Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Outer membrane vesicles (OMV) from Neisseria meningitidis group B containing the PorA P1.4; Neisseria meningitidis group B NHBA fusion protein; Neisseria meningitidis group B NadA protein; Neisseria meningitidis group B fHbp fusion protein
GlaxoSmithKline UK Ltd
J07AH09
Outer membrane vesicles (OMV) from Neisseria meningitidis group B containing the PorA P1.4; Neisseria meningitidis group B NHBA
Suspension for injection
Intramuscular
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 14040000; GTIN: 5000123114641
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BEXSERO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Meningococcal group B Vaccine (rDNA, component, adsorbed) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 y Lesen Sie das vollständige Dokument
OBJECT 1 BEXSERO MENINGOCOCCAL GROUP B VACCINE FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 29-Sep-2017 | GlaxoSmithKline UK This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 (Neisseria Heparin Binding Antigen), NadA (Neisserial 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 TABLE 1. SUMMARY O Lesen Sie das vollständige Dokument