Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) · 4.3 Contraindications · 1

HOS-154967 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5 000 subjects 18 years old and above who received formulations of H5N1 vaccine containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 microgram HA/AS03. Two clinical studies evaluated the incidence of adverse reactions in approximately 824 children aged 3 to < 18 years who received half the adult dose, 0.25 mL, containing A/Indonesia/2005 (H5N1) strain with at least 1.9 microgram HA/AS03. Three clinical studies evaluated the incidence of adverse reactions in approximately 437 children aged 6 months to < 36 months who received either half the adult dose (n=400), 0.25 mL, or a quarter adult dose, 0.125 mL (n=37). 5 List of adverse reactions Adverse reactions reported are listed according to the following frequency: Frequencies are reported as: Very common (1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1 000 to < 1/100) Rare ( 1/10 000 to < 1/1 000) Very rare (< 1/10 000) Adverse reactions from clinical trials with the pandemic preparedness vaccine are listed here below (see section 5.1 for more information on pandemic preparedness vaccines). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adults The following adverse reactions per dose have been reported: System Organ Class Frequency Adverse Reactions Blood and lymphatic system Common Lymphadenopathy disorders Psychiatric disorders Uncommon Insomnia Nervous system disorders Very common Headache Uncommon Dizziness, somnolence, paraesthesia Gastrointestinal disorders Uncommon Gastrointestinal symptoms (such as nausea, diarrhoea, vomiting, abdominal pain) Skin and subcutaneous tissue Common Ecchymosis at the injection site, sweating disorders increased Uncommon Pruritus, rash Musculoskeletal and connective Very common Myalgia, arthralgia tissue disorders General disorders and Very common Pain, redness, swelling

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HOS-154963 · has-contraindication-information · PDF-Seite 3

History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need. See section 4.4.

HOS-154962 · has-indication-information · PDF-Seite 2

Prophylaxis of influenza in an officially declared pandemic situation. Adjupanrix should be used in accordance with official guidance.

HOS-154965 · has-interaction-information · PDF-Seite 4

There are no data on co-administration of Adjupanrix with other vaccines. If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified. 4 The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results may be due to IgM production in response to the vaccine.

HOS-154966 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are currently no data available on the use of Adjupanrix in pregnancy. An AS03-containing vaccine containing HA from H1N1 has been administered to women in each trimester of pregnancy. Information on outcomes from estimated more than 200 000 women who have been vaccinated during pregnancy is currently limited. There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study. Animal studies with Adjupanrix do not indicate reproductive toxicity (see section 5.3). Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity. The use of Adjupanrix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations. Breast-feeding Adjupanrix may be used in lactating women. Fertility No fertility data are available.

HOS-154964 · has-warning-information · PDF-Seite 3

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 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 Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate). Concurrent illness If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection. Thrombocytopenia and coagulation disorders 3 Adjupanrix should under no circumstances be administered intravascularly. There are no data with Adjupanrix using the subcutaneous route. Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings. Protection There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. A protective immune response may not be elicited in all vaccinees (see section 5.1). Syncope 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. Narcolepsy Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Adjupanrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals. In children/adolescents (aged up to 20 years), these studies have indicated an additi

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