Infanrix-IPV+Hib Special Precautions

It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and the possible occurrence of undesirable events) and a clinical examination.
As with other vaccines, the administration of Infanrix-IPV+Hib should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
Infanrix-IPV+Hib should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Infanrix-IPV+Hib contains traces of neomycin and polymyxin and the vaccine should be used with caution in patients with known hypersensitivity to either of these antibiotics.
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.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
The use of Infanrix-IPV+Hib is not recommended in adults, adolescents or children above 5 years of age.
As with all diphtheria, tetanus, and pertussis vaccines, the vaccine should be administered by deep intramuscular injection to the anterolateral thigh. It is preferable that each subsequent dose is given at alternate sites.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
If any of the following events occur in a temporal relationship to the receipt of a DTP-containing vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. These events include: temperature of ≥40.0°C (rectal) within 48 hours, 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.
However, as these events are not associated with permanent sequelae, there may be circumstances, such as a high incidence of pertussis, where the potential benefits outweigh possible risks.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunization until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) or a family history of an adverse event following DTP, IPV and/or Hib vaccination do not constitute contraindications.
Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication.
Excretion of capsular polysaccharide antigen in the urine has been described following receipt of Hib vaccines, and therefore antigen detection may not have a diagnostic value in suspected Hib disease within 1-2 weeks of vaccination.
Infanrix-IPV+Hib should under no circumstances be administered intravenously.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Effects on Ability to Drive and Use Machines: Not relevant.