FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no relevant use of docetaxel in the paediatric population in the indications 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.
Danish: Der er ingen relevant anvendelse af docetaxel i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk karcinom samt hoved- og halskræft med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom..
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multicentre phase III study.
Danish: Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Danish: cyster og polypper) Anden primær malignitet (hyppighed ikke kendt), herunder non-Hodgkin lymfom, er blevet rapporteret, når docetaxel blev givet i kombination med andre anticancer behandlinger, der vides at være forbundet med anden primær malignitet.
English: One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m2) in combination with docetaxel (75 mg/m2) (AT arm) versus doxorubicin (60 mg/m2) in combination with cyclophosphamide (600 mg/m2) (AC arm).
Danish: Et stort randomiseret fase III-studie, med 429 tidligere ubehandlede patienter med metastatisk sygdom, er blevet udført med doxorubicin (50 mg/m2) i kombination med docetaxel (75 mg/2) (AT arm) versus doxorubicin (60 mg/m2) i kombination med cyclophosphamid (600 mg/m2) (AC arm).
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Accord solutions.
Danish: Docetaxel er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af Docetaxel Accord-opløsningerne.
English: In some cases (frequency not known)
Danish: I nogle tilfælde (hyppighed ikke kendt) er der observeret permanent hårtab
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: The infusion solution must not be coupled to the infusion set for more than 6 h at 25°C.
Danish: Infusionsopløsningen må ikke være forbundet med infusionssættet i mere end 6 timer ved 25 °C.
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: An open-label, multicentre, randomised 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 multicenter randomiseret fase III-studie blev udført for at sammenligne docetaxel monoterapi med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin.
English: Docetaxel Accord must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: Docetaxel Accord må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
English: The most commonly reported adverse reactions of docetaxel alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Danish: De mest almindelige bivirkninger af docetaxel givet alene er: Fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
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: If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel Accord concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Danish: Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal pakninger med Docetaxel Accord koncentrat til infusionsvæske, opløsning, stå ved stuetemperatur (under 25°C) i 5 minutter før brug.
English: A total of 449 patients were randomised 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 modtage docetaxel monoterapi 100 mg/m2 givet som 1 times infusion eller paclitaxel 175 mg/m2 givet som en infusion over 3 timer.
English: Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Danish: Docetaxel Accord i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om Docetaxel Accord findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: - For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide.
Danish: • Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder, kan docetaxel anvendes i kombination med doxorubicin eller cyclophosphamid.
English: The concentrate is a clear pale yellow to brownish-yellow solution.
Danish: Koncentratet er en klar, lys gul til brunliggul opløsning.
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 TACarmen døde af dilateret kardiomyopati, og det blev observeret at CHF fortsatte hos 1 patient (0,2 %) i FAC-armen.
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: Produktresumé for capecitabin) .
English: The required volume of Docetaxel Accord concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Den nødvendige mængde Docetaxel Accord koncentrat til infusionsvæske, opløsning, skal via en enkelt injektion (et skud) injiceres i en 250 ml infusionspose indeholdende enten en 5 % glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLE SKRIFT Fritaget fra krav om brailleskrift.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Docetaxel Accord in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated 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 Docetaxel Accord i alle undergrupper af den pædiatriske population med brystkræft, ikkesmåcellet lungekræft, prostatakræft, gastrisk adenokarcinom og hoved- og halskræft med undtagelse af type II og type III lavt differentieret nasofaryngealt karcinom (se pkt.
English: The name of this medicine is Docetaxel Accord.
Danish: Medicinen hedder Docetaxel Accord.
English: Docetaxel in combination with doxorubicin
Danish: Docetaxel i kombination med doxorubicin
English: To be taken into account in pregnant or breast-feeding 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 leversygdomme same epilepsi.
English: As with all parenteral products, Docetaxel Accord infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale lægemidler skal Docetaxel Accord infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal kasseres.
English: Second episode: then reduce docetaxel dose by 20%.
Danish: Anden episode: Reducer så docetaxel-dosis med 20 %
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning, kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Danish: I kombination med capecitabin er den anbefalede docetaxel -dosis 75 mg/m2 hver 3. uge kombineret med capecitabin 1250 mg/m2 to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Danish: Docetaxel øgede responsraten (33 % mod 12 %, p < 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Danish: Effekten af docetaxel ved behandling af patienter med gastrisk adenokarcinom Endepunkt
English: How to use Docetaxel Accord
Danish: Sådan skal du bruge Docetaxel Accord
English: EXP: Shelf life in infusion bag: see the leaflet.
Danish: For holdbarhed i infusionspose: Se indlægssedlen.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-treat analysis)
Danish: Effekt af docetaxel i indledende behandling til patienter med lokale fremskredne SCCHN (intent-to-treat--analyse)
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Danish: Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal destrueres i overrensstemmelse med lokale retningslinjer.
English: - For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.
Danish: • Ved behandling af lungekræft kan docetaxel enten indgives alene eller i kombination med cisplatin.
