FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the brand of methadone cannot be confirmed with certainty it is suspected, based on the availability of the product and pattern of usage in Western Norway that the observed serious adverse reactions (e.g. anaemia and bone marrow disorder) were caused by povidone deposition in drug abusers who have misused methadone oral solutions containing povidone K90.
Danish: Skønt det ikke med sikkerhed kan fastslås, hvilket metadonlægemiddel, der var tale om, antages de iagttagne alvorlige bivirkninger (f.eks. anæmi og knoglemarvslidelser) at skyldes aflejring af povidon hos stofmisbrugere, som har misbrugt orale opløsninger af metadon indeholdende povidon K90.
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for methadone medicinal products for oral use containing povidone.
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 107i i direktiv 2001/83/EF for metadonholdige lægemidler indeholdende povidon,
English: On 2nd April 2014, the Norwegian Medicines Agency, NOMA, triggered a referral under Article 107i of Directive 2001/83/EC concerning methadone-containing medicines for oral use containing povidone asking the PRAC to review the benefit-risk balance of all oral methadone medicines containing polyvinylpyrrolidone (more commonly known as povidone or PVP) authorised in the EU and to make a recommendation to the Human Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) on any measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Danish: Styrelsen anmodede PRAC om at gennemgå benefit/risk-forholdet for alle i EU godkendte orale metadonlægemidler, der indeholder polyvinylpyrrolidon (bedre kendt under navnet povidon eller PVP), og fremsætte en anbefaling til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)) om eventuelle nødvendige foranstaltninger til at sikre sikker og effektiv anvendelse, og om hvorvidt markedsføringstilladelsen for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages.
English: High molecular weight povidone therefore accumulates if injected intravenously and povidone deposition in organs and tissues (in particular bone marrow and bone tissue) have been reported in the literature after substantial intravenous administration leading to ‘povidone storage disease' (Kepes et al. 1993; Kuo et al. 1997; Dunn et al. 1998; Huang et al. 2012).
Danish: Højmolekylært povidon ophobes derfor efter intravenøs injektion, og i litteraturen er beskrevet aflejring af povidon (navnlig i knoglemarv og knoglevæv) efter intravenøs administration af væsentlige mængder, hvilket medfører povidon-aflejringssygdom (»storage disease«) (Kepes et al., 1993; Kuo et al., 1997; Dunn et al., 1998, og Huang et al., 2012).
English: Therefore, the PRAC considered that additional risk minimisation measures could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90).
Danish: PRAC fandt derfor, at yderligere risikominimeringsforanstaltninger ikke kunne afhjælpe den kendte risiko for misbrug hos den påtænkte målpopulation og de tilknyttede alvorlige skader ved injektion af højmolekylært povidon (K90).
English: • The PRAC considered that the proposed risk minimisation measures to update the product information could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90);
Danish: • PRAC fandt derfor, at de foreslåede yderligere risikominimeringsforanstaltninger til ajourføring af produktinformationen ikke kunne afhjælpe den kendte risiko for misbrug hos den påtænkte målpopulation og de tilknyttede potentielle alvorlige skader forårsaget af injektion af højmolekylært povidon (K90),
English: In the context of the review of methadone products containing povidone, the PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml (containing high molecular weight povidone, K90).
Danish: Ved gennemgangen af metadonlægemidler indeholdende povidon konstaterede PRAC, at højmolekylært povidon kun fandtes i én oral metadonopløsning med styrken 2 mg/ml (indeholdende 11,7 mg/ml højmolekylært povidon, K90).
English: The CMDh, having considered the PRAC recommendation dated 23 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Danish: Efter gennemgang af PRAC's anbefaling af 23. juli 2014 nåede CMD(h) til enighed om, at markedsføringstilladelserne for oral metadonopløsning indeholdende højmolekylært povidon (K90) suspenderes i medfør af artikel 107k, stk. 1 og 2, i direktiv 2001/83/EF.
English: in addition to the acknowledged difficulty of adequately mitigate the well-known risk of misuse in the target population, the PRAC concluded that the benefits no longer outweigh the risks for methadone oral solution containing povidone K90.
Danish: I betragtning af de indberettede alvorlige bivirkninger, herunder knoglemarvspåvirkning (f.eks. anæmi), patologiske frakturer og risikoen for ophobning af højmolekylært povidon ved injektion samt den kendte vanskelighed af at mindske risikoen for misbrug tilstrækkeligt hos målpopulationen, konkluderede PRAC, at fordelene ikke længere opvejer risiciene for orale opløsninger af metadon indeholdende povidon K90.
