FrancophonIA/ELRC3.0 huggingface dataset:
English: Ready to add to infusion solution.
Danish: Klar for tilsætning til infusionsvæske.
English: Gastrointestinal haemorrhage (severe:
Danish: Gastrointestinal Hæmoragi (alvorlig:
English: See also section “TAXOTERE contains ethanol (alcohol)” below.
Danish: Se også punktet ”TAXOTERE indeholder ethanol (alkohol)” nedenfor.
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Danish: Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracycline (doxorubicin eller epirubicin).
English: • Premix solution: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Danish: • Præmix-opløsning: Præmix-opløsningen indeholder 10 mg/ml docetaxel og skal bruges straks efter tilberedning.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i overensstemmelse med lokale retningslinjer.
English: It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Danish: Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af enten TAXOTERE præmix-opløsningen eller TAXOTERE infusionsvæske
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Danish: Docetaxel er et antineoplastisk lægemiddel og, som med andre potentielt giftige lægemidler, skal der udvises forsigtighed under håndtering og tilberedning af opløsninger heraf.
English: Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m as a 1-hour infusion, followed by cisplatin
Danish: Gastrisk adenokarcinom Den anbefalede dosis af docetaxel er 75 mg/m som en 1-times infusion, efterfulgt af cisplatin
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Danish: Flere grad 3/4 bivirkninger blev observeret for TAXOTERE monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %).
English: During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Danish: Følgende allergiske reaktioner (kan forekomme hos flere end 1 ud af 10 patienter) kan optræde under infusionen på hospitalet:
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 en gang daglig, 5 dage om ugen til en total dosis på 66 til 70 Gy), eller accelererede/hyperfraktionerede regimer af strålebehandling (to gange daglig, med et minimum interfraktion-interval på 6 timer, 5 dage pr. uge).
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Danish: Tal med din læge, hvis du lider af alkohol afhængighed, epilepsi eller sygdomme i leveren.
English: In both arms, after the last cycle of chemotherapy, patients with positive eostrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Danish: Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen- og/eller progesteron-receptorer tamoxifen 20 mg daglig i op til 5 år.
English: Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Danish: Docetaxel øgede responsraten (33 % mod 12 %, p < 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
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: 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/m
English: Following the administration of a 100 mg/m dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Danish: Efter administration af docetaxel 100 mg/m givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.g/ml.
English: In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate  10% higher in patients who were 65 years of age or greater compared to younger patients.
Danish: Blandt de patienter, der fik docetaxel hver tredje uge, var hyppigheden af relaterede negleforandringer  10 % højere i patientgruppen på 65 år og derover, end i gruppen af yngre patienter.
English: Docetaxel + standard of care Standard of care alone
Danish: Docetaxel+standardpleje
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 < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel * Ujusteret log-rank test ** Ujusteret log-rank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Not Applicable
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 vs. 7 uger) og den samlede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m end for bedste palliative behandling.
English: 4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Danish: 4.1.4 Fjern sprøjten og bland miksturen manuelt ved at vende hætteglasset gentagne gange i mindst 45 sekunder.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m every three weeks, with trastuzumab administered weekly.
Danish: I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m hver 3. uge med en ugentlig administration af trastuzumab.
English: CAUTION: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
Danish: BEMÆRK: Udtag den nødvendige mængde af dette docetaxel koncentrat (20 mg/ml) fra hætteglasset og tilsæt det direkte til infusionsvæsken.
English: CAUTION: Dilution required with the entire contents of the solvent vial.
Danish: BEMÆRK: Skal fortyndes med hele indholdet fra hætteglasset med solvens.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Danish: For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m givet som enkeltstof.
English: Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Danish: Median overlevelse i alt var også signifikant længere til fordel for TPF-armen sammenlignet med PF-armen (median OS: 18,6 vs. 14,5 måneder respektivt) med en 28 % reduktion af risikoen for død, p = 0,0128.
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Danish: I tilfælde af efterfølgende episoder med kompliceret neutropeni, bør dosis af docetaxel reduceres fra 60 mg/m til 45 mg/m 2.
