natgillin/translations-raw huggingface dataset:
Den endelige analyse blev udført, da alle patienter havde nået deres 10 års opfølgningsbesøg (medmindre de havde en DFS hændelse eller tidligere udgik af opfølgning).
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).
Der er gennemført et studie med 14C-mærket docetaxel på 3 kræftpatienter.
A study of 14C-docetaxel has been conducted in three cancer patients.
Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m2 og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 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).
Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3compartment farmakokinetisk model, med halveringstider for ,  og  faserne på henholdsvis 4 min., 36 min. og 11,1 time.
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.
Patienter, som tidligere har haft en overfølsomhedsreaktion over for paclitaxel, kan være i risiko for at udvikle overfølsomhedsreaktion over for docetaxel, inklusive mere alvorlige overfølsomhedsreaktioner.
Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Overfølsomhedsreaktioner (hyppighed ikke kendt) er rapporteret for docetaxel hos patienter, der tidligere har haft overfølsomhedsreaktioner over for paclitaxel.
Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
• hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i Docetaxel Accord (angivet i punkt 6),
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
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)
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Dette skal tages i betragtning hos gravide eller ammende, hos børn samt hos patienter i højrisikogrupper såsom patienter med leversygdomme samt epilepsi.
To be taken into account in pregnant or breast-feeding, in children and high-risk groups such as patients with liver disease, or epilepsy.
Docetaxel Accord gives som infusion i en blodåre (intravenøs anvendelse).
Docetaxel Accord will be given by infusion into one of your veins (intravenous use).
Forekomsten af de følgende bivirkninger (alle grader): Letargi, 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.
Præparer infusionsopløsningen efter retningslinjerne.
Prepare the infusion solution as recommended.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25C.
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af CYP3A, f.eks ciclosporin, ketoconazol 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, erythromycin.
Se også punktet ”Docetaxel Accord indeholder ætanol (alkohol)” nedenfor.
See also section “Docetaxel Accord contains ethanol (alcohol)” below.
Den mængde alkohol, som dette lægemiddel indeholder, kan nedsætte din evne til at køre bil eller betjene maskiner.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
I et fase III-studie med tidligere behandlede patienter var tid til progression (12,3 uger vs. 7 uger) og den samlede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m2 end for bedste palliative 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
Ames test eller i en CHO/HGPRT gen mutation assay.
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var  10 % højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
TTP-medianen var 37,3 uger (95 %CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 %CI: 27,4 - 36,0) i AC-armen.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
I denne studie blev 358 patienter med inoperabelt, lokalt fremskreden SCCHN og WHO funktionsstatus 0 eller 1, randomiseret i en af to behandlingsarme.
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomised to one of two treatment arms.
• Ventrikulær arytmi eller ventrikulær takykardi (manifesteret som uregelmæssig og / eller hurtig hjerterytme, alvorlig åndenød, svimmelhed og / eller besvimelse).
• ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat,
Hvis du er mand og i behandling med docetaxel, rådes du til ikke at avle et barn under og 6 måneder efter behandling samt 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 Accord 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.
Navn og adresse på de fremstilleren, der er ansvarlige for batchfrigivelse
Name and address of the manufacturer responsible for batch release
lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år).
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold, og lægemidlet bør anvendes umiddelbart herefter.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Alvorligheden af bivirkningerne ved docetaxel kan forøges, når docetaxel gives i kombination med andre kemoterapeutiske lægemidler.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Docetaxel blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusiv brændende fornemmelser.
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Vær særlig opmærksom på at informere din læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelser eller feber, og giv lægen resultatet af dine blodprøver.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give any results of your blood tests to your doctor.
Ved den mediane opfølgningsperiode 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.
Docetaxel som enkeltstof
Docetaxel as single agent
Docetaxel Accord i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen- og/eller progesteron-receptorer tamoxifen 20 mg daglig i op til 5 år.
In both arms, after the last cycle of chemotherapy, patients with positive oestrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER CYTOTOKSISK
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med lægemidlet og i forbindelse med overfølsomheds-reaktioner.
Eye disorders Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystkræft (intent-to-treat-analyse)
Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (Intent-to-treat analysis)
• Docetaxel 30 mg/m2 administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i 5
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracycline (doxorubicin eller epirubicin).
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin) -containing chemotherapy.
95 %CI p-værdi†*
95% CI p-value†*
• 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret).
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9,805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
†Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.g/ml.
Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-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.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m2 compared to those with BSC.
Hjælpestoffer: Polysorbat 80, vandfri ætanol (se indlægssedlen for yderligere information) og vandfri citronsyre.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid anhydrous.
Docetaxel Accord koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
Docetaxel Accord concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Docetaxel Accord indeholder ætanol (alkohol)
Docetaxel Accord contains ethanol (alcohol)
Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TAC-patienter (0,3 %) og hos 1 ud af 735 FAC-patienter (0,1 %).
Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m2 givet som enkeltstof.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m2 as a single agent.
Der er ingen relevant anvendelse af docetaxel i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk karcinom samt hoved- og halskræft 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.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium.
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 multicentre phase III study.
cyster og polypper) Anden primær malignitet (hyppighed ikke kendt), herunder non-Hodgkin lymfom, er blevet rapporteret, når docetaxel blev givet i kombination med andre anticancer behandlinger, der vides at være forbundet med anden primær malignitet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Et stort randomiseret fase III-studie, med 429 tidligere ubehandlede patienter med metastatisk sygdom, er blevet udført med doxorubicin (50 mg/m2) i kombination med docetaxel (75 mg/2) (AT arm) versus doxorubicin (60 mg/m2) i kombination med cyclophosphamid (600 mg/m2) (AC arm).
One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m2) in combination with docetaxel (75 mg/m2) (AT arm) versus doxorubicin (60 mg/m2) in combination with cyclophosphamide (600 mg/m2) (AC arm).
Docetaxel er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af Docetaxel Accord-opløsningerne.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Accord solutions.
I nogle tilfælde (hyppighed ikke kendt) er der observeret permanent hårtab
In some cases (frequency not known)
Tabellen nedenfor viser, at hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-studiet.
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm-GEICAM study.
Infusionsopløsningen må ikke være forbundet med infusionssættet i mere end 6 timer ved 25 °C.
The infusion solution must not be coupled to the infusion set for more than 6 h at 25°C.
Blandt de patienter, der fik docetaxel hver tredje uge, var hyppigheden af relaterede negleforandringer  10 % højere i patientgruppen på 65 år og derover, end i gruppen af yngre patienter.
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Et åbent multicenter randomiseret fase III-studie blev udført for at sammenligne docetaxel monoterapi med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin.
An open-label, multicentre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Docetaxel Accord må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
Docetaxel Accord must NOT be administered if you are pregnant unless clearly indicated by your doctor.
De mest almindelige bivirkninger af docetaxel givet alene er: Fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
The most commonly reported adverse reactions of docetaxel alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Patienter, som får febril neutropeni og/eller neutropenisk infektion bør have deres docetaxel-dosis reduceret til 60 mg/m2 i alle efterfølgende cykler (se pkt.
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal pakninger med Docetaxel Accord koncentrat til infusionsvæske, opløsning, stå ved stuetemperatur (under 25°C) i 5 minutter før brug.
If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel Accord concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
449 patienter blev randomiseret til enten at modtage docetaxel monoterapi 100 mg/m2 givet som 1 times infusion eller paclitaxel 175 mg/m2 givet som en infusion over 3 timer.
A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion.
Docetaxel Accord i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
DATO FOR ÆNDRING AF TEKSTEN Yderligere information om Docetaxel Accord findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
• Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder, kan docetaxel anvendes i kombination med doxorubicin eller cyclophosphamid.
- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide.
Koncentratet er en klar, lys gul til brunliggul opløsning.
The concentrate is a clear pale yellow to brownish-yellow solution.
Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 10 år og 5 måneder) havde ingen patienter CHF i TAC-armen og 1 patient i TACarmen døde af dilateret kardiomyopati, og det blev observeret at CHF fortsatte hos 1 patient (0,2 %) i FAC-armen.
At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75 % hos patienter på 60 år eller ældre (Se: Produktresumé for capecitabin) .
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).
Den nødvendige mængde Docetaxel Accord koncentrat til infusionsvæske, opløsning, skal via en enkelt injektion (et skud) injiceres i en 250 ml infusionspose indeholdende enten en 5 % glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske.
The required volume of Docetaxel Accord concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
INFORMATION I BRAILLE SKRIFT Fritaget fra krav om brailleskrift.
INFORMATION IN BRAILLE Justification for not including Braille accepted.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Docetaxel Accord i alle undergrupper af den pædiatriske population med brystkræft, ikkesmåcellet lungekræft, prostatakræft, gastrisk adenokarcinom og hoved- og halskræft med undtagelse af type II og type III lavt differentieret nasofaryngealt karcinom (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Docetaxel Accord in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Medicinen hedder Docetaxel Accord.
The name of this medicine is Docetaxel Accord.
Docetaxel i kombination med doxorubicin
Docetaxel in combination with doxorubicin
Bør overvejes hos gravide og ammende kvinder, børn samt patienter i høj-risiko grupper såsom patienter med leversygdomme same epilepsi.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Som ved alle andre parenterale lægemidler skal Docetaxel Accord infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal kasseres.
As with all parenteral products, Docetaxel Accord infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Anden episode: Reducer så docetaxel-dosis med 20 %
Second episode: then reduce docetaxel dose by 20%.