FrancophonIA/ELRC3.0 huggingface dataset:
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
French: Blöndun alls innihaldsins úr hettuglasinu með leysinum saman við innihaldið í hettuglasinu með Docetaxel Teva Pharma 20 mg innrennslisþykkni tryggir 10 mg/ml dócetaxel styrkleika af forblöndu.
English: Gastrointestinal haemorrhage (G3/4: 0.4%)
French: Útlægur skyntaugakvilli (G3/4: 0,8%)
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
French: Tafla sem sýnir aukaverkanir í kirtilkrabbameini í maga fyrir Dócetaxel 75 mg/m² gefið ásamt cisplatíni og 5-flúóroúracíli
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
French: Tafla sem sýnir aukaverkanir í brjóstakrabbameini fyrir Dócetaxel 75 mg/m² gefið ásamt doxórúbisíni
English: Docetaxel Teva Pharma will be given by infusion into one of your veins (intravenous use).
French: Docetaxel Teva Pharma innrennslislausn á að gefa með innrennsli á 1 klst.
English: • one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
French: Hver askja inniheldur: eitt 6 ml glært hettuglas úr gleri með smelluloki sem inniheldur 0,72 ml af þykkni og eitt 6 ml glært hettuglas úr gleri með smelluloki sem inniheldur 1,28 ml af leysi.
English: Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion docetaxel
French: Docetaxel Teva Pharma 20 mg innrennslisþykkni og leysir, lausn dócetaxel
English: Cough (G3/4: 0%)
French: Hósti (G3/4: 0%)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
French: 2,88 ml (áfyllingarmagn 3,40 ml)
English: Arrhythmia (G3/4: 0.2%)
French: Liðverkir (G3/4: 0,2%)
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
French: Minnkuð starfsemi vinstri slegils (G3/4: 0,3%)
English: Epistaxis (G3/4: <1%)
French: Hósti (G3/4: < 1%);
English: Concentrate and solvent for solution for infusion.
French: Innrennslisþykkni og leysir, lausn.
English: Febrile neutropenia (G3/4: NA)
French: Munnbólga (G3/4:
English: EXPIRY DATE
French: FYRNINGARDAGSETNING
English: Myalgia (G3/4: 0.4%)
French: Kviðverkir (G3/4: 0,4%)
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
French: Blóðleysi (G3/4: 6,9%); Blóðflagnafæð (G4: 0,5%)
English: • The solvent for Docetaxel 80 mg vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
French: Leysir fyrir Docetaxel 80 mg hettuglas er í 15 ml glæru hettuglasi brómóbútíl gúmmítappa og smelluloki.
English: Cardiac disorders Rare cases of myocardial infarction have been reported.
French: Hjarta Greint hefur verið frá mjög sjaldgæfum tilvikum um hjartadrep.
English: Frequency unknown:
French: Ráðlagður skammtur:
English: Dyspepsia (G3/4: 0.8%); Gastrointestinal pain (G3/4: 1.2%);
French: Niðurgangur (G3/4: 1,2%); Munnbólga/kokbólga (G3/4: 0,9%);
English: FORMULATION
French: Endapunktur
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
French: Hægðatregða (G3/4: 1%); Kviðverkir (G3/4: 2%);
English: Hypotension; Hypertension Haemorrhage
French: Náladofi; höfuðverkur; bragðtruflun; tilfinningadofi
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
French: Meðalgildi fyrir heildarúthreinsun var 21 l/klst./m og fyrir stöðugt dreifingarrúmmál 113 l. Mismunur heildarúthreinsunar milli einstaklinga er allt að 50%.
English: Hypersensitivity (G3/4: 1.2%)
French: Heyrnarskerðing (G3/4: 1,2%)
English: 4.2.5 As with all parenteral products, Docetaxel Teva Pharma premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
French: 4.2.5 Eins og við á um öll önnur lyf sem gefin eru í æð á að skoða Docetaxel Teva Pharma forblöndu og innrennslislausn fyrir notkun.
English: Peripheral sensory neuropathy (G3: 0.4%)
French: Útlægur skyntaugakvilli (G3: 0,4%)
English: Method and route of administration
French: Aðferð við lyfjagjöf og íkomuleið
English: Rash erythematous (G3/4: <1%);
French: Hörundsroði með útbrotum (G3/4: < 1%);
English: Nail discolouration; Onycholysis (G3/4: 1%)
French: Naglarlos (G3/4: 1%)
English: Renal insufficiency and renal failure have been reported.
