FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Danish: Patienter med operabel lymfeknude-negativ brystcancer, egnet til behandling med kemoterapi (GEICAM 9805)
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold og lægemidlet bør anvendes umiddelbart herefter.
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: 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 har in vitro vist sig cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for frisk udtaget humant tumorcellevæv i klonogene assays.
English: In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
Danish: I et farmakokinetisk studie med 7 patienter resulterede samtidig administration af docetaxel og den potente CYP3A4-hæmmer ketoconazol i et signifikant fald i docetaxel-clearance på 49%.
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 (prolongeret neutropeni, febril neutropeni eller infektion), bør G¬CSF og dosisreduktion overvejes (se pkt.
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, bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxelinfusion og passende behandling.
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 intravenøs infusion over en time hver tredje uge).
English: The most commonly reported adverse reactions of Docetaxel Mylan alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Danish: De mest almindelige bivirkninger ved Docetaxel Mylan givet alene er: fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Danish: Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), andre sygdomsrelaterede lægemidler (p = 0,06) og strålebehandling (p < 0,01) hos patienter behandlet med docetaxel ved 75 mg/m² end hos patienterne, der fik bedste understøttende behandling.
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Danish: • maveproblemer herunder kvalme, opkastning og diarré, forstoppelse
English: More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Danish: Det kan være nødvendigt at anvende mere end ét hætteglas koncentrat til infusionsvæske, opløsning for at opnå den dosis, der er nødvendig for patienten.
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 randomized multicenter phase III study.
Danish: Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatacancer blev evalueret i et randomiseret multicenter, fase III-studie.
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Danish: Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystcancer (intent-to-treat analyse)
English: All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Danish: Alle patienter i docetaxel-armen fik profylaktisk antibiotika.
English: • swelling caused by faulty lymphatic drainage
Danish: • hævelse forårsaget af ophobning af lymfevæske
English: All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Danish: Alle patienter uden progressiv sygdom skulle have kemo-stråleterapi (CRT) i henhold til protokollen (TPF/CRT).
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m² every three weeks, with trastuzumab administered weekly.
Danish: I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m² hver 3. uge med en ugentlig administration af trastuzumab.
English: General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Danish: Almene symptomer og reaktioner på indgivelsesstedet I studiet TAX 316 fortsatte perifert ødem hos 19 patienter ud af 119 patienter med perifert ødem i TAC-armen og hos 4 patienter ud af de 23 patienter med perifert ødem i FAC-armen.
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Danish: Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med antracyklin (doxorubicin eller epirubicin).
English: The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
Danish: Øvrige indholdsstoffer: polysorbat 80, vandfri ethanol og citronsyre.
English: In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Danish: Efter den sidste cyklus kemoterapi fik patienter i begge studiearme med positive østrogen- og/eller progesteronreceptorer 20 mg tamoxifen dagligt i op til 5 år.
English: The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.
Danish: Koncentratet leveres i et klart, farveløst hætteglas med en gummiprop og en plastik-afrivningshætte.
English: 2-year estimate (%)
Danish: Toårs estimat (%)
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: Ved en hazard ratio på < 1 kan docetaxel+Cisplatin+5-FU med fordel anvendes *Cox model (justering for primært tumorsted, T og N kliniske trin og PSWHO) **Log-rank test *** Chi-square-test
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Danish: In vivo er docetaxel uafhængigt og har i studier vist sig at have bredspektret antitumoraktivitet over for fremskredne murine og transplanterede humane tumorer.
English: Docetaxel increased response rate (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: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Danish: Ved afslutningen af kemoterapi med et mindsteinterval på 4 uger og et maksimuminterval på 7 uger fik patienter, hvis sygdom ikke progredierede, strålebehandling (RT) i syv uger i overensstemmelse med de institutionelle retningslinjer (TPF/RT).
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 primær G¬CSF profylaktisk, efter det blev gjort obligatorisk i TAC-armen i GEICAM-studiet.
English: Following the administration of a 100 mg/m² dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Danish: Efter indgift af en 100 mg/m² dosis givet som infusion over 1 time var det gennemsnitlige plasmaniveau 3,7 µg/ml med et AUC på 4,6 h·µg/ml.
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Danish: Ved afslutningen af kemoterapi med et mindsteinterval på 4 uger og et maksimuminterval på 7 uger modtog patienter, hvis sygdom ikke progredierede, strålebehandling (RT) i 7 uger i overensstemmelse med de institutionelle retningslinjer (PF/RT).
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m²) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m²); however, it has been reported in some patients during the early courses of therapy.
Danish: Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (median kumulativ dosis: 818,9 mg/m²) med præmedicinering set i forhold til patienter uden præmedicinering (median kumulativ dosis: 489,7 mg/m²).
English: The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents.
Danish: Alvorligheden af bivirkningerne af Docetaxel Mylan kan forøges, når Docetaxel Mylan gives i kombination med andre kemoterapeutiske lægemidler.
English: • Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.
Danish: • Mitoxantron 12 mg/m² hver 3. uge i 10 cyklusser.
English: Without affecting overall survival 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 den totale overlevelsestid (docetaxel 15 måneder mod doxorubicin 14 måneder, p = 0,38) eller tiden til progression (docetaxel 27 uger mod doxorubicin 23 uger, p = 0,54) øgede docetaxel responsraten (52% mod 37%, p = 0,01) og gav kortere tid til respons (12 uger mod 23 uger, p = 0,007).
English: C-docetaxel has been conducted in three cancer patients.
Danish: C-mærket docetaxel på 3 cancerpatienter.
English: • feeling of numbness or pins and needles or pain in the joints or muscles
Danish: • følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i led eller muskelfæster
English: Neutropenia (G4: 54.2%);
Danish: Neutropeni (G4: 54,2%);
English: Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Danish: Docetaxel + trastuzumab var effektivt, uanset om patienterne først havde fået adjuverende antracykliner eller ej.
English: As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Danish: Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdomsfri overlevelse (DFS) og total overlevelse (OS), blev det positive fordel/risiko forhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt.
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy.
Danish: Til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer er den anbefalede dosis docetaxel i monoterapi 100 mg/m².
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Danish: Primær G¬CSF-profylakse bør overvejes til patienter, som får docetaxel-, doxorubicin- og cyclophosphamid- (TAC)-adjuverende behandling for brystcancer.
English: Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Danish: Doxetaxel Mylan i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
English: There is no known antidote for docetaxel overdose.
Danish: Der er ingen kendt antidot til docetaxel.
English: Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Danish: Der er rapporteret sjældne tilfælde af strålepneumonitis hos patienter, der er i samtidig stråleterapi.
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 lille antal patienter (n=23) med en klinisk kemi, der tydede på en let til moderat nedsat leverfunktion (ASAT og ALAT ≥ 1,5 gange ULN forbundet med alkalisk phosphatase ≥ 2,5 gange ULN), var den samlede clearance nedsat med gennemsnitligt 27% (se pkt.
English: Docetaxel Mylan is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Mylan solutions.
Danish: Docetaxel Mylan er et antineoplastisk middel, og som med andre potentielt toksiske præparater skal der udvises forsigtighed ved håndtering og præparering af Docetaxel Mylan-opløsninger.
English: Other medicines and Docetaxel Mylan
Danish: Brug af anden medicin sammen med Docetaxel Mylan
English: The cycles were repeated every 3 weeks for 3 cycles.
Danish: Cyklusserne blev gentaget hver tredje uge i 3 cyklusser.
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: Anvend kun denne medicin til børn, gravide og ammende kvinder og patienter i højrisikogruppe som patienter med epilepsi og leversygdomme efter aftale med lægen.
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Danish: • 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (klinisk relevante behandlingsrelaterede bivirkninger er nævnt).
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Danish: Docetaxel er et antineoplastisk stof og som med andre potentielle toksiske lægemidler, skal man udvise forsigtighed ved brug og fremstilling af opløsningerne.
