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French to English: Letter to Healthcare Professionals General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - French
INFORMATIONS
SEC:UIUTE PATIENTS
Septembre 2013
INFORMATION TRANSMISE SOUS L'AUTORITE DE L'ANSM
Lettre aux professionnels de sante
Nouveaux anticoagulants oraux Eliquis®, Pradaxa®, Xarelto® :
Mises en garde sur les facteurs de risque hemorragiques -II est recommande de verifier leur posologie, leurs contre-
indications et leurs mises en garde et precautions d'emploi pour limiter le risque de saignement. ·
Information destinee aux anesthesistes, cardiologues, chirurgiens orthopediques, chirurgiens cardiothoraciques, chirurgiens vasculaires, medecins generalistes, intemistes, geriatres, urgentistes, neurologues, phlebologues, angeiologues, pneumologues hospita/iers, Mmatologues, pharmaciens d'officine et hospitaliers
Madame, Monsieur, Chere Consreur, Cher Confrere,
Eliquis® (apixaban}, Pradaxa® (dabigatran etexilate) et Xarelto® (rivaroxaban) sont des anticoagulants oraux qui ont ete autorises au cours des dernieres annees dans des indications pour lesquelles les antagonistes de Ia vitamine K {warfarine, phenprocoumone et acenocoumarol) ou les heparines de bas poids moleculaire (HBPM) sont utilises depuis des decennies. Contrairement aux antagonistes de Ia vitamine K, !'administration de ces nouveaux medicaments ne necessite pas de surveillance biologique de l'activite anticoagulante en routine.
Cependant, les essais cliniques et !'experience apres Ia mise sur le march€ ont demontre que les evenements Mmorragiques majeurs, y compris ceux ayant entraine une issue fatale, ne concernent pas seulement les antagonistes de Ia vitamine Kl HBPM,
mais sont aussi un risque important associes a !'utilisation des nouveaux anticoagulants oraux. Par ailleurs, les signalements
rapportes apres Ia mise sur le marche de ces speciames indiquent que tous les prescripteurs ne sont pas suffisamment informes
de Ia prise en charge des risques Mmorragiques telle que recommandee dans les Resumes des Caracteristiques du Produit
(RCP).
les in1ormations contenues dans le present courrier ont ete revues et approuvees par I'Agence Europeenne des Medicaments
(EMA) et I'Agence Nationale de Securite du Medicament et des produits de sante (ANSM).
Recommandations
Au vu des -considerations ci·dessus,- les prescripteurs doivent· tenir compte du risque Mmorragique pour chaque patient et respecter Ia posologie, les contre-indications, les mises en garde et les precautions d'emploi. Bien que certaines contra-indications
different d'un nouvel anticoagulant oral a un autre, les nouveaux anticoagulants oraux ont en commun les contra-indications
suivantes:
• Saignement evolutif cliniquement significatif.
• Lesion ou maladie consideree comme a risque significatif de saignement majeur. Cela peut comprendre : ulcere gastro
intestinal en cours ou recent, presence de tumeurs malignes a haut risque de saignement, lesion cerebrate ou rachidienne
recente, chirurgie cerebrate,rachidienne ou ophtalmique recente,hemorragie intracranienne recente,varices resophagiennes
connues ou suspectees, malformations arterioveineuses, anevrismes vasculaires ou anomalies vasculaires majeures
intrarachidiennes ou intracerebrales.
• Traitement concomitant avec tout autre agent anticoagulant, par exemple, Mparine non-fractionnee (HNF), heparines de bas poids moleculaire (enoxaparine, dalteparine, etc.), derives de I'Mparine (fondaparinux, etc.), anticoagulants oraux (warfarine ou autre), sauf en cas de relais par le nouvel anticoagulant oral ou inversement, ou en cas d'administration d'HNF aux doses necessaires au maintien de Ia permeabilite d'un catheter central veineux ou arteriel.
