FrancophonIA/ELRC3.0 huggingface dataset:
English: Use immediately the medicine once added into the non-PVC infusion bag.
Danish: Anvend lægemidlet umiddelbart efter tilsætning til den PVC-fri infusionspose.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, taxaner, ATC-kode: L 01 CD 02
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Danish: Undergruppeanalyser på tværs af alder, køn og race favoriserede konsekvent TCF-armen i forhold til CF-armen.
English: • swelling of the hands, feet, legs
Danish: • hævelse af hænder, fødder eller ben
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Danish: Alt materiale, som har været brugt i forbindelse med fortynding og administration, skal destrueres i overensstemmelse med lokale retningslinjer.
English: In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Danish: Docetaxel viste sig desuden aktivt på nogle, men ikke alle, cellelinjer, der udviste overekspression af P-glycoprotein, som er kodet af multidrug resistance (MDR) genet.
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Danish: Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaoider.
English: Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Danish: Patienter, der får TAC, bør monitoreres nøje (se pkt 4.2 og 4.8).
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Danish: 24,5 Behandlingsforskel: 7.1% [95% CI: 0,7; 13,5] *: Korrigeret for flere sammenligninger og justeret for stratificeringsfaktorer (sygdomsstadie og behandlingsregion), baseret på evaluerbar patientgruppe.
English: Docetaxel Mylan will be administered to you by a healthcare professional.
Danish: Docetaxel Mylan vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Danish: Sekundære endepunkter omfattede smerteændring, global rating af livskvalitet af EuroQoL-5D, lungecancersymptomskala og ændringer i Karnofsky Performance Status.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Danish: Blod og lymfesystem Sjældent: Blødningsepisoder associeret med grad 3/4 thrombocytopeni.
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m² is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Danish: Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/m² er kendt for at resultere i neutropeni hos 97% af patienterne, 76% grad 4, baseret på laveste blodtælling.
English: Preparation for the intravenous administration
Danish: Tilberedning af den intravenøse administration
English: Patients previously treated with chemotherapy with or without radiotherapy
Danish: Patienter, der tidligere er behandlet med kemoterapi med eller uden strålebehandling
English: These reactions sometimes appear during the infusion of the medicinal product.
Danish: Disse reaktioner kan vise sig i forbindelse med infusionen af lægemidlet.
English: During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Danish: I løbet af disse to fase III-studier udviste docetaxel samme sikkerhedsprofil som i fase II-studierne (se pkt.
English: Mitoxantrone every 3 weeks
Danish: Mitoxantron hver tredje uge
English: Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Danish: Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risk-fordeling for TAC sammenlignet med FAC.
English: It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan infusion solution.
Danish: Det er vigtigt at læse hele denne vejledning inden fremstilling af Docetaxel Mylan infusionsvæske.
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 under 1 indikerer, at TAC er forbundet med en længere sygdomsfri overlevelse og total overlevelse sammenlignet med FAC.
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Danish: Reduktionen af risikoen for progression var 32,1% og var forbundet med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Danish: Der er rapporteret om dissemineret intravaskulær koagulation (DIC) ofte i forbindelse med sepsis eller multiorgansvigt.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Danish: Generelt indikerede resultaterne for livskvalitet og kliniske fordele konsekvent en forbedring til fordel for TCF-armen.
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 followup-tid på mere end 5 år (median followup-tid var 77 måneder).
English: Docetaxel achieves high intracellular concentrations with a long cell residence time.
Danish: Docetaxel opnår høje intracellulære koncentrationer ved længere ophold i cellen.
English: Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Danish: Kirurgisk resektion var tilladt efter kemoterapi, før eller efter strålebehandling.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Eventuelt ubrugt præparat eller affald bør bortskaffes i overensstemmelse med lokale regler.
English: The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Danish: Funktionsstatusskalaen med underskalaerne for hoved- og hals (PSS-HN), der er designet til at måle forståelse af patientens tale, evne til at indtage føde offentligt samt normal kost, var signifikant til fordel for TPF sammenlignet med PF.
English: More than one vial may be necessary to obtain the required dose for the patient.
Danish: Der kan være behov for at anvende mere end ét hætteglas for at opnå den dosis, der er nødvendig for patienten.
