Meningococcal Group B Vaccine (Trumenba)

Trade Name : Trumenba

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

INJECTION, SUSPENSION, VACCINE

Strength 6060 ug/.5mLug/.5mL

NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Meningococcal Group B Vaccine (Trumenba) which is also known as Trumenba and Manufactured by Wyeth Pharmaceutical Division of Wyeth Holdings LLC. It is available in strength of 60; 60 ug/.5mL; ug/.5mL per ml. Read more

Meningococcal Group B Vaccine (Trumenba) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Trumenba is indicated for active immunization to prevent invasive disease caused by serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.
  • The effectiveness of the two-dose schedule of Trumenba against diverse serogroup B strains has not been confirmed.
  • Trumenba is indicated for active immunization to prevent invasive disease caused by serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age. ()
  • The effectiveness of the two-dose schedule of Trumenba against diverse serogroup B strains has not been confirmed. ()
  • For intramuscular use only.
  • For intramuscular use only. ()
  • Three-dose schedule:
  • Two-dose schedule:
  • Trumenba is a suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe.
  • Suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. ()
  • Severe allergic reaction after a previous dose of Trumenba.
  • Severe allergic reaction after a previous dose of Trumenba. ()
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting. ()
  • In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at the injection site (u226585%), fatigue (u226560%), headache (u226555%), and muscle pain (u226535%). Nausea was reported in up to 24% of adolescents in early phase studies.
  • The most common solicited adverse reactions in adolescents and young adults were pain at the injection site (u226585%), fatigue (u226560%), headache (u226555%), and muscle pain (u226535%). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
  • In clinical trials, Trumenba was administered concomitantly with HPV4 in adolescents 11 to <18 years of age and with MCV4 and Tdap in adolescents 10 to <13 years of age . tttttt
  • No data
  • Pediatric Use:
  • 8.4
  • Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). The proteins are individually produced in . 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 Aln as AlPO in 10 mM histidine buffered saline at pH 6.0.
  • Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of . The effectiveness of Trumenba was assessed by measuring serum bactericidal activity using human complement (hSBA).
  • fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.
  • Trumenba has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males. Vaccination of female rabbits with Trumenba had no effect on fertility . tttttt
  • The immunogenicity of Trumenba following the three-dose schedule (0, 2, and 6 months) was evaluated in individuals 10 to 25 years of age in the U.S., Canada, and Europe (Studies 1 and 2) and following the two-dose (0 and 6 months) and three-dose schedules (0, 1u20132, and 6 months) in individuals 11 to 18 years of age in Europe (Study 3). Serum bactericidal antibodies were measured with hSBA assays that used each of four meningococcal serogroup B strains. These four primary test strains express fHBP variants representing the two subfamilies (A and B) and, when taken together, are representative of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe. The studies assessed the proportions of subjects with a 4-fold or greater increase in hSBA titer for each of the four primary strains. The studies also assessed the composite response to the four primary strains combined (proportion of subjects who achieved a hSBA titer greater than or equal to 1:8 (three strains) or 1:16 (one strain). To assess the effectiveness of the three-dose schedule of Trumenba against diverse meningococcal serogroup B strains, the proportion of subjects achieving a defined hSBA titer post-dose 3 was evaluated against a panel of 10 additional strains, each expressing a different fHBP variant.
  • No data
  • No data
  • Prior to administration of this vaccine, the healthcare professional should inform the individual, parent, guardian, or other responsible adult of the following:
  • Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
  • U.S. Govt. License No. 3
  • LAB-0722-9.0CPT Code 90621
  • NDC 0005-0100-01Rx only
  • MeningococcalGroup B VaccineTrumenba
  • One Dose (0.5 mL) FOR IM USE ONLY
  • REFRIGERATEDO NOT FREEZESHAKE VIGOROUSLY
  • Wyeth Pharm. IncUS Govt. License No. 3
  • NDC 0005-0100-05
  • MeningococcalGroup B Vaccine
  • Trumenban
  • For use in individuals10 through 25 years of age
  • 5 One-Dose (0.5 mL)Prefilled Syringes
  • Arrayn- Pfizern- Array
  • NDC 0005-0100-10
  • MeningococcalGroup B Vaccine
  • Trumenban
  • For use in individuals10 through 25 years of age
  • 10 One-Dose (0.5 mL)Prefilled Syringes
  • Arrayn- Pfizern- Array
  • NDC 0005-0100-02
  • THIS PACKAGE NOT FOR SALE
  • MeningococcalGroup B Vaccine
  • Trumenban
  • For use in individuals 10 through 25 years of age
  • Pfizer
  • 1 One-Dose (0.5 mL) Prefilled Syringe
  • FOR INTRAMUSCULAR USE ONLY
  • Rx only

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