FrancophonIA/ELRC3.0 huggingface dataset:
English: Taxespira in combination with doxorubicin
Danish: Taxespira i kombination med doxorubicin
English: Both regimens were administered once every 3 weeks for 6 cycles.
Danish: Begge regimener blev administreret én gang hver 3. uge i 6 cyklusser.
English: Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Danish: Uden at påvirke overlevelsestiden (docetaxel 15 måneder vs. doxorubicin 14 måneder, p = 0,38) eller tiden indtil progression (docetaxel 27 uger vs. doxorubicin 23 uger, p = 0,54) øgede docetaxel responsraten (52 % vs. 37 %, p = 0,01) og gav hurtigere respons (12 uger vs. 23 uger, p = 0,007).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Taxespira in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Taxespira i alle undergrupper af den pædiatriske population ved brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk adenokarcinom og hoved- og halskræft med undtagelse af type II og type III lavt differentieret nasofaryngealt karcinom (se pkt.
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold, og lægemidlet bør anvendes umiddelbart herefter.
English: Use immediately the medicine once added into the infusion bag.
Danish: Lægemidlet skal bruges, straks efter at det er tilsat i infusionsposen.
English: • swelling caused by faulty lymphatic drainage
Danish: • hævelse på grund af mangelfuld drænage af lymfe
English: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Danish: For kombinationer med capecitabin vises de mest almindelige behandlingsrelaterede bivirkninger (≥ 5 %), som blev rapporteret i et fase III-studie med brystkræftpatienter, hvor anthracyclinbehandling ikke havde haft effekt (se produktresuméet for capecitabin).
English: Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Danish: Der er i sjældne tilfælde rapporteret tåreflåd med eller uden konjunktivitis som tilfælde af obstruktion af tårekanalerne, der resulterede i usædvanlig kraftigt tåreflåd.
English: • For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
Danish: • Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan Taxespira indgives i kombination med doxorubicin og cyclophosphamid.
English: Clear glass (type I) vial with a chlorobutyl rubber stopper and an aluminium seal with a flip-off cap.
Danish: Hætteglas af klart glas (type I) med chlorobutyl-gummiprop og aluminiumsforsegling med vippelåg.
English: From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold, og infusionsopløsningen bør anvendes umiddelbart herefter.
English: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Danish: Patienter med svær væskeretention i form af pleuraekssudat og perikardieekssudat samt ascites skal observeres nøje.
English: Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Danish: Taxespira i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
English: A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Danish: En opfølgende analyse af overlevelse efter en median opfølgningstid på 41,6 måneder viste ikke længere signifikant forskel, selv om TCF-regimenet altid gav bedre resultater.
English: Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Danish: Efter den anbefalede tilsætning til infusionsposen er docetaxel infusionsvæske, opløsning, stabil i 6 timer, hvis den opbevares ved temperaturer under 25 °C.
English: Taxespira concentrate for solution for infusion is a pale yellow to brownish-yellow solution provided in glass vials.
Danish: Taxespira koncentrat til infusionsvæske, opløsning, er en svagt gul til brun-gul opløsning i hætteglas.
English: In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m
Danish: Som førstebehandling indgives 75 mg/m 2 doxetaxel i kombinationsbehandling med doxorubicin (50 mg/m
English: In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10 % higher in patients who were 65 years of age or greater compared to younger patients.
Danish: Blandt de patienter, der fik docetaxel hver tredje uge, var hyppigheden af relaterede negleforandringer ≥ 10 % højere i patientgruppen på 65 år og derover end i gruppen af yngre patienter.
English: • nasal drainage; inflammation of the throat and nose; cough
Danish: • næseflåd, betændelse i hals og næse, hoste
English: Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Danish: Den fysiske og kemiske stabilitet efter åbning af infusionsopløsningen, der er tilberedt efter anbefalingerne, er påvist i poser uden indhold af PVC i op til 48 timer, når den opbevares ved mellem 2° C og 8° C.
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Danish: G-CSF blev administreret som sekundær profylakse til patienter, som fik kompliceret neutropeni (febril neutropeni, forlænget neutropeni eller infektion).
English: The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Den nødvendige mængde Taxespira koncentrat til infusionsvæske, opløsning, skal via en enkelt injektion (et skud) injiceres i en 250 ml infusionspose eller -flaske indeholdende enten en 5 % glucoseinfusionsopløsning eller en 9 mg/ml (0,9 %) natriumchloridinfusionsopløsning.
English: Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Danish: Ventrikulær arytmi inklusive ventrikulær takykardi (hyppighed ikke kendt), undertiden dødelig, er rapporteret hos patienter behandlet med docetaxel i kombinationsregimer, herunder doxorubicin, 5fluorouracil og/eller cyclofosfamid.