English: Whereas
Danish: K90,
English: As a consequence, following the provisions under Article 107j (3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Danish: • PRAC overvejede en afpasset reaktion på evidensen for skade, anbefaler PRAC, at markedsføringstilladelserne for orale metadonopløsninger indeholdende højmolekylært povidon (K90) suspenderes i medfør af artikel 107j, stk. 3, i direktiv 2001/83/EF.
English: • Based on the available data, the PRAC concluded, that pursuant to Article 116 of Directive
Danish: • PRAC konkluderede på grundlag af de foreliggende data, at risk/benefit-forholdet ikke er positivt i henhold til artikel 116 i direktiv 2001/83/EF for orale metadonopløsninger indeholdende povidon
English: • The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Danish: • PRAC konkluderede, at benefit/risk-forholdet for disse lægemidler var positivt, forudsat at der indføres ændringer i produktinformationen med henblik på at harmonisere og skærpe advarslen om, at tabletterne kun er til oral administration og ikke må injiceres, anbefaler PRAC, at markedsføringstilladelserne for metadontabletter indeholdende lavmolekylært povidon (K25 eller K30) ændres i medfør af bestemmelserne i artikel 107j, stk. 3, i direktiv 2001/83/EF.
English: K30) were to be injected, it is expected to be readily excreted and not to accumulate and therefore was not associated with the potential for harm of oral solutions containing high Mw.
Danish: • PRAC fandt, at det lavmolekylære povidon i metadontabletter (K25 eller K30) ved eventuel injektion let vil udskilles og derfor ikke vil ophobes, hvorfor der ikke er skadespotentiale ved orale opløsninger indeholdende højmolekylært povidon,
English: PC: {number} SN: {number} NN: {number]
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: • 18 months.
Danish: • 18 måneder.
English: • hair loss: in most cases normal hair growth should return.
Danish: • Hårtab: i de fleste tilfælde vil normal hårvækst vende tilbage.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen, da den indeholder vigtige oplysninger.
English: Hormonal receptor status
Danish: Hormonal receptorstatus
English: • raised liver enzymes (hence the need for regular blood tests).
Danish: • Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver).
English: Tumour size <2 cm >2 cm
Danish: <2 cm >2 cm
English: Discard unused contents appropriately.
Danish: Kasser ubrugt indhold på passende måde.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Danish: Den primære testmetode, som blev anvendt til at bestemme HER2-positivitet i dette pivotalstudie var immunohistokemi (IHC).
English: • injection site reactions at the site of a previous reaction
Danish: • Reaktioner på injektionsstedet på stedet for en tidligere reaktion
English: Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Danish: Swensweg 5, PO Box 552, 2003 RN Haarlem, Holland
English: This is because Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Dette er fordi Docetaxel Teva eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
English: A total of 1,006 patients with KPS≥60 were randomised to the following treatment groups:
Danish: I alt 1.006 patienter med KPS ≥ 60 blev randomiseret i følgende behandlingsgrupper:
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: For docetaxel /Carboplatin-kombinationen kunne der hverken bevises ækvivalent eller non-inferior effekt sammenlignet med referencebehandlingskombinationens VCis.
English: • swelling of the hands, feet, legs
Danish: • Hævelse af hænder, fødder, ben
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Danish: • hvis du er allergisk (overfølsom) over for docetaxel eller nogle af de andre indholdsstoffer i
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller inde pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Median survival (months) 11.3
Danish: Median overlevelsestid (måneder) 11,3
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva.
Danish: Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Teva.
English: 2Estimated median survival
Danish: 2Estimeret median overlevelse.
English: Frequency not known (cannot be estimated from the available data):
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Clinical efficacy and safety
Danish: Kliniske virkning og sikkerhed
English: Before each treatment with Docetaxel Teva, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva.
Danish: Før hver behandling med Docetaxel Teva, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få Docetaxel Teva.
English: 2003 RN Haarlem The Netherlands
Danish: 2003 RN Haarlem, Holland
English: 3 weeks for 4 cycles.
Danish: uge i 4 cyklusser.
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne din legemsoverflade i m2 og bestemme den dosis, du skal have.
English: The safety and efficacy of Docetaxel Teva in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: Docetacel Teva sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favour of the TCF arm.
Danish: Nedsættelsen af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
English: Docetaxel Teva will be administered to you by a healthcare professional.
Danish: Docetaxel Teva vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Bør overvejes hos gravide og ammende kvinder, børn samt patienter i høj-risiko grupper såsom patienter med leversygdom, eller epilepsi.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Danish: Dette regime blev administreret hver 3. uge i 4 cyklusser i tilfælde hvor der som mindstemål blev observeret mindre respons (≥ 25 % reduktion i den bidimensionelt målte tumorstørrelse) efter 2 cyklusser.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Danish: • En Hazard ratio på mindre end 1 indikerer, at TAC kan associeres med længere sygdomsfri overlevelse og længere total overlevelse sammenlignet med FAC.
