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[ { "id": "318__text", "type": "abstract", "text": [ "EMEA / H / C / 551 \n PRIALT \n Qu ’ est ce que Prialt ? \n Prialt est une solution pour perfusion contenant le principe actif ziconotide , à des concentrations de 100 ou 25 microgrammes par millilitre . \n Dans quel cas Prialt est-il utilisé ? \n Prialt est indiqué pour le traitement des douleurs intenses , chroniques ( de long terme ) chez les patients nécessitant une analgésie intrarachidienne ( injection dans l ’ espace qui entoure la moelle épinière et le cerveau ). \n Comme le nombre de patients souffrant de douleurs chroniques nécessitant une analgésie intrarachidienne ( analgésiques injectés directement dans la moelle ) est limité , la maladie est considérée comme « rare » et Prialt a reçu la désignation de « médicament orphelin » ( médicament utilisé pour les maladies rares ) le 9 juillet 2001 . \n Comment Prialt est-il utilisé ? \n Le traitement par Prialt ne doit être réalisé que par un médecin ayant l ’ expérience de l ’ administration de médicaments par voie intrarachidienne . \n Prialt doit être administré en perfusion continue très lente par l ’ intermédiaire d ’ un cathéter intrarachidien ( tube inséré dans le canal rachidien ) avec une pompe à perfusion pouvant délivrer un volume de perfusion précis . \n Lorsque les doses nécessaires de Prialt sont faibles , par exemple au début du traitement , il peut s \n La dose peut être augmentée par intervalles de 1 à 2 jours , voire plus , pour obtenir le meilleur équilibre entre le soulagement de la douleur et les effets indésirables éventuels . \n La plupart des patients nécessitent des doses inférieures à 9 , 6 microgrammes par jour . \n La dose quotidienne maximale est de 21 , 6 microgrammes par jour . \n Prialt ne doit pas être utilisé chez l ’ enfant . \n Comment Prialt fonctionne-t-il ? \n Le principe actif de Prialt , le ziconotide , est une copie d ’ une substance naturelle , un oméga-conopeptide , extraite du venin d ’ un type de limace de mer . \n Le ziconotide agit en se fixant à des canaux spéciaux ( les canaux calciques ) à la surface des cellules nerveuses qui transmettent les signaux de la douleur . \n En bloquant le flux de calcium dans les cellules nerveuses , le ziconotide interfère avec la transmission des signaux de douleur dans la moelle et permet de soulager la douleur . \n La troisième étude portait sur l ’ utilisation du médicament pendant 3 semaines chez des patients adultes atteints de douleurs intenses , chroniques . \n Dans les trois études , la principale mesure d ’ efficacité était le changement du score d ’ intensité de la douleur sur l ’ échelle visuelle analogique ( EVA ). \n Quels ont été les bénéfices démontrés par Prialt au cours des études ? \n Prialt a été plus efficace que le placebo dans les deux premières études . \n Avant le traitement , les patients avaient des scores d ’ intensité de la douleur sur l \n Les effets indésirables les plus courants ( observés chez plus d ’ un patient sur 10 ) sont un état confusionnel , des sensations vertigineuses , un nystagmus ( mouvement oculaire incontrôlé ), des troubles mnésiques ( perte de mémoire ), des céphalées , une somnolence ( endormissement ), un flou visuel , des nausées ( mal au cœur ), des vomissements , des troubles de la démarche ( difficulté pour marcher ) et une asthénie ( faiblesse ). \n Pour une description complète des effets indésirables observés sous Prialt , veuillez vous reporter à la notice . \n Prialt ne doit pas être utilisé chez les patients pouvant présenter une hypersensibilité ( allergie ) au ziconotide ou à l ’ un des autres ingrédients . \n Prialt ne doit pas être utilisé chez des patients sous chimiothérapie intrarachidienne ( anti-cancéreux injectés dans le canal rachidien ). \n Pourquoi Prialt a-t-il été approuvé ? \n Le comité des médicaments à usage humain ( CHMP ) a estimé que Prialt était une alternative aux autres analgésiques intrarachidiens , comme les opioïdes . \n Quelles sont les informations que l ’ on attend encore au sujet de Prialt ? \n La société qui fabrique Prialt réalise actuellement une étude sur l ’ utilisation à long terme du médicament , portant en particulier sur la possibilité d ’ un développement de la tolérance au traitement ( lorsque des doses d ’ un médicament qui étaient efficaces deviennent au fur et à mesure moins efficaces ). \n Autres informations relatives à Prialt : \n Le dossier de désignation de Prialt comme médicament orphelin est disponible à l ’ adresse suivante : ici . \n L ’ EPAR complet est disponible à l ’ adresse suivante : ici . \n Prialt \n 1 ml ( 100 μ g / ml ) \n 2 ml ( 100 μ g / ml ) \n 5 ml ( 100 μ g / ml ) \n 25 μ g / ml \n 20 ml ( 25 μ g / ml ) \n Prialt 100 microgrammes / ml , solution pour perfusion . \n Un ml de solution contient 100 μ g de ziconotide ( sous forme d \n Solution transparente et incolore , exempte de particules visibles . \n Le ziconotide est indiqué pour le traitement des douleurs intenses , chroniques chez les patients nécessitant une analgésie intrarachidienne . \n Le traitement par ziconotide ne doit être réalisé que par des médecins ayant l ’ expérience de l ’ administration de médicaments par voie intrarachidienne . \n Prialt est exclusivement destiné à l \n Adultes ( y compris sujets âgés ≥ 65 ans ) \n Le traitement par ziconotide doit être instauré à la dose de 2 , 4 µg / jour et peut ensuite être adapté en fonction de la réponse analgésique du patient et de la survenue d ’ événements indésirables . \n Environ 75 % des patients répondant de façon satisfaisante au traitement nécessitent une posologie ≤ 9 , 6 μ g / jour . \n Le risque de méningite secondaire étant plus élevé lors de l ’ utilisation prolongée d ’ un cathéter sous-arachnoïdien avec système de perfusion externe , les systèmes implantés sont préconisés pour l ’ administration de ziconotide pendant des périodes prolongées . \n Un système de cathéter externe ne sera utilisé que lorsqu ’ un système interne ne peut pas être implanté . \n Prialt ne doit pas être utilisé chez l ’ enfant en dessous de 18 ans suite à un manque de données concernant la sécurité et l ’ efficacité . \n Bien que l ’ efficacité et la sécurité d ’ emploi à long terme du ziconotide ait été étudié au cours d ’ essais cliniques en ouvert , aucun essai contrôlé d ’ une durée supérieure à trois semaines n ’ a été réalisé ( voir rubrique 5 . 1 ). \n La possibilité d ’ effets toxiques locaux à long terme au niveau de la moelle épinière n ’ est pas exclue et les données précliniques disponibles sont limitées ( voir rubrique 5 . 3 ). \n La prudence s ’ impose donc lors d ’ un traitement au long cours . \n Les patients et les médecins doivent être vigilants concernant l ’ apparition de symptômes et signes typiques de méningite . \n Le positionnement intrathécal optimal du cathéter n ’ a pas été établi . \n Le positionnement du cathéter à un niveau plus bas , ex . au niveau lombaire , pourrait peut-être diminuer les réactions neurologiques indésirables liées au ziconotide . \n Le positionnement du cathéter doit donc être évalué soigneusement pour permettre un accès adéquat aux segments nociceptifs rachidiens tout en diminuant les concentrations de médicament au niveau cérébral . \n Le nombre de patients ayant reçu une chimiothérapie systémique et le ziconotide par voie intrarachidienne étant faible , la prudence s \n Des élévations de la créatine phosphokinase ( CPK ), généralement asymptomatiques , sont fréquentes chez les patients traités par ziconotide par voie intrarachidienne . \n Une élévation progressive de la créatine phosphokinase est , en revanche , peu fréquente . \n Une surveillance des taux de créatine phosphokinase est toutefois recommandée . \n Des réactions indésirables cognitives et neuropsychiatriques , en particulier une confusion , ont été fréquemment décrites chez les patients sous ziconotide . \n Les troubles cognitifs apparaissent typiquement après plusieurs semaines de traitement . \n Des épisodes de troubles psychiatriques aigus , tels que hallucinations , réactions paranoïdes , hostilité , délire , psychose et réactions maniaques ont été rapportés chez des patients traités par le ziconotide . \n Des patients ont présenté des troubles de la conscience sous ziconotide . \n La réintroduction du ziconotide est déconseillée chez ces patients . \n Chez les patients présentant des douleurs chroniques intenses , la fréquence des suicides et des tentatives de suicide est plus élevée que dans la population générale . \n Le ziconotide peut provoquer ou aggraver une dépression , avec un risque de suicide chez certains patients . \n Aucune étude clinique spécifique sur les interactions médicamenteuses n \n Toutefois , en raison des faibles concentrations plasmatiques du ziconotide , de son métabolisme assuré par des peptidases ubiquitaires et de sa fixation relativement faible aux protéines plasmatiques ( voir rubrique 5 . 2 ), les interactions médicamenteuses liées au métabolisme ou au déplacement des sites de fixation protéique sont peu probables entre le ziconotide et d ’ autres médicaments . \n Le nombre de patients ayant reçu une chimiothérapie systémique et le ziconotide par voie intrarachidienne étant faible , la prudence s \n Les médicaments interférant avec des peptidases / protéases spécifiques ne devraient pas agir sur les concentrations plasmatiques du ziconotide . \n Le ziconotide ne doit pas être utilisé pendant la grossesse sauf en cas de nécessité absolue . \n La sécurité d ’ emploi du ziconotide administré en perfusion intrarachidienne continue a été évaluée chez plus de 1400 patients participant à des études cliniques évaluant la douleur aiguë et chronique . \n La durée du traitement est allée d ’ une heure de perfusion en bolus à une utilisation continue de plus de 6 ans . \n Dans les études cliniques , 88 % des patients ont présenté des effets indésirables . \n Les effets indésirables les plus fréquemment rapportés dans les études cliniques à long terme ont été les suivants : sensations vertigineuses ( 42 %), nausées ( 30 %), nystagmus ( 23 %), état confusionnel ( 25 %), troubles de la démarche ( 16 %), troubles mnésiques ( 13 %), flou visuel ( 14 %), céphalées ( 12 %), asthénie ( 13 %), vomissements ( 11 %) et somnolence ( 10 %). \n La plupart de ces effets étaient d ’ intensité légère à modérée et ont disparu avec le temps . \n Tous les effets indésirables décrits dans les études cliniques au cours desquelles le ziconotide a été administré par voie intrarachidienne ( administration à court et long termes ) sont présentés ci-dessous par ordre de fréquence . \n Fréquents : anxiété , hallucinations auditives , insomnie , agitation , désorientation , hallucination , hallucinations visuelles , dépression , paranoïa , irritabilité , dépression aggravée , nervosité , labilité émotionnelle , modifications de l \n Peu fréquents : délire , troubles psychotiques , idées suicidaires , tentative de suicide , blocage de la pensée , rêves anormaux , \n Affections du système nerveux \n Très fréquents : sensations vertigineuses , nystagmus , troubles mnésiques , céphalées , somnolence \n Peu fréquents : incohérence , perte de conscience , coma , stupeur , convulsions , accident vasculaire cérébral , encéphalopathie \n Fréquents : diplopie , troubles de la vision , photophobie \n Fréquents : vertige , acouphènes \n Fréquents : hypotension orthostatique , hypotension \n Fréquents : diarrhée , sécheresse buccale , constipation , aggravation des nausées , douleurs abdominales hautes \n Fréquents : prurit , hypersudation \n Fréquents : douleurs dans les membres , myalgie , spasmes musculaires , crampes musculaires , faiblesse musculaire , arthralgie , œdèmes périphériques \n Peu fréquents : rhabdomyolyse , myosite , dorsalgies , clonies , cervicalgies \n Affections du rein et des voies urinaires \n Peu fréquents : insuffisance rénale aiguë \n Très fréquents : anomalies de la démarche , asthénie \n Fréquents : fatigue , pyrexie , léthargie , œdèmes périphériques , frissons , chutes , douleurs thoraciques , sensation de froid , sensation d \n Fréquents : augmentation des taux sanguins de créatine phosphokinase , diminution du poids \n Peu fréquents : électrocardiogramme anormal , aspartate aminotransférase , créatine phosphokinase MM , augmentation de la température corporelle \n Des commentaires spécifiques et des recommandations de prudence concernant la méningite , l ’ élévation des taux de créatine phosphokinase et les effets indésirables sur le SNC figurent à la rubrique 4 . 4 . \n Dans les études de perfusion intraveineuse , des volontaires sains de sexe masculin ont reçu le ziconotide à des doses atteignant 70 000 µg / jour ou 3 , 200 fois la dose journalière maximale recommandée par voie intrarachidienne . \n Une hypotension orthostatique a été observée chez presque tous les sujets ayant reçu de fortes doses intraveineuses de ziconotide . \n La posologie maximale recommandée par voie intrarachidienne est de 21 , 6 µg / jour . \n Dans les études cliniques , la dose maximale prévue de ziconotide administré par voie intrarachidienne était de 912 µg / jour après une augmentation posologique sur 7 jours . \n La plupart des patients sous observation ont récupéré dans les 24 heures suivant l \n L ’ Agence européenne du médicament ( EMEA ) réévaluera chaque année toute nouvelle information qui pourrait être fournie , et si nécessaire cet RCP sera mis à jour . \n De nombreux patients répondant au traitement obtiennent une analgésie quasi-maximale dans les heures suivant l \n Si nécessaire , la posologie peut être diminuée sans limitation de dose ( avec possibilité éventuelle d \n Les effets indésirables neurologiques , notamment les sensations vertigineuses , les nausées et les troubles de la démarche semblent corrélées avec les concentrations céphalo-rachidiennes mais aucune relation définitive n \n Pour limiter la survenue d ’ effets indésirables graves , il est recommandé de ne pas dépasser 21 , 6 µg / jour . \n Cependant , dans les études cliniques , on a observé que les patients qui tolèrent des doses de 21 , 6 µg / jour après une augmentation progressive des \n 8 doses pendant une période de 3 à 4 semaines , tolèrent généralement des doses plus élevées , pouvant atteindre 48 , 0 µg / jour . \n Toutefois , compte tenu des données limitées disponibles , l ’ apparition d ’ une accoutumance ne peut être exclue . \n La perméabilité du cathéter intrarachidien doit être examinée en cas de nécessité d ’ une augmentation continue des doses de ziconotide n \n Trois études cliniques du ziconotide intrarachidien contrôlées contre placebo ont été réalisées . \n Score EVA moyen à la fin du titrage de doses initial , en mm ( ET ) \n _ \n Répondeursa n (%) Dose en fin de titrage de doses ( μ g / h ) \n Placebo ( n = 86 ) \n L ’ étiologie de la douleur dans les études 95 - 001 ( douleur cancéreuse ) et 96 - 002 ( douleur non cancéreuse ) variait , incluant des douleurs osseuses ( n = 380 ), due principalement à des métastases osseuses ( n = 34 ), une myélopathie ( n = 38 ), dont la moitié présentait un traumatisme médullaire avec paralysie ( n = 19 ), neuropathie ( n = 79 ), radiculopathie ( n = 24 ), douleur médullaire ( n = 91 ) due principalement à l ’ échec d ’ une intervention chirurgicale au niveau dorsal ( n = 82 ) et autres étiologies ( n = 82 ). \n Certains patients présentaient plusieurs causes de douleur . \n Le critère de jugement principal était le pourcentage de changement sur l ’ EVA . \n L ’ efficacité de l ’ administration intrarachidienne de ziconotide dans l ’ étude 301 était plus faible que dans les deux études précédentes à court terme . \n La fréquence et la sévérité des effets indésirables étaient également plus faibles . \n Ziconotide ( n = 112 ) \n Placebo ( n = 108 ) \n Les paramètres pharmacocinétiques plasmatiques ont également été étudiés après administration intraveineuse ( 0 , 3 – 10 μ g / kg / 24 h ). \n Paramètres pharmacocinétiques du ziconotide dans le plasma et le LCR [ moyenne ± ET ( médiane )] \n Matrice \n Vd ( ml ) \n t½ ( h ) \n liquide \n Intraveineuse \n Plasma \n CL = clairance ; Vd = volume de distribution ; t½ = demi-vie \n Après administration intrarachidienne pendant une heure ( 1 – 10 µg ), les concentrations cumulées ( SSC ; extrêmes : \n 83 , 6 – 608 ng / h / ml ) et les concentrations maximales ( Cmax ; extrêmes : \n Aucune accumulation plasmatique du ziconotide après administration intrarachidienne à long terme ( jusqu \n Le ziconotide est un peptide constitué de 25 acides aminés naturels en configuration L et il ne semble pas être métabolisé de façon quantifiable dans le LCR . \n Les acides aminés libres générés sont probablement captés par des systèmes de transport cellulaires et soumis ultérieurement au métabolisme intermédiaire habituel ou utilisés comme substrats pour des processus de biosynthèse constitutive . \n La CL moyenne du ziconotide ( 0 , 38 ml / min ) est proche du débit de renouvellement du LCR chez l \n Populations particulières : \n Bien que les données disponibles soient en nombre limité , aucun effet en fonction de la race , l de la taille , du poids , du sexe ou de l \n Ces effets ont été définis par des actions pharmacologiques amplifiées du ziconotide et non par des lésions neurotoxiques ou une toxicité dirigée contre des organes cibles . \n Les observations ont inclus des effets neurologiques transitoires et réversibles , à type de tremblements , incoordination des mouvements et hyper - ou hypoactivité . \n Les modifications éventuelles de la transmission des signaux neurologiques chez l \n Méthionine Chlorure de sodium Eau pour solution injectable Acide chlorhydrique ( ajustement du pH ) Hydroxyde de sodium ( ajustement du pH ) \n La stabilité physico-chimique du produit après première ouverture a été démontrée pendant 60 jours à 37 C . \n Du point de vue microbiologique , si le produit est dilué , il doit être transféré immédiatement dans la pompe de perfusion . \n Flacons en verre de type I à usage unique , avec bouchon en caoutchouc butylique recouverts de polymère fluoré . \n Chaque flacon contient 1 , 2 ou 5 ml de solution pour perfusion . \n Si une dilution est nécessaire , elle doit être effectuée de façon aseptique avec une solution de chlorure de sodium à 9 mg / ml ( 0 , 9 %) pour solution injectable sans conservateurs , avant utilisation . \n La concentration de la solution utilisée dans la pompe à perfusion ne doit pas être inférieure à 5 µg / ml de ziconotide dans une pompe externe et à 25 μ g / ml dans une pompe interne . \n Des conditions aseptiques strictes doivent être respectées pendant la préparation et la manipulation de la solution pour perfusion et le remplissage de la pompe . \n Le patient et le personnel soignant doivent être familiarisés avec la manipulation du système de pompe externe ou interne et être conscients de la nécessité absolue d \n Aux concentrations indiquées ci-dessus , Prialt est compatible chimiquement et physiquement avec la pompe implantable Synchromed et la pompe externe micro-CADD . \n Le produit doit donc être remplacé au bout de 14 jours après remplissage initial de la pompe . \n Prialt s ’ est avéré stable pendant 60 jours à 37 C dans une pompe Synchromed déjà exposée au médicament . \n Dans la pompe CADD-Micro , le produit reste stable pendant 21 jours à température ambiante . \n Par conséquent , après une première utilisation de Prialt , le réservoir doit être vidé et rempli à nouveau au bout de 14 jours . \n Par la suite , la pompe peut être remplie et vidée tous les 60 jours . \n 14 Prialt est une solution limpide et incolore . \n La solution ne doit pas être utilisée si elle est colorée ou trouble ou en cas de présence de particules . \n Tout produit inutilisé doit être éliminé conformément aux réglementations locales . \n Eisai Ltd ., 3 Shortlands London W6 8EE Royaume-Uni \n Des informations détaillées sur ce médicament sont disponibles sur le site internet de l ’ Agence européenne du médicament ( EMEA ) www . emea . europa . eu \n Prialt 25 microgrammes / ml , solution pour perfusion . \n Un ml de solution contient 25 μ g de ziconotide ( sous forme d \n Des réactions indésirables cognitives et neuropsychiatriques , en particulier une confusion , ont été fréquemment décrites chez les patients sous ziconotide . \n Des épisodes de troubles psychiatriques aigus , tels que hallucinations , réactions paranoïdes , hostilité , délire , psychose et réactions maniaques ont été rapportés chez des patients traités par le ziconotide . \n 4 . 6 Grossesse et allaitement \n Affections du rein et des voies urinaires \n 6 . 5 Nature et contenu de l ’ emballage extérieur \n Chaque flacon contient 20 ml de solution pour perfusion . \n Eisai Manufacturing Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN Royaume-Uni \n Un registre patients sera mis en place chez les patients traités après commercialisation de PRIALT ( PRIME ). \n Ce registre permettra de recueillir des données sur l ’ efficacité et la sécurité d ’ emploi du ziconotide en administration intrathécale au long cours , chez des patients présentant des douleurs intenses chroniques cancéreuses ou non . \n L ’ analyse de l ’ évolution de l ’ état des patients sera effectuée en fonction de l ’ étiologie ( cancéreuse ou non ), du mécanisme ( neuropathique ou non ) et de l ’ intensité de la douleur ( score EVA initial supérieur ou inférieur à 50 mm ). \n Ce registre permettra d ’ obtenir des données d ’ utilisation du ziconotide , notamment pour ce qui concerne le schéma posologique optimal et le délai d ’ apparition d ’ une accoutumance éventuelle . \n L ’ utilisation du ziconotide en association avec la morphine ou le baclofène , ou d ’ autres médicaments , la qualité de vie et les effets indésirables observés seront également analysés . \n Les inclusions se poursuivront jusqu ’ à un total d ’ au moins 150 patients . \n Au moment de la réévaluation annuelle , le titulaire de l ’ autorisation de mise sur le marché devra fournir , la mise à jour de l ’ état d ’ avancement des inclusions au registre PRIME , ainsi que les analyses intermédiaires . \n Cette étude a débuté en mars 2008 . \n Le titulaire de l ’ autorisation de mise sur le marché devra soumettre un rapport d ’ étude final au CHMP et à la lumière des résultats obtenus , envisager la nécessité de modifier le RCP de médicament . \n Prialt 100 microgrammes / ml , solution pour perfusion , ziconotide \n 1 ml : \n Chaque ml de solution contient 100 microgrammes de ziconotide ( sous forme d \n 2 ml : \n Chaque ml de solution contient 100 microgrammes de ziconotide ( sous forme d \n 5 ml : \n Chaque ml de solution contient 100 microgrammes de ziconotide ( sous forme d \n méthionine , chlorure de sodium , eau pour préparation injectable , acide chlorhydrique et hydroxyde de sodium . \n 1 ml ( 1 x 1 ml flacon ) \n 2 ml ( 1 x 2 ml flacon ) \n 5 ml ( 1 x 5 ml flacon ) \n Uniquement par voie intrarachidienne \n 3 Shortlands London W6 8EE Royaume-Uni \n Prialt 100 μ g / ml \n Perfusion intrarachidienne \n Prialt 25 microgrammes / ml , solution pour perfusion , ziconotide \n Chaque ml de solution contient 25 microgrammes de ziconotide ( sous forme d ’ acétate ), ( 500 microgrammes par flacon ), \n 20 ml ( 1 x 20 ml flacon ) \n Prialt 25 μ g / ml \n - Si vous avez toute autre question , si vous avez un doute , demandez plus d \n Prialt contient une substance appelée ziconotide , qui appartient à un groupe de médicaments dénommés antalgiques ou \n Prialt est utilisé pour le traitement des douleurs chroniques lorsque le traitement en cours n \n douleur ou écoulement , vous devez le signaler immédiatement à votre médecin qui vous prescrira un traitement contre l \n conseil à votre médecin aussi rapidement que possible car cette augmentation de sensibilité peut être un premier signe d \n fatigue , confusion , sensation de malaise , vomissements ou évanouissements , vous avez peut-être \n Prialt ne doit pas être utilisé pendant la grossesse à moins d \n Demandez conseil à votre médecin si vous devez conduire un véhicule ou utiliser une machine . \n COMMENT UTILISER PRIALT \n Votre médecin discutera avec vous du type de pompe le mieux adapté pour vous et du rythme de remplissage de la pompe . \n La dose maximale est de 21 , 6 microgrammes / jour . \n Au début du traitement , le médecin pourra augmenter la dose tous les 1 à 2 jours ou plus . \n Si nécessaire , le traitement pourra être diminué ou interrompu si les effets indésirables sont trop importants . \n Il est possible que votre médecin , avant d ’ administrer Prialt , décide d ’ arrêter de vous administrer des opiacés dans l ’ espace entourant votre moelle épinière et qu ’ il les remplace par d ’ autres médicaments contre la douleur . \n COMMENT CONSERVER PRIALT \n Conserver au réfrigérateur dans un flacon non ouvert ( 2°C – 8°C ). \n Que contient Prialt \n La substance active est le ziconotide . \n Un ml de solution contient 100 microgrammes de ziconotide ( sous forme d \n Un flacon de 1 ml contient 100 microgrammes ; un flacon de 2 ml contient 200 microgrammes ; \n Les autres composants sont les suivants : méthionine , chlorure de sodium , eau pour préparations injectables , acide chlorhydrique et hydroxyde de sodium . \n Prialt est fourni en conditionnements contenant un seul flacon de 1 ml , 2 ml ou 5 ml . \n Č eská republika Eisai GmbH Tel : + 420 602 311 962 \n Malta Associated Drug Company Ltd Tel : + 356 ( 0 ) 227 780 00 \n Ελλάδα Arriani Pharmaceuticals Τηλ : + 30 ( 0 ) 210 668 3000 \n Portugal EF-Eisai Farmacêutica , Unipessoal Lda Tel : + 351 214 875 540 \n Slovenská republika Eisai GmbH Tel : + 420 602 311 962 \n La dernière date à laquelle cette notice a été approuvée est { MM / AAAA }. \n Cela signifie que à cause de la rareté de cette maladie il est impossible d ’ obtenir des informations complètes sur ce médicament . \n Prialt est fourni sous forme de solution limpide et incolore dans des flacons à usage unique . \n Un flacon de 20 ml contient 500 microgrammes . \n Prialt est fourni en conditionnements contenant un seul flacon de 20 ml .\n" ], "offsets": [ [ 0, 25874 ] ] } ]

