FrancophonIA/ELRC3.0 huggingface dataset:
English: Prednisone and dexamethasone
Danish: Prednison og dexmethason
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Danish: Symptomatisk hjertesvigt blev rapporteret hos 2,2 % af patienterne, som fik docetaxel plus trastuzumab i forhold til 0 % af de patienter, som fik docetaxel alene.
English: See also section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Danish: Se også afsnittet ”DOCETAXEL KABI indeholder alkohol” nedenfor.
English: Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Danish: Overfølsomhedsreaktioner (hyppighed ikke kendt) er rapporteret for docetaxel hos patienter, der tidligere har haft overfølsomhedsreaktioner overfor paclitaxel.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Danish: Forekomsten af de følgende bivirkninger (alle grader): Letargi, stomatitis, neutropenisk infektion opstod ≥ 10 % oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
English: • acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Danish: • Akut myeloid leukæmi og myelodysplastisk syndrom (typer af blodkræft) kan forekomme hos patienter, som behandles med docetaxel sammen med visse andre behandlinger mod kræft.
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Danish: Akut myeloid leukæmi og myelodysplastisk syndrom er blevet rapporteret (hyppighed ikke almindelig) i pivotale kliniske studier med brystkræft med TACregime.
English: If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Danish: Hvis en større dosis end 190 mg docetaxel er påkrævet, anvendes et større volumen infusionsvehikel således at en koncentration på 0,74 mg/ml docetaxel ikke overskrides.
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Danish: Effekten af docetaxel ved behandling af patienter med gastrisk adenokarcinom
English: Docetaxel did not influence the binding of digitoxin.
Danish: Docetaxel påvirkede ikke digitoxins proteinbinding.
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Danish: Fra et mikrobiologisk synspunkt skal rekonstituering/fortynding ske under kontrollerede og aseptiske forhold.
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Danish: Fase I-studier, som evaluerede capecitabins effekt på docetaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på docetaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel på capecitabins hovedmetabolit 5'-DFUR's farmakokinetik.
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 sygdoms-fri overlevelse og længere total overlevelse sammenlignet med FAC.
English: Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Danish: Docetaxel er et antineoplastisk stof, som virker ved at facilitere polymerisering af tubulin til stabile mikrotubuli og hæmme depolymerisering af mikrotubuli til tubulin, hvilket medfører et udtalt fald i koncentrationen af frit tubulin.
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Danish: Den mediane overlevelse var 442 dage (docetaxel + capecitabin) vs. 352 dage (docetaxel alene).
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Danish: Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m2.
English: Meeting relative indication for chemotherapya
Danish: Opfylder relativ indikation for kemoterapi a
English: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Danish: • Ved ethvert efterfølgende tegn på toksicitet eller ved grad 4-toksicitet seponeres docetaxelbehandling.
English: For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Danish: For patienter med operabel lymfeknude-negativ brystkræft bør adjuverende behandling begrænses til patienter egnet til at få kemoterapi ifølge etablerede nationale kriterier for primær behandling af tidlig brystkræft (se pkt.
English: The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Danish: Den primære analyse blev udført, da alle patienter havde en opfølgningstid på mere end 5 år (median opfølgningstid var 77 måneder).
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: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Danish: Den mediane tid indtil progression var 186 dage (docetaxel+ capecitabin) vs. 128 dage (docetaxel alene).
English: In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Danish: I et fase III-studie med tidligere behandlede patienter var tid til progression (12,3 uger vs. 7 uger) og den samlede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m2 end for bedste palliative behandling.
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Danish: Profylaktisk G-CSF kan anvendes til at nedsættes risikoen for hæmatologiske toksiciteter.
English: Use immediately the medicine once added into the infusion bag.
Danish: Anvendes straks, når medicinen er tilsat til en infusionspose.
English: Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Danish: Lokoregional behandling med stråling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy en gang daglig, 5 dage om ugen til en total dosis på 66 til 70 Gy), eller accelererede /hyperfraktionerede regimer af strålebehandling (to gange daglig, med et minimum interfraktion-interval på 6 timer, 5 dage pr. uge).
English: There is no relevant use of DOCETAXEL KABI 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 KABI 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: In combination with cisplatin and 5-fluorouracil
Danish: I kombination med cisplatin og 5-fluoruracil
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Danish: Skønt mulige in vivo-interaktioner mellem docetaxel og andet samtidigt administreret lægemiddel ikke er undersøgt formelt, har in vitro interaktionsstudier med kraftigt proteinbundne stoffer såsom erythromycin, difenhydramin, propranolol, propafenon, fenytoin, salicylat, sulfamethoxazol og natriumvalproat, ikke påvirket docetaxels proteinbinding.
