TicoVac 0.5 ml Suspension for injection in a pre-filled syringeTick-Borne Encephalitis Vaccine (whole Virus, inactivated)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tbe virus antigen

Available from:

Pfizer Healthcare Ireland

ATC code:

J07BA; J07BA01

INN (International Name):

Tbe virus antigen

Dosage:

0.5 millilitre(s)

Pharmaceutical form:

Suspension for injection in pre-filled syringe

Administration route:

intramuscular injection

Units in package:

Pack sizes of 1, 10, 20 and 100 pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

encephalitis vaccines

Therapeutic area:

Encephalitis vaccines; encephalitis, tick borne, inactivated, whole virus

Therapeutic indications:

It is indicated for the active (prophylactic) immunization of persons of 16 years of age and older against tick-borne encephalitis (TBE).

Authorization status:

Marketed

Authorization date:

2004-06-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TICOVAC 0.5 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 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 to use TicoVac 0.5 ml
4.
Possible side effects
5.
How to store TicoVac 0.5 ml
6.
Contents of the pack and other information
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.
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

Summary of Product characteristics

Health Products Regulatory Authority
12 June 2023
CRN00DM4V
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TicoVac 0.5 ml Suspension for injection in a pre-filled
syringeTick-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 t