BEXSERO Indication, Dosage, and Safety Information4
Bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
Infants 2-5 months, primary immunisation consists of either 2 or 3 doses each of 0.5mL; Intervals between primary doses: not less than 2 months for 2 doses schedule or not less than 1 month for 3 doses schedule; Booster: 1 dose in the 2nd year of life with an interval of at least 6 months between the primary series & booster dose.
Infants 6-11 months, primary immunisation consists of 2 doses each of 0.5mL; Intervals between primary doses: not less than 2 months; Booster: 1 dose in the 2nd year of life with an interval of at least 2 months between the primary series & booster dose.
Children 12-23 months, primary immunisation consists of 2 doses each of 0.5mL; Intervals between primary doses: not less than 2 months; Booster: 1 dose with an interval of 12-23 months between the primary series & booster dose.
Children 2-10 years, adolescents from 11 years & adults*, primary immunisation consists of 2 doses each of 0.5mL; Intervals between primary doses: not less than 1 month; Booster: A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations.
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Special warnings and precautions for use: As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection such as cold, should not result in the deferral of vaccination. The vaccine must not be injected intravascularly, subcutaneously or intradermally. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age). The safety and efficacy of Bexsero in individuals above 50 years of age have not been established.
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation.
Adverse Events:
Very common: eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia, fever (≥38°C), injection site tenderness, injection site erythema, injection site swelling, injection site induration, irritability, nausea, myalgia, malaise.
*The safety and efficacy of Bexsero in individuals above 50 years of age have not been established.