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. Les interactions du repevax avec d’autres médicaments ou vaccins. Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). Il est présent dans les selles des personnes contaminées. In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or … It allows continued monitoring of the benefit/risk balance of the medicinal product. The number and schedule of doses should be determined according to local recommendations. The clinical relevance of this observation is unknown. As with any vaccine, a protective immune response may not be elicited in all vaccines (see section 5.1). Nevertheless, as REPEVAX contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. Evaluation of pharmacokinetic properties is not required for vaccines. Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. Ces informations sont destinées aux professionnels de santé et aux patients. Nom du produit : REPEVAX Forme pharmaceutique : Suspension injectable en seringue préremplie. Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling). 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 … The immunogenicity of ADACEL following repeat vaccination 10 years after a previous dose of ADACEL or REPEVAX, has been evaluated. 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. • 98.5% and 99.7% were seroprotected against tetanus at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Pour accéder à l'ensemble des informations concernant Repevax, cliquez sur l'une de ses formes présentées dans … Immunogenicity following repeat vaccination. 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). 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. Adverse events in children were collected from clinical trials conducted in 3 to 5 years of age and 5 to 6 years of age. 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). 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. Sans objet. 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. 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). However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. This site uses cookies. 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. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine. Une pétition a été lancé sur Internet par un professeur. 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. Passive protection of neonates and infants against pertussis. 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. 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). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo. 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. Possible side effects 5. The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 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. 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. Choosing to participate in a study is an important personal decision. What REPEVAX is and what it is used for 2. 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). 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. To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo. For the full list of excipients, see section 6.1. COVID-19 is an emerging, rapidly evolving situation. In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce soit, sans … Read our, ClinicalTrials.gov Identifier: NCT00400309, Interventional C'est uniquement un vaccin de rappel. 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 both studies the rates of most systemic adverse events within 7 to 10 days following vaccination were less than 10%. Les antibiotiques sont donnés sans ordonnance. Ce vaccin n'est pas indiqué en primo-vaccination, ni pour les enfants de moins de 3 ans. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited. Plus ou moins intenses, de durée variable, ces douleurs peuvent être très handicapantes au … • and ≥98.8% were seroprotected against polio (types 1, 2 and 3) at a threshold ≥1:8 dilution. How and when REPEVAX is given 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. * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia. 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. • The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. La poliomyélite est une infection due à un virus qui provoque des paralysies en attaquant le système nerveux. 1Eligible subjects for whom immunogenicity data was available for at least one antigen at the specified time-point. Precautions to be taken before handling or administering the medicinal product. To view the changes to a medicine you must sign up and log in. Prevenar ® est un vaccin administré aux adultes, aux adolescents et aux nourrissons en vue d'immuniser contre certaines infections, otites et pneumonies dues à la bactérie Streptococcus pneumoniae. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with REPEVAX during pregnancy. In both age groups, injection site pain was the most common adverse reaction. Transient severe swelling of the injected upper arm was reported in <1% of children aged 5 to 6 years. pour demander que le vaccin DT Polio simple et sans aluminium soit de nouveau disponible en France. 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. For general information, Learn About Clinical Studies. A single injection of one dose (0.5 mL) of REPEVAX should be administered intramuscularly. To email a medicine you must sign up and log in. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). 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. When suggestions are available use up and down arrows to review and ENTER to select. 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. The clinical relevance of this observation is unknown. They all resolved without sequelae. The rates and severity of adverse events in recipients of tetanus toxoid antigen are influenced by the number of prior doses and level of pre-existing antitoxins. The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity. - 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309. Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including REPEVAX. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. ** 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. Contents of the pack and other information 1. • 82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. • 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). These children received REPEVAX at 5 to 6 years of age. REPEVAX appears as a uniform, cloudy, white suspension. La desvenlafaxine (ou O-desméthylvenlafaxine) est un antidépresseur inhibiteur de la recapture de la sérotonine-noradrénaline (IRSNa). The stoppers, plunger stoppers and caps for all presentations of REPEVAX are latex-free. 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. REPEVAX has not been evaluated in fertility studies. The benefits versus the risks of administering REPEVAX during pregnancy should be evaluated. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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. Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. 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. One additional dose of a diphtheria- and tetanus- (dT) containing vaccine can be administered one month later followed by a 3rd dose of a diphtheria or dT containing vaccine 6 months after the first dose to optimize protection against disease (see section 5.1). 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. Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). Le vaccin ne guérit pas les porteurs chroniques, mais il est efficace de 90 à 95 % pour prévenir l'apparition de cet état. Do not administer by intravascular or intradermal injection. The lower response to diphtheria toxoid in adults probably reflected the inclusion of some participants with an uncertain or incomplete immunization history. Des milliers de personnes souffrent régulièrement de maux de tête ou céphalées. 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. 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. Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company ). Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1).

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