PRADAXA - PRADAXA - CT 10749 - Version anglaise

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Description

Présentation PRADAXA 150 mg, gélule B/60 - Code CIP : 4194538 PRADAXA 110 mg, gélules B/60 - Code CIP : 3852620 Mis en ligne le 30 juil. 2013 Substance active (DCI) dabigatran etexilate (mésilate) Cardiologie - Nouvelle indication Pas d’avantage clinique démontré par rapport aux AVK dans la prévention des AVC et des embolies systémiques en cas de fibrillation atriale non valvulaire PRADAXA a désormais l’AMM dans la prévention de l'accident vasculaire cérébral (AVC) et de l'embolie systémique en cas de fibrillation atriale non valvulaire associée à au moins un facteur de risque.A la posologie de 150 mg x 2/j, il est plus efficace que la warfarine pour prévenir la survenue d’un AVC, la quantité d’effet est modeste et biaisée par la réalisation en ouvert de l’étude. A cette posologie, les arrêts de traitement en raison d’effets indésirables, notamment d’hémorragies gastro-intestinales graves, sont plus fréquents avec PRADAXA qu’avec warfarine.A la posologie de 110 mg x 2/j, seule sa non-infériorité par rapport à la warfarine a été démontrée.L’absence de surveillance de l’hémostase ne doit pas conduire à privilégier la prescription de PRADAXApar rapport à celle d’un antivitamine K (AVK), ce d’autant qu’on ne dispose pas d’antidote.Pour en savoir plus, téléchargez la synthèse ou l'avis complet PRADAXA.l'avis complet PRADAXA Code ATC B01AE07 Laboratoire / fabricant Laboratoire BOEHRINGER INGELHEIM FRANCE PRADAXA 150 mg, gélule B/60 - Code CIP : 4194538 PRADAXA 110 mg, gélules B/60 - Code CIP : 3852620 Mis en ligne le 30 juil. 2013

Sujets

• Embolie
• Troubles du rythme cardiaque
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-vasculaires
• Publié le: 29 février 2012
• Nombre de lectures: 33
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 February 2012 PRADAXA 110 mg, capsules B/60 (CIP code: 385 262-0) PRADAXA 150 mg, capsules B/60 (CIP code: 419 453-8) Applicant: BOEHRINGER INGELHEIM FRANCE dabigatran etexilate (mesylate) ATC Code: B01AE07 List I Date of Marketing Authorisation: 2 August 2011 (European centralised registration procedure) Reasons for request: - Inclusion of the 110 mg capsules on the list of products refundable by National Health Insurance and approved for hospital use in the extension of the indication “prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors”. - Inclusion of the 150 mg capsules on the list of products refundable by National Health Insurance and approved for hospital use in “prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors”, the only indication for this dose. Medical, Economic and Public Health Assessment Division

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1. CHARACTERISTICS OF THE MEDICINAL PRODUCT

1.1. Active ingredient

Dabigatran etexilate (mesylate) 1.2. Background

Dabigatran is the first direct competitive and reversible inhibitor of free or fibrin-bound thrombin1 indicated for oral administration for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation.

A request for CE marking of a specific coagulation test2 for use with dabigatran has been submitted to AFSSAPS.

Dabigatran is characterised by a predictable dose-dependent anticoagulant activity, a shorter half-life than warfarin (9-11 hours versus 35-45 hours), and the absence of a pharmacological interaction with the CYP450 enzyme system or with foodstuffs.3 1.3. Indication

“Prevention of stroke and systemic embolism (SEE) in adult patients with nonvalvular atrial fibrillation with one or more of the following risk factors: - previous stroke, transient ischemic attack or systemic embolism - left ventricular ejection fraction < 40% - symptomatic heart failure,≥New York Heart Association (NYHA) Class 2 - age≥75 years - age≥years associated with one of the following: diabetes mellitus, coronary artery 65 disease or hypertension.”

REMINDER: Since 2008, PRADAXA, at dosages of 75 and 110 mg, has also had a Marketing Authorisation for “Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.” 1.4. Dosage

“The recommended daily dose of Pradaxa is 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term.

1 Thrombin (factor IIa) is the key enzyme in the final phase of coagulation: it catalyses the reaction that converts fibrinogen into fibrin and activates several coagulation factors permitting amplification of phenomena leading to its own activation. 2 This is the HEMOCLOT THROMBIN INHIBITORS test, marketed by HYPHEN BioMed. 3 EPAR, page 41.

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