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Danish: Forsøgsgruppen omfattede patienter med teknisk inoperabel sygdom, patienter med lille sandsynlighed for kirurgisk helbredelse og patienter med bevarelse af organer som mål.
English: The incidence of serious adverse events was higher in the older people compared to younger patients.
Danish: Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre patienter i forhold til gruppen med de yngre patienter.
English: All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Danish: Alle patienter på den docetaxel-indeholdende arm af TAX 323- og TAX 324-studierne modtog profylaktisk antibiotika.
English: Additional cautions for use in adjuvant treatment of breast cancer
Danish: Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystcancer
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Danish: • rødme og hævelse af håndflader eller fodsåler, hvilket kan få huden til at skalle af (kan også forekomme på arme, ansigt eller krop)
English: A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Danish: En farmakokinetisk populationsanalyse af docetaxel er gennemført hos 577 patienter.
English: Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Danish: Der er rapporteret sjældne tilfælde af dehydrering som en konsekvens af gastrointestinale lidelser, gastrointestinal perforering, iskæmisk colitis, colitis og neutropen enterocolitis.
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Danish: Reversibilitets-data er tilgængelige hos 35,3% af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m² som enkelt stof.
English: The active substance is docetaxel.
Danish: Aktivt stof: docetaxel.
English: Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Danish: Patienter skal have terapeutisk G¬CSF straks efter, overdosering er opdaget.
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 followup, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10-års followup.
English: - if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Danish: - hvis du er allergisk over for docetaxel eller et af de øvrige indholdsstoffer i Docetaxel Mylan
English: The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Danish: De primære forventede komplikationer ved en overdosis vil være knoglemarvsdepression, perifer neurotoksicitet og mucositis.
English: If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved opbevaring under 25°C inklusive den time, patienten får infusionen.
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Danish: Neutropeniske komplikationer hos patienter, der får TAC med eller uden primær G¬CSF-profylakse (GEICAM 9805)
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Danish: Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at det nedsætter fertiliteten hos rotter.
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: Patienter i begge behandlingsarme skulle have 7 ugers CRT efterfulgt af induktionskemoterapi med et mindsteinterval på 3 uger og ikke senere end 8 uger efter starten af den sidste cyklus (dag 22-56 i den sidste cyklus).
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Danish: Patienter, der fik docetaxel hver 3. uge, udviste signifikant længere total overlevelse end patienter, der blev behandlet med mitoxantron.
English: Patients with operable node-positive breast cancer (TAX 316)
Danish: Patienter med operabel lymfeknude-positiv brystcancer (TAX 316)
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Danish: Det sekundære endepunkt, progressionsfri overlevelse (PFS), viste 29% reduktion i risikoen for progression eller død og en 22 måneders forbedring i median PFS (35,5 måneder for TPF og 13,1 for PF).
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Danish: Dette regime blev indgivet hver 3. uge i 4 cyklusser i tilfælde, hvor der som mindstemål blev observeret mindre respons (≥ 25% reduktion i den bidimensionalt målte tumorstørrelse) efter 2 cyklusser.
English: With primary G-CSF prophylaxis (n = 421) n (%)
Danish: Med primær G¬CSF profylakse (n = 421) n (%)
English: Ethanol anhydrous Polysorbate 80
Danish: Ethanol, vandfri Polysorbat 80
English: The amount of alcohol in this medicinal product may impair the patients ability to drive or use machines.
Danish: Mængden af alkohol i dette lægemiddel kan nedsætte patientens evne til at køre bil og betjene maskiner.
English: One patient in TAC arm died because of dilated cardiomyopathy.
Danish: En patient i TAC-armen døde af dilateret kardiomyopati.
English: Overall response rate (CR+PR) (%) p-value
Danish: Total responsrate (CR+PR) (%) p-værdi
English: When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Danish: Ved kombination med docetaxel, var clearence ca. 50% højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Danish: Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 34 = G3/4; grad 4 = G4), COSTART-termerne og MedDRA-termerne.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Danish: • Tid til progression (TTP) var væsentlig længere i AT-armen end i AC-armen, p = 0,0138.
English: Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: Tumorresponsrate (%) 95% CI p-værdi* † Stratificeret log-rank test *Tærskel for statistisk signifikans = 0,0175 **PSA: Prostataspecifikt antigen
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
Danish: Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold.
