Menveo · 4.5 Interaction with other medicinal products and other forms of interaction · 2

HOS-154775 · has-adverse-reaction-information · PDF-Seite 22

Summary of the safety profile The most frequently reported adverse reactions within 7 days after vaccination with a single dose of Menveo alone in individuals aged 2 years and above were injection-site pain (42.7%), headache (26.4%), injection-site erythema ≤ 50 mm (18.1%), malaise (17.3%), injection-site induration ≤ 50 mm (15.1%), myalgia (13.5%) and irritability (11.3%) in children aged 2 to 10 years. These adverse reactions were mostly mild or moderate in intensity. Tabulated list of adverse reactions The safety of Menveo in individuals aged 2 years and older was evaluated in 11 randomized studies. 12 775 individuals were included in the safety analyses, of these, 3 334 participants aged 2 to 10 years and 9 441 participants aged 11 to 65 years were exposed to Menveo in completed clinical studies. The following adverse reactions, as listed in Table 1 below, have been identified in clinical studies conducted with Menveo when given to individuals 2 years and older, and during post-marketing surveillance. Adverse reactions are listed below by MedDRA system organ class and frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 22 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 the available data) Table 1: Adverse reactions System organ class Frequency Adverse reactions Blood and lymphatic system Uncommon Lymphadenopathy1 disorders Immune system disorders Uncommon Hypersensitivity1 Not known Anaphylaxis1 Metabolism and nutrition Common Eating disorder2 disorders Nervous system disorders Very common Headache Common Sleepiness2 Uncommon Syncope1, dizziness3 Very rare Tonic convulsion1, febrile convulsion1 Ear and labyrinth disorders Uncommon Vertigo1 Gastrointestinal disorders Common Vomiting2, diarrhoea2, nausea Skin and subcutaneous tissue Common Rash disorders Musculoskeletal and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-154769 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequently reported adverse reactions within 7 days after vaccination with a single dose of Menveo alone in individuals aged 2 years and above were injection-site pain (42.7%), headache (26.4%), injection-site erythema ≤ 50 mm (18.1%), malaise (17.3%), injection-site induration ≤ 50 mm (15.1%), myalgia (13.5%), and irritability (11.3%) in children aged 2 to 10 years. These adverse reactions were mostly mild or moderate in intensity. 5 Tabulated list of adverse reactions The safety of Menveo in individuals aged 2 years and older was evaluated in 11 randomized studies. 12 775 individuals were included in the safety analyses. Of these, 3 334 participants aged 2 to 10 years and 9 441 participants aged 11 to 65 years were exposed to Menveo in completed clinical studies. The following adverse reactions, as listed in Table 1 below, have been identified in clinical studies conducted with Menveo when given to individuals aged 2 years and older, and during post-marketing surveillance. Adverse reactions are listed below by MedDRA system organ class and frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 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 the available data) Table 1: Adverse reactions System organ class Frequency Adverse reactions Blood and lymphatic system Uncommon Lymphadenopathy1 disorders Immune system disorders Uncommon Hypersensitivity1 Not known Anaphylaxis1 Metabolism and nutrition Common Eating disorder2 disorders Nervous system disorders Very common Headache Common Sleepiness2 Uncommon Syncope1, dizziness3 Very rare Tonic convulsion1, febrile convulsion1 Ear and labyrinth disorders Uncommon Vertigo1 Gastrointestinal disorders Common Vomiting2, diarrhoea2, nausea Skin and subcutaneous tissue Common Rash disorders Musculoskeletal and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-154765 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4). As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection is not a contraindication.

HOS-154771 · has-contraindication-information · PDF-Seite 20

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4). As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection is not a contraindication.

HOS-154764 · has-indication-information · PDF-Seite 2

Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.

HOS-154770 · has-indication-information · PDF-Seite 19

Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.

HOS-154773 · has-interaction-information · PDF-Seite 21

Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero). In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines. The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses. Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown. There was evidence of some suppression of antibody 21 response to two of the three pertussis antigens. The clinical relevance of this observation is unknown. After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens. For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo. Concomitant administration of Menveo with vaccines other than those listed above has not been studied. Concomitant vaccines should always be administered at separate injection sites and preferably contralateral. It should be checked if the adverse reactions may be intensified by any co-administration. If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.

HOS-154767 · has-interaction-information · PDF-Seite 5

Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero). In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines. The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses. Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown. There was evidence of some suppression of antibody response to two of the three pertussis antigens. The clinical relevance of this observation is unknown. After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens. For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo. Concomitant administration of Menveo with vaccines other than those listed above has not been studied. Concomitant vaccines should always be administered at separate injection sites and preferably contralateral. It should be checked if the adverse reactions may be intensified by any co-administration. If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.

HOS-154774 · has-pregnancy-information · PDF-Seite 22

Insufficient clinical data on exposed pregnancies are available. In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined. Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant. Therefore, Menveo may be used during breast feeding.

HOS-154768 · has-pregnancy-information · PDF-Seite 5

Insufficient clinical data on exposed pregnancies are available. In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined. Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant. Therefore, Menveo may be used during breast feeding.

HOS-154772 · has-warning-information · PDF-Seite 20

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 Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine. 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 (see section 4.8). It is important that procedures are in place to avoid injury from fainting. Menveo should under no circumstances be administered intravascularly. 20 Limitations of effectiveness Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine. As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1). Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. If an individual is expected to be at particular risk of exposure to Men-A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose. There are no data on the applicability of the vaccine for post-exposure prophylaxis. Immunocompromised individuals In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response. While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines. Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhib

Auszug; vollständigen Abschnitt im Original lesen.

HOS-154766 · 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 Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine. 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 (see section 4.8). It is important that procedures are in place to avoid injury from fainting. Menveo should under no circumstances be administered intravascularly. Limitations of effectiveness Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine. As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1). Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. If an individual is expected to be at particular risk of exposure to Men-A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose. There are no data on the applicability of the vaccine for post-exposure prophylaxis. Immunocompromised individuals In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response. While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines. Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that in

Auszug; vollständigen Abschnitt im Original lesen.