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Uses
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.
Approval of Trumenba is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of Trumenba against diverse serogroup B strains has not been confirmed.
History
There is currently no drug history available for this drug.
Other Information
Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.
Each 0.5 mL dose contains 60 micrograms of each fHBP variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0.
Sources
Acetaminophen Pain Reliever Fever Reducer Manufacturers
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Perrigo New York Inc
Acetaminophen Pain Reliever Fever Reducer | Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.
For intramuscular use only.
2.1 Dose and ScheduleAdminister Trumenba as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.
2.2 AdministrationShake syringe vigorously to ensure that a homogenous white suspension of Trumenba is obtained. Do not use the vaccine if it cannot be re-suspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.
Inject each 0.5 mL dose intramuscularly, using a sterile needle attached to the supplied prefilled syringe. The preferred site for injection is the deltoid muscle of the upper arm. Do not mix Trumenba with any other vaccine in the same syringe.
2.3 Use of Trumenba with other Meningococcal Group B VaccinesSufficient data are not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series.
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