FrancophonIA/ELRC3.0 huggingface dataset:
English: 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/m 2 hver 3. uge kombineret med capecitabin 1250 mg/m2 to gange dagligt (inden for 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Danish: Patienter, der får TCF, bør monitoreres nøje (se pkt.
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients and 4 FAC patients (0.5%).
Danish: Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 8 år) fortsatte perifert ødem hos 19 TAC patienter og hos 4 FAC patienter (0,5 %).
English: This is equivalent to 70 ml of beer or 29 ml of wine.
Danish: Dette svarer til 70 ml øl eller 29 ml vin.
English: • hearing impaired
Danish: • nedsat hørelse
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/m 2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Danish: Den anbefalede doxetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystkræft er 75 mg/m2 hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m2 (TAC-regimen) (se også: Dosisjustering under behandling).
English: Fever (G3/4: 1.2%)
Danish: Feber (G3/4: 1,2 %)
English: Grade1 (includes grade not assessed)
Danish: ikke vurderede grader)
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Danish: Arthralgi (G3/4: 0,3 %); myalgi (G3/4: 0,3 %)
English: • muscle aches and pains; back pain or bone pain
Danish: • muskelømhed og -smerter, rygsmerter eller knoglesmerter
English: Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Danish: Hver ml koncentrat indeholder 20 mg docetaxel (som trihydrat).
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-strålebehandling (TAX 324) Docetaxels sikkerhed og effekt i induktionsbehandlingen af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et åbent, randomiseret fase IIImulticenterstudie (TAX 324).
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Danish: Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var 8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9 %) og hos 16 FAC-patienter (2,2 %).
English: • For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
Danish: • Ved behandling af prostatakræft kan Taxespira indgives i kombination med prednison eller
English: Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Danish: Taxespira i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: Each 1 ml of concentrate contains 20 mg docetaxel (as trihydrate).
Danish: Hver 1 ml koncentrat indeholder 20 mg docetaxel (som trihydrat).
English: MedDRA system organ classes
Danish: MedDRA-systemorganklasse Meget almindelige
English: 120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
Danish: 120 mg/6 ml Hvert hætteglas med 6 ml koncentrat indeholder 3 ml vandfri ethanol (2370 mg).
English: Median TTP (months) (95% CI)
Danish: Median TTP (måneder) (95 % CI)
English: This is equivalent to 60 ml of beer or 25 ml of wine.
Danish: Dette svarer til 60 ml øl eller 25 ml vin.
English: Median progression free survival (months) (95% CI)
Danish: Median progressionsfri overlevelse (måneder) (95 % CI)
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Danish: Immunsystemet Metabolisme og ernæring Nervesystemet
English: 20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Danish: 20 mg/1 ml Hvert hætteglas med 1 ml koncentrat indeholder 0,5 ml vandfri ethanol (395 mg).
English: Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger efter behandling af prostatakræft med Taxespira 75 mg/m² i kombination med prednison eller prednisolon
English: 3 (see section 4.2).
Danish: 4.2 og 4.4).
English: Thrombocytopenia (G3/4:
Danish: Trombocytopeni (G4:
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Danish: Docetaxel i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystkræft, hvis tumorer var HER2-positive, og som ikke tidligere havde fået kemoterapi på grund af metastatisk sygdom.
English: Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: Taxespira i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m administered as a 30-minute to
Danish: • Induktionskemoterapi efterfulgt af kemo-strålebehandling (TAX 324) Til den indledende behandling af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) (ikke muligt at resektere, lav sandsynlighed for kirurgisk helbredelse samt med bevarelse af organer som mål) er den anbefalede dosis docetaxel 75 mg/m2 som en 1-times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m 2 administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m2 som en kontinuerlig infusion fra dag
English: Dyspnoea (severe:
Danish: Dyspnø (alvorlig: 2,7
English: Anorexia (G3/4: 0.6%)
Danish: Anoreksi (G3/4: 0,6 %)
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Danish: Tiden indtil progressiv sygdom var længere i kombinationsarmen med docetaxel + capecitabin
English: Tumour response rate (%) 95% CI p-value*
Danish: Tumor-responsrate (%) 95 % CI p-værdi*
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Danish: Bedste overordnede respons på forsøgsbehandling [kemoterapi +/- strålebehandling] (%) (95 % CI) ***p-værdi
English: Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Danish: Patienter, som får TAC, bør monitoreres omhyggeligt (se pkt.
English: Each ml of solution contains 20 mg of docetaxel (as trihydrate).
Danish: Hver ml opløsning indeholder 20 mg docetaxel (som trihydrat).
English: • chest tightness; difficulty in breathing
Danish: • trykken for brystet, vejrtrækningsbesvær
English: 160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg).
Danish: 160 mg/8 ml Hvert hætteglas med 8 ml koncentrat indeholder 4 ml vandfri ethanol (3160 mg).
English: Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
Danish: Svimmelhed (G3/4: 2,0 %); perifer motorisk neuropati (G3/4: 0,4 %)
English: • alteration in sense of taste
Danish: • smagsforstyrrelser
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Danish: Ved slutningen af kemoterapi fik patienter, hvis sygdomstilstand ikke var forværret, strålebehandling i 7 uger med et interval på mindst 4 uger og maksimalt 7 uger, udført efter fastlagte retningslinjer (TPF/RT).
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Danish: Ved slutningen af kemoterapi fik patienter, hvis sygdomstilstand ikke var forværret, strålebehandling i 7 uger med et interval på mindst 4 uger og maksimalt 7 uger, udført efter fastlagte retningslinjer (PF/RT).
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Danish: • ardannelse og fortykkelse i lungerne sammen med stakåndethed (lungefibrose)
English: 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/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Danish: docetaxel 75 mg/m 2 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, vinorelbin (V) 25 mg/m 2 administreret i løbet af 6
English: Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Danish: Letargi (G3/4: 19,0 %); feber (G3/4: 2,3 %);
English: 9.9%); Fluid retention (severe: 0.7%);
Danish: Asteni (alvorlig: 9,9 %); Væskeretention (alvorlig: 0,7 %);
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Danish: Du skal straks informere din læge, hvis du bliver gravid under behandlingen.
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m 2 i kombination med trastuzumab
English: Frequency of administration
Danish: Indgivelseshyppighed
English: Patients with hepatic impairment 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 2 (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 og af basisk fosfatase på mere end 2,5 gange den øvre normalværdi (se pkt.
English: For patients with serum bilirubin levels > ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Danish: For patienter med serum-bilirubin > øvre normalværdi og/eller ALAT og ASAT > 3,5 gange øvre normalværdi og basiske fosfataser > 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis.
English: 80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
Danish: 80 mg/4 ml Hvert hætteglas med 4 ml koncentrat indeholder 2 ml vandfri ethanol (1580 mg).
English: Weight increased (G3/4: 0%); Weight decreased (G3/4:
Danish: Vægtstigning (G3/4: 0 %); vægttab (G3/4:
English: versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Danish: Det primære endepunkt for effekt i dette studie (OS) var signifikant længere (log-rank-test, p=0,0058) i det regimen, der indeholdt docetaxel sammenlignet med PF (median OS: henholdsvis 70,6 vs. 30,1 måneder) med en reduktion af risikoen for mortalitet på 30 % sammenlignet med PF (hazard ratio (HR) = 0,70, 95 % konfidensinterval (CI) = 0,54-0,90) og med en samlet median opfølgningstid på 41,9 måneder.
English: Dose adjustments during treatment
Danish: Dosisjustering under behandling
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxespira administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Taxespira in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Danish: Du skal fortsætte med at tage præmedicineringen i yderligere 1 til 2 dage for at mindske visse bivirkninger, som kan opstå efter infusion af Taxespira.
English: In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Danish: I studiet TAX316 forekom amenorré i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 202 af 744 TAC patienter (27,2 %) og hos 125 af 736 FAC patienter (17,0 %).
English: Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Danish: Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning
English: Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Danish: Der kan opstå overfølsomhedsreaktioner kan opstå inden for få minutter efter infusion af docetaxel er påbegyndt.
English: Hypersensitivity (G3/4: 0.6%)
Danish: Overfølsomhed (G3/4: 0,6 %)
English: Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Danish: Bedste overordnede respons (CR + PR) på kemoterapi (%) (95 % CI) ***p-værdi
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Danish: Der er udført to randomiserede, sammenlignende fase III-studier med docetaxel doseret hver 3. uge i den anbefalede dosis på 100 mg/m² til patienter med metastatisk brystkræft.
English: Patients with liver impairment In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (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: Patienter med nedsat leverfunktion 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 fosfatase-værdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger.
English: Median OS (months) (95% CI)
Danish: Median OS (måneder) (95 % CI)
English: Third episode: reduce docetaxel dose by 20%.
Danish: Tredje episode: Reducer docetaxel-dosis med 20 %.
English: Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Danish: Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: 80mg/4 ml contains 4 ml of concentrate
Danish: 80 mg/4 ml indeholder 4 ml koncentrat.
English: Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Danish: Bedste overordnede respons (CR + PR) på forsøgsbehandling [kemoterapi +/- kemostrålebehandling] (%) (95 % CI) ***p-værdi
English: Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Danish: Taxespira i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har fået kemoterapi mod denne tilstand.
English: 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Danish: 20 mg/1 ml Et hætteglas med 1 ml koncentrat indeholder 20 mg docetaxel.
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Danish: Reaktioner på infusionsstedet; Ikkehjerterelaterede brystsmerter (alvorlig:
English: OS 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 efter 10 år var også signifikant forøget med TAC i forhold til FAC (henholdsvis 76 % vs. 69 %).
English: 140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel.
Danish: 140 mg/7 ml Et hætteglas med 7 ml koncentrat indeholder 140 mg docetaxel.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger efter behandling af gastrisk adenokarcinom med Taxespira 75 mg/m2 i kombination med cisplatin og 5-fluorouracil
English: G3/4 Blood alkaline phosphatase increased
Danish: G3/4 Forhøjet alkalisk fosfatase i blodet (< 2,5
English: • haemorrhage (bleeding)
Danish: • svamp i mundhulen (trøske)
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m
Danish: • For patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås.
English: In study TAX316, peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Danish: I studiet TAX316 forekom perifer sensorisk neuropati i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden hos 84 patienter (11,3 %) i TAC-armen og hos 15 patienter (2 %) i FAC-armen.
English: 160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel.
Danish: 160 mg/8 ml Et hætteglas med 8 ml koncentrat indeholder 160 mg docetaxel.
English: Patients with renal impairment There are no data available in patients with severely impaired renal function treated with docetaxel.
Danish: Der er ingen tilgængelige data vedrørende behandling med docetaxal af patienter med alvorligt nedsat nyrefunktion.
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Danish: Asteni, som forekom i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden og blev fortsat observeret hos 12 patienter (2,3 %) i TAC-armen og 4 patienter (0,8 %) i FAC-armen.
English: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Danish: Medmindre det er kontraindiceret, kan der til brystkræft og ikke-småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg pr. dag i 3 dage (f.eks. 8 mg 2 gange daglig).
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Danish: I studiet TAX 316 forekom lymfødemi i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 11 af 744 TAC patienter (1,5 %) og hos 1 af 736 FAC patienter (0,1 %).
English: Metabolism and nutrition disorders Nervous system disorders
Danish: Metabolisme og ernæring Nervesystemet
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4:
Danish: Vaskulære sygdomme Hedeture (G3/4: 0,5 %) Hypotension (G3/4: 0 %); flebitis (G3/4: 0
English: • difficulty or painful swallowing
Danish: • synkebesvær eller smerter ved synkning
English: Taxespira 20 mg/1 ml concentrate for solution for infusion
Danish: Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning
English: More than one vial of Taxespira concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Danish: For at kunne udtage den korrekte dosis til patienten kan det være nødvendigt at anvende mere end et hætteglas med Taxespira koncentrat til infusionsvæske, opløsning.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%)patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Danish: Efter 10 års opfølgning i GEICAM 9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2 %) patienter i TAC-armen.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger efter behandling af ikke-småcellet lungekræft med Taxespira 75 mg/m² i kombination med cisplatin
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Danish: Docetaxel blev elimineret både i urin og fæces efter cytocrom P-450-medieret oxidativ metabolisering af tert-butyl-estergruppen.
English: For more details see summary of product characteristics of trastuzumab.
Danish: Se produktresuméet for trastuzumab for yderligere oplysninger.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Danish: Letargi (G3/4: 3,4 %); pyreksi (G3/4: 0,6 %); væskeretention; ødem