FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Velmetia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
French: L'EPAR complet relatif à Velmetia est disponible sur le site web de l'Agence, sous: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Velmetia.
French: Le présent document est un résumé du rapport européen public d'évaluation (EPAR) relatif à Velmetia.
English: It must also not be used in patients who consume excessive amounts of alcohol or who are alcoholic, or in women who are breast-feeding.
French: Il convient également de ne pas l'utiliser chez des patients qui consomment des quantités excessives d'alcool ou qui sont alcooliques, ou chez les femmes pendant l'allaitement.
English: The results of three further studies were used to support the use of Velmetia.
French: Les résultats de trois nouvelles études ont été utilisés pour conforter l'usage de Velmetia.
English: The company carried out additional studies to show that the active substances in Velmetia are absorbed by the body in the same way as the two medicines given separately.
French: La société a effectué des études supplémentaires pour montrer que les principes actifs contenus dans Velmetia étaient absorbés par l'organisme de la même manière que les deux médicaments pris séparément.
English: For more information about treatment with Velmetia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
French: Pour plus d'informations sur le traitement par Velmetia, veuillez consulter la notice (également comprise dans l'EPAR) ou contacter votre médecin ou votre pharmacien.
English: Velmetia was more effective than metformin alone.
French: Velmetia a été plus efficace que la metformine seule.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Velmetia in patients who were not satisfactorily controlled on their existing metformin treatment.
French: La société a présenté les résultats de trois études concernant Januvia/Xelevia pour conforter l'utilisation de Velmetia chez les patients qui n'avaient pas été contrôlés de manière satisfaisante par leur traitement existant à base de metformine.
English: Other information about Velmetia
French: Autres informations relatives à Velmetia:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velmetia.
French: Il explique de quelle manière l'évaluation du médicament à laquelle le comité des médicaments à usage humain (CHMP) a procédé l'a conduit à rendre un avis favorable à l'octroi d'une autorisation de mise sur le marché et à établir ses recommandations relatives aux conditions d'utilisation de Velmetia.
English: Velmetia must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
French: Velmetia ne doit pas être utilisé chez les personnes présentant une hypersensibilité (allergie) à la sitagliptine, à la metformine ou à l'un des autres composants.
English: The CHMP decided that Velmetia's benefits are greater than its risks and recommended that it be given marketing authorisation.
French: Le CHMP a estimé que les bénéfices de Velmetia sont supérieurs à ses risques et a recommandé l'octroi d'une autorisation de mise sur le marché pour ce médicament.
English: In the first of the three further studies, Velmetia was more effective than metformin or sitagliptin alone.
French: Dans la première des trois nouvelles études, Velmetia a été plus efficace que la metformine ou la sitagliptine seule.
English: The most common side effect with Velmetia (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
French: L'effet indésirable le plus fréquemment observé sous Velmetia (observé chez un à dix patients sur 100) est la nausée (envie de vomir).
English: Velmetia should be taken with food to avoid any stomach problems caused by metformin.
French: Velmetia devrait être absorbé avec de la nourriture afin d'éviter les problèmes d'estomac provoqués par la metformine.
English: Velmetia sitagliptin / metformin hydrochloride
French: Velmetia sitagliptine / chlorhydrate de metformine
English: Velmetia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
French: Velmetia est utilisé chez les patients atteints de diabète de type 2 afin d'améliorer le contrôle des taux de glucose (sucre) dans le sang.
English: The active substances in Velmetia, sitagliptin and metformin hydrochloride, each have a different mode of action.
French: Les principes actifs contenus dans Velmetia, la sitagliptine et le chlorhydrate de metformine, ont chacun un mode d'action différent.
English: If Velmetia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
French: Si Velmetia est pris avec une sulphonylurée ou une insuline, il faudra probablement diminuer la dose de la sulphonylurée ou de l'insuline afin d'éviter l'hypoglycémie (faibles taux de sucre dans le sang).
English: What benefit has Velmetia shown during the studies?
French: Quel est le bénéfice démontré par Velmetia au cours des études?
English: What is the risk associated with Velmetia?
French: Quel est le risque associé à l'utilisation de Velmetia?
English: Why has Velmetia been approved?
French: Pourquoi Velmetia a-t-il été approuvé?
English: Velmetia is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
French: Velmetia est un médicament qui contient deux principes actifs: la sitagliptine et le chlorhydrate de metformine.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Velmetia with that of metformin or sitagliptin alone.
French: La première étude a été effectuée sur 1 091 patients qui n'avaient pas été contrôlés de manière satisfaisante par un régime alimentaire et la pratique d'un exercice physique uniquement, et a comparé les effets de Velmetia à ceux de la metformine ou de la sitagliptine seules.
