Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);hepatitis B surface antigen;poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain));Haemophilus influenzae type b polysaccharide

HOS-084208 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course. Tabulated summary of adverse reactions Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies per dose are defined as follows: 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) 7 The following drug-related adverse reactions were reported in clinical studies (data from more than 16,000 subjects) and during post-marketing surveillance. System Organ Class Frequency Adverse reactions Infections and infestations Uncommon Upper respiratory tract infection Blood and lymphatic system disorders Rare Lymphadenopathy2, thrombocytopenia2 Immune system disorders Rare Anaphylactic reactions2, anaphylactoid reactions (including urticaria)2 Allergic reactions (including pruritus)2 Metabolism and nutrition disorders Very common Loss of appetite Psychiatric disorders Very common Crying abnormal, irritability, restlessness Common Nervousness Nervous system disorders Very common Somnolence Rare Collapse or shock-like state (hypotonic- hyporesponsive episode)2 Very rare Convulsions (with or without fever) Respiratory, thoracic and mediastinal Uncommon Cough disorders Rare Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)] Gastrointestinal disorders Common Diarrhoea, vomiting Skin and subcutaneous tissue disorders Rare

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HOS-084204 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or formaldehyde, neomycin and polymyxin. Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines. Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued, and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines. As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.

HOS-084203 · has-indication-information · PDF-Seite 2

2 Infanrix hexa is indicated for primary and booster vaccination of infants from the age of 6 weeks and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. The use of Infanrix hexa should be in accordance with official recommendations.

HOS-084206 · has-interaction-information · PDF-Seite 6

Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine. Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if co- administered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1). The clinical relevance of these observations remains unknown. When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference. Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone. Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8). The immune responses were unaffected. Due to an increased risk of fever, pain at the injection site, loss of appetite and irritability when Infanrix hexa was co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine, separate vaccinations can be considered when possible. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy, an adequate response may not be achieved.

HOS-084207 · has-pregnancy-information · PDF-Seite 6

As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.

HOS-084205 · has-warning-information · PDF-Seite 4

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1). Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. If any of the following events are known to have occurred in temporal relation to receipt of pertussis- containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:  Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause;  Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;  Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;  Convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks. 4 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. As for any vaccination, the risk-benefit of immunising with Infanrix hexa or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder. Infanrix hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Do not administer the vaccine intravascularly or intradermally. A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination. The p

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