Special Warning : אזהרת שימוש

4.4     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.

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

As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba. Procedures should be in place to avoid injury from fainting.

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.

Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.

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 limited data on the use of Trumenba in individuals 40 to 65 years of age and there are no data on the use of Trumenba in individuals older than 65 years of age.


This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Individuals on low sodium diets can be informed that this medicinal product is essentially sodium-free.

Effects on Driving

4.7         Effects on ability to drive and use machines
Trumenba has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.