English: For the full list of all side effects reported with Velmetia, see the package leaflet.
French: Pour une description complète des effets indésirables observés sous Velmetia, voir la notice.
English: What is Velmetia?
French: Qu'est-ce que Velmetia?
English: How is Velmetia used?
French: Comment Velmetia est-il utilisé?
English: How does Velmetia work?
French: Comment Velmetia agit-il?
English: What is Velmetia used for?
French: Dans quel cas Velmetia est-il utilisé ?
English: Ref.: EMEA/264546/2009 EMEA/H/C/770
French: : EMEA/264546/2009 EMEA/H/C/770
English: To get the most benefit from the medicine, it should be used regularly and at the same time every day.
French: Pour tirer le meilleur profit du médicament, il convient de l'utiliser régulièrement et au même moment chaque jour.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avamys to Glaxo Group Ltd on 11 January 2008.
French: La Commission européenne a délivré une autorisation de mise sur le marché valide dans toute l'Union européenne pour Avamys à Glaxo Group Ltd, le 11 janvier 2008.
English: It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit.
French: Il commence généralement à produire ses effets à partir de huit heures après la première pulvérisation, mais plusieurs jours peuvent être nécessaires avant d'obtenir l'effet bénéfique maximal.
English: Similar results were seen in children aged six years and above.
French: Des résultats similaires ont été observés chez des enfants âgés de six ans et plus.
English: Other information about Avamys:
French: Autres informations relatives à Avamys:
English: The effects of Avamys were first tested in experimental models before being studied in humans.
French: Les effets d'Avamys ont d'abord été testés sur des modèles expérimentaux avant d'être étudiés chez l'homme.
English: In all of the studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose.
French: Dans toutes ces études, le principal critère d'évaluation de l'efficacité était la modification des quatre symptômes allergiques affectant le nez.
English: Avamys fluticasone furoate EPAR summary for the public
French: Avamys fluticasone furoate Résumé EPAR à l'intention du public
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
French: Il agit d'une manière similaire à celle des hormones corticostéroïdes naturelles, en réduisant l'activité du système immunitaire en se fixant sur des récepteurs dans différents types de cellules immunes.
English: This is generally mild or moderate and tends to affect adults who have used Avamys for more than six weeks.
French: Celle-ci est généralement d'une intensité légère à modérée et tend à affecter les adultes qui ont utilisé Avamys pendant plus de six semaines.
English: This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
French: Ceci entraîne une réduction de la libération de substances jouant un rôle dans le processus d'inflammation, telles que l'histamine, et réduit les symptômes allergiques.
English: The Committee recommended that Avamys be given marketing authorisation.
French: Le comité a recommandé l'octroi d'une autorisation de mise sur le marché pour Avamys.
English: However, it was not possible to determine if Avamys worked in children below the age of six years, because there were too few children below this age included the studies.
French: Il n'a toutefois pas été possible de déterminer si Avamys avait un effet chez les enfants âgés de moins de six ans, car le nombre d'enfants de cet âge pris en compte dans les études était insuffisant.
English: Each symptom was measured on a scale from 0 to 3, with a maximum total score of
French: Chaque symptôme a été mesuré sur une échelle de 0 à 3, le score total maximal étant de 12.
English: It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness.
French: Elle est souvent accompagnée par des symptômes affectant les yeux, tels que l'irritation, l'écoulement ou la rougeur des yeux.
English: Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
French: Avamys a d'abord été comparé à un placebo (traitement fictif) dans six études principales impliquant près de 2 500 patients.
English: The full EPAR for Avamys can be found here.
French: L'EPAR complet relatif à Avamys est disponible ici.
English: The lowest effective dose that keeps symptoms controlled should be used.
French: Il convient d'administrer la dose minimale efficace pour maintenir les symptômes sous contrôle.
English: Avamys should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
French: Il convient de n'utiliser Avamys que tant que le patient est exposé à l'allergène, comme le pollen, les acariens ou d'autres animaux.
English: This can be reduced to one spray in each nostril once symptoms are controlled.
French: Cette posologie peut être réduite à une pulvérisation dans chaque narine lorsque les symptômes sont contrôlés.
English: The active substance in Avamys, fluticasone furoate, is a corticosteroid.
French: Le principe actif contenu dans Avamys, le fuorate de fluticasone, est un corticostéroïde.
English: In the study of perennial allergic rhinitis, Avamys had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
French: Dans l'étude concernant la rhinite allergique perannuelle, Avamys a réduit les scores de 3,6 points après quatre semaines, par rapport à une réduction de 2,8 points avec le placebo.
English: Avamys should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
French: Avamys ne doit pas être utilisé chez les personnes allergiques au furoate de fluticasone ou à l'un des autres composants.
