natgillin/translations-raw huggingface dataset:
• på injektionsstedet: hudreaktioner, betændelse i venen eller opsvulmen 
• at the injection site; skin reactions, inflammation of the vein or swelling
Dyspepsi; 
Dizziness;
Forholdet mellem fordel/risiko for TAC-patienter med 4+ lymfeknuder blev ikke fuldt defineret i interimanalysen. 
The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Der blev ikke observeret effekt af prednison på docetaxels farmakokinetik. 
No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Sygdomsfri overlevelse 
Disease Free Survival
Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20- 115 mg/m2. 
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
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: 
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
Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaner. 
Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes.
Docefrez leveres som enkeltdosis-hætteglas. 
Docefrez is supplied as single-dose vials.
Docefrez er et antineoplastisk stof (cytostatikum), og som med andre potentielle toksiske lægemidler, skal man udvise forsigtighed ved brug og fremstilling af Docefrez-opløsninger. 
Docefrez is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docefrez solutions.
Flere grad 3/4 bivirkninger blev observeret for Docefrez-monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %). 
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel
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. 
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.
compartment farmakokinetisk model, med halveringstider for α, β og γ faserne på henholdsvis 4 min., 
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
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). 
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).
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). 
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).
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. 
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.
Den rekonstituerede opløsning indeholder 24 mg/ml docetaxel og skal bruges straks efter tilberedning. 
Reconstituted solution The reconstituted solution contains 24 mg/ml docetaxel and should be used immediately after preparation.
• For capecitabin dosismodifikationer: se capecitabins produktresumé. 
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
UDLØBSDATO 
Preclinical data
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. 
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.
Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3-4) 
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection
Mitoxantrone hver 3 .uge 
Docetaxel every week Mitoxantrone every 3 weeks
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. 
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.
Systemorganklasser i henhold til MedDRAdatabasen 
MedDRA system organ classes
G3/4 ASAT forhøjet G3/4 Forhøjet alkalisk fosfatase i blodet 
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
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). 
• 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).
Median varighed af respons til kemoterapi ± strålebehandling (måneder) (95 % CI) 
Median duration of response to chemotherapy ± radiotherapy (months) (95%CI)
Overfølsomhed(ikke alvorlig) 
Hypersensitivity (no severe)
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). 
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).
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). 
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).
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. 
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.
Hovedsagelig hos patienter med præ-eksisterende leversygdomme er der rapporter om meget sjældne tilfælde af hepatitis, nogle gange fatale. 
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m2 givet som enkeltstof. 
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m2 as a single agent.
Co-administrationen af docetaxel, doxorubicin og cyclophosfamid påvirkede ikke deres farmakokinetik. 
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
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. 
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.
docetaxel blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge. 
Docetaxel was administered as a 1-hour infusion, all other drugs were given intravenously on day 1 every three weeks.
(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). 
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).
95 % CI p-værdi* 
95% CI p-value*
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. 
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.
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). 
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).
• 406 patienter som fik docetaxel i kombination med cisplatin. 
• 406 patients who received docetaxel in combination with cisplatin.
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. 
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.
PSA**- response rate (%) 95 % CI p-værdi* 
PSA** response rate (%) 95% CI p-value*
En dosis på 140 mg docetaxel kræver f.eks. én 80 mg pakke og tre 20 mg pakker. 
For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs.
Infektion associeret med G4 neutropeni (G3/4:4,6 
Infection associated with G4 neutropenia (G3/4:4.6%)
Myokardial iskæmi (G3/4: 1,7 %) 
Myocardial ischemia (G3/4: 1.7%)
Forekomsten af tilbagefald ved 5 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 25 % versus 32 %). 
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).
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. 
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.
Progressiv sygdom som bedste overlevelse respons (%) 
Progressive disease as best overall response (%) *Unstratified logrank test
95 % CI p-værdi†* 
95% CI p-value†*
Svimmelhed (G3/4: 2,3 %); Perifer motorisk neuropati 
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy
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. 
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.
LÆGEMIDDELFORM Pulver og solvens til koncentrat til infusionsvæske. 
PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
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. 
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.
Læs indlægssedlen i pakningen før brug. 
Read the package leaflet before use.
