Bexsero

Posology 3 Table 1. 5 ml Not less than 1 month A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations d Adolescents (from 11 years) and adults* a The first dose should be given no earlier than 2 months of age.

The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available. b In case of delay, the booster should not be given later than 24 months of age. 1. The need for and timing of further booster doses has not yet been determined.

1. * There are no data in adults above 50 years of age. Method of administration The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.

Separate injection sites must be used if more than one vaccine is administered at the same time. The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.

6.

Summary of the safety profile The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10 565 subjects (from 2 months of age) who received at least one dose of Bexsero. Among Bexsero recipients, 6 837 were infants and children (less than 2 years of age), 1 051 were children (2 to 10 years of age) and 2 677 were adolescents and adults.

Of the subjects who received primary infant series of Bexsero, 3 285 received a booster dose in the second year of life. In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.

In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38 °C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone.

Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines. When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials.

When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination. In adolescents and adults, the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.

No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series. Tabulated list of adverse reactions Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.

Traceability 4 In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 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. Do not inject intravascularly. 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.

8). It is important that procedures are in place to avoid injury from fainting. This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients. 1). 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 immunosuppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation. 1). Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even if they develop antibodies following vaccination with Bexsero.

1.