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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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
As with other vaccines, administration of Boostrix Polio should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.
If any of the following events have occurred in temporal relation to receipt of pertussis-containing vaccine in infancy, the decision to give subsequent doses of pertussis-containing vaccines should be carefully considered: Temperature of ≥ 40.0°C (rectal) 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, particularly since these events are not associated with permanent sequelae. According to available clinical data, the risk of such reactions is lower with acellular pertussis vaccines than with whole cell pertussis vaccines.
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.
Boostrix Polio should in no circumstances be administered intravascularly.
Boostrix Polio should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. If in accordance with official recommendations, the vaccine may need to be administered subcutaneously to these subjects. With both routes of administration, firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
Collapse or shock-like state (hypotonic-hyporesponsive episode) and convulsions have been reported very rarely following immunisation of children with products containing one or more of the antigenic constituents of Boostrix Polio.
A history of febrile convulsions, a family history of convulsions, sudden infant death syndrome (SIDS) and a family history of an adverse event following DTP 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.
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.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Effects on Ability to Drive and Use Machines: The vaccine is unlikely to produce an effect on the ability to drive and use machines.