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"normalized": [ { "db_name": "UMLS", "db_id": "C0211011" } ] }, { "id": "318_T8", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 217, 223 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T9", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 243, 249 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T10", "type": "DISO", "text": [ "indiqué" ], "offsets": [ [ 254, 261 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1444656" } ] }, { "id": "318_T11", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 270, 280 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "318_T12", "type": "DISO", "text": [ "douleurs intenses" ], "offsets": [ [ 285, 302 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0278140" } ] }, { "id": "318_T13", "type": "DISO", "text": [ "douleurs" ], "offsets": [ [ 285, 293 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T14", "type": "DISO", "text": [ "douleurs", "chroniques" ], "offsets": [ [ 285, 293 ], [ 305, 315 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0150055" } ] }, { "id": "318_T15", "type": "DISO", "text": [ "douleurs", "de long terme" ], "offsets": [ [ 285, 293 ], [ 318, 331 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0150055" } ] }, { "id": "318_T16", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 343, 351 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "318_T17", "type": "PROC", "text": [ "analgésie intrarachidienne" ], "offsets": [ [ 368, 394 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0262672" } ] }, { "id": "318_T18", "type": "ANAT", "text": [ "intrarachidienne" ], "offsets": [ [ 378, 394 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1370196" } ] }, { "id": "318_T19", "type": "PROC", "text": [ "injection" ], "offsets": [ [ 397, 406 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533685" } ] }, { "id": "318_T20", "type": "ANAT", "text": [ "moelle épinière" ], "offsets": [ [ 438, 453 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037925" } ] }, { "id": "318_T21", "type": "ANAT", "text": [ "moelle" ], "offsets": [ [ 438, 444 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0376152" } ] }, { "id": "318_T22", "type": "ANAT", "text": [ "cerveau" ], "offsets": [ [ 460, 467 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006104" } ] }, { "id": "318_T23", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 492, 500 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "318_T24", "type": "DISO", "text": [ "douleurs chroniques" ], "offsets": [ [ 514, 533 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0150055" } ] }, { "id": "318_T25", "type": "DISO", "text": [ "douleurs" ], "offsets": [ [ 514, 522 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T26", "type": "PROC", "text": [ "analgésie intrarachidienne" ], "offsets": [ [ 550, 576 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0262672" } ] }, { "id": "318_T27", "type": "ANAT", "text": [ "intrarachidienne" ], "offsets": [ [ 560, 576 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1370196" } ] }, { "id": "318_T28", "type": "CHEM", "text": [ "analgésiques" ], "offsets": [ [ 579, 591 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0002771" } ] }, { "id": "318_T29", "type": "PROC", "text": [ "injectés" ], "offsets": [ [ 592, 600 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533685" } ] }, { "id": "318_T30", "type": "ANAT", "text": [ "moelle" ], "offsets": [ [ 621, 627 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037925" } ] }, { "id": "318_T31", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 646, 653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "318_T32", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 687, 693 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T33", "type": "CHEM", "text": [ "médicament orphelin" ], "offsets": [ [ 721, 740 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013232" } ] }, { "id": "318_T34", "type": "CHEM", "text": [ "médicament" ], "offsets": [ [ 721, 731 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013227" } ] }, { "id": "318_T35", "type": "CHEM", "text": [ "médicament" ], "offsets": [ [ 745, 755 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013227" } ] }, { "id": "318_T36", "type": "DISO", "text": [ "maladies rares" ], "offsets": [ [ 773, 787 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0678236" } ] }, { "id": "318_T37", "type": "DISO", "text": [ "maladies" ], "offsets": [ [ 773, 781 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "318_T38", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 820, 826 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T39", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 849, 859 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "318_T40", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 864, 870 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T41", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 903, 910 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "318_T42", "type": "PROC", "text": [ "administration" ], "offsets": [ [ 939, 953 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "318_T43", "type": "CHEM", "text": [ "médicaments" ], "offsets": [ [ 957, 968 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013227" } ] }, { "id": "318_T44", "type": "ANAT", "text": [ "intrarachidienne" ], "offsets": [ [ 978, 994 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1370196" } ] }, { "id": "318_T45", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 999, 1005 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T46", "type": "PROC", "text": [ "administré" ], "offsets": [ [ 1016, 1026 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "318_T47", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 1030, 1039 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0204704" } ] }, { "id": "318_T48", "type": "DEVI", "text": [ "cathéter" ], "offsets": [ [ 1089, 1097 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0085590" } ] }, { "id": "318_T49", "type": "ANAT", "text": [ "intrarachidien" ], "offsets": [ [ 1098, 1112 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1370196" } ] }, { "id": "318_T50", "type": "DEVI", "text": [ "tube" ], "offsets": [ [ 1115, 1119 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0175730" } ] }, { "id": "318_T51", "type": "ANAT", "text": [ "canal rachidien" ], "offsets": [ [ 1135, 1150 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037922" } ] }, { "id": "318_T52", "type": "ANAT", "text": [ "canal" ], "offsets": [ [ 1135, 1140 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687028" } ] }, { "id": "318_T53", "type": "ANAT", "text": [ "rachidien" ], "offsets": [ [ 1141, 1150 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037925" } ] }, { "id": "318_T54", "type": "DEVI", "text": [ "pompe" ], "offsets": [ [ 1162, 1167 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0182537" } ] }, { "id": "318_T55", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 1170, 1179 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0204704" } ] }, { "id": "318_T56", "type": "PROC", "text": [ "délivrer" ], "offsets": [ [ 1188, 1196 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "318_T57", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 1210, 1219 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0204704" } ] }, { "id": "318_T58", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 1264, 1270 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T59", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1310, 1320 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "318_T60", "type": "PROC", "text": [ "soulagement de la douleur" ], "offsets": [ [ 1453, 1478 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0451615" } ] }, { "id": "318_T61", "type": "DISO", "text": [ "douleur" ], "offsets": [ [ 1471, 1478 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T62", "type": "DISO", "text": [ "effets indésirables" ], "offsets": [ [ 1486, 1505 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "318_T63", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1535, 1543 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "318_T64", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 1681, 1687 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T65", "type": "LIVB", "text": [ "enfant" ], "offsets": [ [ 1722, 1728 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0008059" } ] }, { "id": "318_T66", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 1741, 1747 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T67", "type": "CHEM", "text": [ "principe actif" ], "offsets": [ [ 1771, 1785 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1372955" } ] }, { "id": "318_T68", "type": "CHEM", "text": [ "Prialt" ], "offsets": [ [ 1789, 1795 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1530575" } ] }, { "id": "318_T69", "type": "CHEM", "text": [ "ziconotide" ], "offsets": [ [ 1801, 1811 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0211011" } ] }, { "id": "318_T70", "type": "OBJC", "text": [ "copie" ], "offsets": [ [ 1822, 1827 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1948062" } ] }, { "id": "318_T71", "type": "OBJC", "text": [ "substance" ], "offsets": [ [ 1836, 1845 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0439861" } ] }, { "id": "318_T72", "type": "PROC", "text": [ "extraite" ], "offsets": [ [ 1881, 1889 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0185115" } ] }, { "id": "318_T73", "type": "CHEM", "text": [ "venin" ], "offsets": [ [ 1893, 1898 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042479" } ] }, { "id": "318_T74", "type": "LIVB", "text": [ "limace de mer" ], "offsets": [ [ 1914, 1927 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0599688" } ] }, { "id": "318_T75", "type": "LIVB", "text": [ "limace" ], "offsets": [ [ 1914, 1920 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0324024" } ] }, { "id": "318_T76", "type": "GEOG", "text": [ "mer" ], "offsets": [ [ 1924, 1927 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0036493" } ] }, { "id": "318_T77", "type": "CHEM", "text": [ "ziconotide" ], "offsets": [ [ 1935, 1945 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0211011" } ] }, { "id": "318_T78", "type": "ANAT", "text": [ "canaux" ], "offsets": [ [ 1970, 1976 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687028" } ] }, { "id": "318_T79", "type": "CHEM", "text": [ "canaux calciques" ], "offsets": [ [ 1992, 2008 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006685" } ] }, { "id": "318_T80", "type": "ANAT", "text": [ "canaux" ], "offsets": [ [ 1992, 1998 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687028" } ] }, { "id": "318_T81", "type": "ANAT", "text": [ "cellules nerveuses" ], "offsets": [ [ 2028, 2046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027882" } ] }, { "id": "318_T82", "type": "ANAT", "text": [ "cellules" ], "offsets": [ [ 2028, 2036 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007634" } ] }, { "id": "318_T83", "type": "ANAT", "text": [ "nerveuses" ], "offsets": [ [ 2037, 2046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027740" } ] }, { "id": "318_T84", "type": "PHEN", "text": [ "transmettent" ], "offsets": [ [ 2051, 2063 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1521797" } ] }, { "id": "318_T85", "type": "PHEN", "text": [ "signaux" ], "offsets": [ [ 2068, 2075 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1710082" } ] }, { "id": "318_T86", "type": "DISO", "text": [ "douleur" ], "offsets": [ [ 2082, 2089 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T87", "type": "PHEN", "text": [ "flux" ], "offsets": [ [ 2109, 2113 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0806140" } ] }, { "id": "318_T88", "type": "CHEM", "text": [ "calcium" ], "offsets": [ [ 2117, 2124 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006675" } ] }, { "id": "318_T89", "type": "ANAT", "text": [ "cellules nerveuses" ], "offsets": [ [ 2134, 2152 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027882" } ] }, { "id": "318_T90", "type": "ANAT", "text": [ "cellules" ], "offsets": [ [ 2134, 2142 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007634" } ] }, { "id": "318_T91", "type": "ANAT", "text": [ "nerveuses" ], "offsets": [ [ 2143, 2152 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027740" } ] }, { "id": "318_T92", "type": "CHEM", "text": [ "ziconotide" ], "offsets": [ [ 2158, 2168 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0211011" } ] }, { "id": "318_T93", "type": "PHEN", "text": [ "transmission" ], "offsets": [ [ 2187, 2199 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1521797" } ] }, { "id": "318_T94", "type": "PHEN", "text": [ "signaux" ], "offsets": [ [ 2204, 2211 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1710082" } ] }, { "id": "318_T95", "type": "DISO", "text": [ "douleur" ], "offsets": [ [ 2215, 2222 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T96", "type": "ANAT", "text": [ "moelle" ], "offsets": [ [ 2231, 2237 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0376152" } ] }, { "id": "318_T97", "type": "PROC", "text": [ "soulager" ], "offsets": [ [ 2251, 2259 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0002766" } ] }, { "id": "318_T98", "type": "DISO", "text": [ "douleur" ], "offsets": [ [ 2263, 2270 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "318_T99", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 2288, 2293 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "318_T100", "type": "CHEM", "text": [ "médicament" ], "offsets": [ [ 2325, 2335 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013227" } ] }, { "id": "318_T101", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2364, 2372 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "318_T102", "type": "LIVB", "text": [ "adultes" ], "offsets": [ [ 2373, 2380 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0001675" } ] }, { "id": "318_T103", "type": "DISO", "text": [ "douleurs intenses" ], "offsets": [ [ 2393, 2410 ] ], "normalized": [ { "db_name": "UMLS", "db_id": 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[ { "id": "345_1__text", "type": "abstract", "text": [ "EMEA / H / C / 122 \n REFLUDAN \n Qu ’ est-ce que Refludan ? \n Refludan se présente sous forme de poudre , conditionnée en flacon , à faire dissoudre pour obtenir une solution injectable ou perfusable ( goutte-à-goutte dans une veine ). \n\n Son principe actif est la lépirudine . \n Dans quels cas Refludan est-il utilisé ? \n Refludan est utilisé pour prévenir la coagulation chez les patients atteints de thrombocytopénie induite par l ’ héparine ( dite TIH – il s ’ agit d ’ une certaine forme d ’ allergie vis-à-vis de l ’ héparine , qui se traduit par une carence de plaquettes sanguines ou une formation de caillots dans les vaisseaux sanguins ) et de maladie thromboembolique ( développement anormal de caillots de sang ) nécessitant un traitement antithrombotique par injection , généralement de l ’ héparine . \n Le diagnostic doit être confirmé par des tests spécifiques , tels que le test HIPAA ( heparin induced platelet aggregation assay ) d ’ activation plaquettaire induite par l ’ héparine . \n Comment Refludan est-il utilisé ? \n Refludan est administré par injection et par perfusion intraveineuse ( goutte-à-goutte dans une veine ). \n Le traitement par Refludan doit être initié sous le contrôle d ’ un médecin ayant une expérience dans le traitement de la coagulation ( formation de caillots sanguins ). \n La dose recommandée est de 0 , 4 mg / kg de poids corporel administrée en une seule injection intraveineuse , suivie de 0 , 15 mg / kg de poids corporel par heure en perfusion intraveineuse continue pendant 2 à 10 jours , voire davantage si nécessaire . \n Les doses doivent être réduites chez les patients souffrant de troubles rénaux . \n Comment Refludan fonctionne-t-il ? \n La lépirudine , principe actif de Refludan , est quasiment identique à l ’ hirudine , substance anticoagulante produite par les sangsues . \n La lépirudine est fabriquée par une levure ayant reçu un gène ( ADN ) qui la rend apte à produire cette substance . \n La lépirudine bloque spécifiquement l ’ une des substances impliquées dans le processus de coagulation , la thrombine . \n Celle-ci se trouve au centre du processus complexe de la coagulation sanguine . \n Refludan réduit fortement le risque de coagulation , prévenant ainsi les dommages subséquents . \n Refludan a été étudié au cours de deux essais regroupant 198 patients . \n Les études se sont penchées sur les décès , les amputations et les nouvelles complications thromboemboliques ( coagulation ). \n Quels bénéfices ont été démontrés par Refludan au cours des études ? \n Dans la comparaison avec les témoins historiques , les deux essais pris dans leur ensemble ont révélé les effets significativement bénéfiques de Refludan sur le taux des nouvelles complications thromboemboliques et en termes d ’ amélioration des conditions de survie . \n Quels sont les risques associés à Refludan ? \n À l ’ instar d ’ autres médicaments antithrombotiques , l ’ effet secondaire le plus fréquemment rapporté de Refludan ( constaté chez plus d ’ un patient sur dix ) est le saignement . \n Un tel saignement conduisant au décès est rapporté chez approximativement un patient sur 100 . \n Pour une description complète des effets indésirables observés sous Refludan , veuillez vous reporter à la notice . \n Pourquoi Refludan a-t-il été approuvé ? \n Du fait qu ’ il s ’ agit d ’ une maladie très grave et qu ’ il n ’ existe pas d ’ autre traitement efficace , le comité des médicaments à usage humain ( CHMP ) a considéré que les bénéfices du Refludan sont supérieurs à ses risques pour le traitement des patients souffrant de thrombocytopénie induite par l ’ héparine et de maladie thromboembolique . \n Il a , dès lors , recommandé l ’ octroi d ’ une autorisation de mise sur le marché pour Refludan . \n Autres informations relatives à Refludan : \n Le 13 mars 1997 , la Commission européenne a délivré une autorisation de mise sur le marché valable dans toute l ’ Union européenne pour Refludan . \n Pour consulter l ’ EPAR complet relatif à Refludan , veuillez cliquer ici . \n Refludan , 20 mg , poudre pour solution injectable ou pour perfusion \n Chaque flacon contient 20 mg de lépirudine . \n ( La lépirudine est un produit ADN recombinant dérivé de cellules de levure ) \n Poudre pour solution injectable ou pour perfusion . \n Poudre lyophilisée blanche à presque blanche . \n Posologie initiale \n Inhibition de la coagulation chez des patients adultes atteints d \n La posologie dépend du poids corporel du patient jusqu \n Chez les patients pesant plus de 110 kg , la posologie ne doit pas dépasser celle calculée pour les patients pesant 110 kg ( voir aussi tableaux 2 et 3 ci-après ). \n Surveillance du traitement par Refludan et modification du schéma posologique \n\n\n" ], "offsets": [ [ 0, 4712 ] ] } ]