English: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Danish: I kombination med capecitabin er de mest almindelige behandlingsrelaterede bivirkninger ( 5 %), som blev rapporteret i et fase III-studium med brystkræftpatienter, hvor anthracyclinbehandling ikke havde haft effekt, medtaget (se: Produktresuméet for capecitabin).
English: In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anaemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher).
Danish: I patienter, som var 75 år eller ældre, blev der rapporteret en højere forekomst af neutropeni, anæmi, diarré, dyspnø, og infektioner i de øvre luftveje, sammenlignet med yngre patienter (mindst 10 % højere).
English: TAXOTERE as single agent
Danish: TAXOTERE som enkeltstof
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Danish: Uden at påvirke overlevelsestiden (docetaxel 15 måneder mod doxorubicin 14 måneder, p = 0,38) eller tiden til progression (docetaxel 27 uger mod doxorubicin 23 uger, p = 0,54), øgede docetaxel responsraten (52 % mod 37 %, p = 0,01) og gav hurtigere respons (12 uger mod 23 uger, p = 0,007).
English: You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)
Danish: Du kan også have influenalignende symptomer på samme tid, såsom feber, kulderystelser eller ømme muskler.)
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 brystkræft 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: • decrease of the sodium and/or magnesium in your blood (electrolyte balance disorders)
Danish: • Nedsat indhold af natrium og/eller magnesium i blodet (forstyrrelse i elektrolytbalancen).
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Danish: I studiet TAX 316 oplevede 26 patienter (3,5%) i TAC-armen og 17 patienter (2,3%) i FAC-armen kongestivt hjertesvigt.
English: Quality of life parameters
Danish: Livskvalitetsparametre
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Danish: I kombinationer med androgen deprivationsbehandling og med prednison eller prednisolon (STAMPEDE studie) præsenteres bivirkninger, der forekommer i de 6 cyklusser af behandlingen med docetaxel og med mindst 2 % højere forekomst i docetaxel-behandlingsarmen, til sammenligning med kontrolarmen, under anvendelse af CTCAE-klasseficeringskalaen.
English: Post-Menopausal
Danish: Præ-menopausal
English: If you are a man being treated with TAXOTERE 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 TAXOTERE, rådes du til ikke at avle 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: It is important that you read the entire contents of this guide prior to the preparation of the TAXOTERE infusion solution.
Danish: Det er vigtigt at læse hele denne vejledning inden fremstilling af TAXOTERE infusionsvæske.
English: Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Danish: Injicer hele indholdet af sprøjten i det tilsvarende hætteglas med TAXOTERE.
English: 4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Danish: 4.1 Fremstilling af TAXOTERE præmix-opløsning (10 mg docetaxel/ml)
English: CYTOTOXIC
Danish: CYTOTOKSISK
English: Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Danish: Docetaxel infusionsvæske er overmættet, den kan derfor udkrystallisere over tid.
English: • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25°C).
Danish: • Infusionsopløsning: Infusionsopløsningen skal bruges inden for 4 timer ved stuetemperatur (under 25°C).
English: Cautions for use in adjuvant treatment of breast cancer There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Danish: Forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosphamid til patienter over 70 år.
English: Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis
Danish: Med docetaxel er der rapporteret tilfælde af kutan lupus erythematosus, bulløst udslæt såsom erythema multiforme og alvorlige kutane bivirkninger såsom Stevens-Johnson syndrom, toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose.
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Danish: En dosis på 140 mg docetaxel kræver f.eks. 7 ml docetaxel koncentrat til infusionsvæske.
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 carboplatins clearence ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi.
English: • blood clots.
Danish: • Blodpropper.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor PR = progesterone receptor a
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Danish: • 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret).
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m 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/m og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 0 til 42 uger).
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m twice daily for 2 weeks followed by 1-week rest period).
Danish: I dette kliniske studium randomiseredes 255 patienter til behandling med docetaxel (75 mg/m² som en 1-times intravenøs infusion hver 3. uge) og capecitabin (1250 mg/m to gange daglig i 2 uger efterfulgt af en uges pause).
