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

Active substance(s): TICK-BORNE ENCEPHALITIS VIRUS ANTIGEN

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Package leaflet: Information for the user

TicoVac Junior 0.25 ml Suspension for injection
in a pre-filled syringe

0727832

Tick-Borne Encephalitis Vaccine (whole virus inactivated)
Read all of this leaflet carefully before you are
given this vaccine because it contains
important information for you
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1 What TicoVac Junior 0.25 ml is and what it is
used for
2 What you need to know 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 Contents of the pack and other 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 to 15 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 transmitted
by tick 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 large
parts of Europe as well as Central and Eastern
Asia. People who live in or go to holidays in
these parts of the world are at risk of contracting
tick-borne encephalitis. 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.
• 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.
• The protection does not last for life. Regular
booster doses are needed (see section 3 for
more information)
• There is no data on post exposure prophylaxis
(vaccination after tick bite)
2. What you need to know 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
formaldehyde or protamine sulphate (used
during the manufacturing process) or
antibiotics such as neomycin and gentamycin.
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 a severe allergic reaction after
eating egg or chicken.
• you have an acute illness with or without fever
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.
Warning and precautions
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

• you are known to be allergic to latex rubber
• you have neurological disorders or seizure
disorders.
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.
Other medicines and TicoVac Junior 0.25 ml
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.
TicoVac Junior 0.25 ml may not complete­
ly protect you if you are under an immuno­
suppressive treatment.
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 and fertility
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.
TicoVac Junior 0.25 ml contains potassium and
sodium
Potassium and sodium are present at levels
less than 1 mmol per dose, i.e. essentially
“potassium- and sodium-free”.
3. How to use TicoVac Junior 0.25 ml
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. The administration of the vaccine
should be documented by the physician, and the
lot number recorded.
First course of injections
The first course of injections 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. The vaccination schedule should
ideally be completed with the third vaccination
within the same tick season or at the least
before the start of the following 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.

Basic
Immunization

Dose

Conventional
Schedule

1st dose 0.25 ml Elected date
2nd dose 0.25 ml 1 to 3 months
after the 1st
vaccination
5 to
3rd dose 0.25 ml
12 months
after the 2nd
vaccination

Rapid
Immunization
Schedule
Elected date
14 days
after the 1st
vaccination
5 to
12 months
after the 2nd
vaccination

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 5 years.
Booster dose
1st booster

Dose
0.25 ml

Sequential
booster doses

0.25 ml

Timing
3 years after
the third dose
every 5 years

Children with impaired immune system
(including 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. The same applies to any of the following
doses.
If you use 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, this medicine may cause side
effects although not everybody gets them. If any
of the side effects gets serious or if you notice
side any effects not listed in this leaflet, please
tell your doctor.
The following frequencies are used to evaluate
side effects:
Very common: may affect more than 1 in
10 people
Common:
may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare:
may affect up to 1 in
1,000 people
Very rare:
may affect up to 1 user in
10,000 people
Not known:
frequency cannot be estimated
from the available data
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.

