Incellipan · 4.3 Contraindications · 1

HOS-288970 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Adults 18 years of age and older The most common local and systemic reactions reported in adults within 7 days following administration were injection site pain (51%), fatigue (22%), headache (20%), malaise (19%), myalgia (14%) and arthralgia (11%). Severe reactions in subjects receiving aH5N1c were reported in 1% or fewer subjects for each reaction. Reactogenicity was higher after the first dose than after the second dose. 5 Data on the safety of a heterologous booster dose with aH5N6c were evaluated in Study V89_18E1 in which 258 subjects were vaccinated. Among the study participants, 158 subjects had received aH5N1c in Study V89_18 approximately 6 years prior. The safety profile after one or two doses of aH5N6c heterologous booster was comparable to the safety profile observed in clinical studies with aH5N1c. Data on the safety of an aH5N8c vaccine were evaluated in Study V205_01 in which 479 subjects were randomised to receive either a homologous priming series of 2 doses (21 days apart) of aH5N8c, or a heterologous priming series of one dose of aH5N8c followed by one dose of aH5N6c vaccine or one dose of aH5N6c vaccine followed by one dose of aH5N8c (21 days apart). Six months after their second priming dose all subjects received an aH5N8c booster vaccination (Day 202). The safety profile for aH5N8c was similar to that observed for aH5N1c and aH5N6c. Tabulated list of adverse reactions The frequencies of adverse reactions are based on three clinical studies with aH5N1c in 3 579 subjects (see section 5.1). The adverse reactions are listed according to the following MedDRA frequency convention and system organ class: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1 000 to <1/100). Table 1: Adverse reactions reported in adults 18 years of age and older MedDRA system Very Common Uncommon organ class common (≥1/100 to <1/10) (≥1/1 000 to <1/100) (≥1/10) Blood and lymphatic Lymphadenopathy system disorders Nervous system Headache Dizziness disorders Gastrointestinal Loss of appetite, Diarrhoea, vomiting disorders nausea Skin and Rash, prurit

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HOS-288966 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80. History of an anaphylactic (i.e. life-threatening) reaction after a previous dose of an influenza vaccine.

HOS-288965 · has-indication-information · PDF-Seite 2

Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incellipan should be used in accordance with official recommendations. 2

HOS-288968 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. If Incellipan is given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered to separate limbs. It should be noted that adverse reactions may be intensified.

HOS-288969 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are limited amount of data from the use of Incellipan in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3. Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations. Breast-feeding Incellipan has not been evaluated during breast-feeding. The vaccine is not expected to be excreted in human milk and no effects on the breastfed newborn/infant are anticipated. Fertility A reproductive and developmental toxicity study in female rabbits dosed with Incellipan revealed no impairment of fertility.

HOS-288967 · 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 medicinal product should be clearly recorded. Hypersensitivity and anaphylaxis Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. 3 Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. However, the presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Limitations of vaccine effectiveness There is no immune correlate of protection established for influenza A (H5N1). Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of Incellipan, a protective immune response, as with any vaccine, may not be elicited in all vaccine recipients. Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain and after a heterologous (H5N6) booster dose (see section 5.1). However, the degree of protection that may be elicited to H5N1 strains of other subtypes or clades is unknown. Duration of protection The duration of protection following the primary vaccination schedule is unknown. A reduction of antibody titres was observed when assessed 6 and 12 months after the primary vaccination series with the A/turkey/Turkey/1/2005 (H5N1) strain. Immunocompromised individuals The efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant ther

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