injection, suspension in pre-filled syringe against tick-borne encephalitis, TBE (the whole virus inactivated)

1. What FSME-Immun Adult is and what it is used for

FSME-IMMUN Adult is a vaccine used to prevent disease caused by the tick-borne encephalitis (TBE) virus. It is suitable for people who are 16 years and older.

  • The vaccine works by affecting the body to produce its own protection ( antibodies ) against the virus.
  • It does not protect against other viruses or bacteria (some of which can also be transmitted via tick bites) and which can cause similar symptoms.

The TBE virus can cause very serious infections in the meninges, brain, and/or spinal cord. Headaches and high fever are early symptoms. In some people and the most severe forms of the disease, this can develop into unconsciousness, coma, or death.

The virus is found in ticks. It is transmitted to humans via tick bites. The risk of being bitten by ticks carrying viruses is very high in large parts of Europe and also in Central and East Asia. People who live or holiday in these parts of the world are at risk of being infected with tick-borne encephalitis. The ticks are not always visible on the skin and the bites are not always noticeable.

  • As with all vaccines, there is a small risk that this vaccine will not provide adequate protection for the vaccinated person.
  • A single dose of the vaccine is unlikely to protect you or your child from infection. You or your child need 3 doses (see section 3 for more information) to achieve the best protection.
  • The protection is not lifelong. Regular refill doses are required (see section 3 for more information).
  • There are no data regarding post-exposure prophylaxis (vaccination after tick bites).

2. What you need to know before you or your child is given FSME-Immun Adult

Do not take FSME-Immun Adult if:

  • you or your child are allergic to the active substance or any of the other ingredients (listed in section 6) or formaldehyde or protamine sulfate (used during the manufacturing process) or antibiotics such as neomycin and gentamicin. If you or your child e.g. have had a skin rash, swelling of the face and neck, difficulty breathing, blue discoloration of the tongue and lips, low blood pressure, and have become unconscious.
  • if you or your child have had a severe allergic reaction in the past after eating eggs or chicken.
  • If you or your child have an acute illness with or without fever, you or your child may need to wait before taking FSME-Immun Adult. The doctor may ask you or your child to wait with the vaccination until you or your child feels better.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before giving the vaccine if you or your child:

  • have a bleeding disorder or easily get bruises
  • have an autoimmune disease (such as rheumatoid arthritis or multiple sclerosis )
  • have a weakened immune system (so that you or your child have poor resistance to infection )
  • has decreased antibody production
  • taking anti-cancer drugs
  • taking drugs called corticosteroids (which reduce inflammation )
  • have a disease that has affected the brain
  • have neurological disorders or seizures.

If any of these apply to you or your child, the vaccine is not always appropriate. Alternatively, your doctor may vaccinate you or your child and later take a blood sample to check that the vaccine has been effective.

Other medicines and FSME-Immun Adult:

Tell your doctor, pharmacist, or nurse if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you if you or your child can be vaccinated with FSME-Immun Adult at the same time as any other vaccine. If you or your child have recently been given another vaccine, your doctor will decide on the time and place of injection for FSME-Immun Adult vaccination.

If you or your child are undergoing immunosuppressive therapy, there is a small risk that the FSME-Immun Adult will not provide adequate protection.

Tell your doctor if you or your child have previously been infected with or been vaccinated against Yellow Fever, Japanese Encephalitis, or Dengue Virus. This is because you or your child may have antibodies in their blood that react with the TBE virus used in tests to check antibody levels. These tests can then give incorrect results.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.

Your doctor will discuss risks and benefit with you. The effect of FSME-Immun Adult on pregnant and lactating women is not known. However, it can be given to women who are pregnant or breastfeeding if the risk of infection is high.

Driving and using machines

FSME-IMMUN Adult is unlikely to affect a person’s ability to drive or use machines. However, you may suffer from visual disturbances or dizziness.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

FSME-IMMUN Adult contains potassium and sodium

The levels of potassium and sodium are lower than 1 mmol per dose, ie almost “potassium and sodium-free”.

3. How FSME-Immun Adult is given

This vaccine is usually injected into a muscle in the upper arm. The vaccine must not be injected into a blood vessel. 
Only in exceptional cases (if you or your child have a bleeding disorder or are receiving blood-thinning medicines, so-called anticoagulants ) can the vaccine be injected under the skin ( subcutaneously ).

This vaccine should not be given to people under 16 years of age. For that age group, a TBE vaccine for children is recommended. Administration of one of the vaccines must be documented by the doctor, and the batch number registered.

Basic vaccination

The basic vaccination schedule consists of three doses of FSME-Immun Adult.

  1. Doctors decide when the first dose should be given.
  2. The second dose should be given 1-3 months later. The second dose can be given two weeks after the first when it is necessary to quickly achieve protection.
  3. The third dose should be given 5-12 months after the second dose.
    • To achieve immunity in the spring when the tick season begins, the first and second doses should preferably be given during the winter months. This is because the tick begins to become active in the spring.
    • The third dose completes the basic vaccination. The vaccination schedule should preferably be completed with the third vaccination within the same tick season, or at least before the next tick season begins.
    • It protects for up to three years.
    • Letting it go too long between the three doses can lead to incomplete protection against infection.

