FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no evidence that eribulin mesilate is a vesicant or an irritant.
Danish: Der er ingen bevis for, at eribulinmesilat er sårdannende eller irriterende.
English: No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
Danish: Der anbefales ingen specifikke dosisjusteringer på basis af patientens alder (se pkt.
English: HALAVEN contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.
Danish: HALAVEN indeholder det aktive stof eribulin og er et lægemiddel mod kræft, som virker ved at stoppe væksten og spredningen af kræftceller.
English: Patients should be advised not to drive or use machines if they feel tired or dizzy.
Danish: Patienterne skal rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de føler sig trætte eller er svimle.
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with HALAVEN.
Danish: Mandlige patienter skal søge rådgivning om opbevaring af sæd før behandling, på grund af muligheden for irreversibel infertilitet ved behandling med HALAVEN.
English: Unchanged eribulin represented most of the total radioactivity in faeces and urine.
Danish: Uomdannet eribulin udgjorde hovedparten af den totale radioaktivitet i fæces og urin.
English: The usual dose of HALAVEN is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors.
Danish: Den normale dosis HALAVEN er 1,23 mg/m2, men lægen kan justere den ud fra dine blodprøveresultater eller andre faktorer.
English: The median duration of treatment was 12.0 weeks for sarcoma patients and 15.9 weeks for breast cancer patients.
Danish: Den mediane behandlingsvarighed var 12,0 uger for sarkompatienter og 15,9 uger for brystcancerpatienter.
English: Halaven is not recommended for children aged under 18 with paediatric sarcomas as it is not yet known how well it works in this age group.
Danish: HALAVEN bør ikke anvendes til børn under 18 år med sarkomer, da det stadig er ukendt, hvor godt det virker hos denne aldersgruppe.
English: Effects of eribulin on the pharmacokinetics of other medicines
Danish: Eribulins virkning på andre lægemidlers farmakokinetik
English: HALAVEN is usually given on Days 1 and 8 of every 21-day cycle.
Danish: HALAVEN indgives normalt på Dag 1 og 8 af hver 21-dags cyklus.
English: In Study 309, a statistically significant improvement in OS was observed in patients randomized to the eribulin arm compared to the control arm.
Danish: I studie 309 blev der observeret en statistisk signifikant forbedring i OS hos patienter, der blev randomiseret til eribulinarmen, sammenlignet med kontrolarmen.
English: Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy d
Danish: Inkluderer foretrukne termer for perifer neuropati, perifer motorisk neuropati, polyneuropati, paræstesi, perifer sensorisk neuropati, perifer sensomotorisk neuropati og demyeliniserende polyneuropati d
English: HALAVEN will be given to you by a doctor or nurse as an injection into a vein, over a period of 2 to 5 minutes.
Danish: Du vil få HALAVEN af en læge eller sygeplejerske som en injektion i en vene, i løbet af en periode på 2 til 5 minutter.
English: HALAVEN may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby.
Danish: HALAVEN kan forårsage alvorlige fødselsdefekter, og bør ikke anvendes hvis du er gravid, medmindre det menes at være klart nødvendigt efter nøje overvejelse af alle risici for dig og barnet.
English: The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Danish: Sikkerhedsprofilen af eribulin hos ældre patienter (≥ 65 år) var sammenlignelig med profilen hos patienter < 65 år, undtagen for asteni/træthed, hvor tendensen var en øget hyppighed med alderen.
English: PROPORTION OF PATIENTS ALIVE
Danish: ANDEL AF PATIENTER I LIVE
English: Reoccurrence of any haematological or non-haematological adverse reactions as specified above
Danish: Recidiv af hæmatologiske eller ikke-hæmatologiske bivirkninger, som specificeret ovenfor
English: In addition there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%).
Danish: Derudover var der 3 dødelige tilfælde af sepsis (0,2 %) og et dødeligt tilfælde af septisk shock (0,1 %).
English: A risk to newborns/infants cannot be excluded and therefore HALAVEN must not be used during breast-feeding (see section 4.3).