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Danish: Behandlingsforskel: 6,2% [95% CI: 0,2; 12,3]
English: Each box contains 1 or 5 vials.
Danish: Hver æske indeholder 1 eller 5 hætteglas.
English: • pneumonia (infection of the lungs)
Danish: • pneumoni (lungebetændelse)
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: Post-Menopausal * 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: Hypersensitivity (no severe)
Danish: Hypersensitivitet (ikke alvorlig)
English: Citric acid (pH adjustment)
Danish: Citronsyre (til pH-justering)
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Danish: • 1312 og 121 patienter, som fik henholdsvis 100 mg/m² og 75 mg/m² af docetaxel som enkeltstof.
English: Docetaxel Mylan contains alcohol.
Danish: Docetaxel Mylan indeholder alkohol.
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: Patienter behandlet med TPF oplevede signifikant mindre forværring af deres globale sundhedsscore sammenlignet med patienter behandlet med PF (p = 0,01 ved brug af EORTC QLQ-C30-skalaen).
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 mod 7 uger) og den totale overlevelse signifikant længere for docetaxel ved 75 mg/m² end for bedste understøttende behandling.
English: • Each vial is for single use and should be used immediately after opening.
Danish: • Hvert hætteglas er til engangsbrug og skal anvendes straks efter åbning.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Mylan concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE anden docetaxelmedicin, der består af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Mylan koncentrat til infusionsvæske, opløsning, der består af 1 hætteglas).
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 død forekom hos en patient i AT-armen (kongestivt hjertesvigt) og hos fire patienter i AC-armen (1 på grund af septisk chok og 3 på grund af kongestivt hjertesvigt).
English: All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Danish: Alle patienter uden progressiv sygdom skulle have CRT i henhold til protokollen (PF/CRT).
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel alene var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm
English: Ready to add to infusion solution.
Danish: Klar til tilsætning til infusionsvæske.
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: Patienter, der blev behandlet med TCF, havde længere tid til 5% definitiv forværring af den globale sundhedsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og længere tid til definitiv forværring af Karnofsky Performance Status (p = 0,0088) sammenlignet med patienter behandlet med CF.
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 deres depolymerisering, hvilket fører til et udtalt fald i fri tubulin.
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Danish: Den anden interimanalyse blev udført efter optagelse af i alt 400 sygdomsfri overlevelser (DFS), hvilket førte til en medianopfølgningstid på 55 måneder.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Danish: Fordelingen af TAC-behandlede patienter i forhold til prospektivt definerede, væsentlige prognostiske faktorer er analyseret som følger:
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: Docetaxel har in vitro vist sig at forstyrre det mikrotubulære netværk i celler, som er essentielle for vital mitose og cellefunktioner i interfasen.
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 i overensstemmelse med en 3-compartment farmakokinetisk model med halveringstider for α, β og γ-faserne på henholdsvis 4 minutter, 36 minutter og 11,1 timer.
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m² and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Danish: Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1.000 mg/m² og median-tiden til reversibilitet af væskeretention var 16,4 uger (varighed 0 til 42 uger).
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Danish: • Total responsrate (ORR) var væsentlig højere i AT-armen end i AC-armen, p = 0,009.
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 for TAC-armen sammenlignet med FAC-armen.
English: The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Danish: De efterfølgende docetaxel-doser blev givet umiddelbart efter ophør af trastuzumab-infusionen, hvis trastuzumab-infusionen var veltolereret.
English: 2 Estimated median survival
Danish: 2Estimeret medianoverlevelse
English: Docetaxel Mylan will be given by infusion into one of your veins (intravenous use).
Danish: Docetaxel Mylan gives som infusion i en vene (intravenøs anvendelse).
English: You must not breast-feed while you are treated with Docetaxel Mylan.
Danish: Du må ikke amme, mens du behandles med Docetaxel Mylan.
English: In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Danish: I ca 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
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 prostatacancerstudie, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
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 dette lægemiddel efter den udløbsdato, der står på pakningen og på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Danish: Der er rapporteret meget sjældne tilfælde af hepatitis, som hos primært patienter med kendt leversygdom i nogle tilfælde har været dødelig.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier af virkningen på evnen til at føre motorkøretøj ogbetjene maskiner.