This document is a summary of the European public assessme t report (EPAR) for Infanrix Penta. It
explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing auth risati n and its recommendations on the conditions of use for Infanrix Penta.
toxoids (chemically weakened toxins) from diphtheria and tetanus;
parts of Bordetella pe tussis (B. pertussis, a bacterium that causes whooping cough);
parts of the he atitis B vi us;
Medicinalinactivated po ioviruses.
What is I f nrix Penta used for?
Infanr x Pe ta is used to protect infants under three years of age against diphtheria, tetanus, pertussis (whoop ng cough), hepatitis B and poliomyelitis (polio).
The vaccine can only be obtained with a prescription.
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
How does Infanrix Penta work?
How is Infanrix Penta used?
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life. Infanrix Penta is given by deep injection into a muscle. The site of injection should be alternated for subsequent injections.
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
A booster dose of Infanrix Penta or a similar vaccine must be given at least sixauthorisedmonths after the last dose of the initial course. The choice of which vaccine to use depends on official recommendations.
Infanrix Penta is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s na ural defences) how to defend itself against diseases. Infanrix Penta contains small amoun s of:
toxoids and other proteins purified from B. pertussis;
surface antigen (proteins from the surface) of the hepatitislongerB virus;
polioviruses (types 1, 2 and 3) that have been inactivated (killed) so that they do not cause any disease.
- Pandemrix - GlaxoSmithKline Biologicals S.A.
- Infanrix hexa - GlaxoSmithKline Biologicals S.A.
- Pumarix - GlaxoSmithKline Biologicals S.A.
- Ambirix - GlaxoSmithKline Biologicals S.A.
- Rotarix - GlaxoSmithKline Biologicals S.A.
- Fendrix - GlaxoSmithKline Biologicals S.A.
Prescription drugs listed. Manufacturer: "GlaxoSmithKline Biologicals S.A."
When an infant is given the vaccine, the immune system rec g ises the parts of the bacteria and viruses as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when the persnon is natura y exposed to the bacteria or viruses. This helps to protect against the diseases that these bacteria and viruses cause.
known as ‘recombinant DNA technology’: hey are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
The vaccine is ‘adsorbed’.productThis means that he active substances are fixed onto aluminium compounds, to stimulate a better response. The surface an igens of the hepatitis B virus are produced by a method
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphthe ia, tetanus, pertussis and polioviruses are available in other vaccines.
How has Infanrix Penta been studied?
MedicinalInfanrix Penta h s been studied in 16 studies looking at the first course of vaccination. The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to
various t me schedules. Infanrix Penta has also been studied in nine studies of booster vaccination nvolv ng over 4,000 infants, 714 of whom received Infanrix Penta as a booster. The main measure of effe t veness was the production of antibodies against the active substances after vaccination.
What benefit has Infanrix Penta shown during the studies?
The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies. After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
What is the risk associated with Infanrix Penta?
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness. For the full list of all side effects reported
Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotic ). It must not be used in infants who have had an allergic reaction after receiving a vaccine contain ng diphtheria, tetanus, pertussis, hepatitis B or polio in the past. Infanrix Penta must not be used in infants who have had encephalopathy (brain disease) of unknown cause within seven days f receiving a vaccine containing pertussis components in the past. Infanrix Penta should be postponed in infants with a severe sudden fever.
As for all vaccines, if Infanrix Penta is used in babies born very prematurely, there is a risk of them experiencing apnoea (brief pauses in breathing). Their breathing should be monitored for up to three days after vaccination.
Why has Infanrix Penta been approved?
The CHMP decided that Infanrix Penta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000. The marketing authorisation is valid for an unlimited period.
The full EPAR for Infanrix Penta can be found here. For more information about treatment with Infanrix Penta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in