Encepur K

Package Leaflet: Information for the User

Encepur K

Suspension for injection
Vaccine against tick-borne encephalitis, inactivated
Dose for children.

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• The vaccine has been prescribed specifically for this person. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Encepur K vaccine and what is it used for
• 2. Important information before using Encepur K vaccine
• 3. How to use Encepur K vaccine
• 4. Possible side effects
• 5. How to store Encepur K vaccine
• 6. Contents of the pack and other information

1. What is Encepur K vaccine and what is it used for

Encepur K vaccine is a vaccine intended for active immunization against tick-borne encephalitis (TBE) in children over one year of age.
In the case of children under two years of age, the doctor may decide to vaccinate after considering the risk-to-benefit ratio (see section 4). For persons 12 years of age and older, the adult vaccine is used.
The disease is caused by a virus transmitted by ticks.
Indications for vaccination include children who temporarily or permanently reside in areas where tick-borne encephalitis occurs.
Vaccines belong to a group of drugs that stimulate the immune system (the body's natural defense against infections) to produce protection against diseases.
Encepur K vaccine cannot cause the disease it protects against.
As with all vaccines, Encepur K vaccine may not provide complete protection in all vaccinated individuals.

2. Important information before using Encepur K vaccine

When not to use Encepur K vaccine

• if the patient has been found to be hypersensitive (allergic) to any component of the vaccine and to formaldehyde, neomycin sulfate, chlorotetracycline, gentamicin sulfate, or egg albumin, which may be present in trace amounts in the vaccine,
• if allergic reactions have occurred after previous administration of a tick-borne encephalitis vaccine,
• if side effects have occurred after vaccination, further doses of the vaccine are contraindicated until the cause of the side effects has been clarified. This applies in particular to undesirable post-vaccination reactions that are not limited to the injection site,
• in children with an acute illness requiring treatment and for two weeks after recovery.

Warnings and precautions

Before starting to use Encepur K vaccine, discuss it with your doctor, pharmacist, or nurse.
Generally, no increased risk is observed with the use of Encepur K vaccine in individuals considered to be "allergic to egg proteins" based solely on a questionnaire or a positive skin test result.
As with all injectable vaccines, the possibility of appropriate treatment and supervision should be ensured in the event of a rare anaphylactic reaction after vaccination.
This vaccine must not be administered intravascularly. Accidental intravascular administration (arterial or venous) of the vaccine may cause an allergic reaction with shock. In such a situation, immediate anti-shock measures should be taken.
Fainting, feeling of weakness, or other anxiety-related reactions may occur as a reaction to needle insertion. If such a reaction has occurred in the patient in the past, inform your doctor or nurse.
The doctor will assess the need to use Encepur K vaccine in a child with previously diagnosed severe neurological disorders.
The tick-borne encephalitis vaccine is not effective against other tick-borne diseases (e.g., Lyme borreliosis), even if they are transmitted simultaneously.
In children under 3 years of age, high fever (≥39.5°C) may occur.
In younger children, fever (≥38°C) occurs, especially after the first dose of the vaccine (see section 4); this occurs more frequently than after the second dose of the vaccine. Consider administering antipyretic drugs if necessary.
Individuals with weakened immune systems, for example, due to HIV infection or due to immunosuppressive drugs, may not achieve full protection after vaccination with Encepur K vaccine.
After each tick bite, the tetanus vaccination status should be checked.
Warning for individuals with latex hypersensitivity:
Syringe with attached needle:
The needle shield is made of natural rubber latex, which may cause allergic reactions in individuals with latex hypersensitivity.
Syringe without attached needle (with needle included in the package):
Although no natural rubber latex has been detected in the syringe tip, the safety of using Encepur K vaccine in individuals with latex hypersensitivity has not been confirmed.

Encepur K vaccine and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
In children who have received immunoglobulin against tick-borne encephalitis virus, vaccination should start at least 4 weeks after immunoglobulin administration. Otherwise, the level of specific antibodies after vaccination may be lower.
When administering more than one vaccine by injection, injections must be performed at different injection sites.

Pregnancy and breastfeeding

Not applicable. Encepur K vaccine is intended for children under 12 years of age.

Driving and using machines

Not applicable.

Encepur K vaccine contains sodium

This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e., the vaccine is considered "sodium-free".

