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Tjeckiska till Engelska Danska till Engelska Nederländska till Engelska Finska till Engelska Franska till Engelska Tyska till Engelska Grekiska till Engelska Gujarati till Engelska Hindi till Engelska Italienska till Engelska Japanska till Engelska Kanaresiska, Kannada till Engelska Konkani till Engelska Koreanska till Engelska Malayalam till Engelska Marathi till Engelska Norska till Engelska Oriya till Engelska Polska till Engelska Portugisiska till Engelska Ryska till Engelska Spanska till Engelska Svenska till Engelska Tamil till Engelska Telugiska till Engelska Turkiska till Engelska Urdu till Engelska Engelska till Arabiska Engelska till Bengali Engelska till Kinesiska Engelska till Tjeckiska Engelska till Danska Engelska till Nederländska Engelska till Finska Engelska till Franska Engelska till Tyska Engelska till Grekiska Engelska till Gujarati Engelska till Hindi Engelska till Italienska Engelska till Japanska Engelska till Kanaresiska, Kannada Engelska till Konkani Engelska till Koreanska Engelska till Malayalam Engelska till Marathi Engelska till Norska Engelska till Oriya Engelska till Polska Engelska till Portugisiska Engelska till Ryska Engelska till Spanska Engelska till Svenska Engelska till Tamil Engelska till Telugiska Engelska till Turkiska Engelska till Urdu
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Arabiska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Bengali till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Kinesiska till Engelska - Rates: 0.06 - 0.08 EUR per character / 20 - 25 EUR per hour Tjeckiska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Danska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme
Nederländska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Finska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Franska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Tyska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Grekiska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Gujarati till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Hindi till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Italienska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Japanska till Engelska - Rates: 0.06 - 0.08 EUR per character / 20 - 25 EUR per hour Kanaresiska, Kannada till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Konkani till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Koreanska till Engelska - Rates: 0.06 - 0.08 EUR per character / 20 - 25 EUR per hour Malayalam till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Marathi till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Norska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Oriya till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Polska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Portugisiska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Ryska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Spanska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Svenska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Tamil till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Telugiska till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Turkiska till Engelska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Urdu till Engelska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Arabiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Bengali – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Kinesiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Tjeckiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Danska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Nederländska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Finska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Franska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Tyska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Grekiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Gujarati – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Hindi – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Italienska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Japanska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Kanaresiska, Kannada – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Konkani – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Koreanska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Malayalam – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Marathi – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Norska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Oriya – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Polska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Portugisiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Ryska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Spanska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Svenska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Tamil – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Telugiska – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme Engelska till Turkiska – Priser: 0.06 - 0.08 EUR per ord / 20 - 25 EUR per timme Engelska till Urdu – Priser: 0.04 - 0.06 EUR per ord / 18 - 22 EUR per timme
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Franska till Engelska: CLINICAL TRIALS General field: Medicin
Källtext - Franska SOURCE : FRENCH
Tridural: Avis de refus – Valeur thérapeutique
Description du médicament
Le tramadol est un analgésique à action centrale doté d’un double mécanisme d’action. Il a une faible activité sur les récepteurs μ des opiacés et il inhibe le recaptage neuronal de la norépinéphrine et de la sérotonine. Les comprimés à prise uniquotidienne sont conçus pour libérer le tramadol en deux phases : l’une rapide, dans les heures suivant son administration, et l’autre lente, sur une période de 24 heures. TriduralMC est indiqué pour la prise en charge de la douleur d’intensité modérée chez les adultes qui ont besoin du traitement pendant plusieurs jours ou plus.
Valeur thérapeutique
L’efficacité analgésique de TriduralMCest documentée par les résultats d’un essai randomisé et contrôlé avec placebo (Burch 2007) portant sur des individus souffrant de douleur causée par de l’arthrose du genou et qui répondent au TriduralMC. Ainsi, comparativement au placebo, TriduralMC apporte une amélioration de 0,7 point seulement sur l’échelle numérique de douleur en 11 points. Habituellement, pour cette échelle, une réponse est jugée cliniquement significative lorsqu’on remarque une différence absolue de 2 points environ.
Au regard de l’innocuité, environ 60 % des individus traités avec TriduralMC éprouvent au moins un effet indésirable. Environ 10 % des sujets se désistent pour cette raison. Les effets indésirables les plus fréquents sont les étourdissements, la nausée et les vomissements ainsi que les céphalées. Par ailleurs, une récente étude de cohorte rétrospective (Torring 2008) sème un doute quant à l’innocuité digestive du tramadol. Il s’agit d’une analyse de dossiers médicaux et d’ordonnances d’environ 1 300 individus hospitalisés pour un ulcère gastrique perforé. On observe qu’une plus forte proportion de personnes recevant le tramadol décèdent dans les 30 jours suivant leur admission, comparativement aux personnes traitées avec des anti-inflammatoires non-stéroïdiens. De plus, un avis des autorités américaines publié en juillet 2004 fait état de nombreux rapports d’abus et de dépendance liés à l’utilisation du tramadol. À cet effet, Santé Canada évalue présentement la possibilité de l’inscrire à l’annexe 1 du Règlement sur les stupéfiants.
