Foclivia · 4.4 Special warnings and precautions for use · 1

HOS-154975 · has-adverse-reaction-information · PDF-Seite 5

Summary of safety profile The safety of H5N1 vaccine combined with MF59C.1 adjuvant (7.5 or 15 micrograms haemagglutinin, HA) containing either the A/turkey/Turkey/1/2005 or the A/Vietnam/1194/2004 strain has been evaluated in nine clinical trials in healthy subjects involving 5055 adults, elderly and children. There were 4041 adult subjects 18 to 60 years of age and 540 elderly subjects 61 years of age and above. In the paediatric population, there were 214 subjects 6 to 35 months of age, 167 subjects 3 to 8 years of age and 93 subjects 9 to 17 years of age. The overall safety profile was similar across the adult, elderly and paediatric populations. Clinical trials in 383 subjects receiving MF59C.1 adjuvanted vaccine with an H1N1, H5N3 or H9N2 strain showed a similar safety profile to the H5N1 trials. Irrespective of antigen dose, antigen subtype or age group, most local and systemic adverse reactions after administration were of short duration, with onset close to the time of vaccination, and were mild or moderate in severity. Across all trials, there was a general trend towards decreased reports of local adverse reactions after the second vaccination compared with the first. Tabulated list of adverse reactions In adults 18 to 60 years, the most frequently reported (≥10%) adverse reactions were injection site pain (59%), myalgia (34%), headache (26%), injection site redness (24%), fatigue (24%), injection site induration (21%), injection site swelling (15%), chills (13%) and maliase (13%). In elderly subjects (≥ 61 years), the most frequently reported (≥10%) adverse reactions were injection site pain (35%), myalgia (24%), injection site redness (17%), headache (16%), chills (12%), fatigue (10%) and malaise (10%). In children and adolescents 3 to 17 years of age, the most frequently reported (≥10%) adverse reactions were injection site pain (95%), headache (61%), myalgia (60%), fatigue (41%), injection site redness (60%), injection site induration (34%), injection site swelling (34%), malaise (32%), nausea (25%), sweating (18%), chills (19%), diarrhoea (18%) and injection site ecchymosis (16%). In infants and children 6 to 35 months of age, the most frequently reported (≥10%) adverse reactions were injection site redness (62%), irritability (57%), tenderness (55%), unusual crying (48%), sleepiness (45%), injection site induration (38%), injection site swelling (37%) change in eating habits (36%), diarrhoea (34%), fever (27%), injection site ecch

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HOS-154981 · has-adverse-reaction-information · PDF-Seite 21

Summary of safety profile The safety of H5N1 vaccine combined with MF59C.1 adjuvant (7.5 or 15 micrograms haemagglutinin, HA) containing either the A/turkey/Turkey/1/2005 or the A/Vietnam/1194/2004 strain has been evaluated in nine clinical trials in healthy subjects involving 5055 adults, elderly and children. There were 4041 adult subjects 18 to 60 years of age and 540 elderly subjects 61 years of age 21 and above. In the paediatric population, there were 214 subjects 6 to 35 months of age, 167 subjects 3 to 8 years of age and 93 subjects 9 to 17 years of age. The overall safety profile was similar across the adult, elderly and paediatric populations. Clinical trials in 383 subjects receiving MF59C.1 adjuvanted vaccine with an H1N1, H5N3 or H9N2 strain showed a similar safety profile to the H5N1 trials. Irrespective of antigen dose, antigen subtype or age group, most local and systemic adverse reactions after administration were of short duration, with onset close to the time of vaccination, and were mild or moderate in severity. Across all trials, there was a general trend towards decreased reports of local adverse reactions after the second vaccination compared with the first. Tabulated list of adverse reactions In adults 18 to 60 years, the most frequently reported (≥10%) adverse reactions were injection site pain (59%), myalgia (34%), headache (26%), injection site redness (24%), fatigue (24%), injection site induration (21%), injection site swelling (15%), chills (13%) and maliase (13%). In elderly subjects (≥61 years), the most frequently reported (≥10%) adverse reactions were injection site pain (35%), myalgia (24%), injection site redness (17%), headache (16%), chills (12%), fatigue (10%) and malaise (10%). In children and adolescents 3 to 17 years of age, the most frequently reported (≥10%) adverse reactions were injection site pain (95%), headache (61%), myalgia (60%), fatigue (41%), injection site redness (60%), injection site induration (34%), injection site swelling (34%), malaise (32%), nausea (25%), sweating (18%), chills (19%), diarrhoea (18%) and injection site ecchymosis (16%). Ininfants and children 6 to 35 months of age, the most frequently reported (≥10%) adverse reactions were injection site redness (62%), irritability (57%), tenderness (55%), unusual crying (48%), sleepiness (45%), injection site induration (38%), injection site swelling (37%) change in eating habits

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HOS-154977 · has-contraindication-information · PDF-Seite 19

History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (eggs, chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide) of this vaccine. However, in a pandemic situation, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need. See section 4.4.

