natgillin/translations-raw huggingface dataset:
Fase I-studier, som undersøgte capecitabins effekt på docetaxels farmakokinetik og omvendt, viste ingen effekt af capecitabin på docetaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel på capecitabins metabolit 5'-DFUR's farmakokinetik.
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LABEL TIL HÆTTEGLAS
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Toårs overlevelse (%)
2-year Survival (%)
Docetaxels clearance i kombinationsbehandling med cisplatin var sammenlignelig med det observerede ved monoterapi.
Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Mediantid til progression var 186 dage (docetaxel + capecitabin) mod 128 dage (docetaxel alene).
The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
• Ved ethvert efterfølgende tegn på toksicitet eller ved grad 4-toksicitet stoppes behandlingen med docetaxel.
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
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.
Den opdaterede analyse blev udført, da alle patienter havde nået deres 10-års (median followup-tid var 10 år og 5 måneder) followup-besøg (medmindre de havde DFS eller tidligere var udgået fra followup).
The updated analysis was performed when all patients had reached their 10-year (median follow up time of 10 years and 5 months) follow-up visit (unless they had a DFS event or were lost to follow-up previously).
• 332 patienter, som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er nævnt).
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Meget almindelig: Hæmatologisk toksicitet var forhøjet hos de patienter, som modtog trastuzumab og docetaxel, i forhold til de patienter som fik behandling med docetaxel alene (32% grad 3/4 neutropeni versus 22%, under anvendelse af NCI-CTC kriterierne).
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin og cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor a
Der er observeret sjældne tilfælde af kramper eller forbigående tab af bevidsthed i forbindelse med indgift af docetaxel.
Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
• interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Alvorlige reaktioner blev karakteriseret ved hypotension og/eller bronkospasmer eller generaliseret udslæt/erythem (se pkt.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Der er rapporteret meget sjældne tilfælde af forbigående synsforstyrrelser (blink, lysglimt, skotom), som typisk er opstået i forbindelse med infusionen af lægemidlet og sammen 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.
Hjerte Der er rapporteret om sjældne tilfælde af myokardieinfarkt.
Cardiac disorders Rare cases of myocardial infarction have been reported.
Øre og labyrint Der er rapporteret om sjældne tilfælde af ototoksicitet, hørenedsættelse og/eller -tab.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Adjuverende strålebehandling blev administreret i henhold til guidelines på 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.
Tid til progressiv sygdom var længere i kombinationsarmen med docetaxel + capecitabin (p < 0,0001).
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
I studiet blev 501 patienter med lokalt fremskreden SCCHN og WHO-funktionsstatus 0 eller 1 randomiseret til en af to behandlingsarme.
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two arms.
I dette studie blev 358 patienter med inoperabel, lokalt fremskreden SCCHN og WHO-funktionsstatus 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.
Det primære endepunkt i dette studie, progressionsfri overlevelse (PFS), var signifikant længere i TPF-armen end i PF-armen, p = 0,0042 (median PFS: 11,4 mod 8,3 måneder) med en total medianopfølgningstid på 33,7 måneder.
The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Hos patienter i behandling med TAC-regimet for lymfeknude-positiv brystcancer 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).
Strålebehandling blev givet med megavoltudstyr med én daglig fraktionering (2 Gy dagligt, 5 dage om ugen i 7 uger til en samlet dosis på 70-72 Gy).
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Immunsystemet Der er rapporteret enkelte tilfælde af anafylaktisk shock, som i nogle tilfælde har haft dødelig udgang.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Patienterne havde operabel lymfeknude-negativ brystcancer 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).
Ved slutningen af followup-perioden (faktisk median followup-tid var 96 måneder) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9%) og hos 16 FAC-patienter (2,2%).
At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Lokoregional strålebehandling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy én gang dagligt, 5 dage pr. uge til en samlet dosis på 66-70 Gy) eller accelererede/hyperfraktionerede regimer af strålebehandling (2 gange dagligt, med et minimalt interfraktionsinterval på 6 timer, 5 dage pr. uge).
