Boostrix 0,5 ml Injection

BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see section 4.2). BOOSTRIX is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see sections 4.2, 4.6 and 5.1). The use of BOOSTRIX should be in accordance with official recommendations.

Posology A single 0,5 ml dose of the vaccine is recommended. BOOSTRIX can be given in accordance with the current local medical practices for booster vaccination with reduced-content combined diphtheria-tetanus vaccine, when a booster against pertussis is desired.

BOOSTRIX can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see sections 4.1, 4.6 and 5.1). BOOSTRIX may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus and pertussis (see section 5.1). Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus. Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as per official recommendations (generally 10 years). BOOSTRIX can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.

Paediatric population The safety and efficacy of Boostrix in children below 4 years of age have not been established.

Method of administration: BOOSTRIX is for deep intramuscular injection, preferably in the deltoid region (see section 4.4).

BOOSTRIX 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 administration of diphtheria, tetanus or pertussis vaccines. BOOSTRIX is contra-indicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria and tetanus vaccines. BOOSTRIX should not be administered to subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus (for convulsions or hypotonic-hyporesponsive episodes (see section 4.4).

As with other vaccines, administration of BOOSTRIX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contra-indication. BOOSTRIX should under no circumstances be administered intravenously. 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 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 u2265 40,0 u00b0C 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 u2265 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) immunisation 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. 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. 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. 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 for diphtheria, tetanus and pertussis vaccination. 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 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.

Boostrix can be given concomitantly with any of the following monovalent or combination vaccines: unadjuvanted inactivated seasonal influenza vaccines, human papilloma virus vaccines, meningococcal serogroups A, C, W-135 and Y (MenACWY) conjugate vaccines and non-live herpes zoster vaccine. Data have shown no clinically relevant interference in the antibody response to each of the vaccine antigens. Clinical data from co-administration of Boostrix with a trivalent inactivated influenza vaccine in subjects aged between 19 and 64 years demonstrated that the immune responses to the tetanus, diphtheria, pertussis toxoid (PT) and influenza antigens were unaffected. Lower geometric mean concentrations (GMCs) were observed for the pertussis filamentous haemagglutinin (FHA) and pertactin (PRN) antigens; however, these data do not suggest clinically relevant interference. No differences were observed in a predefined exploratory cohort when the vaccines were given concomitantly or separately to subjects aged 65 years and older. Clinical data from co-administration of Boostrix with non-live herpes zoster vaccine in subjects aged 50 years and older demonstrated that the immune responses to the tetanus, diphtheria, PT, FHA and herpes zoster antigens were unaffected. Lower GMCs were observed for the PRN antigen; however, these data do not suggest clinically relevant interference. Clinical data from co-administration of Boostrix with MenACWY conjugate vaccines in subjects aged 9 to 25 years demonstrated that the immune responses to the tetanus, diphtheria and meningococcal antigens were unaffected. Lower GMCs were observed for the pertussis antigens; however, these data do not suggest clinically relevant interference. Concomitant use with other inactivated vaccines and with immunoglobulin is unlikely to result in interference with the immune responses. When considered necessary, BOOSTRIX can be administered simultaneously with other vaccines or immunoglobulins. If BOOSTRIX is to be given at the same time as another injectable vaccine or immunoglobulin, the products should always be administered at different sites. As with other vaccines, patients receiving immunosuppressive therapy or patients with immunodeficiency may not achieve an adequate response. In these patients, when tetanus vaccine is needed for tetanus prone wound, plain tetanus vaccine will be used.

Fertility: No human data available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility.

Pregnancy: BOOSTRIX can be used during the second or third trimester of pregnancy in accordance with official recommendations. For data relating to the prevention of pertussis disease in infants born to women vaccinated during pregnancy (see section 5.1). Safety data from a randomized controlled clinical trial (341 pregnancy outcomes) and from a prospective observational study (793 pregnancy outcomes) where BOOSTRIX was administered to pregnant women during the third trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child. Safety data from prospective clinical studies on the use of BOOSTRIX during the first and second trimester of pregnancy are not available. Data from post-marketing surveillance where pregnant women were exposed to BOOSTRIX or to dTpa-IPV vaccine in the second or the third trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child. As with other inactivated vaccines, it is not expected that vaccination with BOOSTRIX harms the foetus at any trimester of pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development.

Lactation: The safety of BOOSTRIX when administered to breastfeeding women has not been evaluated. It is unknown whether BOOSTRIX is excreted in human breast milk. BOOSTRIX should only be used during breastfeeding when the possible advantages outweigh the potential risks.

BOOSTRIX is unlikely to produce an effect on the ability to drive and use machines.

Summary of the safety profile The safety profile presented below is based on data from clinical trials where Boostrix was administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age) (Table 1). The most common events occurring after Boostrix administration in children from 4 to 9 years of age as well as for adults, adolescents and children from the age of 10 years onwards, were injection site reactions (including pain, redness and swelling).

Tabulated list of adverse reactions Adverse reactions reported are listed according to the following frequency: Very common: u2265 1/10 common: u2265 1/100 and < 1/10 uncommon: u2265 1/1 000 and < 1/100 rare: u2265 1/10 000 and < 1/1 000 very rare: < 1/10 000 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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