ELIQUIS - ELIQUIS - CT 11097 - English version
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ELIQUIS - ELIQUIS - CT 11097 - English version

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29 pages
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Introduction ELIQUIS 2.5 mg, film-coated tablets B/10 (CIP code: 419 454-4) B/20 (CIP code: 419 455-0) B/60 (CIP code: 419 456-7) B/60x1 (CIP code: 419 457-3) Posted on Jan 18 2012 Active substance (DCI) apixaban Cardiologie - Nouveau médicament Progrès thérapeutique mineur par rapport à l’énoxaparine dans la prévention des thromboses veineuses après prothèse totale de hanche ou de genou ELIQUIS 2,5mg est un anticoagulant administré par voie orale qui inhibe le facteur Xa. Il a l’AMM dans la prévention des événements thrombo-emboliques veineux (ETEV) chez les adultes bénéficiant d’une pose programmée de prothèse totale de hanche ou de genou.Comme XARELTO (rivaroxaban), ELIQUIS apporte un bénéfice clinique par rapport à l’énoxaparine par voie SC (LOVENOX). Ce bénéfice est modeste et provient essentiellement de la réduction de l’incidence des ETEV asymptomatiques. Le risque hémorragique ne semble pas différent de celui de l’énoxaparine. Pour en savoir plus, téléchargez la synthèse ou l'avis complet ELIQUIS. ATC Code B01AX Laboratory / Manufacturer BRISTOL-MYERS SQUIBB ELIQUIS 2.5 mg, film-coated tablets B/10 (CIP code: 419 454-4) B/20 (CIP code: 419 455-0) B/60 (CIP code: 419 456-7) B/60x1 (CIP code: 419 457-3) Posted on Jan 18 2012

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Publié par
Publié le 18 janvier 2012
Nombre de lectures 27
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  18 January 2012    ELIQUIS 2.5 mg, film-coated tablets B/10 (CIP code: 419 454-4) B/20 (CIP code: 419 455-0) B/60 (CIP code: 419 456-7) B/60x1 (CIP code: 419 457-3)   Applicant: BRISTOL-MYERS SQUIBB  apixaban ATC code: B01AF02  List I Date of Marketing Authorisation: 18 May 2011    Reason for request: Inclusion on the list of medicines refundable by National Health Insurance (B/10, B/20 and B/60) and approved for hospital use (B/60x1).                     Medical, Economic and Public Health Assessment Division
 
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1.
CHARACTERISTICS OF THE MEDICINAL PRODUCT
  1.1. Active ingredient  1 Apixaban  1.2. Indications  “Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.”  1.3. Dosage  “The recommended dose is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window. In patients undergoing total hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing total knee replacement surgery, the recommended duration of treatment is 10 to 14 days. If a dose of ELIQUIS is missed, the patient should immediately take the missed tablet and then continue with twice daily intake as before. Switching treatment from parenteral anticoagulants to apixaban (and vice versa) can be done at the next scheduled dose.
Special populations/situations:  Body weight: no dose adjustment is required. -- Gender: no dose adjustment is required. - Elderly subjects: no dose adjustment is required. - Paediatric population: the safety and efficacy of ELIQUIS in children below age 18 have not been established. - Renal impairment: because there is no clinical experience in patients with creatinine clearance < 15 ml/min or in patients undergoing dialysis, apixaban is not recommended in these patients. Limited clinical data in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that apixaban plasma concentrations are increased in this population, therefore, apixaban is to be used with caution in these patients. No dose adjustment is necessary in patients with mild or moderate renal impairment. - Hepatic impairment: ELIQUIS is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk. It is not recommended in patients with severe hepatic impairment. It should be used with caution in patients with mild or moderate hepatic impairment (Child-Pugh A or B). No dose adjustment is required in patients with mild or moderate hepatic impairment. Patients with elevated liver enzymes (ALT/AST > 2 × ULN) or total bilirubin level 1.5 × ULN were excluded in clinical trials. Therefore ELIQUIS should be used with caution in this population. ALT should be measured as part of the standard pre-operative assessment. - Epidural/spinal anaesthesia or lumbar puncture: When spinal/epidural anaesthesia or lumbar/epidural puncture is employed in patients treated with antithrombotic agents for prevention of thromboembolic complications could risk the appearance of an epidural or
                                            1 Apixaban is the second oral anticoagulant in the class of reversible direct factor Xa inhibitors. Its metabolism seems relatively uninfluenced by the state of kidney and liver function, even in cases of moderate impairment.   2/29
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