French: Greint hefur verið frá nýrnastarfsbilun og nýrnabilun.
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
French: Þetta áfyllingarmagn var ákvarðað við þróun á dócetaxel til þess að bæta upp vökvamissi við blöndun á forblöndu.
English: Myalgia (G3/4: 0.6%)
French: Lystarleysi (G3/4: 0,6%)
English: Lacrimation increased (G3/4: 0.6%)
French: Uppköst (G3/4: 0,6%)
English: The premix solution should be used immediately after preparation.
French: Nota á forblönduna strax eftir blöndun hennar.
English: Asthenia (G3/4: 3%);
French: Þróttleysi (G3/4: 3%);
English: Lacrimation increased (G3/4: 0%)
French: Húðflögnun (G3/4: 0%)
English: Hypotension
French: Ofnæmi
English: Arrhythmia (G3/4: 1.0%)
French: Ofnæmi (G3/4: 1,2%)
English: Cancer pain (G3/4: 0.6%)
French: Bragðtruflun (G3/4: 0,6%);
English: ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
French: ratiopharm Arzneimittel Vertriebs-GmbH
English: Myalgia (severe: 0.5%)
French: Vöðvaverkir (alvarleg tilvik: 0,5%)
English: Hearing impaired (G3/4: 0%)
French: Aukið tárarennsli (G3/4: 0%)
English: The Docetaxel Teva Pharma infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
French: stofuhita (lægri hita en 25°C) og venjulega híbýlalýsingu og innan 4 klst.
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
French: Hver askja inniheldur: eitt hettuglas (2,88 ml) með þykkni (80 mg af dócetaxeli), eitt hettuglas (5,12 ml) með leysi (vatn fyrir stungulyf).
English: Intravenous use.
French: brunatilfinningu.
English: Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
French: Docetaxel Teva Pharma eitt sér er ætlað til meðferðar á sjúklingum með langt gengið brjóstakrabbamein sem er staðbundið eða með meinvörpum þegar ekki hefur fengist svörun við annarri krabbameins-lyfjameðferð.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
French: Verkir fyrir brjósti sem ekki tengjast
English: Cancer pain (G3/4: 1.2%)
French: Vökvasöfnun (G3/4: 1,2%);
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
French: Munnbólga (G3/4: 23,7%); Uppköst (G3/4: 14,3%)
English: G3/4 Blood bilirubin increased
French: G3/4 hækkun bilirúbíns í blóði
English: Diarrhoea (G3/4: 6.2%);
French: Hárlos (G3/4: 6%);
English: • The Docetaxel 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
French: Í Docetaxel 20 mg hettuglasinu er 27,73 mg/ml lausn af dócetaxeli í pólýsorbati 80.
English: There are no active patients;
French: Il n'y a aucun patient actif.
English: It is ongoing in 9 countries with more than 400 patients.
French: Elle est en cours dans 9 pays et inclut plus de 400 patients.
English: National competent authorities competent for the regulatory oversight of these clinical studies should act accordingly.
French: Les autorités nationales compétentes en matière de surveillance réglementaire de ces études cliniques doivent agir en conséquence.
English: It is administered as 150 mg dose subcutaneously once a month.
French: Il est administré par dose de 150 mg par voie sous-cutanée une fois par mois.
English: This is potentially a plausible mechanism which needs to be further investigated.
French: Il s'agit d'un mécanisme potentiellement plausible qui nécessite d'être évalué plus précisément.
English: In addition, the European Commission requested the Agency to give its opinion, as soon as possible, as to whether provisional measures were necessary to protect public health
French: De plus, la Commission européenne a demandé à l'Agence de donner le plus rapidement possible son avis sur la question de la nécessité de mesures provisoires destinées à protéger la santé publique.
English: It was noted that three Clinical studies are currently ongoing:
French: Il a été noté que trois études cliniques sont actuellement en cours.
English: This adverse reaction appears unpredictable and no measure to minimize the risk has been identified at this stage.
French: Cet effet indésirable semble imprévisible et aucune mesure permettant de minimiser les risques n'a été identifiée à ce stade.
English: The MAH plans to terminate the study as a result of the product suspension in the EU.
French: Le TAMM prévoit de terminer l'étude suite à la suspension du produit dans l'UE.
English: In the European Union, as of 30 November 2017, daclizumab beta has been marketed in Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Norway, Poland, Slovenia, Sweden and United Kingdom.
French: Dans l'Union européenne, daclizumab bêta est commercialisé depuis le 30 novembre 2017 en Allemagne, Autriche, Belgique, Danemark, Finlande, Irlande, Italie, Pays-Bas, Norvège, Pologne, Royaume-Uni, Slovénie et Suède.
English: ZEUS: non-interventional study in Germany with 609 patients enrolled currently.
French: «ZEUS»: une étude non interventionnelle en Allemagne portant actuellement sur 609 patients.
English: Zinbryta (daclizumab beta) has been authorised in the European Union (EU) since 1 July 2016.
French: Zinbryta (daclizumab bêta) est autorisé dans l'Union européenne depuis le 1er juillet 2016.
English: The PRAC considered the alternative treatment options for the different stages or manifestations of the disease.
French: Le PRAC a envisagé des alternatives de traitement pour les différents stades ou les différentes manifestations de la maladie.
English: As of November 2017, 2,251 patients had received Zinbryta in the clinical development program.
French: Depuis novembre 2017, 2 251 patients avaient reçu Zinbryta dans le cadre du programme de développement clinique.
English: In addition, no new patients should start treatment with Zinbryta.
French: En outre, aucun nouveau patient ne doit débuter de traitement par Zinbryta.
English: These cases concerned 10 females, 1 male (and 1 unknown), aged between 30 and 69 years-old; 9 cases occurred in Germany, 2 in USA and 1 in Spain.
French: Ces cas concernaient 10 femmes, 1 homme (et 1 patient de sexe inconnu), âgés de 30 à 69 ans; 9 cas sont survenus en Allemagne, 2 aux ÉtatsUnis et 1 en Espagne.
English: All cases were spontaneous reports, except for the Spanish case which came from an extension of a clinical trial.
French: Tous les cas ont été spontanément rapportés, à l'exception du cas espagnol qui est issu d'une extension d'un essai clinique.
English: Due to the conclusion of the previous referral and based on the clinical characteristics of the patients, the MAH has already decided in January 2018 to stop this trial by 30 March 2018;
French: Compte tenu de la conclusion de la saisine précédente et sur la base des caractéristiques cliniques des patients, le TAMM a déjà décidé en janvier 2018 d'arrêter cet essai d'ici le 30 mars 2018.
English: It was acknowledged that the mechanism of action of daclizumab beta is complex.
French: Il a été reconnu que le mécanisme d'action du daclizumab bêta est complexe.
English: The postmarketing exposure in the European Economic Area (EEA) is estimated at 3,290 patients (of which around 2,890 patients in Germany) and worldwide at 5,086 patients.
French: On estime que le nombre de patients exposés au médicament après sa mise sur le marché est de 3 290 (dont environ 2 890 en Allemagne) dans l'Espace économique européen (EEE), et de 5 086 dans le monde.
English: The number of doses received before the event was reported in all but two cases; it ranged between 1 and 8 doses, except for the Spanish patient who had received daclizumab beta for 4 years.
French: Le nombre de doses reçues avant l'événement a été rapporté dans tous les cas sauf deux; il était compris entre 1 et 8 doses, excepté pour le patient espagnol qui a reçu le daclizumab bêta pendant 4 ans.
English: EXTEND: extension study to assess efficacy and safety in patients from the pivotal studies.
French: «EXTEND»: une étude d'extension destinée à évaluer l'efficacité et la sécurité chez les patients issus des études pivots.
English: These cases are characterized by torpid progression and potentially fatal or disabling outcome.
French: Ces cas sont caractérisés par une progression torpide et potentiellement fatale ou une issue invalidante.
English: The PRAC discussed the possibility of the causal relationship of these adverse reactions, as well as the possible mechanism through which they could have been triggered.
French: Le PRAC a discuté de la possibilité d'une relation de causalité de ces effets indésirables, ainsi que du mécanisme possible par lequel ils ont pu être induits.
English: Patients stopping treatment must be followed up for at least 6 months, as symptoms may appear after discontinuation of Zinbryta treatment.
French: Les patients ayant arrêté leur traitement doivent être suivis pendant au moins 6 mois, car des symptômes peuvent apparaître après l'interruption du traitement par Zinbryta.
English: SUSTAIN: A phase 3b open label study to assess efficacy and safety of daclizumab beta in patients switching from natalizumab in 5 countries, 3 in EU (DE, IT and UK).
