Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B
Pfizer Europe MA EEIG
J07AH09
meningococcal group b vaccine (recombinant, adsorbed)
Bacterial vaccines, Meningococcal vaccines
Meningitis, Meningococcal
Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.The use of this vaccine should be in accordance with official recommendations.
Revision: 16
Authorised
2017-05-24
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: _Neisseria meningitidis_ serogroup B fHbp subfamily A 1,2,3 60 micrograms _Neisseria meningitidis_ serogroup B fHbp subfamily B 1,2,3 60 micrograms 1 Recombinant lipidated fHbp (factor H binding protein) 2 Produced in _Escherichia coli _ cells by recombinant DNA technology 3 Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White liquid suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by _Neisseria meningitidis _ serogroup B. See section 5.1 for information on the immune response against specific serogroup B strains. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Primary series _ 2 doses: (0.5 ml each) administered at a 6 month interval (see section 5.1). 3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1). _Booster dose _ A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1). _Other paediatric populations _ Safety and efficacy of Trumenba in children younger than 10 years of age have not been established. 3 Currently available data for children 1 to 9 years of age are described in sections 4.8 and 5.1; however, no recommendation on a posology can be made as data are limited. Method of administration For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm. For instructions on Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: _Neisseria meningitidis_ serogroup B fHbp subfamily A 1,2,3 60 micrograms _Neisseria meningitidis_ serogroup B fHbp subfamily B 1,2,3 60 micrograms 1 Recombinant lipidated fHbp (factor H binding protein) 2 Produced in _Escherichia coli _ cells by recombinant DNA technology 3 Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White liquid suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by _Neisseria meningitidis _ serogroup B. See section 5.1 for information on the immune response against specific serogroup B strains. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Primary series _ 2 doses: (0.5 ml each) administered at a 6 month interval (see section 5.1). 3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1). _Booster dose _ A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1). _Other paediatric populations _ Safety and efficacy of Trumenba in children younger than 10 years of age have not been established. 3 Currently available data for children 1 to 9 years of age are described in sections 4.8 and 5.1; however, no recommendation on a posology can be made as data are limited. Method of administration For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm. For instructions on Pročitajte cijeli dokument