natgillin/translations-raw huggingface dataset:
Mænd, som er i behandling med docetaxel, tilrådes derfor ikke at blive fædre til børn under og op til 6 måneder efter behandling samt til at søge vejledning vedrørende opbevaring af sæd inden behandling.
Therefore, men being treated with docetaxel 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.
Ikke-småcellet lungekræft
Non-small cell lung cancer
Der er observeret lokaliseret erythem på ekstremiterene (håndflader og fodsåler) med ødem efterfulgt af afskalning.
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Diarré grad 3
Diarrhoea grade 3
Docetaxel er et stof, der udvindes af nålene fra takstræer.
Docetaxel is a substance derived from the needles of yew trees.
Patienterne præmedicineres med antiemetika og passende hydrering til administration af cisplatin.
Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
I de 2 her nævnte fase III-studier viste docetaxel den samme sikkerhedsprofil som tidligere blev set i fase II-studierne (se pkt.
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Hvis der opstår alvorlig neutropeni (< 500 celler/mm3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
In the case of severe neutropenia (< 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
• 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, severe shortness of breath, dizziness, and/or fainting).
Reaktioner på infusionsstedet; smerter
Infusion site reaction; Pain
Diskutér det med din læge, hvis du lider af alkoholafhængighed, epilepsi eller nedsat leverfunktion.
Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Alle patienter i studiets docetaxel-arm modtog profylaktisk antibiotika.
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
De patienter, der fik behandling med TPF udviklede signifikant mindre tilbagegang af deres globale sundhedsscore i forhold til patienter i behandling med PF (p = 0,01, under anvendelse 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).
Disse var reversible ved ophør af behandlingen.
These were reversible upon discontinuation of the infusion.
Ydermere påvirkede dexamethason ikke docetaxels proteinbinding.
In addition, dexamethasone did not affect protein binding of docetaxel.
Hvis du er mand i behandling med DOCETAXEL KABI, rådes du til ikke at blive far til 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 KABI 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.
Øre og labyrint: Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/eller tab af hørelse.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Blod og lymfesystem: Sjældent: Blødningsepisoder associeret med grad 3/4 trombocytopeni.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Myelodysplastisk syndrom blev ikke diagnosticeret i nogen af behandlingsgrupperne.
No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
DOCETAXEL KABI er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningen.
DOCETAXEL KABI is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing the solution.
Prednisons virkning på farmakokinetikken for docetaxel administreret med standard prednison præmedicinering 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.
Neutropeni er den hyppigst forekommende bivirkning ved docetaxel.
Neutropenia is the most frequent adverse reaction of docetaxel.
Du må IKKE amme, mens du behandles med DOCETAXEL KABI.
You must not breast-feed while you are treated with DOCETAXEL KABI.
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).
Skal tages i betragtning for gravide eller ammende kvinder, børn eller høj-risiko grupper så som patienter med leversygdom eller 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.
Det er påvist, at docetaxel er embryotoksisk og føtotoksisk i rotter og kaniner.
It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits.
Der er ingen kendt antidot til overdosering med docetaxel.
There is no known antidote for docetaxel overdose.
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 KABI (angivet i punkt 6)
KABI (listed in section 6).
Kompliceret neutropeni
Complicated neutropenia
• Betændelse i tyktarm, tyndtarm, som kan være dødelig (hyppighed ikke kendt); perforering af tarmene.
• inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
Den kombinerede administration af docetaxel, cisplatin og 5-fluoruracil hos 12 patienter med massive tumorer havde ingen indflydelse på farmakokinetikken for hvert af de individuelle lægemidler.
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Den efterfølgende docetaxel-dosis 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.
Hvor ofte gives medicinen Du vil normalt få en infusion én gang hver 3. uge.
You should usually receive your infusion once every 3 weeks.
