FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Danish: Effekten af docetaxel i induktionsbehandling af patienter med inoperabel, lokalt fremskreden SCCHN (intent-to-treat-analyse)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Danish: Docetaxel påvirker ikke clearencen af doxorubicin eller plasmaniveauet af doxorubicinol (en doxorubicinmetabolit), når det anvendes i kombination.
English: Taxespira 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: Taxespira i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle-carcinoma i hoved og hals.
English: In non-clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Danish: Docetaxel har vist genotoksiske virkninger i ikke-kliniske studier og kan ændre fertiliteten hos hanner (se pkt.
English: G3/4 ALT increased
Danish: G3/4 Forhøjet ALAT
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Danish: Hazard ratio: 1,122 [97,2 % CI: 0,937; 1,342]* Behandlingsforskel: 5,4 % [95 % CI: -1,1; 12,0] Behandlingsforskel: 6,2 % [95 % CI: 0,2; 12,3]
English: Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Danish: Udtag aseptisk den ønskede mængde Taxespira koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21Gkanyle.
English: 95% CI p-value
Danish: 95 % CI p-værdi
English: G3/4 Blood bilirubin increased (<5%); G3/4 Blood alkaline phosphatase increased (<4%); G3/4 AST increased (<3%); G3/4 ALT increased (<2%)
Danish: G3/4 Forhøjet bilirubin i blodet (< 5 %); G3/4 Forhøjet alkalisk fosfatase i blodet (< 4 %); G3/4 Forhøjet ASAT (< 3 %); G3/4 Forhøjet ALAT (< 2
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 ciprofloxacin 500 mg oralt 2 gange dagligt i 10 dage, startende på dag 5 i hver cyklus, eller tilsvarende.
English: Taxespira 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: Taxespira i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastroøsofageale forbindelse, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: In addition, physical and chemical in-use stability of the infusion solution prepared as recommended in non-PVC bags or bottles has been demonstrated up to 48 hours when stored between 2°C to 8°C, and for up to 6 hours when stored below 25°C.
Danish: Desuden er den fysiske og kemiske stabilitet efter åbning af infusionsopløsningen, der er tilberedt efter anbefalingerne, påvist i poser uden indhold af PVC i op til 48 timer, når den opbevares ved mellem 2° C og 8° C, og i op til 6 timer, når den opbevares ved temperaturer under 25° C.
English: Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%)
Danish: Neutropeni (G4: 54,2 %); Anæmi (G3/4: 10,8 %); Trombocytopeni (G4: 1,7 %)
English: At the median follow-up time of 77 months, 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 opfølgningsperiode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, hvor TAC-behandlede patienter havde 24 % lavere risiko for dødsfald sammenlignet med FAC-behandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26, p = 0,29).
English: Pfizer AS Tlf: +47 67 52 61 00
Danish: Tlf: +47 67 52 61 00
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: Asthenia (severe:
Danish: Neglesygdomme (alvorlig:
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apotekspersonalet på hospitalet..
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Danish: Efter 10 års opfølgning i TAX 316-studiet blev akut leukæmi rapporteret hos 3 ud af 744 TACpatienter (0,4 %) og hos 1 ud af 736 FAC-patienter (0,1 %).
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 ciprofloxacin 500 mg oralt 2 gange dagligt i 10 dage, startende på dag 5 i hver cyklus, eller tilsvarende.
English: Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Danish: Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura- og perikardieekssudat, ascites og vægtøgning.
English: • bleeding from the nose
Danish: • næseblod
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Danish: G3/4 Forhøjet ASAT (0,5 %); G3/4 Forhøjet alkalisk fosfatase i blodet (0,3 %)
English: • For the treatment of lung cancer, Taxespira could be administered either alone or in
Danish: • Ved behandling af lungekræft kan Taxespira indgives enten alene eller i kombination med
English: G3/4 AST increased
Danish: G3/4 Forhøjet ASAT
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Danish: Reduktion af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
English: Its common name is docetaxel.
Danish: Lægemidlets handelsnavn er docetaxel.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Danish: Primær G-CSF-profylakse bør overvejes til patienter, som får adjuverende behandling med TAC for brystkræft, for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, forlænget neutropeni eller neutropenisk infektion).
English: Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin
Danish: Den anbefalede dosis af docetaxel er 75 mg/m2 som en 1-times infusion, efterfulgt af cisplatin 75
English: Myocardial ischemia (G3/4:1.7%)
Danish: Myokardieiskæmi (G3/4: 1,7 %)
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide (see section 4.8).
Danish: Ventrikulær arytmi inklusive ventrikulær takykardi (undertiden dødelig) er rapporteret hos patienter behandlet med docetaxel i kombinationsregimer inklusive doxorubicin, 5-fluorouracil og/eller cyclofosfamid (se pkt.
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Danish: • hudreaktioner på injektionsstedet, betændelse (flebitis) eller hævelse af venen
English: Data from a multicenter open label randomized trial support the use of Taxespira for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Danish: Data fra et åbent, randomiseret multicenterstudie understøtter anvendelsen af Taxespira som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapi.
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 rapporter om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutika og/eller strålebehandling.
English: Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Danish: Data fra et randomiseret, kontrolleret, klinisk fase 3-multicenterstudie understøtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokal fremskreden eller metastatisk brystkræft, hos hvem cytotoksisk kemoterapi med et anthracyklin har været uden effekt.
English: Description of selected adverse reactions for adjuvant therapy with Taxespira 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 Taxespira 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
English: 160mg/8 ml contains 8 ml of concentrate.
Danish: 160 mg/8 ml indeholder 8 ml koncentrat.
English: This regimen is administered every 3 weeks for 3 cycles.
Danish: Dette regimen administreres hver 3. uge i 3 cyklusser.
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Danish: • betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær (interstitiel lungesygdom).
English: This is equivalent to 80 ml of beer or 33 ml of wine.
Danish: Dette svarer til 80 ml øl eller 33 ml vin.
English: • 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).
Danish: • Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Docetaxels sikkerhed og effekt i induktionsbehandlingen af patienter med pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et åbent, randomiseret fase III-multicenterstudie (TAX 323).
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
Danish: Det blev observeret, at amenorré fortsatte ved afslutningen af opfølgningsperioden (median opfølgningstid på 8 år) hos 121 af 744 TAC-patienter (16,3 %) og hos 86 FAC-patienter (11,7 %).
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 4neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter, der fik primær GCSF-profylakse (se pkt.
English: 140mg/7 ml contains 7 ml of concentrate.
Danish: 140 mg/7 ml indeholder 7 ml koncentrat.
English: 20mg/1 ml contains 1 ml of concentrate.
Danish: 20 mg/1 ml indeholder 1 ml koncentrat.
English: • For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Ved behandling af hoved- og halskræft kan Taxespira indgives i kombination med cisplatin og 5-fluorouracil.
English: In case of
Danish: I alt
English: Dehydration (G3/4: 2%)
Danish: Dehydrering (G3/4: 2 %)
English: Lacrimation increased; Conjunctivitis
Danish: Øget tåreflåd; konjunktivitis
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: På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % vs. 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: kongestivt hjertesvigt (3,8 % vs. 2,8 %), absolut LVEF-nedsættelse > 20 % (13,1 % vs. 6,1 %), absolut LVEF-nedsættelse > 30 % (6,2 % vs. 1,1 %).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Danish: • Induktionskemoterapi efterfulgt af kemo-strålebehandling (TAX 324)
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Danish: Neutropeni (G3/4: 32 %); anæmi (G3/4: 4,9 %)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5.
Danish: Patienter i komparator-armen fik cisplatin (P) 100 mg/m² administreret som en 30 minutter til 3 timers intravenøs infusion på dag 1 efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil (F) 1.000 mg/m²/dag fra dag 1 til dag 5.
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m² hver 3. uge).
English: • 258 patients who received docetaxel in combination with doxorubicin.
Danish: • 258 patienter, som fik docetaxel i kombination med doxorubicin.