[ { "id": "345_1_T1", "type": "CHEM", "text": [ "REFLUDAN" ], "offsets": [ [ 21, 29 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T2", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 48, 56 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T3", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 61, 69 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T4", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 96, 102 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_1_T5", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 121, 127 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_1_T6", "type": "PROC", "text": [ "dissoudre" ], "offsets": [ [ 138, 147 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1285147" } ] }, { "id": "345_1_T7", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 165, 184 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_1_T8", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 174, 184 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_1_T9", "type": "PROC", "text": [ "perfusable" ], "offsets": [ [ 188, 198 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_1_T10", "type": "PROC", "text": [ "goutte-à-goutte dans une veine" ], "offsets": [ [ 201, 231 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021440" } ] }, { "id": "345_1_T11", "type": "ANAT", "text": [ "veine" ], "offsets": [ [ 226, 231 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042449" } ] }, { "id": "345_1_T12", "type": "CHEM", "text": [ "principe actif" ], "offsets": [ [ 242, 256 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1372955" } ] }, { "id": "345_1_T13", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 264, 274 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_1_T14", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 294, 302 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T15", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 322, 330 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T16", "type": "PHYS", "text": [ "coagulation" ], "offsets": [ [ 360, 371 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T17", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 381, 389 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T18", "type": "DISO", "text": [ "thrombocytopénie induite par l ’ héparine" ], "offsets": [ [ 402, 443 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0272285" } ] }, { "id": "345_1_T19", "type": "DISO", "text": [ "thrombocytopénie" ], "offsets": [ [ 402, 418 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040034" } ] }, { "id": "345_1_T20", "type": "CHEM", "text": [ "héparine" ], "offsets": [ [ 435, 443 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019134" } ] }, { "id": "345_1_T21", "type": "DISO", "text": [ "TIH" ], "offsets": [ [ 451, 454 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0272285" } ] }, { "id": "345_1_T22", "type": "DISO", "text": [ "allergie" ], "offsets": [ [ 496, 504 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0020517" } ] }, { "id": "345_1_T23", "type": "CHEM", "text": [ "héparine" ], "offsets": [ [ 522, 530 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019134" } ] }, { "id": "345_1_T24", "type": "DISO", "text": [ "carence de plaquettes sanguines" ], "offsets": [ [ 556, 587 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0392386" } ] }, { "id": "345_1_T25", "type": "ANAT", "text": [ "plaquettes sanguines" ], "offsets": [ [ 567, 587 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005821" } ] }, { "id": "345_1_T26", "type": "DISO", "text": [ "caillots" ], "offsets": [ [ 608, 616 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0302148" } ] }, { "id": "345_1_T27", "type": "ANAT", "text": [ "vaisseaux sanguins" ], "offsets": [ [ 626, 644 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005847" } ] }, { "id": "345_1_T28", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 653, 660 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "345_1_T29", "type": "DISO", "text": [ "maladie thromboembolique" ], "offsets": [ [ 653, 677 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040038" } ] }, { "id": "345_1_T30", "type": "DISO", "text": [ "caillots" ], "offsets": [ [ 705, 713 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0302148" } ] }, { "id": "345_1_T31", "type": "ANAT", "text": [ "sang" ], "offsets": [ [ 717, 721 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "345_1_T32", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 739, 749 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "345_1_T33", "type": "CHEM", "text": [ "antithrombotique" ], "offsets": [ [ 750, 766 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1704311" } ] }, { "id": "345_1_T34", "type": "CHEM", "text": [ "injection" ], "offsets": [ [ 771, 780 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_1_T35", "type": "CHEM", "text": [ "héparine" ], "offsets": [ [ 803, 811 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019134" } ] }, { "id": "345_1_T36", "type": "DISO", "text": [ "diagnostic" ], "offsets": [ [ 819, 829 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0011900" } ] }, { "id": "345_1_T37", "type": "PROC", "text": [ "tests" ], "offsets": [ [ 857, 862 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0683443" } ] }, { "id": "345_1_T38", "type": "PROC", "text": [ "test" ], "offsets": [ [ 889, 893 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0683443" } ] }, { "id": "345_1_T39", "type": "PHYS", "text": [ "activation plaquettaire" ], "offsets": [ [ 951, 974 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032173" } ] }, { "id": "345_1_T40", "type": "ANAT", "text": [ "plaquettaire" ], "offsets": [ [ 962, 974 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C00058213" } ] }, { "id": "345_1_T41", "type": "CHEM", "text": [ "héparine" ], "offsets": [ [ 991, 999 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019134" } ] }, { "id": "345_1_T42", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 1012, 1020 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T43", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 1040, 1048 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T44", "type": "PROC", "text": [ "administré" ], "offsets": [ [ 1053, 1063 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "345_1_T45", "type": "CHEM", "text": [ "injection" ], "offsets": [ [ 1068, 1077 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_1_T46", "type": "PROC", "text": [ "perfusion intraveineuse" ], "offsets": [ [ 1085, 1108 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021440" } ] }, { "id": "345_1_T47", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 1085, 1094 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_1_T48", "type": "PROC", "text": [ "goutte-à-goutte dans une veine" ], "offsets": [ [ 1111, 1141 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021440" } ] }, { "id": "345_1_T49", "type": "ANAT", "text": [ "veine" ], "offsets": [ [ 1136, 1141 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042449" } ] }, { "id": "345_1_T50", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1150, 1160 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "345_1_T51", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 1165, 1173 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T52", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1215, 1222 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "345_1_T53", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1252, 1262 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "345_1_T54", "type": "PHYS", "text": [ "coagulation" ], "offsets": [ [ 1269, 1280 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T55", "type": "DISO", "text": [ "caillots" ], "offsets": [ [ 1296, 1304 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0302148" } ] }, { "id": "345_1_T56", "type": "ANAT", "text": [ "sanguins" ], "offsets": [ [ 1305, 1313 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "345_1_T57", "type": "PHYS", "text": [ "poids corporel" ], "offsets": [ [ 1363, 1377 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005910" } ] }, { "id": "345_1_T58", "type": "DISO", "text": [ "injection intraveineuse" ], "offsets": [ [ 1403, 1426 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0542046" } ] }, { "id": "345_1_T59", "type": "PHYS", "text": [ "poids corporel" ], "offsets": [ [ 1457, 1471 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005910" } ] }, { "id": "345_1_T60", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 1485, 1494 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_1_T61", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1616, 1624 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T63", "type": "DISO", "text": [ "troubles rénaux" ], "offsets": [ [ 1638, 1653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0022658" } ] }, { "id": "345_1_T64", "type": "ANAT", "text": [ "rénaux" ], "offsets": [ [ 1647, 1653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0022646" } ] }, { "id": "345_1_T65", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 1666, 1674 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T66", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 1698, 1708 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_1_T67", "type": "CHEM", "text": [ "principe actif" ], "offsets": [ [ 1711, 1725 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013161" } ] }, { "id": "345_1_T68", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 1729, 1737 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T69", "type": "CHEM", "text": [ "hirudine" ], "offsets": [ [ 1770, 1778 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019573" } ] }, { "id": "345_1_T70", "type": "CHEM", "text": [ "substance anticoagulante" ], "offsets": [ [ 1781, 1805 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0003280" } ] }, { "id": "345_1_T71", "type": "LIVB", "text": [ "sangsues" ], "offsets": [ [ 1823, 1831 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023209" } ] }, { "id": "345_1_T72", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 1839, 1849 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_1_T73", "type": "LIVB", "text": [ "levure" ], "offsets": [ [ 1872, 1878 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0043393" } ] }, { "id": "345_1_T74", "type": "CHEM", "text": [ "ADN" ], "offsets": [ [ 1900, 1903 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012854" } ] }, { "id": "345_1_T75", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 1957, 1967 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_1_T76", "type": "PHYS", "text": [ "coagulation" ], "offsets": [ [ 2045, 2056 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T77", "type": "CHEM", "text": [ "thrombine" ], "offsets": [ [ 2062, 2071 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040018" } ] }, { "id": "345_1_T78", "type": "PHYS", "text": [ "coagulation sanguine" ], "offsets": [ [ 2133, 2153 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T79", "type": "ANAT", "text": [ "sanguine" ], "offsets": [ [ 2145, 2153 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "345_1_T80", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2158, 2166 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T81", "type": "PHYS", "text": [ "coagulation" ], "offsets": [ [ 2197, 2208 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T82", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2256, 2264 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T83", "type": "PROC", "text": [ "étudié" ], "offsets": [ [ 2271, 2277 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "345_1_T84", "type": "PROC", "text": [ "essais" ], "offsets": [ [ 2295, 2301 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "345_1_T85", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2317, 2325 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T86", "type": "PROC", "text": [ "études" ], "offsets": [ [ 2334, 2340 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "345_1_T87", "type": "PHYS", "text": [ "décès" ], "offsets": [ [ 2366, 2371 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0011065" } ] }, { "id": "345_1_T88", "type": "PROC", "text": [ "amputations" ], "offsets": [ [ 2378, 2389 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0002688" } ] }, { "id": "345_1_T89", "type": "DISO", "text": [ "complications thromboemboliques" ], "offsets": [ [ 2407, 2438 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040038" } ] }, { "id": "345_1_T90", "type": "DISO", "text": [ "complications" ], "offsets": [ [ 2407, 2420 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0009566" } ] }, { "id": "345_1_T91", "type": "PHYS", "text": [ "coagulation" ], "offsets": [ [ 2441, 2452 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005778" } ] }, { "id": "345_1_T92", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2496, 2504 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T93", "type": "PROC", "text": [ "études" ], "offsets": [ [ 2518, 2524 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "345_1_T94", "type": "PROC", "text": [ "essais" ], "offsets": [ [ 2589, 2595 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "345_1_T95", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2674, 2682 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T96", "type": "DISO", "text": [ "complications thromboemboliques" ], "offsets": [ [ 2709, 2740 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040038" } ] }, { "id": "345_1_T97", "type": "DISO", "text": [ "complications" ], "offsets": [ [ 2709, 2722 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0009566" } ] }, { "id": "345_1_T98", "type": "DISO", "text": [ "risques" ], "offsets": [ [ 2815, 2822 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0184544" } ] }, { "id": "345_1_T99", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2834, 2842 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T100", "type": "CHEM", "text": [ "médicaments antithrombotiques" ], "offsets": [ [ 2871, 2900 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1704311" } ] }, { "id": "345_1_T101", "type": "CHEM", "text": [ "antithrombotiques" ], "offsets": [ [ 2883, 2900 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1704311" } ] }, { "id": "345_1_T102", "type": "DISO", "text": [ "effet secondaire" ], "offsets": [ [ 2907, 2923 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0543419" } ] }, { "id": "345_1_T103", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2956, 2964 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T104", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 2993, 3000 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T105", "type": "DISO", "text": [ "saignement" ], "offsets": [ [ 3018, 3028 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_1_T106", "type": "DISO", "text": [ "saignement" ], "offsets": [ [ 3040, 3050 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_1_T107", "type": "PHYS", "text": [ "décès" ], "offsets": [ [ 3065, 3070 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0011065" } ] }, { "id": "345_1_T108", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 3110, 3117 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T109", "type": "DISO", "text": [ "effets indésirables" ], "offsets": [ [ 3164, 3183 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "345_1_T110", "type": "PROC", "text": [ "observés" ], "offsets": [ [ 3184, 3192 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0302523" } ] }, { "id": "345_1_T111", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 3198, 3206 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T112", "type": "PROC", "text": [ "notice" ], "offsets": [ [ 3237, 3243 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013191" } ] }, { "id": "345_1_T113", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 3257, 3265 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T114", "type": "DISO", "text": [ "maladie très grave" ], "offsets": [ [ 3323, 3341 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0010340" } ] }, { "id": "345_1_T115", "type": 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3553 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T123", "type": "DISO", "text": [ "thrombocytopénie induite par l ’ héparine" ], "offsets": [ [ 3567, 3608 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2349404" }, { "db_name": "UMLS", "db_id": "C0272285" } ] }, { "id": "345_1_T125", "type": "DISO", "text": [ "thrombocytopénie" ], "offsets": [ [ 3567, 3583 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040034" } ] }, { "id": "345_1_T126", "type": "CHEM", "text": [ "héparine" ], "offsets": [ [ 3600, 3608 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019134" } ] }, { "id": "345_1_T127", "type": "DISO", "text": [ "maladie thromboembolique" ], "offsets": [ [ 3615, 3639 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040038" } ] }, { "id": "345_1_T128", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 3615, 3622 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "345_1_T129", "type": "CHEM", 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4026 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T136", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 4037, 4043 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_1_T137", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 4049, 4068 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_1_T138", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 4058, 4068 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_1_T139", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 4077, 4086 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_1_T140", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 4096, 4102 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_1_T141", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 4121, 4131 ] ], "normalized": [ { "db_name": "UMLS", 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"offsets": [ [ 4387, 4394 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0001765" } ] }, { "id": "345_1_T155", "type": "PHYS", "text": [ "poids corporel" ], "offsets": [ [ 4431, 4445 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005910" } ] }, { "id": "345_1_T156", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 4449, 4456 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T157", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 4474, 4482 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T158", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 4565, 4573 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_1_T159", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 4647, 4657 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "345_1_T160", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 4662, 4670 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_1_T161", "type": "PROC", "text": [ "heparin induced platelet aggregation assay" ], "offsets": [ [ 902, 944 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0919798" } ] }, { "id": "345_1_T162", "type": "PROC", "text": [ "test HIPAA" ], "offsets": [ [ 889, 899 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0919798" } ] }, { "id": "345_1_T163", "type": "PROC", "text": [ "perfusion intraveineuse continue" ], "offsets": [ [ 1485, 1517 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021440" } ] } ]

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[ { "id": "345_2__text", "type": "abstract", "text": [ "EMEA / H / C / 122 \n\n Recommandations standard \n Comme la lépirudine est excrétée et métabolisée en quasi-totalité par le rein ( voir également la rubrique 5 . 2 ), il est nécessaire de connaître l \n Les recommandations posologiques suivantes sont basées sur les résultats d \n Dans tous les autres cas , les ajustements posologiques seront basés sur la créatininémie . \n La vitesse de perfusion doit être réduite selon les indications données dans le tableau 1 . \n Une surveillance plus fréquente du TCA est obligatoire . \n Reconstituer la solution comme il est indiqué en rubrique 6 . 6 . \n Bolus intraveineux initial : \n Le bolus intraveineux est préparé avec une solution dosée à 5 mg / ml . \n pour une posologie de 0 , 2 mg / kg de poids corporel \n 4 La perfusion intraveineuse est préparée avec une solution dosée à 2 mg / ml . \n La vitesse ( ml / h ) de la seringue électrique doit être réglée en fonction du poids corporel . \n Débit de perfusion ( ml / h ) pour une posologie de \n Des réactions anaphylactiques d ’ évolution fatale ont été rapportées lors d ’ une ré-exposition au Refludan . \n Aussi , avant toute ré-exposition au Refludan , une autre alternative thérapeutique devra avoir été envisagée et discutée . \n Ces réactions étant de type immunologique , les patients précédemment traités par l ’ hirudine ou un analogue de l ’ hirudine devront être considérés comme des patients à risque . \n Il peut s ’ avérer nécessaire d ’ exclure les insuffisants rénaux du traitement par lépirudine . \n Une cirrhose du foie peut également affecter l ’ excrétion rénale de la lépirudine . \n La tolérance et l ’ efficacité chez l ’ enfant n ’ ont pas été démontrées . • Patient âgé : \n Les patients d ’ un âge avancé présentent un risque accru de complications hémorragiques avec les anticoagulants . \n Aucun ajustement spécifique de la posologie n ’ est fait chez le sujet âgé . \n Ces ajustements sont basés sur la fonction rénale , le poids et le TCA ( voirrubrique 4 . 2 ). \n Un traitement concomittant par des dérivés coumariniques ( antivitamines K ) ainsi que par des médicaments qui affectent la fonction plaquettaire peuvent également accroître le risque de saignement . \n Par conséquent , Refludan ne doit pas être administré à la femme enceinte ou qui allaite . \n Les cas de saignements menaçant le pronostic vital ( incluant les saignements intracrâniens ) ont été peu fréquents ( \n Un surdosage est susceptible de majorer le risque hémorragique . \n Agent antithrombotique – inhibiteur direct de la thrombine , code ATC : \n La lépirudine ([ Leu1 , Thr2 ]- 63 - désulfohirudine ) est une hirudine recombinante dérivée de cellules de levure ) . \n Ce polypeptide , composé de 65 acides aminés , a un poids moléculaire de 6 979 , 5 Daltons . \n La lépirudine est un inhibiteur direct et hautement spécifique de la thrombine . \n Son activité se mesure par une méthode chromogénique . \n De ce fait , tous les tests de coagulation thrombine-dépendants sont modifiés ; par exemple , le TCA s \n Les informations cliniques à propos des TIH de type II présentées dans ce RCP reposent sur les données de deux essais cliniques prospectifs qui ont inclus un total de 198 patients atteints de TIH de type II traités par Refludan . \n Les propriétés pharmacocinétiques de la lépirudine administrée par voie intraveineuse sont bien décrites par un modèle bicompartimental . \n Environ 35 % de la dose administrée sont excrétés sous forme inchangée . \n Les études réalisées en administration unique ou réitérée chez la souris , le rat et le singe ont mis en évidence les effets secondaires attendus d ’ un effet pharmacodynamique trop intense de la lépirudine . \n Chez le singe sont survenues des hémorragies rétiniennes . \n Mannitol , hydroxyde de sodium pour ajustement du pH à 7 . \n Après reconstitution : utiliser immédiatement . \n Celgene Europe Ltd ., Riverside House , Riverside Walk , Windsor , SL4 1NA , Royaume Uni \n Refludan , 50 mg , poudre pour solution injectable ou pour perfusion \n Chaque flacon contient 50 mg de lépirudine . \n Clairance \n\n\n" ], "offsets": [ [ 0, 4051 ] ] } ]

