TicoVac Junior 0.25ml pre-filled syringe/Tick-Borne Encephalitis Vaccine (Whole Virus, inactivated)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TICK, BORNE ENCEPHALITIS, VIRUS

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

J07BA01

INN (International Name):

TICK-BORNE ENCEPHALITIS VIRUS 1,2

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

TICK-BORNE ENCEPHALITIS VIRUS 1,2

Prescription type:

POM

Therapeutic area:

VACCINES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-12-12

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TICOVAC JUNIOR 0.25 ML SUSPENSION FOR INJECTION IN A PRE-FILLED
SYRINGE
Tick-Borne Encephalitis Vaccine (whole virus inactivated)
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.
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 or your child receives 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 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.
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 large parts of Europe as well
as Central and Eastern Asia. People
who live in or go to holidays in these

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TicoVac 0.5 ml Suspension for injection in a pre-filled syringe
Tick-Borne Encephalitis Vaccine (whole Virus, inactivated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Tick-Borne Encephalitis Virus
1,2
(strain Neudörfl)
2.4 micrograms
1
adsorbed on aluminium hydroxide, hydrated (0.35 milligrams Al
3+
)
2
produced in chick embryo fibroblast cells (CEF cells)
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
After shaking the vaccine is an off-white, opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TicoVac 0.5 ml is indicated for the active (prophylactic) immunization
of persons of 16 years of age and
older against tick-borne encephalitis (TBE).
TicoVac 0.5 ml is to be given on the basis of official recommendations
regarding the need for, and
timing of, vaccination against TBE.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccination schedule_
The primary vaccination schedule is the same for all persons from the
age of 16 onwards and consists
of three doses of TicoVac 0.5 ml.
The first and second dose should be given at a 1 to 3 month interval.
If there is a need to achieve an immune response rapidly, the second
dose may be given two weeks
after the first dose.
After the first two doses sufficient protection for the ongoing tick
season is to be expected (see section
5.1).
The third dose should be given 5 to 12 months after the second
vaccination. After the third dose
protection is expected to last for at least 3 years.
To achieve immunity before the beginning of the seasonal tick
activity, which is in spring, the first and
second doses should preferably be given in the winter months. 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.
3
BASIC IMMUNIZATION
DO