País: Malta
Idioma: anglès
Font: Medicines Authority
TICK, BORNE ENCEPHALITIS, VIRUS
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
J07BA01
TICK-BORNE ENCEPHALITIS VIRUS 1,2 0.5 ml
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
TICK-BORNE ENCEPHALITIS VIRUS 1,2 0.5 ml
POM
VACCINES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2019-12-12
Page 1 of 9 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 Llegiu el document complet
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 Llegiu el document complet