TICOVAC JUNIOR 0.25 ML SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE

PACKAGE LEAFLET: INFORMATION FOR THE USER

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6237400GB01

TicoVac Junior 0.25 ml
Suspension for injection in a pre-filled syringe Tick-Borne Encephalitis Vaccine (whole virus, inactivated)

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Read all of this leaflet carefully before you are given 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 Junior 0.25 ml is and what it is used for 2. Before you receive TicoVac Junior 0.25 ml 3. How TicoVac Junior 0.25 ml is given 4. Possible side effects 5. How to store TicoVac Junior 0.25 ml 6. Further information 1. WHAT TicoVac Junior 0.25 ml IS AND WHAT IT IS USED FOR TicoVac Junior 0.25 ml is a vaccine, which is used to prevent disease caused by Tick-Borne Encephalitis (TBE) Virus. It is suitable for children above 1 and below 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 highest risk. The ticks are not always spotted on the skin and the bites may not be noticed. Like all vaccines TicoVac Junior 0.25 ml may not completely protect everyone who is vaccinated. The 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) to achieve an optimal protection. 2. BEFORE YOU RECEIVE TicoVac Junior 0.25 ml Do not use TicoVac Junior 0.25 ml if: you are allergic (hypersensitive) to the active substance, any of the other ingredients or neomycin, gentamycin, formaldehyde or protamine sulphate (used during the manufacturing process). For example, you have had skin rash, swelling of the face and throat, difficulty in breathing, blue colouring of the tongue or lips, low blood pressure and collapse. you ever had a severe allergic reaction after eating egg or chicken. you have an infection with a fever (raised temperature) you may have to wait before having TicoVac Junior 0.25 ml. Your doctor could ask you to wait for the injection until you feel better.
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you have any brain illness you are known to be allergic to latex rubber. The vaccine may not be suitable, if any of the circumstances above apply to you. Alternatively, the doctor may give you the vaccine. The doctor may request to do a blood test to check whether the vaccine has worked. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you if you can have Ticovac Junior 0.25 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 Junior 0.25 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 Junior 0.25 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 (play in the street or cycle) However, you may have problems with your sight or feel dizzy. Important information about some of the ingredients of TicoVac Junior 0.25 ml Potassium and sodium are present at levels less than 1 mmol per dose, i.e. essentially potassiumand sodium-free. 3. HOW TicoVac Junior 0.25 ml IS GIVEN TicoVac Junior 0.25 ml is usually injected into the muscle of the upper arm. In children under 18 months the vaccine can be injected into the thigh. It must not be injected into a blood vessel TicoVac Junior 0.25 ml should not be given to persons aged 16 years and above. For this age group the TBE vaccine for adults is recommended. First course of injections The first course of injections is the same for all children above 1 year of age and below 16 years of age. It consists of three doses of TicoVac Junior 0.25 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 The first booster dose should be given no more than 3 years after the third dose. Further booster doses should be given every 3 to 5 years, depending on local epidemiology and national recommendations. Children with an impaired immune system (including those undergoing immunosuppressive therapy) 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 Junior 0.25 ml than you should 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, nurse or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, TicoVac may cause side effects although not everybody gets them. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor. The following frequencies are used to evaluate side effects: very common: common: uncommon: rare: very rare: not known: affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data

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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. High temperature (fever) may happen in children. Among young children (aged 1 to 2 years) one in three has some fever after the first injection. Among children aged 3 to 15 years, less than one in 10 have fever. Usually, the fever lasts only 1 2 days. Fever happens less often after the second, third or booster injections. If necessary, your doctor can recommend a treatment to prevent or treat fever. Very common side effects Pain where the injection was given Headaches Fever (see above) Common side effects Swelling, hardness and redness where the injection was given Feeling sick or vomiting, loss of appetite Feeling tired or unwell Restlessness and poor sleep (in younger children) Muscle and joint pains

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Take special care with TicoVac Junior 0.25 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)

