Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Seqirus Netherlands B.V., Paasheuvelweg 28, 1105 BJ Amsterdam, The Netherlands
Hypersensitivity to the active substances, to any of the components of the adjuvant, to any of the excipients listed in section 6.1, or to possible trace residues such as ovalbumin, kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and hydrocortisone.
A severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
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.
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.
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.
The safety of Fluad Tetra has been evaluated in three clinical studies in which 1027 adults 50 to less than 65 years of age (Study V118_23) and 4269 elderly subjects 65 years of age and older (Studies V118_20 and V118_18) received Fluad Tetra.
In all studies, 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 in adults 50 to less than 65 years of age were injection site pain (47.1%), fatigue (29.5%), headache (22.2%), arthralgia (13.7%) and myalgia (13.0%) (V118_23).
Commonly reported (≥10%) adverse reactions across both studies in elderly subjects 65 years of age and older 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.
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.
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); Frequency not known.
Table 1. Adverse reactions reported following vaccination in adult subjects 50 years and older in clinical trials and post-marketing surveillance:
| MedDRA System Organ class | Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1.000 to <1/100) | Frequency not known4 |
|---|---|---|---|---|
| Blood and lymphatic system disorders | Lymphadenopathy | Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm³) | ||
| Immune system disorders | Allergic reactions including anaphylactic shock (in rare cases), anaphylaxis | |||
| Metabolism and nutrition disorders | Loss of appetite | |||
| Nervous system disorders | Headache | Encephalomyelitis, Guillain-Barré syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope | ||
| Vascular disorders | Vasculitis that may be associated with transient renal involvement | |||
| Gastrointestinal disorders | Nausea, Diarrhoea | Vomiting | ||
| Skin and subcutaneous tissue disorders | Generalised skin reactions including erythema multiforme, erythema, urticaria, pruritus or non-specific rash, angioedema | |||
| Musculoskeletal and connective tissue disorders | Myalgia1, Arthralgia1 | Muscular weakness, pain in extremity | ||
| General disorders and administration site conditions | Injection site pain, Fatigue | Ecchymosis*, Chills, Erythema, Induration, Influenza-like illness2, Fever (≥38°C)3 | Extensive swelling of injected limb lasting more than one week, injection-site cellulitislike reaction, asthenia, malaise, pyrexia |
* Or Injection site bruising
1 Reported as Common (≥1/100 to <1/10) in elderly subjects 65 years and older
2 Unsolicited adverse reaction reported in elderly subjects 65 years and older
3 Reported as Uncommon (≥1/1,000 to <1/100) in elderly subjects 65 years and older 4 Adverse reactions reported from post-marketing surveillance for Fluad Tetra or Fluad
There are no post-marketing data available for Fluad Tetra and limited data for Fluad (trivalent formulation) in the paediatric population.
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.
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