English: The most common side effect with Avamys (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
French: L'effet indésirable le plus fréquemment observé sous Avamys (chez plus d'un patient sur 10) est l'épistaxis (saignements de nez).
English: The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
French: Les deux autres études ont porté sur des enfants âgés de deux à 11 ans: la première étude a porté sur 558 enfants souffrant de rhinite allergique perannuelle et la deuxième a porté sur 554 enfants souffrant de rhinite allergique saisonnière.
English: The recommended dose of Avamys for patients aged 12 years and over is two sprays in each nostril once a day.
French: La dose recommandée d'Avamys pour les patients de 12 ans et plus est de deux pulvérisations dans chaque narine une fois par jour.
English: Avamys is for use in patients aged six years and over.
French: Avamys est destiné à une utilisation chez les patients âgés de six ans ou plus.
English: What benefit has Avamys shown during the studies?
French: Quel est le bénéfice démontré par Avamys au cours des études?
English: For children between six and 12 years of age, the recommended dose is one spray in each nostril once a day, although this can be increased to two sprays if symptoms are not controlled.
French: Pour les enfants âgés de six à 12 ans, la posologie recommandée est d'une pulvérisation dans chaque narine une fois par jour, bien qu'il soit possible de la porter à deux pulvérisations si les symptômes ne sont pas contrôlés.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
French: Le comité des médicaments à usage humain (CHMP) a estimé que les bénéfices d'Avamys sont supérieurs à ses risques pour le traitement des symptômes de la rhinite allergique chez les patients âgés de six ans ou plus.
English: For the full list of all side effects reported with Avamys, see the Package Leaflet.
French: Pour une description complète de tous les effets indésirables observés sous Avamys, voir la notice.
English: Avamys is used to treat the symptoms of allergic rhinitis.
French: Avamys est utilisé pour traiter les symptômes de la rhinite allergique.
English: What is the risk associated with Avamys?
French: Quel est le risque associé à l'utilisation d'Avamys?
English: This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing.
French: Il s'agit d'une inflammation des voies nasales provoquée par une allergie, qui cause rhinorrhée, obstruction nasale, prurit nasal et éternuements.
English: In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Avamys reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
French: Dans les études concernant la rhinite allergique saisonnière chez les patients âgés de 12 ans ou plus, Avamys a réduit les scores symptomatiques de 9 points au début de l'étude, à entre 3,6 et 5,4 points sur deux semaines, tandis que la réduction avec le placebo a atteint de 2,3 à 3,7 points.
English: Avamys was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
French: Avamys a été plus efficace que le placebo pour la réduction des symptômes de rhinite allergique chez les patients âgés de six ans et plus.
English: Avamys is a nasal spray that contains the active substance fluticasone furoate.
French: Avamys est un médicament pour pulvérisation nasale contenant le principe actif furoate de fluticasone.
English: Why has Avamys been approved?
French: Pourquoi Avamys a-t-il été approuvé?
English: What is Avamys?
French: Qu'est-ce qu'Avamys?
English: The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis
French: Les quatre premières études ont porté sur l'utilisation d'Avamys chez des patients de 12 ans ou plus: trois d'entre elles étaient des études à court terme, qui ont duré deux semaines et porté sur 886 patients souffrant de rhinite allergique saisonnière (rhume des foins), tandis que la quatrième a duré quatre semaines et a porté sur 302 patients atteints d'allergies perannuelles, comme les allergies aux animaux.
English: How is Avamys used?
French: Comment Avamys est-il utilisé?
English: What is Avamys used for?
French: Dans quel cas Avamys est-il utilisé?
English: How does Avamys work?
French: Comment Avamys agit-il?
English: How has Avamys been studied?
French: Quelles études ont été menées sur Avamys?
English: Introduction by the Executive Director
French: Introduzione del direttore esecutivo
English: The Agency's activities in the field of communication and transparency will see further significant development.
French: Le attività dell'Agenzia nell'ambito della comunicazione e della trasparenza vedranno ulteriori sviluppi significativi.
English: • cooperating with international partners and contributing to international activities;
French: • cooperare con i partner internazionali e contribuire alle attività internazionali;
English: This transition will be managed with care, in order to ensure that any changes ensure strong participation of Member State national competent authorities in the work of the Agency.
French: Questa transizione verrà gestita con attenzione per far sì che qualsiasi cambiamento assicuri la forte partecipazione delle autorità nazionali competenti degli Stati membri alle attività dell'Agenzia.
English: Work programme 2010 of the European Medicines Agency
French: Programma di lavoro 2010 dell'Agenzia europea per i medicinali
English: Implementation of the new remuneration system may take place in 2010, following the pilot project completed in 2009.
French: L'implementazione del nuovo sistema di remunerazione avverrà probabilmente nel 2010, successivamente al progetto pilota completato nel 2009.
