Fsme-immun 0.5 ml

FSME-IMMUN 0.5 ml
Suspension for injection in pre-filled syringe
Tick-borne encephalitis vaccine (whole virus, inactivated)

Please read the entire leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep the leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual only. Do not share it with others.
• If any adverse reactions occur in the patient, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet
1 What FSME-IMMUN 0.5 ml is and what it is used for
2 Important information before using FSME-IMMUN 0.5 ml
3 How to use FSME-IMMUN 0.5 ml
4 Possible side effects
5 How to store FSME-IMMUN 0.5 ml
6 Contents of the pack and other information

1. What FSME-IMMUN 0.5 ml is and what it is used for

FSME-IMMUN 0.5 ml is a vaccine used to prevent disease caused by the tick-borne encephalitis virus. It is intended for vaccination of individuals aged 16 years and older.

• The vaccine stimulates the body to produce its own defense mechanisms (antibodies) against the virus.
• It does not protect against infections caused by other viruses or bacteria (some of which are also transmitted by tick bites) that may cause similar symptoms.

The tick-borne encephalitis virus can cause very serious infections of the brain, spinal cord, or meninges (membranes surrounding the brain and spinal cord). Frequently, the first symptoms are headache and high fever. In some individuals, severe forms of infection may lead to loss of consciousness, coma, and death.
The virus can be transmitted to humans through the bite of a tick. The risk of being bitten by a tick carrying the virus is very high in many parts of Europe, as well as in Central and Eastern Asia. Individuals living in or travelling to these areas are at risk of contracting tick-borne encephalitis. Ticks are not always noticed on the skin, and their bites may be painless.

• As with all vaccines, this vaccine may not provide full protection in all vaccinated individuals.
• A single dose of the vaccine is unlikely to provide protection against infection. Three doses of the vaccine are required (see section 3 for details) to achieve optimal protection.
• Protection does not last for life. Booster doses must be administered regularly (see section 3 for details).
• There is no data available on post-exposure prophylaxis (vaccination after a tick bite).

2. Information before using FSME-IMMUN 0.5 ml

When not to use FSME-IMMUN 0.5 ml

• if the patient is allergic to the active substance, any of the vaccine components (listed in section 6), formaldehyde or protamine sulfate (used during the manufacturing process), or to antibiotics such as neomycin and gentamicin. For example, if skin rash, facial and throat swelling, breathing difficulties, bluish discoloration of the tongue or lips, low blood pressure, or collapse occur.
• if the patient has ever had a severe allergic reaction after eating egg or chicken meat.
• if the patient has an acute illness with or without fever. In such cases, vaccination with FSME-IMMUN 0.5 ml should be postponed. The doctor will decide on the appropriate vaccination timing once the patient feels better.

Warnings and precautions

Before vaccination, inform the doctor, pharmacist, or nurse if:

• the patient has blood clotting disorders or increased tendency to bruising
• the patient has been diagnosed with an autoimmune disease (such as rheumatoid arthritis or multiple sclerosis)
• the patient has been diagnosed with an immunological system disorder (resulting in impaired ability to fight infections)
• the patient has insufficient antibody production
• the patient is taking any anticancer medications
• the patient is taking medications called corticosteroids (which reduce inflammation)
• the patient has been diagnosed with any brain disease
• the patient has neurological disorders or seizures.

If any of the above conditions apply to the patient, administration of this vaccine may be contraindicated. Alternatively, the doctor may decide to administer the vaccine. The doctor may recommend a blood test to check whether the vaccine has been effective.

FSME-IMMUN 0.5 ml and other medicines

Inform the doctor, pharmacist, or nurse about all medicines currently taken or recently used by the patient, including those obtained without a prescription. The doctor will decide whether FSME-IMMUN 0.5 ml can be administered simultaneously with other vaccines. If the patient has recently received another vaccine, the doctor will determine the appropriate site and timing for administration of FSME-IMMUN 0.5 ml.

FSME-IMMUN 0.5 ml may not provide complete protection in patients undergoing immunosuppressive therapy.

Inform the doctor about any previous infection or vaccination against yellow fever virus, Japanese encephalitis virus, or dengue virus. Antibodies against these viruses, which may be present in the patient's blood, may cross-react with the tick-borne encephalitis virus used in antibody detection tests and may lead to false test results.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this vaccine.