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Oralt prednison eller prednisolon 5 mg gives kontinuerligt 2 gange dagligt (se pkt.
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Den anbefalede dosis af docetaxel er 75 mg/m².
The recommended dose of docetaxel is 75 mg/m².
Vær særlig opmærksom på at informere din læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelse 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 results of your blood tests.
Den farmakokinetiske profil af cisplatin, der indgives kort efter infusion med docetaxel, svarer til profilen for cisplatin alene.
The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
• Som ved alle andre parenterale lægemidler skal infusionsvæsken kontrolleres visuelt inden anvendelse, og opløsninger med udfældning skal kasseres.
• As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
• Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324) MedDRA systemorganklasse
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Man bør anvende profylaktisk G¬CSF for at nedsætte risikoen for hæmatologisk toksicitet (se også ”Dosisjustering under behandling”).
Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Efter 10 års followup i TAX 316-studiet blev akut leukæmi rapporteret hos 4 ud af 744 TAC-patienter og hos 1 ud af 736 FAC-patienter.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Der er rapporteret om sjældne tilfælde af ileus og intestinal forstoppelse.
Rare cases of ileus and intestinal obstruction have been reported.
• sløret syn pga. hævet nethinde (cystoidt makulaødem) • nedsat indhold af natrium i blodet.
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema) • decrease of the sodium in your blood.
Patienter med operabel lymfeknude-negativ brystcancer, egnet til behandling med kemoterapi (GEICAM 9805)
Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805)
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.
Profylaktisk G¬CSF kan anvendes til at nedsættes risikoen for hæmatologiske toksiciteter.
Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Docetaxel har in vitro vist sig cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for frisk udtaget humant tumorcellevæv i klonogene assays.
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
I et farmakokinetisk studie med 7 patienter resulterede samtidig administration af docetaxel og den potente CYP3A4-hæmmer ketoconazol i et signifikant fald i docetaxel-clearance på 49%.
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
Hos patienter, som får kompliceret neutropeni (prolongeret neutropeni, febril neutropeni eller infektion), bør G¬CSF og dosisreduktion overvejes (se pkt.
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxelinfusion og passende behandling.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/m² som intravenøs infusion over en time hver tredje uge).
256 patients were randomised to treatment with docetaxel alone (100 mg/m² as a 1 hour intravenous infusion every 3 weeks).
De mest almindelige bivirkninger ved Docetaxel Mylan 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 Mylan alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), andre sygdomsrelaterede lægemidler (p = 0,06) og strålebehandling (p < 0,01) hos patienter behandlet med docetaxel ved 75 mg/m² end hos patienterne, der fik bedste understøttende 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.
• maveproblemer herunder kvalme, opkastning og diarré, forstoppelse
• stomach upsets including nausea, vomiting and diarrhoea, constipation
Det kan være nødvendigt at anvende mere end ét hætteglas koncentrat til infusionsvæske, opløsning for at opnå den dosis, der er nødvendig for patienten.
More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatacancer blev evalueret i et randomiseret multicenter, fase III-studie.
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.
Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystcancer (intent-to-treat analyse)
Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Alle patienter i docetaxel-armen fik profylaktisk antibiotika.
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
• hævelse forårsaget af ophobning af lymfevæske
• swelling caused by faulty lymphatic drainage
Alle patienter uden progressiv sygdom skulle have kemo-stråleterapi (CRT) i henhold til protokollen (TPF/CRT).
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m² hver 3. uge med en ugentlig administration af trastuzumab.
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m² every three weeks, with trastuzumab administered weekly.
Almene symptomer og reaktioner på indgivelsesstedet I studiet TAX 316 fortsatte perifert ødem hos 19 patienter ud af 119 patienter med perifert ødem i TAC-armen og hos 4 patienter ud af de 23 patienter med perifert ødem i FAC-armen.