The following side effects have been reported:
Very common side effects
• Pain where the injection was given
Common side effects
• Headaches
• Swelling, hardness and redness where the
injection was given
• Feeling sick or vomiting, decreased appetite
• Feeling tired or unwell
• Restlessness and poor sleep (in younger
children)
• Muscle pains
• Fever (see above)
Uncommon side effects
• Swelling of lymph glands
• Stomach pain
• Joint pain
• Chills
Rare side effects
• Itching at the injection site
• Abnormal and reduced sensation such as
tingling or numbness along several nerves
• Feeling dizzy
• Vertigo
• Diarrhoea
• Dyspepsia
• Hives
The following additional side effects, from post
marketing surveillance with a rare frequency,
have also been reported.
• Allergic reactions
• Inflammation of the brain, signs of meningeal
irritation like stiffness of the neck
• Neurological symptoms such as facial palsy,
paralysis, inflammation of nerves
• Visual disorders/impairment being more
sensitive to light, pain in the eye
• Ringing in the ears
• Shortness of breath
• Skin reactions, (rashy and/or itchy skin),
redness of the skin, increased sweating
• Musculoskeletal and neck stiffness, pain in
arm and legs
• Influenza-like illness, weakness, swelling of
the skin, unsteady walking
• Fits with or without fever
Guillian Barré syndrome has been reported in
temporal association with the administration of
Tick-Borne Encephalitis vaccines in children.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the
national reporting system listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard.
Ireland
IMB Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2; Tel: +353 1 6764971; Fax:
+353 1 6762517. Website: www.imb.ie; e-mail:
imbpharmacovigilance@imb.ie.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store TicoVac Junior 0.25 ml
• Store in a refrigerator (2°C – 8°C). 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. Contents of the pack and other information
What TicoVac Junior 0.25 ml contains
The active substance is: Tick-Borne Encephalitis
Virus (strain Neudörfl)
One dose (0.25 milliliters) of the vaccine
contains 1.2 micrograms of inactivated TickBorne Encephalitis Virus (strain Neudörfl), 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. The Tip Cap pack (pre-filled syringe
without attached needle) may include up to two
needles of different sizes. All needles are sterile
and for single use only. 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 and
Manufacturer:
Marketing Authorisation Holder:
United Kingdom:
Pfizer Limited
Ramsgate Road
Sandwich,
Kent,
CT13 9NJ
United Kingdom
Ireland:
Pfizer Healthcare Ireland
9 Riverwalk,
National Digital Park,
Citywest Business Campus,
Dublin 24
Ireland
Manufacturer:
Pfizer Manufacturing Austria GmbH
Uferstrasse 15
2304 Orth an der Donau
Austria

France
TicoVac Enfant
0.25 ml
Ireland
TicoVac Junior
0.25 ml

România
FSME-IMMUN 0.25 ml
Junior
suspensie injectabila in
seringa preumpluta
Slovenija
FSME-IMMUN 0,25 ml
za otroke

Ísland
FSME-IMMUN Junior

Slovenská republika
FSME-IMMUN 0,25 ml
Junior Injekcna
suspenzia

Italia
TicoVac 0.25 ml
per uso pediatrico

Suomi/Finland
TicoVac Junior

Latvija
TicoVac 0,25 ml

Sverige
FSME-IMMUN Junior

Lietuva
TicoVac 0,25 ml

United Kingdom
TicoVac Junior 0.25 ml

This leaflet was last revised in 05/2015

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, opalescent,
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).

This medicinal product is authorised in the
Member States of the EEA under the following
names:
België/Belgique/
Belgien
FSME-IMMUN 0.25 ml
Junior

Luxembourg/
Luxemburg
FSME-IMMUN 0,25 ml
Junior

България
Magyarország
FSME-IMMUN 0.25 ml FSME-IMMUN Junior
vakcina fecskendőben
Junior

3. Remove the detached part of the needle
guard from the needle by a vertical movement
(Fig. 3)

Česká republika
Nederland
FSME-IMMUN 0.25 ml FSME-IMMUN 0,25 ml
Junior
Danmark
TicoVac Junior

Norge
TicoVac Junior

Deutschland
Österreich
FSME-IMMUN 0.25 ml FSME-IMMUN
Junior
0.25 ml Junior
Injektionssuspension in
einer Fertigspritze
Eesti
TicoVac 0.25 ml

Polska
FSME-IMMUN 0.25 ml
Junior

Ελλάδα
TicoVac 0.25 ml
Junior

Portugal
FSME-IMMUN 0,25 ml
Junior

Following the removal of the needle guard
TicoVac Junior 0.25 ml must be used imme­
diately.
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.
Additional information for syringe without
attached needle:
After removing the syringe cap, attach the needle
immediately and remove the needle shield prior
to administration. Once the needle is attached,
the vaccine must be administered immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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