Infanrix-IPV Special Precautions

As with other vaccines, the administration of Infanrix-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication.
It is good clinical practice that 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.
If any of the following events occur in temporal relation to receipt of DTP-containing vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since the events are not associated with permanent sequelae. According to available clinical data, the risk benefit ratio of acellular pertussis vaccine is better than the risk benefit ratio of whole cell pertussis vaccine. The following events were previously considered contra-indications for DTPw and can now be considered precautions: 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.
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) and a family history of an adverse event following DTP and/or IPV vaccination do not constitute contra-indications.
Human immunodeficiency Virus (HIV) infection is not considered as a contra-indication.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
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.
Infanrix-IPV contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
As with all diphtheria, tetanus, and pertussis vaccines, the vaccine should be given deep intramuscularly.
Infanrix-IPV 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 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 immunisation 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.
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.
Use in Pregnancy & Lactation: Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Use in Children: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation 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 the Ability to Drive and Use Machines: Not applicable.