Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) NEUDOERFL
Pfizer Healthcare Ireland
J07BA; J07BA01
TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) NEUDOERFL
0.25 millilitre(s)
Suspension for injection in pre-filled syringe
Intramuscular injection
Pack size of 1, 10, 20 and 100
Product subject to prescription which may not be renewed (A)
Baxter AG
Encephalitis vaccines
Encephalitis vaccines; encephalitis, tick borne, inactivated, whole virus
It is indicated for the active (prophylactic) immunization of children aged from 1 year to 15 years against tick-borne encephalitis (TBE).
Marketed
2004-06-25
Page 1 of 8 2020-0063534, 2021-0069378 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 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 Junior 0.25 ml is and what it is used for 2. What you need to know before you or your child receives TicoVac Junior 0.25 ml 3. How to use TicoVac Junior 0.25 ml 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 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 holid Lestu allt skjalið
Health Products Regulatory Authority 06 September 2021 CRN00CGDM Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TicoVac Junior 0.25 ml Suspension for injection in a pre-filled syringeTick-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 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 first and second doses should preferably be given in the winter months. The vaccination schedule should ideally be completed with the third vaccinati Lestu allt skjalið