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Hjertesvigt er observeret hos patienter, som fik docetaxel i kombination med trastuzumab, specielt efter kemoterapi med antracyklin (doxorubicin eller epirubicin).
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Øvrige indholdsstoffer: polysorbat 80, vandfri ethanol og citronsyre.
The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
Efter den sidste cyklus kemoterapi fik patienter i begge studiearme med positive østrogen- og/eller progesteronreceptorer 20 mg tamoxifen 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.
Koncentratet leveres i et klart, farveløst hætteglas med en gummiprop og en plastik-afrivningshætte.
The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.
Toårs estimat (%)
2-year estimate (%)
Ved en hazard ratio på < 1 kan docetaxel+Cisplatin+5-FU med fordel anvendes *Cox model (justering for primært tumorsted, T og N kliniske trin og PSWHO) **Log-rank test *** Chi-square-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
In vivo er docetaxel uafhængigt og har i studier vist sig at have bredspektret antitumoraktivitet over for fremskredne 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.
Docetaxel øgede responsraten (33% mod 12%, p < 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004) samt forlængede overlevelsen (11 måneder mod 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 overall survival (11 months vs. 9 months, p = 0.01).
Ved afslutningen af kemoterapi med et mindsteinterval på 4 uger og et maksimuminterval på 7 uger fik patienter, hvis sygdom ikke progredierede, strålebehandling (RT) i syv uger i overensstemmelse med de institutionelle retningslinjer (TPF/RT).
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Tabellen nedenfor viser, at hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik primær G¬CSF profylaktisk, efter det blev gjort obligatorisk i TAC-armen 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.
Efter indgift af en 100 mg/m² dosis givet som infusion over 1 time var det gennemsnitlige plasmaniveau 3,7 µg/ml med et AUC på 4,6 h·µg/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.
Ved afslutningen af kemoterapi med et mindsteinterval på 4 uger og et maksimuminterval på 7 uger modtog patienter, hvis sygdom ikke progredierede, strålebehandling (RT) i 7 uger i overensstemmelse med de institutionelle retningslinjer (PF/RT).
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (median kumulativ dosis: 818,9 mg/m²) med præmedicinering set i forhold til patienter uden præmedicinering (median kumulativ dosis: 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.
Alvorligheden af bivirkningerne af Docetaxel Mylan kan forøges, når Docetaxel Mylan gives i kombination med andre kemoterapeutiske lægemidler.
The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents.
• Mitoxantron 12 mg/m² hver 3. uge i 10 cyklusser.
• Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.
Uden at påvirke den totale overlevelsestid (docetaxel 15 måneder mod doxorubicin 14 måneder, p = 0,38) eller tiden til progression (docetaxel 27 uger mod doxorubicin 23 uger, p = 0,54) øgede docetaxel responsraten (52% mod 37%, p = 0,01) og gav kortere tid til respons (12 uger mod 23 uger, p = 0,007).
Without affecting overall survival 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).
C-mærket docetaxel på 3 cancerpatienter.
C-docetaxel has been conducted in three cancer patients.
• følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i led eller muskelfæster
• feeling of numbness or pins and needles or pain in the joints or muscles
Neutropeni (G4: 54,2%);
Neutropenia (G4: 54.2%);
Docetaxel + trastuzumab var effektivt, uanset om patienterne først havde fået adjuverende antracykliner eller ej.
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdomsfri overlevelse (DFS) og total overlevelse (OS), blev det positive fordel/risiko forhold 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).
Til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer er den anbefalede dosis docetaxel i monoterapi 100 mg/m².
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy.
Primær G¬CSF-profylakse bør overvejes til patienter, som får docetaxel-, doxorubicin- og cyclophosphamid- (TAC)-adjuverende behandling for brystcancer.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Doxetaxel Mylan i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Der er ingen kendt antidot til docetaxel.
There is no known antidote for docetaxel overdose.
Der er rapporteret sjældne tilfælde af strålepneumonitis hos patienter, der er i samtidig stråleterapi.
Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.