Hexyon · 4.1 Therapeutic indications · 1

HOS-096802 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile In clinical studies in individuals who received Hexyon, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema. Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses. The safety of Hexyon in children over 24 months of age has not been studied in clinical trials. 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 available data) Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness. Table 1: Adverse Reactions from clinical trials and post marketing surveillance System Organ Class Frequency Adverse Events Immune system disorders Uncommon Hypersensitivity reaction Rare Anaphylactic reaction* Metabolism and nutrition Very common Anorexia (decreased appetite) disorders Nervous system disorders Very common Crying, somnolence Common Abnormal crying (prolonged crying) Rare Convulsions with or without fever* Very rare Hypotonic reactions or hypotonic- hyporesponsive episodes (HHE) Gastrointestinal disorders Very common Vomiting Common Diarrhoea Skin and subcutaneous Rare Rash tissue disorders General disorders and Very common Pyrexia (body temperature ≥38.0°C) administration site Irritability conditions Injection-site pain, injection-site erythema, injection-site swelling Common Injection-site induration Uncommon Pyrexia (body temperature ≥39.6°C) Injection-site nodule Rare E

Auszug; vollständigen Abschnitt im Original lesen.

HOS-096798 · has-contraindication-information · PDF-Seite 4

History of an anaphylactic reaction after a previous administration of Hexyon. Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexyon or a vaccine containing the same components or constituents. Vaccination with Hexyon is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine (whole cell or acellular pertussis vaccines). In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines. Pertussis vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.

HOS-096797 · has-indication-information · PDF-Seite 3

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

HOS-096800 · has-interaction-information · PDF-Seite 6

Hexyon can be administered simultaneously with a pneumococcal polysaccharide conjugate vaccine, measles, mumps, rubella (MMR) and varicella-containing vaccines, rotavirus vaccines, a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine, or meningococcal group B vaccine (MenB). Due to an increased risk of fever when Hexyon was co-administered with MenB vaccine, separate vaccinations can be considered when possible. If co-administration with another vaccine is considered, immunisation should be carried out on separate injection sites. Hexyon must not be mixed with any vaccines or other parenterally administered medicinal products. No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4). For interference with laboratory testing, see section 4.4.

HOS-096801 · has-pregnancy-information · PDF-Seite 6

Not applicable. This vaccine is not intended for administration to women of child-bearing age.

HOS-096799 · 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. Hexyon 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. Hexyon 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. Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins. Prior to immunisation Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection. The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination. Vaccination should be preceded by a review of the person’s medical history (in particular previous vaccinations and possible adverse reactions). The administration of Hexyon must be carefully 4 considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components. Before the injection of any biological medicinal product, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. If any of the following events are known to have occurred after receiving any pertussis containing vaccine, the decision to give further doses of pertussis containing vaccine should be carefully considered: • Temperature of ≥40°C within 48 hours of vaccination not due to another identifiable cause; • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of va

Auszug; vollständigen Abschnitt im Original lesen.