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548 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037633" } ] }, { "id": "345_2_T8", "type": "PROC", "text": [ "Bolus intraveineux" ], "offsets": [ [ 592, 610 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1511237" } ] }, { "id": "345_2_T9", "type": "PROC", "text": [ "bolus intraveineux" ], "offsets": [ [ 626, 644 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1511237" } ] }, { "id": "345_2_T10", "type": "OBJC", "text": [ "solution" ], "offsets": [ [ 666, 674 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037633" } ] }, { "id": "345_2_T11", "type": "PHYS", "text": [ "poids corporel" ], "offsets": [ [ 736, 750 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005910" } ] }, { "id": "345_2_T12", "type": "ANAT", "text": [ "corporel" ], "offsets": [ [ 742, 750 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0242821" } ] }, { "id": "345_2_T13", "type": "PROC", "text": [ "perfusion intraveineuse" ], "offsets": [ [ 758, 781 ] ], "normalized": [ { "db_name": 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}, { "id": "345_2_T39", "type": "LIVB", "text": [ "Patient âgé" ], "offsets": [ [ 1673, 1684 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0001795" }, { "db_name": "UMLS", "db_id": "C0001792" } ] }, { "id": "345_2_T40", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1693, 1701 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_2_T41", "type": "PHYS", "text": [ "âge" ], "offsets": [ [ 1709, 1712 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0001779" } ] }, { "id": "345_2_T42", "type": "DISO", "text": [ "risque" ], "offsets": [ [ 1734, 1740 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C3251812" } ] }, { "id": "345_2_T43", "type": "DISO", "text": [ "complications" ], "offsets": [ [ 1750, 1763 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0009566" } ] }, { "id": "345_2_T44", "type": "DISO", "text": [ "hémorragiques" ], "offsets": [ [ 1764, 1777 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": 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"risque de saignement" ], "offsets": [ [ 2159, 2179 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C3251812" } ] }, { "id": "345_2_T59", "type": "DISO", "text": [ "saignement" ], "offsets": [ [ 2169, 2179 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_2_T60", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 2201, 2209 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_2_T61", "type": "LIVB", "text": [ "femme enceinte" ], "offsets": [ [ 2243, 2257 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0033011" } ] }, { "id": "345_2_T62", "type": "LIVB", "text": [ "femme" ], "offsets": [ [ 2243, 2248 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0043210" } ] }, { "id": "345_2_T63", "type": "PHYS", "text": [ "allaite" ], "offsets": [ [ 2265, 2272 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006147" } ] }, { "id": "345_2_T64", "type": "DISO", "text": [ "saignements" ], "offsets": [ [ 2288, 2299 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_2_T65", "type": "DISO", "text": [ "saignements" ], "offsets": [ [ 2343, 2354 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_2_T66", "type": "ANAT", "text": [ "intracrâniens" ], "offsets": [ [ 2355, 2368 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0230041" } ] }, { "id": "345_2_T67", "type": "PROC", "text": [ "TCA" ], "offsets": [ [ 1952, 1955 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030605" } ] }, { "id": "345_2_T68", "type": "DISO", "text": [ "surdosage" ], "offsets": [ [ 2400, 2409 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0029944" } ] }, { "id": "345_2_T69", "type": "DISO", "text": [ "risque hémorragique" ], "offsets": [ [ 2440, 2459 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C3251812" } ] }, { "id": "345_2_T70", "type": "DISO", "text": [ "hémorragique" ], "offsets": [ [ 2447, 2459 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_2_T71", "type": "CHEM", "text": [ "Agent antithrombotique" ], "offsets": [ [ 2464, 2486 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0016018" } ] }, { "id": "345_2_T72", "type": "CHEM", "text": [ "antithrombotique" ], "offsets": [ [ 2470, 2486 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0003440" } ] }, { "id": "345_2_T73", "type": "CHEM", "text": [ "inhibiteur direct de la thrombine" ], "offsets": [ [ 2489, 2522 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0003440" } ] }, { "id": "345_2_T74", "type": "CHEM", "text": [ "thrombine" ], "offsets": [ [ 2513, 2522 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040018" } ] }, { "id": "345_2_T75", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 2541, 2551 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_2_T76", "type": "CHEM", "text": [ "hirudine" ], "offsets": [ [ 2601, 2609 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019573" } ] }, { "id": "345_2_T77", "type": "CHEM", "text": [ "cellules de levure" ], "offsets": [ [ 2634, 2652 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0669253" } ] }, { "id": "345_2_T78", "type": "ANAT", "text": [ "cellules" ], "offsets": [ [ 2634, 2642 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007634" } ] }, { "id": "345_2_T79", "type": "LIVB", "text": [ "levure" ], "offsets": [ [ 2646, 2652 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0043393" } ] }, { "id": "345_2_T80", "type": "CHEM", "text": [ "polypeptide" ], "offsets": [ [ 2662, 2673 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1305923" } ] }, { "id": "345_2_T81", "type": "CHEM", "text": [ "acides aminés" ], "offsets": [ [ 2690, 2703 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0002520" } ] }, { "id": "345_2_T82", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 2757, 2767 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_2_T83", "type": "CHEM", 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"offsets": [ [ 3191, 3205 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0877016" } ] }, { "id": "345_2_T90", "type": "PROC", "text": [ "traités" ], "offsets": [ [ 3206, 3213 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "345_2_T91", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 3218, 3226 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_2_T92", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 3271, 3281 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_2_T93", "type": "PROC", "text": [ "administrée" ], "offsets": [ [ 3282, 3293 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "345_2_T94", "type": "PROC", "text": [ "administrée" ], "offsets": [ [ 3395, 3406 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1533734" } ] }, { "id": "345_2_T95", "type": "PHYS", "text": [ "excrétés" ], "offsets": [ [ 3412, 3420 ] ], "normalized": [ { 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[ { "id": "345_3__text", "type": "abstract", "text": [ "EMEA / H / C / 122 \n\n 4 . 3 Contre-indications \n CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Allemagne \n 25 MENTIONS DEVANT FIGURER SUR L ’ EMBALLAGE EXTERIEUR ET SUR LE CONDITIONNEMENT PRIMAIRE \n 1 flacon contient 20 mg de lépirudine . \n Contient également : mannitol , hydroxyde de sodium . \n 1 flacon de poudre pour solution injectable ou pour perfusion . \n Reconstituer le flacon ( 20 mg de lépirudine ) avec 0 , 4 ml d ’ eau pour préparations injectables ou d ’ une solution de chlorure de sodium à 9 mg / ml ( 0 , 9 %). \n Une dilution ultérieure est nécessaire avant utilisation . \n La solution reconstituée doit être utilisée immédiatement . \n Ne pas utiliser de solutions troubles ou qui contiennent des particules . \n 27 MENTIONS DEVANT FIGURER SUR L ’ EMBALLAGE EXTERIEUR ET SUR LE CONDITIONNEMENT PRIMAIRE \n 10 x 1 flacon de poudre pour solution injectable ou pour perfusion . \n Refludan 20 mg en poudre pour solution injectable ou pour perfusion . lépirudine Voie intraveineuse \n Refludan 50 mg en poudre pour solution injectable ou pour perfusion lépirudine \n 1 flacon contient 50 mg de lépirudine . \n Reconstituer le flacon ( 50 mg de lépirudine ) avec 1 ml d ’ eau pour préparations injectables ou d ’ une solution de chlorure de á sodium 9 mg / ml ( 0 , 9 %). \n Refludan 50 mg en poudre pour solution injectable ou pour perfusion lépirudine Voie intraveineuse \n Refludan 20 mg en poudre pour solution injectable ou pour perfusion Lepirudine \n QU ’ EST-CE QUE REFLUDAN ET DANS QUEL CAS EST-IL UTILISE \n Refludan est un antithrombotique . \n Les antithrombotiques sont des médicaments destinés à prévenir la formation de caillots sanguins ( thrombose ). \n Refludan est utilisé pour inhiber la coagulation chez des patients adultes atteints d ’ une thrombopénie induite par l ’ héparine ( TIH ) de type II et de maladie thrombo-embolique nécessitant un traitement antithrombotique injectable . \n La thrombopénie induite par l ’ héparine ( TIH ) de type II est une maladie qui peut survenir après que vous ayez pris des médicaments contenant de l ’ héparine . \n Cela peut conduire ensuite à un dépôt de ces caillots dans certains organes . \n De même , veuillez prévenir votre médecin si vous souffrez d ’ insuffisance rénale ou d ’ une cirrhose du foie ( maladie du foie à un stade avancé ), car il faudra dans ce cas réduire la posologie de Refludan . \n Vous devez également prévenir votre médecin si jamais vous avez déjà pris du Refludan , une autre hirudine ou un analogue de l ’ hirudine . \n Les médicaments destinés à détruire les caillots sanguins ou les comprimés destinés à prévenir leur formation ( coumariniques ) peuvent accroître le risque de saignement lorsqu ’ ils sont administrés en même temps que Refludan . \n Refludan ne doit pas être administré aux femmes enceintes ou qui allaitent \n COMMENT UTILISER REFLUDAN \n Votre médecin déterminera et contrôlera la posologie et la durée de votre traitement par Refludan en fonction de votre état clinique , de votre poids corporel et de certains paramètres biologiques . \n Si vous avez l ’ impression que l ’ effet de Refludan est trop fort ou trop faible , consultez votre médecin ou votre pharmacien . \n Refludan , une fois reconstitué avec le solvant approprié , sera administré dans une veine , par injection et ensuite par perfusion . \n Très fréquent ( au moins 1 personne sur 10 ) \n 38 Anémie ou baisse du taux d ’ hémoglobine sans source de saignement manifeste , contusion , saignement au niveau des sites de ponction , saignement nasal , sang dans les urines , saignement gastrointestinal , saignement vaginal , saignement rectal , hémorragie pulmonaire , saignement au niveau de la poitrine et autour du cœur suite à une intervention chirurgicale , saignement au niveau du cerveau . \n Une hémorragie sévère et , en particulier , une hémorragie intracrânienne peut être fatale . \n Lors de la surveillance post-marketing intensive , dans la TIH de type II , ont été rapportées des hémorragies fatales chez 1 % des patients et des hémorragies intracrâniennes chez 0 , 2 % des patients . \n Une hémorragie sévère peut provoquer une diminution du volume de sang circulant , une pression artérielle basse , un état de choc , et les séquelles cliniques qui en résultent . \n COMMENT CONSERVER REFLUDAN \n Conserver le flacon dans l ’ emballage extérieur . \n Ne pas utiliser Refludan si la solution reconstituée est trouble ou contient des particules . \n Une fois reconstitué , Refludan doit être utilisé immédiatement . \n Toute solution non utilisée doit être jetée de manière appropriée . \n La substance active est la lépirudine , idem RCPun composé produit par la technique d ’ ADN recombinant à partir de cellules de levure . \n Les autres composants sont le mannitol ( E 421 ) et l ’ hydroxyde de sodium pour l ’ ajustement du pH . \n Qu ’ est-ce que REFLUDAN et contenu de l ’ emballage extérieur Refludan est une poudre blanche pour solution injectable ou perfusion fournie dans un flacon contenant 20 mg de lépirudine . \n Refludan est disponible en boîtes de 1 ou 10 flacons . \n Fabricant CSL Behring GmbH , Emil-von-Behring-Straße 76 , 35041 Marburg , Germany . \n Refludan 50 mg en poudre pour solution injectable ou pour perfusion Lepirudine \n Les autres composants sont le mannitol ( E 421 ) et l ’ hydroxyde de sodium pour l ’ ajustement du pH . \n Qu ’ est-ce que REFLUDAN et contenu de l ’ emballage extérieur Refludan est une poudre blanche pour solution injectable ou perfusion fournie dans un flacon contenant 50 mg de lépirudine .\n" ], "offsets": [ [ 0, 5531 ] ] } ]

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"offsets": [ [ 311, 317 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T8", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 321, 327 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T9", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 333, 352 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T10", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 342, 352 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T11", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 361, 370 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_3_T12", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 391, 397 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T13", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 409, 419 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_3_T14", "type": "CHEM", "text": [ "eau" ], "offsets": [ [ 440, 443 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0043047" } ] }, { "id": "345_3_T15", "type": "CHEM", "text": [ "préparations injectables" ], "offsets": [ [ 449, 473 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T16", "type": "PROC", "text": [ "injectables" ], "offsets": [ [ 462, 473 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T17", "type": "OBJC", "text": [ "solution de chlorure de sodium" ], "offsets": [ [ 485, 515 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0036082" } ] }, { "id": "345_3_T18", "type": "CHEM", "text": [ "chlorure de sodium" ], "offsets": [ [ 497, 515 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037494" } ] }, { "id": "345_3_T19", "type": "PROC", "text": [ "dilution" ], "offsets": [ [ 546, 554 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0029740" } ] }, { "id": "345_3_T20", "type": "CHEM", "text": [ "solution reconstituée" ], "offsets": [ [ 606, 627 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C3199333" } ] }, { "id": "345_3_T21", "type": "CHEM", "text": [ "solutions" ], "offsets": [ [ 684, 693 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037633" } ] }, { "id": "345_3_T22", "type": "CHEM", "text": [ "particules" ], "offsets": [ [ 726, 736 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0597177" } ] }, { "id": "345_3_T23", "type": "DEVI", "text": [ "EMBALLAGE" ], "offsets": [ [ 776, 785 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013194" } ] }, { "id": "345_3_T24", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 840, 846 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T25", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 850, 856 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T26", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 862, 881 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T27", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 871, 881 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T28", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 890, 899 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_3_T29", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 904, 912 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T30", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 922, 928 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T31", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 934, 953 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T32", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 943, 953 ] ], "normalized": [ { 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] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0817096" } ] }, { "id": "345_3_T152", "type": "ANAT", "text": [ "cœur" ], "offsets": [ [ 3700, 3704 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0018787" } ] }, { "id": "345_3_T153", "type": "DISO", "text": [ "intervention chirurgicale" ], "offsets": [ [ 3717, 3742 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0549433" } ] }, { "id": "345_3_T154", "type": "DISO", "text": [ "saignement" ], "offsets": [ [ 3745, 3755 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T155", "type": "ANAT", "text": [ "cerveau" ], "offsets": [ [ 3769, 3776 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006104" } ] }, { "id": "345_3_T156", "type": "DISO", "text": [ "hémorragie" ], "offsets": [ [ 3785, 3795 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T157", "type": "DISO", "text": [ "hémorragie intracrânienne" ], "offsets": [ [ 3829, 3854 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0151699" } ] }, { "id": "345_3_T158", "type": "DISO", "text": [ "hémorragie" ], "offsets": [ [ 3829, 3839 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T159", "type": "ANAT", "text": [ "intracrânienne" ], "offsets": [ [ 3840, 3854 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0230041" } ] }, { "id": "345_3_T160", "type": "DISO", "text": [ "TIH de type II" ], "offsets": [ [ 3935, 3949 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0877016" } ] }, { "id": "345_3_T161", "type": "DISO", "text": [ "hémorragies" ], "offsets": [ [ 3975, 3986 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T162", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 4008, 4016 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_3_T163", "type": "DISO", "text": [ "hémorragies intracrâniennes" ], "offsets": [ [ 4024, 4051 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0151699" } ] }, { "id": "345_3_T164", "type": "DISO", "text": [ "hémorragies" ], "offsets": [ [ 4024, 4035 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T165", "type": "ANAT", "text": [ "intracrâniennes" ], "offsets": [ [ 4036, 4051 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0230041" } ] }, { "id": "345_3_T166", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 4069, 4077 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "345_3_T167", "type": "DISO", "text": [ "hémorragie" ], "offsets": [ [ 4086, 4096 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019080" } ] }, { "id": "345_3_T168", "type": "ANAT", "text": [ "sang" ], "offsets": [ [ 4147, 4151 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "345_3_T169", "type": "DISO", "text": [ "pression artérielle basse" ], "offsets": [ [ 4168, 4193 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0020649" } ] }, { "id": "345_3_T170", "type": "DISO", "text": [ "état de choc" ], "offsets": [ [ 4199, 4211 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0036974" } ] }, { "id": "345_3_T171", "type": "CHEM", "text": [ "REFLUDAN" ], "offsets": [ [ 4280, 4288 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T172", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 4304, 4310 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T173", "type": "DEVI", "text": [ "emballage" ], "offsets": [ [ 4320, 4329 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013194" } ] }, { "id": "345_3_T174", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 4360, 4368 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T175", "type": "OBJC", "text": [ "solution" ], "offsets": [ [ 4375, 4383 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037633" } ] }, { "id": "345_3_T176", "type": "CHEM", "text": [ "particules" ], "offsets": [ [ 4425, 4435 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0597177" } ] }, { "id": "345_3_T177", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 4463, 4471 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T178", "type": "OBJC", "text": [ "solution" ], "offsets": [ [ 4514, 4522 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037633" } ] }, { "id": "345_3_T179", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 4605, 4615 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_3_T180", "type": "CHEM", "text": [ "ADN recombinant" ], "offsets": [ [ 4666, 4681 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012931" } ] }, { "id": "345_3_T181", "type": "CHEM", "text": [ "cellules de levure" ], "offsets": [ [ 4694, 4712 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0669253" } ] }, { "id": "345_3_T182", "type": "ANAT", "text": [ "cellules" ], "offsets": [ [ 4694, 4702 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007634" } ] }, { "id": "345_3_T183", "type": "LIVB", "text": [ "levure" ], "offsets": [ [ 4706, 4712 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0043393" } ] }, { "id": "345_3_T184", "type": "CHEM", "text": [ "mannitol" ], "offsets": [ [ 4747, 4755 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024730" } ] }, { "id": "345_3_T185", "type": "CHEM", "text": [ "hydroxyde de sodium" ], "offsets": [ [ 4773, 4792 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037517" } ] }, { "id": "345_3_T186", "type": "CHEM", "text": [ "REFLUDAN" ], "offsets": [ [ 4839, 4847 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T187", "type": "DEVI", "text": [ "emballage" ], "offsets": [ [ 4866, 4875 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013194" } ] }, { "id": "345_3_T188", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 4886, 4894 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T189", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 4903, 4909 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T190", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 4923, 4942 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T191", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 4932, 4942 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T192", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 4946, 4955 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_3_T193", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 4972, 4978 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T194", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 4998, 5008 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_3_T195", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 5013, 5021 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T196", "type": "OBJC", "text": [ "boîtes" ], "offsets": [ [ 5040, 5046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179400" } ] }, { "id": "345_3_T197", "type": "OBJC", "text": [ "flacons" ], "offsets": [ [ 5058, 5065 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T198", "type": "ANAT", "text": [ "sanguins" ], "offsets": [ [ 1657, 1665 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "345_3_T199", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 5156, 5164 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T200", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 5174, 5180 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T201", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 5186, 5205 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T202", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 5195, 5205 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T203", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 5214, 5223 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_3_T204", "type": "CHEM", "text": [ "Lepirudine" ], "offsets": [ [ 5224, 5234 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_3_T205", "type": "CHEM", "text": [ "mannitol" ], "offsets": [ [ 5267, 5275 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024730" } ] }, { "id": "345_3_T206", "type": "CHEM", "text": [ "hydroxyde de sodium" ], "offsets": [ [ 5293, 5312 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037517" } ] }, { "id": "345_3_T207", "type": "CHEM", "text": [ "REFLUDAN" ], "offsets": [ [ 5359, 5367 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T208", "type": "DEVI", "text": [ "emballage" ], "offsets": [ [ 5386, 5395 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013194" } ] }, { "id": "345_3_T209", "type": "CHEM", "text": [ "Refludan" ], "offsets": [ [ 5406, 5414 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0661608" } ] }, { "id": "345_3_T210", "type": "CHEM", "text": [ "poudre" ], "offsets": [ [ 5423, 5429 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032861" } ] }, { "id": "345_3_T211", "type": "CHEM", "text": [ "solution injectable" ], "offsets": [ [ 5443, 5462 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086466" } ] }, { "id": "345_3_T212", "type": "PROC", "text": [ "injectable" ], "offsets": [ [ 5452, 5462 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "345_3_T213", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 5466, 5475 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031001" } ] }, { "id": "345_3_T214", "type": "OBJC", "text": [ "flacon" ], "offsets": [ [ 5492, 5498 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0179376" } ] }, { "id": "345_3_T215", "type": "CHEM", "text": [ "lépirudine" ], "offsets": [ [ 5518, 5528 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0772394" } ] }, { "id": "345_3_T216", "type": "DISO", "text": [ "TIH" ], "offsets": [ [ 1965, 1968 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0272285" } ] }, { "id": "345_3_T217", "type": "DISO", "text": [ "TIH" ], "offsets": [ [ 1815, 1818 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0272285" } ] }, { "id": "345_3_T218", "type": "DISO", "text": [ "sang dans les urines" ], "offsets": [ [ 3533, 3553 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0018965" } ] }, { "id": "345_3_T219", "type": "DISO", "text": [ "saignement au niveau du cerveau" ], "offsets": [ [ 3745, 3776 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0553692" } ] }, { "id": "345_3_T220", "type": "DISO", "text": [ "saignement", "autour du cœur" ], "offsets": [ [ 3651, 3661 ], [ 3690, 3704 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1390172" } ] }, { "id": "345_3_T221", "type": "DISO", "text": [ "saignement au niveau de la poitrine" ], "offsets": [ [ 3651, 3686 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1390061" } ] }, { "id": "345_3_T222", "type": "CHEM", "text": [ "coumariniques" ], "offsets": [ [ 2634, 2647 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0010206" } ] }, { "id": "345_3_T223", "type": "CHEM", "text": [ "E 421" ], "offsets": [ [ 5278, 5283 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024730" } ] }, { "id": "345_3_T224", "type": "CHEM", "text": [ "E 421" ], "offsets": [ [ 4758, 4763 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024730" } ] } ]

