FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Danish: Der er rapporteret sjældne tilfælde af enterocolitis, herunder colitis, iskæmisk colitis og neutropenisk enterocolitis med en potentielt dødelig udgang (hyppighed ikke kendt).
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Danish: Under strålebehandlingsforløbet blev der givet carboplatin (AUC 1,5) ugentligt som en 1-times intravenøs infusion med et maksimum på 7 doser.
English: As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women.
Danish: Som andre cytotoksiske lægemidler kan docetaxel være fosterskadeligt, hvis det gives til gravide.
English: The following adverse reactions are frequently observed with docetaxel:
Danish: Følgende bivirkninger er jævnligt observeret med docetaxel:
English: A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Danish: En farmakokinetisk populationsanalyse af docetaxel er blevet gennemført hos 577 patienter.
English: Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Danish: Patienter skal præmedicineres med antiemetika og hydreres passende (før og efter cisplatin administration).
English: In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Danish: I tilfælde af CMO-diagnose skal docetaxel seponeres og passende behandling initieres (se pkt.
English: • 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Danish: • 1.312 og 121 patienter, som fik henholdsvis 100 mg/m2 og 75 mg/m2 af docetaxel som enkeltstof.
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 denne medicin efter den udløbsdato, der står på pakningen og på hætteglassets etiket efter Exp.Udløbsdatoen er den sidste dag i den nævnte måned.
English: Fluid retention (severe/lifethreatening: 1%)
Danish: Væskeretention (alvorlig/livstruende: 1 %)
English: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Danish: I ikke-kliniske studier har docetaxel genotoksiske virkninger og kan ændre den mandlige fertilitet (se pkt.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Danish: Infusionsvæsken skal anvendes indenfor 6 timer opbevaret under 25ºC inklusive en time infusion til patienten.
English: Cisplatin and 5-fluorouracil
Danish: Cisplatin og 5-fluoruracil
English: Age category 1 <50 years ≥50 years
Danish: Alderskategori 1 <50 år ≥50 år
English: Discontinue treatment if these toxicities persist (see section 4.4).
Danish: Afbryd behandlingen, hvis disse toksiciteter varer ved (se pkt.
English: Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Danish: Recall-reaktion på injektionsstedet (tilbagefald af hudreaktion på et sted med tidligere ekstravasation efter administration af docetaxel på et andet sted) er observeret på stedet for tidligere ekstravasation (hyppighed ikke kendt).
English: In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Danish: I pivotalstudiet blev den initiale docetaxel-infusion givet dagen efter den første dosis trastuzumab.
English: These reactions sometimes appear during the infusion of the medicinal product.
Danish: Disse reaktioner er også set under infusion med lægemidlet.
English: FAC Hazard ratio (TAC/FAC)
Danish: Hazard ratio (TAC/FAC)
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Danish: • Tiden til progression (TTP) var signifikant længere i AT-armen i forhold til AC-armen, p = 0,0138.
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: 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/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel er: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
English: • pneumonia (infection of the lungs)
Danish: • Pneumoni (lungebetændelse)
English: Tell your doctor, hospital pharmacist or nurse if you have experienced an allergic reaction to previous paclitaxel therapy.
Danish: Kontakt lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du har haft en allergisk reaktion ved tidligere behandling med paclitaxel.
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 % nedsat risiko for forværring eller død og en 22 måneder forbedring i median PFS (35,5 måned for TPF og 13,1 måned for PF).
English: Disease free survival
Danish: Sygdoms-fri overlevelse
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Danish: Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3-4)
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Danish: Fordelingen af TAC-behandlede patienter ifølge allerede definerede større prognostiske faktorer blev analyseret:
English: Diarrhoea grade 4
Danish: Diarré grad 4
English: Patients previously treated with chemotherapy with or without radiotherapy
Danish: Patienter, der tidligere har fået behandling med kemoterapi med eller uden strålebehandling.
English: Post-marketing experience
Danish: Erfaringer efter markedsføring:
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Danish: Alle 3 behandlingsregimer blev administreret i kombination med prednison eller prednisolon 5 mg to gange daglig, kontinuerligt.
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 induktions-kemoterapi skulle patienter i begge behandlingsarme modtage 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: 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 henholdsvis hos 12,1 % og 3,4 % af patienterne, når patienterne modtog profylaktisk G-CSF, hos 15,6 % og 12,9 % af patienterne uden profylaktisk G-CSF (se punkt 4.2).
