Encepur Adults

Package Leaflet: Information for the User

Encepur Adults

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

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 you. Do not pass it on to others.
• If you experience 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 Adults vaccine and what is it used for
• 2. Important information before using Encepur Adults vaccine
• 3. How to use Encepur Adults vaccine
• 4. Possible side effects
• 5. How to store Encepur Adults vaccine
• 6. Contents of the pack and other information

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

Encepur Adults vaccine is a vaccine intended for active immunization against tick-borne encephalitis in individuals from 12 years of age and adults. The disease is caused by a virus transmitted by ticks. Indications for vaccination include individuals who stay temporarily or permanently in areas where tick-borne encephalitis occurs.
Vaccines belong to a group of medicines that stimulate the immune system (the body's natural defense against infections) to produce protection against diseases.
Encepur Adults vaccine cannot cause the disease it protects against.
As with all vaccines, Encepur Adults vaccine may not provide full protection in all vaccinated individuals.

2. Important information before using Encepur Adults vaccine

When not to use Encepur Adults vaccine

• in individuals with acute illness requiring treatment and for two weeks after recovery.

Warnings and precautions

Before starting to use Encepur Adults vaccine, discuss it with your doctor, pharmacist, or nurse.
Generally, no increased risk has been found to be associated with the use of Encepur Adults vaccine in individuals considered to be "allergic to chicken 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 case 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 a shock reaction, including anaphylaxis. 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, the doctor or nurse should be informed.
The doctor will assess the need to use Encepur Adults vaccine in individuals 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.
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 Adults 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 attached to the package):
Although no natural rubber latex has been detected in the syringe tip, the safety of using Encepur Adults vaccine in individuals with latex hypersensitivity has not been confirmed.

Encepur Adults vaccine and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In individuals who have received immunoglobulin against tick-borne encephalitis virus, vaccination should be started at least 4 weeks after immunoglobulin administration. Otherwise, the level of specific antibodies after vaccination may be lower.
In the case of injectable administration of more than one vaccine, injections must be performed at different body sites.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this vaccine.
Pregnant or breastfeeding women should only be vaccinated after careful consideration of the risk-to-benefit ratio, as the safety of using Encepur Adults vaccine in pregnant and breastfeeding women has not been studied.

Driving and using machines

No relevant data are available.

Encepur Adults vaccine contains sodium

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

Encepur Adults vaccine contains trace amounts of formaldehyde, chlorotetracycline, gentamicin, and neomycin

Tell your doctor if you have had an allergic reaction to any of these components in the past.

3. How to use Encepur Adults vaccine

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

Dosage and administration

The dose of Encepur Adults vaccine (0.5 ml) is intended for individuals from 12 years of age.
Encepur Adults 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 schemes below:

The second dose of the vaccine may be administered no earlier than 14 days after the first dose (rapid scheme).

The patient will be informed about the date of the next required dose of Encepur Adults vaccine.
If necessary, the doctor may use a more flexible vaccination scheme. For more information, contact your doctor.
Administration method
Shake before use.
The vaccine is administered intramuscularly, usually into the deltoid muscle.
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 than recommended dose of Encepur Adults vaccine

No data on overdose are available.

4. Possible side effects

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

• headache
• muscle pain
• general weakness
• transient pain at the injection site Common(may affect up to 1 in 10 people):
• nausea
• joint pain
• redness of the skin at the injection site, swelling at the injection site
• fever over 38°C
• flu-like symptoms (excessive sweating, fever, chills), especially in individuals vaccinated for the first time. These symptoms usually resolve within 72 hours. Uncommon(may affect up to 1 in 100 people):
• vomiting Severe allergic reactionsSevere allergic reactions, whose frequency cannot be estimated from the available data, including:
• generalized urticaria (hives that may affect the whole body),
• swelling (most often of the head and neck, including the face, lips, tongue, and throat or other parts of the body),
• wheezing (a high-pitched sound when breathing, caused by narrowing/constriction of the airways),
• shortness of breath, difficulty breathing,
• constriction of the airways (bronchospasm),
• drop in 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 Adults vaccine, whose frequency cannot be estimated from the available data. These include:
• enlarged lymph nodes (lymph nodes on the neck, armpits, and groin),
• numbness, tingling,
• muscle and joint pain in the neck area, which may be a symptom of irritation of the meninges (such as in meningitis). These symptoms are very rare and resolve completely within a few days,
• dizziness,
• pre-syncope,
• fainting,
• diarrhea,
• a lump associated with inflammation (granuloma) at the injection site, sometimes with fluid accumulation,
• fatigue,
• asthenia (feeling of weakness).

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 Adverse Reaction 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Encepur Adults vaccine

Store the vaccine out of sight and reach of children.
Store in a refrigerator (2°C - 8°C). Store in the original package to protect the contents from light.
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 package after "EXP".
The expiry date refers to the last day of the 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 Adults vaccine contains

The active substance of the vaccine is inactivated tick-borne encephalitis virus, strain K23.
One dose of the vaccine (0.5 ml) contains 1.5 micrograms of tick-borne encephalitis virus, strain K23, which is produced in chicken embryo cells and adsorbed onto hydrated aluminum hydroxide (0.3 - 0.4 mg Al).
The other ingredients of the vaccine are: sucrose, trometamol, sodium chloride, water for injections.

What Encepur Adults vaccine looks like and contents of the pack

Encepur Adults vaccine is a white, turbid suspension for injection.
Encepur Adults vaccine is available in the following packs:
1 pre-filled syringe (with attached needle or with needle attached to the package) of 0.5 ml in a cardboard box.
10 pre-filled syringes (with attached needle) of 0.5 ml in a cardboard box.
Not all pack sizes may be marketed.

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: