TicoVac 0.5ml pre-filled syringe/Tick-Borne Encephalitis Vaccine (Whole Virus, inactivated)

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

TICK, BORNE ENCEPHALITIS, VIRUS

可用日期:

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

ATC代码:

J07BA01

INN（国际名称）:

TICK-BORNE ENCEPHALITIS VIRUS 1,2 0.5 ml

药物剂型:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

组成:

TICK-BORNE ENCEPHALITIS VIRUS 1,2 0.5 ml

处方类型:

POM

治疗领域:

VACCINES

產品總結:

Licence number in the source country: NOT APPLICAPABLE

授权状态:

Authorised

授权日期:

2019-12-12

资料单张

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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 TicoVac 0.5 ml is given
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
encephalit

产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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, 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 with the third vaccination within the same tick season or
at the least before the start of
the follo