HOS-154971 · has-contraindication-information · PDF-Seite 3

History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (eggs, chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide) of this vaccine. However, in a pandemic situation, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need. See section 4.4.

HOS-154970 · has-indication-information · PDF-Seite 2

Prophylaxis of influenza in an officially declared pandemic situation. Foclivia should be used in accordance with Official Guidance.

HOS-154976 · has-indication-information · PDF-Seite 19

Prophylaxis of influenza in an officially declared pandemic situation. Foclivia should be used in accordance with Official Guidance.

HOS-154979 · has-interaction-information · PDF-Seite 21

Foclivia may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs. There are no data on co-administration of Foclivia with vaccines other than non-adjuvanted seasonal influenza 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.

HOS-154973 · has-interaction-information · PDF-Seite 4

Foclivia may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs. There are no data on co-administration of Foclivia with vaccines other than non-adjuvanted seasonal influenza 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.

HOS-154980 · has-pregnancy-information · PDF-Seite 21

Pregnancy Limited data obtained from women who became pregnant during the course of clinical trials with Foclivia or other pandemic vaccines adjuvanted with MF59C.1 were insufficient to inform vaccine- associated risks in pregnancy. However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia. Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy. In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls. Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations. Breast-feeding There are no data regarding the use of Foclivia during breast-feeding. The potential benefits and risks to the mother and infant should be considered before administering Foclivia. Fertility There are no data concerning human fertility. A study in female rabbits did not indicate reproductive or developmental toxicity of Foclivia (see section 5.3). Male fertility has not been assessed in animals.

HOS-154974 · has-pregnancy-information · PDF-Seite 4

Pregnancy Limited data obtained from women who became pregnant during the course of clinical trials with Foclivia or other pandemic vaccines adjuvanted with MF59C.1 were insufficient to inform vaccine- associated risks in pregnancy. However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia. Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy. In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls. Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations. Breast-feeding There are no data regarding the use of Foclivia during breast-feeding. The potential benefits and risks to the mother and infant should be considered before administering Foclivia. Fertility 4 There are no data concerning human fertility. A study in female rabbits did not indicate reproductive or developmental toxicity of Foclivia (see section 5.3). Male fertility has not been assessed in animals.

HOS-154972 · 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. Caution is needed when administrating this vaccine to persons with a known hypersensitivity to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs, chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide). 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. If the pandemic situation allows, immunisation should be postponed in patients with febrile illness until the fever is resolved. Immunocompromised individuals Immunocompromised individuals, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced immune response to active immunisation. The vaccine should under no circumstances be administered intravascularly or intradermally. There are no data with Foclivia using the subcutaneous route of administration. 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 bleeding. Protection against influenza There is no immune correlate of protection established for influenza A (H5N1). A protective immune response 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. However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1). There are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines. 3 While no data are available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria, an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia. The majority of febrile convulsions occurred in paediatric subjects. Some cases were observed in subjects with a history of epilepsy. Particular attention should be given t

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HOS-154978 · has-warning-information · PDF-Seite 19

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. 19 Caution is needed when administrating this vaccine to persons with a known hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (eggs, chicken proteins, ovalbumin, kanamycin sulphate, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide). 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. If the pandemic situation allows, immunisation should be postponed in patients with febrile illness until the fever is resolved. Immunocompromised individuals Immunocompromised individuals, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced immune response to active immunisation. The vaccine should under no circumstances be administered intravascularly or intradermally. There are no data with Foclivia using the subcutaneous route of administration. 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 bleeding. Protection against influenza There is no immune correlate of protection established for influenza A (H5N1). A protective immune response 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. However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1). There are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines. While no data are available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria, an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia. The majority of febrile convulsions occurred in paediatric subjects. Some cases were observed in subjects with a history of epilepsy. Particular attention sho

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