Respirationssygdomme
Respiratory disorders
Mængden af alkohol i dette lægemiddel kan ændre virkningen af andre lægemidler.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
Ved lette symptomer på overfølsomhed såsom lokal rødme eller lokaliserede kutane reaktioner, er det ikke nødvendigt at afbryde behandlingen.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Prednison og dexmethason
Prednisone and dexamethasone
Symptomatisk hjertesvigt blev rapporteret hos 2,2 % af patienterne, som fik 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.
Se også afsnittet ”DOCETAXEL KABI indeholder alkohol” nedenfor.
See also section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Overfølsomhedsreaktioner (hyppighed ikke kendt) er rapporteret for docetaxel hos patienter, der tidligere har haft overfølsomhedsreaktioner overfor paclitaxel.
Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
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.
• Akut myeloid leukæmi og myelodysplastisk syndrom (typer af blodkræft) kan forekomme hos patienter, som behandles med docetaxel sammen med visse andre behandlinger mod kræft.
• acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Akut myeloid leukæmi og myelodysplastisk syndrom er blevet rapporteret (hyppighed ikke almindelig) i pivotale kliniske studier med brystkræft med TACregime.
Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Hvis en større dosis end 190 mg docetaxel er påkrævet, anvendes et større volumen infusionsvehikel således at en koncentration på 0,74 mg/ml docetaxel ikke overskrides.
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Effekten af docetaxel ved behandling af patienter med gastrisk adenokarcinom
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Docetaxel påvirkede ikke digitoxins proteinbinding.
Docetaxel did not influence the binding of digitoxin.
Fra et mikrobiologisk synspunkt skal rekonstituering/fortynding ske under kontrollerede og aseptiske forhold.
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Fase I-studier, som evaluerede capecitabins effekt på docetaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på docetaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel på capecitabins hovedmetabolit 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.
* En Hazard ratio på mindre end 1 indikerer, at TAC kan associeres med længere sygdoms-fri overlevelse og længere total overlevelse sammenlignet med FAC.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Docetaxel er et antineoplastisk stof, som virker ved at facilitere polymerisering af tubulin til stabile mikrotubuli og hæmme depolymerisering af mikrotubuli til tubulin, hvilket medfører et udtalt fald i koncentrationen af frit 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 mediane overlevelse var 442 dage (docetaxel + capecitabin) vs. 352 dage (docetaxel alene).
Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
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.
Opfylder relativ indikation for kemoterapi a
Meeting relative indication for chemotherapya
• Ved ethvert efterfølgende tegn på toksicitet eller ved grad 4-toksicitet seponeres docetaxelbehandling.
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
For patienter med operabel lymfeknude-negativ brystkræft 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).
Den primære analyse blev udført, da alle patienter havde en opfølgningstid på mere end 5 år (median opfølgningstid var 77 måneder).
The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Stråling blev udført med megavolt udstyr, med en daglig fraktionering (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 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).
Den mediane tid indtil progression var 186 dage (docetaxel+ capecitabin) vs. 128 dage (docetaxel alene).
The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
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 Care.
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.
Anvendes straks, når medicinen er tilsat til en infusionspose.
Use immediately the medicine once added into the infusion bag.
Lokoregional behandling med stråling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy en gang daglig, 5 dage om ugen til en total dosis på 66 til 70 Gy), eller accelererede /hyperfraktionerede regimer af strålebehandling (to gange daglig, med et minimum interfraktion-interval 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).
Der er ingen relevant anvendelse af DOCETAXEL KABI 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 KABI 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.
I kombination med cisplatin og 5-fluoruracil
In combination with cisplatin and 5-fluorouracil
Skønt mulige in vivo-interaktioner mellem docetaxel og andet samtidigt administreret lægemiddel ikke er undersøgt formelt, har in vitro interaktionsstudier med kraftigt proteinbundne stoffer såsom erythromycin, difenhydramin, propranolol, propafenon, fenytoin, salicylat, sulfamethoxazol og natriumvalproat, ikke påvirket docetaxels proteinbinding.