English: Cautions for use in gastric adenocarcinoma cancer 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: Forsigtighedsregler ved behandling af gastrisk adenokarcinom Blandt 300 patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som fik behandling med docetaxel i kombination med cisplatin og 5-fluoruracil i studiet af gastrisk kræft, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m and 113 l, respectively.
Danish: Gennemsnitsværdierne for den totale clearence og steady-state distributionsvolumen var henholdsvis 21 l/h/m og 113 l. Den interindividuelle variation i totalclearance var ca 50 %.
English: Menopausal status Pre-Menopausal
Danish: Menopausal status
English: • feeling of numbness or pins and needles or pain in the joints or muscles
Danish: • Følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i muskelfæster
English: - For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
Danish: • Ved behandling af prostatakræft kan TAXOTERE indgives i kombination med prednison eller prednisolon.
English: Febrile neutropenia (G3-4: 15%)
Danish: Febril neutropeni (G3-4: 15%)
English: TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: TAXOTERE i kombination med doxorubicin og cyclophosphamid: Adjuverende behandling
English: Docetaxel infusion solution is supersaturated, therefore may cristallize over time.
Danish: Docetaxel-infusionsvæsken er overmættet, den kan derfor udkrystallisere over tid.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Danish: Skal gives under vejledning af en læge med erfaring i behandling med cytostatika.
English: TAXOTERE in combination with capecitabine
Danish: TAXOTERE i kombination med capecitabin
English: RECOMMENDATIONS FOR THE SAFE HANDLING
Danish: INSTRUKTIONER VEDRØRENDE SIKKER HÅNDTERING
English: PSA response** at 6 months - N(%) p-valuea*
Danish: PSA respons** ved 6 måneder - N(%) p-værdia*
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Danish: Der var en forøget forekomst af meget alvorlige bivirkninger (40 % mod 31 %) og grad 4 alvorlige bivirkninger (34 % mod 23 %) i kombinationsarmen trastuzumab sammenlignet med docetaxel enkeltbehandling.
English: You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.
Danish: Du kan også have influenzalignende symptomer på samme tid, så som feber, kulderystelser eller ømme muskler.
English: G3/4 AST increased
Danish: G3/4 ALAT forhøjet
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m in phase I studies.
Danish: Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20- 115 mg/m2.
English: • Each vial is for single use and should be used immediately after opening.
Danish: • Hvert hætteglas er til engangsbrug og bør anvendes straks efter anbrud.
English: Data from a multi-centre open label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS  80%, between 18 and 70 years of age.
Danish: Data fra et multicenter åbent randomiseret studium støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS > 80 % i alderen mellem 18 og 70 år.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Danish: Posen med infusionsopløsningen skal bruges inden for 6 timer ved opbevaring under 25°C inklusive den time, patienten får infusionen.
English: TAXOTERE in combination with trastuzumab
Danish: TAXOTERE i kombination med trastuzumab
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om TAXOTERE findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Danish: I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75 % hos patienter på 60 år eller ældre (Se: Produktresumé for capecitabin)
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Danish: • 300 gastrisk adenokarcinoma-patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som blev behandlet med docetaxel i kombination med cisplatin og 5fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions.
Danish: TAXOTERE er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af TAXOTERE-opløsningerne.
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Danish: Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m end hos patienterne, der fik bedste palliative behandling.
English: Infusion site reaction
Danish: Reaktioner på infusionstedet
English: The concentrate is a clear viscous, yellow to brown-yellow solution.
Danish: Koncentratet er en klar viskøs, gul til brunliggul opløsning.
English: TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Danish: TAXOTERE i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle-carcinoma i hoved og hals.
English: - AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
Danish: - AGEP symptomer kan omfatte et rødt skællende udbredt udslæt med knopper under hævede hud (herunder dine hudfolder, mave og øvre ekstremiteter) og blærer ledsaget af feber.