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TICOVAC 0.5 ML SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE

Active substance: TICK-BORNE ENCEPHALITIS VIR.INACT.STN.NEUDOERFL EX CEF CELLS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TicoVac 0.5 ml Suspension for injection
in a pre-filled syringe

0724879new_s

Tick-Borne Encephalitis Vaccine (whole virus inactivated)

What is in this leaflet:
1 What TicoVac 0.5 ml is and what it is used for
2 What you need to know 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 Contents of the pack and other information

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2.  hat you need to know before you receive
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TicoVac 0.5 ml
Do not use TicoVac 0.5 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
0.5  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 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 0.5 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 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.
Ticovac 0.5 ml may not completely protect you if
you are under an immunosuppressive 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 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.
TicoVac 0.5 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.  ow to use TicoVac 0.5 ml
H
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. 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 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. 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 0.5 ml Elected date
2nd dose 0.5 ml 1 to 3 months
after the 1st
vaccination
5 to
3rd dose 0.5 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
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 5 years.
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.
Booster
dose ≥ 16 to
< 60  years
1st booster

Dose

Timing

0.5 ml

Sequential
booster doses

0.5 ml

3 years after
the third dose
every 5 years

Booster dose
≥ 60 years
All booster
doses

Dose

Timing

0.5 ml

every 3 years

Persons 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 0.5 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 or pharmacist.
4.  ossible side effects
P
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
any side 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 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.

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1.  hat TicoVac 0.5 ml is and what it is used
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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 16 years of age and older.
• 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 0.5 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)

• you are known to be allergic to latex rubber

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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.

The following side effects have been reported:
Very common side effects
• Pain where the injection was given
Common side effects
• Headaches
• Nausea
• Muscle and joint pains
• Feeling tired or unwell
Uncommon side effects
• Swelling of lymph glands
• Vomiting
• Fever
• Bruising at the injection site
Rare side effects
• Allergic reactions
• Sleepiness
• Motion sickness
• Diarrhoea
• Abdominal pain
• Redness, tissue hardening, swelling, itching,
tingling and warmth at the injection site
The following additional side effects, from post
marketing surveillance with a rare frequency,
have also been reported
• Shingles
• Triggering of autoimmune disorders, e.g.
multiple sclerosis
• Allergic reactions
• Neurological disorders such as encephalo­
myelitis, inflammation of the central nervous
system (guillain-barré syndrome) and spinal
cord (myelitis, transverse myelitis)
• Inflammation of the brain, fits, inflammation of
the meninges (layers lining the brain)
• Signs of meningeal irritation like pain and
stiffness of neck
• Neurological symptoms such as facial palsy,
paralysis, inflammation of nerves, abnormal
or reduced sensation such as tingling or
numbness, stabbing or throbbing pain along
one or more nerves, inflammation of the visual
nerve
• Feeling dizzy
Visual disorders/impairment, being more

sensitive to light, pain in the eye
• Ringing in the ears
• Rapid beating of the heart
• Shortness of breath
• Skin reactions, (rashy and/or itchy skin),
dermatitis, redness of the skin, increased
sweating, inflammation of the skin
• Pain in the back, joint swelling, neck pain,
musculoskeletal and neck stiffness, pain in
arm and legs
Chills, influenza-like illness, weakness,

edema, unsteady walking, accumulation of
fluid beneath the skin
• Joint pain at the injection site, nodule and
inflammation at the injection site
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.  ow to store TicoVac 0.5 ml
H
• 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.  ontents of the pack and other information
C
What TicoVac 0.5 ml contains
The active substance is: Tick-Borne Encephalitis
Virus (strain Neudörfl)
One dose (0.5 milliliters) of the vaccine contains
2.4 micrograms of inactivated Tick-Borne
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 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 prefilled 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.

Eesti
TicoVac 0.5 ml

Polska
FSME-IMMUN 0.5 ml

Ελλάδα
TicoVac 0.5 ml
France
TicoVac 0,5 ml
ADULTES

Portugal
FSME-IMMUN 0,5 ml
România
FSME-IMMUN 0.5 ml
suspensie injectabila in
seringa preumpluta
Slovenija
FSME-IMMUN 0,5 ml
Slovenská republika
FSME-IMMUN 0,5 ml
Injekčná suspenzia
Suomi/Finland
TicoVac
Sverige
FSME-IMMUN Vuxen
United Kingdom
TicoVac 0.5 ml

Ireland
TicoVac 0.5 ml
Ísland
FSME-IMMUN Vuxen
Italia
TicoVac 0,5 ml
Latvija
TicoVac 0,5 ml
Lietuva
TicoVac 0,5 ml

This leaflet was last revised in 03/2015

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 0.5 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.

Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:

Any unused product or waste material should
be disposed of in accordance with local
requirements.

United Kingdom:
Pfizer Limited
Ramsgate Road
Sandwich,
Kent,
CT13 9NJ
United Kingdom

Remove needle guard as follows:
1. Hold syringe at the lower part of the needle
guard fixed onto the glass recipient (Fig. 1).

Ireland:
Pfizer Healthcare Ireland
9 Riverwalk,
National Digital Park,
Citywest Business Campus,
Dublin 24
Ireland
Manufacturer:
Baxter AG
Industriestraße 67
A-1221 Vienna
Austria

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

This medicinal product is authorised in the
Member States of the EEA under the following
names:
België/Belgique/
Luxembourg/
Belgien
Luxemburg
FSME-IMMUN 0,5 ml FSME-IMMUN 0,5 ml
Magyarország
България
FSME-IMMUN 0.5 ml FSME-IMMUN 0,5 ml
felnőtteknek
Česká republika
Nederland
FSME-IMMUN 0.5 ml FSME-IMMUN 0,5 ml
Danmark
Norge
TicoVac
TicoVac
Deutschland
FSME-IMMUN
Erwachsene

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).

Österreich
FSME-IMMUN 0,5 ml
Injektionssuspension in
einer Fertigspritze

Following the removal of the needle guard
d
TicoVac 0.5 ml must be used imme­ iately.
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
attached needle:

for

syringe

without

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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