Basic immunization Dose Conventional immunization schedule Abbreviated immunization schedule
Dos 1 0.5 ml Day 0 Day 0
Dos 2 0.5 ml 1 to 3 months after the first vaccination 14 days after the first vaccination
Dos 3 0.5 ml 5 to 12 months after the second vaccination 5 to 12 months after the second vaccination

Refill doses

Persons 16–60 years

If you are younger than 60, you will need your first refill dose 3 years after the third dose. The following replenishment doses should be given every 3 to 5 years, depending on the risk of infection and national recommendations.

People over 60 years of age (older people)

The range of refill doses – the first and subsequent refill doses – should generally be 3 years.

Top-up dose ≥ 16 to <60 years Dose Time
First refill dose 0.5 ml 3 years after the third dose one
The following refill doses 0.5 ml Every fifth year

Top-up dose ≥ 60 years Dose Time
All refill doses 0.5 ml Every Three years

If there is too much time between vaccine doses, it may lead to you not being protected against TBE, however, a subsequent single dose (so-called catch-up dose ) of FSME-Immun Adult is sufficient to continue the vaccination schedule if you have taken at least two vaccinations before. It is not necessary to start vaccination according to the original schedule. Contact a doctor for further information.

People with compromised immune systems (including those undergoing immunosuppressive therapy)

Doctors may consider determining the antibody levels in your blood four weeks after the second dose. If you have not received a sufficient immune response, you can receive another dose. The same applies to all subsequent dose you

If you take more SME-IMMUN Vuxen than you should

It is unlikely that overdose will occur when the syringe is pre-filled and vaccination is performed by healthcare professionals.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

As with all vaccines, severe allergic reactions may occur. They are very rare, but appropriate medical treatment and monitoring must always be available. Symptoms of a severe allergic reaction include:

  • swelling of the lips, mouth, and throat (which may make it difficult to swallow or breathe)
  • rash and swelling of hands, feet, and ankles
  • unconsciousness due to a drop in blood pressure

These symptoms usually occur shortly after the injection is given, as you are still at the reception. If any of these symptoms occur after you have left the clinic where the injection was given, seek medical advice IMMEDIATELY.

The following side effects have been reported:

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

  • Injection site pain

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

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 1,000 people):

  • Allergic reactions
  • Somnolence
  • Motion sickness
  • Diarrhea
  • Stomach pain
  • Redness, hardening of tissue one, swelling, itching, tingling, and increased heat at the injection site

The following additional side effects have also been reported, occurring with infrequent post-marketing frequency:

  • Shingles
  • Triggering of autoimmune diseases, e.g. multiple sclerosis
  • Allergic reactions
  • Neurological disorders such as encephalomyelitis, inflammation of the spinal cord ( myelitis, transverse myelitis )
  • A condition consisting of muscle weakness, abnormal sensation, tingling in the arms, legs, and upper body (Guillain-Barré syndrome)
  • Encephalitis, seizures, inflammation of the meninges (membranes that line the brain.
  • Signs of encephalitis, such as pain and stiffness in the neck
  • Neurological symptoms such as facial paralysis, paralysis, inflammation of nerves, abnormal or decreased sensation such as tingling or numbness, stabbing or throbbing pain along one or more nerves, inflammation of optic nerve a
  • Feeling dizzy
  • Visual disturbance/impairment, increased sensitivity to light, eye pain
  • Ringing in the eagles
  • Fast heartbeat
  • Respiratory distress
  • Skin reactions (rash and/or itching ), eczema, reddening of the skin, increased sweating, inflammation of the skin
  • Back pain, joint swelling, neck pain, musculoskeletal stiffness and stiffness in the neck, pain in arms and legs
  • Chills, flu-like illness, weakness, edema, unsteady gait, accumulation of fluid under the skin
  • Joint pain at the injection site, the appearance of a small lump, and inflammation at the injection site

In a small comparative study of the immune response after injection into a muscle ( intramuscularly ) and injection under the skin ( subcutaneously ) of FSME-Immun in healthy adults, more local reactions were observed at the injection site (eg redness, swelling, itching, and pain) after injection under the skin, especially in women.

5. How to store FSME-Immun Adult

Store in a refrigerator (2 ºC-8 ºC). Store the syringe in the outer carton. Sensitive to light.

Do not freeze. Do not use this vaccine if there are visible signs of foreign particles or leakage.

  • Keep this vaccine out of the reach and sight of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines that are no longer in use. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

Content declaration

The active substance is: TBE- Virus (strain Neudörfl)

One dose (0.5 ml) of the vaccine contains 2.4 micrograms of inactivated TBE virus (strain Neudörfl), 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 (hydrogenated) is included in this vaccine as an adsorbent. Adsorbents are substances contained in certain vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

What the medicine looks like and the contents of the pack

The vaccine Adult supplied as 0.5 ml (1 dose ) injection, suspension in a prefilled syringe with or without an integrated needle. The package may contain either 1 or no needle. The needles are sterile and for single use only. Packs are available with 1, 10, 20, or 100 pre-filled syringes. Not all pack sizes may be marketed.

After shaking, the suspension is whitish and milky.

Each pre-filled syringe is packed in a blister. The opening of the blister seal is intended for and allows moisture equalization during the heating time recommended before the administration of the vaccine. Open the blister by removing the cap and then removing the syringe. Do not push the syringe through the blister.

Marketing Authorization Holder and Manufacturer

Pfizer Innovations AB

191 90 Sollentuna

Tel: 08 – 550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Pfizer Manufacturing Belgium, NV

Rijksweg 12

2870, Puurs

Belgium

Muhammad Nadeem

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