TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

4.1. Therapeutic indications

Trumenba is indicated in individuals 10 years and older for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

See section 5.1 for information on protection against specific serogroup B strains – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Dosing of Trumenba should be determined taking into consideration the risk of invasive meningococcal B disease by each country or region. The use of this vaccine should be in accordance with official recommendations.

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Severe allergic reaction (e.g., anaphylaxis) after any previous dose of Trumenba or to any component of this vaccine.

4.2. Posology and method of administration

Posology

Standard schedule for routine immunization: Administer 0.5 ml at 0 and 6 months.

Schedule for individuals at increased risk of invasive meningococcal disease: Administer 2 doses of 0.5 ml at least 1 month apart, followed by a third dose at least 4 months after the second dose.

Booster Dose

A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric Population

Safety and efficacy of Trumenba in children below the age of 10 years of age have not been established.

Elderly

Trumenba has not been studied in adults older than 65 years of age.

Method of administration

For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm.

Separate injection sites and different syringes must be used if more than one vaccine is administered at the same time.

There are no data available on the interchangeability of Trumenba with other meningococcal serogroup B vaccines to complete the vaccination series.