Uncommon side effects Swelling of lymph glands The following side effects, which occur with an unknown frequency, have also been reported. Allergic reactions with all degrees of severity Feeling dizzy, signs of meningeal irritation like stiffness of neck, unsteady walking, inflamed nerves, convulsions Neck pain Blurred vision or being more sensitive to light, pain in the eye Rash Redness and itchy skin Chills and feeling tired Inflammatory reactions of the brain Fits in association with high fever in children under 3 Aggravation of autoimmune diseases like multiple sclerosis or iridocyclitis (a type of inflammation of the eye) 5. HOW TO STORE OF TicoVac Junior 0.25 ml Store in a refrigerator (2C 8C). Keep the syringe in the outer carton, in order to protect from light. Do not freeze. Do not use TicoVac if you notice any visible signs of foreign particulate matter or leakage. Keep out of the reach and sight of children. Do not use TicoVac after the expiry date which is 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. 6. FURTHER INFORMATION What TicoVac Junior 0.25 ml contains The active substance is: Tick-Borne Encephalitis Virus (strain Neudrfl) One dose (0.25 milliliters) of the vaccine contains 1.2 micrograms of inactivated Tick-Borne Encephalitis Virus (strain Neudrfl), which is produced in chick embryo cells. The other ingredients are: human albumin, sodium chloride, disodium phosphate-dihydrate, potassium dihydrogen phosphate, sucrose and water for injections. Aluminum hydroxide (hydrated) 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.

What TicoVac Junior 0.25 ml looks like and contents of the pack TicoVac Junior 0.25 ml is supplied as a 0.25 milliliter (one dose) suspension for injection in a pre-filled syringe with or without 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 offwhite and milky. Marketing Authorisation Holder: Baxter AG Industriestrae 67, A-1221 Vienna, Austria Manufacturer: Baxter AG Industriestrae 67, A-1221 Vienna, Austria This medicinal product is authorized in the Member States of the EEA under the following names: Belgie/Belgique/Belgien FSME-IMMUN 0,25 ml Junior esk republika FSME-IMMUN 0,25 ml Junior Danmark TicoVac Junior 0,25 ml Deutschland FSME-IMMUN 0,25 ml Junior Eesti TicoVac 0,25 ml France TicoVac 0,25 ml Enfants Ireland TicoVac Junior 0.25 ml sland FSME-IMMUN Junior Italia TicoVac 0,25 ml per uso pediatrico Latvija TicoVac 0,25 ml Lietuva TicoVac 0,25 ml Luxembourg/Luxemburg FSME-IMMUN 0,25 ml Junior Magyaroszg FSME-IMMUN Junior vakcina fecskendben Nederland FSME-IMMUN 0,25 ml Junior Norge TicoVac Junior sterreich FSME-IMMUN 0,25 ml Junior Polska FSME-IMMUN 0,25 ml Junior

Portugal FSME-IMMUN 0,25 ml Junior Slovenija FSME-IMMUN 0,25 ml za otroke Slovensk republika FSME-IMMUN 0,25 ml Junior Injekcna suspenzia Suomi/Finland TicoVac Junior Sverige FSME-IMMUN Junior United Kingdom TicoVac Junior 0.25 ml This leaflet was last approved in May 2009

The following information is intended for medical or healthcare professionals only:
The vaccine should reach room temperature before administration. Shake well prior to administration to thoroughly mix the vaccine suspension. After shaking, TicoVac Junior 0.25 ml is an off-white, opaque, homogeneous suspension. The vaccine should be inspected visually for any foreign particulate matter and/or variation in physical appearance prior to administration. In the event of either being observed, discard the vaccine. Any unused product or waste material should be disposed of in accordance with local requirements. For vaccine with attached needle, remove needle guard as follows: 1. Hold syringe at the lower part of the needle guard fixed onto the glass recipient (Fig. 1). 2. Use the other hand to take the upper part of the needle guard between thumb and forefinger and twist to break the seal (tamper evident) (Fig. 2). 3. Remove the detached part of the needle guard from the needle by a vertical movement (Fig. 3).

Fig. 1

Fig. 2

Fig. 3

Following the removal of the needle guard TicoVac Junior 0.25 ml must be used immediately. To avoid loss of sterility and/or clogging of the needle, it should not be left without protection for prolonged periods of time. Therefore, the needle guard should only be removed after shaking and immediately prior to use.