Bexsero

Meningococcal group B vaccine (rDNA, component, adsorbed)

Active immunisation of individuals ≥2 mth of age against invasive meningococcal disease caused by Neisseria meningitidis group B.

IM Adult, adolescent ≥11 yr & childn 2-10 yr Primary immunisation: 2 doses w/ not less than 1 mth intervals between primary doses. Booster: Consider in individuals at continued risk of exposure. Childn 12-23 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose w/ 12-23 mth intervals between primary series & booster dose. Infant 6-11 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose in the 2nd yr of life w/ at least 2 mth intervals between primary series & booster dose. Infant 2-5 mth Primary immunisation: 3 doses w/ not less than 1 mth intervals between primary doses, or 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose between 12 & 15 mth of age w/ at least 6 mth intervals between primary series & booster dose.

Hypersensitivity.

Anaphylactic event following vaccination. Do not inj intravascularly, subcutaneously or intradermally. Postpone vaccination in case of acute severe febrile illness. Do not give to individuals w/ thrombocytopenia or any coagulation disorder. Not expected to provide protection against all circulating meningococcal group B strains. Risk of temp elevation following vaccination in infants & childn <2 yr; initiate antipyretic medication according to local guidelines. Reduced Ab response in individuals w/ impaired immune responsiveness. Increased risk for invasive disease caused by Neisseria meningitidis group B in individuals w/ familial complement deficiencies (eg, C3 or C5 deficiencies) & those receiving treatments that inhibit terminal complement activation (eg, eculizumab). Consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering primary immunisation series to very premature infants (born ≤28 wk of gestation) & those w/ previous history of resp immaturity. Latex & kanamycin hypersensitivity. May temporarily affect ability to drive or use machines. Pregnancy & lactation. No data in subjects >50 yr. Safety & efficacy in infants <8 wk of age has not yet been established. Limited data in patients w/ chronic medical conditions.

Headache; arthralgia; inj site erythema, swelling & induration. Adults & adolescents ≥11 yr: Nausea; myalgia; inj site pain, malaise. Infants & childn ≤10 yr: Eating disorders; sleepiness, unusual crying; diarrhoea, vomiting; rash; fever ≥38°C, inj site tenderness, irritability.

Increased risk of fever, tenderness at inj site, change in eating habits & irritability w/ the following vaccine antigens: diphtheria, tetanus, acellular pertussis, HIB, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, MMR, varicella, & meningococcal group A, C, W, Y conjugate; consider separate vaccinations when possible. Administer at separate inj sites when given concomitantly w/ other vaccines.

Vaccines, Antisera & Immunologicals

J07AH09 - meningococcus B, multicomponent vaccine ; Belongs to the class of meningococcal bacterial vaccines.

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