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Risk and Reporting

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Trumenba is contraindicated in patients with hypersensitivity to the active substances or excipients listed in section 6.1 of the Summary of Product Characteristics.

Special warnings and precautions for use

In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Vaccination should be postponed in individuals 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 intravenously, intradermally, or subcutaneously.

Trumenba 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 Trumenba may not protect all vaccine recipients.

Limitations of clinical trials

There are no data on the use of Trumenba in immunocompromised individuals. Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.
There are no data on the use of Trumenba in subjects above 65 years of age.

Interaction with other medicinal products and other forms of interaction

Trumenba can be given concomitantly with any of the following vaccines: Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis, and Inactivated Poliovirus Vaccine (TdaP-IPV), Quadrivalent Human Papillomavirus vaccine (HPV4), Meningococcal Serogroups A, C, Y, W conjugate vaccine (MenACWY) and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap).

When given concomitantly with other vaccines Trumenba must be administered at a separate injection site. Trumenba should not be mixed with other vaccines in the same syringe.

For more information visit https://www.medicines.org.uk/emc/medicine/33454

Adverse Events

The most commonly reported adverse events reported in Trumenba clinical studies were headache, diarrhoaea, nausea, vomiting, fever, chills; fatigue; redness (erythema), swelling (induration) and pain at injection site

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard . Adverse events should also be reported to Pfizer Medical Information on 01304 616161 or emailed to [email protected] (link sends e-mail).

Further information on adverse event reporting can be found by clicking here. Summary of Product Characteristics can be found on electronic Medicines Compendium (eMC).