FrancophonIA/ELRC3.0 huggingface dataset:
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 docetaxels farmakokinetik indgivet med standard præmedicinering med dexamethason er undersøgt hos 42 patienter.
English: For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Danish: For patienter med operabel lymfeknude-negativ brystcancer bør adjuverende behandling begrænses til patienter egnet til at få kemoterapi ifølge etablerede nationale kriterier for primær behandling af tidlig brystkræft (se pkt.
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Danish: Febril neutropeni og neutropenisk infektion blev set hos hhv. 17,2% og 13,5% af patienterne, uanset om der var brugt G¬CSF.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Danish: Dog induceredes ingen mutagenitet i Ames test eller i en CHO/HGPRRT genmutationsassay.
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Danish: I forbindelse med strålebehandling blev der indgivet en ugentlig dosis carboplatin (AUC 1,5) som en intravenøs infusion over en time med maksimalt 7 doser.
English: Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Danish: Total overlevelse var også signifikant længere (p = 0,0201) til fordel for TCF-armen med en reduktion af risikoen for mortalitet på 22,7%.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
Danish: I studiet TAX 316 blev alopeci, der persisterede ind i followup-perioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter og hos 645 ud af 736 FAC-patienter.
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 af patienterne (2%), som fik docetaxel, afbrød behandlingen på grund af væskeretention, mens 15 af patienterne (9%), som fik doxorubicin, afbrød behandlingen på grund af hjertetoksicitet (tre tilfælde af kongestivt hjertesvigt med dødelig udgang).
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 followup before).
Danish: Den endelige analyse blev udført, da alle patienter havde nået deres 10 års followup-besøg (medmindre de havde DFS-hændelse eller udgik tidligere fra followup).
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: Docetaxel Mylan 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: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Danish: Docetaxel Mylan er ordineret af din læge til behandling af brystkræft, specielle former for lungekræft (ikke-småcellet lungekræft), prostatakræft, gastrisk kræft eller hoved- og halskræft: - Ved behandling af fremskreden brystkræft kan docetaxel enten indgives alene eller i kombination med doxorubicin, trastuzumab eller capecitabin.
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 totale objektive responsrater i den randomiserede patientgruppe (investigators vurdering) var 41,6% (docetaxel + capecitabin) mod 29,7% (docetaxel alene), p = 0,0058.
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 fodsyndrom), men også på arme, ansigt og thorax.
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: 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 hhv. 12,1% og 3,4% af patienterne, når patienterne havde fået profylaktisk G¬CSF, og hos hhv. 15,6% og 12,9% af patienterne, der ikke havde fået profylaktisk G¬CSF (se pkt.
English: Discuss with your doctor if you suffer from alcohol dependency or liver impairment.
Danish: Fortæl din læge, hvis du er afhængig af alkohol, eller hvis du har nedsat leverfunktion.
English: Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Danish: Perifer sensorisk neuropati fortsatte ved opfølgning hos 10 patienter ud af 84 patienter med perifer sensorisk neuropati ved slutningen af kemoterapien i det lymfeknude-positive brystcancer-studie (TAX 316).
English: The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Danish: Den etårige overlevelsesrate var ligeledes signifikant længere med docetaxel (40%) i forhold til bedste understøttende behandling (16%).
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Danish: Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m².
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Danish: Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TACpatienter og hos 1 ud af 736 FAC-patienter.
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Danish: Alle tre regimer blev indgivet kontinuerligt i kombination med 5 mg prednison eller prednisolon 2 gange dagligt..
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: Ved en hazard ratio på < 1 kan docetaxel + cisplatin + fluoruracil anvendes med fordel *ikke-justeret log-rank test **ikke-justeret log-rank test, ikke justeret for flere sammenligninger ***Chi square-test, ikke justeret for flere sammenligninger NA - ej relevant
English: Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added to the infusion solution.
Danish: Docetaxel Mylan koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
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 de følgende bivirkninger (alle grader): lethargi, stomatitis, neutropenisk infektion opstod ≥ 10% oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
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 trastuzumabarmen, havde 64% modtaget en tidligere behandling med antracyklin som adjuverende behandling sammenlignet med 55% i docetaxel-armen alene.
English: If you are a man being treated with Docetaxel Mylan 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 i behandling med Docetaxel Mylan, rådes du til ikke at blive far til et barn under og 6 måneder efter behandling og til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel kan nedsætte den mandlige fertilitet.
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Danish: Der er rapporteret meget sjældne tilfælde af kutan lupus erythematosus og bulløse udbrud som f.eks. erythema multiforme, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse i forbindelse med docetaxel.
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 cancer, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
English: Dyspnoea (severe: 2.7%)
Danish: Dyspnø (alvorlig: 2,7%)
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 kan hæmme enzymet kompetitivt) af CYP3A, f.eks ciclosporin, ketokonazol og erythromycin.
English: There is no relevant use of docetaxel in the paediatric population in the indications 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 docetaxel i den pædiatriske population til indikationerne brystcancer, ikke-småcellet lungecancer, prostatacancer, gastrisk karcinom samt hoved-halscancer med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom.
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Danish: Symptomatisk hjertesvigt blev rapporteret hos 2,2% af patienterne, som modtog docetaxel plus trastuzumab i forhold til 0% af de patienter, som fik docetaxel alene.