Veuillez consulter les Resumes des Caracteristiques du Produit (RCP) d'Eiiquis®, Pradaxa® et Xarelto® (http://www.ema.europa.eu/ema!) pour connaitre les autres contra-indications specifiques a chaque medicament.
Translation - English
PATIENT SAFETY
INFORMATION
September 2013
INFORMATION TRANSMITTED UNDER THE AUTHORITY OF THE ANSM
Letter to health professionals
New oral anticoagulants – Eliquis®, Pradaxa®, Xarelto® :
Warning against hæmorrhagic risk factors – recommendation to check the dosage, contra-
indications, warnings and usage precautions to reduce the risk of bleeding.
Information for anæsthetists, cardiologists, orthopædic surgeons, cardiothoracic surgeons, vascular surgeons, general practitioners, gastro-enterologists, geriatricians, emergency medicine specialists, neurologists, phlebologists, angeologists, hospital pneumologists, hæmatologists, dispensing and hospital pharmacists.
Dear Sir, dear Madam, dear Colleague,
Eliquis® (apixaban), Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban) are oral anticoagulants that have been permitted in recent years in indications for which vitamin K antagonists (warfarin, phenprocoumone and acenocoumarol) or low molecular weight heparins (LMWH) have been used for decades. Contrary to vitamin K antagonists, the administration of these new medicines does not require routine supervision of anticoagulant activity.
Nevertheless, clinical trials and experience once these medicines have been made available have shown that major hæmorrhagic events, including those that produced a fatal outcome, have not only involved vitamin K/LMWH but are also an important risk associated with the use of these new oral anticoagulants. Furthermore, indications reported after these specialities were made available indicate that not all prescribers are sufficiently well informed of how to deal with the hæmorrhagic risks, as recommended in the Summary of Product Characteristics (SPC).
The information contained in the present letter has been reviewed and approved by the European Medicines Agency (EMA) and the French Agence Nationale de Securité du Medicament et les Produits de Santé (ANSM).
Recommendations
In view of the above considerations, prescribers should consider the hæmorrhagic risk for each patient and comply with the dosage, contra-indications, warnings and precautions for use. Although certain contra-indications vary from one anticoagulant to another, the new oral anticoagulants share the following contra-indications:
• Clinically significant bleeding.
• Lesion or condition considered to be at significant risk of major bleeding. These could include: current or recent gastro-intestinal ulcer, presence of malign tumours at high risk of bleeding, recent cerebral or spinal lesion, recent brain, spinal or ophthalmic surgery, recent intracranial bleeding, known or suspected œsophagal varicose veins, arterio-venous malformations vascular aneurisms or intra-spinal or intra-cerebral major vascular anomalies
• Treatment concomitant with any other anticoagulant, such as unfractionated heparin, low molecular weight heparins (LMWH) (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin or others), except where a new oral anticoagulant is taking over from a previous one or vice versa, or in the case of the administration of a non-fractionated heparin in the doses needed to maintain permeability using a central venous or arterial catheter.
Please consult the Summaries of Product (Characteristics (SPC) of Eiiquis®, Pradaxa® and Xarelto® (http://www.ema.europa.eu/ema!) to discover other contra-indications specific to each medicine.
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Other - Diploma in simultaneous interpreting, Hebrew U., diploma in law for translators, Westminster U.
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Years of experience: 64. Registered at ProZ.com: Jan 2000.
French to English (American Translators Association, verified) Hebrew to English (American Translators Association) English to Hebrew (Institute of Translation and Interpreting) Arabic to English (American Translators Association)
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Hebrew and French to English translator, interpreter and conference interpreter, based in the UK. Mac and PC capability. Also Hebrew typesetting. 38 years experience. Clients for simult. interpreting in French and Hebrew include BBC, Sky, CNN, etc. Specialist subjects: legal, food technology and organic chemistry, computer hardware and software, telecoms.
Also professional editor and copy writer and journalist (author of 12 books).
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