English: Meeting relative indication for chemotherapya
Danish: Opfylder relative indication for kemoterapia
English: Progressive disease as best overall Response (%) *Unstratified log rank test
Danish: Progressiv sygdom som bedste overlevelse respons (%) *Ustratificerede logrank test
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol (see leaflet for further information).
Danish: Docetaxel koncentrat hætteglas: polysorbat 80, vandfri ethanol (se indlægssedlen for yderligere information).
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Danish: Reversibilitetsdata tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxelbehandling med 100 mg/m2 som enkelt stof.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Danish: Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 3-4 = G3/4; grad 4 = G4) og COSTART-termerne og MEdDRA-termerne.
English: This medicine should not be used after the expiry date which is stated on the carton and vials after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og hætteglassene efter ”EXP”.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Danish: Derimod induceredes ingen mutationer i Ames test eller i en CHO/HGPRT genmutationsassay.
English: It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva premix solution or the Docetaxel Teva infusion solution
Danish: Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af enten Docetaxel Teva præmix-opløsningen eller Docetaxel Teva infusionsvæske.
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Danish: Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og under opfølgningsperioden.
English: Dry skin;
Danish: Tør hud;
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Danish: Post-menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel var: Neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Danish: fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: • One vial of solvent
Danish: • Et hætteglas med solvens
English: Fluid retention (severe/life threatening: 1%)
Danish: Væskeretention (alvorlig/livstruende: 1 %).
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Danish: I dette studie blev 501 patienter med lokalt fremskredent SCCHN og en WHO-funktionsstatus på 0 eller 1, randomiseret i en af to arme.
English: Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Danish: Efter induktionskemoterapi skulle patienter i begge behandlingsarme modtage 7 ugers CRT med et minimumsinterval på 3 uger, og ikke senere end 8 uger efter påbegyndelse af sidste cyklus (dag 22 til dag 56 af sidste cyklus).
English: Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: Docetaxel Teva må IKKE anvendes, hvis du er gravid, medmindre det klart er anvist af din læge.
English: Overall Age category 1 <50 years
Danish: Alderskategori 1 <50 år
English: Docetaxel Teva should not be used after the expiry date shown on the carton and vials.
Danish: Docetaxel Teva må ikke anvendes efter udløbsdatoen, som er anført på karton og hætteglas.
English: Docetaxel Teva vials should not be stored above 25°C and should be protected from light.
Danish: Docetaxel Teva hætteglas må ikke opbevares ved temperaturer over 25 ºC) og skal beskyttes mod lys.
English: You must not breast-feed while you are treated with Docetaxel Teva.
Danish: Du må ikke amme, mens du behandles med Docetaxel Teva.
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders)
Danish: • Nedsat indhold af natrium, kalium, magnesium og/eller calcium i blodet(forstyrrelse i elektrolytbalancen).
English: In some cases (frequency not known) permanent hair loss has been observed
Danish: I nogle tilfælde (frekvens ikke kendt) er permanent hårtab blevet observeret
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Danish: Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m2 og mediantiden til reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger).
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Teva may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med denne medicin og skal bruge effektiv prævention under behandlingen fordi Docetaxel Teva kan skade det ufødte barn.
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).
Danish: - Øvrige indholdsstoffer: Polysorbat 80 og 25,1 % (w/w) vandfri ethanol (se punkt 2).
English: The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Danish: Mængden af alkohol i dette lægemiddel kan forringe din evne til at køre bil eller betjene maskiner.
English: Docetaxel Teva contains alcohol.
Danish: Docetaxel Teva indeholder alkohol.
English: Overall survival was also significantly longer (p=0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Danish: Overlevelse i alt var også signifikant længere (p = 0,0201) til fordel for TCF-armen med en nedsættelse af risikoen for død på 22,7 %.
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Danish: Der er rapporteret om meget sjældne tilfælde af hepatitis, nogle gange fatale, hovedsageligt hos patienter med præ-eksisterende leversygdomme.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Danish: Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudie, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
English: to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p=0.0121) and a longer time to definitive worsening of Karnofsky performance status (p=0.0088) compared to patients treated with CF.
Danish: De patienter, der blev behandlet i TCF-armen, havde længere tid til 5 % definitiv forværring af den globale sundhedsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og en længere tid til definitiv forværring af Karnofsky performance status (p = 0,0088) sammenlignet med patienterne, som fik behandling med CF.
English: Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Danish: Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risiko-fodeling for TAC sammenlignet med FAC.
English: Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Danish: Stråling blev udført med megavolt-udstyr, med en daglig fraktionering (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 70-72 Gy).
English: Docetaxel Teva will be given by infusion into one of your veins (intravenous use).
Danish: Docetaxel Teva gives som infusion i en vene (intravenøs anvendelse).