The doctor should inform the patient about the potential risks and benefits associated with vaccination. The effects of FSME-IMMUN 0.5 ml during pregnancy and breastfeeding are unknown. Nevertheless, administration of FSME-IMMUN 0.5 ml may be considered if the risk of infection is high.

Driving and operating machinery

It is unlikely that the vaccine affects the ability to drive or operate machinery. However, visual disturbances or dizziness may occur.

FSME-IMMUN 0.5 ml contains potassium and sodium

Potassium and sodium are present in amounts below 1 mmol per dose, meaning the medicine is considered "sodium- and potassium-free".

3. How to use FSME-IMMUN 0.5 ml

This vaccine is usually administered into the deltoid muscle. The vaccine must not be injected into a blood vessel.
Only in exceptional cases (if the patient has blood clotting disorders or is taking blood-thinning medicines, known as anticoagulants) may the vaccine be administered subcutaneously.

This vaccine should not be given to children and adolescents under 16 years of age. For this age group, a tick-borne encephalitis vaccine intended for children is recommended.

Vaccination should be documented by a physician, including recording of the batch number.

Primary vaccination
The primary vaccination consists of three doses of FSME-IMMUN 0.5 ml.

1. The timing of the first dose is determined by the physician.

2. The second dose should be administered 1 to 3 months after the first dose. If rapid protection is required, the second dose may be given as early as two weeks after the first dose.

3. The third dose should be administered 5 to 12 months after the second dose.

   • Tick activity begins in spring. Therefore, it is best to receive the first and second doses during winter. This allows sufficient time to develop adequate protection before the start of the tick season.
   • The third dose completes the primary vaccination series. It is best to complete the vaccination schedule by administering the third dose during the same tick season or, at the latest, before the beginning of the next tick season.
   • This provides protection for up to three years.
   • If the interval between the three doses is too long, the patient may not achieve full protection against infection.

Booster doses
Individuals aged 16 to 59 years
If the patient has not yet reached 60 years of age, the first booster dose should be administered
3 years after the third dose. Subsequent booster doses should be given every 5 years.
Individuals aged 60 years and older
Generally, the first and subsequent booster doses are administered at 3-year intervals.

Booster dose
If individual doses of the vaccine are administered with too long an interval between them, the vaccine
may not provide adequate protection against tick-borne encephalitis. However, administration of
one booster dose of FSME-IMMUN is sufficient to continue the vaccination schedule if the patient has previously received at least two doses of the vaccine. There is no need
to restart the entire primary vaccination cycle. For additional information, consult a physician.
Individuals with weakened immune systems (including those receiving immunosuppressive
treatment)
The physician may consider measuring antibody levels in the blood four weeks after the second dose,
and if no immune response is detected, may recommend administration of an additional dose. The same
applies to each subsequent dose.
Administration of a higher than recommended dose of FSME-IMMUN 0.5 ml
Overdose is very unlikely, as the vaccine is available in a pre-filled syringe containing a single dose and is administered by a healthcare professional.
In case of any doubts regarding the use of the vaccine, consult a physician, nurse, or pharmacist.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although not everybody experiences
them. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet
occur, a doctor or pharmacist should be informed.
As with all vaccines, severe allergic reactions may occur. These are very rare, but appropriate
medical equipment and care should always be readily available in case they occur. Symptoms of
serious allergic reactions include:

• swelling of the lips, mouth, or throat (which may make swallowing or breathing difficult)
• rash and swelling of the hands, feet, and ankles
• fainting due to low blood pressure

The above symptoms usually occur very soon after injection, often while still at the clinic or doctor's
office. If any of these symptoms occur after leaving the place where the injection was given, medical
attention should be sought IMMEDIATELY.
The following adverse reactions 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 generally 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
• Diarrhea
• Abdominal pain
• Redness, hardening of tissue, swelling, itching, tingling, and feeling of warmth at the injection site

Additional adverse reactions reported after marketing authorization with rare frequency:

• Herpes zoster
• Induction of autoimmune disorders, e.g. multiple sclerosis
• Allergic reactions
• Neurological disorders such as encephalitis and myelitis, spinal cord inflammation (myelitis, transverse myelitis)
• A disease characterized by muscle weakness, sensory disturbances, tingling in hands, feet, and upper body (Guillain-Barré syndrome)
• Encephalitis, seizures, meningitis (inflammation of the membranes covering the brain)
• Symptoms 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, stabbing or pulsating pain along one or more nerves, optic neuritis
• Dizziness
• Visual disturbances / abnormal vision, increased sensitivity to light, eye pain
• Ringing in the ears
• Rapid heartbeat
• Shortness of breath
• Skin reactions (redness and (or) itching), skin inflammation, skin redness, increased sweating
• Back pain, joint swelling, neck pain, musculoskeletal stiffness and neck stiffness, pain in arms and legs
• Chills, influenza-like symptoms, weakness, swelling, gait disturbances, subcutaneous fluid accumulation
• Joint pain at the injection site, lump and inflammation at the injection site

In a small comparative study assessing the immunological response after intramuscular and
subcutaneous administration of FSME-IMMUN 0.5 ml to healthy adults, subcutaneous
administration was shown to lead to a higher number of local reactions at the injection site
(i.e. redness, swelling, itching, and pain), particularly in women.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should
be reported to a doctor or pharmacist. Adverse reactions can be reported directly to the Department
of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the vaccine.

5. How to store FSME-IMMUN 0.5 ml

• Store in a refrigerator (2°C - 8°C). Keep the syringe in the outer packaging to protect from light. Do not freeze. If foreign particles of solid matter are observed or if the packaging is damaged or leaking, this vaccine must not be used.
• Keep out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

What FSME-IMMUN 0.5 ml looks like and contents of the pack
The FSME-IMMUN 0.5 ml vaccine is supplied as a 0.5 ml (1 dose) suspension for injection in a
pre-filled syringe. The pack may not contain a needle or may contain 1 separate needle per syringe.
The needles are sterile and intended 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 white-grey in
colour and has a milky appearance.
Each pre-filled syringe is packed in a blister. The opening in the blister seal is intentional and allows
for moisture equilibrium during recommended warming prior to administration of the vaccine. Open
the blister by removing the lid and removing the syringe. Do not push the syringe out of the blister.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information about this medicine, contact the local representative of the Marketing
Authorisation Holder:
Pfizer Polska Sp. z o.o.
Tel: +48 22 335 61 00

This medicinal product is authorised for marketing in the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:
Belgium, Luxembourg, Netherlands, Poland, FSME-IMMUN 0.5 ml
Portugal, Slovenia
Czech Republic FSME-IMMUN
Bulgaria FSME-IMMUN 0.5 ml
Denmark, Norway, Finland, Iceland, Greece, TicoVac
Cyprus
Germany FSME-IMMUN 0.5 ml Erwachsene
Estonia, Italy, Latvia, Lithuania TicoVac 0.5 ml
Croatia FSME-IMMUN 0.5 ml, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv krpeljnog encefalitisa, inaktivirano
Ireland, United Kingdom (Northern TicoVac 0.5 ml
Ireland)
France TicoVac 0.5 ml ADULTES
Sweden FSME-IMMUN Vuxen
Hungary FSME-IMMUN 0.5 ml felnőtteknek
Malta TicoVac 0.5 ml Suspension for injection in pre-filled syringe
Austria FSME-Immun 0.5 ml Erwachsene Injektionssuspension in einer Fertigspritze
Romania FSME-IMMUN 0.5 ml suspensie injectabila in seringa preumpluta
Slovakia FSME-IMMUN 0.5 ml Injekčná suspenzia

Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
https://www.gov.pl/web/urpl/

Information intended exclusively for healthcare professionals

The vaccine should reach room temperature before administration. Shake well before use to ensure the suspension is thoroughly mixed. After shaking, the FSME-IMMUN 0.5 ml vaccine is a grey-white, opalescent, homogeneous suspension. Visually inspect the vaccine for any foreign particulate matter and/or physical changes in appearance. If any changes are observed, the vaccine must be discarded.
After removing the syringe cap, immediately attach the needle and remove the needle cover prior to administration. The vaccine must be administered immediately after attaching the needle. In exceptional cases, when administering subcutaneously, an appropriate needle should be used.
Any unused product or waste material should be disposed of in accordance with local regulations.