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Danish: De objektive responsrater i den randomiserede population (investigators vurdering) var 41,6 % (docetaxel+capecitabin) vs. 29,7 % (docetaxel alene); p = 0,0058.
English: Capecitabine
Danish: Capecitabin
English: Dose adjustment
Danish: Dosis justering
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polysorbate 80
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Polysorbat 80
English: The carcinogenic potential of docetaxel has not been studied.
Danish: Karcinogeniciteten af docetaxel er ikke undersøgt.
English: Rare cases of ileus and intestinal obstruction have been reported.
Danish: Der er rapporter om sjældne tilfælde af ileus og intestinal obstruktion.
English: Eruptions generally occurred within one week after the docetaxel infusion.
Danish: Udbruddene opstår ofte inden for en uge efter docetaxel-infusion.
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 udvikler akutte problemer med lungerne (feber, åndenød eller hoste), eller de bliver værre, skal du straks fortælle det til lægen eller sundhedspersonalet.
English: Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure.
Danish: To patienter i TAC-armen og 4 patienter i FAC-armen døde af hjertesvigt.
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 interim-analyse blev udført efter optagelse af i alt 400 sygdoms-fri overlevelser (DFS), hvilket førte til en median opfølgningstid på 55 måneder.
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 1 patient i AT-armen (hjerteinsufficiens) og i 4 patienter i AC-armen (1 på grund af septisk shock og 3 på grund af hjerteinsufficiens).
English: Additional cautions for use in adjuvant treatment of breast cancer
Danish: Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft.
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 1000 mg/m2 og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 0 til 42 uger).
English: Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Danish: Patienter, som tidligere har haft en overfølsomhedsreaktion overfor paclitaxel kan være i risiko for at udvikle overfølsomhedsreaktion overfor docetaxel, inklusive mere alvorlige overfølsomhedsreaktioner.
English: 1-year Survival (%)
Danish: 1-års overlevelse (%)
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: 6.2 Uforligeligheder Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
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 til 5 % definitiv forværring af den globale sundhedsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og en længere tid til definitiv forværring af Karnofsky performance status (p = 0,0088) sammenlignet med patienterne, som fik behandling med CF.
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: Behandlingsforskel (95 %CI:0,7;13,5) *: rettet for multible sammenligninger og justeret for stratification faktorer (stadie af sygdommen og behandlingsregion), baseret på beregnelig patientpopulation.
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 svært hånd og fod syndrom), men også arme, ansigt og thorax.
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 eksplorativ undergruppeanalyse af sygdoms-fri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT population).
English: Women of childbearing potential/ Contraception in males and females Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Danish: Kvinder i den fertile alder/prævention til mænd og kvinder Kvinder i den fertile alder, der får docetaxel, skal rådes til at undgå at blive gravide og til straks at informere den behandlende læge, hvis det skulle ske.
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Danish: Uden primær GCSF- profylakse (n = 111) n (%)
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 clearance hos patienter med svær væskeretention.
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 docetaxel - plus trastuzumab-armen, havde 64 % modtaget en tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene.
English: Dry skin ; Desquamation
Danish: Tør hud; Afskalning
English: Second primary malignancies (including acute myeloid leukemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Danish: Anden primær malignitet (herunder akut myeloid leukæmi, myelodysplastisk syndrom og non-Hodgkin lymfom) kan forekomme flere måneder eller år efter behandling med docetaxel.
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 prostatakræftstudium, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
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 G-CSF-profylakse (GEICAM 9805)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket hætteglas
English: DOCETAXEL KABI will be given by infusion into one of your veins (intravenous use).
Danish: DOCETAXEL KABI gives som infusion i en vene (intravenøs anvendelse).
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 blive fædre til børn under og op til 6 måneder efter behandling samt til at søge vejledning vedrørende opbevaring af sæd inden behandling.
English: Non-small cell lung cancer
Danish: Ikke-småcellet lungekræft
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 ekstremiterene (håndflader og fodsåler) med ødem efterfulgt af afskalning.
English: Diarrhoea grade 3
Danish: Diarré grad 3
English: Docetaxel is a substance derived from the needles of yew trees.
