Boostrix Special Precautions

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give doses of pertussis-containing vaccines should be carefully considered: Temperature of ≥40.0°C within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsiveness 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.
As for any vaccination, the risk-benefit of immunising with Boostrix or deferring this vaccination should be weighed carefully in a child suffering from a new onset or progression of a severe neurological disorder.
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.
Boostrix should be administered with caution to subjects with thrombocytopenia (see Contraindications) or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. If in accordance with official recommendations, the vaccine may 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.
Boostrix should in no circumstances be administered intravascularly.
A history or a family history of convulsions and a family history of an adverse event following DTP vaccination do not constitute contraindications.
Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. 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.
Excipients: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
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.
Effects on ability to drive and use machines: The vaccine is unlikely to produce an effect on the ability to drive and use machines.