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The recommended dose (0.5 ml) of the vaccine must be administered.
As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations. The primary immunisation course consists of 3 doses with boosters during the second and sixth year of life.
Active primary immunization against diphtheria, tetanus and pertussis for age 2 months. Booster (for children previously immunized, with 3/4 doses of DTPa or DTPw).
This product 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 INFANRIX diphtheria and tetanus vaccine and DTPw.
This product is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria and tetanus vaccine. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including Infanrix. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
As with other vaccines, administration of Infanrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection is not a contra-indication.
It is good clinical practice that immunisation should be preceded by a review of the medical history (especially with regard to previous immunisation and possible occurrence of undesirable events) and a clinical examination. If any of the following events occur in temporal relation to receipt of DTPa or DTPw, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. 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. The following events were previously considered contra-indications for DTPw and can now be considered general precautions:
Temperature of ≥ 40.5°C 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.
A history of febrile convulsions and a family history of convulsive fits do not constitute contraindications.
HIV infection is not considered as a contra-indication.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunisation.
As for all diphtheria, tetanus and pertussis vaccines, the vaccine should be given deep intramuscularly and preferably at alternate injection sites. This product should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
This drug should under no circumstances be administered intravenously.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
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.
Metabolism and nutrition disorders Common: appetite lost.
Psychiatric disorders Very common: irritability. Common: restlessness, crying abnormal.
Nervous system disorders Very common: somnolence
Gastrointestinal disorders Common: gastrointestinal disorders such as diarrhoea and vomiting
Skin and subcutaneous tissue disorders Common: pruritus
General disorders and administration site conditions Very common: redness, local swelling at the injection site (≤50 mm), fever ≥ 38.0°C. Common: pain, local swelling at the injection site (>50 mm).
Wording for those that do not have a booster indication in children ≥ 4 years of age: Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days.
Wording for those having a booster indication in children ≥ 4 years of age: Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. Local swelling at the injection site (>50 mm) and diffuse swelling may be more frequent (very common and common, respectively) when the booster dose is administered between 4 and 6 years. These reactions resolve over an average of 4 days. reported with D and T vaccines.
For full details see prescribing information.
This product can be administered in any temporal relationship with other childhood vaccines.
This product can be mixed in the same syringe with Hiberix® or other PRP-T Hib vaccines. Other injectable vaccines should always be administered at different injection sites.
In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved.
Pregnancy and Lactation
Pregnancy: As this product is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available.
Lactation: As this product is not intended for use in adults, adequate human data on use during lactation and adequate animal reproduction studies are not available.
Cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.