FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Danish: Postmenopausal *En hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC.
English: Ethanol (anhydrous) Citric acid monohydrate
Danish: Ethanol (vandfri) Citronsyremonohydrat
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Danish: • Tiden indtil progression (TTP) var signifikant længere i AT-armen end i AC-armen, p = 0,0138.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Danish: Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudie var 209 patienter 65 år eller derover, og 68 patienter var ældre end 75 år.
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4 % of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Danish: Febril neutropeni og neutropenisk infektion forekom hos henholdsvis 12,1 % og 3,4 % af patienterne, når patienterne fik profylaktisk G-CSF, og hos 15,6 % og 12,9 % af patienterne uden profylaktisk G-CSF (se punkt 4.2).
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Danish: Docetaxel må derfor ikke anvendes til gravide, medmindre det er på tvingende indikation.
English: • weight gain or loss.
Danish: • vægtstigning eller vægttab.
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up timepoint.
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.
English: What you need to know before you use Taxespira
Danish: Det skal du vide, før du begynder at bruge Taxespira
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 administreret ugentligt i de første 5 uger i en 6-ugers cyklus i 5 cyklusser.
English: Patients who received docetaxel every three weeks demonstrated significantly longer OS compared to those treated with mitoxantrone.
Danish: De patienter, der fik docetaxel hver 3. uge, viste signifikant længere overordnet overlevelse sammenlignet med dem, der fik mitoxantron.
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Danish: Alle 3 behandlingsregimener blev administreret i kombination med prednison eller prednisolon 5 mg to gange dagligt kontinuerligt.
English: It is important that you read the entire contents of this guide prior to the preparation of the Taxespira infusion solution.
Danish: Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af Taxespira koncentrat til infusionsvæske, opløsning.
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Danish: Øre og labyrint Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/eller tab af hørelse.
English: Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Danish: Efter induktionskemoterapi skulle patienter i begge behandlingsarme have 7 ugers CRT med et minimumsinterval på 3 uger og ikke senere end 8 uger efter påbegyndelse af sidste cyklus (dag 22 til dag 56 af sidste cyklus).
English: - The active substance is docetaxel (as trihydrate).
Danish: - Aktivt stof: docetaxel (som trihydrat).
English: Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: Taxespira må IKKE anvendes, hvis du er gravid, medmindre din læge udtrykkeligt ønsker det.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC
Danish: *En Hazard ratio på mindre end 1 indikerer, at TAC kan associeres med længere sygdomsfri overlevelse og længere total overlevelse sammenlignet med FAC.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Taxespira was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Danish: Taxespira blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Danish: • Den overordnede responsrate (ORR) var signifikant højere i AT-armen end i AC-armen, p = 0,009.
English: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Danish: • Ved ethvert efterfølgende tegn på toksicitet eller grad 4-toksiciteter seponeres docetaxelbehandlingen.
English: Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Danish: Toksisk dødsfald forekom hos 1 patient i AT-armen (kongestivt hjertesvigt) og hos 4 patienter i AC-armen (1 på grund af septisk shock og 3 på grund af kongestivt hjertesvigt).
English: Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Danish: Der er observeret lokaliseret erythem på ekstremiteterne (håndflader og fodsåler) med ødem efterfulgt af afskalning.
English: Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Danish: De patienter, der fik behandling med TPF, fik signifikant mindre forværring af deres globale helbredsscore i forhold til patienter i behandling med PF (p = 0,01, med anvendelse af EORTC QLQC30-skalaen).
English: Use the vial immediately after its opening.
Danish: Hætteglasset skal bruges umiddelbart efter åbning.
English: Disease free survival Hazard ratio*
Danish: Sygdomsfri overlevelse Hazard ratio*
English: Overall response rate (CR+PR) (%) p-value
Danish: Overordnet responsrate (CR+PR) (%) p-værdi
English: The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow-up before).
Danish: Den endelige analyse blev udført, da alle patienter havde nået deres 10-års opfølgningsbesøg (medmindre de havde DFS eller udgik tidligere fra opfølgning).