3. How to use Encepur K vaccine

Encepur K vaccine should always be used in accordance with the doctor's recommendations. In case of doubts, contact your doctor or pharmacist again.

Vaccination schedule Dosing

Children from 1 to 11 years of age receive the same dose of 0.25 ml of the vaccine.
Encepur K vaccine is administered as three separate injections, preferably during the cooler months to ensure protection during the period of increased risk (spring/summer).
The vaccine is administered according to one of the two schedules below:

The second dose of the vaccine may be administered no earlier than 14 days after the first dose (accelerated classic schedule).

The patient will be informed about the date of the next required dose of Encepur K vaccine.
If necessary, the doctor may use a more flexible vaccination schedule. For more information, contact your doctor.
Method of administration
Shake before use.
The vaccine is administered intramuscularly, usually into the deltoid muscle or thigh, depending on muscle mass. In justified cases, e.g., in patients with bleeding disorders (increased tendency to bleed), the vaccine may be administered subcutaneously.
The vaccine must not be administered intravascularly!

Use of a higher dose of Encepur K vaccine than recommended

There are no data on overdose.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Very common(may affect at least 1 in 10 people):

• headache (in children aged 3 and older)
• drowsiness (in children under 3)
• transient pain at the injection site
• fever (above 38°C) in children aged 1 to 2 years Common(may affect less than 1 in 10 people):
• nausea
• joint pain
• muscle pain
• redness of the skin at the injection site, swelling at the injection site
• fever (above 38°C) in children aged 3 to 11 years
• flu-like symptoms (excessive sweating, fever, chills), especially in first-time vaccinated individuals and usually resolving within 72 hours,
• general malaise
• general weakness, apathy

Rare(may affect less than 1 in 1000 people):

• vomiting
• diarrhea Severe allergic reactionsSevere allergic reactions, whose frequency cannot be estimated from the available data, including: ̶ generalized urticaria ̶ erythema multiforme ̶ angioedema ̶ wheezing (high-pitched sound when breathing due to narrowing/edema of the airways) ̶ breathing difficulties, shortness of breath ̶ bronchospasm (constriction of the airways) ̶ decreased blood pressure ̶ circulatory disorders (with possible accompanying, transient, non-specific visual disturbances) ̶ temporary decrease in platelet count, which is short-lived but may be severe. If the above symptoms occur, they usually develop very quickly after vaccination, while the patient is still under medical supervision. If any of the above symptoms occur after the patient has left the doctor's office, contact your doctor IMMEDIATELY.Other side effectsOther side effects have been reported after administration of Encepur K vaccine, whose frequency cannot be estimated from the available data. These include: ̶ lymphadenopathy (enlarged lymph nodes on the neck, armpits, and groin) ̶ numbness, tingling ̶ musculoskeletal pain in the neck area, which may be a sign of meningeal irritation (such as in meningitis). These symptoms occur very rarely and resolve completely within a few days. ̶ fainting ̶ inflammatory nodule (granuloma) at the injection site, sometimes with serous fluid accumulation ̶ seizures.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the vaccine.

5. How to store Encepur K vaccine

Store the vaccine out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze! Do not use the vaccine if it has been frozen.
The vaccine should be used immediately after opening.
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 given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Encepur K vaccine contains

The active substance of the vaccine is inactivated tick-borne encephalitis virus, strain K23.
One dose of the vaccine (0.25 ml) contains 0.75 micrograms of tick-borne encephalitis virus, strain K23, which is produced in chick embryo cells and adsorbed on hydrated aluminum hydroxide (0.15 - 0.2 mg Al).
The other ingredients of the vaccine are: sucrose, trometamol, sodium chloride, and water for injections.

What Encepur K vaccine looks like and contents of the pack

Encepur K vaccine is a white, turbid suspension for injection.
Encepur K vaccine is available in the following packs:
1 pre-filled syringe (with attached needle or with needle included in the package) of 0.25 ml in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bavarian Nordic A/S
Philip Heymans Alle 3
2900 Hellerup Denmark

Manufacturer

Bavarian Nordic A/S
Hejreskovvej 10A
3490 Kvistgaard
Denmark
GSK Vaccines GmbH
Emil-von-Behring-Str. 76
D-35041 Marburg
Germany

Date of last revision of the leaflet: