FrancophonIA/ELRC3.0 huggingface dataset:
English: Both regimens were administered once every 3 weeks for 6 cycles.
Danish: Begge regimer blev administreret en gang hver 3. uge i 6 cykler.
English: What you need to know before you use DOCETAXEL KABI
Danish: Det skal du vide, før du begynder at bruge DOCETAXEL KABI
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Der blev vist signifikant længere sygdoms-fri overlevelse i TAC-armen end FAC-armen.
English: • 406 patients who received docetaxel in combination with cisplatin.
Danish: • 406 patienter, som fik docetaxel i kombination med cisplatin.
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥ 1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Danish: Hos et beskedent antal patienter (n = 23) med en klinisk kemi, der tydede på en let til moderat nedsat leverfunktion (ASAT og ALAT ≥ 1,5 gange øvre normalværdi og basisk fosfatase ≥ 2,5 gange øvre normalværdi), var clearance nedsat med gennemsnitlig 27 %.
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 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/m2 to gange daglig i 2 uger efterfulgt af en uges pause).
English: • nasal drainage; inflammation of the throat and nose; cough
Danish: • Næseflåd, betændelse i hals og næse, hoste
English: Reporting of adverse effects
Danish: Indberetning af bivirkninger
English: - For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone.
Danish: • Ved behandling af prostatakræft kan DOCETAXEL KABI indgives i kombination med prednison eller prednisolon.
English: Hypertension; Haemorrhage
Danish: Hypotension; Hypertension; Hæmoragi
English: • Each vial is for single use and should be used immediately after opening.
Danish: o Hvert hætteglas er til engangsbrug og skal anvendes straks efter åbning.
English: Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Danish: Strålepneumonitis er blevet rapporteret hos patienter i samtidig strålebehandling.
English: Quality of life parameters
Danish: Livskvalitetsparamte
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Danish: Der er rapporter om mindre hyppige, alvorlige reaktioner såsom udslæt efterfulgt af afskalning, der sjældent førte til afbrydelse eller ophør med docetaxel-behandlingen (se pkt.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Danish: Co-administrationen af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinetik.
English: An open-label, multi-centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Danish: Et åbent multicenter randomiseret fase III-studie blev udført for at sammenligne docetaxel monoterapi med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin.
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: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
Danish: - Øvrige indholdsstoffer: polysorbat 80, ethanol vandfri (se afsnit 2) og citronsyre vandfri (til pHjustering)
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Danish: Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (TAC-arm), eller doxorubicin 50 mg/m2, fulgt af fluoruracil 500 mg/ m2 og cyclophosphamid 500 mg/m2 (FAC-arm).
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Danish: Vaskulære sygdomme: Venøse tromboemboliske tilfælde er sjældent rapporteret.
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats (see section 5.3).
Danish: Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at de nedsætter fertiliteten hos rotter.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Danish: Primær G-CSF-profylakse bør overvejes til patienter, som får adjuverende behandling med TAC for brystkræft for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, forlænget neutropeni eller neutropenisk infektion).
English: Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Danish: Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura-og perikardieekssudat, ascites og vægtøgning.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Danish: Patienter i behandling med TCF bør have profylaktisk G-CSF for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller neutropenisk infektion).
English: - For the treatment of lung cancer, DOCETAXEL KABI could be administered either alone or in combination with cisplatin.
Danish: • Ved behandling af lungekræft kan DOCETAXEL KABI enten indgives alene eller i kombination med cisplatin.
English: DOCETAXEL KABI in combination with capecitabine
Danish: DOCETAXEL KABI i kombination med capecitabin
English: Arrhythmia (no severe)
Danish: Arytmi (ikke alvorlig)
English: This regimen is administered every 3 weeks for 4 cycles.
Danish: Dette regime blev administreret hver 3. uge i 4 cyklusser.
English: Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Danish: Derfor er den anbefalede dosis docetaxel 75mg/m2 til de patienter, der har forhøjet leverfunktionstest (LFT), og LFT skal måles ved start og før hver behandlingscyklus (se pkt.
English: Anhydrous citric acid (pH adjustment)
Danish: Citronsyre, vandfri (pH-justering)
English: • Mix the infusion bag or bottle manually using a rocking motion.
Danish: o Bland infusionsposen- eller flasken manuelt med vippende bevægelser.
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Danish: Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20- 115 mg/m2.
English: This regimen is administered every 3 weeks for 3 cycles.
Danish: Dette regime administreres hver 3. uge i 3 cyklusser.
English: DOCETAXEL KABI 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: DOCETAXEL KABI 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: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Danish: Patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3.
English: For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Danish: For cisplatin- og 5-fluoruracil-dosis justeringer: Se tilsvarende produktresumé.
English: In some cases (frequency not known)
Danish: I nogle tilfælde (hyppighed ikke kendt) er permanent hårtab observeret.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter):
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Danish: Hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter der fik primær G- CSF-profylakse (se pkt.
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Danish: Bivirkningerne for docetaxel kan blive mere alvorlige, når docetaxel gives i kombination med andre kemoterapeutiske midler.
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/ or cyclophosphamide (see section 4.8).
Danish: Ventrikulær arytmi inklusive ventrikulær takykardi (undertiden dødelig) er rapporteret hos patienter behandlet med docetaxel i kombinationsregimer inklusive doxorubicin, 5-fluorouracil og/eller cyclofosfamid (se pkt.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter):
English: DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Danish: DOCETAXEL KABI i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastrooesophageale forbindelse, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: • From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Danish: o Fra et mikrobiologisk synspunkt skal rekonstituering/fortynding ske under kontrollerede og aseptiske forhold, og lægemidlet skal anvendes straks.
