Infanrix Hexa

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

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This is a summary of the European public assessment report (EPAR) for Infanrix hexa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Infanrix hexa.

For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.

What is Infanrix hexa and what is it used for?

Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib). Infanrix hexa contains the following active substances:

  • toxoids (chemically weakened toxins) from diphtheria and tetanus;
  • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
  • parts of the hepatitis B virus;
  • inactivated polioviruses;
  • polysaccharides (sugars) from Haemophilus influenzae type b.

 

How is Infanrix hexa used?

Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection. The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life. Infanrix hexa is given by deep injection into a muscle. Subsequent injections should be given in different areas.

A booster dose of Infanrix hexa or a similar vaccine must be given at least 6 months after the last dose of the initial course. The choice of booster vaccine depends on official recommendations.

The vaccine can only be obtained with a prescription. For more information, see the package leaflet.

How does Infanrix hexa work?

Infanrix hexa is a vaccine that protects against a range of infections. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections.

When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses. This helps to protect against the diseases that these bacteria and viruses cause.

The vaccine is ‘adsorbed’. This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.

What benefits of Infanrix hexa have been shown in studies?

Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. Over 3,000 of the children received a course of vaccination with Infanrix hexa. The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances. The main measure of effectiveness was the production of protective antibodies.

Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances. Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.

An additional five studies looked at the effects of a booster vaccination with Infanrix hexa. These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.

What is the risk associated with Infanrix hexa?

The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness. For the full list of side effects reported with Infanrix hexa, see the package leaflet.

Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde. It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib. Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine. Infanrix hexa should be postponed in infants with a severe sudden fever.

Why is Infanrix hexa approved?

Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib. The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions. The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Infanrix hexa?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa have been included in the summary of product characteristics and the package leaflet.

Other information about Infanrix hexa:

The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.

For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Infanrix Hexa : EPAR - Summary for the public BG = bălgarski 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public ES = español 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public CS = čeština 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public DA = dansk 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public DE = Deutsch 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public ET = eesti keel 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public EL = elliniká 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public EN = English 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public FR = français 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public IT = italiano 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public LV = latviešu valoda 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public LT = lietuvių kalba 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public HU = magyar 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public MT = Malti 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public NL = Nederlands 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public PL = polski 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public PT = português 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public RO = română 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public SK = slovenčina 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public SL = slovenščina 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public FI = suomi 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public SV = svenska 2008-12-23 2017-11-29
Infanrix Hexa : EPAR - Summary for the public HR = Hrvatski 2008-12-23 2017-11-29

This EPAR was last updated on 29/11/2017 .

Authorisation details

Product details

Product details for Infanrix Hexa
NameInfanrix Hexa
Agency product numberEMEA/H/C/000296
Active substance

diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis B surface antigen / poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)) / Haemophilus influenzae type-b polysaccharide

International non-proprietary name (INN) or common name

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Therapeutic area Meningitis, HaemophilusHepatitis BDiphtheriaPoliomyelitisWhooping CoughImmunizationTetanus
Anatomical therapeutic chemical (ATC) code J07CA09

Publication details

Publication details for Infanrix Hexa
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision35
Date of issue of marketing authorisation valid throughout the European Union23/10/2000

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

07/07/2017  Infanrix Hexa -EMEA/H/C/000296 -IB/0220

Name Language First published Last updated
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa : EPAR - Product Information HR = Hrvatski 2008-11-26 2017-08-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10
Infanrix Hexa : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2017-08-10

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Infanrix Hexa : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2008-11-26 2017-08-10
Infanrix Hexa-H-C-296-P46-126 : EPAR - Assessment Report HR = Hrvatski 2017-06-01  
Infanrix Hexa-H-C-296-P46-121 : EPAR - Assessment Report HR = Hrvatski 2017-02-06  
Infanrix hexa-H-C-296-P46-123: EPAR - Assessment report HR = Hrvatski 2016-12-08  
Infanrix Hexa-H-C-296-P46-124 : EPAR - Assessment report HR = Hrvatski 2016-11-30  
Infanrix Hexa-H-C-296-P46-120 : EPAR - Assessment Report HR = Hrvatski 2016-11-14  
Infanrix Hexa-H-C-296-P46-0119 : EPAR - Assessment Report HR = Hrvatski 2016-08-12  
Infanrix Hexa-H-C-296-P46-117 : EPAR - Assessment Report HR = Hrvatski 2016-04-28  
Infanrix Hexa-H-C-PSUSA-00001122-201410 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2015-09-09  
Infanrix Hexa-H-C-296-P46-0113: EPAR - Assessment Report HR = Hrvatski 2015-01-12  
Infanrix Hexa-H-C-296-P45-0089/P46-0099 : EPAR - Assessment Report HR = Hrvatski 2014-11-04  
Infanrix Hexa-H-C-296-P46-0106 : EPAR - Assessment Report HR = Hrvatski 2014-08-11  
Infanrix Hexa-H-C-296-P46-099.1 : EPAR - Assessment Report HR = Hrvatski 2014-08-11  
Infanrix Hexa-H-C-296-P46-106.1 : EPAR - Assessment Report HR = Hrvatski 2014-08-11  
Infanrix Hexa-H-C-296-P46-0110 : EPAR - Assessment Report HR = Hrvatski 2014-08-11  
Infanrix Hexa-H-C-296-P46-106.2 : EPAR - Assessment Report HR = Hrvatski 2014-08-11  
Infanrix Hexa-H-C-296-P46-0106 : EPAR - Assessment Report HR = Hrvatski 2013-06-26  
Infanrix Hexa-H-C-296-P46-0104 : EPAR - Assessment Report HR = Hrvatski 2013-06-26  
Infanrix Hexa-H-C-296-P46-0105 : EPAR - Assessment Report HR = Hrvatski 2013-06-26  
Infanrix Hexa : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 2005-10-21  

Initial marketing-authorisation documents

Name Language First published Last updated
Infanrix Hexa : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Infanrix Hexa : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21  

Authorised

This medicine is approved for use in the European Union