0.5 ml Suspension for injection, 
tick vaccine against tick-borne encephalitis (TBE) (inactivated)

Read this leaflet carefully before you receive this vaccine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Encepur is and what it is used for 
2. What you need to know before you take Encepur 
3. How Encepur is given 
4. Possible side effects 
5. How to store Encepur 
6. Contents of the packaging and other information 

1. What Encepur is and what it is used for

Encepur contains inactivated virus of the type that causes tick-borne encephalitis (TBE).

The Encepur vaccine is intended for use in people from the age of 12 to prevent disease caused by the TBE virus. TBE virus is an important cause of viral infections in the central nervous system. Most infections with this virus are caused by tick bites.

The vaccine is intended for people who are permanently or temporarily staying in areas where TBE occurs.

Vaccines belong to a group of drugs that affect the immune system (the body’s natural defenses against infections ) to protect against diseases.

As with other vaccines, it is possible that Encepur does not completely protect all vaccinated individuals.

For children from 1 to 11 years of age, Encepur Barn is used.

What you need to know before you take Encepur

Do not use Encepur

  • if you have an acute illness that requires treatment. You should not be vaccinated until at least 2 weeks after recovery
  • if you have any complications after previous vaccination with Encepur. In this case, you should not be vaccinated with the same vaccine until the cause of the complications has been investigated
  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Encepur

  • Encepur may contain residues of eggs and chicken protein, such as ovalbumin (an egg white protein ). If you have reacted with anaphylactic symptoms, such as hives, swelling of the upper respiratory tract (lips, tongue, throat), narrowing of the airways ( bronchospasm ), a drop in blood pressure, or a rapid drop in blood pressure that has caused an acute condition ( shock ), after exposure to eggs or chicken protein, talk to your doctor or nurse before receiving the vaccine. In such very rare cases, injection is recommended one is given under close supervision. In general, however, there is no increased risk of vaccination with Encepur if you have been diagnosed as “allergic to chicken protein” only via a questionnaire or positive spot test.
  • The doctor or nurse will be careful not to inject the vaccine into a blood vessel. Accidental injection into a blood vessel can in extreme cases provoke a shock reaction.
  • As with all injected vaccines, appropriate medical treatment and monitoring should always be available in the event of a rare anaphylactic reaction following vaccination.
  • Your doctor or nurse will assess the need for vaccination if you have an existing, serious, neurological illness.
  • Fainting, fainting, or other stress-related reactions can occur as a reaction to all kinds of needle injections. Tell your doctor or nurse if you have previously reacted in this way.
  • The TBE vaccine does not protect against other tick-borne diseases (eg Lyme disease ) even if they are transmitted at the same time as tick-borne encephalitis.
  • If you have a weakened immune system, for example, because of HIV – infection or because of drugs that inhibit the body’s immune system, the effect of Encepur be limited or uncertain.

Latex-sensitive people:

Pre-filled syringe without a needle:

Natural rubber latex could not be detected in the tip guard of the syringe, but the safe use of Encepur in latex-sensitive individuals has not been established.

Pre-filled syringe with a needle:

The needle cover contains latex. May cause severe allergic reactions. Talk to your doctor before receiving Encepur if you are allergic to latex.

Other medicines and Encepur

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

If more than one vaccine is given at the same time, they must be given at different injection sites.

Pregnancy and breastfeeding

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.

No controlled clinical trials have been performed in pregnant women. It should therefore only be used after careful consideration of the risks and benefits to pregnant and lactating women.

Driving and using machines

No studies have been performed with Encepur to assess the effect on the ability to drive and use machines (see also section 4, Possible side effects ).

Some of the side effects described in section 4 may affect the ability to drive and use machines.

Encepur contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

This vaccine contains trace amounts of formaldehyde, chlortetracycline, gentamycin, and neomycin. Tell your doctor if you have had an allergic reaction to these ingredients.

3. How Encepur is given

Your doctor or pharmacist will tell you how to get this vaccine.

One dose of Encepur (0.5 ml) for adults and adolescents from 12 years of age.

Encepur is given as a total of 3 injections, preferably during the cold months of the year to protect during the risk period (spring/summer). The vaccine is given according to one of the following schedules:

Standard schedule (preferred vaccination schedule)
Dos 1 Optional day
Dos 2 14 days to 3 months after the first dose.
Dos 3 9 to 12 months after the second dose.
Top-up dose 1 3 years after the third dose one.
Additional refill dose Persons 12-49 years: every 5 yearsPersons> 49 years: every 3 years 

The second vaccination can be given no earlier than 14 days after the first vaccination.

