The use of Infanrix hexa should be in accordance with official recommendations. 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. 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. L5N 6L4 This is duplicated text of a letter from GlaxoSmithKline Inc. The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation. The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances. How to take it. INFANRIX hexa(combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, and adsorbed conjugated Haemophilus influenzaetype b vaccine) is indicated for: active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, Should you have any questions or require additional information regarding the use of Infanrix Hexa® please contact your healthcare professional. Vaccination is the best way to protect against these diseases. Infanrix Hexa® is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b diseases. Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension. 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. Booster doses of some components are required in childhood: a Hib booster (Hierixb ®) is given at 15 months 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. Health-care professional information: November 2, 2012 - Important safety information regarding the use of INFANRIX-Hexa. Infanrix hexa is … Shake the suspension in the syringe well until it is evenly mixed. 1. Infanrix Hexa® Indication (prévention) ... Avis de la HAS (26/06/2013) Données épidémiologiques: Données épidémiologiques – Site Santé Publique France. Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Possible sid e effects 5. Status: AuthorisedAuthorisation Date: 2000-10-23Therapeutic Area: Meningitis, Haemophilus Listing a study does not mean it has been evaluated by the U.S. Federal Government. No contamination was found in the vaccine. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. INFANRIX hexa comes in two parts. Mississauga, Ontario Infanrix ® -hexa is a combination vaccine that protects infants from six diseases. 4.2 Annustamine ja manustamisviis . INFANRIX HEXA has been the principal Hib-containing vaccine available in Italy since 2006. Poliomyelitis is the acute illness following infection of the gastrointestinal tract with one of the three types of polio virus. For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363. INFANRIX hexa® (combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, and adsorbed conjugated Haemophilus influenzae type b vaccine) contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (69 kiloDalton outer membrane protein)], hepatitis B … 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. How to store Infanrix hexa 6. The vaccine consists of both a 0.5 mL monodose pre-filled syringe and a vial containing a lyophilised pellet. been altered or updated since it was archived. Infanrix is a combination immunizing agent containing diphtheria toxoid (the children's dose), tetanus toxoid and acellular pertussis vaccine. Infanrix hexa is given by deep injection into a muscle. This patient group direction (PGD) template supports the administration of hexavalent vaccine, DTaP/IPV/Hib/HepB (Infanrix®-hexa), in accordance with … A hexavalent vaccine, or 6-in-1 vaccine, is a combination vaccine with six individual vaccines conjugated into one, intended to protect people from multiple diseases. Annustamine . We comply with the HONcode standard for trustworthy health information -. Diphtheria This means that the active substances are fixed onto aluminium compounds, to stimulate a better response. 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 4.2 … TetanusPharmacotherapeutic Group: Vaccines. The main measure of effectiveness was the production of protective antibodies. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections. Note: This document contains side effect information about diphtheria and tetanus toxoids / pertussis, acellular. Očkování proti záškrtu, tetanu, černému kašli, haemophillus influeanze b, žloutenka B a dětské obrně. Contents of the pack and other information . This vaccine requires three doses, at 6 weeks, 3 months and 5 months of age, to be fully effective and to induce long-lived immunity. GlaxoSmithKline has sent a letter to healthcare professionals informing them about this recall.  This information may be obtained on the Canadian web site of GlaxoSmithKline or on the Health Canada Web site. Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine. Contact the company for a copy of any references, attachments or enclosures. Uses of INFANRIX HEXA. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. GSK sincerely apologizes for this situation and is working closely with health authorities to prevent any impact on children's immunization schedule. Infanrix hexa. DTPa-hepB-IPV-Hib (Infanrix Hexa®) - Neonatal Page 2 of 3 DTPa-hepB-IPV-Hib (Infanrix Hexa®)Vaccine- Neonatal Inspect the contents of the syringe and the pellet for discolouration. Infanrix Hexa ® is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b diseases. How Infanrix hexa is given 4. alternate formats by contacting us. Telephone: 613-954-5590, 1-866-844-0018 INFANRIX hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzaetype b (Hib). GlaxoSmithKline, in consultation with Health Canada, would like to inform you of its decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa® vaccine as a result of detection of contamination in the environment where material used to make the recalled vaccine had been placed. 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). The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Infanrix hexa kasutamisel tuleb järgida ametlikke soovitusi. Fax: 613-954-9874; 1-866-844-5931. Infanrix-hexa Printed copies are not controlled and may not be the current version in use Ref.236711 Authorised by: Clinical Director Neonatal Page 1 of 3 March 2016 INFANRIX®-HEXA Trade Name INFANRIX®-hexa (Glaxo-Smith-Klyne) Class Vaccine Mechanism of action INFANRIX ®-hexa is a combined vaccine containing diphtheria- The vaccine works by causing the body to produce its … Any case of serious or unexpected adverse events in patients receiving Infanrix Hexa® should be reported to GSK or your local health department at the following addresses: GlaxoSmithKline Inc. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with health product treatments. Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000. Registered for use in infants and children aged ≥6 weeks. toxoids (chemically weakened toxins) from diphtheria and tetanus. Infanrix hexa este indicat pentru vaccinare primară şi de rapel a sugarilor şi copiilor mici, împotriva difteriei, tetanosului, tusei convulsive, hepatitei B, poliomielitei şi a bolii determinate de Haemophilus influenzae tip b. Administrarea Infanrix Hexa trebuie făcută conform recomandărilor oficiale. A search of the GSK worldwide safety database did not identify any reported adverse events that appear to be linked to contamination. For the full list of side effects reported with Infanrix hexa, see the package leaflet. This helps to protect against the diseases that these bacteria and viruses cause. The second part is the Hib vaccine and is a white pellet in a separate glass vial. Date de mise à jour: 30/06/2020 2017 - droit d'auteur ANSM. May 1, 2018 - Important safety information for several GlaxoSmithKline Inc. vaccines: Potential Risk of Underdosing. This medicine is a pack that contains more than one part. 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 est contre-indiqué chez les nourrissons et les enfants en bas âge ayant présenté une encéphalopathie d'étiologie inconnue, survenue dans les 7 jours suivant une vaccination antérieure par un vaccin contenant la valence coquelucheuse. Recalls and safety alerts mobile application. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Infanrix-hexa is the schedule vaccine for infants and children. Esmane vaktsinatsioon koosneb kahest või kolmest (0,5 ml) annusest, mis tuleb manustada ametlike soovituste kohaselt (vt tabel allpool ja vt lõik 5.1). The first part is a white, milky liquid (0.5 mL) in a pre-filled syringe that consists of the combined diphtheria, tetanus, pertussis, hepatitis B and inactivated poliovirus vaccine. The vaccine is ‘adsorbed’. 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 vaccine is administered at 3, 5 and 11 months of age and coverage has exceeded 95%. INFANRIX HEXA is the only hexavalent vaccine refunded in France (since March 2008) for the primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and infections caused by Haemophilus influenzae type b. Vice President, Medical and Chief Medical Officer What Infanrix hexa is and what it is used for . Infanrix Hexa® is only currently offered through vaccination programs in British Columbia and the Yukon Territory. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Hepatitis B The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses. There have been reports of leakage from CCT syringes used for several GlaxoSmithKline Inc. vaccines during vaccine preparation or administration. 4.1 Hypersensitivity . Side effects requiring immediate medical attention Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Ce document intitulé « INFANRIX QUINTA - Indications, posologie et effets secondaires » issu de Journal des Femmes (sante-medecine.journaldesfemmes.fr) est soumis au droit d'auteur. Infanrix hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib). Infanrix hexa is a vaccine that protects against a range of infections. Dr. Glenn Crater Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce …