FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Teva 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 Teva i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med lokale, fremskredne skællede celle-carcinoma i hoved og hals.
English: In GEICAM 9805 study, 3 patients (0.6%) in TAC arm and 3 patients (0.6%) in FAC arm developed congestive heart failure during the follow-up period.
Danish: I studiet GEICAM9805 udviklede 3 patienter (0,6%) i TAC-armen og 3 patienter (0,6%) i FAC-armen kongestivt hjertesvigt i opfølgningsperioden.
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Danish: Med docetaxel er der rapporter om meget sjældne tilfælde af kutan erytematøs lupus, bulløst udslæt, såsom erythema multiforme, Stevens-Johnson syndrom og toksisk epidermal nekrolyse.
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Danish: De anbefalede dosismodifikationer for gastrointestinal toksicitet hos patienter behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (5-FU):
English: Docetaxel Teva is supplied as single-dose vials.
Danish: Docetaxel Teva leveres som enkeltdosis-hætteglas.
English: Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Danish: Docetaxel Teva i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
English: Thrombocytopenia (G3/4: Febrile neutropenia
Danish: Trombocytopeni (G3/4: Febril neutropeni
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 sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m2 end hos patienterne, der fik bedste palliative behandling.
English: Disease Free Survival Hazard ratio*
Danish: Sygdomsfri overlevelse Hazard ratio*
English: If you are a man being treated with Docetaxel Teva you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Danish: Hvis du er mand og i behandling med Docetaxel Teva, rådes du til ikke at blive far til et barn under og 6 måneder efter behandlingen og til at søge vejledning om opbevaring af sæd inden behandlingen, fordi docetaxel kan nedsætte den mandlige fertilitet.
English: Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Danish: Median varighed af respons til kemoterapi ± strålebehandling (måneder) (95 % CI)
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1,250 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 1.250 mg/m2 to gange daglig (inden for 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med anthracyklin uden effekt, blev docetaxel sammenlignet med kombinationsbehandling med mitomycin C og vinblastin (12 mg/m2 hver 6. uge og 6 mg/m2 hver 3. uge).
English: Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
Danish: Docetaxel Teva koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til gulbrun opløsning.
English: The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow-up before).
Danish: Den endelige analyse blev udført, da alle patienter havde nået deres 10 års opfølgningsbesøg (medmindre de havde en DFS eller udgik tidligere fra opfølgning).
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Danish: • 300 gastrisk adenocarcinoma-patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som blev behandlet med docetaxel i kombination med cisplatin og 5
English: Other medicines and Docetaxel Teva
Danish: Brug af anden medicin sammen med Docetaxel Teva
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Danish: Asteni (alvorlig: 12,4 %); Væskeretention (alvorlig: 0,8 %); Smerter
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Danish: Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatakræft blev undersøgt i et randomiseret multicenter fase IIIstudie.
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Der blev vist signifikant længere sygdomsfri overlevelse i TAC-armen end FAC-armen.
English: Blood and lymphatic Neutropenia (G3/4:
Danish: Blod og lymfesystem Neutropeni (G4:
English: • The solvent for Docetaxel Teva composition is water for injections.
Danish: • Sammensætningen af solvens til Docetaxel Teva er vand til injektionsvæsker
English: Gastrointestinal disorders
Danish: Gastrointestinale
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Danish: Meget almindelige bivirkninger Almindelige bivirkninger neutropeni (inklusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis
English: (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Danish: Hos patienter, der behandles med docetaxel som enkeltstof i dosis på 100 mg/m2, som har en serumtransaminase-værdi (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi samtidig med, at de serum-basiske fosfataseværdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger, såsom toksisk dødsfald inklusive sepsis og maveblødning, som kan blive fatal, febril neutropeni, infektioner, trombocytopeni, stomatitis og asteni.
English: VIAL LABEL - CONCENTRATE 80 mg/2.88 ml
Danish: ETIKET TIL HÆTTEGLAS - KONCENTRAT 80 mg/2,88 ml
English: • one vial of 1.28 ml solvent (water for injections).
Danish: • et hætteglas a 1,28 ml solvens (vand til injektionsvæsker).
English: The solvent for Docetaxel Teva is water for injections.
Danish: Solvens (opløsningsvæske) til Docetaxel Teva er vand til injektionsvæsker.
English: Myalgia (severe: 0.5%)
Danish: Myalgi (alvorlig: 0,5 %)
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: Inject the required premix volume into a non-PVC 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Injicer derefter den beregnede mængde præmix i en 250 ml ikke-PVC-infusionspose eller -flaske med enten 5 % glucoseinfusionsvæske eller natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Danish: Injicer hele indholdet af sprøjten i det tilsvarende hætteglas med Docetaxel Teva.
English: - For the treatment of prostate cancer, Docetaxel Teva is administered in combination with prednisone or prednisolone.
Danish: - Ved behandling af prostatakræft kan Docetaxel Teva indgives i kombination med prednison eller prednisolon.
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Danish: Docetaxel Teva blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: - For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin.
Danish: - Ved behandling af lungekræft kan Docetaxel Teva enten indgives alene eller i kombination med cisplatin.
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: Hepatic impairment 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 (ALAT og ASAT ≥ 1,5 gange øvre normalværdi og basisk fosfatase ≥ 2,5 gange øvre normalværdi), var clearance nedsat med gennemsnitlig 27 % (se pkt.
English: Pregnancy, breast-feeding and fertility
Danish: Graviditet og amning og frugtbarhed
English: Docetaxel Teva 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 Teva i kombination med cisplatin og 5-fluoruracil 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.
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: 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 (1,000 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-fluoruracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluoruracil (1.000 mg/m2 pr. dag i 5 dage).
English: • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Danish: • Hvert hætteglas med solvens indeholder 1,28 ml vand til injektionsvæsker (påfyldningsvolumen: 1,71 ml).
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Danish: • et hætteglas (2,88 ml) med koncentrat (80 mg docetaxel),
English: 4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: 4.2.2 Injicer derefter den beregnede mængde præmix i en 250 ml ikke-PVC-infusionspose ellerflaske med enten 5 % glucoseinfusionsvæske eller natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Danish: I henhold til den beregnede dosis udtrykt i mg udtages det tilsvarende volumen præmix indeholdende 10 mg/ml docetaxel aseptisk med en gradueret sprøjte.
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 duration of response
Danish: Gennemsnitlig tid til progression
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller hospitalsfarmaceut, hvis du bruger anden medicin eller har brugt det for nylig.
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
Danish: Hvert hætteglas med koncentrat indeholder 25,1 % (w/w) vandfri ethanol (181 mg af vandfri ethanol).
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 (1,250 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 (1.250 mg/m2 to gange daglig i 2 uger efterfulgt af en uges pause).
English: As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale produkter, skal både Docetaxel Teva-præmix og -infusionsvæske kontrolleres for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
English: CF n=224
Danish: N=224
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 GCSF-profylakse (se pkt.
English: • one vial of 0.72 ml concentrate (20 mg of docetaxel),
Danish: • et hætteglas a 0,72 ml koncentrat (20 mg docetaxel),
English: in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Danish: Ved afslutningen af opfølgningsperioden (median opfølgningstid på 10 år og 5 måneder) blev det observeret, at amenorré fortsatte hos 7 patienter (1,3 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen.
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: Total overlevelse ved 10 år var også signifikant forøget med TAC i forhold til FAC (henholdsvis 76 % versus 69 %).
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; perifert ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Danish: Co-administrationen af docetaxel, doxorubicin og cyclofosfamid påvirkede ikke deres farmakokinetik.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Danish: Luftveje, thorax og mediastinum Akut respiratorisk åndedrætsbesvær og tilfælde af interstitial pneumoni/ pneumonitis, interstitiel lungesygdom, pulmonar fibrose og respirationssvigt, sommetider letale, er rapporteret sjældent.
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 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%).
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: 1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
Danish: 1.060 patienter blev randomiseret til at få enten Docetaxel Teva 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (539 patienter i TAC-armen) eller doxorubicin 50 mg/m2 efterfulgt af fluoruracil 500 mg/m2 og cyclophosphamid 500 mg/m2 (521 patienter i FAC-armen) som adjuverende behandling.
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Danish: • For capecitabin dosisjusteringer, se capecitabins produktresumé.
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Danish: Docetaxel i kombination med doxorubicin og cyclofosfamid: Adjuverende behandling
English: How to store Docetaxel Teva
Danish: Sådan skal du tage Docetaxel Teva
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: Almene symptomer og reaktioner på administrationsstedet Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed, flebitis eller blodudtrækninger og hævelse af venen.
English: • chest tightness; difficulty in breathing
Danish: • trykken for brystet, besvær med at trække vejret,
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol).
Danish: Hvert hætteglas med koncentrat indeholder vandfri ethanol 25,1 % (w/w) vandfri ethanol (723 mg af vandfri ethanol).
English: - For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
Danish: - Ved behandling af metastatisk gastrisk kræft indgives Docetaxel Teva i kombination med cisplatin og 5-fluoruracil.
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: Et multicenter, åbent, randomiseret studie har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom af den gastroøsofageale forbindelse.
English: If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Danish: Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva-æsker stå i stuetemperatur (under 25 °C) i 5 minutter før brug.
English: 2.1 Docetaxel Teva 20 mg/0.72 ml vial:
Danish: 2.1 Docetaxel Teva 20 mg/0,72 ml hætteglas:
English: Obligation to conduct post-authorisation measures Not applicable
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Data from a multi-centre open-label randomised 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, åbent, randomiseret forsøg støtter anvendelsen af Docetacel Teva som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling.
English: 3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Danish: minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m pr. dag som en kontinuerlig infusion fra dag 1 til dag 4.
English: 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Danish: 4.1.1 Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva-æsker stå i stuetemperatur (under 25 °C) i 5 minutter før brug.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 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 cyclophosphamide 500 mg/m2 (FAC arm).
Danish: Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1.491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50 mg/m2 og cyclofosfamid 500 mg/m2 (TAC arm), eller doxorubicin 50 mg/m2, fulgt af fluoruracil 500 mg/m2og cyclofosfamid 500 mg/m2 (FAC arm).
English: Teva (listed in section 6).
Danish: Docetaxel Teva (angivet i punkt 6)
English: PSA** response rate (%) 95% CI p-value*
Danish: PSA**-responsrate (%) 95 % CI p-værdi*
English: Alopecia (G3/4: 4.0%).
Danish: Alopeci (G3/4: 4,0 %).
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Danish: I studiet TAX 316 blev alopeci, der fortsatte ind i opfølgningsperioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter (92,3%) og hos 645 ud af 736 FAC-patienter (87,6%).
English: 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: docetaxel 75 mg/m som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml pr. min) administreret i løbet af 30-60 minutter hver 3. uge eller 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: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Danish: For cisplatin-dosisjustering se tilsvarende produktresumé.
English: Solvent vial: Water for injections
Danish: Solvens hætteglas: vand til injektionsvæsker
English: 4.2.4 The Docetaxel Teva 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 Docetaxel Teva 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.