Poliomyelitis 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. Infanrix Hexa® is only currently offered through vaccination programs in British Columbia and the Yukon Territory. Dr. Glenn Crater Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension. How to report a suspected Adverse Event following Immunization: 4.2 … Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine. Listing a study does not mean it has been evaluated by the U.S. Federal Government. How to store Infanrix hexa 6. For the full list of side effects reported with Infanrix hexa, see the package leaflet. Esmane vaktsinatsioon koosneb kahest või kolmest (0,5 ml) annusest, mis tuleb manustada ametlike soovituste kohaselt (vt tabel allpool ja vt lõik 5.1). Annustamine . Health-care professional information: November 2, 2012 - Important safety information regarding the use of INFANRIX-Hexa. 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. 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. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce … The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections. 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. For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363. 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. 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 Mississauga, Ontario 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. alternate formats by contacting us. 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. 4 CONTRAINDICATIONS . Recent investigations detected contamination in the environment where one of the components of this Lot was placed. GSK sincerely apologizes for this situation and is working closely with health authorities to prevent any impact on children's immunization schedule. 7333 Mississauga Road Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. Infanrix ® -hexa is a combination vaccine that protects infants from six diseases. Whooping Cough These parts are mixed together before use. 2. The use of Infanrix hexa should be in accordance with official recommendations. Phone: 1-800-387-7374. 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: STN: BL 103647 Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: INFANRIX Manufacturer: … 4.1 Hypersensitivity . The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation. Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib. 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. The main measure of effectiveness was the production of protective antibodies. 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. 3 . The vaccine is ‘adsorbed’. For more information, see the package leaflet. 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 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 … Recalls and alerts more than 4 years old are automatically archived. 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. Infanrix Hexa® Indication (prévention) ... Avis de la HAS (26/06/2013) Données épidémiologiques: Données épidémiologiques – Site Santé Publique France. The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000. This is duplicated text of a letter from GlaxoSmithKline Inc. 4.2 Annustamine ja manustamisviis . 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. Infanrix hexa is a vaccine that protects against a range of infections. Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form. 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 comes in two parts. Infanrix hexa je hexavakcína pro děti, která je součástí povinných očkování. An additional five studies looked at the effects of a booster vaccination with Infanrix hexa. Infanrix is a combination immunizing agent containing diphtheria toxoid (the children's dose), tetanus toxoid and acellular pertussis vaccine. This medicine is a pack that contains more than one part. We comply with the HONcode standard for trustworthy health information -. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Refer to DOSAGE AND ADMINISTRATION for further information. GlaxoSmithKline Inc. Communications Policy of the Government of Canada, Adverse Events Following Immunization Reporting Form. 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. 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. TetanusPharmacotherapeutic Group: Vaccines. Booster doses of some components are required in childhood: a Hib booster (Hierixb ®) is given at 15 months Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Fax: 613-954-9874; 1-866-844-5931. 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. As per the Communications Policy of the Government of Canada, you can request Očkování proti záškrtu, tetanu, černému kašli, haemophillus influeanze b, žloutenka B a dětské obrně. 1. For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Date de mise à jour: 30/06/2020 2017 - droit d'auteur ANSM. Subject: Voluntary recall of GlaxoSmithKline (GSK) Infanrix Hexa® Vaccine Lot A21CB242A due to potential contamination. Shake the suspension in the syringe well until it is evenly mixed. 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 … The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances. 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 is a suspension for injection available in 0.5-mL single-dose vials and 0.5-mL single-dose, prefilled TIP-LOK syringes. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. How Infanrix hexa is given 4. This helps to protect against the diseases that these bacteria and viruses cause. 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, The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions. 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. Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. 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. Possible sid e effects 5. The vaccine consists of both a 0.5 mL monodose pre-filled syringe and a vial containing a lyophilised pellet. 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. 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 vaccine works by causing the body to produce its … Infanrix-hexa is the schedule vaccine for infants and children. Infanrix hexa is given by deep injection into a muscle. Telephone: 613-954-5590, 1-866-844-0018 Recalls and safety alerts mobile application. toxoids (chemically weakened toxins) from diphtheria and tetanus. 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). While this information can still be accessed in the database, it has not 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. 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. Infanrix hexa is given by deep injection into a muscle. 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.

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