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: Docetaxel i kombination med doxorubicin og cyclophosphamid: Adjuverende behandling
English: Each box contains one vial of 1 ml concentrate.
Danish: Hver karton indeholder et hætteglas med 1 ml koncentrat.
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) (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: 445 patienter med KPS  70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluoruracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluoruracil (1000 mg/m2 pr. dag i 5 dage).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Danish: • Induktions kemoterapi efterfulgt af kemostråleterapi (TAX 324)
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-treat analysis)
Danish: Effekt af docetaxel i indledende behandling til patienter med inoperable, lokale fremskredne SCCHN (intent-to-treat-analyse)
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Danish: Hazard ratio (95 %CI) **p-værdi Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
English: Other medicines and Docetaxel Accord
Danish: Brug af anden medicin sammen med Docetaxel Accord
English: - For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
Danish: • Ved behandling af prostatakræft kan docetaxel indgives i kombination med prednison eller prednisolon.
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 vinblastine (12 mg/m2 hver 6. uge og 6 mg/m2 hver 3. uge).
English: Aseptically withdraw the required amount of Docetaxel Accord concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Danish: Udtag aseptisk den ønskede mængde Docetaxel Accord koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
English: Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Danish: Docetaxel Accord i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle-carcinoma i hoved og hals.
English: G3/4 AST increased G3/4 ALT increased
Danish: G3/4 ASAT forhøjet G3/4 ALAT forhøjet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg docetaxel.
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 en klinisk kemi, 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 clearance nedsat med gennemsnitlig 27 %.
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Danish: Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau  1.500 celler/mm3 og blodplader gendannes til et niveau
English: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Danish: Patienter med en udgangsværdi for neutrofile værdier på < 1.500 celler/mm3.
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients
Danish: Det blev observeret, at amenorré fortsatte ved afslutningen af opfølgningsperioden (median opfølgningstid på 8 år) hos 121 af 744 TAC patienter (16,3 %) og hos 86 FAC patienter (11,7 %).
English: Description of selected adverse reactions for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
English: Infections and infestations Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Danish: Infektioner (G3/4: 5,7 %; inklusive sepsis og pneumoni, letal hos
English: Docetaxel infusion solution is supersaturated, therefore may crystallise over time.
Danish: Docetaxel infusionsvæske er overmættet, den kan derfor udkrystallisere over tid.
English: Hand-foot syndrome (G3/4: Alopecia (G3/4: 6%);
Danish: Hånd- og fodsyndrom (G3/4: Alopeci (G3/4: 6 %);
English: Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Danish: Docetaxel Accord i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastrooesophageale forbindelse, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: If Docetaxel Accord concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis Docetaxel Accord infusionskoncentrat eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
English: Docetaxel in combination with capecitabine
Danish: Docetaxel i kombination med capecitabin
English: Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Danish: Docetaxel kan gives, når neutrocyttallet er  1.500 celler/mm3.
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 Docetaxel Accord koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
English: mostly associated with dehydration, vomiting and pneumonia.
Danish: Der er rapporteret tilfælde af hyponatriæmi, typisk forbundet med dehydrering, opkastning og pneumoni.
English: Data from a multicentre open-label randomised trial support the use of docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Danish: Data fra et multicenter, åbent, randomiseret studium støtter anvendelsen af docetaxel som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Danish: I studiet TAX 316 blev alopeci, der persisterede ind i opfølgningsperioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter (92,3 %) og hos 645 ud af 736 FAC-patienter (87,6 %).
English: 2Estimated median survival
Danish: 1Fuldt analysesæt (intent-to-treat) 2Estimeret median overlevelse.
English: Ethanol anhydrous Citric acid anhydrous
Danish: Vandfri ætanol Citronsyre, vandfri
English: In Docetaxel Accord vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i Docetaxel Accord er 20 mg/ml.
English: If Docetaxel Accord concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel Accord infusionskoncentrat eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
English: Data from one multicentre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Danish: Data fra et randomiseret, kontrolleret, klinisk fase 3-multicenterstudie understøtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokal fremskreden eller metastatisk brystkræft hos hvem cytotoksisk kemoterapi med et anthracyklin, har været uden effekt.
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m2 every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m2 hver 3. uge).
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 af infusionsvæsken tilberedt som anbefalet i infusionsposer uden indhold af PVC er påvist at være op til 48 timer ved opbevaring mellem 2 °C og 8 °C.
English: What you need to know before you use Docetaxel Accord
Danish: Det skal du vide, før du begynder at bruge Docetaxel Accord Brug ikke Docetaxel Accord
English: Patients with operable node-positive breast cancer (TAX 316) Data from a multicentre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Danish: Data fra et multicenter åbent randomiseret studium støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS > 80 % i alderen mellem 18 og 70 år.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Danish: Tabel over bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data:
English: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: Febrile neutropenia
Danish: Neutropeni (G3/4: 83,2 %); Trombocytopeni (G3/4: 8,8 %); Febril neutropeni