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 det er nødvendigt at anvende en dosis på mere end 190 mg docetaxel, skal der anvendes en større mængde af infusionsopløsningen, så man ikke overstiger en koncentration på 0,74 mg docetaxel/ml.
English: If the vials are stored under refrigeration, allow the required number of boxes of Taxespira 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 Taxespira koncentrat til infusionsvæske, opløsning, stå ved under 25° C i 5 minutter før brug.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Danish: Blod og lymfesystem Sjælden: Blødningsepisoder forbundet med trombocytopeni grad 3/4.
English: Harmful for those suffering from alcoholism.
Danish: Kan være skadeligt for alkoholikere.
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 følgende bivirkninger (alle grader): letargi, stomatitis, neutropenisk infektion var ≥ 10 % højere end hos de patienter, som var 65 år eller derover, end hos de yngre patienter.
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Danish: De patienter, der blev behandlet i TCF-armen, havde længere tid indtil 5 % definitiv forværring af global helbredsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og en længere tid indtil definitiv forværring af Karnofskys performance status (p = 0,0088) sammenlignet med patienterne, som fik behandling med CF.
English: 3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Danish: 3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
English: Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Danish: Alvorlige negleforandringer er karakteriseret ved hypo- eller hyperpigmentering og sommetider smerter og onykolyse.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF
English: C-docetaxel has been conducted in three cancer patients.
Danish: C-mærket docetaxel på tre kræftpatienter.
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 én fraktionering dagligt (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 70-72 Gy).
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 fremme polymerisering af tubulin til stabile mikrotubuli og hæmme depolymerisering af mikrotubuli til tubulin, hvilket medfører et udtalt fald i koncentrationen af frit tubulin.
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Danish: Med en hazard ratio på under 1 kan docetaxel + cisplatin + fluorouracil anvendes med fordel *ikke-justeret log-rank-test **ikke-justeret log-rank-test, ikke justeret for multiple sammenligninger ***Chi-kvadrat-test, ikke justeret for multiple sammenligninger NA - not applicable (ikke relevant)
English: Therefore, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment
Danish: Mænd, som er i behandling med docetaxel, tilrådes derfor ikke at få børn under og op til 6 måneder efter behandling samt til at søge vejledning vedrørende opbevaring af sæd inden behandling.
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Danish: Vaskulære sygdomme Venøse tromboemboliske hændelser er rapporteret i sjældne tilfælde.
English: All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Danish: Alle patienter i studiets docetaxel-arm fik profylaktisk antibiotika.
English: Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Danish: Reaktionerne var karakteriseret ved udslæt inklusive lokale udbrud, hovedsagelig på fødder og hænder (inklusive alvorligt hånd-/fodsyndrom), men også på arme, ansigt og thorax.
English: The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Danish: Prednisons virkning på farmakokinetikken for docetaxel administreret med standardpræmedicinering med prednison er undersøgt hos 42 patienter.
English: Taxespira has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
Danish: Taxespira er ordineret af din læge til behandling af brystkræft, specielle former for lungekræft (ikkesmåcellet lungekræft), prostatakræft, mavekræft eller hoved- og halskræft:
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 andre samtidigt administrerede lægemidler ikke er undersøgt formelt, har in vitrointeraktioner med kraftigt proteinbundne stoffer såsom erythromycin, diphenhydramin, propranolol, propafenon, phenytoin, salicylat, sulfamethoxazol og natriumvalproat ikke påvirket docetaxels proteinbinding.
English: If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Danish: Hvis du får akutte problemer med lungerne (feber, åndenød eller hoste), eller de bliver værre, skal du straks fortælle det til lægen, apotekspersonalet på hospitalet eller sundhedspersonalet.
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Danish: De anbefalede dosismodifikationer ved toksiciteter hos patienter, der er behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (5-FU):
English: If you are a man being treated with Taxespira you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility.
