suitable if any of the above conditions apply to you or your child. Alternatively, the doctor may still administer the vaccine. The doctor may ask you to have a blood test to check whether the vaccine has worked.

Other medicines and TICOVAC 0.5 ml
Tell your doctor, pharmacist, or nurse if you or your child are taking or have recently taken any other medicines, including those obtained without a prescription. The doctor will tell you whether you or your child can receive TICOVAC 0.5 ml at the same time as other vaccines. If you or your child have recently received another vaccine, the doctor will decide where and when to administer TICOVAC 0.5 ml.
TICOVAC 0.5 ml may not provide complete protection if you or your child are receiving immunosuppressive treatment.
Inform your doctor if you or your child have ever been infected with or vaccinated against yellow fever, Japanese encephalitis, or Dengue virus. This is because you or your child may have antibodies in the blood that could react with the tick-borne encephalitis (TBE) virus used in tests to measure antibody levels. Such tests could therefore give incorrect results.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this vaccine.
The doctor will discuss with you the possible risks and benefits. The effect of TICOVAC 0.5 ml during pregnancy or breastfeeding is unknown. However, it may still be administered if the risk of infection is high.

Driving and using machines
It is unlikely that the vaccine will affect the ability to drive or operate machinery. However, you may experience vision problems or dizziness.

TICOVAC 0.5 ml contains potassium and sodium
Potassium and sodium are present at levels less than 1 mmol per dose; therefore, the product is essentially “free of potassium and sodium”.

3. How to use TICOVAC 0.5 ml

This vaccine is usually injected into the muscle of the upper arm. The vaccine must not be injected into a blood vessel. Only in exceptional cases (if you or your child has a bleeding disorder or are taking blood-thinning medicines called anticoagulants), the vaccine may be administered under the skin (subcutaneously).
This vaccine must not be given to people under 16 years of age. For this age group, a TBE vaccine for pediatric use is recommended. The administration of the vaccine must be documented by the doctor, who records the batch number.

Primary vaccination schedule
The primary vaccination course consists of three doses of TICOVAC 0.5 ml:

6. Your doctor will decide when to administer the first dose.
7. The second dose should be given 1–3 months after the first. It may be administered as early as two weeks after the first dose if rapid protection is required.
8. The third dose should be given 5–12 months after the second dose.

• It is preferable that the first and second doses are administered during the winter season, as ticks become active in spring. This will allow you to develop adequate protection before the onset of tick season.
• The third dose completes the primary vaccination course. The vaccination schedule should ideally be completed with the third dose within the same tick season or, at the very least, before the start of the next tick season.
• This provides protection for up to three years.
• If too much time passes between the three doses, you may not achieve full protection against infection.

Booster vaccinations
People aged between 16 and 59 years
If you are younger than 60 years, your first booster dose should be administered 3 years after the third dose. Further booster doses should be administered every 5 years.
People aged 60 years and older
In general, you should receive booster doses – the first and all subsequent booster doses – at intervals of three years.

Catch-up dose
If too much time passes between one vaccine dose and the next, you may not be protected against
TBE. However, a single catch-up dose with TICOVAC is sufficient to continue the vaccination
schedule if you have previously received at least two doses. It is not necessary to restart the entire
vaccination cycle. Please consult your doctor for further information.
People with weakened immune systems (including those receiving immunosuppressive
therapy)
Your doctor may decide to measure the antibodies present in your blood four weeks after the
second dose and to administer an additional dose if there is no evidence of an immune response
at that time. The same applies for each subsequent dose.
If you receive more TICOVAC 0.5 ml than you should
An overdose is highly unlikely, as the injection is administered by a healthcare professional using
a single-dose syringe.
If you have any doubts about the use of this vaccine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

As with all vaccines, severe allergic reactions may occur. These are very rare, but appropriate treatment and medical supervision must always be readily available. Symptoms of severe allergic reactions include:

• swelling of the lips, mouth, throat (which may make swallowing or breathing difficult)
• rash and swelling of the hands, feet and ankles
• loss of consciousness due to a drop in blood pressure

These signs or symptoms usually occur very rapidly after injection, while the person is still at the clinic or in the doctor's office. If you experience any of these symptoms after leaving the place where you received the injection, seek medical attention IMMEDIATELY.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• Pain at the injection site

Common (may affect up to 1 in 10 people):

• Headache
• Nausea
• Muscle and joint pain
• Feeling tired or unwell

Uncommon (may affect up to 1 in 100 people):

• Swollen lymph nodes
• Vomiting
• Fever
• Bruising at the injection site

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

• Allergic reactions
• Drowsiness
• Motion sickness
• Diarrhoea
• Abdominal pain
• Redness, tissue hardening, swelling, itching, tingling, and warmth at the injection site

The following additional side effects have also been reported during post-marketing surveillance with rare frequency:

• Shingles (Herpes zoster)
• Onset of autoimmune disorders, e.g. multiple sclerosis
• Allergic reactions
• Neurological disorders such as encephalomyelitis, inflammation of the spinal cord (myelitis, transverse myelitis)
• A condition characterised by muscle weakness, abnormal sensations, tingling in arms, legs and upper body (Guillain-Barré syndrome)
• Brain inflammation, seizures, meningitis (inflammation of the membranes covering the brain)
• Signs of meningeal irritation such as neck pain and stiffness
• Neurological symptoms such as facial paralysis, paralysis, nerve inflammation, abnormal or reduced sensation such as tingling or numbness, pulsating or stabbing pain in one or more nerves, optic neuritis
• Dizziness
• Visual disturbances, increased sensitivity to light, eye pain
• Ringing sensation in the ears
• Rapid heartbeat
• Shortness of breath
• Skin reactions (skin rash and/or itching), dermatitis, skin redness, increased sweating, skin inflammation
• Back pain, joint swelling, neck pain, musculoskeletal and neck stiffness, pain in arms and legs
• Chills, flu-like malaise, weakness, oedema, unsteady gait, fluid accumulation under the skin
• Joint pain at injection site, nodules and inflammation at injection site

In a small comparative study on the immune response after intramuscular and subcutaneous administration of TICOVAC in healthy adults, the subcutaneous route led to higher local reactions at the injection site (e.g., redness, swelling, itching and pain), particularly in women.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store TICOVAC 0.5 ml

• Store in a refrigerator (2°C - 8°C). Keep the syringe in the outer packaging to protect the medicine from light. Do not freeze. Do not use this vaccine if there are any visible signs of foreign particles or leakage.
• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
• Do not dispose of any vaccine via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer required. This will help protect the environment.

6. Package contents and other information

What TICOVAC 0.5 ml contains
The active substance is: tick-borne encephalitis virus (strain Neudörfl).
One dose (0.5 millilitres) of the vaccine contains 2.4 micrograms of inactivated tick-borne encephalitis virus (strain Neudörfl), produced on chicken embryo cells.
The other components are: human albumin, sodium chloride, disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate, sucrose and water for injections. Aluminium hydroxide (hydrated) is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

Description of the appearance of TICOVAC 0.5 ml and package contents
TICOVAC 0.5 ml is an injectable suspension supplied in a 0.5 millilitre pre-filled syringe (one dose). The package may not contain a needle or may contain 1 separate needle per syringe. The needles are sterile and for single use only. Pack sizes of 1 and 10 pre-filled syringes are available. Not all pack sizes may be marketed. After shaking, the suspension is white and cloudy.
Each pre-filled syringe is packaged in a blister. The opening in the blister seal is intentional and allows for humidity equilibration during heating, as recommended prior to vaccine administration. To remove the syringe, open the blister by peeling off the lid. Do not press the syringe against the blister.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pfizer S.r.l.
Via Isonzo, 71 - 04100 Latina
Italy
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
België/Belgique/Belgien, Luxembourg/Luxemburg, Nederland, Polska, Portugal, Slovenija
FSME-IMMUN 0.5 ml
Česká republika FSME-IMMUN
България FSME-IMMUN 0.5 ml
Danmark, Norge, Suomi/Finland, Ísland, Ireland, United Kingdom (Northern Ireland) TicoVac
Ελλάδα, Κύπρος
Deutschland FSME-IMMUN 0.5 ml Erwachsene
Eesti, Italia, Latvija, Lietuva TicoVac 0.5 ml
Hrvatska FSME-IMMUN 0.5 ml, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv krpeljnog encefalitisa, inaktivirano
France TicoVac 0.5 ml ADULTES
Sverige FSME-IMMUN Vuxen
Magyarország FSME-IMMUN 0.5 ml felnőtteknek
Malta TicoVac 0.5 ml Suspension for injection in pre-filled syringe
Österreich FSME-Immun 0.5 ml Erwachsene Injektionssuspension in einer Fertigspritze
România FSME-IMMUN 0.5 ml suspensie injectabila in seringa preumpluta
Slovenská republika FSME-IMMUN 0.5 ml Injekčná suspenzia

Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia italiana del farmaco), https://www.aifa.gov.it.

---

The following information is intended for healthcare professionals only:
The vaccine should be brought to room temperature before administration. Shake well before administration to ensure the vaccine suspension is thoroughly mixed. After shaking, TICOVAC 0.5 ml appears as a homogeneous, whitish, opalescent suspension.
Before administration, the vaccine should be inspected visually for any foreign particles and/or physical changes. If any such condition is observed, do not use the vaccine.
After removing the syringe cap, attach the needle immediately and remove the needle protection before administration. Once the needle is attached, the vaccine should be administered immediately. In exceptional cases where subcutaneous administration is required, an appropriate needle must be used.
Any unused product or waste material should be disposed of in accordance with local requirements.