, Sc, Classe pharmacothérapeutique : Pneumococcus, antigènes polysaccharidiques purifiés. /Length 3541 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. Adjuvants are added to some vaccines to: help to boost our immune response; make the vaccine more effective and long-lasting; reduce the amount of antigen needed in a vaccine Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. 90 0 obj /ca 1 Non-clinical data revealed no special hazard for humans based on conventional studies of repeated doses toxicity. • The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. endobj /Root 80 0 R Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu. 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. << 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. En pharmacie de ville : Prix hors honoraire de dispensation : 21,15 €, Les indications ouvrant droit au remboursement par l'Assurance Maladie sont disponibles en cliquant ici, Amélioration du service médical rendu (ASMR), Autres informations (cliquer pour afficher). >> active substance(s): diphtheria toxoid adsorbed purified / pertactin adsorbed purified / pertussis adsorbed purified filamentous haemagglutinin / pertussis fimbrial agglutinogens 2 and 3 adsorded purified / pertussis toxoid purified adsorbed / poliomyelitis inactivated virus type pdf options: view fullscreen download pdf Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. /Subtype /TrueType 79 0 obj 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. /DisplayDocTitle true Do not administer by intravascular or intradermal injection. /BaseFont /TimesNewRomanPS-BoldMT No studies on the effects on the ability to drive or use machines have been performed. What REPEVAX is and what it is used for 2. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited. Cet avis est consultable à partir du lien "Avis du jj/mm/aaaa" ou encore sur demande auprès de la HAS (plus d'informations dans l'aide). Continue typing to refine. A single injection of one dose (0.5 mL) of REPEVAX should be administered intramuscularly. << elast. (intervalle de dix ans à partir de 65 ans, compte tenu de l’immunosénescence), en utilisant un vaccin combiné tétanique, poliomyélitique et diphtérique à dose réduite d’anatoxine (dTP). What you need to know before REPEVAX is given to you or your child 3. Confinement : quels sont ses effets sur l’évolution de l’épidémie ? 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. 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. Conditions de prescription et de délivrance : 5 0 obj • As with other vaccines, administration of REPEVAX should be postponed in persons suffering from an acute severe febrile illness. The highest frequency from either study is presented. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine. >> 0 0 250 333 250 278 500 500 500 500 Repevax peut en outre être administré simultanément avec d'autres vaccins : contre la grippe chez les personnes de plus de 60 ans, contre l'hépatite B et le papillomavirus. /Name /F2 /Flags 32 À 25 ans, le rappel concerne également la coqueluche. They all resolved without sequelae. Diphtheria, Tetanus, Pertussis (Acellular, Component) And Poliomyelitis (Inactivated) Vaccine (Adsorbed) is reported as an ingredient of Repevax in the following countries: Important Notice: The Drugs.com international database is in BETA release. était de 91,7 %. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. /Parent 42 0 R These children received REPEVAX at 5 to 6 years of age. For the full list of excipients, see section 6.1. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Distanciation physique : comment la respecter et est-elle efficace contre le Covid-19 ? >> Start typing to retrieve search suggestions. %���� « 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. /Lang (en-US) 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. To email a medicine you must sign up and log in. Zona : Pour les personnes entre 65 et 74 ans. << Squalene oil is the adjuvant added to the trivalent flu vaccine for adults aged 65 and over. 333 500 500 278 278 500 278 778 500 500 /StemV 42 Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling). >> Do not freeze. 333 500 556 278 333 556 278 833 556 500 26482.01.11 %%EOF /Type /Catalog Consult with your healthcare professional before taking any medication. 89 0 obj /E 6929 ��G�J�|�h�����-(ۍ���/. /Version /1.7 556 0 444 389 333 556 500 722 0 500] The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. /StemV 40 0 0 0 0 0 500 556 444 556 444 /Type /Font >> Table 2: Immune responses 4 weeks after vaccinationAntigen, † Primed with DTaP at 3 and 5 months with a booster at 12 months of age, ‡ Primed with DTwP at 2, 3 and 4 months of age. It is recommended to postpone the vaccination until the end of such disease or treatment if practical. 0 444] REPEVAX should not be used for primary immunization. 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). /F2 85 0 R When suggestions are available use up and down arrows to review and ENTER to select. The stoppers, plunger stoppers and caps for all presentations of REPEVAX are latex-free. /Name /F3 Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including REPEVAX. /Type /FontDescriptor 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. /BM /Normal Pour les adultes, un rappel dTP est nécessaire tous les 20 ans : à 25 ans, 45 ans, 65 ans, puis tous les 10 ans à partir de 65 ans. 500 500 333 389 278 500 500 722 500 500 Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. For instructions on handling of the medicinal product before administration, see section 6.6. 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. /FontBBox [-665 -210 2000 728] 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). %PDF-1.4 Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Les libellés affichés ci-dessous ne sont que des résumés ou extraits issus des avis rendus par la Commission de la Transparence. >> >> >> (See Table 1). >> It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Select one or more newsletters to continue. Keep the container in the outer carton in order to protect from light. /O 82 Possible side effects 5. Ce vaccin peut également être utilisé chez des patients présentant une blessure à risque tétanigène. 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. /Info 41 0 R /Type /FontDescriptor Auparavant recommandé tous les 10 ans, le rappel de vaccination dTP chez les adultes se fait depuis 4 ans à âge fixe. 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. /MediaBox [0 0 612 792] 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. 83 0 obj 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.