FrancophonIA/ELRC3.0 huggingface dataset:
English: In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
Danish: I studiet GEICAM 9805 fortsatte lymfødem hos 4 ud af 5 patienter i TAC-armen og hos 1 ud af 2 patienter i FAC-armen ved slutningen af kemoterapien, og blev ikke forbedret i followup-perioden (median followup-tid var 10 år og 5 måneder).
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m in all subsequent cycles (see sections 4.4 and 4.8).
Danish: Patienter, som får febril neutropeni og/eller neutropenisk infektion bør have deres docetaxel-dosis reduceret til 60 mg/m² i alle efterfølgende cyklusser (se pkt.
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: MedDRA system organ classes Very common adverse reactions
Danish: MedDRA systemorganklasse Meget almindelige bivirkninger
English: 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).
Danish: Efter stratificering i forhold til antallet af positive lymfeknuder (1-3, 4+) blev 1.491 patienter randomiseret til enten at få 75 mg/m² docetaxel 1 time efter 50 mg/m² doxorubicin og 500 mg/m² cyclophosphamid (TAC-arm), eller 50 mg/m² doxorubicin efterfulgt af 500 mg/m² fluoruracil og 500 mg/m² cyclophosphamid (FAC-arm).
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: 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 PgR+ tumorer 20 mg tamoxifen en gang daglig i op til 5 år efter den sidste kemoterapicyklus.
English: 95% CI p-value*
Danish: 95% CI p-værdi† *
English: • operable node-positive breast cancer
Danish: • operabel, lymfeknude-positiv brystcancer
English: In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Danish: 3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
English: Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Danish: Patienter i TAC-armen fik antibiotisk profylakse med 500 mg ciprofloxacin oralt 2 gange dagligt i 10 dage, startende på femte dagen af hver cyklus, eller tilsvarende.
English: Efficacy results are presented in the table below:
Danish: Effektresultaterne er vist i nedenstående tabel:
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy
Danish: cyster og polypper) Der er rapporteret om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom i forbindelse med indgift af docetaxel, når lægemidlet er brugt i kombination med anden kemoterapi og/eller strålebehandling.
English: Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Danish: Patienter i TPF-armen fik antibiotisk profylakse med 500 mg ciprofloxacin oralt 2 gange dagligt i 10 dage, startende på femtedagen af hver cyklus eller tilsvarende.
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 75 mg/m² til de patienter, der har forhøjet leverfunktionstest (LFT), og LFT skal måles ved start og før hver behandlingscyklus (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mg/10 ml
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Danish: Perifer sensorisk neuropati (G3: 3,7%); Perifer motorisk neuropati (G3/4: 2%)
English: Infections and infestations Blood and lymphatic system disorders
Danish: Infektioner og parasitære sygdomme Blod og lymfesystem Neutropeni
English: Docetaxel Mylan contains ethanol
Danish: Docetaxel Mylan indeholder ethanol (alkohol)
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Danish: G3/4 ASAT forhøjet G3/4 Forhøjet alkalisk phosphatase i blodet
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND THE REACH OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
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: 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, 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: I et fase III-studie blev 1.218 patienter med inoperabel, ikke-småcellet lungecancer, stadium IIIB eller IV med KPS ≥ 70%, og som ikke tidligere havde fået kemoterapi mod denne tilstand, randomiseret til enten 75 mg/m² docetaxel (T) som en infusion over 1 time umiddelbart efterfulgt af 75 mg/m² cisplatin (Cis) indgivet over 30-60 minutter hver 3. uge, 75 mg/m² docetaxel som infusion over 1 time i kombination med carboplatin (AUC 6 mg/ml/min) indgivet over 30-60 minutter hver 3. uge, eller 25 mg/m² vinorelbin (V) indgivet over 6-10 minutter på dag 1, 8, 15, 22, efterfulgt af 100 mg/m² cisplatin indgivet på førstedagen af cyklusserne og gentaget hver 4. uge.
English: Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Danish: Medianvarighed af respons på kemoterapi +/strålebehandling (måneder) (95% CI)
English: Myocardial ischemia (G3/4:1.7%)
Danish: Myokardisk iskæmi (G3/4: 1,7%)
English: At the median follow-up time of 77 months, overall survival (OS) was 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: Ved den mediane followup-periode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, 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: Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Danish: Prednison Der er ikke observeret påvirkning fra prednison på docetaxels farmakokinetik.
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Danish: Ikke-kardiale brystsmerter (alvorlig: 0,4%)
English: Diarrhoea (G3/4: 6.2%);
Danish: Diarré (G3/4: 6,2%);
English: Dehydration (G3/4: 2%)
Danish: Dehydrering (G3/4: 2%)
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Danish: Svimmelhed (G3/4: 2,3%); Perifer motorisk neuropati (G3/4: 1,3%)
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 docetaxel-dosis 75 mg/m² hver 3. uge kombineret med capecitabin 1250 mg/m² to gange dagligt (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution for infusion.
Danish: For eksempel skal der til en beregnet dosis på 140 mg docetaxel udtages 7 ml koncentrat til infusionsvæske.
English: Docetaxel Mylan 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 Mylan i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastroøsofageale overgang, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: You must not be given Docetaxel Mylan
Danish: Brug ikke Docetaxel Mylan:
English: Myalgia (severe: 0.5%)
Danish: Myalgi (alvorlig 0,5%)
English: G3/4 Blood bilirubin increased (2.1%);
Danish: G3/4 Forhøjet bilirubin i blodet (2,1%);
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Danish: Hos patienter, som tidligere havde fået alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m² hver 3. uge).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Danish: • Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Sikkerheden og effektiviteten af docetaxel i induktionsbehandling af patienter med lokalt fremskreden pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, openlabel, fase III-studie (TAX 324).
English: Median TTP (months) (95% CI)
Danish: Median TTP (måneder) (95% CI)
English: • operable node-negative breast cancer
Danish: • operabel, lymfeknude-negativ brystcancer
English: G3/4 Blood alkaline phosphatase increased
Danish: G3/4 Forhøjet alkalisk phosphatase i blodet
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: Anaemia (G3/4: 10.8%);
Danish: Anæmi (G3/4: 10,8%);
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/1 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg/4 ml
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Danish: Fald i den kardiale venstre ventrikelfunktion (G3/4: 0,3%)
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Danish: Den totale overlevelse i år ti var ligeledes væsentlig højere i TAC-armen sammenlignet med FAC-armen (hhv. 76% og 69%), dvs. en absolut reduktion af risikoen for død med 7% (p=0,002).
English: Each vial contains 1 ml of concentrate.
Danish: Hvert hætteglas indeholder 1 ml koncentrat.
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: Modsat udviste AC-armen højere forekomst af svær anæmi (15,8% mod 8,5%) end AT-armen samt en højere forekomst af svær hjertetoksicitet: kongestivt hjertesvigt (3,8% mod 2,8%), absolut LVEF-nedsættelse ≥ 20% (13,1% mod 6,1%), absolut LVEFnedsættelse ≥ 30% (6,2% mod 1,1%).
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Danish: I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenokarcinom ekskluderede pivotalstudiet patienter med ALAT og/eller ASAT > 1,5 gange ULN associeret med alkalisk phosphatase > 2,5 x ULN, og bilirubin > 1 x ULN.
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: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: • Injicer via en enkelt injektion (et stik) derefter den nødvendige mængde Docetaxel Mylan koncentrat til infusionsvæske, opløsning i en 250 ml infusionspose eller -flaske indeholdende enten 5% glucoseinfusionsvæske eller 9 mg/ml (0,9%) natriumchloridinfusionsvæske.
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Danish: - Ved behandling af metastatisk gastrisk kræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
English: Data from a multicenter open label randomized trial support the use of docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Danish: Data fra et multicenter, open-label randomiseret studie støtter anvendelsen af docetaxel som adjuverende behandling til patienter med operabel lymfeknude-negativ brystcancer, der er egnede til kemoterapibehandling.
English: 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 4.4).
Danish: Ved prostatacancer 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.
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Danish: • For capecitabin dosisjusteringer se capecitabins produktresumé.
English: First episode: stop 5-FU only, at all subsequent cycles.
Danish: Stomatitis/mucositis grad 4 Første episode: Stop kun 5-FU i alle efterfølgende cyklusser.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Danish: Første episode: Reducer docetaxel- og 5-FU-dosis med 20%.
English: Dyspnoea; Cough; Rhinorrhoea
Danish: Alopeci; Erythem; Udslæt; Neglesygdomme
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 75 mg/m² docetaxel (T) efterfulgt af 75 mg/m² cisplatin (P) efterfulgt af 750 mg/m² 5-fluoruracil (F) dagligt som kontinuerlig infusion i 5 dage.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² followed by 5-fluorouracil (F) 1000 mg/m² per day for 5 days.
Danish: Patienter i komparatorarmen fik 100 mg/m² cisplatin (P) efterfulgt af 1.000 mg/m² 5-fluoruracil (F) dagligt i 5 dage.
English: G3/4 Blood bilirubin increased (< 5%);
Danish: G3/4 Forhøjet bilirubin i blodet (< 5%);
English: Thrombocytopenia (G4: 1.7%)
Danish: Thrombocytopeni (G4: 1,7%)
English: Hypersensitivity (G3/4: 1.2%)
Danish: Hypersensitivitet (G3/4: 1,2%)
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: Effektendepunkterne for docetaxel-armen i forhold til kontrolarmen er opsummeret i nedenstående tabel:
English: G3/4 Blood bilirubin increased (< 2.5%);
Danish: G3/4 Forhøjet bilirubin i blodet (< 2,5%);
English: MedDRA system organ classes Very common adverse
Danish: MedDRA systemorganklasse Meget almindelige
English: Asthenia (severe: Fluid retention (severe:
Danish: Konstipation (alvorlig: Mavesmerter (alvorlig: Gastrointestinal hæmorrhage (alvorlig:
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Danish: For eksempel skal der til en beregnet dosis på 140 mg docetaxel udtages 7 ml docetaxel koncentration til infusionsvæske, opløsning.
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m² (see sections 4.4 and 5.2).
Danish: På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m², er den anbefalede dosis docetaxel 75 mg/m² til patienter, som både har forhøjelse af transaminase (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi (ULN) og af basisk phosphatase på mere end 2,5 gange den øvre normalværdi (se pkt.
English: TAC FAC
Danish: TAC
English: Patients with baseline neutrophil count of < 1,500 cells/mm
Danish: Patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3.
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; Perifert ødem; Pyrexi; Træthed; Inflammation i slimhinderne; Smerter;
English: Box of 1 vial, or 5 vials.
Danish: Æske indeholdende 1 eller 5 hætteglas.
English: Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
Danish: Synkope (G3/4: 0%); Neurotoksicitet (G3/4: Døsighed (G3/4: 0%)
English: Description of selected adverse reactions for 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
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv brystcancer (TAX 316) og lymfeknude-negativ brystcancer (GEICAM 9805)
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Danish: • hudreaktioner på injektionsstedet, betændelse eller hævelse af venen (flebitis)
English: • Induction chemotherapy followed by radiotherapy (TAX 323)
Danish: • Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) MedDRA systemorganklasse
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Danish: Træthed/svaghed (G3/4: 5%); Perifert ødem (G3/4: 1%)
English: The infusion bag solution should be used within 6 hours below 25 °C and normal lighting conditions including the one hour infusion to the patient.
Danish: Den fortyndede opløsning skal bruges inden for 6 timer og anvendes under aseptiske forhold som en 1-times infusion ved temperaturer under 25°C og under normale lysforhold.
English: Clinical efficacy and safety
Danish: Klinisk virkning og sikkerhed Brystcancer
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg docetaxel (vandfri).
English: If Docetaxel Mylan concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis Docetaxel Mylan koncentrat eller infusionsvæske skulle komme i berøring med huden, skal man straks vaske sig grundigt med vand og sæbe.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour infusion followed by cisplatin 75 mg/m² over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for five days.
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskreden pladecellekarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m² som en 1-times infusion, efterfulgt af 1-times infusion med cisplatin 75 mg/m² på dag 1, efterfulgt af 5-fluoruracil som en kontinuerlig infusion på 750 mg/m² pr. dag i fem dage.
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Danish: Behandling med docetaxel bør gentages, når neutrocyttallet igen er ≥ 1.500 celler/mm
English: If not used immediately, inuse storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstider ogforhold brugerens ansvar.
English: Thrombocytopenia (G3/4: 3%)
Danish: Thrombocytopeni (G3/4: 3%)
English: Peripheral sensory neuropathy (G3: 0.4%)
Danish: Perifer sensorisk neuropati (G3: 0,4%)
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Danish: Den anbefalede dosis af doxetaxel til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystcancer, er 75 mg/m² hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m² og cyclophosphamid 500 mg/m² (TAC-regimen) (se også: Dosisjustering under behandling).