Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
NEISSERIA MENINGITIDES GROUP B STRAIN NZ98/254; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
GLAXO SMITH KLINE (ISRAEL) LTD
J07AH06
SUSPENSION FOR INJECTION
NEISSERIA MENINGITIDES GROUP B STRAIN NZ98/254 25 MCG; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN 50 MCG; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN 50 MCG; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN 50 MCG
I.M
Required
GLAXO SMITHKLINE VACCINES S.R.L., ITALY
MENINGOCOCCUS B, OUTER MEMBRANE VESICLE VACCINE
Bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
2021-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician's prescription only Bexsero suspension for injection in pre-filled syringe Each dose (0.5 ml) contains: four recombinant proteins from the Neisseria meningitidis group B bacteria: For the list of the inactive and allergenic ingredients in the medicine, see section 2 – "Important information about some of the ingredients in the medicine" and section 6 – "Additional information". Read the leaflet carefully in its entirety before you or your child are using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you or for your child. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitides group B bacteria. Therapeutic group: Meningococcal group B vaccine Recombinant Neisseria meningitidis group B NHBA fusion protein 50 microgram Recombinant Neisseria meningitidis group B NadA protein 50 microgram Recombinant Neisseria meningitidis group B fHbp fusion protein 50 microgram Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 25 microgram Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis group B. 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 immune system of the vaccinated person. This results in protection against the disease. 2. BEFORE USING THE MEDICINE Do not use the medicine if: Přečtěte si celý dokument
Page 1 of 23 Summary of Product characteristics 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 immunization 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. Page 2 of 23 4.2 Posology and method of administration Posology 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 mon Přečtěte si celý dokument