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TICOVAC 0.5 ML SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE

Active substance(s): TICK-BORNE ENCEPHALITIS VIR.INACT.STN.NEUDOERFL EX CEF CELLS / TICK-BORNE ENCEPHALITIS VIR.INACT.STN.NEUDOERFL EX CEF CELLS / 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

2017-0006780A

• have a weak immune system (so that you or
your child do not fight infections well)
• do not produce antibodies well
• take any medicine for cancer
• take medicines called corticosteroids (that
reduce inflammation)
• have any brain illness
• have neurological disorders or seizure disorders.
The vaccine may not be suitable, if any of the
circumstances above apply to you or your child.
Alternatively, the doctor may give you or your child
the vaccine. The doctor may request to do a blood
test to check whether the vaccine has worked.

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 or your
child receives 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

Other medicines and TicoVac 0.5 ml
Tell your doctor, pharmacist or nurse if you or
your child are taking or have recently taken any
other medicines, including medicines obtained
without a prescription. Your doctor will tell you if
you or your child can have TicoVac 0.5 ml at the
same time as other vaccines. If you or your child
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 provide complete
protection if you or your child are under an
immunosuppressive treatment.
Tell your doctor if you or your child have ever
been infected with, or been vaccinated against,
Yellow fever, Japanese encephalitis or Dengue
viruses. This is because you or your child 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.

1. 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 16 years of age and older.
• The vaccine causes the 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.

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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, this vaccine may not
completely protect everyone who is
vaccinated.
• A single dose of the vaccine is not likely to
protect you or your child against infection.
You or your child 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 or your
child receives TicoVac 0.5 ml

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Do not use TicoVac 0.5 ml:
• If you or your child is allergic to the active
substance, any of the other ingredients (listed
in section 6), formaldehyde or protamine
sulfate (used during the manufacturing
process) or antibiotics such as neomycin and
gentamycin. For example, you or your child
have had skin rash, swelling of the face and
throat, difficulty in breathing, blue discolouring
of the tongue or lips, low blood pressure and
have collapsed.
• If you or your child ever had a severe allergic
reaction after eating egg or chicken
• If you or your child has an acute illness with
or without fever you or your child may have
to wait before having TicoVac 0.5 ml. Your
doctor could ask you or your child to wait for
the injection until you or your child feel better.
Warning and precautions
Talk to your doctor, pharmacist or nurse before
receiving the vaccine if you or your child:
• have an autoimmune disease (such as
rheumatoid arthritis or multiple sclerosis)

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
receiving this vaccine.
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. How to use TicoVac 0.5 ml
This vaccine is usually injected into the muscle
of the upper arm. The vaccine must not be
injected into a blood vessel. This vaccine 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.

Date: 20 Jul 2017
New Component Nº 2017-0006780A
OLD Component Nº N/A

Packaging Site Baxter

Smallest

Time: 11:46
Market Ireland, United Kingdom
Proof Nº 02

Component Leaflet

Barcode Nº N/A

Code 2/5 FPO

BODY TEXT Size 8 pt

Drawing Nº TSBP20

Dimensions 195 x 342 mm
Notes N/A
PAR Number PAR-2017-0006780

Basic
Immunisation

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
Immunisation
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

If you leave too much time between vaccine
doses, you may not be protected against TBE,
however, a single catch-up dose with TicoVac is
sufficient to continue the vaccination schedule
if you received at least two vaccinations in
the past. Restarting the entire first course of
vaccinations is not required. Ask your doctor for
more information.
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, nurse or
pharmacist.
4. Possible side effects
Like all medicines, this vaccine may cause side
effects, although not everybody gets them. If any
of the side effects get serious or if you notice any
side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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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Read all of this leaflet carefully before you or your
child receives this vaccine because it contains
important information for you or your child.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or
your child only. Do not pass it on to others.
• If you or your child get any side effects, talk
to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in
this leaflet. See section 4.

FPO

Tick-Borne Encephalitis Vaccine (whole virus inactivated)

The following side effects have been reported:
Very common (may affect more than 1 in
10 people):
• Pain where the injection was given

5. How to store TicoVac 0.5 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
this vaccine if you notice any visible signs of
foreign particulate matter or leakage.

Common (may affect up to 1 in 10 people):
• Headaches
• Nausea
• Muscle and joint pains
• Feeling tired or unwell
Uncommon (may affect up to 1 in 100 people):
• Swelling of lymph glands
• Vomiting
• Fever
• Bruising at the injection site
Rare (may affect up to 1 in 1,000 people):
• 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
encephalomyelitis, inflammation of the
spinal cord (myelitis, transverse myelitis)
• An illness consisting of muscle weakness,
abnormal sensations, tingling in the arms,
legs, and upper body (Guillain-Barré
syndrome)
• 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 (see details below).
By reporting side effects you can help provide
more information on the safety of this vaccine.
United Kingdom:
The
Yellow
Card
www.mhra.gov.uk/yellowcard.

Scheme

Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie

at:

Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2.

• Keep this vaccine out of the sight and reach of
children.
• Do not use this vaccine after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
• Do not throw away any vaccines via
wastewater or household waste. Ask your
pharmacist how to throw away vaccines you
no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information

Pfizer manufacturing Austria GmbH
Uferstrasse 15
2304 Orth an der Donau
Austria
This medicinal product is authorised in the
Member States of the EEA under the following
names:
België/Belgique/
FSME-IMMUN 0,5 ml
Belgien, Česká
republika, Luxembourg/
Luxemburg, Nederland,
Portugal, Slovenija
България, Polska

FSME-IMMUN 0.5 ml

Danmark, Norge,
Suomi/Finland

TicoVac

Deutschland

FSME-IMMUN
Erwachsene

Eesti, Italia, Latvija,
Lietuva

TicoVac 0,5 ml

Ελλάδα, Ireland,
United Kingdom

TicoVac 0.5 ml

France

TicoVac 0,5 ml ADULTES

Ísland, Sverige

FSME-IMMUN Vuxen

Magyarország

FSME-IMMUN 0,5 ml
felnőtteknek

Österreich

FSME-Immun 0,5 ml
Injektionssuspension in
einer Fertigspritze

România

FSME-IMMUN 0.5 ml
suspensie injectabila in
seringa preumpluta

Slovenská republika

FSME-IMMUN 0,5 ml
Injekčná suspenzia

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 pre-filled
syringe without an attached needle. The pack
may include 0 needles or 1 needle. 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.
Each pre-filled syringe is packed in a blister.
The opening in the blister seal is intended
and allows for the equilibration of moisture
during the recommended warm-up prior to the
administration of the vaccine. Open the blister by
removing the lid to take out the syringe. Do not
press the syringe through the blister.
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

Date: 20 Jul 2017
New Component Nº 2017-0006780A
OLD Component Nº N/A

Packaging Site Baxter

Smallest

Manufacturer:

Time: 11:46
Market Ireland, United Kingdom
Proof Nº 02

Component Leaflet

Barcode Nº N/A

Code 2/5 FPO

BODY TEXT Size 8 pt

Drawing Nº TSBP20

Dimensions 195 x 342 mm
Notes N/A
PAR Number PAR-2017-0006780

This leaflet was last revised in: UK 06/2017
IE 07/2017

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.
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.
Any unused product or waste material should
be disposed of in accordance with local
requirements.
Ref: TI 6_0

Colours
Printing

Non-Printing

PMS 287

Profile

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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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