Fsme-immun 0,5 ml

PATIENT INFORMATION LEAFLET: USER INFORMATION

FSME-IMMUN 0.5 ml

Suspension for injection in a pre-filled syringe

This vaccine is a tick-borne encephalitis (whole virus, inactivated) vaccine.

You should carefully read the contents of this leaflet before using the vaccine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of 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 and over.

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

Tick-borne encephalitis virus can cause very serious brain, spinal cord, or meningeal infections (surrounding the brain). Often the first symptoms are headache and high fever. In some individuals, the most severe forms of infection can lead to loss of consciousness, coma, and death.
The virus can be transmitted to the human body during a tick bite. 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 or staying on vacation in these parts of the world are at risk of contracting tick-borne encephalitis. Ticks are not always noticed on the skin, and their bites can be imperceptible.

• Like all vaccines, this vaccine may not provide full protection for all vaccinated individuals.
• It is unlikely that a single dose of the vaccine will provide protection against infection. Three doses of the vaccine should be taken (see section 3 for details) to achieve optimal protection.
• Protection does not last a lifetime. Booster doses should be taken regularly (see section 3 for details).
• There is no data on post-exposure prophylaxis (vaccination after a tick bite).

2. Important information before using FSME-IMMUN 0.5 ml

When not to use FSME-IMMUN 0.5 ml

Warnings and precautions

Before vaccination, the doctor, pharmacist, or nurse should be informed if:

• the patient has bleeding disorders or increased bruising
• the patient has an autoimmune disease (such as rheumatoid arthritis or multiple sclerosis)
• the patient has a disorder of the immune system (resulting in infections not being properly fought)
• the patient has insufficient antibody production
• the patient is taking any anticancer drugs
• the patient is taking corticosteroids (which reduce inflammation)
• the patient has any brain disease
• the patient has neurological or seizure disorders.

If the patient has any of the above conditions, the administration of this vaccine may be contraindicated. Alternatively, the doctor may administer the vaccine. The doctor may recommend a blood test to check if the vaccine has worked.

FSME-IMMUN 0.5 ml and other medicines

The doctor, pharmacist, or nurse should be told about all medicines the patient is currently taking or has recently taken, even those that are available without a prescription. The doctor will decide whether FSME-IMMUN 0.5 ml can be administered simultaneously with other vaccines. If the patient has been vaccinated with another vaccine recently, the doctor will decide on the place and time of administration of the FSME-IMMUN 0.5 ml vaccine.
FSME-IMMUN 0.5 ml may not provide complete protection for patients undergoing immunosuppressive treatment.
The doctor should be informed 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, can react with the tick-borne encephalitis virus used in tests to determine antibodies and may cause false test results.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this vaccine.
The doctor should inform the patient about the possible risks and benefits associated with vaccination. The effects of FSME-IMMUN 0.5 ml during pregnancy and breastfeeding are unknown.
However, FSME-IMMUN 0.5 ml can be used if the risk of infection is high.

Driving and using machines

It is unlikely that the vaccine will affect the ability to drive and use machines. However, vision disturbances or dizziness may occur.

FSME-IMMUN 0.5 ml contains potassium and sodium

Potassium and sodium are present in an amount of less than 1 mmol per dose, which means the vaccine 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 administered into a blood vessel. Only in exceptional cases (if the patient has bleeding disorders or is taking anticoagulant medications) can the vaccine be administered subcutaneously.
This vaccine should not be administered 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 the doctor along with the batch number.
Basic vaccination
Basic vaccination consists of three doses of FSME-IMMUN 0.5 ml.

• 1. The doctor decides on the date of administration of the first dose.
• 2. The second dose should be administered 1 to 3 months after the first dose. If necessary, the second dose can be administered 2 weeks after the first dose.
• 3. The third dose should be administered 5 to 12 months after the second dose of the vaccine.
• Tick activity begins in the spring. Therefore, it is best to take the first and second doses in the winter. This will provide sufficient protection before the start of the tick activity season.
• The third dose completes the basic vaccination. The vaccination schedule should be completed by administering the third dose during the same tick activity season or at the latest before the start of the next tick activity 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

If the patient is under 60 years of age, the first booster dose should be administered 3 years after the third dose. Subsequent booster doses should be administered at 5-year intervals.

Individuals aged 60 and over

Generally, the first and subsequent booster doses are administered at 3-year intervals.

Additional dose
If individual doses of the vaccine are administered at too great an interval, the vaccine may not provide adequate protection against tick-borne encephalitis. However, the administration of a single additional 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 basic vaccination cycle. For further information, consult a doctor.
Individuals with weakened immune systems (including those undergoing immunosuppressive treatment)
The doctor may consider determining antibodies in the blood after 4 weeks after the second dose and if no immune response is detected, may recommend an additional dose. The same applies to each subsequent dose.

