The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses. Očkování proti záškrtu, tetanu, černému kašli, haemophillus influeanze b, žloutenka B a dětské obrně. 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. ATC Code: J07CA09Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.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 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. This means that the active substances are fixed onto aluminium compounds, to stimulate a better response. May 1, 2018 - Important safety information for several GlaxoSmithKline Inc. vaccines: Potential Risk of Underdosing. Dr. Glenn Crater Annustamine . Uses of 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. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Status: AuthorisedAuthorisation Date: 2000-10-23Therapeutic Area: Meningitis, Haemophilus Whooping Cough The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation. Side effects requiring immediate medical attention 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. The choice of booster vaccine depends on official recommendations. 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. For more information, see the package leaflet. Infanrix hexa is given by deep injection into a muscle. Infanrix hexa is given by deep injection into a muscle. Subject: Voluntary recall of GlaxoSmithKline (GSK) Infanrix Hexa® Vaccine Lot A21CB242A due to potential contamination. 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. Esmane vaktsinatsioon koosneb kahest või kolmest (0,5 ml) annusest, mis tuleb manustada ametlike soovituste kohaselt (vt tabel allpool ja vt lõik 5.1). If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at: Listing a study does not mean it has been evaluated by the U.S. Federal Government. toxoids (chemically weakened toxins) from diphtheria and tetanus. Contents of the pack and other information . The Adverse Events Following Immunization Reporting Form and Guidelines can be found on the Public Health Agency of Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties. been altered or updated since it was archived. These parts are mixed together before use. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. GSK has decided to initiate a voluntary recall of this Lot as a precautionary measure. This patient group direction (PGD) template supports the administration of hexavalent vaccine, DTaP/IPV/Hib/HepB (Infanrix®-hexa), in accordance with … Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 4.2 Annustamine ja manustamisviis . 4.2 … 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. Vice President, Medical and Chief Medical Officer 4 CONTRAINDICATIONS . An additional five studies looked at the effects of a booster vaccination with Infanrix hexa. Contact the company for a copy of any references, attachments or enclosures. If discoloured, discard vaccine. This medicine is a pack that contains more than one part. 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. What Infanrix hexa is and what it is used for . The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances. For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Managing marketed health product-related adverse events depends on health care professionals and consumers reporting them. 3 . 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, Note: This document contains side effect information about diphtheria and tetanus toxoids / pertussis, acellular. 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. Some of the dosage forms listed on this page may not apply to the brand name Infanrix (DTaP).. For the Consumer. Fax: 613-954-9874; 1-866-844-5931. Infanrix hexa is … 4.1 Hypersensitivity . Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form. The main measure of effectiveness was the production of protective antibodies. 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. 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. INFANRIX hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzaetype b (Hib). This is duplicated text of a letter from GlaxoSmithKline Inc. The use of Infanrix hexa should be in accordance with official recommendations. 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. Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection. Shake the suspension in the syringe well until it is evenly mixed. INFANRIX hexa comes in two parts. 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 safety of Infanrix hexa is similar to other vaccines used to prevent these conditions. 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. 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) Mississauga, Ontario Available for Android and iOS devices. Vaccination is the best way to protect against these diseases. What INFANRIX hexa is used for 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). Recalls and safety alerts mobile application. For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363. Infanrix hexa. As per the Communications Policy of the Government of Canada, you can request The second part is the Hib vaccine and is a white pellet in a separate glass vial. 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 is a combination vaccine that protects infants from six diseases. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. How Infanrix hexa is given 4. Infanrix hexa kasutamisel tuleb järgida ametlikke soovitusi. INFANRIX hexa is also indicated for use as booster dose if boosting with hepatitis B, poliomyelitis, and Haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. This helps to protect against the diseases that these bacteria and viruses cause. INFANRIX is a suspension for injection available in 0.5-mL single-dose vials and 0.5-mL single-dose, prefilled TIP-LOK syringes. Infanrix Hexa® is only currently offered through vaccination programs in British Columbia and the Yukon Territory. 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 The vaccine works by causing the body to produce its … Hepatitis B The vaccine is administered at 3, 5 and 11 months of age and coverage has exceeded 95%. Telephone: 613-954-5590, 1-866-844-0018 A search of the GSK worldwide safety database did not identify any reported adverse events that appear to be linked to contamination. 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. 1. 7333 Mississauga Road Date de mise à jour: 30/06/2020 2017 - droit d'auteur ANSM. 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. Diphtheria GSK sincerely apologizes for this situation and is working closely with health authorities to prevent any impact on children's immunization schedule. L5N 6L4 How to store Infanrix hexa 6. Refer to DOSAGE AND ADMINISTRATION for further information. 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. 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. Vaccination is the best way to protect against these diseases. 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 … INFANRIX-Hexa Vaccines INFANRIX-Hexa Product information: INFANRIX-Hexa product monograph. What you need to know before your child receives Infanrix hexa 3. Poliomyelitis Should you have any questions or require additional information regarding the use of Infanrix Hexa® please contact your healthcare professional. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 2. Infanrix is a combination immunizing agent containing diphtheria toxoid (the children's dose), tetanus toxoid and acellular pertussis vaccine. 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 the schedule vaccine for infants and children. GlaxoSmithKline Inc. Communications Policy of the Government of Canada, Adverse Events Following Immunization Reporting Form. While this information can still be accessed in the database, it has not Poliomyelitis is the acute illness following infection of the gastrointestinal tract with one of the three types of polio virus. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine. No contamination was found in the vaccine. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Possible sid e effects 5. Patient information: The vaccine can only be obtained with a prescription. Infanrix hexa should be postponed in infants with a severe sudden fever. 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 vaccine is ‘adsorbed’. Infanrix Hexa® Indication (prévention) ... Avis de la HAS (26/06/2013) Données épidémiologiques: Données épidémiologiques – Site Santé Publique France. Recent investigations detected contamination in the environment where one of the components of this Lot was placed. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. Health-care professional information: November 2, 2012 - Important safety information regarding the use of INFANRIX-Hexa. TetanusPharmacotherapeutic Group: Vaccines. How to report a suspected Adverse Event following Immunization: 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. We comply with the HONcode standard for trustworthy health information -. Infanrix hexa je hexavakcína pro děti, která je součástí povinných očkování. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce … Immunization 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 contains the following active substances: Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection. 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). Phone: 1-800-387-7374. Infanrix hexa is a vaccine that protects against a range of infections. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000. Recalls and alerts more than 4 years old are automatically archived. 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. Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension. 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. The vaccine in a series of five doses is administered by intramuscular (IM) injection to protect children from diphtheria, tetanus and pertussis infections. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, How to take it. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections. STN: BL 103647 Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: INFANRIX Manufacturer: … Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib. DTPa -hepB- IPV -Hib — diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus- Haemophilus influenzae type b combination vaccine. For the full list of side effects reported with Infanrix hexa, see the package leaflet. alternate formats by contacting us. Over 3,000 of the children received a course of vaccination with Infanrix hexa. The vaccine consists of both a 0.5 mL monodose pre-filled syringe and a vial containing a lyophilised pellet. INFANRIX HEXA has been the principal Hib-containing vaccine available in Italy since 2006. 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. There have been reports of leakage from CCT syringes used for several GlaxoSmithKline Inc. vaccines during vaccine preparation or administration. This medicine is used in the immunization against diphtheria, tetanus, pertussis, hepatitis B, and Hib in infants from the age of 6 weeks and in infants who received 1st dose of hepatitis B vaccine at birth. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. Registered for use in infants and children aged ≥6 weeks. Subsequent injections should be given in different areas. 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. 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. Booster doses of some components are required in childhood: a Hib booster (Hierixb ®) is given at 15 months 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.