Bexsero

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

Deep IM inj Preferably in anterolateral aspect of thigh in infants or deltoid muscle region of upper arm in older subject. Adult & adolescent (from 11 yr), childn 2-10 yr Primary immunisation: 2 doses each of 0.5 mL. Interval between primary doses: Not <1 mth. Booster dose: Consider in individuals at continued risk of exposure to meningococcal disease, based on official recommendations. Childn 12-23 mth Primary immunisation: 2 doses each of 0.5 mL. Interval between primary doses: Not <2 mth. Booster dose: 1 dose w/ an interval of 12-23 mth between primary series & booster dose. Infant 6-11 mth Primary immunisation: 2 doses each of 0.5 mL. Interval between primary doses: Not <2 mth. Booster dose: 1 dose in 2nd yr of life w/ an interval of at least 2 mth between primary series & booster dose; 2-5 mth Primary immunisation: 2 doses each of 0.5 mL. Interval between primary doses: Not <2 mth; Primary immunisation: 3 doses each of 0.5 mL. Interval between primary doses: Not <1 mth. Booster dose: 1 dose in 2nd yr of life w/ an interval of at least 6 mth between primary series & booster dose.

Hypersensitivity.

Not to be inj intravascularly, SC or intradermally. Case of an anaphylactic event following the administration. Postpone administration in subjects suffering from an acute severe febrile illness. Should not result in deferral of vaccination in presence of minor infection, eg, cold. May not protect all vaccine recipients. Not a protection against all circulating meningococcal group B strains. Increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination in individuals receiving treatment that inhibits terminal complement activation (eg, eculizumab). May reduce Ab response to active immunisation in individuals w/ impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic disorder, or other causes. Individuals w/ complement deficiencies, asplenia, or splenic dysfunction. Patients w/ chronic medical conditions. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions. Latex-sensitive individuals. May temporarily affect the ability to drive or use machines. Pregnancy & lactation. Elevated temp may occur following vaccination of infants & childn (<2 yr).

Headache; inj site pain [(including severe inj site pain defined as unable to perform normal daily activity in adults & adolescents from 11 yr; tenderness (including severe inj site tenderness defined as crying when injected limb is moved in childn up to 10 yr & infant)], swelling, induration, erythema. Adults & adolescents from 11 yr: Nausea; myalgia, arthralgia; malaise. Childn up to 10 yr & infants: Eating disorders; sleepiness, unusual crying; diarrhoea, vomiting (uncommon after booster); rash [childn 12-23 mth (uncommon after booster)]; arthralgia; fever (≥38°C), irritability. Rash (infants & childn 2-10 yr).

Concomitant administration w/ vaccines containing whole cell pertussis. Administer at separate inj sites when given w/ other vaccines.

Vaccines, Antisera & Immunologicals

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

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