BEXSERO neisseria meningitidis serogroup nhba fusion protein antigen fhbp and nada injection suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN (UNII: 28E911Y7AE) (NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN - UNII:28E911Y7AE)

Dostopno od:

Novartis Vaccines and Diagnostics SRL

INN (mednarodno ime):

NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN

Sestava:

NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN 50 ug in 0.5 mL

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

BEXSERO- NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN
ANTIGEN, NEISSERIA
MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN AND NEISSERIA
MENINGITIDIS SEROGROUP B
NADA PROTEIN ANTIGEN INJECTION, SUSPENSION
NOVARTIS VACCINES AND DIAGNOSTICS SRL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BEXSERO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BEXSERO.
BEXSERO® (MENINGOCOCCAL GROUP B VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
BEXSERO is a vaccine indicated for active immunization to prevent
invasive disease caused by _Neisseria meningitidis_
serogroup B. BEXSERO is approved for use in individuals 10 through 25
years of age. (1)
Approval of BEXSERO is based on demonstration of immune response, as
measured by serum bactericidal activity against
three serogroup B strains representative of prevalent strains in the
United States. The effectiveness of BEXSERO against
diverse serogroup B strains has not been confirmed. (1)
DOSAGE AND ADMINISTRATION
For intramuscular use only. (2)
Administer two doses (0.5 mL each) of BEXSERO at least 1 month apart.
(2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for intramuscular injection in 0.5 mL single-dose
pre-filled syringes. (3)
CONTRAINDICATIONS
Hypersensitivity, including severe allergic reaction, to any component
of the vaccine, or after a previous dose of
BEXSERO. (4)
WARNINGS AND PRECAUTIONS
The tip caps of the pre-filled syringes contain natural rubber latex
which may cause allergic reactions in latex sensitive
individuals. (5.3)
ADVERSE REACTIONS
The most common solicited adverse reactions observed in clinical
trials were pain at the injection site (≥83%), myalgia
(≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%),
induration (≥ 28%), nausea (≥18%), and arthralgia (≥13%).
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS VACCINES AT
1-877-683-4732 OR VAERS AT 1-
800-822-7967 OR HTTP://VAERS.HHS.G