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Danish: Docetaxel blev indgivet som infusion over 1 time, alle andre lægemidler blev indgivet som intravenøs bolusinjektion på førstedagen.
English: It should be used within 6 hours (including the one hour infusion intravenous administration).
Danish: Den bør anvendes inden for 6 timer (inklusive den time, patienten får infusionen).
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: I kombination med capecitabin er de mest almindelige behandlingsrelaterede bivirkninger (≥ 5%), som blev rapporteret i et fase III-studie med brystcancerpatienter, hvor antracyklinbehandling ikke havde haft effekt, medtaget (se: Produktresuméet for capecitabin).
English: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
Danish: Udtag den ønskede mængde af docetaxel koncentrat (20 mg/ml) fra hætteglasset og tilføj det direkte til infusionsvæsken.
English: Docetaxel Mylan must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: Docetaxel Mylan må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Danish: Det primære effektendepunkt i dette studie, total overlevelse (OS), var signifikant længere (log-rank test, p = 0,0058) i det regime, som indeholdt docetaxel, sammenlignet med PF (median OS: 70,6 mod 30,1 måneder), med en 30% reduktion i risikoen for mortalitet sammenlignet med PF (hazard ratio (HR) = 0,70, 95% konfidensinterval (CI) = 0,54-0,90) med en total medianopfølgningstid på 41,9 måneder.
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Danish: Til prostatacancer er præmedicineringen oral dexamethason 8 mg, 12 timer, 3 timer og 1 time før docetaxel-infusionen (se pkt.
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Danish: Forekomsten af tilbagefald i år ti var reduceret hos patienter, som fik TAC sammenlignet med dem, som fik FAC (hhv. 39% og 45%), dvs. en absolut reduktion i risiko med 6% (p=0,0043).
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Danish: G¬CSF blev indgivet som sekundær profylakse til patienter som oplevede kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller infektion).
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 svigt af forudgående platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m² givet som enkeltstof.
English: Headache (G3/4: < 1%); Neuropathy peripheral
Danish: Hovedpine (G3/4: < 1%); Perifer neuropati
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: In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Danish: Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusiv prolongeret neutropeni, febril neutropeni eller infektion), blev G¬CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser.
English: As with all parenteral products, Docetaxel Mylan concentrate for solution or diluted solution for infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som alle andre parenterale præparater bør Docetaxel Mylan koncentrat til infusionsvæske eller fortyndet opløsning til infusionsvæske inspiceres visuelt inden brug, og opløsninger med udfældning skal kasseres.
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 hoved-halscancer-patienter, som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk relevante behandlingsrelaterede bivirkninger er nævnt).
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: See also section “Docetaxel Mylan contains ethanol” below.
Danish: Se også afsnittet ”Docetaxel Mylan indeholder ethanol (alkohol)”.
English: Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Danish: Overlevelse var bedre i kombinationsarmen med docetaxel + carpecitabin (p = 0,0126).
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Danish: De anbefalede dosis-justeringer for toksicitet hos patienter behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (5-FU):
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Danish: På baggrund af den dosis, der er nødvendig for patienten udtrykt i mg, udtages den tilsvarende mængde af 20 mg/ml docetaxel aseptisk fra det passende antal hætteglas med en gradueret sprøjte med påsat 21G-kanyle.
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 i in vitro mikronucleus- og kromosomaborrationstest i CHOK1-celler samt i in vivo mikronucleustest med mus.
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Danish: Effekten af docetaxel i behandlingen af patienter med gastrisk adenokarcinom
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m².
Danish: I tilfælde af efterfølgende episoder med kompliceret neutropeni, bør dosis af docetaxel reduceres fra 60 mg/m² til 45 mg/m².
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Danish: Immunsystemet Metabolisme og ernæring Nervesystemet neuropati (G3: 4,1%); Perifer motorisk neuropati (G3/4: 4%); Dysgeusi (alvorlig:
English: • Docetaxel 30 mg/m² administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Danish: • Docetaxel 30 mg/m² indgivet ugentlig de første 5 uger i en cyklus på 6 uger i 5 cyklusser.