Use 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 doctor.
In case of any doubts about the use of the vaccine, consult a 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 get serious, or if you notice any side effects not listed in this leaflet, you should inform your doctor or pharmacist.
As with all vaccines, severe allergic reactions can occur. These happen very rarely, but it is always necessary to ensure access to appropriate medical equipment and care in case they occur. Symptoms of severe allergic reactions include:

• swelling of the lips, mouth, and 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 shortly after injection, while still in the doctor's office or clinic. If the above symptoms occur after leaving the place where the injection was administered, you should contact your doctor 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):

• enlarged lymph nodes
• vomiting
• fever
• bruising at the injection site

Rare (may affect up to 1 in 1000 people):

• allergic reactions
• drowsiness
• motion sickness
• diarrhea
• abdominal pain
• redness, hardening of tissue, swelling, itching, tingling, and feeling of heat at the injection site

Additional side effects reported after the product was placed on the market with a rare frequency:

• shingles
• autoimmune disorders, such as multiple sclerosis
• allergic reactions
• neurological disorders, such as encephalitis and meningitis (inflammation of the brain and spinal cord)
• Guillain-Barré syndrome (a condition that causes muscle weakness, numbness, tingling in the hands and feet, and upper body)
• encephalitis, seizures, meningitis (inflammation of the membranes surrounding the brain)
• symptoms of meningeal irritation, such as neck pain and stiffness
• neurological symptoms, such as facial paralysis, paralysis, neuritis, abnormal or decreased sensation, such as tingling or numbness, shooting or pulsating pain along one or more nerves, optic neuritis
• dizziness
• vision disturbances/abnormal vision, increased sensitivity to light, eye pain
• ringing in the ears
• rapid heartbeat
• shortness of breath
• skin reactions (redness and/or itching), dermatitis, skin redness, increased sweating
• back pain, joint swelling, neck pain, muscle and skeletal stiffness, and neck stiffness, arm and leg pain
• chills, flu-like symptoms, weakness, swelling, gait disturbances, fluid accumulation under the skin
• pain at the injection site, nodule, and inflammation at the injection site

In a small comparative study evaluating the immune response after intramuscular and subcutaneous administration of FSME-IMMUN 0.5 ml to healthy adults, it was shown that subcutaneous administration leads to a higher number of local reactions at the injection site (i.e., redness, swelling, itching, and pain), especially in women.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store FSME-IMMUN 0.5 ml

• Store in a refrigerator (2°C - 8°C). Store the pre-filled syringe in the outer packaging to protect from light. Do not freeze. If foreign particles or solid matter are detected or the packaging is damaged, the vaccine should not be used.
• Store out of 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 month stated.
• Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What FSME-IMMUN 0.5 ml contains

The active substance of the vaccine is: tick-borne encephalitis virus (Neudörfl strain).
One dose of the vaccine (0.5 ml) contains 2.4 micrograms of inactivated tick-borne encephalitis virus (Neudörfl strain), which is produced in chicken embryo cells.
The other ingredients are: human albumin, sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, sucrose, and water for injections.
Aluminum hydroxide (hydrated) contained in this vaccine is an adjuvant. Adjuvants are substances contained in some vaccines to enhance, increase, and/or prolong the protective effect of the vaccine.

What FSME-IMMUN 0.5 ml looks like and contents of the pack

FSME-IMMUN 0.5 ml is supplied as a 0.5 ml (1 dose) suspension for injection in a pre-filled syringe. The packaging may not contain a needle or contain 1 separate needle for the syringe. Needles are sterile and intended for single use. Available pack sizes contain 1 or 10 pre-filled syringes. Not all pack sizes may be marketed. After shaking, the suspension has a greyish-white color and a milky appearance.
Each pre-filled syringe is packaged in a blister. The hole in the blister seal is made intentionally and allows for moisture level equalization during the recommended warming before vaccine administration. The blister should be opened by removing the cover and taking out the syringe. Do not push the syringe out of the blister.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain further detailed information on the vaccine, contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
Phone: +48 22 335 61 00

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Belgium, Luxembourg, Netherlands, Poland,

Portugal, Slovenia

FSME-IMMUN 0.5 ml

Czech Republic

FSME-IMMUN

Bulgaria

FSME-IMMUN 0.5 ml

Denmark, Norway, Finland, Iceland, Greece,

Cyprus

TicoVac

Germany

FSME-IMMUN 0.5 ml Erwachsene

Estonia, Italy, Latvia, Lithuania

TicoVac 0.5 ml

Croatia

FSME-IMMUN 0.5 ml, suspension for injection in a pre-filled syringe, vaccine against tick-borne encephalitis, inactivated

Ireland, United Kingdom (Northern Ireland)

TicoVac 0.5 ml

France

TicoVac 0.5 ml ADULTES

Sweden

FSME-IMMUN Vuxen

Hungary

FSME-IMMUN 0.5 ml for adults

Malta

TicoVac 0.5 ml Suspension for injection in a pre-filled syringe

Austria

FSME-Immun 0.5 ml Erwachsene
Injektionssuspension in einer Fertigspritze

Romania

FSME-IMMUN 0.5 ml
suspension for injection in a pre-filled syringe

Slovakia

FSME-IMMUN 0.5 ml Injection suspension

Date of last revision of the leaflet: 10/2024

Other sources of information

Detailed information on this medicinal product 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 for healthcare professionals only

Before administration, the vaccine should be at room temperature. Before administration, shake the vaccine well to ensure the suspension is thoroughly mixed. After shaking, FSME-IMMUN 0.5 ml is a greyish-white, opalescent, homogeneous suspension. Visually inspect the vaccine for any foreign particles or changes in physical appearance. If any changes are observed, the vaccine should be discarded.
After removing the syringe cap, the needle should be attached immediately and its cover removed before administration. After attaching the needle, the vaccine must be administered immediately. In exceptional cases, during subcutaneous administration, an appropriate needle should be used.
Any unused product or waste material should be disposed of in accordance with local regulations.