FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal SCCHN studies, patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g. day 6-15) in all subsequent cycles.
Danish: Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusive prolongeret neutropeni, febril neutropeni eller infektion), blev G-CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser.
English: You must not breast-feed while using Docefrez.
Danish: Du må IKKE amme, mens du behandles med Docefrez.
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The reconstituted solution contains approximately 24 mg/ml docetaxel and should be used immediately after preparation.
Danish: Den rekonstituerede opløsning indeholder ca. 24 mg/ml docetaxel og skal bruges straks efter tilberedning.
English: 79199 Kirchzarten Germany tel. +49 (0) 7661 90 91 58-0
Danish: Germany tel. +49 (0) 7661 90 91 58-0
English: A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Danish: Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Danish: Kraftige reaktioner var karakteriseret ved hypotension og/eller astma eller generelt udslæt/erythem (se pkt.
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Danish: In vivo er docetaxels aktivitet uafhængig af behandlingsregimet og har eksperimentelt vist et bredt spektrum af antineoplastisk aktivitet over for murine og transplanterede humane tumorer.
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: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Danish: Tid indtil progressiv sygdom var længere i kombinationsarmen med Xeloda + docetaxel (p < 0,0001).
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Danish: Som førstebehandling indgives 75 mg/m2 docetaxel i kombinationsbehandling med doxorubicin (50 mg/m2).
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 adenocarcinoma-patienter (221 patienter i fase III-delen af undersøgelsen og 79 patienter i fase II-delen af undersøgelsen), som blev behandlet med docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: • CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: (see sections 4.4 and 4.8).
Danish: 4.4 og 4.8).
English: Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemoterapy agents and/or radiotherapy.
Danish: Der er rapporter om meget sjældne tilfælde af akut myeloid leukemi og myelodyplasisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutiske stoffer og/eller radioterapi.
English: Docetaxel in combination with doxorubicin
Danish: Docefrez i kombination med doxorubicin
English: Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Danish: Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed, flebitis eller blodudtrækninger og hævelse af venen.
English: Do not use Docefrez after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke Docefrez efter den udløbsdato, der står på pakningen og hætteglasset.
English: The docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1 hour infusion under room temperature and normal lighting conditions.
Danish: Docetaxel-infusionsvæsken skal bruges inden for 4 timer og anvendes under aseptiske forhold som en infusion over 1 time ved stuetemperatur og under normale lysforhold.
English: Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Danish: Docefrez i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
English: Overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Danish: Samlet overlevelse (SO) var også længere i TAC-armen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FACbehandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
English: TCis n=408
Danish: TCis n = 408 VCis n = 404
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller sygeplejersken, hvis du bruger anden medicin eller har brugt det for nylig.
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Danish: Tabellen nedenfor viser, at hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-forsøget.
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Danish: Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau > 1.500 celler/mm3 og blodplader gendannes til et niveau > 100.000
English: **un-adjusted log-rank test, not adjusted for multiple comparisons
Danish: ** Ujusteret logrank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Not Applicable
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 80 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Pakning 80 mg
English: A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Danish: 449 patienter blev randomiseret til enten at modtage docetaxel monoterapi 100 mg/m2 givet som 1 times infusion eller paclitaxel 175 mg/m2 givet som en infusion over 3 timer.
English: In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Danish: For patienter, behandlet med docetaxel, doxorubicin og cyclophosfamid (TAC), kræver risikoen for forsinket myelodysplasi eller myolid leukæmi hæmatologisk opfølgning.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Spørg din læge eller sygeplejerske, hvis du har flere spørgsmål om brugen af dette lægemiddel.
English: • at the injection site; skin reactions, inflammation of the vein or swelling
Danish: • på injektionsstedet: hudreaktioner, betændelse i venen eller opsvulmen
English: Dizziness;
Danish: Dyspepsi;
English: The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Danish: Forholdet mellem fordel/risiko for TAC-patienter med 4+ lymfeknuder blev ikke fuldt defineret i interimanalysen.
English: No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Danish: Der blev ikke observeret effekt af prednison på docetaxels farmakokinetik.
English: Disease Free Survival
Danish: Sygdomsfri overlevelse
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 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: Adjuvant therapy with Docetaxel 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: Adjuverende behandling med Docefrez 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft - pooled data:
English: Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes.
Danish: Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaner.
English: Docefrez is supplied as single-dose vials.
Danish: Docefrez leveres som enkeltdosis-hætteglas.
English: Docefrez is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docefrez solutions.
Danish: Docefrez er et antineoplastisk stof (cytostatikum), og som med andre potentielle toksiske lægemidler, skal man udvise forsigtighed ved brug og fremstilling af Docefrez-opløsninger.
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel
Danish: Flere grad 3/4 bivirkninger blev observeret for Docefrez-monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %).
English: There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease-related medications (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: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and
Danish: compartment farmakokinetisk model, med halveringstider for α, β og γ faserne på henholdsvis 4 min.,
English: A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Danish: 445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluorouracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluorouracil (1000 mg/m2 pr. dag i 5 dage).
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-forsøg med brystkræftpatienter, hvor anthracyclinbehandling ikke havde haft effekt, medtaget (se: Produktresuméet for capecitabin).
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: Derfor anbefales det, at mænd der behandles med docetaxel ikke avler børn under behandlingen og op til 6 måneder efter behandlingen, samt at de inden behandlingen søger vejledning om konservering af sædceller.
English: Reconstituted solution The reconstituted solution contains 24 mg/ml docetaxel and should be used immediately after preparation.
Danish: Den rekonstituerede opløsning indeholder 24 mg/ml docetaxel og skal bruges straks efter tilberedning.
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Danish: • For capecitabin dosismodifikationer: se capecitabins produktresumé.
English: Preclinical data
Danish: UDLØBSDATO
English: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Danish: Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5-fluorouracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G-CSF.
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection
Danish: Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3-4)
English: Docetaxel every week Mitoxantrone every 3 weeks
Danish: Mitoxantrone hver 3 .uge
English: 4.2.4 The Docefrez infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Danish: 4.2.4 Docefrez-infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25°C) og under normale lysforhold.
English: MedDRA system organ classes
Danish: Systemorganklasser i henhold til MedDRAdatabasen
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Danish: G3/4 ASAT forhøjet G3/4 Forhøjet alkalisk fosfatase i blodet
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: Median duration of response to chemotherapy ± radiotherapy (months) (95%CI)
Danish: Median varighed af respons til kemoterapi ± strålebehandling (måneder) (95 % CI)
English: Hypersensitivity (no severe)
Danish: Overfølsomhed(ikke alvorlig)
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Danish: Dog har præmixopløsningen vist fysisk og kemisk stabilitet i en periode på 8 timer, både når den blev opbevaret mellem 2 °C og 8 °C, og når den blev opbevaret ved stuetemperatur (under 25 °C).
English: One large randomized phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Danish: Et stort randomiseret fase III-studie, med 429 tidligere ubehandlede patienter med metastatisk sygdom, er blevet udført med doxorubicin (50 mg/m2) i kombination med docetaxel (75 mg/2) (ATarm) versus doxorubicin (60 mg/m2) i kombination med cyclophosfamid (600 mg/m2) (AC-arm).
English: Median overall survival was also significantly longer in favor 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 ialt 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: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Danish: Hovedsagelig hos patienter med præ-eksisterende leversygdomme er der rapporter om meget sjældne tilfælde af hepatitis, nogle gange fatale.
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/m2 givet som enkeltstof.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Danish: Co-administrationen af docetaxel, doxorubicin og cyclophosfamid påvirkede ikke deres farmakokinetik.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Danish: I kombination med capecitabin er den anbefalede Docefrez-dosis 75 mg/m2 hver 3. uge kombineret med capecitabin 1250 mg/m2 to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: Docetaxel was administered as a 1-hour infusion, all other drugs were given intravenously on day 1 every three weeks.
