Fluad · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100977 · has-adverse-reaction-information · PDF-Seite 4

Data for the adjuvanted quadrivalent influenza vaccine (Fluad Tetra) are relevant to Fluad because both vaccines are manufactured using the same process and have overlapping compositions. Summary of the safety profile Safety in adults 50 to less than 65 years of age, and elderly 65 years of age and older was assessed in 4 clinical studies. In these studies, 9 729 subjects received Fluad (N=3 545, Study V70_27), an adjuvanted quadrivalent influenza vaccine (N=5 296, Studies V118_18, V118_20 and V118_23) or one of two formulations of an adjuvanted trivalent comparator (N=888). 4 The most commonly reported (≥10%) adverse reactions in adults 50 to less than 65 years of age who received adjuvanted quadrivalent influenza vaccine were injection site pain (47%), fatigue (30%), headache (22%), arthralgia (14%) and myalgia (13%). The most commonly reported (≥10%) adverse reactions in subjects 65 years of age who received Fluad, adjuvanted quadrivalent influenza vaccine or adjuvanted trivalent comparators were injection site pain (32%), injection site tenderness (21%), fatigue (16%), myalgia (15%) and headache (13%). Most reactions were reported as mild or moderate in intensity and resolved within the first 3 days after vaccination. . 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); Frequency not known. 5 Table 1: Adverse reactions reported following vaccination in adult subjects 50 years and older in clinical trials and post-marketing surveillance MedDRA System Very common Common Uncommon Frequency not known4 Organ class (≥1/10) (≥1/100 to <1/10) (≥1/1,000 to <1/100) Blood and Lymphadenopathy Thrombocytopenia lymphatic system (some very rare cases disorders were severe with platelet counts less than 5,000

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100973 · has-contraindication-information · PDF-Seite 3

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.

HOS-100972 · has-indication-information · PDF-Seite 2

Prophylaxis of influenza in adults 50 years of age and older. Fluad should be used in accordance with official recommendations.

HOS-100975 · has-interaction-information · PDF-Seite 4

No clinical data on concomitant administration of Fluad with other vaccines are available. If Fluad 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.

HOS-100976 · has-pregnancy-information · PDF-Seite 4

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 in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

HOS-100974 · has-warning-information · PDF-Seite 3

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. Hypersensitivity and anaphylaxis Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Concurrent illness Vaccination should be postponed in patients with febrile illness until the fever is resolved. Thrombocytopenia and coagulation disorders As with all injectable vaccines, Fluad must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration. Anxiety-related reactions 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 3 disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Immunocompromised patients Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza. Limitations of vaccine effectiveness A protective immune response may not be elicited in all vaccine recipients. Excipients with known effect Sodium This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’. Potassium This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say essentially ‘potassium-free’.