natgillin/translations-raw huggingface dataset:
Patienter i begge behandlingsarme skulle have 7 ugers CRT efterfulgt af induktionskemoterapi med et mindsteinterval på 3 uger og ikke senere end 8 uger efter starten af den sidste cyklus (dag 22-56 i den sidste cyklus).
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Patienter, der fik docetaxel hver 3. uge, udviste signifikant længere total overlevelse end patienter, der blev behandlet med mitoxantron.
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Patienter med operabel lymfeknude-positiv brystcancer (TAX 316)
Patients with operable node-positive breast cancer (TAX 316)
Det sekundære endepunkt, progressionsfri overlevelse (PFS), viste 29% reduktion i risikoen for progression eller død og en 22 måneders forbedring i median PFS (35,5 måneder for TPF og 13,1 for PF).
The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Dette regime blev indgivet hver 3. uge i 4 cyklusser i tilfælde, hvor der som mindstemål blev observeret mindre respons (≥ 25% reduktion i den bidimensionalt målte tumorstørrelse) efter 2 cyklusser.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Med primær G¬CSF profylakse (n = 421) n (%)
With primary G-CSF prophylaxis (n = 421) n (%)
Ethanol, vandfri Polysorbat 80
Ethanol anhydrous Polysorbate 80
Mængden af alkohol i dette lægemiddel kan nedsætte patientens evne til at køre bil og betjene maskiner.
The amount of alcohol in this medicinal product may impair the patients ability to drive or use machines.
En patient i TAC-armen døde af dilateret kardiomyopati.
One patient in TAC arm died because of dilated cardiomyopathy.
Total responsrate (CR+PR) (%) p-værdi
Overall response rate (CR+PR) (%) p-value
Ved kombination med docetaxel, var clearence ca. 50% højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 34 = G3/4; grad 4 = G4), COSTART-termerne og MedDRA-termerne.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
• Tid til progression (TTP) var væsentlig længere i AT-armen end i AC-armen, p = 0,0138.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Tumorresponsrate (%) 95% CI p-værdi* † Stratificeret log-rank test *Tærskel for statistisk signifikans = 0,0175 **PSA: Prostataspecifikt antigen
Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
Behandlingsforskel: 6,2% [95% CI: 0,2; 12,3]
Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Hver æske indeholder 1 eller 5 hætteglas.
Each box contains 1 or 5 vials.
• pneumoni (lungebetændelse)
• pneumonia (infection of the lungs)
Post-Menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC.
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Hypersensitivitet (ikke alvorlig)
Hypersensitivity (no severe)
Citronsyre (til pH-justering)
Citric acid (pH adjustment)
• 1312 og 121 patienter, som fik henholdsvis 100 mg/m² og 75 mg/m² af docetaxel som enkeltstof.
• 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Docetaxel Mylan indeholder alkohol.
Docetaxel Mylan contains alcohol.
Patienter behandlet med TPF oplevede signifikant mindre forværring af deres globale sundhedsscore sammenlignet med patienter behandlet med PF (p = 0,01 ved brug af EORTC QLQ-C30-skalaen).
Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
I et fase III-studie med tidligere behandlede patienter var tid til progression (12,3 uger mod 7 uger) og den totale overlevelse signifikant længere for docetaxel ved 75 mg/m² end for bedste understøttende behandling.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
• Hvert hætteglas er til engangsbrug og skal anvendes straks efter åbning.
• Each vial is for single use and should be used immediately after opening.
ANVEND IKKE anden docetaxelmedicin, der består af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Mylan koncentrat til infusionsvæske, opløsning, der består af 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Mylan concentrate for solution for infusion, which contains only 1 vial).
Toksisk død forekom hos en patient i AT-armen (kongestivt hjertesvigt) og hos fire patienter i AC-armen (1 på grund af septisk chok og 3 på grund af kongestivt hjertesvigt).
Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Alle patienter uden progressiv sygdom skulle have CRT i henhold til protokollen (PF/CRT).
All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
De mest almindeligt rapporterede bivirkninger med docetaxel alene var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm
Klar til tilsætning til infusionsvæske.
Ready to add to infusion solution.