French: «SUSTAIN»: une étude en ouvert de phase 3b destinée à évaluer l'efficacité et la sécurité du daclizumab bêta chez des patients préalablement traités par le natalizumab dans 5 pays, 3 dans l'UE (Allemagne, Italie et Royaume-Uni).
English: Healthcare professionals should contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives as a matter of urgency.
French: Les professionnels de santé doivent contacter les patients actuellement sous traitement par Zinbryta et doivent arrêter leur traitement et envisager de toute urgence des solutions de remplacement.
English: • In view of the above, the PRAC considered that the benefit-risk balance of Zinbryta is no longer favourable and that urgent measures are needed to protect patients.
French: • Compte tenu de ce qui précède, le PRAC a estimé que le rapport bénéfice/risque de Zinbryta n'est plus favorable et que des mesures urgentes sont nécessaires pour protéger les patients.
English: On 26 February 2018, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zinbryta should be maintained, varied, suspended or revoked.
French: Le 26 février 2018, au titre de l'article 20 du règlement (CE) n° 726/2004, la Commission européenne a demandé à l'Agence d'émettre une recommandation sur le maintien, la modification, la suspension ou le retrait de l'autorisation de mise sur le marché de Zinbryta.
English: Three of these cases had a fatal outcome, 2 cases are still intubated, 1 has an Expanded Disability Status Scale (EDSS) score 9.5, 1 recovered with sequelae, 1 partially recovered, and the remaining cases had an unknown outcome.
French: Trois de ces cas ont eu une évolution fatale, 2 patients sont toujours intubés, 1 a présenté un score EDSS (Expanded Disability Status Scale) de 9,5, 1 a conservé des séquelles, 1 s'est partiellement remis, et les cas restants ont eu une issue inconnue.
English: The use and the marketing authorisation for Zinbryta should be suspended and the product should be recalled from the market at the level of pharmacies and hospitals.
French: L'utilisation et l'autorisation de mise sur le marché de Zinbryta doivent être suspendues et le produit doit être retiré du marché au niveau des pharmacies et des hôpitaux.
English: Furthermore, the analysis of PSUR data indicated that a range of immune-mediated disorders were reported in other organs than the brain and liver following the use of Zinbryta.
French: Par ailleurs, l'analyse des données du PSUR a indiqué que divers troubles à médiation immunitaire ont été signalés dans d'autres organes que le cerveau et le foie suite à l'utilisation de Zinbryta.
English: On 20 February 2018, the Paul Ehrlich Institute (PEI) informed the EMA about five patients who were treated in 2016 and 2017 with daclizumab beta in Germany, and experienced worsening of disease after initiation of therapy.
French: Le 20 février 2018, l'institut Paul Ehrlich (Paul Ehrlich Institute, PEI) a informé l'EMA du fait que cinq patients traités en 2016 et 2017 par le daclizumab bêta en Allemagne ont présenté une aggravation de leur maladie après le début de leur traitement.
English: Further to that on 22 February, PEI informed about 2 new cases of immunemediated disease with CNS involvement.
French: Ensuite, le 22 février, le PEI a signalé 2 nouveaux cas de maladie à médiation immunitaire avec atteinte du SNC.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC.
French: • Le PRAC a étudié la procédure au titre de l'article 20 du règlement (CE) nº 726/2004 résultant des données de pharmacovigilance pour Zinbryta, en particulier la nécessité de mesures provisoires conformément à l'article 20, paragraphe 3, du règlement (CE) n° 726/2004, en tenant compte des principes établis aux articles 116 et 117 de la directive 2001/83/CE.
English: More information concerning these immune-mediated events had been requested to the MAH to be submitted in the third PSUR.
French: Il a été demandé au TAMM que des informations supplémentaires concernant ces événements à médiation immunitaire soient soumises dans le troisième PSUR.
English: Activation and expansion of NK cells may lead to a higher cytotoxic response that may be involved in the pathogenesis of autoimmune hepatitis and other autoimmune diseases.
French: L'activation et l'expansion des cellules tueuses naturelles peuvent conduire à une réponse cytotoxique plus forte, qui peut être impliquée dans la pathogénèse de l'hépatite autoimmune et d'autres maladies auto-immunes.
English: From the third PSUR (period from 27 May 2017 - 26 November 2017), there have also been some cases of unexpected deaths, attributed to cerebrovascular accidents, but with no detailed information on them that would conclusive allow for the exclusion of encephalitis.
