Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Neisseria meningitidis Group B, Neisseria meningitidis Group B, Neisseria meningitidis Group B, Neisseria meningitidis Group B
laboratory: Novartis Vac. and Diagn.

Injectable suspension
Box of 1 pre-filled syringe (with separate needle) 0.5 mL
All forms

Indication

Bexsero is indicated for the active immunization of subjects starting at 2 months of age against invasive meningococcal infection caused by Neisseria meningitidis Group B. The impact of invasive infection at different age groups as well as the Epidemiological variability of antigens of Group B strains in different geographical areas should be taken into account during vaccination. See section 5.1 Pharmacodynamic properties for more information on protection against group B-specific strains. This vaccine should be used according to official recommendations.

Dosage BEXSERO Suspension for injection Box of 1 pre-filled syringe (with separate needle) 0.5 mL

Dosage

Table 1. Summary of dosage

age range

Primary vaccination

Intervals between doses of primary vaccination

Recall

Infants 2 to 5 months

Three doses of 0.5 ml each, with a first dose administered at 2 months of age.

1 month minimum

Yes, a dose between 12 and 23 months b

Unvaccinated infants from 6 to 11 months

Two doses of 0.5 ml each

2 months minimum

Yes, a dose in the second year with an interval of at least 2 months between the primary vaccination and the booster dose b

Unvaccinated children 12 to 23 months

Two doses of 0.5 ml each

2 months minimum

Yes, a dose with an interval of 12 to 23 months between primary vaccination and booster dose b

Children from 2 to 10 years

Two doses of 0.5 ml each

2 months minimum

Need not established c

Teenagers (from 11 years old) and adults *

Two doses of 0.5 ml each

1 month minimum

Need not established c

The first dose should be given at 2 months of age. The safety and effectiveness of Bexsero in infants under 8 weeks of age have not been established. No data available.

b See section 5.1 Pharmacodynamic properties . The need and timing of a booster dose has not yet been determined.

c See section 5.1 Pharmacodynamic properties .

* There are no data for adults over 50

Administration mode

The vaccine is administered by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the region of the deltoid muscle of the upper arm in older subjects.

Separate injection sites should be used if multiple vaccines are administered simultaneously.

The vaccine should not be injected intravenously, subcutaneously or intradermally and should not be mixed with other vaccines in the same syringe.

For instructions on handling the vaccine before administration, see the section Instructions for use, handling and disposal .

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition .

Bexsero side effects

Summary of the security profile


The safety of Bexsero was evaluated in 8 studies, including 7 randomized controlled clinical trials involving 6427 subjects (2 months of age and older) who received at least one dose of Bexsero. Of those vaccinated with Bexsero, 4, 843 were infants and young children, and 1, 584 were adolescents and adults. Of the infants who received the primary vaccination doses of Bexsero, 1630 received a booster dose in their second year of life.

In infants and children (<2 years of age), the most common local and systemic adverse reactions observed in clinical trials were sensitivity and erythema at the injection site, fever, and irritability.

In clinical studies in infants, fever was more common when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal heptavalent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) only when administered alone. More frequent use of antipyretics was also reported in infants vaccinated with Bexsero and routine vaccines. When Bexsero was administered alone, the frequency of fever was similar to that associated with routine vaccines given to infants during clinical trials. Fever cases generally followed a predictable pattern, usually resolving the day after vaccination.

In adolescents and adults, the most common local and systemic adverse reactions were injection site pain, malaise and headache.

No increase in the incidence or severity of adverse reactions was observed with the successive doses of the vaccination schedule.

Tabulated list of adverse effects

Adverse effects (following the primary vaccination or booster dose) considered to be at least probably related to vaccination were classified by frequency.

The frequencies are defined as follows:
Very common : (≥1 / 10)
Frequent (≥1 / 100 to <1/10)
Rare : (≥1 / 1000 to <1/100)
Rare: (≥1 / 10, 000 to <1/1000)
Very rare : (<1 / 10, 000)
In each frequency group, the adverse effects are presented in order of decreasing severity.

Infants and children (up to the age of 10)

Metabolism and nutrition disorders

Very common: eating disorders

Nervous system disorders

Very common: somnolence, unusual crying Uncommon: convulsions (including febrile seizures)

Vascular disorders

Uncommon: pallor (rare after the booster)

Rare: Kawasaki syndrome

Gastrointestinal disorders

Very common: diarrhea, vomiting (infrequent after booster)

Skin and subcutaneous tissue disorders

Very common: rash (uncommon after recall)

Uncommon: eczema, urticaria

General disorders and administration site conditions

Very common: fever (≥38 ° C), tenderness at the injection site (including severe injection site sensitivity defined by crying during movement of the injected limb), erythema at the site injection, swelling of the injection site, induration at the injection site, irritability Uncommon: fever (≥40 ° C)

Adolescents (from 11 years old) and adults

Nervous system disorders

Very common: headache

Gastrointestinal disorders

Very common: nausea

General disorders and administration site conditions

Very common: injection site pain (including severe injection site pain defined by inability to perform normal daily activities), injection site swelling, injection site induration, erythema at the site injection, discomfort

Musculoskeletal and systemic disorders

Very common: myalgia, arthralgia

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