TicoVac Junior 0.25 ml Suspension for injection in a pre-filled syringeTick-Borne Encephalitis Vaccine (whole Virus, inactivated)

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) NEUDOERFL

MAH:

Pfizer Healthcare Ireland

ATC_code:

J07BA; J07BA01

INN:

TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) NEUDOERFL

dosage:

0.25 millilitre(s)

pharmaceutical_form:

Suspension for injection in pre-filled syringe

administration_route:

Intramuscular injection

units_in_package:

Pack size of 1, 10, 20 and 100

prescription_type:

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

manufactured_by:

Baxter AG

therapeutic_group:

Encephalitis vaccines

therapeutic_area:

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

therapeutic_indication:

It is indicated for the active (prophylactic) immunization of children aged from 1 year to 15 years against tick-borne encephalitis (TBE).

authorization_status:

Marketed

authorization_date:

2004-06-25

PIL

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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 to use TicoVac Junior 0.25 ml
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 in large parts of Europe as well as
Central and Eastern Asia. People who
live in or go to holid

SPC

Health Products Regulatory Authority
06 September 2021
CRN00CGDM
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TicoVac Junior 0.25 ml Suspension for injection in a pre-filled
syringeTick-Borne Encephalitis Vaccine (whole Virus, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.25 ml) contains:
Tick-Borne Encephalitis Virus
1,2
(strain Neudörfl) 1.2 micrograms
1
adsorbed on aluminium hydroxide, hydrated (0.17 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 Junior 0.25 ml is indicated for the active (prophylactic)
immunization of children aged from 1 year to 15 years against
tick-borne encephalitis (TBE).
TicoVac Junior 0.25 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 above 1
year of age and 15 years of age and consists of three
doses of TicoVac Junior 0.25 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 a 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 vaccinati