Danish: Docetaxel er et stof, der udvindes af nålene fra takstræer.
English: Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Danish: Patienterne præmedicineres med antiemetika og passende hydrering til administration af cisplatin.
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 de 2 her nævnte fase III-studier viste docetaxel den samme sikkerhedsprofil som tidligere blev set i fase II-studierne (se pkt.
English: In the case of severe neutropenia (< 500 cells/mm3 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: Hvis der opstår alvorlig neutropeni (< 500 celler/mm3) 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: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting).
Danish: • Ventrikulær arytmi eller ventrikulær takykardi (manifesteret som uregelmæssig og / eller hurtig hjerterytme, alvorlig åndenød, svimmelhed og / eller besvimelse).
English: Infusion site reaction; Pain
Danish: Reaktioner på infusionsstedet; smerter
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Danish: Diskutér det med din læge, hvis du lider af alkoholafhængighed, epilepsi eller nedsat leverfunktion.
English: All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Danish: Alle patienter i studiets docetaxel-arm modtog profylaktisk antibiotika.
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 udviklede signifikant mindre tilbagegang af deres globale sundhedsscore i forhold til patienter i behandling med PF (p = 0,01, under anvendelse af EORTC QLQ-C30-skalaen).
English: These were reversible upon discontinuation of the infusion.
Danish: Disse var reversible ved ophør af behandlingen.
English: In addition, dexamethasone did not affect protein binding of docetaxel.
Danish: Ydermere påvirkede dexamethason ikke docetaxels proteinbinding.
English: If you are a man being treated with DOCETAXEL KABI 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 i behandling med DOCETAXEL KABI, rådes du til ikke at blive far til et barn under og 6 måneder efter behandling samt til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel kan nedsætte den mandlige fertilitet.
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: 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 trombocytopeni.
English: No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Danish: Myelodysplastisk syndrom blev ikke diagnosticeret i nogen af behandlingsgrupperne.
English: DOCETAXEL KABI is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing the solution.
Danish: DOCETAXEL KABI er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningen.
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 standard prednison præmedicinering er undersøgt hos 42 patienter.
English: Neutropenia is the most frequent adverse reaction of docetaxel.
Danish: Neutropeni er den hyppigst forekommende bivirkning ved docetaxel.
English: You must not breast-feed while you are treated with DOCETAXEL KABI.
Danish: Du må IKKE amme, mens du behandles med DOCETAXEL KABI.
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 % versus 17 % for de patienter, der fik behandling med docetaxel alene).
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: Skal tages i betragtning for gravide eller ammende kvinder, børn eller høj-risiko grupper så som patienter med leversygdom eller epilepsi.
English: It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits.
Danish: Det er påvist, at docetaxel er embryotoksisk og føtotoksisk i rotter og kaniner.
English: There is no known antidote for docetaxel overdose.
Danish: Der er ingen kendt antidot til overdosering med docetaxel.
English: Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Danish: Betændelse i lungerne kan også udvikles, når docetaxelbehandling anvendes sammen med strålebehandling).
English: KABI (listed in section 6).
Danish: DOCETAXEL KABI (angivet i punkt 6)
English: Complicated neutropenia
Danish: Kompliceret neutropeni
English: • inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
Danish: • Betændelse i tyktarm, tyndtarm, som kan være dødelig (hyppighed ikke kendt); perforering af tarmene.
English: The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Danish: Den kombinerede administration af docetaxel, cisplatin og 5-fluoruracil hos 12 patienter med massive tumorer havde ingen indflydelse på farmakokinetikken for hvert af de individuelle lægemidler.
English: The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Danish: Den efterfølgende docetaxel-dosis blev givet umiddelbart efter ophør af trastuzumab-infusionen, hvis trastuzumab-infusionen var veltolereret.
English: You should usually receive your infusion once every 3 weeks.
Danish: Hvor ofte gives medicinen Du vil normalt få en infusion én gang hver 3. uge.
English: Respiratory disorders
Danish: Respirationssygdomme
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Danish: Mængden af alkohol i dette lægemiddel kan ændre virkningen af andre lægemidler.
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Danish: Ved lette symptomer på overfølsomhed såsom lokal rødme eller lokaliserede kutane reaktioner, er det ikke nødvendigt at afbryde behandlingen.