XARELTO - XARELTO - CT 11771 - Version anglaise

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2012

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2012

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Publié par

haute-autorite-sante-maladies-vasculaires

Publié le

14 mars 2012

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Présentation XARELTO 15 mg, comprimé pelliculé B/14 - Code CIP : 2192251 B/28 - Code CIP : 2192268 B/42 - Code CIP : 2192274 B/10 - Code CIP : 2192280 B/100 - Code CIP : 5814167 XARELTO 20 mg, comprimé pelliculé B/14 - Code CIP : 2192297 B/28 - Code CIP : 2192305 B/10 - Code CIP : 2192311 B/100 - Code CIP : 5814196 Mis en ligne le 30 juil. 2013 Substance active (DCI) rivaroxaban Cardiologie - Nouveau médicament Pas d’avantage clinique démontré par rapport aux AVK en prévention des AVC et des embolies systémiques associés à la fibrillation auriculaire XARELTO (15 et 20 mg) a l’AMM en prévention des AVC et des embolies systémiques chez les patients ayant une fibrillation atriale non valvulaire et au moins un autre facteur de risque d’AVC.Il est non-inférieur à la warfarine et son risque hémorragique semble similaire.L’absence de surveillance de l’hémostase des patients traités par rivaroxaban ne doit pas conduire à privilégier sa prescription par rapport à celle d’un AVK, en particulier chez les patients les plus âgés (au delà de 75 ans) et/ou en cas de risque hémorragique élevé. Il n’existe pas d’antidote au rivaroxaban.Pour en savoir plus télécharger la synthèse ou l'avis complet XARELTO. Code ATC B01AX06 Laboratoire / fabricant Laboratoire BAYER SANTE XARELTO 15 mg, comprimé pelliculé B/14 - Code CIP : 2192251 B/28 - Code CIP : 2192268 B/42 - Code CIP : 2192274 B/10 - Code CIP : 2192280 B/100 - Code CIP : 5814167 XARELTO 20 mg, comprimé pelliculé B/14 - Code CIP : 2192297 B/28 - Code CIP : 2192305 B/10 - Code CIP : 2192311 B/100 - Code CIP : 5814196 Mis en ligne le 30 juil. 2013

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Publié par

haute-autorite-sante-maladies-vasculaires

Publié le

14 mars 2012

Licence :

En savoir +

Langue

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The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 14 March 2012 XARELTO 15 mg film-coated tablets B/14 (CIP code: 34009 219 225 1 6) B/28 (CIP code: 34009 219 226 8 4) B/42 (CIP code: 34009 219 227 4 5) B/10 (CIP code: 34009 219 228 0 6) B/100 (CIP code: 34009 581 416 7 6) XARELTO 20 mg film-coated tablets B/14 (CIP code: 34009 219 229 7 4) B/28 (CIP code: 34009 219 230 5 6) B/10 (CIP code: 34009 219 231 1 7) B/100 (CIP code: 34009 581 419 6 6) Applicant: BAYER SANTE Rivaroxaban ATC code: B01AX06 List I Date of Marketing Authorisation (centralised European): 09 December 2011 (Rapporteur country: Sweden) Reason for request: Inclusion on the list of medicines refundable by National Health Insurance (B/14, B/28 and B/42 for the 15 mg/tablet dosage and B/14 and B/28 for the 20 mg/tablet dosage) and approved for hospital use (B/10 and B/100 for both dosages) in the extension of indication: “Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack . Medical, Economic and Public Health Assessment Division

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CHARACTERISTICS OF THE MEDICINAL PRODUCT

1.1. Active ingredient Rivaroxaban1 1.2. Indications “Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥ years, diabetes mellitus, prior stroke or transient ischaemic 75 attack. Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults . This extension of the indication was also the subject of a request for inclusion. NB: XARELTO 10 mg tablets are indicated for “Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery(total prosthesis of the hip or knee). 1.3. Dosage “Prevention of stroke and systemic embolism: The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Therapy with XARELTO should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding. If a dose is missed the patient should take XARELTO immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. Special populations/situations: Elderly population

“No dose adjustment. Renal impairment

“No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min). In patients with moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment the following dosage recommendations apply for the prevention of stroke and systemic embolism, the recommended dose is 15 mg once daily. Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma concentrations are significantly increased, therefore, XARELTO is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min. Hepatic impairment “XARELTO is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.

1 Rivaroxaban is an anticoagulant that is a direct (does not act via antithrombin), competitive, reversible and specific inhibitor of factor Xa. It is active following oral administration in one single fixed daily dose.

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