Ainsi, les résultats d’un essai clinique contre placebo témoignent d’une efficacité faible qui s’accompagne de nombreux effets indésirables. Une méta-analyse de Cochrane (Cepeda 2006) fait le même constat, à savoir que tramadol peut diminuer l’intensité de la douleur, mais que ce bénéfice est faible. En outre, son utilisation est limitée par une forte incidence d’effets indésirables, lesquels peuvent mener à l’abandon du traitement. De plus, la possibilité d’une reclassification du tramadol à l’annexe 1 du Règlement sur les stupéfiants, en raison de son potentiel d’abus, ainsi que les résultats d’une étude de cohorte rétrospective portant sur la mortalité associée à des ulcères gastriques perforés suggèrent que ce produit pourrait présenter des risques qui, jusqu’ici, ont été ignorés. Pour ces raisons, le Conseil juge que la valeur thérapeutique de TriduralMC n’est pas démontrée.
Ainsi, le Conseil est d’avis que TriduralMC ne rencontre pas le critère de la valeur thérapeutique et a recommandé de ne pas l’inscrire sur les listes de médicaments.
Översättning - Engelska TARGET : ENGLISH
Tridural: Non-Acceptance Report (Refusal notice) - Therapeutic Value
Description of the drug
Tramadol is a centrally acting analgesic with a dual mechanism of action. It has low activity on μ opioid receptors (MOR1) and inhibits the neuronal reuptake of norepinephrine and serotonin (SNRIS2). The once-daily tablets are designed to release the tramadol into two phases: a rapid one, within hours of its administration, and the other slow, over a period of 24 hours. Tridural ™ recommended for handling moderate pain in adults who require treatment for several days or even longer.
Therapeutic value
The analgesic efficacy of TRIDURALTM is documented by the results of a randomized controlled trial with placebo (Burch 2007) on individuals suffering from pain caused by osteoarthritis of the knee and responding to TRIDURALTM. Thus, compared to placebo, Tridural ™ provides an improvement of 0.7 points only on the11 point numerical scale of pain. Usually, for this scale, a response is considered clinically significant when we notice an absolute difference of about 2 points.
In view of safety, approximately 60% of individuals treated with TRIDURALTM are experiencing at least one adverse event (side effect). For this reason about 10% of patients have withdrawn from the study. The most common side effects are dizziness, nausea and vomiting and headache. Moreover, a recent retrospective cohort study (Torring 2008) casts doubt about the gastrointestinal safety of tramadol. It is an analysis of medical records and prescriptions for about 1 300 individuals hospitalized for a perforated gastric ulcer4. We observe that a higher proportion of people receiving tramadol die within 30 days after admission, compared to those treated with anti-inflammatory non-steroid drugs. In addition, a notice issued by the U.S. authorities in July 2004 reported numerous reports of abuse and dependence associated with the use of tramadol. To this end, Health Canada is currently assessing the possibility of its inclusion in Annex 1 of the Narcotic Control Regulations.
Thus, the results of a clinical trial against placebo show a low efficiency that comes with many side effects. A Cochrane meta-analysis (Cepeda 2006) made the same point, namely that tramadol may decrease the intensity of pain, but this benefit is quite low. In addition, its use is limited by a high incidence of side effects, which can lead to discontinuation of the treatment. Moreover, the possibility of a reclassification of tramadol in Annex 1 of the Narcotic Control Regulations, based on its abuse potential and the results of a retrospective cohort study on mortality rate associated with perforated gastric ulcer, suggest that this product may present risks that have hitherto been ignored. For these reasons, the Commission finds that the therapeutic value of TRIDURALTM is not established.
Thus the Council believes that Tridural ™ does not meet the criterion of therapeutic value and has recommended for not including it in the lists of drugs.
Note:
1. The μ-opioid receptors (MOR) are a class of opioid receptors with high affinity for enkephalins and beta-endorphin but low affinity for dynorphins. They are also referred to as μ opioid peptide (MOP) receptors. The prototypical μ receptor agonist is the opium alkaloid morphine; μ (mu) refers to morphine.
2 (SNRIS).Serotonin-norepinephrine reuptake inhibitors in the … - Dell'Osso - Cited by 39
http://cat.inist.fr/?aModele=afficheN&cpsidt=17763459
3.A retrospective cohort study, also called a historic cohort study, is a medical research study in which the medical records of groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and those who do not smoke) are compared for a particular outcome (such as lung cancer).[1] In retrospective cohort studies, the odds ratio gives an assessment of relative risk.[2]
4.Perforated gastric ulcer.
J. Wilson-Macdonald, N. J. Mortensen, and R. C. Williamson
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2418177/
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