(0.25 ml), solution for injection, suspension. Tick-borne encephalitis (TBE) vaccine, inactivated
What Encepur Kinder is and what it is used for
Encepur Kinder is a vaccine that contains inactivated virus of the type that causes tick-borne encephalitis (TBE).
The Encepur Kinder vaccine is intended for children from 1 to 11 years of age 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.
Benefits of encepur kinder vaccine are mainly for children. The vaccine is intended for children who are permanently or temporarily staying in areas where TBE occurs. For adults and adolescents from 12 years of age, Encepur is used, adults.
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.
What you need to know before your child receives Encepur Kinder
Encepur Children should not be given
- if your child has an acute illness that requires treatment. Your child should not be vaccinated until at least 2 weeks after recovery.
- if your child has had complications after previous vaccination with Encepur Kinder. In this case, your child should not be vaccinated with the same vaccine until the cause of the complications has been investigated.
- if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions of encepur kinder vaccine
Talk to your doctor, pharmacist, or nurse before your child receives Encepur Kinder.
- In general, there is no increased risk of vaccination with Encepur children if your child has been diagnosed as “allergic to chicken protein” only through 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.
- The doctor or nurse will assess the need for vaccination if the child has an existing, serious, neurological disease.
- Fainting, fainting, or other stress-related reactions can occur as a reaction to all kinds of needle injections. Tell your doctor or nurse if the child has 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.
- Children under 3 years of age may develop a high fever (≥39.5 ° C).
- Fever (> 38 ° C) occurs mainly after the first vaccination. This phenomenon is less common after the second vaccination. In such cases, antipyretic treatment should be considered (see section 4 Possible side effects ).
- If your child has 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 children be limited.
If your child is sensitive to latex:
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 Kinder 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 a doctor before the child receives Encepur Kinder if the child is allergic to latex.
Other medicines and Encepur Kinder vaccine
Tell your doctor, pharmacist, or nurse if your child is taking, has 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.
Composition of Encepur Kinder
less than 1 mmol sodium (23 mg per dose ), ie essentially ‘sodium-free’.
This vaccine contains trace amounts of formaldehyde, neomycin, gentamycin, and chlortetracycline. Tell your doctor if your child has had an allergic reaction to these ingredients.
How to give encepur kinder vaccine, insctructions:
Your doctor or pharmacist will tell you how to get the encepur kinder vaccine for your child. Following are the detailed instruction of giving encepur kinder vaccine.
Encepur kinder vaccination schedule
Children from 1 to 11 years of age should receive 1 dose (0.25 ml) with each injection.
tick borne encephalitis vaccine is given as a total of 3 injections, preferably starting 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||Every 5 years.|
The second dose of tick borne encephalitis vaccine can be brought forward and given no earlier than 14 days after the first dose of encepur kinder vaccine(abbreviated vaccination schedule)
|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||Every 5 years.|
You will be informed when your child will return for the next dose.
If necessary, the vaccination schedule can be more flexible. Talk to a doctor or nurse for more information.
over dose of tick borne encephalitis vaccine
It is not known what risks and types of side effects may occur if your child is given more than the recommended dose.
Possible side effects of encepur kinder vaccine
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A very common side effect tick borne encephalitis vaccine is (occurring in more than 1 in 10)
- headache (in children from 3 years of age)
- drowsiness (in children under 3 years of age)
- transient pain at the injection site
- fever (above 38 ° C) in children aged 1-2 years.
Common adverse side effects of encepur kinder vaccine (affecting less than 1 in 10)
- joint pain
- muscle aches
- skin redness at the injection site, swelling at the injection site
- fever (above 38 ° C) in children aged 3-11 years
- flu-like symptoms (sweating, fever, tremors) including fever may develop, especially after the first vaccination, but usually subside within 72 hours
- general malaise
Rare side effects of encepur vaccine (affects less than 1 user in 1,000)
Severe allergic reactions of tick borne encephalitis vaccine
Severe allergic reactions for which the frequency can not be calculated from available information are:
- 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
- Reactions in the circulatory system (possibly accompanied by transient, non-specific visual disturbances)
- Low levels of platelets 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 of encepur vaccine are
Other side effects of encepur kinder vaccine for which the frequency cannot be calculated from the available information have been reported after vaccination with Encepur Kinder. These are:
- Swollen lymph nodes ( glands in the throat, armpits, or groin).
- Numbness and tingling.
- Joint pain and muscle pain in the neck 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.
- Knot due to inflammation at the injection site (granuloma), sometimes with accumulation of fluid.
How to store Encepur Kinder vaccine
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 ° C-8 ° C). 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.
Contents of the packaging and other information
- One dose (0.25 ml) contains 0.75 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 Children is a whitish turbid injection, suspension, in a prefilled syringe.
Encepur Children are supplied in single-dose syringes (with or without a needle). Each syringe contains 0.25 ml.
Pack sizes: 1 x 0.25 ml, 10 x 0.25 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bavarian Nordic A / S
Philip Heymans Allé 3
GSK Vaccines GmbH