natgillin/translations-raw huggingface dataset:
Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdomsfri 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.
For opbevaringsforhold for det fortyndede lægemiddel, se pkt.
For storage conditions of the diluted medicinal product, see section 6.3.
Koncentratet er en svagt gul til brun-gul opløsning.
The concentrate is a pale yellow to brownish-yellow solution.
Patienter uden progressiv sygdom skulle have (CRT) ifølge protokollen (PF/CRT).
All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Medianoverlevelsen var 442 dage (docetaxel + capecitabin) vs. 352 dage (docetaxel alene).
Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Adjuverende stråleterapi blev givet i henhold til eksisterende vejledninger i de deltagende centre og blev givet til 69 % af patienterne, som fik TAC, og 72 % af patienterne, som fik FAC.
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69 % of patients who received TAC and 72% of patients who received FAC.
Hos patienter i behandling med TAC-regimenet for lymfeknude-positiv brystkræft har risikoen for CHF vist sig at være højere i det første år efter behandling (se pkt.
In patients treated with the TAC regimen for node positive breast cancer, the risk of CHF has been shown to be higher during the first year after treatment (see sections 4.8 and 5.1).
Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale.
Some cases of anaphylactic shock, sometimes fatal, have been reported.
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 kræft, 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.
I tilfælde af efterfølgende episoder med kompliceret neutropeni bør dosis af docetaxel reduceres fra 60 mg/m til 45 mg/m 2.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Stomatitis/mucositis grad 3 Første episode: Reducer 5-FU-dosis med 20 %.
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Der blev påvist signifikant længere sygdomsfri overlevelse i TAC-armen end i FAC-armen.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
• betændelse i øjet eller øget tåreflåd
• inflammation of the eye or increased tearing of the eyes
Docetaxel øgede responsraten (33 % vs. 12 %, p < 0,0001), forlængede tiden til progression (19 uger vs. 11 uger, p = 0,0004) og forlængede overlevelsen (11 måneder vs. 9 måneder, p = 0,01).
Docetaxel increased response rate (33% vs. 12%, p <0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged OS (11 months vs. 9 months, p = 0.01).
De mest almindeligt indberettede bivirkninger af Taxespira alene er: fald i antallet af røde og hvide blodlegemer, hårtab (alopeci), kvalme, opkastning, sår i munden, diarré og træthed.
The most commonly reported adverse reactions of Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Taxespira i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Akut respiratorisk distress syndrom og tilfælde af interstitiel pneumoni/pneumonitis, interstitiel lungesygdom, lungefibrose og respirationssvigt, sommetider fatale, er rapporteret sjældent.
Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
I dette studie blev 358 patienter med inoperabel, lokalt fremskreden SCCHN og WHO performance status 0 eller 1 randomiseret til en af to behandlingsarme.
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
Alvorlige reaktioner var kendetegnet ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erytem (se pkt.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Dehydrering og lungeødem er sjældent rapporteret.
Dehydration and pulmonary oedema have rarely been reported.
Til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft er den anbefalede dosis docetaxel i monoterapi 100 mg/m 2.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
• Hos patienter, der første gang udvikler grad 2-toksicitet, der vedvarer til tidspunktet for den næste behandling med docetaxel/capecitabin, skal behandlingen udsættes, indtil toksiciteten er grad 0-1, og derefter genoptages som 100 % af den oprindelige dosis.
• For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
Fordeling Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time blev en gennemsnitlig, maksimal plasmakoncentration på 3,7 µg/ml opnået med et tilsvarende AUC på 4,6 t.µg/ml.
Distribution 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.
Median OS var også signifikant længere til fordel for TPF-armen sammenlignet med PF-armen (median OS: henholdsvis 18,6 og 14,5 måneder) med en reduktion af risikoen for mortalitet på 28 %, p = 0,0128.
Median OS was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Taxespira som enkeltstof
Taxespira as single agent
Hvert hætteglas er til engangsbrug og bør anvendes umiddelbart efter anbrud.
Each vial is for single use and should be used immediately after opening.
Der er rapporteret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet), typisk forekommende under infusion af lægemidlet og i forbindelse med overfølsomhedsreaktioner.
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.
Docetaxels plasmaproteinbinding er over 95 %.
Docetaxel is more than 95% bound to plasma proteins.
For eksempel vil en dosis på 140 mg docetaxel kræve 7 ml Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning.
For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion.
Docetaxel har vist sig at være mutagent in vitro i mikronukleus- og kromosom-aberrationstesten i CHO-K1 celler samt in vivo i mikronukleustesten i mus.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Patienter med et neutrofiltal ved baseline på < 1.500 celler/mm
Patients with baseline neutrophil count of <1,500 cells/mm
Øsofagitis (alvorlig:
Oesophagitis (severe:
Docetaxel + trastuzumab var effektivt til patienterne, uanset om de havde fået adjuverende anthracyclin eller ikke.
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
• maveproblemer, herunder kvalme, opkastning og diarré, forstoppelse
• stomach upsets including nausea, vomiting and diarrhoea, constipation
Adjuverende strålebehandling blev administreret i henhold til retningslinjerne for de deltagende behandlingssteder og blev givet til 57,3 % af de patienter, der fik TAC, og til 51,2 % af de patienter, der fik FAC.
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3 % of patients who received TAC and 51.2 % of patients who received FAC.
Der er ingen relevant anvendelse af Taxespira 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 Taxespira in the paediatric population for the indication of 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.
ORR var 59,3 % (95 % CI: 52,8 - 65,9) i AT-armen vs. 46,5 % (95 % CI: 39,8 - 53,2) i AC-armen.
The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in
• blodpropper.
• blood clots.
mg/m2 (TAC-arm) eller doxorubicin 50 mg/m 2, efterfulgt af fluoruracil 500 mg/m2 (FAC-arm).
50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
I behandlingsarmen på docetaxel plus trastuzumab havde 64 % fået tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55 % i behandlingsarmen på docetaxel alene.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Med en hazard ratio på under 1 kan docetaxel + cisplatin + 5-FU anvendes med fordel *Cox-model (justering for primært tumorsted, kliniske T- og N-stadier og PSWHO) **Log-rank-test *** Chi-kvadrat-test
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
• lungebetændelse (pneumoni)
• pneumonia (infection of the lungs)
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret fase III-multicenterstudie.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Docetaxel er et antineoplastisk stof, og ligesom andre potentielt toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningerne.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Ydre karton
Outer Carton
Patienter, der tidligere har fået behandling med kemoterapi med eller uden strålebehandling I et fase III-studie med tidligere behandlede patienter var tiden indtil progression (12,3 uger vs. 7 uger) og den overordnede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/m² end for bedste palliative behandling.
Patients previously treated with chemotherapy with or without radiotherapy In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Patienter med 4+ lymfeknuder
Patients with 4+ nodes
Hjælpestoffer: polysorbat 80, vandfri ethanol (læs indlægssedlen for yderligere information), citronsyremonohydrat.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Der blev udført eksplorative undergruppeanalyser af sygdomsfri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT-population).
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Taxespira er et antineoplastisk stof, og ligesom andre potentielt toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningerne med Taxespira.
Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions.
Hvis samtidige anvendelse af en potent CYP3A4-hæmmer (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) ikke kan undgås, er tæt klinisk overvågning nødvendig, og dosisjustering af docetaxel kan være hensigtsmæssig under behandling med potente CYP3A4-hæmmere (se pkt.
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m som 1 times intravenøs infusion hver 3. uge).
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
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 her/him the results of your blood tests.
Til prostatakræft er præmedicineringen oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusionen (se 4.2).
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316) Data fra et åbent, randomiseret multicenterstudie understøtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS ≥ 80 % i alderen 18 til 70 år.
Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥80%, between 18 and 70 years of age.
Taxespira indeholder:
What Taxespira contains
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)
Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (kumulativ mediandosis: 818,9 mg/m 2) med præmedicinering sammenlignet med patienter uden præmedicinering (kumulativ mediandosis: 489,7 mg/m2).