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[ { "id": "425_1__text", "type": "abstract", "text": [ "EMEA / H / C / 603 \n TYSABRI \n Qu ’ est-ce que Tysabri ? \n Tysabri est une solution à diluer pour perfusion ( goutte-à-goutte dans une veine ). \n\n Il contient le principe actif natalizumab . \n Dans quel cas Tysabri est-il utilisé ? \n Tysabri est utilisé dans le traitement des adultes atteints de sclérose en plaques ( SEP ). \n Comment Tysabri est-il utilisé ? \n Le traitement par Tysabri doit être mis en place et surveillé par un médecin expérimenté dans le traitement des maladies du système nerveux , et qui a accès à un certain type de scanner , appelé appareil d ’ imagerie par résonance magnétique ( IRM ). \n Cette machine permettra au médecin de surveiller tout changement dans le cerveau lié à la SEP ou à une infection rare du cerveau , appelée leucoencéphalite multifocale progressive ( LEMP ). \n Tysabri est administré en perfusion d ’ une durée d ’ une heure toutes les quatre semaines . \n La perfusion étant susceptible de provoquer une réaction allergique , le patient doit être surveillé pendant toute la durée de la perfusion et pendant l ’ heure qui suit . \n Si le patient ne présente aucun signe de bénéfice évident après six mois , le médecin devra réévaluer le traitement . \n Les patients traités par Tysabri doivent recevoir une carte d ’ alerte spéciale qui résume les principales informations sur la sécurité du médicament . \n Le patient doit montrer cette carte à son partenaire ou à son aide-soignant , ainsi qu ’ à ses autres médecins , car ceux-ci sont susceptibles de remarquer des symptômes de LEMP dont le patient n ’ est pas conscient , tels que des variations d ’ humeur , de comportement ou de langage . \n Les effets de Tysabri ont d ’ abord été testés sur des modèles expérimentaux avant d ’ être étudiés chez l ’ homme . \n Deux études , toutes deux d ’ une durée de deux ans , ont permis d ’ évaluer Tysabri dans la SEP . \n L ’ une de ces études a comparé Tysabri administré seul ( monothérapie ) à un placebo ( un traitement fictif ) chez 942 patients . \n Les principaux critères d ’ évaluation de l ’ efficacité étaient le nombre de rechutes et l ’ évolution du degré d ’ handicap des patients , mesuré à l ’ aide de l ’ échelle d ’ évaluation du handicap ( Expanded Disability Status Scale ). \n Quel est le bénéfice démontré par Tysabri au cours des études ? \n Tysabri s ’ est également révélé plus efficace qu ’ un placebo sur les effets handicapants de la SEP : en deux ans , le risque d ’ aggravation du handicap a été réduit de 42 % par rapport à un placebo . \n Les patients , leurs aides-soignants et les médecins doivent être conscients que Tysabri peut être lié à des infections , notamment une LEMP . \n La LEMP présente des symptômes similaires à ceux ressentis lors d ’ une poussée de SEP et entraîne généralement un handicap grave ou le décès . \n En cas de suspicion de LEMP , le médecin doit arrêter le traitement jusqu ’ à ce qu ’ il soit établi avec certitude que le patient ne souffre pas de cette infection . \n Au cours des études , les effets indésirables les plus couramment observés sous Tysabri ( chez un à dix patients sur 100 ) étaient les suivants : infections des voies urinaires ( infection des structures véhiculant l ’ urine ), rhinopharyngite ( inflammation du nez et de la gorge ), urticaire ( éruption cutanée ), maux de tête , vertiges , vomissements , nausée , arthralgie ( douleurs articulaires ), frissons , pyrexie ( fièvre ) et fatigue . \n Pour une description complète des effets indésirables observés sous Tysabri , voir la notice . \n Tysabri ne doit pas être utilisé chez les personnes pouvant présenter une hypersensibilité ( allergie ) au natalizumab ou à l ’ un des autres composants . \n Il ne doit pas être administré à des patients souffrant de LEMP ou à des patients présentant un risque d ’ infection , y compris les patients immunodéprimés par leur maladie ou un autre traitement actuel ou antérieur . \n Tysabri ne doit pas être associé à l ’ interféron bêta ou à l ’ acétate de glatiramère ( d ’ autres médicaments utilisés dans le traitement de longue durée de la SEP ). \n Il ne doit pas non plus être prescrit à des patients atteints de cancer ( sauf dans le cas d ’ un type de cancer de la peau appelé carcinome baso-cellulaire ), ni à des sujets de moins de 18 ans . \n 2 / 3 Pourquoi Tysabri a-t-il été approuvé ? \n Le comité a recommandé l ’ octroi d ’ une autorisation de mise sur le marché pour Tysabri . \n Quelles sont les mesures prises pour assurer la sécurité de Tysabri ? \n La société fabricant Tysabri s ’ assurera que tous les médecins prescrivant Tysabri ont reçu un kit d ’ informations comportant toutes les données dont ils ont besoin pour être sûrs que ce médicament est utilisé correctement et que les patients sont étroitement surveillés . \n Autres informations relatives à Tysabri : \n La Commission européenne a délivré une autorisation de mise sur le marché valide dans toute l ’ Union européenne pour Tysabri à Elan Pharma International Ltd , le 27 juin 2006 . \n L ’ EPAR complet relatif à Tysabri est disponible : ici . \n Tysabri \n TYSABRI 300 mg solution à diluer pour perfusion . \n Chaque ml de solution à diluer contient 20 mg de natalizumab . \n Le natalizumab est un anticorps anti-α 4 - intégrine humanisé recombinant , produit dans une lignée cellulaire murine par génie génétique . \n Après dilution ( voir rubrique 6 . 6 ), la solution pour perfusion contient environ 2 , 6 mg / ml de natalizumab . \n TYSABRI est indiqué en monothérapie comme traitement de fond des formes très actives de sclérose en plaques ( SEP ) rémittente-récurrente pour les groupes de patients suivants : \n • Patients présentant une forme très active de la maladie malgré un traitement par interféron bêta ( voir rubrique 5 . 1 ); \n • Patients présentant une sclérose en plaques rémittente-récurrente sévère d ’ évolution rapide ( voir rubrique 5 . 1 ). \n Le traitement par TYSABRI doit être instauré et surveillé par des médecins spécialistes , ayant l ’ expérience du diagnostic et du traitement des affections neurologiques , dans des centres bénéficiant d ’ un accès rapide à l \n Les patients traités par TYSABRI doivent recevoir une carte patient spéciale . \n Le matériel nécessaire à la prise en charge d ’ éventuelles réactions d ’ hypersensibilité ainsi qu ’ un accès à l ’ IRM devront être disponibles . \n Par conséquent , le médecin devra vérifier l ’ absence d ’ immunosuppression avant l ’ instauration du traitement par TYSABRI . \n La poursuite du traitement devra être reconsidérée soigneusement chez les patients ne présentant aucun signe de bénéfice thérapeutique au-delà de 6 mois . \n On ne dispose pas de données sur la sécurité et l ’ efficacité du natalizumab au-delà de 2 ans . \n La prolongation du traitement après ce délai ne devra être envisagée qu ’ après une ré-évaluation du rapport bénéfice-risque . \n\n\n" ], "offsets": [ [ 0, 6823 ] ] } ]

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"db_id": "C0023524" } ] }, { "id": "425_1_T52", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 1511, 1520 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_1_T53", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 1537, 1544 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_1_T54", "type": "DISO", "text": [ "variations d ’ humeur" ], "offsets": [ [ 1582, 1603 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0525045" } ] }, { "id": "425_1_T55", "type": "DISO", "text": [ "comportement" ], "offsets": [ [ 1609, 1621 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0004930" } ] }, { "id": "425_1_T56", "type": "DISO", "text": [ "langage" ], "offsets": [ [ 1628, 1635 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023015" } ] }, { "id": "425_1_T57", "type": "CHEM", "text": [ "Tysabri" ], "offsets": [ [ 1654, 1661 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_1_T58", "type": "LIVB", "text": [ "homme" ], "offsets": [ [ 1749, 1754 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086418" } ] }, { "id": "425_1_T59", "type": "PROC", "text": [ "études" ], "offsets": [ [ 1764, 1770 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_1_T60", "type": "CHEM", "text": [ "Tysabri" ], "offsets": [ [ 1836, 1843 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_1_T61", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 1852, 1855 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_1_T62", "type": "PROC", "text": [ "études" ], "offsets": [ [ 1875, 1881 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_1_T63", "type": "CHEM", "text": [ "Tysabri" ], "offsets": [ [ 1892, 1899 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_1_T64", "type": "CHEM", "text": [ "placebo" ], "offsets": [ [ 1938, 1945 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1696465" } ] }, { "id": "425_1_T65", "type": "PROC", "text": [ "traitement fictif" ], "offsets": [ [ 1951, 1968 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0032042" } ] }, { "id": "425_1_T66", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1951, 1961 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_1_T67", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1980, 1988 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_1_T68", "type": "PHEN", "text": [ "rechutes" ], "offsets": [ [ 2071, 2079 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0035020" } ] }, { "id": "425_1_T69", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2123, 2131 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_1_T70", "type": "DISO", "text": [ "handicap" ], "offsets": [ [ 2185, 2193 ] ], "normalized": [ { "db_name": "UMLS", "db_id": 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"maladie" ], "offsets": [ [ 5649, 5656 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "425_1_T185", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 5667, 5677 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_1_T186", "type": "CHEM", "text": [ "interféron bêta" ], "offsets": [ [ 5682, 5697 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015980" } ] }, { "id": "425_1_T187", "type": "LIVB", "text": [ "Patients" ], "offsets": [ [ 5727, 5735 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_1_T188", "type": "DISO", "text": [ "sclérose en plaques" ], "offsets": [ [ 5751, 5770 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_1_T189", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 5851, 5861 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_1_T190", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 5866, 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[ { "id": "425_2__text", "type": "abstract", "text": [ "\n\n TYSABRI 300 mg est administré en perfusion intraveineuse une fois toutes les 4 semaines . \n TYSABRI n ’ est pas recommandé chez les sujets âgés de plus de 65 ans en raison de l ’ absence de données dans cette population . \n TYSABRI est contre indiqué chez les enfants et les adolescents ( voir rubrique 4 . 3 ). \n Aucune étude n ’ a été effectuée pour examiner les effets d ’ une insuffisance rénale ou hépatique . \n Le mécanisme d ’ élimination et les résultats des études de pharmacocinétique de populations suggèrent qu ’ il n ’ est pas nécessaire d ’ ajuster la posologie en cas d ’ insuffisance rénale ou hépatique . \n L ’ efficacité d ’ une réadministration n ’ a pas été établie ; pour la sécurité d ’ emploi , voir rubrique 4 . 4 \n Hypersensibilité au natalizumab ou à l ’ un des excipients . \n Leucoencéphalopathie multifocale progressive ( LEMP ). \n Patients présentant un risque accru d ’ infections opportunistes , y compris patients immunodéprimés ( patients sous traitement immunosuppresseur ou patients immunodéprimés par des traitement s antérieurs , par exemple mitoxantrone ou cyclophosphamide , voir également les rubriques 4 . 4 et 4 . 8 ). \n Association avec les interférons bêta ou l ’ acétate de glatiramère . \n Cancers diagnostiqués en évolution , à l ’ exception des carcinomes cutanés baso-cellulaires . \n Leucoencéphalopathie multifocale progressive ( LEMP ) \n Un examen d ’ imagerie par résonance magnétique ( IRM ) récent ( effectué généralement dans les 3 mois précédents ) doit être disponible préalablement à l ’ instauration du traitement par TYSABRI . \n Les patients doivent être surveillés à intervalles réguliers , afin de détecter l ’ apparition ou l ’ aggravation de symptômes ou de signes neurologiques pouvant évoquer une LEMP . \n Le médecin devra examiner soigneusement le patient pour déterminer si les symptômes indiquent un dysfonctionnement neurologique , et si c ’ est le cas il devra établir si ces symptômes sont typiques d ’ une SEP ou évocateurs d ’ une LEMP . \n En cas de doute , des examens complémentaires , notamment une IRM , de préférence avec produit de contraste ( à comparer avec l ’ IRM réalisée avant traitement ) et un dosage de l ’ ADN du virus JC dans le LCR ainsi que des examens neurologiques répétés devront être envisagés , tels que décrits dans le Guide de Prescription pour la prise en charge des patients présentant une sclérose en plaques et traités par TYSABRI ( voir conduite éducative ). \n Le traitement par natalizumab ne pourra redémarrer qu ’ après exclusion du diagnostic de LEMP ( si nécessaire après avoir réitéré les examens cliniques , d ’ imagerie et / ou biologiques si un doute clinique subsiste ). \n Le médecin devra être particulièrement attentif à l ’ apparition de symptômes évocateurs d ’ une LEMP que le patient pourrait ne pas remarquer ( par exemple , symptômes cognitifs ou psychiatriques ). \n En cas d ’ apparition d ’ une LEMP , le traitement par TYSABRI devra être arrêté définitivement . \n Après reconstitution du système immunitaire chez les patients immunodéprimés ayant une LEMP , on a observé une stabilisation ou une amélioration de l ’ évolution ( voir rubrique 5 . 2 ). \n Actuellement on ne sait pas si la détection précoce d ’ une LEMP et l ’ arrêt du traitement par TYSABRI peuvent conduire à une telle stabilisation ou amélioration de l ’ évolution . \n Autres infections opportunistes \n Des infections opportunistes ont également été décrites chez des patients souffrant de SEP et traités par TYSABRI en monothérapie ( voir rubrique 4 . 8 ). \n En cas de suspicion d ’ infection opportuniste , le traitement par TYSABRI devra être suspendu jusqu ’ à ce que la présence d ’ une telle infection soit exclue à la suite d ’ examens complémentaires . \n La survenue d ’ une infection opportuniste sous TYSABRI doit conduire à l ’ arrêt définitif du traitement . \n 4 Tous les médecins ayant l ’ intention de prescrire TYSABRI doivent avoir pris connaissance du Guide de Prescription pour la prise en charge des patients présentant une sclérose en plaques et traités par TYSABRI . \n Les patients devront être informés qu ’ en cas d ’ apparition d ’ une quelconque infection , ils devront prévenir leur médecin qu ’ ils sont traités par TYSABRI . \n Les médecins doivent informer les patients de l ’ importance de ne pas interrompre le traitement , particulièrement lors des premiers mois de traitement ( voir rubrique Hypersensibilité ). \n Des réactions d ’ hypersensibilité ont été associées à l ’ utilisation de TYSABRI , elles peuvent être des réactions systémiques graves ( voir rubrique 4 . 8 ). \n Ces réactions surviennent généralement pendant la perfusion ou dans l ’ heure qui suit la fin de la perfusion . \n Le risque de réactions d ’ hypersensibilité a été plus important au cours des premières perfusions ainsi que chez les patients recevant de nouveau TYSABRI après une exposition initiale courte ( une ou deux perfusions ) suivie d ’ une période prolongée sans traitement ( trois mois ou plus ). \n Néanmoins ce risque de réactions d ’ hypersensibilité doit être envisagé à chaque perfusion . \n Le matériel nécessaire à la prise en charge d ’ éventuelles réactions d ’ hypersensibilité devra être disponible . \n Le traitement par TYSABRI devra être interrompu et un traitement approprié devra être instauré dès les premiers signes ou symptômes d ’ hypersensibilité . \n Les patients ayant présenté une réaction d ’ hypersensibilité doivent arrêter définitivement le traitement par TYSABRI . \n Traitement associé ou traitement antérieur par immunosuppresseurs \n L ’ efficacité et la tolérance de TYSABRI en association à d ’ autres traitements immunosuppresseurs ou anticancéreux n ’ ont pas été totalement établies . \n L ’ utilisation concomitante de ces médicaments avec TYSABRI est susceptible de majorer le risque d ’ infections , y compris les infections opportunistes , et est par conséquent contre-indiquée ( voir rubrique 4 . 3 ). \n Les patients ayant reçu un traitement antérieur par immunosuppresseurs , ( dont cyclophosphamide et mitoxantrone ), peuvent présenter une immunosuppression prolongée et donc un risque accru de LEMP . \n Chez les patients ayant reçu un traitement antérieur par immunosuppresseur , il faudra veiller à laisser un délai suffisant pour permettre la reconstitution du système immunitaire . \n Avant de débuter le traitement par TYSABRI , les médecins devront évaluer chaque cas individuellement pour mettre en évidence une éventuelle immunosuppression ( voir rubrique 4 . 3 ). \n Au cours des études cliniques de Phase 3 réalisées dans la SEP , le traitement concomitant des poussées par des corticoïdes sur une courte période n ’ a pas été associé à une augmentation du taux des infections . \n Des cures courtes de corticoïdes peuvent être administrées en association avec TYSABRI . \n Une aggravation de la maladie ou la survenue d ’ évènements liés à la perfusion peuvent faire suspecter le développement d ’ anticorps anti - natalizumab . \n Il conviendra chez ces patients de détecter la présence d ’ anticorps avant la reprise du traitement ; en cas de résultat positif confirmé par un second test effectué 6 semaines plus tard , le traitement ne devra pas être réintroduit . \n Des troubles hépatiques graves ont été rapportés spontanément depuis la mise sur le marché de Tysabri . \n Ces troubles hépatiques peuvent survenir à tout moment au cours du traitement , même après la première perfusion . \n La fonction biologique hépatique des patients traités doit être surveillée de façon appropriée ; les patients doivent être avertis de la nécessité de contacter leur médecin en cas de survenue de signes ou symptômes évocateurs de troubles hépatiques tels qu \n En cas de troubles hépatiques significatifs , le traitement par TYSABRI devra être arrêté . \n Arrêt du traitement par TYSABRI \n En cas de décision d ’ arrêt du traitement , le médecin doit être averti que le natalizumab reste présent dans le sang et a des effets pharmacodynamiques ( par exemple , augmentation des lymphocytes ) pendant environ 12 semaines après la dernière administration . \n\n\n" ], "offsets": [ [ 0, 8104 ] ] } ]