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes, og derfor må HALAVEN ikke anvendes under amning (se pkt.
English: The dose reduction recommendations shown below are also shown as the dose of eribulin to be administered based on the strength of the ready to use solution.
Danish: Anbefalingerne for dosisreduktion, der vises nedenunder, vises også som den dosis eribulin, der skal administreres, baseret på styrken af injektionsvæsken, der er klar til brug.
English: The development of severe peripheral neurotoxicity requires a delay or reduction of dose (see section 4.2)
Danish: Udviklingen af svær perifer neurotoksicitet kræver en udsættelse eller reduktion af dosis (se pkt.
English: There is no known antidote for eribulin overdose.
Danish: Der er ingen kendt antidot mod en overdosis af eribulin.
English: Do not drive or use machines if you feel tired or dizzy.
Danish: Lad være med at føre motorkøretøj eller betjene maskiner, hvis du føler dig træt eller er svimmel.
English: No significant accumulation of eribulin is observed on weekly administration.
Danish: Der blev ikke observeret nogen signifikant akkumulering af eribulin ved ugentlig indgivelse.
English: HALAVEN may cause side effects such as tiredness (very common) and dizziness (common).
Danish: HALAVEN kan forårsage bivirkninger, såsom træthed (meget almindelig) og svimmelhed (almindelig).
English: The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
Danish: Ovenstående doser kan anvendes ved let og moderat nedsat leverfunktion, men der anbefales nøje monitorering, da det kan være nødvendigt at justere doserne igen.
English: Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Danish: Metabolitkoncentrationer udgjorde < 0,6 % af det oprindelige stof, hvilket bekræfter, at der ikke er nogen betydende humane metabolitter for eribulin.
English: After administration of 14C-eribulin to patients, approximately 82% of the dose was eliminated in faeces and 9% in urine indicating that renal clearance is not a significant route of eribulin elimination.
Danish: Efter indgivelse af 14C-eribulin til patienter blev ca. 82 % af dosis elimineret i fæces og 9 % i urinen hvilket indikerer, at nyreclearance ikke er en signifikant eliminationsvej for eribulin.
English: - The active substance is eribulin.
Danish: - Aktivt stof: Eribulin.
English: The overall survival in patients in HER2 negative and HER2 positive patients in the eribulin and control groups in Study 305 and Study 301 is shown below:
Danish: Den samlede overlevelse hos HER2-negative og HER2-positive patienter i eribulin- og kontrolgrupperne i studie 305 og studie 301 vises nedenfor:
English: Good peripheral venous access, or a patent central line, should be ensured prior to administration.
Danish: God perifer veneadgang eller et åbent centralt kateter bør sikres før indgivelse.
English: HALAVEN may cause adverse reactions such as tiredness and dizziness which may lead to minor or moderate influence on the ability to drive or use machines.
Danish: HALAVEN kan forårsage bivirkninger, såsom træthed og svimmelhed, hvilket i mindre eller moderat grad kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Such elevations appeared to have occurred early with eribulin treatment in cycle 1 - 2 for the majority of these patients and whilst thought likely to be a phenomenon of adaptation to eribulin treatment by the liver and not a sign of significant liver toxicity in most patients, hepatotoxicity has also been reported.
Danish: Sådanne forhøjelser forekom at være opstået tidligt i eribulinbehandlingen (i cyklus 1-2) for hovedparten af disse patienter, og selvom det menes at være sandsynligt, at det er et fænomen i forbindelse med leverens tilpasning til eribulinbehandlingen og ikke tegn på signifikant levertoksicitet hos de fleste patienter, er der også blevet rapporteret hepatotoksicitet.
English: HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling.
Danish: HALAVEN er et cytotoksisk lægemiddel mod cancer og som for andre toksiske stoffer, skal der udvises forsigtighed ved håndtering.
English: HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
Danish: HALAVEN må kun indgives under supervision af en kvalificeret læge med erfaring i den hensigtsmæssige brug af cytotoksiske lægemidler.