Shortened vaccination schedule (when immediate protection is needed)
Dos 1 Optional day
Dos 2 7 days after the first dose one.
Dos 3 21 days after the second dose one.
Top-up dose 1 12-18 months after the third dose one.
Additional refill dose Persons 12-49 years: every 5 yearsPersons> 49 years: every 3 years

You will be informed when to return for the next dose.

If necessary, the vaccination schedule can be more flexible. Talk to your doctor or nurse for more information.

Use for children and adolescents

Encepur should not be used in children under 12 years of age. Encepur Barn is recommended for this age group.

Your doctor will give Encepur an injection into your upper arm muscle.

The vaccine should not be given (deep) into the skin as protection may be impaired.

The vaccine should never be given to a friend.

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

If you take more Encepur then you should

It is not known what risks and types of side effects may occur if you are given more than the recommended dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A very common side effect is (occurring in more than 1 in 10)

  • headache
  • muscle aches
  • transient pain at the injection site
  • general malaise.

Common adverse s (affecting less than 1 in 10)

  • nausea
  • joint pain
  • skin redness at the injection site, swelling at the injection site
  • fever (above 38 ° C)
  • flu-like symptoms (sweating, fever, tremors) may develop, especially after the first vaccination, but usually subside within 72 hours.

Less common side effects are (by less than 1 in 100)

  • vomiting.

Severe allergic reactions

Severe allergic reactions for which the frequency can not be calculated from available information are:

  • generalized skin rash
  • swelling (most clearly in the head and neck, including the face, lips, tongue, and throat, or any other part of the body)
  • stridor (a wheezing breathing noise caused by blocked/swollen airways)
  • shortness of breath, difficulty breathing
  • narrowing of the airways ( bronchospasm )
  • drop in blood pressure
  • cardiovascular reactions (possibly accompanied by transient, non-specific visual disturbances)
  • low levels of platelets that are only short-lived but can be severe

When these signs and symptoms occur, they usually develop very quickly after injection one while you are still under the supervision of healthcare professionals. If any of these symptoms occur after leaving your doctor or nurse, you must seek medical advice immediately.

Other side effects are

Other adverse reactions for which the frequency cannot be calculated from the available information have been reported after vaccination with Encepur. These are:

  • swollen lymph nodes ( glands in the throat, armpits, or groin)
  • numbness and tingling
  • muscle aches and joint pain in the neck that may indicate meningism (irritation of the meninges seen in, for example, meningitis ). These symptoms are very rare and go away within a few days without any sequelae.
  • dizziness
  • fainting sensation
  • fainting
  • diarrhea
  • nodule due to inflammation at the injection site (granuloma), sometimes with accumulation of fluid
  • fatigue
  • weakness.

5. How to store Encepur

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ºC-8 ºC). Sensitive to light.

Do not freeze. Vaccines that have been frozen must not be used.

The vaccine should be inspected visually for particulate matter and discoloration before administration. In case of visible abnormalities, the vaccine should be discarded.

Use immediately after opening the container.

Do not use this medicine after the expiry date which is stated on the carton and container after “EXP. dat ”or“ Exp. ”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • One dose (0.5 ml) contains 1.5 mg of the active substance inactivated TBE (tick-borne encephalitis) virus, strain K23 grown in primary chicken embryo cells, inactivated with formaldehyde and with aluminum hydroxide as adjuvant. An adjuvant is a different component of the vaccine than the antigen (the active substance in vaccines) that enhances the immune response (the body’s natural protection against infections ) to the antigen.
  • The other ingredients (excipients) are trometamol, sucrose, sodium chloride, and water for injections. The vaccine contains trace amounts of formaldehyde, chlortetracycline, gentamycin, and neomycin, and may contain residues of eggs and chicken protein.

What the medicine looks like and the contents of the pack

Encepur is a whitish turbid injection, suspension in a prefilled syringe.

Encepur is available in the following pack sizes:

  • Pack of 1 pre-filled syringe (with/without needle) each containing 0.5 mL injection, suspension
  • Pack of 10 pre-filled syringes (with/without needle) each containing 0.5 mL injection, suspension
  • Pack of 20 pre-filled syringes (with/without needle) each containing 0.5 mL injection, suspension (2×10 packs)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: 
Bavarian Nordic A / S

Philip Heymans Allé 3

2900 Hellerup

Denmark

Manufacturer:

Bavarian Nordic A / S

Hejreskovvej 10A

3490 Kvistgård

Denmark

GSK Vaccines GmbH

Emil-von-Behring-Straße 76 
D-35041 Marburg

Germany

Muhammad Nadeem

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