Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TBE VIRUS ANTIGEN
Baxter Vaccine AG
TBE VIRUS ANTIGEN
%v/v
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Page 2 of 9 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 ARE GIVEN THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. • If you get any side effects, talk to your doctor or pharmacist. 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 receive TicoVac Junior 0.25 ml 3. How TicoVac Junior 0.25 ml is given 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 your 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 Lugege kogu dokumenti
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) For a 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 firs Lugege kogu dokumenti