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/ItalicAngle 0 0 0 0 0 0 0 0 0 0 0 /BM /Normal Les vaccins sont utilisés pour protéger contre les maladies infectieuses. Code Identifiant de Spécialité (CIS) : 60614280, Service médical rendu (SMR) : /StemV 44 What REPEVAX is and what it is used for 2. /F3 87 0 R Date of first authorisation/renewal of the authorisation. Grippe saisonnière : Vaccination chaque année pour toutes les personnes âgées de 65 ans et plus. Discard the vaccine if it has been frozen. 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). 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. 0 0 0 0 400 0 0 0 0 0 26482.02.01 REPEVAX BT x 1 VIAL x 0,5ml 12,19 € 14,01 € 19,75 € Vianex A.E. La pertinence clinique de la plus faible réponse en anticorps observée après revaccination par rapport à une primovaccination est inconnue. 91 0 obj /E 6929 The clinical relevance of this observation is unknown. /Encoding /WinAnsiEncoding 26482.01.11 Procedures should be in place to prevent falling injury and manage syncopal reactions. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. /Lang (en-US) * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia. /Font << The benefits versus the risks of administering REPEVAX during pregnancy should be evaluated. 5 0 obj In both age groups, injection site pain was the most common adverse reaction. /AvgWidth 441 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. >> Quatre semaines après la vaccination, la réponse immunitaire VZV spécifique observée suite à  une administration concomitante n'était pas similaire à la réponse immunitaire VZV spécifique observée suite à une administration non concomitante. L'utilisation de REPEVAX pendant la grossesse permet de transférer à votre enfant une protection contre la coqueluche pendant les premiers mois de sa vie. 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. /CapHeight 728 The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. To email a medicine you must sign up and log in. 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. /Pages 42 0 R Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. • 82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Select one or more newsletters to continue. 0 0 0 0 0 0 0 0 0 0 /XHeight 250 elast. Adverse events in children were collected from clinical trials conducted in 3 to 5 years of age and 5 to 6 years of age. /XHeight 250 Any unused medicinal product or waste material should be disposed of in accordance with local requirements. /LastChar 32 These children received REPEVAX at 5 to 6 years of age. Pour les autres sérotypes, le nombre de cas détectés dans cette étude était trop faible pour conclure sur une protection spécifique par sérotype. %�쏢 90 0 obj Conditions de prescription et de délivrance : /F1 83 0 R The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 85 0 obj /Type /Group Continue typing to refine. 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 Le service médical rendu par REPEVAX reste important dans les indications de l’AMM et les populations recommandées. 0 0 0 0 0 0 0 0 0 0 /Descent -210 << << /Leading 42 REPEVAX appears as a uniform, cloudy, white suspension. Ce médicament n'appartient à aucun groupe générique, Ce médicament peut être pris en charge ou remboursé par l'Assurance Maladie dans les cas suivants :Rappel de vaccination contre la diphtérie, le tétanos, la coqueluche et la poliomyélite chez les adolescents de 16-18 ans et les adultes non à jour de leur vaccination, adultes susceptibles de devenir parents dans les mois ou années à venir, et membres de l'entourage familial de l'enfant à naître à l'occasion d'une grossesse, dans le cadre de la mise à jour des vaccinations, selon certaines modalités ; JOURNAL OFFICIEL ; 26/06/12. 86 0 obj 1Eligible subjects for whom immunogenicity data was available for at least one antigen at the specified time-point. 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). Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. 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. /FirstChar 32 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. 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. The immunogenicity of ADACEL following repeat vaccination 10 years after a previous dose of ADACEL or REPEVAX, has been evaluated. /Length 63 Immunogenicity following repeat vaccination. SYR(with chlorobr. 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. /FontWeight 700 /FontWeight 400 /MaxWidth 2665 Possible side effects 5. /AvgWidth 401 /CS /DeviceRGB /Filter /FlateDecode >> 0 0 0 0 0 500 556 444 556 444 /Ascent 905 *M�� endobj 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. plunger-stopper) x 0,5ml με προσαρμοσμένη βελόνα (1 δόση) 12,19 € 14,01 € 19,75 € Vianex A.E. The lower response to diphtheria toxoid in adults probably reflected the inclusion of some participants with an uncertain or incomplete immunization history. /FontDescriptor 84 0 R 0 0 0 0 0 0 0 0 0 0 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). Vaccin diphtérique, tétanique, coquelucheux (acellulaire, multicomposé) et poliomyélitique (inactivé), (adsorbé, à teneur réduite en antigène (s)) Date de l'autorisation : 04/10/2002 . Il a été rapporté que plus la vaccination est ancienne, plus l'efficacité diminue, en particulier chez les sujets très âgés (85 ans et plus). It comes from fish oil and is highly purified before being used in the flu vaccine. /Type /Font >> The presence of a minor infection (e.g., mild upper respiratory infection) is not a contraindication. /Info 41 0 R Seul l'avis complet de la Commission de la Transparence fait référence. 0 0 0 722 0 722 722 667 0 0 /Root 80 0 R >> /BaseFont /TimesNewRomanPSMT 78 0 obj The clinical significance of this observation is not known. • 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). << It is recommended to postpone the vaccination until the end of such disease or treatment if practical. %PDF-1.7 /Type /FontDescriptor /ExtGState << << startxref REPEVAX préviendra uniquement ces maladies si elles sont causées par les bactéries ou virus ciblés par le vaccin. /XHeight 250 stream >  antigène pertussique : anatoxine pertussique, >  antigène pertussique : hémagglutinine filamenteuse, >  antigènes pertussiques : fimbriae type 2 et 3, >  virus poliomyelitique souche Mahoney de type 1 inactivé, >  virus poliomyélitique souche MEF-1 de type 2 inactivé, >  virus poliomyélitique souche Saukett de type 3 inactivé, Titulaire de l'autorisation : SANOFI PASTEUR EUROPE, Conditions de prescription et de délivrance : Aucune, Type de procédure :   When suggestions are available use up and down arrows to review and ENTER to select. Médicament non soumis à prescription médicale. Contre-indications >> 88 0 obj /MaxWidth 2558 /Encoding /WinAnsiEncoding The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. /FontName /ArialMT /Names 65 0 R However, a trend of lower anti-HPV GMTs was observed in the concomitant group. /Ascent 891 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). 0 0 0 0 0 444 500 444 500 444 /ItalicAngle 0 /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. La protection d'un vaccin 6-valent vis-à-vis des pneumonies à pneumocoques, critère principal dans ces études, était de 76,1 %, celle d'une préparation 12-valent. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Les rappels de l'adulte sont recommandés à âges fixes (25, 45, 65 ans puis tous les 10 ans). Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. << REPEVAX may be administered concomitantly with a dose of hepatitis B vaccine. (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). 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. 87 0 obj 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. Classe pharmacothérapeutique : Vaccin contre la diphtérie, le tétanos, la coqueluche et la poliomyélite - code ATC : J07CA02. endobj Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu. Pour plus d'information sur les pictogrammes, consultez l'aide. 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. << /L 109731 /Filter /FlateDecode /Prev 109242 /H [6929 189] 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.

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