English: As with all parenteral products, docetaxel infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale lægemidler skal infusionsopløsningen med docetaxel kontrolleres visuelt inden brug, og opløsninger med udfældning skal kasseres.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Danish: Gennemsnitsværdierne for den totale clearence og steady state-distributionsvolumen var henholdsvis 21 l/h/m2 og 113 l. Den interindividuelle variation i samlet clearance var ca. 50 %.
English: As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale lægemidler skal infusionsopløsningen kontrolleres visuelt inden brug, og opløsninger med udfældning skal kasseres.
English: The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents.
Danish: Bivirkningerne af Taxespira kan blive mere alvorlige, når det gives i kombination med andre kemoterapeutiske midler.
English: How to store Taxespira 6.
Danish: Sådan skal du bruge Taxespira 4.
English: A total of 445 patients with KPS >70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F)
Danish: 445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluoruracil (F) (750 mg/m2 pr.
English: There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Danish: Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosphamid til patienter over 70 år.
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Danish: Tabellen nedenfor viser, at hyppigheden af grad 4-neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-studiet.
English: In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Danish: For patienter, behandlet med docetaxel, doxorubicin og cyclophosphamid (TAC), kræver risikoen for forsinket myelodysplasi eller myolid leukæmi hæmatologisk opfølgning.
English: No of positive nodes Overall
Danish: Antal positive lymfeknuder I alt
English: A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Danish: 449 patienter blev randomiseret til enten at få monoterapi med docetaxel 100 mg/m² givet som 1 times infusion eller paclitaxel 175 mg/m² givet som en infusion over 3 timer.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 patienter):
English: • For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Danish: • Ved behandling af fremskreden brystkræft kan Taxespira enten indgives alene eller i kombination med doxorubicin, trastuzumab eller capecitabin.
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Danish: • 300 patienter med gastrisk adenokarcinom (221 patienter i studiets fase III-del og 79 patienter i fase II-delen), som fik docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk relevante behandlingsrelaterede bivirkninger er medtaget).
English: In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to
Danish: Desuden er den fysiske og kemiske stabilitet efter åbning af infusionsopløsningen, der er tilberedt med natriumchlorid 9 mg/ml (0,9 %) eller 5 % glucoseopløsning i poser uden indhold af PVC eller med 5 % glucose i glasflasker, påvist i op til 48 timer, når den opbevares ved mellem 2° C og 8° C og i op til 6 timer ved opbevaring under 25 °C.
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Danish: Der var en øget forekomst af meget alvorlige bivirkninger (40 % mod 31 %) og grad 4 alvorlige bivirkninger (34 % mod 23 %) i kombinationsarmen trastuzumab sammenlignet med docetaxel som monoterapi.
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Danish: Almene symptomer og reaktioner på administrationsstedet Der er sjældne rapporter om radiation recall-fænomen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: 10, DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Hospira Enterprises B.V. Randstad 22-11
Danish: Randstad 22-11
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Danish: Infektion forbundet med G4-neutropeni (G3/4: 4,6 %)
English: Efficacy results are presented in the table below:
Danish: Effektresultaterne vises i nedenstående tabel:
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Danish: Med docetaxel er der rapporter om meget sjældne tilfælde af kutan lupus erythematosus og bulløst udslæt, såsom erythema multiforme, Stevens-Johnson syndrom og toksisk epidermal nekrolyse.
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Danish: • 174 og 251 patienter med hoved- og halskræft, der fik docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk relevante behandlingsrelaterede bivirkninger er medtaget).
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Danish: Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20-115 mg/m2.
English: The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Danish: Evalueringen af effekt og sikkerhed blev foretaget udelukkende ud fra kriterier om overlevelse.
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Danish: Tilfælde af cystoidt makulaødem (CMO) er blevet rapporteret hos patienter, der blev behandlet med docetaxel.
English: An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Danish: Et åbent, randomiseret fase III-multicenterstudie blev udført for at sammenligne monoterapi med docetaxel med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin.
English: General disorders and administration site conditions Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Danish: Almene symptomer og reaktioner på administrationsstedet Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed i huden, flebitis eller blodudtrækninger og hævelse af venen.
English: In some cases (frequency not known)
Danish: I nogle tilfælde (frekvens ikke kendt) er permanent hårtab blevet observeret
English: Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
Danish: Trombocytopeni (G3/4: 0,6 %); febril neutropeni
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m immediately followed by cisplatin 75 mg/m over 30-60 minutes.
