TICOVAC JUNIOR 0.25 ML

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS

Dostupné z:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC kód:

J07BA01

Forma lieku:

SUSPENSION FOR INJECTION

Zloženie:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS 1.2 MCG / 0.25 ML

Spôsob podávania:

I.M

Typ predpisu:

Required

Výrobca:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Terapeutické oblasti:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS

Terapeutické indikácie:

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).

Dátum Autorizácia:

2019-06-11

Príbalový leták

Ticovac Ju ior
. l, PIL, CC TC
2023-0088615
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
TICOVAC
® JUNIOR 0.25 ML
,
SUSPENSION FOR INJECTION
Each dose (0.25 ml) contains: 1.2 micrograms of whole inactivated
_Tick-Borne _
_Encephalitis Virus_
_ _
Inactive ingredients and allergens: See section 2 under ‘Important
information about
some of this medicine’s ingredients’ and section 6 'Further
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
TicoVac Junior 0.25 ml is an active vaccine intended to prevent a
disease caused by
the _Tick-Borne Encephalitis Virus_. The vaccine is intended for
children between the
ages of 1-15 years.
The vaccine causes the body to produce antibodies against the virus.
It does not
protect against other viruses and bacteria (some of which are also
transmitted by tick
bites) that may cause similar symptoms.
THERAPEUTIC GROUP: Encephalitis vaccine
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
Your child is sensitive (allergic) to the active ingredient or to any
of the other
ingredients contained in this medicine (listed in section 6). For
example, your
child had a rash, swelling of the face or throat, difficulty in
breathing, blue
discoloring of the tongue or lips, low blood pressure and has
collapsed. Pay
attention to cross-sensitivity with aminoglycosides aside from
neomycin and
gentamycin.
•
Your child had a severe allergic reaction after eating eggs or
chicken.
•
Your child has a moderate or severe acute illness (with or without
fever). Delay
the vaccination.
SPECIAL WARNINGS REGARDING USE OF THE M

Súhrn charakteristických

Ticovac Junior 0.25 ml, LPD, Israel, CC TC 151123
2023-0088615
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TicoVac Junior 0.25 ml, Suspension for injection in a pre-filled
syringe
Tick-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, homogenous, 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 from 1
year to 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
Ticovac Junior 0