Trumenba
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
20-10-2023
Karatteristiċi tal-prodott
(SPC)
20-10-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
06-06-2017
Ingredjent attiv:
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
Disponibbli minn:
Pfizer Europe MA EEIG
Kodiċi ATC:
J07AH09
INN (Isem Internazzjonali):
meningococcal group b vaccine (recombinant, adsorbed)
Grupp terapewtiku:
Bacterial vaccines, Meningococcal vaccines
Żona terapewtika:
Meningitis, Meningococcal
Indikazzjonijiet terapewtiċi:
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.
Sommarju tal-prodott:
Revision: 16
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2017-05-24
Fuljett ta 'informazzjoni
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
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
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
Aqra d-dokument sħiħ