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263, 270 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0008059" } ] }, { "id": "425_2_T8", "type": "LIVB", "text": [ "adolescents" ], "offsets": [ [ 278, 289 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0205653" } ] }, { "id": "425_2_T9", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 324, 329 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_2_T10", "type": "DISO", "text": [ "insuffisance rénale" ], "offsets": [ [ 383, 402 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1565489" } ] }, { "id": "425_2_T11", "type": "ANAT", "text": [ "rénale" ], "offsets": [ [ 396, 402 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0022646" } ] }, { "id": "425_2_T12", "type": "DISO", "text": [ "hépatique" ], "offsets": [ [ 406, 415 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1306571" } ] }, { "id": "425_2_T13", "type": "ANAT", "text": [ "hépatique" ], "offsets": [ [ 406, 415 ] ], "normalized": [ { "db_name": "UMLS", "db_id": 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[ { "id": "425_3__text", "type": "abstract", "text": [ "\n\n L ’ instauration d ’ autres traitements au cours de cette période conduira donc à une exposition concomitante au natalizumab . \n Au cours des essais cliniques , une exposition concomitante de cette durée à l ’ interféron ou à l ’ acétate de glatiramère n ’ a pas été associée à des problèmes de sécurité . \n Il n ’ existe actuellement aucune donnée sur l ’ exposition concomitante aux immunosuppresseurs chez les patients souffrant de SEP . \n L ’ utilisation de ces médicaments peu après l ’ arrêt du natalizumab peut conduire à un effet immunosuppresseur additif . \n Ceci devra être considéré avec attention , au cas par cas et l ’ instauration d ’ une fenêtre thérapeutique pourrait être appropriée . \n Au cours des essais cliniques , le traitement des poussées par des corticoïdes sur une courte période n ’ a pas été associé à une augmentation du taux des infections . \n Le natalizumab ne doit pas être administré au cours de la grossesse sauf en cas de nécessité absolue . \n En cas de grossesse débutant sous TYSABRI , l ’ arrêt de TYSABRI devra être envisagé . \n Le passage de TYSABRI dans le lait maternel n ’ est pas connu , cependant il a été observé chez l ’ animal ( voir rubrique 5 . 3 ). \n Par conséquent , les femmes traitées par TYSABRI ne doivent pas allaiter . \n Compte tenu du mécanisme d ’ action pharmacologique du natalizumab , l ’ utilisation de TYSABRI ne devrait pas modifier l ’ aptitude du patient à conduire des véhicules ou à utiliser des machines . \n Dans les études contrôlées contre placebo réalisées chez 1 617 patients souffrant de SEP et traités par natalizumab pendant un maximum de 2 ans ( placebo : \n 6 à l ’ arrêt du traitement se sont produits chez 5 , 8 % des patients sous natalizumab ( placebo : \n Pendant les deux années de ces études , 43 , 5 % des patients traités par le natalizumab ont présenté des effets indésirables liés au médicament ( placebo : \n Les effets indésirables liés au médicament , rapportés sous natalizumab avec une incidence supérieure de 0 , 5 % par rapport au placebo , sont présentés ci-dessous . \n Les fréquences ont été définies comme suit : \n Fréquent ( ≥ 1 / 100 , à \n Affections musculo-squelettiques et systémiques Fréquent \n Dans les études cliniques contrôlées réalisées sur 2 ans chez des patients atteints de SEP , un événement lié à la perfusion a été défini comme un événement indésirable survenant pendant la perfusion ou dans l ’ heure suivant l ’ arrêt de celle-ci . \n Ce type d ’ événement s ’ est produit chez 23 , 1 % des patients souffrant de SEP traités par natalizumab ( placebo : \n Les événements qui ont été rapportés plus souvent sous natalizumab que sous placebo comportaient : sensations vertigineuses , nausées , urticaire et frissons . \n Au cours des études cliniques contrôlées réalisées sur 2 ans chez des patients atteints de SEP , des réactions d ’ hypersensibilité sont survenues chez 4 % des patients . \n Des anticorps anti - natalizumab ont été décelés chez 10 % des patients au cours des études contrôlées réalisées sur 2 ans chez des patients atteints de SEP . \n Des anticorps ont été détectés à une seule reprise chez 4 % des patients . \n La présence des anticorps persistants a été associée à une diminution importante de l ’ efficacité de TYSABRI et à une augmentation de la fréquence des réactions d ’ hypersensibilité . \n Les autres réactions liées à la perfusion et associées à la présence d ’ anticorps persistants ont comporté : frissons , nausées , vomissements et bouffées vasomotrices ( voir rubrique 4 . 4 ). \n Lorsqu ’ après environ 6 mois de traitement , la présence d ’ anticorps persistants est suspectée , du fait d ’ une diminution de l ’ efficacité , ou de la survenue d ’ évènements liés à la perfusion , une recherche des anticorps sera effectuée et le résultat positif devra être confirmé par un second test effectué 6 semaines plus tard . \n Etant donné que la présence de ces anticorps peut être associée à une diminution de l ’ efficacité du traitement et à une augmentation des réactions d ’ hypersensibilité ou des réactions liées à la perfusion , il conviendra d ’ interrompre le traitement chez les patients porteurs d ’ anticorps persistants . \n Infections , y compris LEMP et infections opportunistes \n Dans d ’ autres études cliniques , d ’ autres cas d ’ infections opportunistes ont été rapportés , certains ont été fatals . \n Dans les études cliniques , la survenue d ’ infections herpétiques ( virus Varicelle-Zona , virus Herpès-Simplex ) a été un peu plus fréquente chez les patients traités par natalizumab que chez les patients sous placebo . \n Après commercialisation , des cas graves ont été rapportés , dont un cas fatal d ’ encéphalite herpétique . \n La majorité des patients n ’ a pas interrompu le traitement par natalizumab au cours des infections et leur guérison a été obtenue par un traitement approprié . \n Des cas de LEMP ont été rapportés au cours des études cliniques . \n Cette leucoencéphalopathie entraîne généralement un handicap sévère ou le décès ( voir rubrique 4 . 4 ). \n Deux cas , dont un mortel , sont survenus au cours des études pivots chez les patients souffrant de SEP et ayant reçu un traitement concomitant par interféron bêta - 1a pendant plus de 2 ans . \n Par ailleurs , au cours d ’ un autre essai , une LEMP ayant entraîné le décès est survenue chez un patient atteint de la maladie de Crohn , qui avait reçu antérieurement de manière prolongée des traitements immunosuppresseurs et qui présentait une lymphopénie associée . \n Des cas de LEMP chez des patients ayant reçu TYSABRI en monothérapie ont été rapportés après commercialisation . \n Des cas de troubles hépatiques graves , des cas d ’ augmentation des enzymes hépatiques , et d ’ hyperbilirubinémie , ont été rapportés spontanément depuis la mise sur le marché de Tysabri ( voir rubrique 4 . 4 ). \n Effets sur les paramètres biologiques \n Ces augmentations étaient comprises entre 35 % et 140 % pour les types cellulaires individuels ( lymphocytes , monocytes , éosinophiles et basophiles ), mais les numérations moyennes sont restées comprises dans les limites de la normale . \n Le traitement par TYSABRI a également été associé à de faibles diminutions de l ’ hémoglobine ( diminution moyenne de 0 , 6 g / dl ), de l ’ hématocrite ( diminution moyenne de 2 %) et des érythrocytes ( diminution moyenne de 0 , 1 x 106 / l ). \n Ces anomalies n ’ ont pas été associées à des symptômes cliniques et les paramètres hématologiques se sont normalisés généralement dans les 16 semaines après la dernière administration de TYSABRI . \n Agent immunosuppresseur sélectif , code ATC : \n Il se fixe sur la sous-unité α 4 des intégrines humaines , fortement exprimée à la surface de tous les leucocytes , à l ’ exception des neutrophiles . \n Plus spécifiquement , le natalizumab se lie à l ’ intégrine α 4β 1 en bloquant l ’ interaction de cette molécule avec son récepteur , la molécule VCAM - 1 ( vascular cell adhesion molecule - 1 ) et les ligands ostéopontine , ainsi qu ’ un variant d ’ épissage de la fibronectine , le CS - 1 ( connecting segment - 1 ). \n Le natalizumab bloque l ’ interaction de l ’ intégrine α 4β 7 avec la molécule MadCAM - 1 ( mucosal addressin cell adhesion molecule - 1 ). \n L ’ inhibition de ces interactions moléculaires empêche la transmigration des leucocytes mononucléés à travers l ’ endothélium vers les tissus parenchymateux inflammatoires . \n Un autre mécanisme d ’ action du natalizumab pourrait être de supprimer les réactions inflammatoires en cours dans les tissus pathologiques en inhibant les interactions des leucocytes exprimant la sous-unité α 4 avec leurs ligands dans la matrice extracellulaire et sur les cellules parenchymateuses . \n Par conséquent , le natalizumab pourrait agir en supprimant l ’ activité inflammatoire au site de la maladie et en inhibant le recrutement ultérieur de cellules immunitaires dans les tissus inflammatoires . \n Il semble que , dans la SEP , les lésions apparaissent lorsque les lymphocytes T activés traversent la barrière hémato-encéphalique ( BHE ). \n\n\n" ], "offsets": [ [ 0, 8065 ] ] } ]

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"normalized": [ { "db_name": "UMLS", "db_id": "C0011065" } ] }, { "id": "425_3_T140", "type": "PROC", "text": [ "études" ], "offsets": [ [ 5095, 5101 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_3_T141", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 5118, 5126 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_3_T142", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 5140, 5143 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_3_T143", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 5161, 5171 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_3_T144", "type": "CHEM", "text": [ "interféron bêta - 1a" ], "offsets": [ [ 5188, 5208 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0254119" } ] }, { "id": "425_3_T145", "type": "CHEM", "text": [ "interféron" ], "offsets": [ [ 5188, 5198 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021747" } ] }, { "id": "425_3_T146", "type": "PROC", "text": [ "essai" ], "offsets": [ [ 5272, 5277 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_3_T147", "type": "DISO", "text": [ "LEMP" ], "offsets": [ [ 5284, 5288 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_3_T148", "type": "PHYS", "text": [ "décès" ], "offsets": [ [ 5307, 5312 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0011065" } ] }, { "id": "425_3_T149", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 5334, 5341 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_3_T150", "type": "DISO", "text": [ "maladie de Crohn" ], "offsets": [ [ 5356, 5372 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0010346" } ] }, { "id": "425_3_T151", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 5356, 5363 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "425_3_T152", "type": "PROC", "text": [ "traitements" ], "offsets": [ [ 5430, 5441 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013216" } ] }, { "id": "425_3_T153", "type": "CHEM", "text": [ "immunosuppresseurs" ], "offsets": [ [ 5442, 5460 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021081" } ] }, { "id": "425_3_T154", "type": "DISO", "text": [ "lymphopénie" ], "offsets": [ [ 5483, 5494 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024312" } ] }, { "id": "425_3_T155", "type": "DISO", "text": [ "LEMP" ], "offsets": [ [ 5519, 5523 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_3_T156", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 5533, 5541 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_3_T157", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 5553, 5560 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_3_T158", "type": "DISO", "text": [ "troubles hépatiques" ], "offsets": [ [ 5634, 5653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086565" } ] }, { "id": "425_3_T159", "type": "ANAT", "text": [ "hépatiques" ], "offsets": [ [ 5643, 5653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023884" } ] }, { "id": "425_3_T160", "type": "CHEM", "text": [ "enzymes hépatiques" ], "offsets": [ [ 5692, 5710 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0443764" } ] }, { "id": "425_3_T161", "type": "ANAT", "text": [ "hépatiques" ], "offsets": [ [ 5700, 5710 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023884" } ] }, { "id": "425_3_T162", "type": "DISO", "text": [ "hyperbilirubinémie" ], "offsets": [ [ 5720, 5738 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0020433" } ] }, { "id": "425_3_T163", "type": "CHEM", "text": [ "Tysabri" ], "offsets": [ [ 5804, 5811 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_3_T164", "type": "ANAT", "text": [ "lymphocytes" ], "offsets": [ [ 5976, 5987 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024264" } ] }, { "id": "425_3_T165", "type": "ANAT", "text": [ "monocytes" ], "offsets": [ [ 5990, 5999 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026473" } ] }, { "id": "425_3_T166", "type": "ANAT", "text": [ "éosinophiles" ], "offsets": [ [ 6002, 6014 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0014467" } ] }, { "id": "425_3_T167", "type": "ANAT", "text": [ "basophiles" ], "offsets": [ [ 6018, 6028 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0004827" } ] }, { "id": "425_3_T168", "type": "PROC", "text": [ "numérations" ], "offsets": [ [ 6041, 6052 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007584" } ] }, { "id": "425_3_T169", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 6123, 6133 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_3_T170", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 6138, 6145 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_3_T171", "type": "CHEM", "text": [ "hémoglobine" ], "offsets": [ [ 6202, 6213 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0019046" } ] }, { "id": "425_3_T172", "type": "PROC", "text": [ "administration" ], "offsets": [ [ 6537, 6551 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C3469597" } ] }, { "id": "425_3_T173", "type": "PROC", "text": [ "hématocrite" ], "offsets": [ [ 6261, 6272 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0518014" } ] }, { "id": "425_3_T174", "type": "ANAT", "text": [ "érythrocytes" ], "offsets": [ [ 6309, 6321 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0014792" } ] }, { "id": "425_3_T175", "type": "DISO", "text": [ "symptômes cliniques" ], "offsets": [ [ 6413, 6432 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037088" } ] }, { "id": "425_3_T176", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 6413, 6422 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_3_T177", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 6555, 6562 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_3_T178", "type": "CHEM", "text": [ "Agent immunosuppresseur" ], "offsets": [ [ 6567, 6590 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021081" } ] }, { "id": "425_3_T179", "type": "CHEM", "text": [ "intégrines" ], "offsets": [ [ 6652, 6662 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021701" } ] }, { "id": "425_3_T180", "type": "LIVB", "text": [ "humaines" ], "offsets": [ [ 6663, 6671 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0086418" } ] }, { "id": "425_3_T181", "type": "ANAT", "text": [ "leucocytes" ], "offsets": [ [ 6718, 6728 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023516" } ] }, { "id": "425_3_T182", "type": "ANAT", "text": [ "neutrophiles" ], "offsets": [ [ 6751, 6763 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027950" } ] }, { "id": "425_3_T183", "type": "CHEM", "text": [ "natalizumab" ], "offsets": [ [ 6793, 6804 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1172734" } ] }, { "id": "425_3_T184", "type": "CHEM", "text": [ "intégrine" ], "offsets": [ [ 6818, 6827 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021701" } ] }, { "id": "425_3_T185", "type": "PHYS", "text": [ "interaction" ], "offsets": [ [ 6851, 6862 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_3_T186", "type": "CHEM", "text": [ "récepteur" ], "offsets": [ [ 6890, 6899 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0001640" } ] }, { "id": "425_3_T187", "type": "OBJC", "text": [ "molécule" ], "offsets": [ [ 6905, 6913 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0567416" } ] }, { "id": "425_3_T188", "type": "CHEM", "text": [ "VCAM - 1" ], "offsets": [ [ 6914, 6922 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0078056" } ] }, { "id": "425_3_T189", "type": "CHEM", "text": [ "vascular cell adhesion molecule - 1" ], "offsets": [ [ 6925, 6960 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0078056" } ] }, { "id": "425_3_T190", "type": "CHEM", "text": [ "ligands" ], "offsets": [ [ 6970, 6977 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023688" } ] }, { "id": "425_3_T191", "type": "CHEM", "text": [ "ostéopontine" ], "offsets": [ [ 6978, 6990 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0069676" } ] }, { "id": "425_3_T192", "type": "CHEM", "text": [ "fibronectine" ], "offsets": [ [ 7034, 7046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0016055" } ] }, { "id": "425_3_T193", "type": "CHEM", "text": [ "CS - 1" ], "offsets": [ [ 7052, 7058 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0172284" } ] }, { "id": "425_3_T194", "type": "CHEM", "text": [ "connecting segment - 1" ], "offsets": [ [ 7061, 7083 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0172284" } ] }, { "id": "425_3_T195", "type": "CHEM", "text": [ "natalizumab" ], "offsets": [ [ 7092, 7103 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1172734" } ] }, { "id": "425_3_T196", "type": "PHYS", "text": [ "interaction" ], "offsets": [ [ 7115, 7126 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_3_T197", "type": "CHEM", "text": [ "MadCAM - 1" ], "offsets": [ [ 7168, 7178 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1138490" } ] }, { "id": "425_3_T198", "type": "CHEM", "text": [ "mucosal addressin cell adhesion molecule - 1" ], "offsets": [ [ 7181, 7225 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1138490" } ] }, { "id": "425_3_T199", "type": "PHYS", "text": [ "interactions" ], "offsets": [ [ 7253, 7265 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_3_T200", "type": "ANAT", "text": [ "leucocytes mononucléés" ], "offsets": [ [ 7309, 7331 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023517" } ] }, { "id": "425_3_T201", "type": "ANAT", "text": [ "leucocytes" ], "offsets": [ [ 7309, 7319 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023516" } ] }, { "id": "425_3_T202", "type": "ANAT", "text": [ "endothélium" ], "offsets": [ [ 7346, 7357 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0014257" } ] }, { "id": "425_3_T203", "type": "ANAT", "text": [ "tissus parenchymateux" ], "offsets": [ [ 7367, 7388 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2986654" } ] }, { "id": "425_3_T204", "type": "ANAT", "text": [ "tissus" ], "offsets": [ [ 7367, 7373 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040300" } ] }, { "id": "425_3_T205", "type": "CHEM", "text": [ "natalizumab" ], "offsets": [ [ 7441, 7452 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1172734" } ] }, { "id": "425_3_T206", "type": "PHYS", "text": [ "réactions inflammatoires" ], "offsets": [ [ 7484, 7508 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021368" } ] }, { "id": "425_3_T207", "type": "ANAT", "text": [ "tissus" ], "offsets": [ [ 7527, 7533 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040300" } ] }, { "id": "425_3_T208", "type": "PHYS", "text": [ "interactions" ], "offsets": [ [ 7564, 7576 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_3_T209", "type": "ANAT", "text": [ "leucocytes" ], "offsets": [ [ 7581, 7591 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023516" } ] }, { "id": "425_3_T210", "type": "CHEM", "text": [ "ligands" ], "offsets": [ [ 7631, 7638 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023688" } ] }, { "id": "425_3_T211", "type": "ANAT", "text": [ "matrice extracellulaire" ], "offsets": [ [ 7647, 7670 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015350" } ] }, { "id": "425_3_T212", "type": "ANAT", "text": [ "cellules parenchymateuses" ], "offsets": [ [ 7682, 7707 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0227525" } ] }, { "id": "425_3_T213", "type": "CHEM", "text": [ "natalizumab" ], "offsets": [ [ 7732, 7743 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1172734" } ] }, { "id": "425_3_T214", "type": "PHYS", "text": [ "activité inflammatoire" ], "offsets": [ [ 7776, 7798 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021368" } ] }, { "id": "425_3_T215", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 7813, 7820 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "425_3_T216", "type": "ANAT", "text": [ "cellules immunitaires" ], "offsets": [ [ 7864, 7885 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0312737" } ] }, { "id": "425_3_T217", "type": "ANAT", "text": [ "tissus" ], "offsets": [ [ 7895, 7901 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040300" } ] }, { "id": "425_3_T218", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 7945, 7948 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_3_T219", "type": "DISO", "text": [ "lésions" ], "offsets": [ [ 7955, 7962 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0175677" } ] }, { "id": "425_3_T220", "type": "ANAT", "text": [ "lymphocytes T" ], "offsets": [ [ 7988, 8001 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0039194" } ] }, { "id": "425_3_T221", "type": "PHYS", "text": [ "barrière hémato-encéphalique" ], "offsets": [ [ 8024, 8052 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1305865" } ] }, { "id": "425_3_T222", "type": "PHYS", "text": [ "BHE" ], "offsets": [ [ 8055, 8058 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1305865" } ] }, { "id": "425_3_T223", "type": "PROC", "text": [ "essais cliniques" ], "offsets": [ [ 145, 161 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0008976" } ] }, { "id": "425_3_T224", "type": "CHEM", "text": [ "acétate de glatiramère" ], "offsets": [ [ 233, 255 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0289884" } ] }, { "id": "425_3_T225", "type": "CHEM", "text": [ "glatiramère" ], "offsets": [ [ 244, 255 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0717787" } ] }, { "id": "425_3_T226", "type": "PHYS", "text": [ "allaiter" ], "offsets": [ [ 1270, 1278 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006147" } ] }, { "id": "425_3_T227", "type": "LIVB", "text": [ "virus" ], "offsets": [ [ 4437, 4442 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042776" } ] }, { "id": "425_3_T228", "type": "CHEM", "text": [ "intégrine α 4β 7" ], "offsets": [ [ 7134, 7150 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0648695" } ] }, { "id": "425_3_T229", "type": "DISO", "text": [ "tissus inflammatoires" ], "offsets": [ [ 7895, 7916 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0007642" } ] } ]

