Boostrix Polio

/ GSK

A single 0.5 ml dose of the vaccine is recommended.
Boostrix Polio may be administered from the age of four years onwards.
Boostrix Polio contains low (adult) dose diphtheria, tetanus and pertussis antigens in combination with poliomyelitis antigens. Therefore, Boostrix Polio should be administered in accordance with official recommendations and/or local practice.
In subjects ≥ 40 years of age that had not received any diphtheria or tetanus containing vaccine in the past 20 years (including those who have never been vaccinated or whose vaccination status was unknown), one dose of Boostrix Polio induces an antibody response against pertussis and protects against tetanus and diphtheria in the majority of cases. Two additional doses of a diphtheria and tetanus containing vaccine will maximize the vaccine response against diphtheria and tetanus when administered one and six months after the first dose.
Boostrix Polio can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine and for whom a booster against diphtheria, pertussis and polio is indicated. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations. Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations.
Paediatric population: The safety and efficacy of Boostrix Polio in children below 4 years of age have not been established.
For full details see prescribing information.

For booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. Not intended for primary immunisation. The administration should be based on official recommendations.

Should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administrations of diphtheria, tetanus, pertussis or poliomyelitis vaccines. Should not be used in subjects with known hypersensitivity to neomycin, polymyxin, polysorbate 80 and formaldehyde. In subjects who have experienced encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. Individuals with an incomplete or no history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with Boostrix Polio. Is not precluded in subjects with an incomplete or no history of previous pertussis or polio vaccination.

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 pertussiscontaining 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 Polio 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 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. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes. Boostrix Polio 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 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. 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. Pregnancy and lactation: Should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the fetus. Should be used in women who are breastfeeding only when clearly needed.
For full details see prescribing information.

Metabolism and nutrition disorders: Common – anorexia
Psychiatric disorders: Common – irritability
Nervous system disorders: Very common – somnolence Common – headache
General disorders and administration site conditions: Very common – injection site reactions (such as redness and/or swelling), injection site pain Common: pyrexia (fever ≥ 37.5°C, including fever > 39°C), extensive swelling of vaccinated limb (sometimes involving the adjacent joint), injection site reactions (such as haemorrhage, pruritus and induration)
Nervous system disorders: Very common: headache
Gastrointestinal disorders: Common – gastrointestinal disorders (such as vomiting, abdominal pain, nausea)
General disorders and administration site conditions: Very common – injection site reactions (such as redness and/or swelling), fatigue, injection site pain Common: pyrexia (fever ≥37.5°C), injection site reactions (such as haematoma, pruritus, induration and warmth numbness).  For full details see prescribing information.

Use with other vaccines or immunoglobulins: Boostrix Polio may be administered concomitantly with human papilloma virus vaccine with no clinically relevant interference with antibody response to any of the components of either vaccine. Concomitant administration of Boostrix Polio and other vaccines or with immunoglobulins has not been studied. It is unlikely that co-administration will result in interference with the immune responses.
According to generally accepted vaccine practices and recommendations, if concomitant administration of Boostrix Polio with other vaccines or immunoglobulins is considered necessary, the products should be given at separate sites.
Use with immunosuppressive treatment:  As with other vaccines, patients receiving immunosuppressive therapy may not achieve an adequate response.

Fertility: No human data from prospective clinical studies are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility.
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development. As with other inactivated vaccines, it is not expected that vaccination with Boostrix Polio harms the foetus. However, human data from prospective clinical studies on the use of Boostrix-IPV during pregnancy are not available. Therefore, Boostrix Polio should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women.
Breastfeeding: The effect of administration of Boostrix Polio during lactation has not been assessed. Nevertheless, as Boostrix Polio contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering Boostrix Polio to breastfeeding women should carefully be evaluated by the health-care providers.

Cases of overdose have been reported during post-marketing surveillance. Adverse events following overdose, when reported, were similar to those reported with normal vaccine administration.