ACTILYSE - ACTILYSE - CT 12124 - English version

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Introduction ACTILYSE, powder and solvent for solution for injection 10 mg vial (CIP code: 557 184-2) 20 mg vial (CIP code: 558 529-3) 50 mg vial (CIP code: 558 530-1) Posted on Jul 04 2012 Active substance (DCI) alteplase Progrès thérapeutique modéré dans le délai de 0 à 4h30 (au lieu de 0 à 3h) suivant un AVC ischémique ACTILYSE a désormais l’AMM dans le délai de 0 à 4 heures 30 suivant l’apparition des symptômes d’un accident vasculaire cérébral (AVC) ischémique, donc après avoir exclu une hémorragie intracrânienne (au lieu de 3 heures dans l’indication précédente).Sa quantité d’effet est faible versus placebo. Il existe un risque d’hémorragie intracrânienne.Il n’y a pas de donnée sur son efficacité clinique à long terme (conséquence sur le handicap, la survie…).Le résultat clinique est d’autant plus favorable que ce médicament est administré précocement,Il apporte un progrès thérapeutique modéré dans la prise en charge de l’AVC ischémique dans le délai compris entre 0 et 4 heures 30 suivant un AVC ischémique. ATC Code B01AD02 Laboratory / Manufacturer BOEHRINGER INGELHEIM FRANCE ACTILYSE, powder and solvent for solution for injection 10 mg vial (CIP code: 557 184-2) 20 mg vial (CIP code: 558 529-3) 50 mg vial (CIP code: 558 530-1) Posted on Jul 04 2012

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-vasculaires
• Publié le: 04 juillet 2012
• Nombre de lectures: 16
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

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The legally binding text is the original French version   TRANSPARENCY COMMITTEE

  OPINION   4 July 2012     ACTILYSE, powder and solvent for solution for injection 10 mg vial (CIP code: 557 184-2) 20 mg vial (CIP code: 558 529-3) 50 mg vial (CIP code: 558 530-1)     Applicant: BOEHRINGER INGELHEIM FRANCE   alteplase ATC code: B01AD02 (antithrombotic agents)   List I Reserved for hospital use and for use in emergency situations in accordance with Article R5121-96 of the French Public Health Code   Date of Marketing Authorisation (mutual recognition): 11 April 1991 Date of the extension of indication: 27 February 2012     Reason for request: Inclusion on the list of medicines approved for hospital use in the new indication: “Fibrinolytic treatment of acute ischaemic stroke within 4.5 hours after onset of symptoms”, as opposed to within 3 hours in the preivous indication.                                     Medical, Economic and Public Health Assessment Division

 

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CONTEXT

    Alteplase is an antithrombotic agent administered by infusion. ACTILYSE is notably indicated in the treatment of acute ischaemic stroke. It can only be used from 0 to 3 hours following the onset of stroke symptoms. Indeed, its efficacy has only been demonstrated within this time- frame. This treatment window has been increased to 4.5 hours in the new Marketing Authorisation.      2 CHARACTERISTICS OF THE MEDICINAL PRODUCT

 

2.1. Active ingredient   Alteplase  

2.2. Indications   “Thrombolytic treatment in acute myocardial infarction - minutes) accelerated dose regimen (see section on dosage and method of (90 administration), for patients in whom treatment can be started within 6 hours after symptom onset. - h 3 dose regimen (see section on dosage and method of administration): for patients in whom treatment can be started between 6 - 12 h after symptom onset provided that the diagnosis has been clearly confirmed. Alteplase has proven to reduce 30-day-mortality in patients with acute myocardial infarction.    Thrombolytic treatment in acute massive pulmonary embolism with haemodynamic instability The diagnosis should be confirmed whenever possible by objective means such as pulmonary angiography or non-invasive procedures such as lung scanning. There is no evidence for positive effects on mortality and late morbidity related to pulmonary embolism.   Fibrinolytic treatment of acute ischaemic stroke Treatment must be started as early as possible within4.5 hours(as opposed to within 3 hours as stated in the previous indication)after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.”  

 

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