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[ { "id": "425_4__text", "type": "abstract", "text": [ "\n\n L ’ interaction entre l ’ intégrine α 4β 1 et ses cibles est une composante importante de l ’ inflammation pathologique cérébrale , qui diminue avec l ’ inhibition de ces interactions . \n Dans le contexte de l ’ inflammation du système nerveux central ( SNC ) associée à la SEP , c ’ est l ’ interaction de l ’ intégrine α 4β 1 avec les VCAM - 1 , CS - 1 et ostéopontine qui sert de médiateur à l ’ adhésion ferme et la transmigration des leucocytes dans le parenchyme cérébral , pouvant perpétuer la cascade inflammatoire dans le tissu du SNC . \n TYSABRI est indiqué en monothérapie comme traitement de fond de la sclérose en plaques rémittente-récurrente afin de prévenir les poussées et retarder la progression du handicap . \n Compte tenu des problèmes de sécurité ( voir rubriques 4 . 4 et 4 . 8 ), le traitement est limité aux groupes de patients suivants : \n • Patients n ’ ayant pas répondu à un traitement complet et bien conduit par interféron bêta . \n Les patients doivent avoir présenté au moins 1 poussée au cours de l ’ année précédente alors qu ’ ils étaient sous traitement et doivent présenter au moins 9 lésions hyperintenses en T2 à l ’ IRM cérébrale ou au moins 1 lésion rehaussée après injection de Gadolinium . \n • Patients présentant une sclérose en plaques rémittente-récurrente sévère et d ’ évolution rapide , définie par 2 poussées invalidantes ou plus au cours d ’ une année associées à 1 ou plusieurs lésion ( s ) rehaussée ( s ) après injection de Gadolinium sur l ’ IRM cérébrale ou une augmentation significative de la charge lésionnelle en T2 par rapport à une IRM antérieure récente . \n L ’ efficacité en monothérapie a été évaluée au cours d ’ une étude de 2 ans ( étude AFFIRM ) randomisée , en double insu , contrôlée versus placebo , réalisée chez des patients atteints de SEP rémittente-récurrente ayant présenté au moins 1 poussée clinique au cours de l ’ année précédant l ’ inclusion dans l ’ étude , et dont le score EDSS ( Kurtzke Expanded Disability Status Scale , échelle d ’ évaluation du handicap ) était compris entre 0 et 5 . \n L ’ âge médian était de 37 ans et la durée médiane de la maladie de 5 ans . \n Des examens neurologiques ont été effectués toutes les 12 semaines et en cas de suspicion de poussées . \n Les examens IRM ( recherche de lésions rehaussées par gadolinium avec pondération en T1 et recherche de lésions hyperintenses en T2 ) ont été effectués tous les ans . \n Les caractéristiques et les résultats de l ’ étude sont présentés dans le tableau ci-dessous . \n SEP RR ( critères de McDonald ) \n Deux ans \n Handicap \n 12 semaines , critère d ’ évaluation principal ) \n ( p \n 11 Nombre moyen de lésions rehaussées \n Ces résultats ont été obtenus à partir d ’ une analyse post-hoc et doivent donc être \n Il n ’ y a pas de données disponibles sur la sévérité des poussées avant l ’ inclusion des patients dans l ’ étude . \n Après administration intraveineuse répétée d ’ une dose de 300 mg de natalizumab chez des patients souffrant de SEP , les concentrations sériques maximales moyennes ont été de 110 ± 52 μ g / ml . \n Les concentrations minimales moyennes à l ’ équilibre au cours de la période de traitement étaient comprises entre 23 μ g / ml et 29 μ g / ml . \n Le délai prévu pour atteindre l ’ équilibre était d ’ environ 36 semaines . \n Une analyse de pharmacocinétique de population a été effectuée sur des groupes de plus de 1 100 patients souffrant de SEP recevant des doses comprises entre 3 et 6 mg / kg de natalizumab . \n Parmi ces patients , 581 ont reçu une dose fixe de 300 mg en monothérapie . \n La clairance moyenne ± ET à l ’ équilibre était de 13 , 1 ± 5 , 0 ml / h , avec une demi-vie moyenne ± ET de 16 ± 4 jours . \n L ’ analyse a exploré les effets de covariables sélectionnées sur les paramètres pharmacocinétiques , notamment le poids , l ’ âge , le sexe , la fonction hépatique et rénale ainsi que la présence d ’ anticorps anti - natalizumab . \n Seuls le poids et la présence d ’ anticorps anti - natalizumab ont modifié l ’ élimination du natalizumab . \n L ’ effet du poids n ’ a pas été totalement proportionnel , puisqu ’ une variation de 43 % du poids a conduit à une variation de 31 % à 34 % de la clairance . \n Cette modification de la clairance n ’ a pas été cliniquement significative . \n La présence d ’ anticorps anti - natalizumab persistants a approximativement triplé la clairance du natalizumab , ce qui est cohérent avec la diminution des concentrations sériques de natalizumab observée chez les patients porteurs de ce type d ’ anticorps ( voir rubrique 4 . 8 ). \n Les paramètres pharmacocinétiques du natalizumab n ’ ont pas été étudiés chez l ’ enfant et chez l ’ insuffisant rénal ou hépatique . \n L ’ effet des échanges plasmatiques sur la clairance et les paramètres pharmacodynamiques du natalizumab a été évalué lors d ’ une étude chez 12 patients atteints de SEP . \n L ’ élimination du médicament après 3 échanges plasmatiques ( sur une période de 5 à 8 jours ) est estimée à environ 70 - 80 %. \n Ceci est à comparer au taux d ’ environ 40 % mesuré lors d ’ études antérieures dans lesquelles les dosages avaient été effectués après arrêt du traitement , sur une période d ’ observation identique . \n L ’ impact des échanges plasmatiques sur la reprise de la migration lymphocytaire et par conséquent leur utilité clinique ne sont pas connus . \n Du fait de l ’ activité pharmacologique du natalizumab , une modification de la circulation des lymphocytes , une augmentation des globules blancs ainsi qu ’ une hypersplénie ont été observées dans la plupart des études in vivo . \n Ces modifications ont été réversibles et n ’ ont pas semblé provoquer d ’ effets toxiques . \n 12 Dans les études réalisées chez la souris , l ’ administration de natalizumab n ’ a pas provoqué de croissance ni d ’ apparition de métastases de tumeurs de type mélanome ou leucémie lymphoblastique . \n Le natalizumab n ’ a exercé aucun effet clastogène ou mutagène dans les tests d ’ Ames ou dans les tests d ’ aberrations chromosomiques de cellules humaines . \n Il n ’ a , par ailleurs , présenté aucun effet dans les essais in vitro de prolifération de lignées tumorales intégrine α 4 - positives et aucune cytotoxicité . \n Aucun effet sur les taux d ’ avortements n ’ a été observé dans aucune autre étude . \n Une étude chez la femelle singe cynomolgus gravide a mis en évidence des modifications fœtales attribuées au natalizumab , notamment une faible anémie , une diminution des plaquettes , une augmentation du poids de la rate ainsi qu ’ une diminution du poids du foie et du thymus . \n Ces modifications ont été associées à une augmentation de l ’ hématopoïèse extramédullaire splénique , ainsi qu ’ à une atrophie du thymus et à une diminution de l ’ hématopoïèse hépatique . \n Le taux des plaquettes était également diminué chez les nouveau-nés de mères traitées par le natalizumab jusqu ’ à la mise-bas , cependant il n ’ a pas été observé d ’ anémie chez ces nouveau-nés . \n Toutes ces modifications observées à des doses supérieures à celles utilisées chez l ’ homme ont disparu après élimination du natalizumab . \n Phosphate de sodium , monobasique , monohydraté Phosphate de sodium , dibasique , heptahydraté Chlorure de sodium Polysorbate 80 ( E433 ) Eau pour préparation injectable . \n TYSABRI ne doit pas être mélangé avec d ’ autres médicaments à l ’ exception de ceux mentionnés dans la rubrique 6 . 6 . \n\n\n" ], "offsets": [ [ 0, 7421 ] ] } ]

[ { "id": "425_4_T1", "type": "PHYS", "text": [ "interaction" ], "offsets": [ [ 7, 18 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_4_T2", "type": "CHEM", "text": [ "intégrine α 4β 1" ], "offsets": [ [ 29, 45 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0209606" } ] }, { "id": "425_4_T3", "type": "DISO", "text": [ "inflammation" ], "offsets": [ [ 97, 109 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021368" } ] }, { "id": "425_4_T4", "type": "ANAT", "text": [ "cérébrale" ], "offsets": [ [ 123, 132 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006104" } ] }, { "id": "425_4_T5", "type": "PHYS", "text": [ "interactions" ], "offsets": [ [ 174, 186 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_4_T6", "type": "DISO", "text": [ "inflammation du système nerveux central" ], "offsets": [ [ 215, 254 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0178264" } ] }, { "id": "425_4_T7", "type": "ANAT", "text": [ "système nerveux central" ], "offsets": [ [ 231, 254 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0927232" } ] }, { "id": "425_4_T8", "type": "ANAT", "text": [ "SNC" ], "offsets": [ [ 257, 260 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0927232" } ] }, { "id": "425_4_T9", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 277, 280 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_4_T10", "type": "PHYS", "text": [ "interaction" ], "offsets": [ [ 295, 306 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0687133" } ] }, { "id": "425_4_T11", "type": "CHEM", "text": [ "intégrine α 4β 1" ], "offsets": [ [ 314, 330 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0209606" } ] }, { "id": "425_4_T12", "type": "CHEM", "text": [ "VCAM - 1" ], "offsets": [ [ 340, 348 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0078056" } ] }, { "id": "425_4_T13", "type": "CHEM", "text": [ "CS - 1" ], "offsets": [ [ 351, 357 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0172284" } ] }, { "id": "425_4_T14", "type": "CHEM", "text": [ "ostéopontine" ], "offsets": [ [ 361, 373 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0069676" } ] }, { "id": "425_4_T15", "type": "ANAT", "text": [ "leucocytes" ], "offsets": [ [ 442, 452 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023516" } ] }, { "id": "425_4_T16", "type": "ANAT", "text": [ "tissu" ], "offsets": [ [ 534, 539 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0040300" } ] }, { "id": "425_4_T17", "type": "ANAT", "text": [ "SNC" ], "offsets": [ [ 543, 546 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0927232" } ] }, { "id": "425_4_T18", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 551, 558 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_4_T19", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 593, 603 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_4_T20", "type": "DISO", "text": [ "sclérose en plaques" ], "offsets": [ [ 618, 637 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_4_T21", "type": "DISO", "text": [ "handicap" ], "offsets": [ [ 720, 728 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0231172" } ] }, { "id": "425_4_T22", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 809, 819 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_4_T23", "type": "LIVB", "text": [ "groupes" ], "offsets": [ [ 835, 842 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1257890" } ] }, { "id": "425_4_T24", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 846, 854 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T25", "type": "LIVB", "text": [ "Patients" ], "offsets": [ [ 870, 878 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T26", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 906, 916 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_4_T27", "type": "CHEM", "text": [ "interféron bêta" ], "offsets": [ [ 945, 960 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015980" } ] }, { "id": "425_4_T28", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 969, 977 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T29", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1081, 1091 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_4_T30", "type": "DISO", "text": [ "lésions" ], "offsets": [ [ 1124, 1131 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0175677" } ] }, { "id": "425_4_T31", "type": "PROC", "text": [ "IRM" ], "offsets": [ [ 1158, 1161 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024485" } ] }, { "id": "425_4_T32", "type": "ANAT", "text": [ "cérébrale" ], "offsets": [ [ 1162, 1171 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006104" } ] }, { "id": "425_4_T33", "type": "DISO", "text": [ "lésion" ], "offsets": [ [ 1186, 1192 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0221198" } ] }, { "id": "425_4_T34", "type": "PROC", "text": [ "injection" ], "offsets": [ [ 1209, 1218 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "425_4_T35", "type": "CHEM", "text": [ "Gadolinium" ], "offsets": [ [ 1222, 1232 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0016911" } ] }, { "id": "425_4_T36", "type": "LIVB", "text": [ "Patients" ], "offsets": [ [ 1239, 1247 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T37", "type": "DISO", "text": [ "sclérose en plaques" ], "offsets": [ [ 1263, 1282 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_4_T38", "type": "DISO", "text": [ "lésion ( s" ], "offsets": [ [ 1432, 1442 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0221198" } ] }, { "id": "425_4_T39", "type": "PROC", "text": [ "injection" ], "offsets": [ [ 1467, 1476 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021485" } ] }, { "id": "425_4_T40", "type": "CHEM", "text": [ "Gadolinium" ], "offsets": [ [ 1480, 1490 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0016911" } ] }, { "id": "425_4_T41", "type": "PROC", "text": [ "IRM" ], "offsets": [ [ 1499, 1502 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024485" } ] }, { "id": "425_4_T42", "type": "ANAT", "text": [ "cérébrale" ], "offsets": [ [ 1503, 1512 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006104" } ] }, { "id": "425_4_T43", "type": "PROC", "text": [ "IRM" ], "offsets": [ [ 1596, 1599 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0024485" } ] }, { "id": "425_4_T44", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 1685, 1690 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_4_T45", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 1702, 1707 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_4_T46", "type": "CHEM", "text": [ "placebo" ], "offsets": [ [ 1764, 1771 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1696465" } ] }, { "id": "425_4_T47", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1792, 1800 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T48", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 1813, 1816 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_4_T49", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 1937, 1942 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_4_T50", "type": "DISO", "text": [ "handicap" ], "offsets": [ [ 2038, 2046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0231172" } ] }, { "id": "425_4_T51", "type": "DISO", "text": [ "maladie" ], "offsets": [ [ 2137, 2144 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012634" } ] }, { "id": "425_4_T52", "type": "PROC", "text": [ "examens neurologiques" ], "offsets": [ [ 2162, 2183 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027853" } ] }, { "id": "425_4_T53", "type": "DISO", "text": [ "lésions" ], "offsets": [ [ 2295, 2302 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0221198" } ] }, { "id": "425_4_T54", "type": "CHEM", "text": [ "gadolinium" ], "offsets": [ [ 2318, 2328 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0303704" } ] }, { "id": "425_4_T55", "type": "DISO", "text": [ "lésions" ], "offsets": [ [ 2368, 2375 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0221198" } ] }, { "id": "425_4_T56", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 2478, 2483 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_4_T57", "type": "DISO", "text": [ "SEP RR" ], "offsets": [ [ 2530, 2536 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0751967" } ] }, { "id": "425_4_T58", "type": "DISO", "text": [ "Handicap" ], "offsets": [ [ 2575, 2583 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0231172" } ] }, { "id": "425_4_T59", "type": "DISO", "text": [ "lésions" ], "offsets": [ [ 2662, 2669 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0221198" } ] }, { "id": "425_4_T60", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2861, 2869 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T61", "type": "PROC", "text": [ "étude" ], "offsets": [ [ 2879, 2884 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2603343" } ] }, { "id": "425_4_T62", "type": "CHEM", "text": [ "natalizumab" ], "offsets": [ [ 2958, 2969 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1172734" } ] }, { "id": "425_4_T63", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2979, 2987 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_4_T64", "type": "DISO", "text": [ "souffrant" ], "offsets": [ [ 2988, 2997 ] ], "normalized": [ { 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[ { "id": "425_5__text", "type": "abstract", "text": [ "\n\n Solution diluée \n À conserver au réfrigérateur ( entre 2°C et 8°C ). \n 15 ml de TYSABRI dans un flacon ( verre type I ) muni d ’ un bouchon de caoutchouc ( bromobutyle ) serti avec une bague ( aluminium ) surmonté d ’ une capsule protectrice plastique . \n Avant de diluer et d ’ administrer TYSABRI , inspectez le flacon pour vérifier l ’ absence de particules . \n Le flacon ne doit pas être utilisé s ’ il contient des particules et / ou si le liquide n ’ est pas incolore , limpide à légèrement opalescent . \n Respectez les conditions d ’ asepsie pour préparer la solution de TYSABRI pour perfusion intraveineuse ( IV ). \n Retirez la capsule du flacon . \n Introduisez l ’ aiguille de la seringue dans le flacon en perçant le centre du bouchon de caoutchouc et aspirez 15 ml de solution à diluer pour perfusion . \n Ajoutez les 15 ml de solution à diluer pour perfusion à 100 ml d ’ une solution injectable de chlorure de sodium à 9 mg / ml ( 0 , 9 %). \n TYSABRI ne doit pas être mélangé avec d ’ autres médicaments ou diluants . \n Inspectez visuellement le produit dilué pour vérifier l ’ absence de particules ou de coloration avant l ’ administration . \n Ne pas utiliser en cas de présence de particules ou de coloration . \n Le produit dilué doit être utilisé dès que possible et dans un délai maximum de 8 heures après la dilution . \n Si le produit dilué est conservé à une température de 2 à 8 °C ( ne pas congeler ), laissez la solution se réchauffer à température ambiante avant la perfusion . \n La solution diluée doit être perfusée par voie intraveineuse pendant 1 heure à un débit d ’ environ 2 ml / minute . \n Dès que la perfusion est terminée , rincez la voie intraveineuse avec une solution injectable de chlorure de sodium à 9 mg / ml ( 0 , 9 %). \n Tout produit restant ou inutilisé doit être traité conformément aux dispositions réglementaires nationales . \n Elan Pharma International Ltd ., Monksland , Athlone , County Westmeath , Irlande \n Des informations détaillées sur ce médicament sont disponibles sur le site internet de l ’ Agence européenne du médicament ( EMEA ) http : / / www . emea . europa . eu / \n Biogen Idec Inc 5000 Davis Drive Research Triangle Park NC 27709 - 4627 USA \n Biogen Idec B . V . \n Robijnlaan 8 NL - 2132 Hoofddorp Pays-Bas \n Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK - 3400 Hillerød Danemark \n Le titulaire de l ’ autorisation de mise sur le marché devra s ’ assurer sur un plan national , préalablement à la commercialisation et comme convenu avec les autorités compétentes des états membres que tous les médecins ayant l ’ intention de prescire TYSABRI , aient bien à leur disposition un dossier médical contenant les éléments suivants : • Monographie du médicament • Information médicale sur TYSABRI • Carte patient . \n L ’ information médicale sur TYSABRI devra comporter les éléments clés suivants : • Indication restreinte • Infections atypiques / opportunistes , notamment la LEMP et incluant : \n Diagnostic de LEMP avec différenciation entre la LEMP et les poussées de SEP Arbre de décision de prise en charge de la LEMP Possibilité d ’ autres infections opportunistes \n Le titulaire de l ’ AMM devra s ’ assurer que le système de pharmacovigilance est en place et qu ’ il fonctionne avant de mettre le médicament sur le marché et cela aussi longtemps que le produit commercialisé sera utilisé . \n Le titulaire de l ’ AMM s ’ engage à effectuer les études et autres actions de pharmacovigilance détaillées dans le plan de pharmacovigilance . \n Un plan de gestion des risques actualisé devrait être fourni conformément au Guideline CHMP relatif aux systèmes de gestion des risques des médicaments à usage humain . \n TYSABRI 300 mg solution à diluer pour perfusion natalizumab \n Chaque flacon de 15 ml de concentré contient 300 mg de natalizumab ( 20 mg / ml ); \n phosphate de sodium , monobasique , monohydraté ; phosphate de sodium , dibasique , heptahydraté ; chlorure de sodium ; polysorbate 80 ( E433 ) et eau pour préparation injectable . \n Diluer avant perfusion . \n Elan Pharma International Ltd . \n Monksland Athlone County Westmeath Irlande \n - Il est important que vous conserviez cette carte avec vous pendant le traitement et pendant les 6 \n mois suivant l ’ administration de la dernière dose de TYSABRI car des effets secondaires peuvent se produire même après l ’ arrêt du traitement . \n Qu ’ est ce que TYSABRI et dans quel cas est-il utilisé 2 . \n Comment utiliser TYSABRI 4 . \n\n\n" ], "offsets": [ [ 0, 4474 ] ] } ]

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[ { "id": "425_6__text", "type": "abstract", "text": [ "\n\n QU ’ EST-CE QUE TYSABRI ET DANS QUEL CAS EST-IL UTILISE \n TYSABRI est utilisé pour traiter la sclérose en plaques ( SEP ). \n Les symptômes de SEP peuvent varier d ’ un patient à l ’ autre et il est possible que vous ne présentiez aucun des symptômes décrits ici , notamment : troubles de la marche , engourdissement du visage , des bras ou des jambes , problèmes de vue , fatigue , sensation de déséquilibre ou d ’ étourdissement , problèmes urinaires et intestinaux , difficultés à penser et à se concentrer , dépression , douleur aiguë ou chronique , problèmes sexuels , ainsi que raideurs et spasmes musculaires . \n L ’ aggravation de ces symptômes est une récidive ( ou poussée de SEP ). \n Elle peut être brutale , avec apparition des symptômes en quelques heures , ou progressive , évoluant sur plusieurs jours . \n Les symptômes s ’ améliorent ensuite progressivement ( phénomène qualifié de rémission ). \n La SEP provoque une inflammation du cerveau , susceptible d ’ endommager les cellules nerveuses . \n La substance active de TYSABRI est le natalizumab , une protéine comparable à vos propres anticorps . \n Au cours des études cliniques , TYSABRI a réduit de moitié la progression des effets invalidants de la SEP et a également diminué de deux-tiers environ le nombre de poussées de SEP . \n Cependant , TYSABRI ne peut pas réparer les dommages qui ont été provoqués par la maladie . \n Par conséquent , lorsque vous serez traité par TYSABRI , vous ne constaterez peut-être pas d ’ amélioration mais le traitement par TYSABRI pourra empêcher l ’ aggravation de votre maladie . \n 25 Il est essentiel de continuer votre traitement aussi longtemps que vous et votre médecin pensez qu ’ il est utile . \n Avant de débuter le traitement par TYSABRI , il est primordial de discuter avec votre médecin des bénéfices que vous pouvez attendre de ce traitement ainsi que des risque éventuels qui lui sont associés . \n N ’ utilisez jamais TYSABRI • Si vous êtes allergique ( hydpersensible ) au natalizumab ou à l ’ un des autres composants contenus dans TYSABRI ( voir les composants en rubrique 6 ). \n • Si vous avez des perturbations graves du système immunitaire ( dues à une maladie , telle que leucémie ou infection à VIH , ou dues à un médicament que vous prenez ou avez pris ). \n • Si vous avez un cancer ( sauf s ’ il s ’ agit d ’ un cancer de la peau de type baso-cellulaire ). \n • Si vous êtes âgé ( e ) de moins de 18 ans . \n Faites attention avec TYSABRI Des cas d ’ infection cérébrale rare appelée LEMP ( leucoencéphalopathie multifocale progressive ) ont été rapportés chez des patients traités par TYSABRI . \n Cette leucoencéphalopathie entraîne généralement un handicap sévère ou le décès . \n Par conséquent , si vous pensez que votre SEP s ’ aggrave ou si vous remarquez de nouveaux symptômes , il est très important d ’ en parler à votre médecin dès que possible . \n Discutez de votre traitement avec votre conjoint ou avec le personnel soignant . \n Ils pourraient voir de nouveaux symptômes que vous n ’ avez pas remarqués vous-même , tels que des changements d ’ humeur ou de comportement , des trous de mémoire , des difficultés d ’ élocution ou de communication , que votre médecin devra évaluer afin d ’ éliminer une LEMP éventuelle . \n Vous trouverez également ces informations sur la carte patient qui vous a été remise par votre médecin . \n Il est important de conserver cette carte et de la montrer à votre conjoint ou au personnel soignant . \n Des infections graves peuvent survenir sous TYSABRI . \n En cas d ’ infection ou si vous développez des symptômes tels qu ’ une fièvre inexpliquée , une diarrhée sévère , des vertiges / céphalées / raideur de la nuque prolongés , une perte de poids ou une lassitude , ou d ’ autres symptômes potentiellement associés à une infection pendant votre traitement par TYSABRI , vous devez en parler à votre médecin dès que possible et lui montrer la carte patient , ainsi que cette notice . \n Il est important que vous conserviez cette carte . \n Grossesse et allaitement Vous ne devez pas utiliser TYSABRI si vous êtes enceinte , sauf si vous en avez discuté au préalable avec votre médecin . \n Veillez à informer immédiatement votre médecin de toute grossesse en cours , suspectée ou envisagée . \n Vous ne devez pas allaiter pendant le traitement par TYSABRI . \n Vous devrez discuter avec votre médecin du choix d ’ allaiter ou d ’ être traitée par TYSABRI . \n Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout autre médicament . \n Conduite de véhicules et utilisation de machines TYSABRI ne devrait pas avoir d ’ effet sur l ’ aptitude à conduire des véhicules et à utiliser des machines . \n Si vous êtes concerné ( e ), discutez-en avec votre médecin . \n COMMENT UTILISER TYSABRI \n TYSABRI sera préparé et administré par un médecin . \n Les instructions relatives à la préparation et l ’ administration de TYSABRI sont fournies à la fin de cette notice à l ’ attention des professionnels de santé . \n TYSABRI doit être dilué avant son administration . \n Quelques patients ont présenté une réaction allergique à TYSABRI . \n Votre médecin vérifiera l ’ absence de réactions allergiques pendant la perfusion et dans l ’ heure qui suit la fin de la perfusion . \n Il est très important de ne pas interrompre le traitement par TYSABRI , en particulier dans les tout premiers mois du traitement . \n En effet , les patients ayant reçu une ou deux perfusions de TYSABRI suivies d ’ une période d ’ arrêt de traitement de trois mois ou plus sont plus à risque de présenter une réaction allergique lors de la reprise du traitement . \n 27 Signes d ’ allergie à TYSABRI , pendant ou peu après la perfusion : • Éruption et démangeaisons ( urticaire ) • œdème du visage , des lèvres ou de la langue • Difficultés respiratoires • Douleur ou gêne thoracique • Augmentation ou diminution de la tension artérielle ( constatée par votre médecin ou votre infirmière lors de la mesure de votre tension artérielle ). \n\n\n" ], "offsets": [ [ 0, 5992 ] ] } ]

