Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein
GSK Vaccines S.r.l.
J07AH09
meningococcal group B Vaccine (rDNA, component, adsorbed)
Meningococcal vaccines
Meningitis, Meningococcal
Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.,
Revision: 33
Authorised
2013-01-13
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER BEXSERO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Meningococcal group B Vaccine (rDNA, component, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE THIS MEDICINE 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 or nurse. - This vaccine has been prescribed for you or your child only. - If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bexsero is and what it is used for 2. What you need to know before you or your child receive Bexsero 3. How to use Bexsero 4. Possible side effects 5. How to store Bexsero 6. Contents of the pack and other information 1. WHAT BEXSERO IS AND WHAT IT IS USED FOR Bexsero is a Meningococcal group B Vaccine. Bexsero contains four different components from the surface of the bacteria _ Neisseria meningitidis_ group B. Bexsero is given to individuals from 2 months of age and older to help protect against disease caused by the _Neisseria meningitidis_ group B bacteria. These bacteria can cause serious, and sometimes life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning). The vaccine works by specifically stimulating the body’s natural defense system of the vaccinated person. This results in protection against the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVE BEXSERO DO NOT USE BEXSERO - if you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you or your child receive Bexsero: - if you or your child have a severe infection with a high temperature. If this is the case, then vaccination will be postponed. The presence of Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Bexsero suspension for injection in pre-filled syringe _ _ Meningococcal group B Vaccine (rDNA, component, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Recombinant _Neisseria meningitidis_ group B NHBA fusion protein 1, 2, 3 50 micrograms Recombinant _Neisseria meningitidis _ group B NadA protein 1, 2, 3 50 micrograms Recombinant _Neisseria meningitidis_ group B fHbp fusion protein 1, 2, 3 50 micrograms Outer membrane vesicles (OMV) from _Neisseria meningitidis _ group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2 25 micrograms 1 produced in _E. coli_ cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al 3+ ) 3 NHBA (Neisserial Heparin Binding Antigen), NadA ( _Neisseria_ adhesin A), fHbp (factor H binding protein) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White opalescent liquid suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by _Neisseria meningitidis_ group B. The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating. See section 5.1 for information on protection against specific group B strains. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 3 TABLE 1. SUMMARY OF POSOLOGY AGE AT FIRST DOSE PRIMARY IMMUNISATION INTERVALS BETWEEN PRIMARY DOSES BOOSTER INFANTS, 2 MONTHS TO 5 MONTHS A Three doses each of 0.5 ml Not less than 1 month Yes, one dose between 12 and 15 months of age with an interval of at least 6 months between the primary series and booster dose b, c Two doses each of 0.5 ml Not less than 2 months INFA Прочетете целия документ