English: aCox proportional hazard bStratified by geographic region, HER2/neu status
Danish: aCox proportional hazard bStratificeret af geografisk region, HER2/neu-status
English: There was no difference in efficacy between eribulin and dacarbazine in patients with advanced or metastatic leiomyosarcoma.
Danish: Der var ingen forskel i virkningen mellem eribulin og decarbazin hos patienter med fremskreden eller metastatisk leiomyosarkom.
English: Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Danish: Eribulin hæmmer vækstfasen af mikrotubuli uden at påvirke forkortelsesfasen og isolerer tubulin til ikke-produktive aggregater.
English: Eribulin should be avoided in patients with congenital long QT syndrome.
Danish: Eribulin skal undgås hos patienter med medfødt langt QT-syndrom.
English: Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged and irreversible mitotic blockage.
Danish: Eribulin udøver sin virkning via en tubulin-baseret, antimitotisk mekanisme, som fører til blokering af G2/M celle-cyklus og afbrydelse af de mitotiske tentråde, hvilket i sidste ende fører til apoptotisk celledød efter langvarig og irreversibel mitotisk blokade.
English: In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia (Grade 3) on Day 7.
Danish: I et tilfælde af overdosering fik patienten utilsigtet 7,6 mg eribulin (ca. 4 gange den planlagte dosis) og udviklede derefter en overfølsomhedsreaktion (grad 3) på Dag 3 og neutropeni (grad 3) på Dag 7.
English: No drug-drug interactions are expected with CYP3A4 inhibitors and inducers.
Danish: Der forventes ingen lægemiddel-lægemiddel-interaktioner med CYP3A4-hæmmere og induktorer.
English: If not used immediately HALAVEN as the undiluted solution in a syringe should not normally be stored longer than 4 hours at 25°C and ambient lighting, or 24 hours at 2°C - 8°C.
Danish: Hvis det ikke straks anvendes, må HALAVEN ufortyndet opløsning i en injektionssprøjte normalt ikke opbevares i mere end 4 timer ved en temperatur på 25 °C og i det omgivende lys eller i 24 timer ved temperaturer på 2 °C - 8 °C.
English: The study met its primary endpoint with an overall survival (OS) result that was statistically significantly better in the eribulin group compared to TPC at 55% of events.
Danish: Studiet opfyldte det primære endepunkt med en samlet overlevelse (overall survival, OS), som var statistisk signifikant bedre i eribulin-gruppen sammenlignet med TPC-gruppen, efter at 55 % af de forventede hændelser var indtrådt.
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Danish: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Storbritannien.
English: 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively).
Danish: Henholdsvis 18 % og 13 % af de eribulinbehandlede patienter fik G-CSF i de to fase 3brystcancerstudier (studie 305 og 301).
English: An embryofoetal development study in rat confirmed the developmental toxicity and teratogenic potential of eribulin.
Danish: Et embryoføtal udviklingsstudie hos rotter bekræftede udviklingstoksicitet og teratogent potentiale af eribulin.
English: In liposarcoma the efficacy of eribulin is supported by the pivotal Phase 3 sarcoma study (Study 309).
Danish: Ved liposarkom støttes virkningen af eribulin af det pivotale fase 3-sarkomstudie (studie 309).
English: Eribulin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test).
Danish: Eribulin var ikke mutagent in vitro i den bakterielle reverse mutationsassay (Ames-test).
English: The plasma protein binding of eribulin (100-1000 ng/ml) ranged from 49% to 65% in human plasma.
Danish: Plasmaproteinbindingen af eribulin (100 - 1000 ng/ml) varierede fra 49 % til 65 % i humant plasma.
English: These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis.
Danish: De kan være tegn på en sygdom, der kaldes Stevens-Johnsons syndrom/toksisk epidermal nekrolyse.
English: In vitro studies have also indicated that eribulin is not a substrate for OCT1.
Danish: In vitro-studier har også indikeret, at eribulin ikke er substrat for OCT1.
English: *Disseminated intravascular coagulation b
Danish: *Dissemineret intravaskulær koagulation b
English: Patients had received at least two prior chemotherapy regimens, one of which must have been an anthracycline (unless contraindicated).