Danish: docetaxel blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
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: (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: 95% CI p-value*
Danish: 95 % CI p-værdi*
English: Docetaxel 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: Docefrez i kombination med cisplatin og 5-fluorouracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle-carcinoma i hoved og hals.
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 forsøg randomiseredes 255 patienter til behandling med docetaxel (75 mg/m2 som en 1times intravenøs infusion hver 3. uge) og capecitabin (1250 mg/m2 to gange daglig i 2 uger efterfulgt af en uges pause).
English: • 406 patients who received docetaxel in combination with cisplatin.
Danish: • 406 patienter som fik docetaxel i kombination med cisplatin.
English: This volume of concentrate should be injected into a 250 ml infusion bag or bottle containing either glucose 50 mg/ml (5%) solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Dette volumen koncentrat injiceres i en 250 ml infusionspose eller -flaske med enten 50 mg/ml glucoseopløsning (5 %) eller 9 mg/ml natriumchloridopløsning (0,9 %) til infusion.
English: PSA** response rate (%) 95% CI p-value*
Danish: PSA**- response rate (%) 95 % CI p-værdi*
English: For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs.
Danish: En dosis på 140 mg docetaxel kræver f.eks. én 80 mg pakke og tre 20 mg pakker.
English: Infection associated with G4 neutropenia (G3/4:4.6%)
Danish: Infektion associeret med G4 neutropeni (G3/4:4,6
English: Myocardial ischemia (G3/4: 1.7%)
Danish: Myokardial iskæmi (G3/4: 1,7 %)
English: Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i.e. an absolute risk reduction by 7% (p=0.001).
Danish: Forekomsten af tilbagefald ved 5 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 25 % versus 32 %).
English: Data from a multicenter open label randomized 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 forsøg støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS ≥ 80 % i alderen mellem 18 og 70 år.
English: Progressive disease as best overall response (%) *Unstratified logrank test
Danish: Progressiv sygdom som bedste overlevelse respons (%)
English: 95% CI p-value†*
Danish: 95 % CI p-værdi†*
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy
Danish: Svimmelhed (G3/4: 2,3 %); Perifer motorisk neuropati
English: 4.1 Reconstitution of Docefrez Powder for Solution for Infusion 4.1.1 Allow the required number of Docefrez boxes which are stored in a refrigerator, to stand at room temperature (below 25ºC) for 5 minutes.
Danish: 4.1 Fremstilling af Docefrez præmix-opløsning 4.1.1 Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docefrez-æsker stå i stuetemperatur (under 25°C) i 5 minutter før brug.
English: PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM Pulver og solvens til koncentrat til infusionsvæske.
English: The overfills are included to ensure that, after dilution with the entire volume of the accompanying solvent vial, the minimum extractable volume of reconstituted concentrate containing 20 mg or 80 mg docetaxel, respectively, may be withdrawn from the vial.
Danish: Overfyldningerne er inkluderet for at sikre, at der efter fortynding med hele indholdet af det medfølgende solvenshætteglas, minimum kan udtages en mængde rekonstitueret koncentrat indeholdende 20 mg eller 80 mg docetaxel fra hætteglasset.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen i pakningen før brug.
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: Docefrez i kombination med doxorubicin og cyclophosfamid: adjuverende behandling
English: • shortness of breath, cough*
Danish: • åndenød, hoste*
English: • nausea, vomiting, indigestion*, bellyache* • diarrhoea, constipation*
Danish: • kvalme, opkastning, fordøjelsesbesvær*, mavepine*
English: Docetaxel in combination with capecitabine
Danish: Docefrez i kombination med capecitabin
English: • For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel / capecitabine treatment, delay treatment until resolved to Grade 0- 1, and resume at 100% of the original dose.
Danish: • Hos patienter, der første gang udvikler grad 2-toksicitet, der vedvarer til tidspunktet for den næste docetaxel/capecitabin-behandling skal behandlingen udsættes, til der er grad 0-1toksicitet.
English: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Danish: Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3.