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Danish: Medianoverlevelse var 442 dage (docetaxel + capecitabin) mod 352 dage (docetaxel alene).
English: Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Danish: Amenoré fortsatte ved opfølgning hos 121 patienter ud af 202 patienter med amenoré ved slutningen af kemoterapien i studiet TAX 316.
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 followup-periode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
English: Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Danish: Patienterne præmedicineres med antiemetika og passende hydrering ved administration af cisplatin.
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Danish: Fase I-studier, som undersøgte capecitabins effekt på docetaxels farmakokinetik og omvendt, viste ingen effekt af capecitabin på docetaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel på capecitabins metabolit 5'-DFUR's farmakokinetik.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LABEL TIL HÆTTEGLAS
English: 2-year Survival (%)
Danish: Toårs overlevelse (%)
English: Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Danish: Docetaxels clearance i kombinationsbehandling med cisplatin var sammenlignelig med det observerede ved monoterapi.
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Danish: Mediantid til progression var 186 dage (docetaxel + capecitabin) mod 128 dage (docetaxel alene).
English: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Danish: • Ved ethvert efterfølgende tegn på toksicitet eller ved grad 4-toksicitet stoppes behandlingen med docetaxel.
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: 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 followup-tid var 10 år og 5 måneder) followup-besøg (medmindre de havde DFS eller tidligere var udgået fra followup).
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 nævnt).
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 modtog trastuzumab og docetaxel, i forhold til de patienter som fik behandling med docetaxel alene (32% grad 3/4 neutropeni versus 22%, under anvendelse af NCI-CTC kriterierne).
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor a
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin og cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Danish: Der er observeret sjældne tilfælde af kramper eller forbigående tab af bevidsthed i forbindelse med indgift af docetaxel.
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Danish: • interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Danish: Alvorlige reaktioner blev karakteriseret ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erythem (se pkt.
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 (blink, lysglimt, skotom), som typisk er opstået i forbindelse med infusionen af lægemidlet og sammen med overfølsomhedsreaktioner.
English: Cardiac disorders Rare cases of myocardial infarction have been reported.
Danish: Hjerte Der er rapporteret om sjældne tilfælde af myokardieinfarkt.
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Danish: Øre og labyrint Der er rapporteret om sjældne tilfælde af ototoksicitet, hørenedsættelse og/eller -tab.
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 guidelines på 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: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Danish: Tid til progressiv sygdom var længere i kombinationsarmen med docetaxel + capecitabin (p < 0,0001).
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 studiet blev 501 patienter med lokalt fremskreden SCCHN og WHO-funktionsstatus 0 eller 1 randomiseret til en af to behandlingsarme.
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-funktionsstatus 0 eller 1 randomiseret til en af to behandlingsarme.
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: 11,4 mod 8,3 måneder) med en total medianopfølgningstid på 33,7 måneder.
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-regimet for lymfeknude-positiv brystcancer har risikoen for CHF vist sig at være højere i det første år efter behandling (se pkt.
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: Strålebehandling blev givet med megavoltudstyr med én daglig fraktionering (2 Gy dagligt, 5 dage om ugen i 7 uger til en samlet dosis på 70-72 Gy).
English: Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Danish: Immunsystemet Der er rapporteret enkelte tilfælde af anafylaktisk shock, som i nogle tilfælde har haft dødelig udgang.
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).
Danish: Patienterne havde operabel lymfeknude-negativ brystcancer med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år).
English: At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Danish: Ved slutningen af followup-perioden (faktisk median followup-tid var 96 måneder) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9%) og hos 16 FAC-patienter (2,2%).
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 strålebehandling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy én gang dagligt, 5 dage pr. uge til en samlet dosis på 66-70 Gy) eller accelererede/hyperfraktionerede regimer af strålebehandling (2 gange dagligt, med et minimalt interfraktionsinterval på 6 timer, 5 dage pr. uge).
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Danish: Oralt prednison eller prednisolon 5 mg gives kontinuerligt 2 gange dagligt (se pkt.
English: The recommended dose of docetaxel is 75 mg/m².
Danish: Den anbefalede dosis af docetaxel er 75 mg/m².
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 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 fornemmelse eller feber, og giv lægen resultatet af dine blodprøver.
English: The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
Danish: Den farmakokinetiske profil af cisplatin, der indgives kort efter infusion med docetaxel, svarer til profilen for cisplatin alene.
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: • Som ved alle andre parenterale lægemidler skal infusionsvæsken kontrolleres visuelt inden anvendelse, og opløsninger med udfældning skal kasseres.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Danish: • Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324) MedDRA systemorganklasse
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Danish: Man bør anvende profylaktisk G¬CSF for at nedsætte risikoen for hæmatologisk toksicitet (se også ”Dosisjustering under behandling”).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Danish: Efter 10 års followup i TAX 316-studiet blev akut leukæmi rapporteret hos 4 ud af 744 TAC-patienter og hos 1 ud af 736 FAC-patienter.
English: Rare cases of ileus and intestinal obstruction have been reported.
Danish: Der er rapporteret om sjældne tilfælde af ileus og intestinal forstoppelse.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema) • decrease of the sodium in your blood.
Danish: • sløret syn pga. hævet nethinde (cystoidt makulaødem) • nedsat indhold af natrium i blodet.