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"normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_6_T8", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 171, 178 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_6_T9", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 243, 252 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_6_T10", "type": "DISO", "text": [ "troubles de la marche" ], "offsets": [ [ 279, 300 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0575081" } ] }, { "id": "425_6_T11", "type": "DISO", "text": [ "engourdissement du visage" ], "offsets": [ [ 303, 328 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0239511" } ] }, { "id": "425_6_T12", "type": "ANAT", "text": [ "bras" ], "offsets": [ [ 335, 339 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0446516" } ] }, { "id": "425_6_T13", "type": "ANAT", "text": [ "jambes" ], "offsets": [ [ 347, 353 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1140621" } ] }, { "id": "425_6_T14", "type": "DISO", "text": [ "problèmes de vue" ], "offsets": [ [ 356, 372 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042798" } ] }, { "id": "425_6_T15", "type": "DISO", "text": [ "fatigue" ], "offsets": [ [ 375, 382 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015672" } ] }, { "id": "425_6_T16", "type": "DISO", "text": [ "sensation de déséquilibre" ], "offsets": [ [ 385, 410 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0234966" } ] }, { "id": "425_6_T17", "type": "DISO", "text": [ "étourdissement" ], "offsets": [ [ 418, 432 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0012833" } ] }, { "id": "425_6_T18", "type": "DISO", "text": [ "problèmes urinaires" ], "offsets": [ [ 435, 454 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0809944" } ] }, { "id": "425_6_T19", "type": "ANAT", "text": [ "urinaires" ], "offsets": [ [ 445, 454 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1508753" } ] }, { "id": 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"normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_6_T77", "type": "DISO", "text": [ "infection cérébrale" ], "offsets": [ [ 2479, 2498 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021311" } ] }, { "id": "425_6_T78", "type": "DISO", "text": [ "cérébrale" ], "offsets": [ [ 2489, 2498 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C2882690" } ] }, { "id": "425_6_T79", "type": "DISO", "text": [ "LEMP" ], "offsets": [ [ 2512, 2516 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_6_T80", "type": "DISO", "text": [ "leucoencéphalopathie multifocale progressive" ], "offsets": [ [ 2519, 2563 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_6_T81", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 2593, 2601 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_6_T82", "type": "PROC", "text": [ "traités" ], "offsets": [ [ 2602, 2609 ] ], "normalized": [ { 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"médecin" ], "offsets": [ [ 3356, 3363 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_6_T102", "type": "LIVB", "text": [ "conjoint" ], "offsets": [ [ 3435, 3443 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0682323" } ] }, { "id": "425_6_T103", "type": "LIVB", "text": [ "personnel soignant" ], "offsets": [ [ 3450, 3468 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0025106" } ] }, { "id": "425_6_T104", "type": "DISO", "text": [ "infections" ], "offsets": [ [ 3477, 3487 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021311" } ] }, { "id": "425_6_T105", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 3517, 3524 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_6_T106", "type": "DISO", "text": [ "infection" ], "offsets": [ [ 3540, 3549 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021311" } ] }, { "id": "425_6_T107", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 3576, 3585 ] ], 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"db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_6_T133", "type": "PHYS", "text": [ "allaiter" ], "offsets": [ [ 4383, 4391 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0006147" } ] }, { "id": "425_6_T134", "type": "PROC", "text": [ "traitée" ], "offsets": [ [ 4404, 4411 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_6_T135", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 4416, 4423 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_6_T136", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 4453, 4460 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_6_T137", "type": "LIVB", "text": [ "pharmacien" ], "offsets": [ [ 4472, 4482 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031323" } ] }, { "id": "425_6_T138", "type": "CHEM", "text": [ "médicament" ], "offsets": [ [ 4511, 4521 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013227" } ] }, { "id": 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"db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_6_T152", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 5058, 5066 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_6_T153", "type": "DISO", "text": [ "réaction allergique" ], "offsets": [ [ 5084, 5103 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1527304" } ] }, { "id": "425_6_T154", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 5106, 5113 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_6_T155", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 5124, 5131 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_6_T156", "type": "DISO", "text": [ "réactions allergiques" ], "offsets": [ [ 5157, 5178 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1527304" } ] }, { "id": "425_6_T157", "type": "PROC", "text": [ "perfusion" ], "offsets": [ [ 5190, 5199 ] ], "normalized": [ { "db_name": "UMLS", "db_id": 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[ { "id": "425_7__text", "type": "abstract", "text": [ "\n\n Signes évocateurs d ’ éventuels troubles hépatiques : • Jaunisse ( coloration jaune de la peau ou du blanc des yeux ) • Urines anormalement foncées . \n TYSABRI peut également avoir d ’ autres effets indésirables . \n Ces effets indésirables sont listés ci-dessous par ordre de fréquence d ’ apparition au cours des études cliniques : \n Effets indésirables fréquents pouvant survenir chez moins de 10 patients sur 100 : • Infection urinaire • Mal de gorge et écoulement nasal ou nez bouché • Frissons • Éruption et démangeaisons ( urticaire ) • Maux de tête • Sensations vertigineuses • Nausées • Vomissements • Douleurs articulaires • Fièvre • Fatigue . \n Effets indésirables peu fréquents pouvant survenir chez moins de 1 patient sur 100 : • Allergie sévère ( hypersensibilité ). \n Les symptômes de LEMP peuvent être comparables à une poussée de SEP . • Par conséquent , si vous pensez que votre SEP s ’ aggrave ou si vous remarquez de nouveaux symptômes , vous devez en parler à votre médecin dès que possible . • Discutez de votre traitement avec votre conjoint ou le personnel soignant . \n Ils pourraient voir de nouveaux symptômes que vous-même n ’ avez pas remarqués , tels que des changements d ’ humeur ou de comportement , des trous de mémoire , des difficultés d ’ élocution ou de communication , que votre médecin devra évaluer afin d ’ éliminer une LEMP éventuelle . • Montrez la carte d ’ alerte patient ainsi que cette notice à tout médecin que vous pourriez consulter , et non pas seulement à votre neurologue . \n • Parlez à votre médecin dès que possible si vous pensez avoir une infection . • Montrez la carte patient ainsi que cette notice à tout médecin impliqué dans votre traitement et pas uniquement à votre neurologue . \n TYSABRI sera-t-il toujours efficace ? \n Chez certains patients recevant TYSABRI , les défenses naturelles de l ’ organisme finissent par empêcher TYSABRI d ’ agir correctement ( car l ’ organisme produit des anticorps dirigés contre TYSABRI ). \n Votre médecin pourra vérifier si c ’ est le cas en dosant ces anticorps dans votre sang et arrêtera le traitement par TYSABRI , si nécessaire . \n COMMENT CONSERVER TYSABRI \n Ne pas utiliser TYSABRI après la date de péremption mentionnée sur l ’ étiquette et la boîte . \n Ne pas utiliser TYSABRI si vous remarquez la présence de particules dans le liquide et / ou une coloration du liquide dans le flacon . \n Que contient TYSABRI Chaque flacon de 15 ml de solution à diluer pour perfusion contient 300 mg de natalizumab ( 20 mg / ml ). \n Phosphate de sodium , monobasique , monohydraté Phosphate de sodium , dibasique , heptahydraté Chlorure de sodium Polysorbate 80 ( E433 ) Eau pour préparation injectable . \n Chaque boîte contient un flacon en verre . \n Titulaire de l ’ autorisation de mise sur le marché Elan Pharma International Ltd . \n Fabricant Biogen Idec B . V . \n Ces informations sont fournies à la fin de la notice \n België / Belgique / Belgien Biogen Idec Belgium N . V . / S . A . \n Luxembourg / Luxemburg Biogen Idec Belgium N . V . / SA . \n Magyarország Gedeon Richter Plc . \n Č eská republika Biogen Idec ( Czech Republic ) s . r . o . \n Malta Interpharma Co . \n Danmark Biogen Idec Denmark A / S Tlf : + 45 77 41 57 88 \n Nederland Biogen Idec International B . V . \n Deutschland Biogen Idec GmbH Tel : + 49 ( 0 ) 89 99 6170 \n Norge Biogen Idec Norway AS Tlf : + 47 23 00 52 50 \n Eesti Richter Gedeon Eesti filiaal Tel : + 372 742 0200 \n Österreich Biogen Idec Austria GmbH Tel : + 43 1 484 46 13 \n Polska Gedeon Richter Plc . \n Przedstawicielstwo w Polsce Tel .: + 48 22 642 67 39 \n 30 España Biogen Idec Iberia SL Tel : + 34 91 310 7110 \n Portugal Biogen Idec Portugal Sociedade Farmacêutica Unipessoal , Lda Tel : + 351 21 318 8450 \n România MEDISON PHARMA SRL Tel : + 40 31 7104035 \n Ireland Biogen Idec ( Ireland ) Ltd . \n Slovenija Biogen Idec d . o . o . \n Slovenská republika Biogen Idec ( Slovak Republic ) s . r . o Tel : + 421 2 324 101 88 \n Italia Biogen-Dompé s . r . l . \n Suomi / Finland Biogen Idec Finland Oy Puh / Tel : + 358 207 401 200 \n Κύπρος Genesis Pharma Cyprus Ltd Τηλ : + 3572 2 769946 \n Sverige Biogen Idec Sweden AB Tel : + 46 8 594 113 60 \n Latvija Gedeon Richter Plc . \n United Kingdom Biogen Idec Limited Tel : + 44 ( 0 ) 1628 50 1000 \n Lietuva Gedeon Richter Plc . \n Inspectez visuellement le produit dilué pour vérifier l ’ absence de particules ou de coloration avant l ’ administration . \n Si le produit dilué est conservé à une température de 2 à 8 °C ( ne pas congeler ), laissez la solution se réchauffer à température ambiante avant la perfusion .\n" ], "offsets": [ [ 0, 4598 ] ] } ]

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"normalized": [ { "db_name": "UMLS", "db_id": "C0042036" } ] }, { "id": "425_7_T8", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 155, 162 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T9", "type": "DISO", "text": [ "effets indésirables" ], "offsets": [ [ 195, 214 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "425_7_T10", "type": "DISO", "text": [ "effets indésirables" ], "offsets": [ [ 223, 242 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "425_7_T11", "type": "PROC", "text": [ "études cliniques" ], "offsets": [ [ 317, 333 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0008972" } ] }, { "id": "425_7_T12", "type": "DISO", "text": [ "Effets indésirables" ], "offsets": [ [ 338, 357 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "425_7_T13", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 402, 410 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_7_T14", "type": "DISO", "text": [ "Infection urinaire" ], "offsets": [ [ 423, 441 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042029" } ] }, { "id": "425_7_T15", "type": "DISO", "text": [ "Infection" ], "offsets": [ [ 423, 432 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021311" } ] }, { "id": "425_7_T16", "type": "ANAT", "text": [ "urinaire" ], "offsets": [ [ 433, 441 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1508753" } ] }, { "id": "425_7_T17", "type": "DISO", "text": [ "Mal de gorge" ], "offsets": [ [ 444, 456 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0242429" } ] }, { "id": "425_7_T18", "type": "ANAT", "text": [ "gorge" ], "offsets": [ [ 451, 456 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031354" } ] }, { "id": "425_7_T19", "type": "DISO", "text": [ "écoulement nasal" ], "offsets": [ [ 460, 476 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1260880" } ] }, { "id": "425_7_T20", "type": "ANAT", "text": [ "nasal" ], "offsets": [ [ 471, 476 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0028489" } ] }, { "id": "425_7_T21", "type": "DISO", "text": [ "nez bouché" ], "offsets": [ [ 480, 490 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027424" } ] }, { "id": "425_7_T22", "type": "ANAT", "text": [ "nez" ], "offsets": [ [ 480, 483 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0028489" } ] }, { "id": "425_7_T23", "type": "DISO", "text": [ "Frissons" ], "offsets": [ [ 493, 501 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0036973" } ] }, { "id": "425_7_T24", "type": "DISO", "text": [ "Éruption" ], "offsets": [ [ 504, 512 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0302295" } ] }, { "id": "425_7_T25", "type": "DISO", "text": [ "démangeaisons" ], "offsets": [ [ 516, 529 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0033774" } ] }, { "id": "425_7_T26", "type": "DISO", "text": [ "urticaire" ], "offsets": [ [ 532, 541 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042109" } ] }, { "id": "425_7_T27", "type": "DISO", "text": [ "Maux de tête" ], "offsets": [ [ 546, 558 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0018681" } ] }, { "id": "425_7_T28", "type": "DISO", "text": [ "Nausées" ], "offsets": [ [ 588, 595 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0027497" } ] }, { "id": "425_7_T29", "type": "DISO", "text": [ "Vomissements" ], "offsets": [ [ 598, 610 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0042963" } ] }, { "id": "425_7_T30", "type": "DISO", "text": [ "Douleurs" ], "offsets": [ [ 613, 621 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030193" } ] }, { "id": "425_7_T31", "type": "ANAT", "text": [ "articulaires" ], "offsets": [ [ 622, 634 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0022417" } ] }, { "id": "425_7_T32", "type": "DISO", "text": [ "Fièvre" ], "offsets": [ [ 637, 643 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015967" } ] }, { "id": "425_7_T33", "type": "DISO", "text": [ "Fatigue" ], "offsets": [ [ 646, 653 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0015672" } ] }, { "id": "425_7_T34", "type": "DISO", "text": [ "Effets indésirables" ], "offsets": [ [ 658, 677 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0559546" } ] }, { "id": "425_7_T35", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 725, 732 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_7_T36", "type": "DISO", "text": [ "Allergie" ], "offsets": [ [ 745, 753 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0020517" } ] }, { "id": "425_7_T37", "type": "DISO", "text": [ "hypersensibilité" ], "offsets": [ [ 763, 779 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0020517" } ] }, { "id": "425_7_T38", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 789, 798 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_7_T39", "type": "DISO", "text": [ "LEMP" ], "offsets": [ [ 802, 806 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_7_T40", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 849, 852 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_7_T41", "type": "DISO", "text": [ "SEP" ], "offsets": [ [ 899, 902 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0026769" } ] }, { "id": "425_7_T42", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 948, 957 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_7_T43", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 989, 996 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T44", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1036, 1046 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_7_T45", "type": "LIVB", "text": [ "conjoint" ], "offsets": [ [ 1058, 1066 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0682323" } ] }, { "id": "425_7_T46", "type": "LIVB", "text": [ "personnel soignant" ], "offsets": [ [ 1073, 1091 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0025106" } ] }, { "id": "425_7_T47", "type": "DISO", "text": [ "symptômes" ], "offsets": [ [ 1128, 1137 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1457887" } ] }, { "id": "425_7_T48", "type": "DISO", "text": [ "changements d ’ humeur" ], "offsets": [ [ 1190, 1212 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0085633" } ] }, { "id": "425_7_T49", "type": "DISO", "text": [ "trous de mémoire" ], "offsets": [ [ 1238, 1254 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0751295" } ] }, { "id": "425_7_T50", "type": "DISO", "text": [ "difficultés d ’ élocution" ], "offsets": [ [ 1261, 1286 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0037822" } ] }, { "id": "425_7_T51", "type": "DISO", "text": [ "difficultés", "de communication" ], "offsets": [ [ 1261, 1272 ], [ 1290, 1306 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0481701" } ] }, { "id": "425_7_T52", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1319, 1326 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T53", "type": "DISO", "text": [ "LEMP" ], "offsets": [ [ 1363, 1367 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0023524" } ] }, { "id": "425_7_T54", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 1411, 1418 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_7_T55", "type": "PROC", "text": [ "notice" ], "offsets": [ [ 1435, 1441 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013191" } ] }, { "id": "425_7_T56", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1449, 1456 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T57", "type": "LIVB", "text": [ "neurologue" ], "offsets": [ [ 1516, 1526 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0237426" } ] }, { "id": "425_7_T58", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1548, 1555 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T59", "type": "DISO", "text": [ "infection" ], "offsets": [ [ 1598, 1607 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0021311" } ] }, { "id": "425_7_T60", "type": "LIVB", "text": [ "patient" ], "offsets": [ [ 1629, 1636 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_7_T61", "type": "PROC", "text": [ "notice" ], "offsets": [ [ 1653, 1659 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0013191" } ] }, { "id": "425_7_T62", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1667, 1674 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T63", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 1695, 1705 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_7_T64", "type": "LIVB", "text": [ "neurologue" ], "offsets": [ [ 1732, 1742 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0237426" } ] }, { "id": "425_7_T65", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 1747, 1754 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T66", "type": "LIVB", "text": [ "patients" ], "offsets": [ [ 1801, 1809 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0030705" } ] }, { "id": "425_7_T67", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 1819, 1826 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T68", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 1893, 1900 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T69", "type": "ANAT", "text": [ "organisme" ], "offsets": [ [ 1933, 1942 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0029235" } ] }, { "id": "425_7_T70", "type": "CHEM", "text": [ "anticorps" ], "offsets": [ [ 1955, 1964 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0003241" } ] }, { "id": "425_7_T71", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 1980, 1987 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T72", "type": "LIVB", "text": [ "médecin" ], "offsets": [ [ 1999, 2006 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0031831" } ] }, { "id": "425_7_T73", "type": "CHEM", "text": [ "anticorps" ], "offsets": [ [ 2055, 2064 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0003241" } ] }, { "id": "425_7_T74", "type": "ANAT", "text": [ "sang" ], "offsets": [ [ 2076, 2080 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0005767" } ] }, { "id": "425_7_T75", "type": "PROC", "text": [ "traitement" ], "offsets": [ [ 2096, 2106 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C0087111" } ] }, { "id": "425_7_T76", "type": "CHEM", "text": [ "TYSABRI" ], "offsets": [ [ 2111, 2118 ] ], "normalized": [ { "db_name": "UMLS", "db_id": "C1529600" } ] }, { "id": "425_7_T77", "type": "CHEM", "text": [ 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