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Svære negleforandringer er karakteriseret ved hypo- eller hyper-pigmentering og sommetider smerter og onykolyse.
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Hvis det ikke anvendes straks, er brugeren ansvarlig for i-brug opbevaringstid- og betingelser.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
In vitro-studier har vist, at Docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner 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.
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).
Docetaxel fandtes in vitro at være cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for humane tumorceller fra frisk udtaget væv 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.
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.
Prednison eller prednisolon 5 mg 2 gange daglig gives kontinuerligt (se pkt.
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Da fordelene hos patienter med 4+lymfeknuder ikke var statistisk signifikant for DFS og OS, blev den positive benefit/risk fordeling for TAC hos patienter med 4+lymfeknuder ikke helt demonstreret ved den endelige analyse.
As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis.
Responsrate i alt (CR+PR) (%) p-værdi
Overall Response Rate (CR+PR) (%) p-value
• Hævelse forårsaget af mangelfuld drænage af lymfe
• swelling caused by faulty lymphatic drainage
Efter anbefalet tilsætning til infusionspose, er docetaxel infusionsopløsningen stabil i 6 timer, hvis den opbevares under 25ºC.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Patienter bør monitoreres for anden primær malignitet (se pkt.
Patients should be monitored for second primary malignancies (see section 4.8).
• Den totale responshyppighed var signifikant højere i AT-armen i forhold til AC-armen, p = 0,009.
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Tilfælde af lakrimation med eller uden konjunktivitis, da der er sjældne rapporter om tilfælde af obstruktion af tårekanalerne, som resulterede i usædvanlig kraftigt tåreflod.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
• 332 patienter, som fik docetaxel i kombination med prednison eller prednisolon (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Med primær GCSF- profylakse (n = 421) n (%)
With primary G-CSF prophylaxis (n = 421) n (%)
Hvis hætteglassene er blevet opbevaret på køl, så lad de påkrævede antal æsker af DOCETAXEL KABI koncentrat til infusionsvæske, opløsning stå 5 minutter under 25˚C før brug.
If the vials are stored under refrigeration, allow the required number of boxes of DOCETAXEL KABI concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Tilsvarende andre parenterale produkter, skal DOCETAXEL KABI visuelt inspiceres før brug, og opløsninger indeholdende et bundfald skal kasseres.
As with all parenteral products, DOCETAXEL KABI infusion solution should be visually inspected prior to use, and solutions containing a precipitate should be discarded.
Mængden af alkohol i dette lægemiddel kan påvirke din evne til at køre motorkøretøj eller arbejde med maskiner.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Hvis dette sker, skal du omgående fortælle det til lægen.
If this happens, you must tell your doctor immediately
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, eller bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxel-infusion og passende terapi.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
• Interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Sygdoms-fri overlevelse Hazard ratio*
Disease Free Survival Hazard ratio*
Docetaxel opnår høje intracellulære koncentrationer og forbliver længe intracellulært.
Docetaxel achieves high intracellular concentrations with a long cell residence time.
Median-antallet af cyklusser administreret pr. patient var 6 (med en range på 1-16) for TCF-armen sammenlignet med 4 (med en range på 1-12) for CF-armen.
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med 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.
Docetaxel infusionsvæske er overmættet og kan derfor udkrystallisere over tid.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
†Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Dette skal tages i betragtning hos gravide eller ammende, til børn og høj-risiko grupper så som patienter med leversygdom eller epilepsi.
To be taken into account in pregnant or breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, herunder enterocolitis og gastrointestinal perforation.
Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation .
DOCETAXEL KABI blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
DOCETAXEL KABI was administered as a 1-hour infusion, all other medicinal product were given intraveinously on day 1 every three weeks.
Efter kemoterapi bør patienterne få strålebehandling.
Following chemotherapy, patients should receive radiotherapy.