Danish: For patienter der ikke tidligere er behandlet med kemoterapi, der behandles for ikke-småcellet lungekræft, er den anbefalede dosis af docetaxel 75 mg/m2, straks efterfulgt af cisplatin 75 mg/m givet over 30-60 minutter.
English: Dizziness; Headache (G3/4: <1%); Neuropathy peripheral
Danish: Svimmelhed; hovedpine (G3/4: <1 %); perifer neuropati
English: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm
Danish: hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, som har en minimumsblodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Danish: Patienter, som får febril neutropeni og/eller neutropenisk infektion, bør have deres docetaxel-dosis reduceret til 60 mg/m2 i alle efterfølgende cykler (se pkt.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Danish: Samtidig administration af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinetik.
English: Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Danish: Udtag aseptisk den ønskede mængde koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Danish: Effekten af docetaxel i induktionsbehandling af patienter med lokalt fremskreden SCCHN (intent-to-treat-analyse)
English: MedDRA System Organ classes
Danish: MedDRAsystemorganklasse
English: Tell your doctor, hospital pharmacist or nurse if you have vision problems.
Danish: Fortæl det til din læge, apotekspersonalet på hospitalet eller sundhedspersonalet, hvis du har problemer med synet.
English: In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Danish: I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75 % hos patienter på 60 år eller ældre (Se produktresuméet for capecitabin).
English: You must not be given Taxespira
Danish: Brug ikke Taxespira
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Danish: I studiet GEICAM 9805 udviklede 3 patienter (0,6 %) i TAC-armen og 3 patienter (0,6 %) i FACarmen kongestivt hjertesvigt i opfølgningsperioden.
English: At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Danish: Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 10 år og 5 måneder) havde ingen patienter CHF i TAC-armen, og 1 patient i TAC-armen døde af dilateret kardiomyopati, og det blev observeret, at CHF fortsatte hos 1 patient (0,2 %) i FAC-armen.
English: MedDRA system organ classes Very common adverse reactions Common adverse reactions Blood and lymphatic system disorders
Danish: MedDRA-systemorganklasse Meget almindelige bivirkninger Almindelige bivirkninger Blod og lymfesystem
English: Taxespira in combination with capecitabine
Danish: Taxespira i kombination med capecitabin
English: Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Danish: Prednison Der blev ikke observeret nogen effekt af prednison på docetaxels farmakokinetik.
English: First episode: reduce 5-FU dose by 20%.
Danish: Første episode: Reducer 5-FU-dosis med 20 %.
English: For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Danish: For beregning af capecitabin-dosis i overensstemmelse med legemsoverflade se capecitabin-produktresuméet.
English: MedDRA system organ classes Very common adverse reactions Common adverse reactions Infections and infestations
Danish: MedDRA-systemorganklasse Meget almindelige bivirkninger Almindelige bivirkninger Infektioner og parasitære sygdomme
English: All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Danish: Patienter uden progressiv sygdom skulle have kemo-strålebehandling (CRT) ifølge protokollen (PF/CRT).
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Danish: For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m
English: General Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm
Danish: Generelt Docetaxel bør gives, hvis neutrofiltallet er ≥ 1.500 celler/mm
English: (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Danish: dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluoruracil (1.000 mg/m2 pr. dag i 5 dage).
English: Taxespira in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: Taxespira i kombination med doxorubicin og cyclophosphamid: adjuverende behandling
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Danish: Hos et beskedent antal patienter (n = 23) med kliniske kemidata, der tydede på en let til moderat nedsat leverfunktion (ASAT og ALAT ≥ 1,5 gange øvre normalværdi og basisk fosfatase ≥ 2,5 gange øvre normalværdi), var den samlede clearance nedsat med gennemsnitligt 27 % (se pkt.
English: • Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle.
Danish: Injicer den nødvendige dosis (i mg) via en enkelt injektion (et skud) i en 250 ml infusionspose (uden indhold af PVC), der indeholder enten 5 % glucoseinfusionsopløsning eller 9 mg/ml (0,9 %) natriumchloridinfusionsopløsning eller med 5 % glucoseinfusionsopløsning i en glasflaske.
English: Other medicines and Taxespira
Danish: Brug af anden medicin sammen med Taxespira
English: This regimen is administered every 3 weeks for 4 cycles.
Danish: Dette regimen administreres hver 3. uge i 4 cyklusser.
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med anthracyclin uden effekt, blev docetaxel sammenlignet med kombinationsbehandling med mitomycin C og vinblastin (12 mg/m² hver 6. uge og 6 mg/m² hver 3. uge).