English: Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Danish: Svære negleforandringer er karakteriseret ved hypo- eller hyper-pigmentering og sommetider smerter og onykolyse.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er brugeren ansvarlig for i-brug opbevaringstid- og betingelser.
English: Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Danish: In vitro-studier har vist, at Docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner i interfasen.
English: Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Danish: Meget almindelig: Hæmatologisk toksicitet var forhøjet hos de patienter, som modtog trastuzumab og docetaxel, i forhold til de patienter som fik behandling med docetaxel alene (32 % grad 3/4 neutropeni versus 22 %, under anvendelse af NCI-CTC kriterierne).
English: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Danish: Docetaxel fandtes in vitro at være cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for humane tumorceller fra frisk udtaget væv i klonogene assays.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Danish: Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var ≥ 10 % højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Danish: Prednison eller prednisolon 5 mg 2 gange daglig gives kontinuerligt (se pkt.
English: As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis.
Danish: Da fordelene hos patienter med 4+lymfeknuder ikke var statistisk signifikant for DFS og OS, blev den positive benefit/risk fordeling for TAC hos patienter med 4+lymfeknuder ikke helt demonstreret ved den endelige analyse.
English: Overall Response Rate (CR+PR) (%) p-value
Danish: Responsrate i alt (CR+PR) (%) p-værdi
English: • swelling caused by faulty lymphatic drainage
Danish: • Hævelse forårsaget af mangelfuld drænage af lymfe
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 anbefalet tilsætning til infusionspose, er docetaxel infusionsopløsningen stabil i 6 timer, hvis den opbevares under 25ºC.
English: Patients should be monitored for second primary malignancies (see section 4.8).
Danish: Patienter bør monitoreres for anden primær malignitet (se pkt.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Danish: • Den totale responshyppighed var signifikant højere i AT-armen i forhold til AC-armen, p = 0,009.
English: Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Danish: Tilfælde af lakrimation med eller uden konjunktivitis, da der er sjældne rapporter om tilfælde af obstruktion af tårekanalerne, som resulterede i usædvanlig kraftigt tåreflod.
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Danish: • 332 patienter, som fik docetaxel i kombination med prednison eller prednisolon (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: With primary G-CSF prophylaxis (n = 421) n (%)
Danish: Med primær GCSF- profylakse (n = 421) n (%)
English: If the vials are stored under refrigeration, allow the required number of boxes of DOCETAXEL KABI concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Danish: Hvis hætteglassene er blevet opbevaret på køl, så lad de påkrævede antal æsker af DOCETAXEL KABI koncentrat til infusionsvæske, opløsning stå 5 minutter under 25˚C før brug.
English: As with all parenteral products, DOCETAXEL KABI infusion solution should be visually inspected prior to use, and solutions containing a precipitate should be discarded.
Danish: Tilsvarende andre parenterale produkter, skal DOCETAXEL KABI visuelt inspiceres før brug, og opløsninger indeholdende et bundfald skal kasseres.
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 påvirke din evne til at køre motorkøretøj eller arbejde med maskiner.
English: If this happens, you must tell your doctor immediately
Danish: Hvis dette sker, skal du omgående fortælle det til lægen.
English: However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Danish: Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, eller bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxel-infusion og passende terapi.
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Danish: • Interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.
English: Disease Free Survival Hazard ratio*
Danish: Sygdoms-fri overlevelse Hazard ratio*
English: Docetaxel achieves high intracellular concentrations with a long cell residence time.
Danish: Docetaxel opnår høje intracellulære koncentrationer og forbliver længe intracellulært.
English: The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
Danish: Median-antallet af cyklusser administreret pr. patient var 6 (med en range på 1-16) for TCF-armen sammenlignet med 4 (med en range på 1-12) for CF-armen.
English: Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Danish: Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med lægemidlet og i forbindelse med overfølsomhedsreaktioner.
English: Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Danish: Docetaxel infusionsvæske er overmættet og kan derfor udkrystallisere over tid.
English: †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
English: To be taken into account in pregnant or breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Dette skal tages i betragtning hos gravide eller ammende, til børn og høj-risiko grupper så som patienter med leversygdom eller epilepsi.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation .
Danish: Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, herunder enterocolitis og gastrointestinal perforation.
English: DOCETAXEL KABI was administered as a 1-hour infusion, all other medicinal product were given intraveinously on day 1 every three weeks.
Danish: DOCETAXEL KABI blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: Following chemotherapy, patients should receive radiotherapy.
Danish: Efter kemoterapi bør patienterne få strålebehandling.
English: G3/4 Blood alkaline phosphatase increased
Danish: G3/4 Forhøjet alkalisk fosfatase i blodet
English: Fluid retention is cumulative in incidence and severity (see section 4.4).
Danish: Væskeretention er kumulativ i forekomst og sværhedsgrad (se pkt.
English: The recommended dose of docetaxel is 75 mg/m2.
Danish: Den anbefalede dosis af docetaxel er 75 mg/m2.
English: • inflammation of the eye or increased tearing of the eyes
Danish: • Betændelse i øjet eller øget tåreflåd
English: Dehydration and pulmonary oedema have rarely been reported.
Danish: Dehydrering og pulmonar ødem er sjældent rapporteret.
English: Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Danish: Docetaxel har vist sig at være mutagent in vitro i mikronucleus -og kromosom-aberrationstesten i CHO-K1 celler, samt in vivo i mikronucleustesten i mus.
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Danish: • Opstød fra maven inklusive kvalme, opkastning og diarré, forstoppelse
English: Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
Danish: Overfølsomhedsreaktioner opstod generelt inden for få minutter efter starten af docetaxelinfusionen, og reaktionerne var ofte milde til moderate.
English: For more details see summary of product characteristics of trastuzumab.
Danish: For flere detaljer, se produktresumé for trastuzumab.
English: 2 year Survival (%)
Danish: 2-års overlevelse (%)
English: Subgroups
Danish: Undergruppe
English: Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Danish: Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusive brændende fornemmelser.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a
English: Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Danish: Blandt 300 patienter (221 patienter i fase III-delen af undersøgelsen og 79 patienter i fase II-delen af undersøgelsen), som fik behandling med docetaxel i kombination med cisplatin og 5-fluoruracil i undersøgelsen af gastrisk kræft, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
English: Single-use vial.
Danish: Kun til engangsbrug.
English: For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Danish: Hos patienter, som får kompliceret neutropeni (forlænget neutropeni, febril neutropeni eller infektion), bør G-CSF og dosisreduktion overvejes (se pkt.
English: Cases of electrolyte imbalance have been reported.
Danish: Tilfælde af elektrolytforstyrrelser er rapporteret.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Danish: Alvorlige reaktioner blev karakteriseret ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erytem (se pkt.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m2 som 1 times intravøs infusion hver 3. uge).
English: Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Danish: Adjuverende stråleterapi blev givet i henhold til eksisterende vejledninger på de deltagende centre og blev givet til 69 % af patienterne, som fik TAC, og 72 % af patienterne som fik FAC.
English: Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Danish: Der er rapporteret tilfælde af hyponatriæmi, typisk forbundet med dehydrering, opkastning og pneumoni.
English: • tiredness; or flu-like symptoms
Danish: • Træthed eller influenza-lignende symptomer
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Danish: Man bør anvende profylaktisk G-CSF for at nedsætte risikoen for hæmatologisk toksicitet (se også ”Dosisjustering under behandling”).
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Danish: Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret i den primære analyse (ved median opfølgningsperiode på 77 måneder) (se tabel nedenfor):
English: A study of 14C-docetaxel has been conducted in three cancer patients.
Danish: Der er gennemført en undersøgelse med 14C-mærket docetaxel på 3 kræftpatienter.
English: Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
Danish: Adjuverende strålebehandling blev administreret i henhold til guidelines på de deltagende behandlingssteder og blev givet til 57,3 % af de patienter, der fik TAC, og til 51,2 % af de patienter, der fik FAC.
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Danish: Det primære endepunkt i denne undersøgelse, progression-fri overlevelse (PFS), var signifikant længere i TPF-armen sammenlignet med PF-armen, p = 0,0042 (median PFS: 11,4 vs. 8,3 måneder respektivt) med en samlet median opfølgningstid på 33,7 måneder.
English: Hypersensitivity (no severe)
Danish: Overfølsomhed (ikke alvorlig)
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Danish: Overlevelsesprocenten var 93,7 % i TAC-armen og 91,4 % i FAC-armen ved tidspunktet for 8-års opfølgning, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10-års opfølgning.