FrancophonIA/ELRC3.0 huggingface dataset:
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 fik trastuzumab og docetaxel, sammenlignet med de patienter, som fik behandling med docetaxel alene (32 % grad 3/4 neutropeni vs. 22 % med anvendelse af NCI-CTC-kriterierne).
English: The updated analysis was performed when all patients had reached their 10-year (median follow up time of 10 years and 5 months) follow-up visit (unless they had a DFS event or were lost to follow-up previously).
Danish: Den opdaterede analyse blev udført, da alle patienter havde nået deres 10-års (median opfølgningstid var 10 år og 5 måneder) opfølgningsbesøg (medmindre de havde DFS eller tidligere var udgået fra opfølgning).
English: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat,
Danish: • ventrikulær arytmi eller ventrikulær takykardi (manifesteret som uregelmæssig og/eller hurtig hjerterytme, alvorlig åndenød, svimmelhed og/eller besvimelse).
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Danish: Flere grad 3/4 bivirkninger blev observeret for monoterapi med docetaxel (55,4 %) sammenlignet med paclitaxel (23,0 %).
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 relevante behandlingsrelaterede bivirkninger er medtaget).
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Danish: Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold.
English: Nervous system The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
Danish: Nervesystemet Udvikling af alvorlig perifer neurotoksicitet kræver en dosisreduktion (se pkt.
English: At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdomsfri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: For opbevaringsforhold for det fortyndede lægemiddel, se pkt.
English: The concentrate is a pale yellow to brownish-yellow solution.
Danish: Koncentratet er en svagt gul til brun-gul opløsning.
English: All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Danish: Patienter uden progressiv sygdom skulle have (CRT) ifølge protokollen (PF/CRT).
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Danish: Medianoverlevelsen var 442 dage (docetaxel + capecitabin) vs. 352 dage (docetaxel alene).
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 i de deltagende centre og blev givet til 69 % af patienterne, som fik TAC, og 72 % af patienterne, som fik FAC.
English: In patients treated with the TAC regimen for node positive breast cancer, the risk of CHF has been shown to be higher during the first year after treatment (see sections 4.8 and 5.1).
Danish: Hos patienter i behandling med TAC-regimenet for lymfeknude-positiv brystkræft har risikoen for CHF vist sig at være højere i det første år efter behandling (se pkt.
English: Some cases of anaphylactic shock, sometimes fatal, have been reported.
Danish: Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale.
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 studiet og 79 patienter i fase II-delen af studiet), som fik behandling med docetaxel i kombination med cisplatin og 5-fluoruracil i studiet af gastrisk kræft, var 74 patienter 65 år eller ældre, og 4 patienter var 75 år eller ældre.
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/m til 45 mg/m 2.
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Danish: Stomatitis/mucositis grad 3 Første episode: Reducer 5-FU-dosis med 20 %.
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Der blev påvist signifikant længere sygdomsfri overlevelse i TAC-armen end i FAC-armen.
English: • inflammation of the eye or increased tearing of the eyes
Danish: • betændelse i øjet eller øget tåreflåd
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 OS (11 months vs. 9 months, p = 0.01).
Danish: Docetaxel øgede responsraten (33 % vs. 12 %, p < 0,0001), forlængede tiden til progression (19 uger vs. 11 uger, p = 0,0004) og forlængede overlevelsen (11 måneder vs. 9 måneder, p = 0,01).
English: The most commonly reported adverse reactions of Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Danish: De mest almindeligt indberettede bivirkninger af Taxespira alene er: fald i antallet af røde og hvide blodlegemer, hårtab (alopeci), kvalme, opkastning, sår i munden, diarré og træthed.
English: Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Danish: Taxespira i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Danish: Akut respiratorisk distress syndrom og tilfælde af interstitiel pneumoni/pneumonitis, interstitiel lungesygdom, lungefibrose og respirationssvigt, sommetider fatale, er rapporteret sjældent.
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
Danish: I dette studie blev 358 patienter med inoperabel, lokalt fremskreden SCCHN og WHO performance status 0 eller 1 randomiseret til en af to behandlingsarme.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Danish: Alvorlige reaktioner var kendetegnet ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erytem (se pkt.
English: Dehydration and pulmonary oedema have rarely been reported.
Danish: Dehydrering og lungeødem er sjældent rapporteret.
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 brystkræft er den anbefalede dosis docetaxel i monoterapi 100 mg/m 2.
English: • For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
Danish: • Hos patienter, der første gang udvikler grad 2-toksicitet, der vedvarer til tidspunktet for den næste behandling med docetaxel/capecitabin, skal behandlingen udsættes, indtil toksiciteten er grad 0-1, og derefter genoptages som 100 % af den oprindelige dosis.
English: Distribution 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: Fordeling Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time blev en gennemsnitlig, maksimal plasmakoncentration på 3,7 µg/ml opnået med et tilsvarende AUC på 4,6 t.µg/ml.
English: Median OS was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Danish: Median OS var også signifikant længere til fordel for TPF-armen sammenlignet med PF-armen (median OS: henholdsvis 18,6 og 14,5 måneder) med en reduktion af risikoen for mortalitet på 28 %, p = 0,0128.
English: Taxespira as single agent
Danish: Taxespira som enkeltstof
English: Each vial is for single use and should be used immediately after opening.
Danish: Hvert hætteglas er til engangsbrug og bør anvendes umiddelbart efter anbrud.
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 rapporteret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet), typisk forekommende under infusion af lægemidlet og i forbindelse med overfølsomhedsreaktioner.
English: Docetaxel is more than 95% bound to plasma proteins.
Danish: Docetaxels plasmaproteinbinding er over 95 %.
English: For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion.
Danish: For eksempel vil en dosis på 140 mg docetaxel kræve 7 ml Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning.
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 mikronukleus- og kromosom-aberrationstesten i CHO-K1 celler samt in vivo i mikronukleustesten i mus.
English: Patients with baseline neutrophil count of <1,500 cells/mm
Danish: Patienter med et neutrofiltal ved baseline på < 1.500 celler/mm
English: Oesophagitis (severe:
Danish: Øsofagitis (alvorlig:
English: Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Danish: Docetaxel + trastuzumab var effektivt til patienterne, uanset om de havde fået adjuverende anthracyclin eller ikke.
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Danish: • maveproblemer, herunder kvalme, opkastning og diarré, forstoppelse
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 retningslinjerne for 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: There is no relevant use of Taxespira in the paediatric population for the indication of 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 Taxespira 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 ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in
Danish: ORR var 59,3 % (95 % CI: 52,8 - 65,9) i AT-armen vs. 46,5 % (95 % CI: 39,8 - 53,2) i AC-armen.
English: • blood clots.
Danish: • blodpropper.
English: 50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
Danish: mg/m2 (TAC-arm) eller doxorubicin 50 mg/m 2, efterfulgt af fluoruracil 500 mg/m2 (FAC-arm).
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Danish: I behandlingsarmen på docetaxel plus trastuzumab havde 64 % fået tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55 % i behandlingsarmen på docetaxel alene.
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: Med en hazard ratio på under 1 kan docetaxel + cisplatin + 5-FU anvendes med fordel *Cox-model (justering for primært tumorsted, kliniske T- og N-stadier og PSWHO) **Log-rank-test *** Chi-kvadrat-test
English: • pneumonia (infection of the lungs)
Danish: • lungebetændelse (pneumoni)
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 prostatakræft blev undersøgt i et randomiseret fase III-multicenterstudie.
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 ligesom andre potentielt toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningerne.
English: Outer Carton
Danish: Ydre karton
English: Patients previously treated with chemotherapy with or without radiotherapy In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Danish: Patienter, der tidligere har fået behandling med kemoterapi med eller uden strålebehandling I et fase III-studie med tidligere behandlede patienter var tiden indtil progression (12,3 uger vs. 7 uger) og den overordnede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m² end for bedste palliative behandling.
English: Patients with 4+ nodes
Danish: Patienter med 4+ lymfeknuder
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Danish: Hjælpestoffer: polysorbat 80, vandfri ethanol (læs indlægssedlen for yderligere information), citronsyremonohydrat.
English: Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Danish: Der blev udført eksplorative undergruppeanalyser af sygdomsfri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT-population).
English: Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions.
Danish: Taxespira er et antineoplastisk stof, og ligesom andre potentielt toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningerne med Taxespira.
English: If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Danish: Hvis samtidige anvendelse af en potent CYP3A4-hæmmer (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) ikke kan undgås, er tæt klinisk overvågning nødvendig, og dosisjustering af docetaxel kan være hensigtsmæssig under behandling med potente CYP3A4-hæmmere (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/ m som 1 times intravenøs infusion hver 3. uge).
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him the results of your blood tests.
Danish: Vær særlig opmærksom på at informere din læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelser eller feber, og giv lægen resultatet af dine blodprøver.
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 prostatakræft er præmedicineringen oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusionen (se 4.2).
English: Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized 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: Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316) Data fra et åbent, randomiseret multicenterstudie understøtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS ≥ 80 % i alderen 18 til 70 år.
English: What Taxespira contains
Danish: Taxespira indeholder:
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 brystkræft (intent-to-treat-analyse)
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 (kumulativ mediandosis: 818,9 mg/m 2) med præmedicinering sammenlignet med patienter uden præmedicinering (kumulativ mediandosis: 489,7 mg/m2).
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Danish: Bivirkningerne af docetaxel kan blive mere alvorlige, når docetaxel gives i kombination med andre kemoterapeutiske midler.
English: One large randomized 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) vs. doxorubicin (60 mg/m²) i kombination med cyclophosphamid (600 mg/m²) (AC-arm).
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Danish: I studiet TAX 316 fik 26 patienter (3,5 %) i TAC-armen og 17 patienter (2,3 %) i FAC-armen kongestivt hjertesvigt.
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 af kemoterapi fik patienter i begge arme, der havde positive østrogen- og/eller progesteronreceptorer, tamoxifen 20 mg dagligt i op til 5 år.
English: Both regimens were administered on day 1 every 3 weeks.
Danish: Begge regimener blev administreret på dag 1 hver 3. uge.
English: Both regimens were administered every 3 weeks.
Danish: Begge regimener blev administreret hver 3. uge.
English: • 1,276 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 og 532 i henholdsvis TAX 316 og GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (klinisk relevante behandlingsrelaterede
English: No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Danish: Der foreligger ingen data for patienter med nedsat leverfunktion, der får kombinationsbehandling med docetaxel i de andre indikationer.
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 (e.g., day 6-15) in all subsequent cycles.
Danish: Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusive prolongeret neutropeni, febril neutropeni eller infektion), blev G-CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser.
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 fordels-/risikoforhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt.
English: General disorders and administration site conditions Investigations
Danish: Almene symptomer og reaktioner på administrationsstedet Undersøgelser
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), anden sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m² end hos patienterne, der fik bedste palliative behandling.
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 anthracyklin (doxorubicin eller epirubicin).
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 docetaxels aktivitet uafhængig af behandlingsregimenet og har eksperimentelt vist et bredt spektrum af antineoplastisk aktivitet over for murine og transplanterede humane tumorer.
English: Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Danish: På grund af risikoen for skadelige påvirkninger af barnet skal amning derfor ophøre under behandling med docetaxel.
English: Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Danish: Der kan også opstå betændelse i lungerne, når behandling med docetaxel bruges sammen med strålebehandling