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. À 25 ans, le rappel concerne également la coqueluche. They all resolved without sequelae. • 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). Vous ou votre enfant pourrez toujours contracter des maladies similaires si elles sont causées par d'autres bactéries ou virus. A single injection of one dose (0.5 mL) of REPEVAX should be administered intramuscularly. 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. /CA 1 /LastChar 233 444 0 0 0 0 0 0 0 0 0 endobj 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. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu. Code Identifiant de Spécialité (CIS) : 60614280, Service médical rendu (SMR) : - 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. << /Name /F3 /F3 87 0 R The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. 0 0 0 0 0 444 500 444 500 444 However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. • and ≥98.8% were seroprotected against polio (types 1, 2 and 3) at a threshold ≥1:8 dilution. /Tabs /S /ItalicAngle 0 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. 0 0 0 0 0 0 0 0 0 0 << The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. 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. >> 778 389 0 0 667 944 0 778 611 0 Pour plus d'information sur les pictogrammes, consultez l'aide. 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. >> 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). La revaccination faite à un intervalle de moins de trois ans n'est pas recommandée en raison du risque accru d'effets indésirables. /Leading 33 Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with REPEVAX during pregnancy. >> 333 500 556 278 333 556 278 833 556 500 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. 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. 87 0 obj 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. Ce vaccin peut également être utilisé chez des patients présentant une blessure à risque tétanigène. 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. /Type /Group As with other inactivated vaccines, it is not expected that vaccination with REPEVAX during any trimester would harm the fetus.