FLUAD TETRA Suspension for injection in pre-filled syringe Ref.[27852] Active ingredients: Influenza, inactivated, surface antigen

Traceability

In order to improve the traceability of biological medicinal products, the name and the 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.

Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.

As with all injectable vaccines, Fluad Tetra must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.

A protective immune response may not be elicited in all vaccine recipients.

No clinical data on concomitant administration of Fluad Tetra with other vaccines are available. If Fluad Tetra is to be used at the same time as another vaccine, it should be administered at separate injection sites and preferably on different limbs. It should be noted that the adverse reactions may be intensified by any co-administration.

Women of childbearing potential

This medicine is not indicated in women of childbearing potential (see section 4.1). It is not to be used in women who are, or may be, pregnant or breast-feeding.

Pregnancy

There are no data from the use of Fluad Tetra in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Fluad Tetra has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Elderly population

The safety of Fluad Tetra in elderly subjects 65 years of age and older was evaluated in two clinical studies (V118_20 and V118_18), in which 4269 received Fluad Tetra.

Solicited local and systemic adverse reactions were collected for 7 days after vaccination. Unsolicited adverse reactions were collected for 21 days after vaccination.

Commonly reported (≥10%) adverse reactions across both studies were injection site pain (16.3% and 31.9%), fatigue (10.5% and 16.0%) and headache (10.8% and 12.0%) (for V118_18 and V118_20, respectively). Most solicited reactions were reported as mild or moderate in intensity and resolved within the first 3 days after vaccination.

Paediatric population

Fluad Tetra is not indicated for use in children, see section 4.2. Safety information in the paediatric population is presented in section 5.1.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency categories: Very common (≥1/10); Common (≥1/100 - <1/10); Uncommon (≥1/1,000 - <1/100).

Table 1. Adverse reactions reported following vaccination in elderly subjects 65 years and older in clinical trials:

^* Or Injection site bruising

Adverse reactions reported from post-marketing surveillance

In addition to the adverse reactions observed during clinical trials, the following adverse events were reported from post-marketing surveillance in individuals 65 years of age and older for Fluad Tetra, and/or for Fluad (trivalent formulation), which is relevant because both vaccines are manufactured using the same process and have overlapping compositions:

Blood and lymphatic system disorders: Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm³), lymphadenopathy

General disorders and administration site conditions: Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction, asthenia, malaise, pyrexia

Immune system disorders: Allergic reactions including anaphylactic shock (in rare cases), anaphylaxis

Musculoskeletal and connective tissue disorders: Muscular weakness, pain in extremity

Nervous system disorders: Encephalomyelitis, Guillain-Barré syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope

Skin and subcutaneous tissue disorders: Generalised skin reactions including erythema multiforme, erythema, urticaria, pruritus or nonspecific rash, angioedema

Vascular disorders: Vasculitis that may be associated with transient renal involvement

Paediatric population

There are no post-marketing data available for Fluad Tetra and limited data for Fluad (trivalent formulation) in the paediatric population.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.