The effect of administration of REPEVAX during lactation has not been assessed. 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. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited. 1Eligible subjects for whom immunogenicity data was available for at least one antigen at the specified time-point. 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). • 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). 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. 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. FAS: Full Analysis Set – includes all subjects who received the study vaccine dose and for whom the post-vaccination immunogenicity evaluation was available. 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. Confinement : les annulations chez les médecins en hausse de 30%. 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. Suspension for injection in pre-filled syringe. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Indications Repevax est un vaccin utilisé en rappel de protection contre la diphtérie, le tétanos, la coqueluche et la poliomyélite. The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. Aluminium phosphate 1,5 mg (0,33 mg aluminium), ≥ 95,8 % des adultes étaient séropositifs (≥ 5 UI/ml) pour les anticorps dirigés contre tous les antigènes pertussiques contenus dans le vaccin. The clinical significance of this observation is not known. 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). The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. Precautions to be taken before handling or administering the medicinal product. A persistent nodule at the site of injection may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue. For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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. Non-clinical data revealed no special hazard for humans based on conventional studies of repeated doses toxicity. 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Ce médicament n'appartient à aucun groupe générique. Serological correlates for protection against pertussis have not been established. These children received REPEVAX at 5 to 6 years of age. Renutryl - Indications, posologie et effets secondaires, Revaxis - Indications, posologie et effets secondaires. REPEVAX should not be used for primary immunization. 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. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with REPEVAX during pregnancy. In the event of either being observed, discard the medicinal product. The clinical relevance of this observation is unknown. Les informations recueillies sont destinées à CCM BENCHMARK GROUP pour vous assurer l'envoi de votre newsletter. Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling). 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). 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. Évaluation des effets secondaires des vaccins. 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). 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). 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. Comme tous les médicaments, REPEVAX peut provoquer des effets indésirables, mais ils ne surviennent pas systématiquement chez tout le monde. 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. Elles seront également utilisées sous réserve des options souscrites, à des fins de ciblage publicitaire. Conditions de prescription et de délivrance : The presence of a minor infection (e.g., mild upper respiratory infection) is not a contraindication. In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products. 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. The number and schedule of doses should be determined according to local recommendations. As with other inactivated vaccines, it is not expected that vaccination with REPEVAX during any trimester would harm the fetus. There was a trend for higher rates of local and systemic reactions in adolescents than in adults. 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. • As with other vaccines, administration of REPEVAX should be postponed in persons suffering from an acute severe febrile illness. Immunogenicity following repeat vaccination. Pharmacotherapeutic Group: Vaccine against diphtheria, tetanus, pertussis and poliomyelitis. 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. The normal appearance of the vaccine is a uniform cloudy, white suspension which may sediment during storage. 98,5 % et 99,7 % étaient séroprotégés vis-à-vis du tétanos à des seuils de ≥ 0,1 et ≥ 0,01 UI/ml respectivement. 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). 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. 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. Limited clinical data have shown there is interference with the immune response to other antigens (i.e. Discard the vaccine if it has been frozen. REPEVAX may be administered concomitantly with a dose of hepatitis B vaccine. Important, Résumé des Caractéristiques Produits (RCP) des autorisations de mise sur le marché (AMM) françaises et européennes, Livret des interactions médicamenteuses de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM), Documents de référence de la Haute Autorité de Santé (HAS) : fiches de transparence, fiches de bon usage, documents SAM (Système d’Aide à la décision par Médicament), Prix et remboursements du Comité économique des produits de santé (CEPS), Informations des laboratoires titulaires de l’AMM (CF supra dans l’onglet « Autres informations » de cette page), Assurance maladie (CNAMTS) : guide des affectations de longues durées (ALD), Agence technique de l'information sur l'hospitalisation (ATIH) : classification CIM10, Organisation mondiale de la santé (OMS) : classification ATC, Pharmacopée européenne : Standard Terms et classification EPhMRA, Ministère de la santé : substances dopantes. The lower response to diphtheria toxoid in adults probably reflected the inclusion of some participants with an uncertain or incomplete immunization history. To bookmark a medicine you must sign up and log in. In both age groups, injection site pain was the most common adverse reaction. 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. - 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. 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. 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. 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. 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. 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) - pack size of 1, 10 or 20. Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 2 prospective observational studies (2670 pregnancy outcomes), 4 retrospective observational studies (81,701 pregnancy outcomes), and from passive surveillance of women who received REPEVAX or ADACEL (Tdap component of REPEVAX; containing the same amounts of diphtheria, tetanus and pertussis antigens) during the 2nd or 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. However, a trend of lower anti-HPV GMTs was observed in the concomitant group. Vous bénéficiez d’un droit d’accès et de rectification de vos données personnelles, ainsi que celui d’en demander l’effacement dans les limites prévues par la loi. Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. 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. Continue, 2. , Sc, Classe pharmacothérapeutique : Diphtérie - coqueluche - poliomyélite - tétanos. Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène (s)), boîte de 1 seringue préremplie avec aiguille de ½ mL, Rhume : trop de prescriptions médicamenteuses inutiles voire dangereuses, Dépakine : elle multiplie par 5 le risque de troubles du développement, selon une étude, Médicaments sans ordonnance : les dangers de l’automédication pointés du doigt par 60 millions de consommateurs, Maladie de Parkinson : une association alerte sur la pénurie de médicaments, Charte de données personnelles et cookies, Encéphalopathie d'étiologie inconnue survenue 7 jours après vaccination coquelucheuse, Réaction anaphylactique après injection du vaccin, Antécédent de syndrome de Guillain Barré ou de neuropathie du plexus brachial après vaccin tétanique, Déficit immunitaire excepté l'infection à VIH, Forme pharmaceutique : Suspension injectable, Voie d'administration : Médicament non soumis à prescription médicale. It allows continued monitoring of the benefit/risk balance of the medicinal product. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine. Nevertheless, as REPEVAX contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. REPEVAX has no or negligible influence on the ability to drive and use machines. 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. For the full list of excipients, see section 6.1. • 98.5% and 99.7% were seroprotected against tetanus at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. A single injection of one (0.5 mL) dose is recommended in all indicated age groups. As with any vaccine, a protective immune response may not be elicited in all vaccines (see section 5.1). 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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