Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.

HOS-097411 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), pyrexia (≥38°C), decreased appetite, and vomiting. The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials. In a clinical study where Vaxelis was administered concomitantly with Prevenar 13 (PCV13) as a booster dose of both vaccines, fever ≥38.0°C was reported in 52.5% of children, compared to 33.1% to 40.7% of children during the primary series. Fever ≥39.5°C was observed in 3.7% of children (post- booster) and 0.2% to 0.8% of children (post-primary) receiving Vaxelis with PCV13 (see sections 4.4 and 4.5). Almost all fevers after primary and booster doses were mild or moderate (<39.5°C) and transient (duration of ≤2 days). Tabulated list of adverse reactions The following convention has been used for the classification of adverse reactions: 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: List of Adverse Reactions from clinical trials and post-marketing surveillance MedDRA System Organ Frequency Adverse Reactions Class Infections and infestations Uncommon Rhinitis Blood and lymphatic system Uncommon Lymphadenopathy disorders Immune system disorders Rare Hypersensitivity*, Anaphylactic reaction* 6  MedDRA System Organ Frequency Adverse Reactions Class Metabolism and nutrition Very Common Decreased appetite disorders Uncommon Increased appetite Psychiatric disorders Uncommon Sleep disorders including insomnia, restlessness Nervous system disorders Very Common Somnolence Uncommon Hypotonia Not known Convulsions with or without fever†,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097407 · has-contraindication-information · PDF-Seite 3

History of an anaphylactic reaction after a previous administration of Vaxelis or a vaccine containing the same components or constituents. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin). Encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued, and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis, and Hib vaccines. Uncontrolled neurologic disorder or uncontrolled epilepsy: pertussis vaccination should not be administered until treatment for the condition has been established, the condition has stabilised, and the benefit clearly outweighs the risk. 3

HOS-097406 · has-indication-information · PDF-Seite 2

Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations. 2

HOS-097409 · has-interaction-information · PDF-Seite 5

Vaxelis may be administered simultaneously with pneumococcal polysaccharide conjugate vaccines, rotavirus vaccines, measles, mumps, rubella (MMR) and varicella containing vaccines, meningococcal B and C conjugate vaccines. Data from a clinical study indicate that, when Vaxelis is co-administered with pneumococcal conjugate vaccine (PCV13), the rate of fever is higher following the booster dose in the second year of life compared to the primary series. Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days) (see section 4.8). Co-administration of Vaxelis with other injectable vaccines must be carried out at separate injection 5 sites and, preferably, separate limbs. Vaxelis should not be mixed with any other vaccine or other parenterally administered medicinal products. Immunosuppressive therapy may interfere with the development of expected immune response (see section 4.4). Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when a different hexavalent vaccine with a similar reactogenicity profile to Vaxelis was co- administered with Meningococcal B vaccine, separate vaccinations can be considered.

HOS-097410 · has-pregnancy-information · PDF-Seite 6

This vaccine is not intended for administration to women of child-bearing potential.

HOS-097408 · has-warning-information · PDF-Seite 4

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. Protection Vaxelis 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. Vaxelis will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens. Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases. Vaxelis does not protect against disease caused by Haemophilus influenzae other than type b or by other microorganisms that cause invasive disease such as meningitis or sepsis, including N. meningitidis. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Prior to immunisation Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions). As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine (see section 4.3). As with other vaccines, administration of Vaxelis should be postponed in children suffering from moderate to severe acute disease, with or without fever. The presence of a minor illness and /or low- grade fever does not constitute a contraindication. If any of the following events have occurred after administration of a pertussis-containing vaccine, the decision to administer further doses of a pertussis-containing vaccine should be carefully considered: • Temperature of ≥40.5°C within 48 hours, not attributable to another identifiable cause • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination • Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination • Convulsions with or without fever, occurring within 3 days of vaccination. There may be some circumstances, such

Auszug; vollständigen Abschnitt im Original lesen.