Docefrez i kombination med doxorubicin og cyclophosfamid: adjuverende behandling 
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
• åndenød, hoste* 
• shortness of breath, cough*
• kvalme, opkastning, fordøjelsesbesvær*, mavepine* 
• nausea, vomiting, indigestion*, bellyache* • diarrhoea, constipation*
Docefrez i kombination med capecitabin 
Docetaxel in combination with capecitabine
• 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. 
• 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.
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3. 
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Ved prostatakræft er det anbefalede præmedicineringsregime, på grund af den samtidige behandling med prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxelinfusion (se pkt. 
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section
Bland opløsningen i infusionsposen eller -flasken manuelt med en vuggende bevægelse. 
The solution in the infusion bag or bottle should be allowed to mix manually using a rocking motion.
Docefrez i kombination med cisplatin og 5-fluorouracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom i den gastroøsofageale forbindelse, som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom. 
Docetaxel 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.
Hvert hætteglas indeholder 80 mg docetaxel (vandfri) Efter rekonstitution indeholder 1 ml koncentratet 24 mg/ml docetaxel. 
Each single-dose vial of powder contains 80 mg docetaxel (anhydrous) After reconstitution 1 ml of concentrate contains 24 mg docetaxel.
Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal bortskaffes i henhold til standardprocedurer. 
All materials that have been utilised for dilution and administration and any unused product should be disposed of in accordance with local requirements.
4.1.2 Med en sprøjte med påsat kanyle udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docefrez ved at holde hætteglasset på skrå. 
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docefrez vial by partially inverting the vial.
Vær ekstra forsigtig med at bruge Docefrez 
Take special care with Docefrez
*Ustratificerede logrank-test 
*un-adjusted log-rank test
• 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). 
• 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, multicenter, open-label, randomized study (TAX323).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Docefrez 20 mg 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docefrez 20 mg
HÆTTEGLAS/SOLVENS TIL DOCEFREZ 80 MG 
Solvent for Docefrez 80 mg
meget almindelig (≥ 1/10); almindelig (≥ 1/100, < 1/10); ikke almindelig (≥ 1/1000, < 1/100); sjælden (≥ 1/10.000, < 1/1000); meget sjælden (< 1/10.000). 
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data)
Patienter i docetaxel-armen modtog docetaxel 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5- fluorouracil (F) 750 mg/m2 daglig som en kontinuerlig infusion i 5 dage. 
Patients on the docetaxel arm received docetaxel 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 .
Antal patienter Smerte-response rate (%) 
Pain response rate (%)
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, 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. 
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).
Docefrez som enkeltstof 
Docetaxel as single agent
Der er sjældne rapporter om radiation recall-fænomen. 
Radiation recall phenomena have rarely been reported.
● Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) 
• Induction chemotherapy followed by radiotherapy (TAX 323).
For yderligere oplysninger se indlægssedlen. 
See leaflet for further information.
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 %). 
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 anemia (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%).
CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm 
ER/PR-negative or Grade 3 or tumor size >5 cm
MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt. 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
For cisplatin- og 5-fluorouracil-dosisjusteringer: se tilsvarende produktresumé. 
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Febril neutropeni (inklusiv neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis 
Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Asteni (alvorlig: 12,4 %); Væskeretention (alvorlig: 0,8 %); Smerter 
Asthenia (severe 12.4%); Fluid retention (severe 0.8%); Pain
• 255 patienter som fik docetaxel i kombination med capecitabin. 
• 255 patients who received docetaxel in combination with capecitabine.
Docetaxel kan gives, når neutrocyttallet er ≥ 1.500 celler/mm3. 
Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Trombocytopeni; (G3/4: 0,6 %); Febril neutropeni 
Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
Effekt af docetaxel i indledende behandling til patienter med lokale fremskredne SCCHN (Hensigt at behandle-analyse) 
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
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 
In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT,
Docefrez 80 mg pulver og solvens til koncentrat til infusionsvæske, opløsning: Pulverhætteglas: Docefrez er et hvidt lyofiliseret pulver, der leveres i et farveløst hætteglas med en grå non-latex gummiprop og en rød aluminiumforsegling. 
Docefrez 80 mg powder and solvent for concentrate for solution for infusion: Powder vial: Docefrez is a white lyophilised powder, supplied in a colourless glass vial with a grey non-latex rubber stopper and a red aluminium seal.
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 cyclophosfamid 500 mg/m2 (TAC arm), eller doxorubicin 50 mg/m2, fulgt af fluorouracil 500 mg/ m2 og cyclophosfamid 500 mg/m2 (FAC arm). 
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized 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).