French: Le troisième PSUR (période du 27 mai 2017 au 26 novembre 2017) a également indiqué des cas de décès inattendus, attribués à des accidents vasculaires cérébraux, mais sans aucune information précise qui permettrait d'exclure une encéphalite.
English: Whilst the absolute numbers for each disorder is low, this raises concerns that these disorders could be induced by immune-mediated effects and could be causally associated with Zinbryta.
French: Tandis que le nombre absolu de chaque trouble est faible, des inquiétudes sont exprimées quant au fait que ces troubles pourraient être induits par des effets à médiation immunitaire et pourraient être associés à Zinbryta.
English: • Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the risks related to Zinbryta and provide instructions related to the cessation of the treatment and the follow-up of patients having received Zinbryta.
French: • Par ailleurs, le PRAC a recommandé qu'une communication avec les professionnels de santé soit diffusée pour informer les professionnels de santé des risques liés à Zinbryta et fournir des instructions relatives à l'arrêt du traitement et au suivi des patients ayant reçu Zinbryta.
English: In light of all of the above and having carefully assessed all available data, PRAC considered at this stage that the benefit-risk balance of the product is no longer favourable and that urgent measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC, are needed to protect patients.
French: À la lumière de ce qui précède et après avoir soigneusement évalué toutes les données disponibles, le PRAC a estimé à ce stade que le rapport bénéfice/risque du produit n'est plus favorable et que des mesures urgentes sont nécessaires pour protéger les patients, conformément à l'article 20, paragraphe 3, du règlement (CE) n° 726/2004 et compte tenu des principes établis aux articles 116 et 117 de la directive 2001/83/CE, .
English: It is plausible that the immunomodulatory effects of the drug are involved in immune-mediated adverse effects, such as autoimmune hepatitis, and could be related to the reported cases of encephalitis and/or meningoencephalitis.
French: Il est plausible que les effets immunomodulateurs du médicament soient impliqués dans des effets indésirables à médiation immunitaire, tels que l'hépatite autoimmune, et pourraient être liés aux cas d'encéphalite et/ou de méningoencéphalite rapportés.
English: Overall, 12 cases of encephalitis or encephalopathy in patients treated with daclizumab beta for multiple sclerosis have been identified.
French: Globalement, 12 cas d'encéphalite ou d'encéphalopathie chez des patients atteints de sclérose en plaques traités par le daclizumab bêta ont été identifiés.
English: Immune-mediated or autoimmune conditions such as type I diabetes, colitis, autoimmune thyroiditis, pancreatitis, glomerulonephritis, among other, were reported in low numbers.
French: Des affections à médiation immunitaire ou auto-immunes telles que le diabète de type I, la colite, la thyroïdite auto-immune, la pancréatite, la glomérulonéphrite, entre autres, ont été signalées en faible nombre.
English: It was initially indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
French: Il était initialement indiqué dans le traitement des patients adultes atteints de formes récurrentes de la sclérose en plaques (SEP).
English: • The PRAC reviewed the totality of the available data, including data provided by the marketing authorisation holder in writing and in an oral explanation on the 12 cases of serious encephalitis and meningo-encephalitis (of which three fatal) reported since the initial marketing authorisation and safety data from clinical trials, in relation to the overall risk of immune-mediated disorders with CNS involvement during treatment with Zinbryta.
French: • Le PRAC a examiné la totalité des données disponibles, y compris les données fournies par le titulaire de l'autorisation de mise sur le marché par écrit et dans une explication orale sur les 12 cas d'encéphalite et de méningo-encéphalite graves (dont trois ont été fatals) rapportés depuis l'autorisation initiale de mise sur le marché et les données de sécurité issues d'essais cliniques, en relation avec le risque global de troubles à médiation immunitaire avec une atteinte du SNC au cours du traitement par Zinbryta.
English: In the second PSUR (period from 27 November 2016 - 26 May 2017), the review of autoimmune encephalitis cases and other immune-related disorders cases showed that there was a wide variety of immune-mediated disorders reported (such as encompassed seronegative arthritis, blood dyscrasias, thyroid disorders, glomerulonephritis and skin and subcutaneous disorders).
French: Dans le deuxième PSUR (période du 27 novembre 2016 au 26 mai 2017), l'examen des cas d'encéphalite auto-immune et d'autres cas de troubles immunitaires a montré que des troubles à médiation immunitaire très divers ont été rapportés (tels qu'une arthrite séronégative, une dyscrasie sanguine, des troubles thyroïdiens, une glomérulonéphrite et des troubles dermatologiques et souscutanés).