TicoVac 0.5 ml
Suspension for injection in pre-filled syringe
Tick-Borne Encephalitis Vaccine
(Inactivated)
Read all of this leaflet carefully before you start having this vaccine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What TicoVac 0.5 ml is and what it is used for
- 2. Before you receive TicoVac 0.5 ml
- 3. How TicoVac 0.5 ml is given
- 4. Possible side effects
- 5. How to store TicoVac 0.5 ml
- 6. Further information
WHAT TicoVac 0.5 ml IS AND WHAT IT IS USED FOR
TicoVac 0.5 ml is a vaccine, which is used to prevent disease caused by Tick-Borne Encephalitis (TBE) Virus. It is suitable for persons of at least 16 years of age.
- The vaccine causes your body to make its own protection (antibodies) against the virus.
- It will not protect against other viruses and bacteria (some of which are also caught from insect bites) that may cause similar symptoms.
The Tick-Borne Encephalitis Virus can cause very serious infections of the brain or the spine and its covering. These often start with headache and high temperature. In some people and in the most severe forms, they can progress to loss of consciousness, coma and death.
The virus can be carried by ticks. It is passed on to man by tick bites. The chance of being bitten by ticks that carry the virus is very high in some parts of central and northern Europe. People who live in or take holidays in these parts of Europe are most at risk. The ticks are not always spotted on the skin and the bites may not be noticed.
- Like all vaccines, TicoVac 0.5 ml may not completely protect everyone who is vaccinated.
- Also, protection does not last for life.
- A single dose of the vaccine is not likely to protect you against infection. You need 3 doses (see section 3 for more information).
BEFORE YOU RECEIVE TicoVac 0.5 ml
Do not use TicoVac 0.5 ml if:
- you ever had an allergic reaction to a previous dose of this vaccine or to any ingredient of the vaccine. For example, you have had skin rash, swelling of the face and throat, difficulty in breathing, blue discolouring of the tongue or lips, low blood pressure and collapse.
- you ever had an allergic reaction to neomycin or gentamicin or to formaldehyde or protamine sulphate (used during the manufacturing process).
- you ever had a severe allergic reaction after eating egg or chicken.
- you are known to be allergic to latex rubber.
- you have an infection with a fever (raised temperature) you may have to wait before having TicoVac 0.5 ml. Your doctor could ask you to wait for the injection until you feel better.
Take special care with TicoVac 0.5 ml
Talk to your doctor before having the vaccine if:
- you have an autoimmune disease (such as rheumatoid arthritis or multiple sclerosis)
- you have a weak immune system (so that you do not fight infections well)
- you do not produce antibodies well
- you take any medicine for cancer
- you take medicines called corticosteroids (that reduce inflammation)
- you have any brain illness
If any of these apply to you, the vaccine may not be suitable. Or, the doctor may give you the vaccine but want to take a simple blood test later, to check that it has worked.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines which you bought without a prescription. Your doctor will tell you if you can have TicoVac 0.5 ml at the same time as other vaccines. If you have recently had another vaccine, your doctor will decide where and when to give the TicoVac 0.5 ml vaccine.
Tell your doctor if you have ever been infected with or been vaccinated against yellow fever, Japanese encephalitis or Dengue viruses. This is because you may have antibodies in your blood that can react with the Tick-Borne Encephalitis (TBE) Virus used in tests to measure your antibody levels.
These tests could then give wrong results.
Pregnancy and breast-feeding
Tell your doctor before having this injection if:
- you may be pregnant, or are planning to become pregnant;
- you are breast-feeding.
Your doctor will discuss with you the possible risks and benefits. The effect of TicoVac 0.5 ml during pregnancy or while breast-feeding is not known.
However, it may still be given if the risk of infection is high.
Driving and using machines
The vaccine is unlikely to affect a person being able to drive or use machines. However, you may have problems with your sight or feel dizzy.
HOW TicoVac 0.5 ml IS GIVEN
TicoVac 0.5 ml is usually injected into the muscle of the upper arm. The vaccine must not be injected into a blood vessel. TicoVac 0.5 ml should not be given to persons under 16 years of age. For this age group a TBE vaccine for children is recommended.
First course of injections
The first course of injections is the same for all persons from the age of 16 onwards and consists of three doses of TicoVac 0.5 ml.
- 1. Your doctor will decide when to give the first injection.
