Bexsero Special Precautions

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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. 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 (see Adverse Reactions). It is important that procedures are in place to avoid injury from fainting.
As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients.
Bexsero is not expected to provide protection against all circulating meningococcal group B strains (see Pharmacology: Pharmacodynamics: Pharmacodynamic effects under Actions).
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). Prophylactic administration of antipyretics at the time of and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
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.
Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunction (see Pharmacology: Pharmacodynamics: Pharmacodynamic effects: Immunogenicity under Actions).
Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination with Bexsero.
The safety and efficacy of Bexsero in individuals above 50 years of age have not been established.
There are limited data in patients with chronic medical conditions.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Latex-sensitive individuals: Although no natural rubber latex is detected in the syringe tip cap, the safe use of Bexsero in latex-sensitive individuals has not been established.
Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose. The safe use of Bexsero in kanamycin-sensitive individuals has not been established.
Effects on Ability to Drive and Use Machine: Bexsero has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.