English: Infection (G3/4: 3.3%)
Danish: Infektion (G3/4: 3,3 %)
English: Taxespira in combination with platinum agents in chemotherapy-naïve patients 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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Danish: Taxespira i kombination med platinmidler til patienter, der ikke tidligere behandlet med kemoterapi 1,218 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/m 2 administreret i løbet af 30-60 minutter hver 3. uge (TCis),
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Danish: Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m² ved intravenøs infusion på dag 1 efterfulgt af cisplatin (P) 100 mg/m² administreret som en 30 minutter til 3 timers intravenøs infusion efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil(F) 1.000 mg/m²/dag fra dag 1 til dag 4.
English: This is equivalent to 10 ml of beer or 4 ml of wine.
Danish: Dette svarer til 10 ml øl eller 4 ml vin.
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 prostatakræft er det anbefalede præmedicineringsregimen, 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: After opening of the vial
Danish: Efter anbrud af hætteglasset
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Luftveje, thorax og mediastinum
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: Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med kontrolarmen på mitoxantron.
English: G3/4 Blood bilirubin increased (<2.5%);
Danish: G3/4 Forhøjet bilirubin i blodet (< 2,5 %);
English: If Taxespira concentrate should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis koncentratet med Taxespira kommer i kontakt med slimhinder, afvaskes området straks grundigt med vand.
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: A multicenter, open-label, randomized 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 åbent, randomiseret multicenterstudie blev gennemført for at undersøge sikkerheden og effekten af docetaxel til behandling af patienter med metastatisk gastrisk adenokarcinom, herunder adenokarcinom i den gastroøsofageale forbindelse.
English: • operable node-positive breast cancer
Danish: • operabel, lymfeknude-positiv brystkræft • operabel, lymfeknude-negativ brystkræft
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Danish: , og mediantiden indtil reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger).
English: PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL TAXESPIRA 20 KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Danish: Udvikling af svær perifer neurotoksicitet kræver reduktion af dosis (se pkt.
English: G3/4 Blood bilirubin increased (<2%)
Danish: G3/4 Forhøjet bilirubin i blodet (< 2 %)
English: • heart failure
Danish: • hjertesvigt
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 apotekspersonalet på hospitalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Danish: Første episode: Reducer docetaxel- og 5-FU-dosis med 20 %.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Taxespira 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Danish: Tabel over bivirkninger ved adjuverende behandling med Taxespira 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - samlede data
English: Pack size:
Danish: Pakningsstørrelse:
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 efter 10 år var reduceret hos de patienter, som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % vs. 45 %).
English: 120mg/6 ml contains 6 ml of concentrate.
Danish: 120 mg/6 ml indeholder 6 ml koncentrat.
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
Danish: Synkope (G3/4: 0 %); neurotoksicitet (G3/4: 0 %); somnolens (G3/4:
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 fosfatase > 2,5 x ULN og bilirubin > 1 x ULN.
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 PR+ tumorer 20 mg tamoxifen én gang dagligt i op til 5 år efter den sidste kemoterapicyklus.
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Danish: Resumé af sikkerhedsprofilen for alle indikationer De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos:
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis det kommer i kontakt med slimhinder, afvaskes området straks grundigt med vand.
English: 140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg).
Danish: 140 mg/7 ml Hvert hætteglas med 7 ml koncentrat indeholder 3,5 ml vandfri ethanol (2765 mg).
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Danish: Ved den mediane opfølgningsperiode på 10 år og 5 måneder havde TAC-behandlede patienter en 9 % lavere risiko for dødsfald sammenlignet med FAC-behandlede patienter (hazard ratio = 0,91; 95 % CI
English: Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Danish: Hætteglas med 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml og 160 mg/8 ml fås i pakninger med et enkelt hætteglas.
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Danish: Smerter i ekstremiteter (G3/4: < 1 %); rygsmerter (G3/4: 1 %)
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Danish: Behandling med docetaxel bør gentages, når neutrofiltallet igen er ≥ 1.500 celler/mm