- 2. The second injection will be given 1 to 3 months later. It can be given two weeks after the first dose if you need urgent protection.
- 3. The third injection will be given 5 to 12 months after the second injection.
- It is best to have the first and second doses in the winter. This is because the tick starts being active in spring. This allows you to develop enough protection before the tick season starts.
- The third dose completes the primary course of injections. It can be given during summer or autumn as early as five months after the second dose or, at the latest, before the start of next tick season. It gives protection for up to three years.
- If you leave too much time between the 3 doses, you may not have full protection against infection.
Booster vaccinations
Persons from 16 to 60 years of age
If you are younger than 60, you will need the first booster dose 3 years after the third dose. Further booster doses should be given every 3 to 5 years, depending on local epidemiology and national recommendations.
Persons above 60 years of age (elderly persons)
In general, you will need booster doses – the first and all further booster doses – at three years intervals.
Persons with an impaired immune system (including those undergoing immuno-suppressive therapy) and persons above 60 years of age (elderly persons)
Your doctor may consider determining the antibodies in your blood at four weeks after the second dose and administer an additional dose if there is no evidence of immune response at this time. A third dose should be given as scheduled.
If you are given more TicoVac 0.5 ml than you should be given
An overdose is highly unlikely to happen because the injection is given from a single-dose syringe by a doctor.
If you have any further questions on the use of this vaccine, ask your doctor or pharmacist.
Ticovac Side Effects
Like all medicines, TicoVac may cause side effects, although not everybody gets them. If any of the side effects persist or worsen and worry you or if you notice side effects not listed in this leaflet, please contact your doctor.
As with all vaccines, severe allergic reactions can happen. They are very rare, but the right medical treatment and supervision must always be readily available. Symptoms of serious allergic reactions include:
- swelling of the lips, mouth, throat (which may make it difficult to swallow or breathe),
- a rash and swelling of the hands, feet and ankles,
- loss of consciousness due to a drop in blood pressure.
These signs or symptoms usually happen very quickly after the injection is given, while the person is still in the clinic or surgery. If any of these symptoms happen after you leave the place where your injection was given, you must see a doctor IMMEDIATELY.
Very common side effects (affect more than 1 in 10 people)
- Pain and tenderness where the injection was given
Common side effects (affect less than 1 in 10 people)
Nausea
Feeling tired or unwell
Headaches
Muscle and joint pains
Uncommon side effects (affect less than 1 in 100 people)
Swelling, hardness and redness where the injection was given
Vomiting
Swelling of lymph glands, fever
Very rare side effects (affect less than 1 in 10,000 people)
- Feeling dizzy, muscle and joint pain in the neck region, unsteady walking, inflamed nerves, convulsions
- Blurred vision or being more sensitive to light, pain in the eye
- Tachycardia
- Diarrhoea
- Rash
- Redness and itchy skin
- Severe shivering and high temperature
- Flu-like illness, weakness, swelling
- Inflammatory reactions of the brain
- Aggravation of autoimmune diseases like multiple sclerosis or iridocyclitis (a type of inflammation of the eye)
HOW TO STORE TicoVac 0.5 ml
- Store in a refrigerator (2°C – 8°C). Keep the syringe in the outer carton, as this provides protection from light. Do not freeze. Do not use TicoVac 0.5 ml if you notice any visible signs of foreign particulate matter or leakage.
- Keep out of the reach and sight of children.
- Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that 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 protect the environment.
Further Information
What TicoVac 0.5 ml contains
One dose (0.5 milliliters) of the vaccine contains as the active ingredient 2.4 micrograms of in-activated Tick-Borne Encephalitis Virus (strain Neudörfl), which is produced in chick embryo cells.
Aluminum hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other ingredients in the vaccine are human albumin, sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. Potassium and sodium are present at levels less than 1 mmol per dose, i.e. essentially “potassium- and sodium-free”.
Trace amount of formaldehyde, neomycin, gentamicin, protamine sulfate may be present.
What TicoVac 0.5 ml looks like and contents of the pack
TicoVac 0.5 ml is supplied as a 0.5 milliliter (one dose) suspension for injection in a pre-filled syringe with an attached needle. Pack sizes of 1, 10, 20 or 100 pre-filled syringes are available. Not all pack sizes may be marketed. After shaking, the suspension is off-white and milky.
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorized in the Member States of the EEA under the following names:
United Kingdom
This leaflet was last approved in March 2006
Product Reference Code 6237300EA07
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