English: Following the recent legislation on advanced therapy medicinal products, a number of additional legislative changes have already come into effect, or will soon.
French: A seguito della recente legislazione sui medicinali per la terapia avanzata, sono già entrate in vigore, o entreranno presto in vigore, alcune ulteriori modifiche normative.
English: • successfully implementing tasks vested by new legislation;
French: • implementare con successo i compiti previsti da nuove norme;
English: The same challenges that affect the Agency also affect the network, amid growing pressure on scientific resources of the national competent authorities.
French: Le stesse sfide che riguardano l'Agenzia riguardano anche la rete, all'interno di una pressione crescente sulle risorse scientifiche delle autorità nazionali competenti.
English: Therefore, the volume of activities, as well as their complexity, is growing from year to year, and has to be accommodated by the Agency and its network of partners.
French: La mole delle attività, pertanto, e la loro complessità, cresce di anno in anno, e deve essere gestita dall'Agenzia e dalla rete dei partner.
English: The work programme for 2010 is set against a dynamic background of changes in the Agency's legislative and business environment.
French: Il programma di lavoro 2010 è fissato a fronte di un contesto dinamico di cambiamenti nell'ambito legislativo ed operativo dell'Agenzia.
English: • strengthening the European medicines network;
French: • rafforzare la rete europea per i medicinali;
English: • conducting the Agency's core activities to the highest quality standards, amid the increasing volume and complexity of activities;
French: • condurre le attività principali dell'Agenzia ai più alti livelli qualitativi standard, nel contesto dell'incremento del volume e della complessità delle stesse;
English: • contributing to an environment that stimulates innovation and improved availability of medicines.
French: • contribuire a un ambiente che stimola l'innovazione e migliora la disponibilità dei medicinali.
English: The Agency will start implementing its Transparency Policy, developed in 2009, and will continue discussions within the EU regulatory network to have, as far as possible, a common approach in the field of transparency.
French: L'Agenzia inizierà a implementare la propria politica sulla trasparenza, sviluppata nel 2009, e continuerà a dialogare con la rete di regolamentazione dell'UE al fine di avere, per quanto possibile, un approccio comune nell'ambito della trasparenza.
English: • fostering communication, provision of information and increasing transparency;
French: • promuovere la comunicazione, la fornitura di informazioni e l'aumento della trasparenza;
English: This year completes the implementation of the Agency's longterm strategy (Road Map to 2010) adopted by the Management Board in December 2004, and lays the ground for the new strategy document, which will span to 2015.
French: Quest'anno si assisterà al completamento della strategia a lungo termine dell'Agenzia (Tracciato per il 2010), adottata dal consiglio di amministrazione nel dicembre 2004, e verranno poste le basi per il nuovo documento strategico che giungerà fino al 2015.
English: This work will result in the provision of better and more useful information to interested parties, including the health-technologyassessment bodies.
French: Tale attività comporterà la fornitura di informazioni migliori e più utili alle parti interessate, compresi gli organismi di valutazione delle tecnologie sanitarie.
English: For veterinary medicines, the Agency provides input to the European Technology Platform for Global Animal Health and the Action Plan for the Community Animal Health Strategy.
French: Per quanto concerne i medicinali per uso veterinario l'Agenzia fornisce il proprio contributo alla piattaforma tecnologica europea per la salute animale globale e al piano d'azione per la strategia comunitaria sulla salute degli animali.
English: As in previous years, significant attention will be given to further work in the field of safety-monitoring of medicines.
French: Come negli anni precedenti vi sarà una particolare attenzione nell'ambito del monitoraggio sulla sicurezza dei medicinali.
English: At the same time, the Agency's experts contribute to the Innovative Medicines Initiative (IMI) - the panEuropean work aimed at supporting innovation.
French: Al tempo stesso gli esperti dell'Agenzia apportano il proprio contributo all'iniziativa in materia di medicinali innovativi (IMI) - la rete pan-europea volta a sostenere l'innovazione.
English: This trend is strengthened by the increasing number and complexity of applications across most of the Agency's activities, not least those relating to the recent legislation on advanced therapy medicinal products and paediatric medicines.
French: Questa tendenza è rafforzata dal numero e dalla complessità crescenti delle applicazioni nella maggior parte delle attività dell'Agenzia, non da ultimo quelle relative alla recente legislazione sui medicinali per le terapia avanzata e sui medicinali per uso pediatrico.
English: The Agency will also commence preparations for possible future legislative changes in the areas of pharmacovigilance and counterfeit medicines.
French: L'Agenzia inizierà anche a prepararsi in vista di possibili future modifiche normative nei settori della farmacovigilanza e dei medicinali contraffatti.