Danish: Patienterne havde fået mindst to tidligere kemoterapibehandlinger, hvoraf den ene skal have været et antracyklin (medmindre det er kontraindiceret).
English: Some patients with moderately or severely impaired renal function (creatinine clearance <50 ml/min) may have increased eribulin exposure and may need a reduction of the dose.
Danish: Nogle patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance <50 ml/min) kan have en øget eksponering for eribulin og behov for dosisreduktion.
English: From a microbiological point of view unless the method of opening precludes the risk of microbial contamination the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet straks anvendes, medmindre anbrudsmetoden udelukker en risiko for mikrobiel forurening.
English: This translated into a 2 month improvement in median OS (13.5 months for eribulin treated patients vs. 11.5 months for dacarbazine treated patients).
Danish: Dette viste sig som en 2-måneders forbedring af median-OS (13,5 måneder for eribulinbehandlede patienter vs.11,5 måneder for dacarbazinbehandlede patienter).
English: Testicular toxicity has been observed in rats and dogs (see section 5.3).
Danish: Der er blevet observeret testikeltoksicitet hos rotter og hunde (se pkt.
English: In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1.
Danish: I et ikke-kontrolleret, ublindet EKG-studie på 26 patienter blev QT-forlængelse observeret på Dag 8, uafhængigt af eribulin-koncentrationen, og ingen QT-forlængelse blev observeret på Dag 1.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendt RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients may experience nausea or vomiting.
Danish: Patienterne kan opleve kvalme og opkastning.
English: TIME (months) NUMBER OF PATIENTS AT RISK
Danish: TID (måneder) ANTAL PATIENTER I RISIKOGRUPPEN
English: Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Danish: Tidligere behandling skal have omfattet et antracyklin og et taxan, enten som tillægsbehandling eller i metastatisk regi, medmindre patienterne ikke var egnede til disse behandlinger.
English: The patients in this study (n=452) had locally recurrent, inoperable and/or metastatic soft tissue sarcoma of one of two subtypes - leiomyosarcoma or liposarcoma.
Danish: Patienterne i dette studie (n=452) havde lokalt, recidiverende, inoperabelt og/eller metastatisk bløddelssarkom af en ud af to undertyper - leiomyosarkom eller liposarkom.
English: In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
Danish: I fase 3-sarkomstudiet (studie 309) fik 26 % af de eribulinbehandlede patienter G-CSF.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding af lægemidler før administration, se pkt.
English: HALAVEN should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents.
Danish: HALAVEN skal kun forberedes og indgives af personale med hensigtsmæssig træning i håndtering af cytotoksiske midler.
English: It should not be diluted in glucose 5% infusion solution.
Danish: Den må ikke fortyndes i glucose 5 % infusionsvæske.
English: Cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.
Danish: Tilfælde af dissemineret intravaskulær koagulation er blevet rapporteret, typisk i forbindelse med neutropeni og/eller sepsis.
English: The efficacy of HALAVEN in breast cancer is primarily supported by two randomized Phase 3 comparative studies.
Danish: HALAVENs virkning ved brystcancer er primært dokumenteret i to randomiserede, komparative fase 3-studier.
English: It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
Danish: Det må ikke blandes med andre lægemidler, og det må ikke fortyndes i glucose 5 % infusionsvæske, opløsning.
English: For information relevant to the handling of cytotoxic medicinal products see section 6.6.
Danish: For information med relevans for håndtering af cytotoksiske lægemidler, se pkt.
English: The transport protein involved in the excretion is presently unknown.
Danish: Transportproteinet, som er involveret i denne udskillelse, kendes ikke på nuværende tidspunkt.
English: HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).
Danish: HALAVEN blev ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh C).
English: Eribulin is eliminated primarily by biliary excretion.
Danish: Eribulin elimineres hovedsageligt via biliær udskillelse.
English: Neutrophil counts of < 0.5 x 109/l that lasted for more than 7 days occurred in 13% of breast cancer patients treated with eribulin in the EMBRACE study.
