Encepur Vaccine 0.5 ml Suspension for injection,
tick vaccine against tick-borne encephalitis (TBE) (inactivated)
What Encepur Vaccine Is And What It Is Used For
It contains inactivated virus of the type that causes tick-borne encephalitis (TBE).
The Encepur kinder 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.
Benefits Of Encepur Vaccine
The vaccine is beneficial for people who are permanently or temporarily staying in areas where TBE occurs.
Encepur kinder vaccine 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 Kinder is used.
What You Need To Know Before You Take Encepur Vaccination
Do Not Use Encepur Vaccine
- 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 it. 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 vaccine 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 the Encepur vaccine be limited or uncertain.
Latex-Allergic People:
Encepur Vaccine 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.
Encepur Vaccine 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 Vaccine
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, it must be given at different injection sites.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this Encepur vaccine.
No controlled clinical trials have been performed on 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 the Encepur vaccine to assess the effect on the ability to drive and use machines (see also section 4, Possible side effects ).
Some of the tbe vaccine side effects described in section 4 may affect the ability to drive and use machines.
Tbe vaccine side effects
This vaccine contains trace amounts of formaldehyde, chlortetracycline, gentamycin, and neomycin. Tell your doctor if you have had an allergic reaction to these ingredients.
Encepur Vaccine Schedule And Dosing
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.
It 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. |
| 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. |
| Dos 3 | 21 days after the second dose. |
| Top-up dose 1 | 12-18 months after the third dose. |
| 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.
Encepur vaccine 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 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 about the use of this vaccine, ask your doctor, pharmacist, or nurse.
Overdose Of The Encepur Vaccine
It is not known what risks and types of side effects may occur if you are given more than the recommended dose.
Side Effects Of The Encepur Vaccine
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A very common Encepur vaccine side effect (occurring in more than 1 in 10)
Common adverse side effects of the Encepur vaccine (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 Encepur vaccine side effects (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, 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 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 vaccination
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 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
How To Store The Encepur Vaccine
- 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.
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 Does The Encepur Vaccine Medicine Look Like And The Contents Of The Pack?
The vaccine is a whitish turbid injection, suspension in a prefilled syringe.
Encepur vaccine 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 Of Encepur Vaccine For TBE
Marketing Authorization Holder:
Bavarian Nordic A / S
Philip Heymans Allé 3
2900 Hellerup
Denmark
Manufacturer:
Bavarian Nordic A / S
Hejreskovvej 10A
3490 Kvistgård
Denmark
Emil-von-Behring-Straße 76
D-35041 Marburg
Germany