Patienter, der blev behandlet med TCF, havde længere tid til 5% definitiv forværring af den globale sundhedsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og længere tid til definitiv forværring af Karnofsky Performance Status (p = 0,0088) sammenlignet med patienter behandlet med CF.
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Docetaxel er et antineoplastisk stof, som virker ved at fremme polymerisering af tubulin til stabile mikrotubuli og hæmme deres depolymerisering, hvilket fører til et udtalt fald i fri tubulin.
Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Den anden interimanalyse blev udført efter optagelse af i alt 400 sygdomsfri overlevelser (DFS), hvilket førte til en medianopfølgningstid på 55 måneder.
The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Fordelingen af TAC-behandlede patienter i forhold til prospektivt definerede, væsentlige prognostiske faktorer er analyseret som følger:
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Docetaxel har in vitro vist sig at forstyrre det mikrotubulære netværk i celler, som er essentielle for vital mitose og cellefunktioner i interfasen.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Docetaxels kinetiske profil er dosisuafhængig og i overensstemmelse med en 3-compartment farmakokinetisk model med halveringstider for α, β og γ-faserne på henholdsvis 4 minutter, 36 minutter og 11,1 timer.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1.000 mg/m² og median-tiden til reversibilitet af væskeretention var 16,4 uger (varighed 0 til 42 uger).
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m² and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
• Total responsrate (ORR) var væsentlig højere i AT-armen end i AC-armen, p = 0,009.
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Der blev påvist signifikant længere sygdomsfri overlevelse for TAC-armen sammenlignet med FAC-armen.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
De efterfølgende docetaxel-doser blev givet umiddelbart efter ophør af trastuzumab-infusionen, hvis trastuzumab-infusionen var veltolereret.
The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
2Estimeret medianoverlevelse
2 Estimated median survival
Docetaxel Mylan gives som infusion i en vene (intravenøs anvendelse).
Docetaxel Mylan will be given by infusion into one of your veins (intravenous use).
Du må ikke amme, mens du behandles med Docetaxel Mylan.
You must not breast-feed while you are treated with Docetaxel Mylan.
I ca 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatacancerstudie, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Der er rapporteret meget sjældne tilfælde af hepatitis, som hos primært patienter med kendt leversygdom i nogle tilfælde har været dødelig.
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Der er ikke udført studier af virkningen på evnen til at føre motorkøretøj ogbetjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Prednisons virkning på docetaxels farmakokinetik indgivet med standard præmedicinering med dexamethason er undersøgt hos 42 patienter.
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
For patienter med operabel lymfeknude-negativ brystcancer bør adjuverende behandling begrænses til patienter egnet til at få kemoterapi ifølge etablerede nationale kriterier for primær behandling af tidlig brystkræft (se pkt.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Febril neutropeni og neutropenisk infektion blev set hos hhv. 17,2% og 13,5% af patienterne, uanset om der var brugt G¬CSF.
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Dog induceredes ingen mutagenitet i Ames test eller i en CHO/HGPRRT genmutationsassay.
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
I forbindelse med strålebehandling blev der indgivet en ugentlig dosis carboplatin (AUC 1,5) som en intravenøs infusion over en time med maksimalt 7 doser.
During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Total overlevelse var også signifikant længere (p = 0,0201) til fordel for TCF-armen med en reduktion af risikoen for mortalitet på 22,7%.
Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
I studiet TAX 316 blev alopeci, der persisterede ind i followup-perioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter og hos 645 ud af 736 FAC-patienter.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
Tre af patienterne (2%), som fik docetaxel, afbrød behandlingen på grund af væskeretention, mens 15 af patienterne (9%), som fik doxorubicin, afbrød behandlingen på grund af hjertetoksicitet (tre tilfælde af kongestivt hjertesvigt med dødelig udgang).
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Den endelige analyse blev udført, da alle patienter havde nået deres 10 års followup-besøg (medmindre de havde DFS-hændelse eller udgik tidligere fra followup).
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 followup before).
Betændelse i lungerne kan også udvikles, når docetaxelbehandling anvendes sammen med strålebehandling)
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Docetaxel Mylan er ordineret af din læge til behandling af brystkræft, specielle former for lungekræft (ikke-småcellet lungekræft), prostatakræft, gastrisk kræft eller hoved- og halskræft: - Ved behandling af fremskreden brystkræft kan docetaxel enten indgives alene eller i kombination med doxorubicin, trastuzumab eller capecitabin.
Docetaxel Mylan has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
De totale objektive responsrater i den randomiserede patientgruppe (investigators vurdering) var 41,6% (docetaxel + capecitabin) mod 29,7% (docetaxel alene), p = 0,0058.
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Reaktionerne var karakteriseret ved udslæt inklusive lokale udbrud, hovedsagelig på fødder og hænder (inklusive svært hånd- og fodsyndrom), men også på arme, ansigt og thorax.
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Forekomsten af febril neutropeni/neutropenisk sepsis var også forhøjet hos de patienter, der fik behandling med Herceptin plus docetaxel (23% versus 17% for de patienter, der fik behandling med docetaxel alene).
The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Febril neutropeni og neutropenisk infektion forekom hos hhv. 12,1% og 3,4% af patienterne, når patienterne havde fået profylaktisk G¬CSF, og hos hhv. 15,6% og 12,9% af patienterne, der ikke havde fået profylaktisk G¬CSF (se pkt.
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Fortæl din læge, hvis du er afhængig af alkohol, eller hvis du har nedsat leverfunktion.
Discuss with your doctor if you suffer from alcohol dependency or liver impairment.
Perifer sensorisk neuropati fortsatte ved opfølgning hos 10 patienter ud af 84 patienter med perifer sensorisk neuropati ved slutningen af kemoterapien i det lymfeknude-positive brystcancer-studie (TAX 316).
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Den etårige overlevelsesrate var ligeledes signifikant længere med docetaxel (40%) i forhold til bedste understøttende behandling (16%).
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Patienter, som får grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m².
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TACpatienter og hos 1 ud af 736 FAC-patienter.
Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Alle tre regimer blev indgivet kontinuerligt i kombination med 5 mg prednison eller prednisolon 2 gange dagligt..
All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Ved en hazard ratio på < 1 kan docetaxel + cisplatin + fluoruracil anvendes med fordel *ikke-justeret log-rank test **ikke-justeret log-rank test, ikke justeret for flere sammenligninger ***Chi square-test, ikke justeret for flere sammenligninger NA - ej relevant
A Hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Docetaxel Mylan koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added to the infusion solution.
Forekomsten af de følgende bivirkninger (alle grader): lethargi, stomatitis, neutropenisk infektion opstod ≥ 10% oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
I docetaxel - plus trastuzumabarmen, havde 64% modtaget en tidligere behandling med antracyklin som adjuverende behandling sammenlignet med 55% i docetaxel-armen alene.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Hvis du er mand og i behandling med Docetaxel Mylan, rådes du til ikke at blive far til et barn under og 6 måneder efter behandling og til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel kan nedsætte den mandlige fertilitet.
If you are a man being treated with Docetaxel Mylan 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.
Der er rapporteret meget sjældne tilfælde af kutan lupus erythematosus og bulløse udbrud som f.eks. erythema multiforme, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse i forbindelse med docetaxel.
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.
Blandt 300 patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som fik behandling med docetaxel i kombination med cisplatin og 5-fluoruracil i studiet af gastrisk cancer, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Dyspnø (alvorlig: 2,7%)
Dyspnoea (severe: 2.7%)
In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således kan hæmme enzymet kompetitivt) af CYP3A, f.eks ciclosporin, ketokonazol og erythromycin.
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin .
Der er ingen relevant anvendelse af docetaxel i den pædiatriske population til indikationerne brystcancer, ikke-småcellet lungecancer, prostatacancer, gastrisk karcinom samt hoved-halscancer med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom.
There is no relevant use of docetaxel in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Symptomatisk hjertesvigt blev rapporteret hos 2,2% af patienterne, som modtog docetaxel plus trastuzumab i forhold til 0% af de patienter, som fik docetaxel alene.
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Medianoverlevelse var 442 dage (docetaxel + capecitabin) mod 352 dage (docetaxel alene).
Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Amenoré fortsatte ved opfølgning hos 121 patienter ud af 202 patienter med amenoré ved slutningen af kemoterapien i studiet TAX 316.
Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Ved den mediane followup-periode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Patienterne præmedicineres med antiemetika og passende hydrering ved administration af cisplatin.
Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.