Danish: Hvis du er mand, og du er i behandling med Taxespira, frarådes du at få børn under og op til 6 måneder efter behandlingen samt til at søge vejledning vedrørende opbevaring af sæd inden behandlingen, da docetaxel kan ændre mandens frugtbarhed.
English: Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Danish: Docetaxels clearance var ikke påvirket hos patienter med let til moderat væskeretention, og der findes ingen data for clearancen hos patienter med svær væskeretention.
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy, or liver impairment.
Danish: Fortæl det til din læge, hvis du er afhængig af alkohol, epilepsi eller lider af leversvækkelse.
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
Danish: Median TTP var 37,3 uger (95 % CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 % CI: 27,436,0) i AC-armen.
English: • tiredness or flu-like symptoms
Danish: • træthed eller influenza-lignende symptomer
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
Danish: In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af CYP3A, f.eks. ciclosporin, ketoconazol og erythromycin.
English: Previous therapy should have included an anthracycline.
Danish: Tidligere behandling skal have omfattet et anthracyklin.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin
Danish: Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1.491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50
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.4.2).
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Danish: Docetaxels kinetiske profil er dosisuafhængig og svarer til en trekamret farmakokinetisk model med halveringstider for α-, β- og γ-faserne på henholdsvis 4 min., 36 min. og 11,1 timer.
English: Following chemotherapy, patients should receive radiotherapy.
Danish: Efter kemoterapi bør patienterne have strålebehandling.
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 dette studie, progressionsfri overlevelse (PFS), var signifikant længere i TPF-armen end i PF-armen, p = 0,0042 (median PFS: henholdsvis 11,4 og 8,3 måneder) med en overordnet median opfølgningstid på 33,7 måneder.
English: Elderly people
Danish: Ældre
English: If Taxespira concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis koncentratet eller infusionsopløsningen med Taxespira kommer i kontakt med huden, afvaskes området straks grundigt med sæbe og vand.
English: Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Danish: Tre patienter (2 %), der fik docetaxel, ophørte med behandlingen grundet væskeretention, hvorimod 15 patienter (9 %), der fik doxorubicin, stoppede behandlingen grundet hjertetoksicitet (3 tilfælde af fatalt, kongestivt hjertesvigt).
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: 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 docetaxel-infusion og passende terapi.
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 antal af cyklusser administreret pr. patient var 6 (med et interval på 1-16) for TCF-armen sammenlignet med 4 (med et interval på 1-12) for CF-armen.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.
Danish: - Øvrige indholdsstoffer: polysorbat 80, vandfri ethanol (se punkt 2) og citronsyremonohydrat.
English: Disease free survival
Danish: Sygdomsfri overlevelse
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: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two arms.
Danish: I dette studie blev 501 patienter med lokalt fremskreden SCCHN og WHO performance status 0 eller 1 randomiseret til en af to behandlingsarme.
English: If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Danish: Er du i tvivl om anvendelsen af dette lægemiddel, så spørg lægen eller apotekspersonalet på hospitalet.
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 docetaxel-infusionen, og reaktionerne var ofte milde til moderate.
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: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Danish: Mediantiden indtil progression var 186 dage (docetaxel+ capecitabin) vs. 128 dage (docetaxel alene).
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 én gang dagligt 5 dage om ugen til en total dosis på 66 til 70 Gy) eller accelererede/hyperfraktionerede regimener af strålebehandling (to gange dagligt med et minimumsinterfraktionsinterval på 6 timer, 5 dage pr. uge).
English: Mix the infusion bag or bottle manually using a rocking motion.
Danish: Bland opløsningen i infusionsposen eller -flasken manuelt med vippende bevægelser.
English: The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Danish: Forekomsten af febril neutropeni/neutropenisk sepsis var også forhøjet hos de patienter, der fik behandling med Herceptin plus docetaxel (23 % vs. 17 % for de patienter, der fik behandling med docetaxel alene).
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Danish: • sløret syn på grund af hævelse på øjets nethinde (cystoidt makulaødem)