Danish: Neutrofiltal på < 0,5 x 109/l, der varede i over 7 dage, forekom hos 13 % af patienterne med brystcancer, som blev behandlet med eribulin i EMBRACE-studiet.
English: Women of childbearing potential must be advised to avoid becoming pregnant whilst they or their male partner are receiving HALAVEN and have to use effective contraception during and up to 3 months after treatment.
Danish: Kvinder i den fertile alder skal rådes til at undgå at blive gravide, mens de eller deres mandlige partner får HALAVEN, og de skal anvende sikker kontraception under behandlingen og i 3 måneder efter behandlingen.
English: Myelosuppression is dose dependent and primarily manifested as neutropenia (section 4.8).
Danish: Myelosuppression er dosisafhængig og manifesterer sig primært som neutropeni (pkt.
English: Pregnant rats were treated with eribulin mesilate equivalent to 0.009, 0.027, 0.088 and 0.133 mg/kg eribulin at gestation days 8, 10 and 12.
Danish: Drægtige rotter blev behandlet med eribulinmesilat svarende til 0,009, 0,027, 0,088 og 0,133 mg eribulin/kg på gestationsdagene 8, 10 og 12.
English: The positive effect on OS was seen in both taxane-refractory and non-refractory groups of patients .
Danish: Den positive virkning på den samlede overlevelse blev set hos både de taxan-refraktære og ikkerefraktære patientgrupper.
English: Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Danish: Der er blevet rapporteret dødelige tilfælde af febril neutropeni, neutropenisk sepsis, sepsis og septisk shock.
English: Preclinical in vitro studies indicate that eribulin is transported by Pgp.
Danish: Prækliniske in vitro-studier indikerer, at eribulin transporteres af Pgp.
English: HALAVEN should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Danish: HALAVEN må ikke anvendes under graviditeten, medmindre det er klart nødvendigt, og kun efter nøje vurdering af moderens behov og risikoen for fosteret.
English: Treatment effects of eribulin were limited to patients with liposarcoma (45% dedifferentiated, 37% myxoid/round cell and 18% pleomorphic in Study 309) based on pre-planned subgroup analyses of OS and PFS.
Danish: Virkningen af eribulinbehandling var begrænset til patienter med liposarkom (45 % dedifferentierede, 37 % myksoide/runde celler og 18 % pleomorfe i studie 309), baseret på undergruppeanalyser af OS og PFS planlagt på forhånd.
English: Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in section 4.2.
Danish: Patienter, der oplever febril neutropeni, svær neutropeni eller trombocytopeni, bør behandles i henhold til anbefalingerne i pkt.
English: Hyperglycaemia Hypophosphataemia Hypocalcaemia
Danish: Hyperglykæmi Hypofosfatæmi Hypocalcæmi
English: It is unknown whether eribulin/metabolites are excreted in human or animal breast milk.
Danish: Det er ukendt, om eribulin udskilles i human mælk eller i mælken hos dyr.
English: Eribulin has a low clearance (range of means 1.16 to 2.42 l/h/m2).
Danish: Eribulin har en lav clearance (gennemsnitsinterval 1,16 til 2,42 l/t/m2).
English: The pack sizes are cartons of 1 or 6 vials.
Danish: Pakningsstørrelserne er kartoner med 1 eller 6 hætteglas.
English: In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4.
Danish: In vitro data indikerer, at eribulin er en svag hæmmer af det vigtige lægemiddelmetaboliserende enzym CYP3A4.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der er trykt på kartonen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Danish: Denne medicin indeholder en mindre mængde alkohol, mindre end 100 mg pr. dosis.
English: The median time to Grade 2 peripheral neuropathy was 18.4 weeks.
Danish: Mediantiden til grad 2 perifer neuropati var 18,4 uger.
English: Increased eribulin exposure was seen in some patients with moderately or severely impaired renal function, with high between-subject variability.
Danish: Der blev observeret en øget eksponering for eribulin hos nogle patienter med moderat eller svært nedsat nyrefunktion, med højt inter-individuel variabilitet.