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1 X 0.5 ml
1 X 0.5 ml
A single 0.5 ml dose of the vaccine is recommended. Boostrix may be administered from the age of ten years onwards.
Boostrix should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide low (adult) dose diphtheria, tetanus and pertussis antigens.
In subjects 40 years of age that had not received any diphtheria or tetanus containing vaccine in the past 20 years, one dose of Boostrix 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. This product 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 and pertussis is indicated. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations. Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as per official recommendations (generally 10 years).
Paediatric population: The safety and efficacy of Boostrix in children below 4 years of age have not been established.
Booster vaccine against diphtheria, tetanus and pertussis from 10 years of age and onwards.
Hypersensitivity to any of the components, severe febrile illness, acute infection.
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 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 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. Extremely rare cases of collapse or shock-like state (hypotonic-hyporesponsiveness episode) and convulsions within 2 to 3 days of vaccination have been reported in DTPa and DTPa combination vaccines. 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.
Metabolism and nutrition disorders: Common – anorexia
Psychiatric disorders: Very common – irritability
Nervous system disorders: Very common – somnolence Common: headache
Gastrointestinal disorders: Common – diarrhoea, vomiting, gastrointestinal disorders
General disorders and administration site conditions: Very common – injection site reactions (such as redness and/or swelling), injection site pain, fatigue Common: pyrexia (fever ≥ 37.5°C including fever > 39.0°C), extensive swelling of vaccinated limb (sometimes involving the adjacent joint).
Nervous system disorders: Very common – headache Common: dizziness
Gastrointestinal disorders: Common – nausea, gastrointestinal disorders
General disorders and administration site conditions: Very common – injection site reactions (such as redness and/or swelling), malaise, fatigue, injection site pain Common: pyrexia (fever > 37.5°C), injection site reactions (such as injection site mass and injection site abscess sterile)
Use with other vaccines or immunoglobulins: Boostrix 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 with 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 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.
Pregnancy and Lactation
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 harms the foetus.
However, human data from prospective clinical studies on the use of Boostrix during pregnancy are not available. Therefore, the vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus.
Breastfeeding: The effect of administration of Boostrix during lactation has not been assessed. Nevertheless, as Boostrix contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering Boostrix 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.