Table 1 presents adverse reactions observed in clinical trials and also includes additional adverse events which have been spontaneously reported during the post-marketing use of REPEVAX worldwide. 0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobromobutyl or bromobutyl or chlorobutyl elastomer) with attached needle and needle guard (translucent polypropylene rigid safeshield and polyisoprene) - pack size of 1, 10 or 20. REPEVAX should not be administered to individuals with a progressive or unstable neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized. In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of REPEVAX vaccine must be carefully considered. A l’occasion de la semaine européenne de la vaccination du 23 au 29 avril 2017, l’Assurance Maladie aide les adultes à savoir quand effectuer leurs rappels DTP, … Les antibiotiques sont donnés sans ordonnance. On comparison with data from the Sweden I pertussis efficacy trials conducted between 1992 and 1996, where primary immunization with Sanofi Pasteur Limited's acellular pertussis infant DTaP formulation confirmed a protective efficacy of 85% against pertussis disease, it is considered that REPEVAX had elicited protective immune responses. What REPEVAX is and what it is used for REPEVAX (Tdap-IPV) is a vaccine. What you need to know before REPEVAX is given to you or your child 3. REPEVAX may contain traces of formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin, which are used during the manufacturing process (see sections 4.3 and 4.4). Continue typing to refine. • The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. REPEVAX should be used in accordance with official recommendations. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. Une pétition a été lancé sur Internet par un professeur. The highest frequency from either study is presented. In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products. C'est uniquement un vaccin de rappel. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce soit, sans … The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. How to store REPEVAX 6. However, in accordance with commonly accepted immunization guidelines, since REPEVAX is an inactivated product it may be administered concomitantly with other vaccines or immunoglobulins at separate injection sites. Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses. They all resolved without sequelae. Parenteral products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. Do not freeze. Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. Pivotal studies conducted with ADACEL provide serology follow-up data at 3, 5 and 10 years, in individuals previously immunized with a single booster dose of ADACEL. This site uses cookies. pour demander que le vaccin DT Polio simple et sans aluminium soit de nouveau disponible en France. • Maternal antibody directed against pertussis antigens persists for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see section 4.4). Safety of REPEVAX® Given One Month After REVAXIS® The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity. The number and schedule of doses should be determined according to local recommendations. It allows continued monitoring of the benefit/risk balance of the medicinal product. FAS: Full Analysis Set – includes all subjects who received the study vaccine dose and for whom the post-vaccination immunogenicity evaluation was available. By continuing to browse the site you are agreeing to our policy on the use of cookies. These signs and symptoms usually were mild in intensity and occurred within 48 hours following vaccination (Adverse Events have been observed within 24 hours and 7 days following vaccination in children 3 through 6 years). Le vaccin contre l'hépatite B (en anglais, Hepatitis B vaccine ou HBV) prévient la contamination par le virus de l'hépatite B depuis 1982. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309. - One hundred and fifty children primed at 2, 3, and 4 months of age with a DTwP vaccine (with no additional dose in the second year of life) received REPEVAX at 3 to 5 years of age. Transient severe swelling of the injected upper arm was reported in <1% of children aged 5 to 6 years. Please remove one or more studies before adding more. Le vaccin ne guérit pas les porteurs chroniques, mais il est efficace de 90 à 95 % pour prévenir l'apparition de cet état. REPEVAX can be used for repeat vaccination to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 year intervals (see section 5.1). However, a trend of lower anti-HPV GMTs was observed in the concomitant group. Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo. The clinical relevance of this observation is unknown. Enfants âgés de 3 à 5 ans (150 sujets) Cent cinquante enfants ayant reçu une primovaccination à 2, 3 et 4 mois avec un vaccin combiné diphtérique, tétanique et coquelucheux germes entiers (sans dose additionnelle dans la seconde année de vie) ont été vaccinés avec REPEVAX à l’âge de 3 à 5 ans. Table 1: Adverse events from clinical trials and worldwide post marketing experience, Anaphylactic reactions, such as urticaria, face oedema and dyspnea*, Convulsions, Vasovagal Syncope, Guillain Barré syndrome, Facial Palsy, Myelitis, Brachial Neuritis, Transient paresthesia/hypoesthesia of vaccinated limb, Dizziness*, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Injection site pain, Injection site swelling, Injection site erythema, Irritability, Injection site dermatitis, Injection site bruising, Injection site pruritus, Malaise§, Pallor*, Extensive limb swelling‡, Injection site induration*, † Fever was measured as temperature ≥37.5°C in Children groups and measured as temperature ≥38°C in Adolescents and Adults group, § was observed at a frequency of very common in adolescents and adults, in studies with ADACEL (Tdap component of REPEVAX; containing the same amounts of diphtheria, tetanus and pertussis antigens), Description of selected adverse reactions. The lower response to diphtheria toxoid in adults probably reflected the inclusion of some participants with an uncertain or incomplete immunization history. REPEVAX (Tdap-IPV) is indicated for: Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. As with other inactivated vaccines, it is not expected that vaccination with REPEVAX during any trimester would harm the fetus. In a subsequent study, robust immune responses were observed following a single dose of REPEVAX in UK children 3.5 to 4.0 years of age previously primed with either an acellular pertussis combination vaccine (DTaP-IPV-Hib) or whole cell pertussis combination vaccine (DTwP//Hib) and OPV. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine. In clinical trials REPEVAX was given to a total of 1,384 persons including 390 children 3 through 6 years of age and 994 adolescent and adults. Vaccin diphtérique (contenu réduit en antigène), tétanique, coquelucheux acellulaire et poliomyélitique (inactivé), (adsorbé) B/1 seringue préremplie en verre de 0,5 ml munie d'un bouchon-piston sans aiguille et avec un capuchon tip-cap (CIP : 359 642-4) Extensive limb swelling which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters has been reported following administration of REPEVAX. For general information, Learn About Clinical Studies. The safety profile of REPEVAX in 390 children 3 to 6 years of age as presented in Table 1 is derived from two clinical studies: - In a clinical study, 240 children were primed at 3, 5 and 12 months of age with a DTaP vaccine with no additional dose in the second year of life. Study record managers: refer to the Data Element Definitions if submitting registration or results information. In the event of either being observed, discard the medicinal product. REPEVAX est indiqué pour : - l'immunisation active contre la diphtérie, le tétanos, la coqueluche et la poliomyélite chez les sujets à partir de l'âge de 3 ans en rappel après primovaccination. Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine. In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Gardasil concomitantly with REPEVAX showed that there was more injection-site swelling and headache reported following concomitant administration. Reporting suspected adverse reactions after authorisation of the medicinal product is important. REPEVAX has no or negligible influence on the ability to drive and use machines. These children received REPEVAX at 5 to 6 years of age. • and ≥98.8% were seroprotected against polio (types 1, 2 and 3) at a threshold ≥1:8 dilution. In both age groups, injection site pain was the most common adverse reaction. Dites-le au vaccinateur (s'il est infirmier, en principe il faut une ordonnance). Date of first authorisation/renewal of the authorisation. Clinical data in adults have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of REPEVAX as early as 4 weeks, compared to at least 5 years after a preceding dose of tetanus and diphtheria-containing vaccine. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. • 98.5% and 99.7% were seroprotected against tetanus at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. • REPEVAX should not be administered to persons with known hypersensitivity, - to diphtheria, tetanus, pertussis or poliomyelitis vaccines, - to any other component of the vaccine (see Section 6.1). For the full list of excipients, see section 6.1. This information is intended for use by health professionals, REPEVAX, suspension for injection, in pre-filled syringe, Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content), Diphtheria Toxoid ...........................................................Not less than 2 IU* (2 Lf), Pertussis Toxoid ............................................................2.5 micrograms, Filamentous Haemagglutinin .........................................5 micrograms, Pertactin ........................................................................3 micrograms, Fimbriae Types 2 and 3 .................................................5 micrograms, Type 1 ............................................................................40 D antigen units, Type 2 ............................................................................8 D antigen units, Type 3 ............................................................................32 D antigen units, Adsorbed on aluminium phosphate ................................1.5 mg (0.33 mg aluminium). Nos vaccins - Repevax. • 82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Possible side effects 5. Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine, Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C), Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days, Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3, Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination. The clinical relevance of this observation is unknown. Start typing to retrieve search suggestions. One month post-vaccination ≥ 98.5% of study participants achieved seroprotective antibody levels (≥ 0.1 IU/ml) for diphtheria and tetanus, and ≥ 84% achieved booster responses to the pertussis antigens. Légiférer sans passer par le Parlement. Des milliers de personnes souffrent régulièrement de maux de tête ou céphalées. This is based on the results from a clinical trial in which REPEVAX was administered concomitantly with the first dose of Gardasil (see section 4.8). Ce virus n'existe que chez l'être humain. After administration of one dose of REPEVAX to 330 adults ≥40 years of age that had not received any diphtheria- and tetanus-containing vaccine in the past 20 years: • ≥95.8% of adults were seropositive (≥ 5 IU/mL) for antibodies to all vaccine-containing pertussis antigens. To bookmark a medicine you must sign up and log in. Listing a study does not mean it has been evaluated by the U.S. Federal Government. REPEVAX, suspension injectable en seringue préremplie. To view the changes to a medicine you must sign up and log in. • As with other vaccines, administration of REPEVAX should be postponed in persons suffering from an acute severe febrile illness. Continue, 2. REPEVAX peut être administré simultanément avec une dose de vaccin contre l'Hépatite B. REPEVAX peut être administré simultanément avec une dose de vaccin papillomavirus humain recombinant, sans interférence clinique significative avec la réponse en anticorps vis-à … Table 3: Persistence of Seroprotection/Seropositivity Rates in Children, Adolescents and Adults at 3-, 5- and 10- years following a dose of ADACEL (Tdap component of REPEVAX) (PPI Population1), N = number of subjects with available data; SN: seroneutralisation; ELISA: Enzyme Linked Immunoassay. After administration of two additional doses of diphtheria- tetanus- and polio-containing vaccine to 316 subjects, one and six months after the first dose, the seroprotection rates against diphtheria were 94.6% and 100% (≥0.1 and ≥ 0.01 IU/mL, respectively), against tetanus 100% (≥0.1 IU/mL), and against polio (types 1, 2 and 3) 100% (≥1:8 dilution) (see Table 4). Nom du produit : REPEVAX Forme pharmaceutique : Suspension injectable en seringue préremplie. In serology follow-up studies conducted with REPEVAX, seroprotective antibody levels (≥1:8 dilution) for each poliovirus (type1, 2 and 3) were maintained in 95% to 100% of the children, adolescents and adults at the 5-year follow-up time point, and in 100% of the adolescents at the 10-year follow-up time point. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). To email a medicine you must sign up and log in. Cette pétition a obtenu plus 1 026 000 signatures. Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. REPEVAX; VAXELIS; Légende Médicament ayant des présentations disponibles sans ordonnance. REPEVAX should not be used for primary immunization. REPEVAX has not been evaluated in fertility studies. Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated). Choosing to participate in a study is an important personal decision. Procedures should be in place to prevent falling injury and manage syncopal reactions. The normal appearance of the vaccine is a uniform cloudy, white suspension which may sediment during storage. Il a été développé par le laboratoire Wyeth (racheté depuis par Pfizer), et est commercialisé sous le nom de Pristiq.La desvenlafaxine correspond à l'un des métabolites de la venlafaxine (vendue sous le nom d'Effexor). No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. Adverse reactions are ranked under headings of frequency using the following convention: cannot be estimated from the available data. - to any residual substances carried over from manufacture (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin), which may be present in undetectable trace amounts. Serological correlates for protection against pertussis have not been established. La contamination se fait principalement par voie digestive, lors de la consommation d'eau contaminée, d'aliments souillés (crudités, par exemple), ou par les mains sales. Immunogenicity following repeat vaccination. For instructions on handling of the medicinal product before administration, see section 6.6. 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. In the case of immunosuppressive therapy please refer to Section 4.4. La vaccination contre la diphtérie, le tétanos et la poliomyélite (DTP) est obligatoire ou simplement recommandée selon l'âge et la situation de la personne.

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