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Bivirkningerne af docetaxel kan blive mere alvorlige, når docetaxel gives i kombination med andre kemoterapeutiske midler.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
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) vs. doxorubicin (60 mg/m²) i kombination med cyclophosphamid (600 mg/m²) (AC-arm).
One large randomized 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).
I studiet TAX 316 fik 26 patienter (3,5 %) i TAC-armen og 17 patienter (2,3 %) i FAC-armen kongestivt hjertesvigt.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Efter den sidste cyklus af kemoterapi fik patienter i begge arme, der havde positive østrogen- og/eller progesteronreceptorer, tamoxifen 20 mg dagligt i op til 5 år.
In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Begge regimener blev administreret på dag 1 hver 3. uge.
Both regimens were administered on day 1 every 3 weeks.
Begge regimener blev administreret hver 3. uge.
Both regimens were administered every 3 weeks.
• 1.276 patienter (744 og 532 i henholdsvis TAX 316 og GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclophosphamid (klinisk relevante behandlingsrelaterede
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Der foreligger ingen data for patienter med nedsat leverfunktion, der får kombinationsbehandling med docetaxel i de andre indikationer.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusive prolongeret neutropeni, febril neutropeni eller infektion), blev G-CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser.
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g., day 6-15) in all subsequent cycles.
Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdomsfri overlevelse (DFS) og total overlevelse (OS), blev det positive fordels-/risikoforhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt.
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Almene symptomer og reaktioner på administrationsstedet Undersøgelser
General disorders and administration site conditions Investigations
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m² end hos patienterne, der fik bedste palliative behandling.
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.
Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med anthracyklin (doxorubicin eller epirubicin).
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
In vivo er docetaxels aktivitet uafhængig af behandlingsregimenet og har eksperimentelt vist et bredt spektrum af antineoplastisk aktivitet over for murine og transplanterede humane tumorer.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
På grund af risikoen for skadelige påvirkninger af barnet skal amning derfor ophøre under behandling med docetaxel.
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Der kan også opstå betændelse i lungerne, når behandling med docetaxel bruges sammen med strålebehandling
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Taxespira i kombination med doxorubicin
Taxespira in combination with doxorubicin
Begge regimener blev administreret én gang hver 3. uge i 6 cyklusser.
Both regimens were administered once every 3 weeks for 6 cycles.
Uden at påvirke overlevelsestiden (docetaxel 15 måneder vs. doxorubicin 14 måneder, p = 0,38) eller tiden indtil progression (docetaxel 27 uger vs. doxorubicin 23 uger, p = 0,54) øgede docetaxel responsraten (52 % vs. 37 %, p = 0,01) og gav hurtigere respons (12 uger vs. 23 uger, p = 0,007).
Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Taxespira i alle undergrupper af den pædiatriske population ved brystkræft, ikke-småcellet 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 Taxespira in all subsets of the paediatric population in 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 (see section 4.2 for information on paediatric use).
Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og aseptiske forhold, og lægemidlet bør anvendes umiddelbart herefter.
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Lægemidlet skal bruges, straks efter at det er tilsat i infusionsposen.
Use immediately the medicine once added into the infusion bag.
• hævelse på grund af mangelfuld drænage af lymfe
• swelling caused by faulty lymphatic drainage
For kombinationer med capecitabin vises de mest almindelige behandlingsrelaterede bivirkninger (≥ 5 %), som blev rapporteret i et fase III-studie med brystkræftpatienter, hvor anthracyclinbehandling ikke havde haft effekt (se produktresuméet for capecitabin).
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Der er i sjældne tilfælde rapporteret tåreflåd med eller uden konjunktivitis som tilfælde af obstruktion af tårekanalerne, der resulterede i usædvanlig kraftigt tåreflåd.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
• Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan Taxespira indgives i kombination med doxorubicin og cyclophosphamid.
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
Hætteglas af klart glas (type I) med chlorobutyl-gummiprop og aluminiumsforsegling med vippelåg.
Clear glass (type I) vial with a chlorobutyl rubber stopper and an aluminium seal with a flip-off cap.