Rx Item-Bexsero Meningo prefilld Syg 10 by Glaxosmithkline Vaccines Refrigerated

Clinical Information: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


Gen. Code and Des.
71917 meningococcal B vaccine,4-comp INTRAMUSC SYRINGE 50-50/0.5
GCN and Des.
35944 meningococcal B vaccine,4-comp INTRAMUSC SYRINGE 50-50/0.5
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
15354 Neisseria meningitidis group B, NHBA recombinant
15457 Neisseria meningitidis group B, NadA protein,rec
15458 Neisseria meningitidis group B, fHBP,recombinant
15459 Neisseria meningitidis group B, OMV NZ98/254
Inactive Ingredients
2598 sucrose 57501





BEXSERO- neisseria meningitidis serogroup b nhba fusion protein antigen, neisseria meningitidis serogroup b fhbp fusion protein antigen, neisseria meningitidis serogroup b nada protein antigen and neisseria meningitidis serogroup b strain nz98/254 outer membrane vesicle injection, suspension
GlaxoSmithKline Biologicals SA
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.
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.
For intramuscular use only.
Shake the syringe immediately before use to form a homogeneous suspension. Do not use the vaccine if it cannot be resuspended. 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.

Administer BEXSERO as a 0.5 mL intramuscular injection into the deltoid muscle of the upper arm.
Sufficient data are not available on the safety and effectiveness of using BEXSERO and other meningococcal group B vaccines interchangeably to complete the vaccination series.
BEXSERO is a suspension for intramuscular injection in 0.5 mL single-dose pre-filled syringes.

Bexsero prefilld Syg 10 by Gla
Bexsero prefilld Syg 10 by Glaxosmithkline Vaccines Refrigerated NDC No.new 58160-0976-20 58160-976-20 58160097620 5816097620 UPC/GTIN No.3-58160-97620-9 358160-976209 358160976209 MPN 097620

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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 inje

MENINGOCOCCAL B VACC,4-CO
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Bexsero prefilld Syg 10 by Gla
Bexsero prefilld Syg 10 by Glaxosmithkline Vaccines Refrigerated NDC No.new 58160-0976-20 58160-976-20 58160097620 5816097620 UPC/GTIN No.3-58160-97620-9 358160-976209 358160976209 MPN 097620