TICOVAC 0.5 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

J07BA01

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS 2.4 MCG / 0.5 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Therapeutic area:

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS

Therapeutic indications:

Ticovac 0.5 ml is indicated for the active (prophylactic) immunization of adolescents from 16 years of age and adults against tick-borne encephalitis (TBE).

Authorization date:

2019-06-11

Patient Information leaflet

Ticovac .
ml PIL, CC TC
-
88
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
TICOVAC
® 0.5 ML,
SUSPENSION FOR INJECTION
Each dose (0.5 ml) contains 2.4 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 0.5 ml is an active vaccine intended to prevent a disease
caused by the
_Tick-Borne Encephalitis Virus_. The vaccine is intended for
adolescents from the age
of 16 and adults.
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:
•
You or your child are sensitive (allergic) to the active ingredient or
to any of the
other ingredients contained in this medicine (listed in section 6).
For example,
you or 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 have
collapsed. Pay attention to cross-sensitivity with aminoglycosides
aside from
neomycin and gentamycin.
•
You or your child had a severe allergic reaction after eating eggs or
chicken.
•
You or your child have a moderate or severe acute illness (with or
without
fever). Delay the vaccination.
SPECIAL WARNINGS REGARDING USE OF THE MEDICI

Summary of Product characteristics

TicoVac 0.5 ml, LPD, Israel, CC
TC 151123
2023-0088615
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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, homogenous , opalescent
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TicoVac 0.5 ml is indicated for the active (prophylactic) immunization
of adolescents from 16 years of age and
adults 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
TicoVac 0.5 ml, LPD, Israel, CC
TC 151123
2023-0088615
Pag