Nimenrix · 4.4 Special warnings and precautions for use · 1

HOS-155211 · has-adverse-reaction-information · PDF-Seite 35

Summary of the safety profile The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:  A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).  Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age. Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older. 35 Local and general adverse reactions In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity. The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms (including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age and older. Tabulated list of adverse reactions Adverse reactions reported are listed according to the following frequency categories: 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) Not known (cannot be estimated from available data) Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience. Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults. Table 1: Tabulated summary of adverse reactions by system organ class System Organ Class Frequency Adverse reactions Blood and lymphatic system Not known*** Lymphadenop

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HOS-155205 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:  A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).  Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age. Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older. 6 Local and general adverse reactions In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity. The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms (including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age and older. Tabulated list of adverse reactions Adverse reactions reported are listed according to the following frequency categories: 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) Not known (cannot be estimated from available data) 7 Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience. Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults. Table 1: Tabulated summary of adverse reactions by system organ class System Organ Class Frequency Adverse reactions Blood and lymphatic system

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HOS-155207 · has-contraindication-information · PDF-Seite 32

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-155201 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-155206 · has-indication-information · PDF-Seite 31

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y.

HOS-155200 · has-indication-information · PDF-Seite 2

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y.

HOS-155209 · has-interaction-information · PDF-Seite 34

In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and with 10-valent pneumococcal conjugate vaccine. From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine. In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV- IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2). Whenever possible, Nimenrix and a TT-containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Nimenrix should be administered at least one month before the TT- containing vaccine. One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown. There was no impact of co-administration on immune responses to the other nine pneumococcal serotypes. One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no 34 impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens included in Tdap. If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. It may be expected that in patients receiving immunosuppressive treatment, an adequa

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HOS-155203 · has-interaction-information · PDF-Seite 5

In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and with 10-valent pneumococcal conjugate vaccine. From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine. In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV- IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2). Whenever possible, Nimenrix and a TT-containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Nimenrix should be administered at least one month before the TT- containing vaccine. One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown. There was no impact of co-administration on immune responses to the other nine pneumococcal serotypes. One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no 5 impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens included in Tdap. If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. It may be expected that in patients receiving immunosuppressive treatment, an adequa

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HOS-155210 · has-pregnancy-information · PDF-Seite 35

Pregnancy There is limited experience with use of Nimenrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus. Breast-feeding It is unknown whether Nimenrix is excreted in human milk. Nimenrix should only be used during breast-feeding when the possible advantages outweigh the potential risks. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

HOS-155204 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is limited experience with use of Nimenrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus. Breast-feeding It is unknown whether Nimenrix is excreted in human milk. Nimenrix should only be used during breast-feeding when the possible advantages outweigh the potential risks. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

HOS-155202 · 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. Nimenrix should under no circumstances be administered intravascularly, intradermally or subcutaneously. It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Intercurrent illness Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Syncope Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents 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. Thrombocytopenia and coagulation disorders Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. 3 Immunodeficiency It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even if they develop antibodies following vaccination with Nimenrix. Protection against meningococcal disease Nimenrix will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups. A protective immune response may not be elicited in all vaccinees. Effect of prior vaccination with plain polysaccharide meningococcal vaccine Subjects previously vaccinated with a plai

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HOS-155208 · has-warning-information · PDF-Seite 32

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. Nimenrix should under no circumstances be administered intravascularly, intradermally or subcutaneously. It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Intercurrent illness Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Syncope Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents 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. Thrombocytopenia and coagulation disorders Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. 32 Immunodeficiency It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even if they develop antibodies following vaccination with Nimenrix. Protection against meningococcal disease Nimenrix will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups. A protective immune response may not be elicited in all vaccinees. Effect of prior vaccination with plain polysaccharide meningococcal vaccine Subjects previously vaccinated with a plai

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