TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily A Protein; Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily B Protein

Disponível em:

PFIZER PRIVATE LIMITED

Código ATC:

J07AH09

Forma farmacêutica:

INJECTION, SUSPENSION

Composição:

Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily A Protein 0.06 mg/0.5ml; Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily B Protein 0.06 mg/0.5ml

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

Prescription Only

Fabricado por:

Pfizer Ireland Pharmaceuticals

Status de autorização:

ACTIVE

Data de autorização:

2019-02-21

Folheto informativo - Bula

TRUMENBA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Trumenba
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
MnB rLP2086 subfamily A
60 µg
MnB rLP2086 subfamily B
60 µg
Excipients with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
The vaccine is a homogeneous white suspension.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Trumenba is indicated in individuals 10 years and older for active
immunization to prevent invasive
meningococcal disease caused by
_Neisseria meningitidis_
serogroup B.
See section 5.1 for information on protection against specific
serogroup B strains.
Dosing of Trumenba should be determined taking into consideration the
risk of invasive meningococcal
B disease by each country or region. The use of this vaccine should be
in accordance with official
recommendations.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard schedule for routine immunization: Administer 0.5 ml at 0 and
6 months.
Schedule for individuals at increased risk of invasive meningococcal
disease: Administer 2 doses of
0.5 ml at least 1 month apart, followed by a third dose at least 4
months after the second dose.
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).
PEDIATRIC POPULATION
Safety and efficacy of Trumenba in children below the age of 10 years
of age have not been established.
ELDERLY
Trumenba has not been studied in adults older than 65 years of age.
Page 2 of 18
Method of administration
For intramuscular injection only. The preferred site for injection is
the deltoid muscle of the upper arm.
Separate injection sites and different syringes must be used if more
than one vaccine is administered at
the same time.
There are no data available on the

Características técnicas

TRUMENBA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 18
1. NAME OF THE MEDICINAL PRODUCT
Trumenba
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
MnB rLP2086 subfamily A
60 µg
MnB rLP2086 subfamily B
60 µg
Excipients with known effect:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a homogeneous white suspension.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Trumenba is indicated in individuals 10 years and older for active
immunization to prevent
invasive meningococcal disease caused by _Neisseria meningitidis_
serogroup B.
See section 5.1 for information on protection against specific
serogroup B strains.
Dosing of Trumenba should be determined taking into consideration the
risk of invasive
meningococcal B disease by each country or region. The use of this
vaccine should be in
accordance with official recommendations.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard schedule for routine immunization: Administer 0.5 ml at 0 and
6 months.
Schedule for individuals at increased risk of invasive meningococcal
disease: Administer
2 doses of 0.5 ml at least 1 month apart, followed by a third dose at
least 4 months after the
second dose.
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).
Page 2 of 18
PEDIATRIC POPULATION
Safety and efficacy of Trumenba in children below the age of 10 years
of age have not been
established.
ELDERLY
Trumenba has not been studied in adults older than 65 years of age.
Method of administration
For intramuscular injection only. The preferred site for injection is
the deltoid muscle of the
upper arm.
Separate injection sites and different syringes must be used if more
than one vaccine is
administered at the same time.
There are no data available on the