Encepur adults

Package leaflet: Information for the user

Encepur Adults
Suspension for injection
Inactivated tick-borne encephalitis vaccine.
Adult dose
Please read all of this leaflet carefully before this vaccine is used, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for a specific individual. 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.

Contents of the leaflet

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

Encepur Adults vaccine is a vaccine intended to provide active immunisation against tick-borne meningitis and encephalitis in adolescents from the age of 12 years and adults. The disease is caused by a virus transmitted by ticks. Vaccination is recommended for individuals travelling temporarily or residing permanently in areas where tick-borne meningitis and encephalitis occur.
Vaccines belong to a group of medicines that stimulate the immune system (the body's natural defence 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 complete protection in all vaccinated individuals.

2. Important information before using Encepur Adults vaccine

When not to use Encepur Adults vaccine

• if the patient has a known allergy (hypersensitivity) to any component of the vaccine or to formaldehyde, neomycin sulfate, chlorotetracycline, gentamicin sulfate, or chicken egg albumin, which may be present in trace amounts in the vaccine,
• if allergic symptoms occurred after previous administration of tick-borne encephalitis vaccine,
• if adverse reactions occurred after vaccination, further doses of the vaccine should not be administered until the cause has been investigated. This particularly applies to adverse post-vaccination reactions not limited to the injection site,
• in individuals with an acute illness requiring treatment and within two weeks after recovery.

Warnings and precautions
Before starting treatment with Encepur Adults vaccine, discuss this with your doctor, pharmacist,
or nurse.
Generally, there is no increased risk associated with the use of Encepur Adults vaccine in individuals
considered "allergic to chicken proteins" based solely on a questionnaire result or a positive skin test.
As with all injectable vaccines, appropriate medical treatment and supervision must be available in
case a rare anaphylactic reaction occurs after vaccination.
Under no circumstances should this vaccine be administered intravenously.
Accidental intravenous (arterial or venous) administration of the vaccine may cause a shock reaction.
In such a case, immediate anti-shock measures must be initiated.
Fainting, feeling of weakness, or other anxiety-related reactions may occur as a response to needle
injection.
If such a reaction has occurred previously in the patient, inform the doctor or nurse.
The doctor will assess the need for Encepur Adults vaccination in individuals with previously
diagnosed severe neurological disorders.
The tick-borne encephalitis vaccine is not effective against other diseases transmitted by ticks (e.g.
Lyme borreliosis), even if they are transmitted simultaneously.
Individuals with weakened immune systems, for example due to HIV infection or immunosuppressive
medications, may not achieve full protection after administration of Encepur Adults vaccine.
After every tick bite, the tetanus vaccination status should be checked.

Warning for individuals with latex hypersensitivity:
Prefilled syringe with attached needle:
The needle shield is made from natural rubber containing latex, which may cause allergic reactions in
individuals sensitive to latex.
Prefilled syringe without attached needle (with needle supplied separately in the package):
Although no latex derived from natural rubber has been detected in the syringe cap, the safety of
Encepur Adults vaccine in individuals with latex hypersensitivity has not been confirmed.

Encepur Adults vaccine and other medicines
Inform your doctor about all medicines currently or recently taken by the patient, as well as any
medicines the patient plans to take.
In individuals who have received immunoglobulin against tick-borne encephalitis virus, vaccination
should begin no sooner than 4 weeks after immunoglobulin administration. Otherwise, the level of
specific antibodies after vaccination may be reduced.
When administering more than one vaccine by injection, injections must be given at different body
sites.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this vaccine.
Pregnant or breastfeeding women should only be vaccinated after careful risk-benefit assessment, as
the safety of Encepur Adults vaccine in pregnant and breastfeeding women has not been established.

Driving and operating machinery
There are no adequate data.

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

Encepur Adults vaccine contains trace amounts of formaldehyde, chlorotetracycline,
gentamicin, and neomycin
Inform your doctor if the patient has previously experienced an allergic reaction to any of these
components.

3. How to use Encepur Adults vaccine

Encepur Adults vaccine should always be used according to the doctor's instructions. If in
doubt, consult your doctor or pharmacist again.
Dosage and method of administration
The Encepur Adults vaccine dose (0.5 ml) is intended for individuals aged 12 years and older.
Encepur Adults vaccine is administered as three separate injections, preferably during the cooler
season to ensure protection during the period of increased risk (spring/summer).
The vaccine is given according to one of the two following schedules:

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

The patient will be informed of the date for the required next dose of Encepur Adults vaccine.

If necessary, the physician may apply a more flexible vaccination schedule. For additional information, please contact your doctor.



Method of administration

Shake well before use.

The vaccine is administered intramuscularly, usually into the deltoid muscle.

In justified cases, e.g. in patients with haemorrhagic diathesis (increased tendency to bleed), the vaccine may be administered subcutaneously.

Under no circumstances should the vaccine be administered intravenously.



Administration of a higher than recommended dose of Encepur Adults vaccine

There is no data available on overdose.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone will experience them.

Very common (may occur in at least 1 in 10 people):

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

Common (may occur in less than 1 in 10 people):

• nausea
• joint pain
• redness at the injection site, swelling at the injection site
• fever above 38°C
• flu-like symptoms (excessive sweating, fever, chills), particularly in individuals receiving the vaccine for the first time. These symptoms usually resolve within 72 hours.

Uncommon (may occur in less than 1 in 100 people):

• vomiting

Severe allergic reactions
Severe allergic reactions, the frequency of which cannot be estimated from available data, including:

• generalized urticaria (hives which may affect the entire body),
• swelling (most commonly of the head and neck, including face, lips, tongue and throat, or other body parts),
• wheezing (a high-pitched sound during breathing caused by narrowing/edema of the airways),
• shortness of breath, difficulty breathing,
• narrowing of the airways (bronchospasm),
• drop in blood pressure,
• circulatory disturbances (with possible accompanying transient, non-specific visual disturbances),
• transient decrease in platelet count, which is short-lived but may be severe.

If any of the above symptoms occur, they usually develop very rapidly after vaccination, at a time when the patient is still under the supervision of a doctor or nurse. If any of the above symptoms occur after the patient has left the clinic, seek medical advice IMMEDIATELY.

Other adverse reactions
Other adverse reactions have been reported following administration of Encepur Adults, the frequency of which cannot be estimated from available data. These include:

• enlarged lymph nodes (lymph nodes in the neck, armpits, and groin),
• numbness, tingling,
• neck muscle and joint pain, which may be a sign of meningeal irritation (as seen in meningitis). These symptoms are very rare and resolve completely within a few days,
• dizziness,
• pre-syncope (feeling faint),
• fainting (syncope),
• diarrhoea,
• inflammatory nodule (granuloma) at the injection site, sometimes with accumulation of serous fluid,
• fatigue,
• asthenia (feeling of weakness).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the Encepur Adults vaccine

Keep the vaccine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Keep in the original packaging 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 packaging after "EXP".
The expiry date refers to the last day of the stated 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 in the vaccine is inactivated Tick-borne encephalitis virus, strain K23.
One dose of 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 aluminium hydroxide (0.3–0.4 mg Al).
Other ingredients of the vaccine are: sucrose, tris(hydroxymethyl)aminomethane, 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 pack sizes:
1 pre-filled syringe (with fixed needle or with needle supplied in the pack) containing 0.5 ml
in a cardboard box.
10 pre-filled syringes (with fixed needle) containing 0.5 ml each in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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