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. This site uses cookies. Les antibiotiques sont donnés sans ordonnance. To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo. Start typing to retrieve search suggestions. FAS: Full Analysis Set – includes all subjects who received the study vaccine dose and for whom the post-vaccination immunogenicity evaluation was available. Table 5: Vaccine effectiveness (VE) against pertussis disease in young infants born to mothers vaccinated during pregnancy with REPEVAX or ADACEL in 3 retrospective studies. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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). Separate limbs must be used for the site of injection. Parenteral products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. • REPEVAX should not be administered to persons who experienced an encephalopathy of unknown origin within 7 days of previous immunization with a pertussis-containing vaccine. To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults. 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. REPEVAX, suspension injectable en seringue préremplie. In both age groups, injection site pain was the most common adverse reaction. REPEVAX can be used in the management of tetanus prone injuries with or without concomitant administration of Tetanus Immunoglobulin according to official recommendations. To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo. Repevax fait partie de la famille des vaccins. Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company ). Healthcare professionals are asked to report any suspected adverse reactions via the Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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. REPEVAX; VAXELIS; Légende Médicament ayant des présentations disponibles sans ordonnance. What REPEVAX is and what it is used for 2. They all resolved without sequelae. Plusieurs chaînes de pharmacies, notamment au Caire, sont ouvertes 24h/24. 2Age at which subjects received a dose of ADACEL, 3Percentage of subjects with antibodies ≥ 4 EU/mL for PT, FHA and PRN, and ≥ 17 EU/mL for FIM for the 3 year follow-up; ≥ 4 EU/mL for PT, FIM and PRN, and ≥ 3 EU/mL for FHA for the 5-year and 10-year follow-up. The use of REPEVAX in children aged 3 to 5 years is based upon studies in which REPEVAX was given as the fourth dose (first booster) of diphtheria, tetanus, pertussis and poliomyelitis vaccines. REPEVAX should not be used for primary immunization. The immune responses of adults, adolescents and children 3 to 6 years of age one-month after vaccination with REPEVAX are shown in the table below. In the case of immunosuppressive therapy please refer to Section 4.4. 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. REPEVAX may be administered to pregnant women during the second or third trimester to provide passive protection of infants against pertussis (see sections 4.1, 4.4, 4.6 and 5.1). The safety and immunogenicity of REPEVAX in adults and adolescents was shown to be comparable to that observed with a single booster dose of Td adsorbed or Td Polio adsorbed vaccines containing a similar amount of tetanus and diphtheria toxoids and inactivated poliovirus types 1, 2 and 3. • As with other vaccines, administration of REPEVAX should be postponed in persons suffering from an acute severe febrile illness. • The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. 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 … Based on findings from multiple studies of REPEVAX and ADACEL administered to pregnant women primarily during the 2nd or 3rd trimester of gestation: • Pertussis antibody responses in pregnant women are generally similar to those in non-pregnant women. Une pétition a été lancé sur Internet par un professeur. These children received REPEVAX at 5 to 6 years of age. Therefore, the frequency category “Not known” is assigned to these adverse events. Ce virus n'existe que chez l'être humain. A single injection of one (0.5 mL) dose is recommended in all indicated age groups. avec aiguille attachée – boîte de 1, 10 ou 20. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce soit, sans … 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. 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 … In these situations and following official recommendations the administration of REPEVAX by deep subcutaneous injection may be considered, although there is a risk of increased local reactions. The benefits versus the risks of administering REPEVAX during pregnancy should be evaluated. Dites-le au vaccinateur (s'il est infirmier, en principe il faut une ordonnance). The presence of a minor infection (e.g., mild upper respiratory infection) is not a contraindication. There was a trend for higher rates of local and systemic reactions in adolescents than in adults. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. 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. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. By continuing to browse the site you are agreeing to our policy on the use of cookies. 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. To bookmark a medicine you must sign up and log in. REPEVAX appears as a uniform, cloudy, white suspension. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309. Transient severe swelling of the injected upper arm was reported in <1% of children aged 5 to 6 years. 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). As with other inactivated vaccines, it is not expected that vaccination with REPEVAX during any trimester would harm the fetus. Nos vaccins - Repevax. The risk appears to be dependent on the number of prior doses of d/DTaP vaccine, with a greater risk following the 4th and 5th doses. - 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. Le vaccin ne guérit pas les porteurs chroniques, mais il est efficace de 90 à 95 % pour prévenir l'apparition de cet état. Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. The clinical relevance of this observation is unknown. If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including REPEVAX should be based on careful consideration of the potential benefits and possible risks. 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. 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. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Possible side effects 5. In both studies the rates of most systemic adverse events within 7 to 10 days following vaccination were less than 10%. Pharmacotherapeutic Group: Vaccine against diphtheria, tetanus, pertussis and poliomyelitis. When suggestions are available use up and down arrows to review and ENTER to select. Discard the vaccine if it has been frozen. In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or tetanus, one dose of REPEVAX® can be administered as part of a vaccination series to protect against pertussis and poliomyelitis and in most cases also against tetanus and diphtheria. As with any vaccine, a protective immune response may not be elicited in all vaccines (see section 5.1). Toutes les présentations peuvent ne pas être commercialisées. * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia. In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products. Table 4: Serological immune status (seroprotection/seroresponse rates and GMC/GMT) before vaccination and after each dose of a 3 dose-vaccination schedule including REPEVAX® (Dose 1) followed by 2 doses of REVAXIS® 1 and 6 months later (Dose 2 and 3) in subjects vaccinated according to protocol (FAS), GMC: Geometric mean of antibody concentrations; GMT: Geometric mean of antibody titres; CI: Confidence Interval; SN: seroneutralisation; ELISA: Enzyme Linked Immunoassay; dil: dilution. REPEVAX may be administered concomitantly with a dose of hepatitis B vaccine. Only fever (≥37.5°C) and fatigue were reported in more than 10 % of subjects 3 to 6 years of age. C'est uniquement un vaccin de rappel. Continue, 2. Premier site institutionnel sur la vaccination en direction du grand public, vaccination-info-service apporte des informations factuelles, pratiques et scientifiquement validées, pour répondre aux questions du public sur la vaccination. For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees. Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). Suspension for injection in pre-filled syringe. The highest frequency from either study is presented. Comme le repevax contient des germes inactifs, il peut être injecté, simultanément avec une dose de vaccin contre : La grippe, à condition que le médicament contient des germes inactifs. 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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including REPEVAX. Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo. Légiférer sans passer par le Parlement. Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated). L’ordonnance, prévue à l’article 38 de la Constitution, peut être assimilée à un contournement de cette règle. [ Time Frame: 7 days ], injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events [ Time Frame: 14 days ]. The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. Ce vaccin n'est pas indiqué en primo-vaccination, ni pour les enfants de moins de 3 ans. Non-clinical data revealed no special hazard for humans based on conventional studies of repeated doses toxicity. How to store REPEVAX 6. REPEVAX should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see section 4.4). 1Eligible subjects for whom immunogenicity data was available for at least one antigen at the specified time-point. 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. How and when REPEVAX is given 4. To view the changes to a medicine you must sign up and log in. The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity. The immunogenicity of ADACEL following repeat vaccination 10 years after a previous dose of ADACEL or REPEVAX, has been evaluated. 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. Precautions to be taken before handling or administering the medicinal product. Adverse reactions are ranked under headings of frequency using the following convention: cannot be estimated from the available data. Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. Immunogenicity following repeat vaccination. Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling). Based on the serology follow-up and repeat vaccination data, REPEVAX can be used instead of a dT vaccine or dT-IPV vaccine to boost immunity to pertussis in addition diphtheria, tetanus and polio. 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. In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or … The number and schedule of doses should be determined according to local recommendations. Talk with your doctor and family members or friends about deciding to join a study. • 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). Adverse events in children were collected from clinical trials conducted in 3 to 5 years of age and 5 to 6 years of age. Ces informations sont destinées aux professionnels de santé et aux patients. 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). Nom du produit : REPEVAX Forme pharmaceutique : Suspension injectable en seringue préremplie. 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. (A pertussis booster response was defined as a post-vaccination antibody concentration ≥ 4 times the LLOQ if the pre-vaccination level was < LLOQ; ≥ 4 times the pre-vaccination level if that was ≥ LLOQ but < 4 times LLOQ; or ≥ 2 times the pre-vaccination level if that was ≥ 4 times the LLOQ). In the event of either being observed, discard the medicinal product. REPEVAX may be administered concurrently with a dose of recombinant Human Papillomavirus vaccine with no significant interference with antibody response to any of the components of either vaccine. 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. Il est présent dans les selles des personnes contaminées. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). Source : Base de données du Ministère des Affaires Sociales et de la Santé, medicaments.gouv.fr Recevez chaque jour des conseils d'experts pour prendre soin de vous. REPEVAX may be administered concomitantly with a dose of inactivated influenza vaccine, based on the results of a clinical trial conducted in persons 60 years of age and older. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. Do not administer by intravascular or intradermal injection. ** EU = ELISA units: Antibody levels of >5 EU/mL were postulated as possible surrogate markers for protection against pertussis by Storsaeter J. et al, Vaccine 1998;16:1907-16. 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. The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. 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. 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. • 82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Please remove one or more studies before adding more. What you need to know before REPEVAX is given to you or your child 3. Choosing to participate in a study is an important personal decision. Ce document intitulé « REPEVAX - Indications, posologie et effets secondaires » issu de Journal des Femmes (sante-medecine.journaldesfemmes.fr) est soumis au droit d'auteur. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. REPEVAX should be used in accordance with official recommendations. Regarding the interval between a booster dose of REPEVAX and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). Pour accéder à l'ensemble des informations concernant Repevax, cliquez sur l'une de ses formes présentées dans … Limited clinical data have shown there is interference with the immune response to other antigens (i.e. Entre la moitié et les trois quarts des adultes âgés de 18 à 65 ans dans le monde ont présenté ce symptôme au cours de l'année écoulée. As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine. 0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobromobutyl or bromobutyl or chlorobutyl elastomer), without attached needle, with a tip-cap (chlorobromobutyl elastomer or synthetic isoprene-bromobutyl elastomer ) and 1 or 2 separate needles - pack size of 1 or 10.

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