English: The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Danish: Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitxantron kontrol-armen.
English: Description of selected adverse reactions for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med DOCETAXEL KABI 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
English: DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: DOCETAXEL KABI i kombination med doxorubicin og cyclophosphamid: Adjuverende behandling
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Danish: • Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) MedDRA Systemorganklasser
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg docetaxel vandfri.
English: Amenorrhoea (G3/4: NA)
Danish: Amenorré (G3/4: NA)
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Danish: Almene symptomer og reaktioner på administrationsstedet: Der er sjældne rapporter om radiation recall-fænomen.
English: Once added to the infusion bag
Danish: Efter tilsætning til infusionspose
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Danish: Effekt af docetaxel i indledende behandling til patienter med inoperable, lokale fremskredne SCCHN (Hensigt at behandle-analyse)
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Danish: 1218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m2 administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m2 administreret i løbet af 30-60 minutter hver 3. uge (TCis), docetaxel 75 mg/m2 som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml per min) administreret i løbet af 30-60 minutter hver 3. uge, vinorelbin (V) 25 mg/ m2 administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/m2 administreret på dag 1 af cyklusser gentaget hver 4. uge (VCis).
English: Neutropenia (G3/4: 32%);
Danish: Neutropeni (G3/4: 32 %);
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Danish: Forekomsten af tilbagefald ved 10 år var reduceret hos de patienter, som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % versus 45 %).
English: Median survival (months)
Danish: Total overlevelse (Primær endepunkt) Median overlevelsestid (måneder)
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne din legemsoverflade i m2
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Danish: Asteni (alvorlig: 12,4 %); Væskeretention (alvorlig: 0,8 %); smerter
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Danish: Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TAC-patienter (0,3 %) og hos 1 ud af 736 FAC-patienter (0,1 %).
English: Abdominal pain upper; Dry mouth
Danish: Øvre mavesmerter; Tør mund
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m2 hver 3. uge).
English: Very common adverse reactions
Danish: Meget almindelige bivirkninger
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia;
Danish: Kvalme; diarré; opkastning; konstipation; stomatitis; dyspepsi; mavesmerter
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Danish: • For capecitabin dosis-justeringer, se capecitabins produktresumé.
English: Fluid retention (severe: 6.5%); Asthenia (severe: 11.2%); Pain
Danish: Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig: 11,2 %); smerter
English: - For the treatment of metastatic gastric cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Ved behandling af metastatisk gastrisk kræft indgives DOCETAXEL KABI i kombination med cisplatin og 5-fluoruracil.
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Danish: Den anbefalede dosis af docetaxel er 75 mg/m2 som en 1-times infusion, efterfulgt af cisplatin 75 mg/m2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m2 pr. dag, givet som en 24-timers kontinuerlig infusion i 5 dage, med start efter endt cisplatin-infusion.
English: • 255 patients who received docetaxel in combination with capecitabine.
Danish: • 255 patienter, som fik docetaxel i kombination med capecitabin.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Danish: Tabel over bivirkninger ved adjuverende behandling med DOCETAXEL KABI 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data:
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Danish: TAC-behandlede patienter havde 32 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,68; 95 % CI (0,49-0,93); p = 0,01).
English: A multi-centre, open-label, randomised study, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Danish: En multicenter, åben, randomiseret undersøgelse har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom af den gastrooesophagele forbindelse.
English: Ask your doctor for advice before being given any medicine.
Danish: Graviditet, amning og frugtbarhed Spørg din læge til råds, før du tager nogen form for medicin.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Danish: Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5fluoruracil 750 mg/m2 daglig som en kontinuerlig infusion i 5 dage.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: Pyrexia (G3/4: 1%);
Danish: Pyrexi (G3/4: 1 %);
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Danish: • Lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød)
English: DOCETAXEL KABI in combination with doxorubicin
Danish: DOCETAXEL KABI i kombination med doxorubicin
English: Infection (G3/4: 6.3%); Neutropenic infection
Danish: Infektion (G3/4: 3,6 %) Neutropenisk infektion
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Danish: På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % versus 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: Hjerteinsufficiens (3,8 % versus 2,8 %), total LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 1,1 %).
English: • bleeding from the nose
Danish: • Næseblod
English: 95% CI p-value*
Danish: 95 %CI p-værdi
English: 1 vial with 180 mg/9 ml
Danish: 1 hætteglas med 180 mg/9 ml.
English: Alopecia (G3/4: 4.0%)
Danish: Alopeci (G3/4: 4,0 %)
English: No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Danish: Der foreligger ingen data for patienter med nedsat leverfunktion i kombinationsbehandling ved andre indikationer.
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: Nedsættelsen af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.Overlevelse i alt var også signifikant længere (p = 0,0201) til fordel for TCFarmen med en nedsættelse af risikoen for død på 22,7 %.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
Danish: I begge arme fik patienter med ER + og/eller PR+ tumorer 20 mg tamoxifen en gang daglig i op til 5 år efter den sidste kemoterapicyklus.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Danish: • Sløret syn pga. hævet nethinde (cystoidt makulaødem)
English: • Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multi-centre, open-label, randomised study (TAX323).
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i en fase III, multicenter, åben, randomiseret undersøgelse (TAX323).
English: Data from a multi-centre open-label randomisedtrial support the use of DOCETAXEL KABI for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Danish: Data fra et multicenter, åbent, randomiseret studium støtter anvendelsen af DOCETAXEL KABI som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling.
English: G3/4 Blood bilirubin increased (< 2.5%);
Danish: G3/4 Forhøjet bilirubin i blodet (< 2,5 %);