FrancophonIA/ELRC3.0 huggingface dataset:
English: - Any difficulty breathing, or swelling of your face, mouth, tongue or throat.
Danish: - Vejrtrækningsproblemer eller hævelse af ansigt, mund, tunge eller hals.
English: The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles).
Danish: Mediantiden til grad 2 perifer neuropati var 12,6 uger (efter 4 cyklusser).
English: A 1.5-fold (90% CI: 0.9-2.5) higher dose-normalised AUC(0-inf) was observed in patients with moderate and severe renal impairment.
Danish: Der blev observeret et 1,5 gange (90 % CI: 0,9-2,5) øget dosisnormaliseret AUC(0-inf) hos patienter med moderat og svært nedsat nyrefunktion.
English: Dose related increased number of resorptions and decreased foetal weight were observed at doses ≥ 0.088 mg/kg and increased incidence of malformations (absence of lower jaw, tongue, stomach and spleen) was recorded at 0.133 mg/kg.
Danish: Et dosisrelateret forøget antal resorptioner og en dosisrelateret nedsat fostervægt blev observeret ved doser ≥ 0,088 mg/kg, og en øget forekomst af misdannelser (manglende underkæbe, tunge, mave og milt) blev registreret ved 0,133 mg/kg.
English: Caution and monitoring for adverse events is recommended with concomitant use of substances that have a narrow therapeutic window and that are eliminated mainly via CYP3A4-mediated metabolism (eg alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Danish: Det anbefales at udvise forsigtighed og overvåge for bivirkninger ved samtidig anvendelse af lægemidler med et snævert terapeutisk vindue, eller som primært elimineres via CYP3A4-medieret metabolisme (f.eks. alfentanil, ciclosporin, ergotamin, fentanyl, pimozid, kinidin, sirolimus, tacrolimus).
English: Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m2.
Danish: Beregningen af den individuelle dosis, der skal administreres til patienten, skal baseres på styrken af injektionsvæsken, der er klar til brug og indeholder 0,44 mg/ml eribulin, og dosisanbefalingen på 1,23 mg/m2.
English: They were randomized 1:1 to receive either eribulin 1.23 mg/m2 on days 1 and 8 of a 21 day cycle or dacarbazine 850 mg/m2, 1000 mg/m2 or 1200 mg/m2 (dose determined by the investigator prior to randomization),
Danish: De blev randomiseret i forholdet 1:1 til at få enten eribulin 1,23 mg/m2 på dag 1 og 8 i en 21-dages cyklus eller dacarbazin 850 mg/m2, 1000 mg/m2 eller 1200 mg/m2 (dosis bestemt af investigator før randomisering) hver 21. dag.
English: Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Danish: Samlet var sikkerhedsprofilerne for patientpopulationerne med brystcancer og bløddelssarkom sammenlignelige.
English: A fertility study was not conducted with eribulin, but based on non-clinical findings in repeated-dose studies where testicular toxicity was observed in both rats (hypocellularity of seminiferous epithelium with hypospermia/aspermia) and dogs, male fertility may be compromised by treatment with eribulin.
Danish: Der er ikke blevet udført et fertilitetsstudie med eribulin, men baseret på prækliniske fund i studier, hvor tesikulær toksicitet blev observeret hos både rotter (hypocellularitet af seminiferus epitel med hypospermi/aspermi) og hunde, mandlig fertilitet med gentagne doser kan mandlig fertilitet kompromitteres under behandling med eribulin.
English: Common (Frequency %)
Danish: Almindelig (Hyppighed %)
English: The HER2 status of the patients was: 15.3% positive, 68.5% negative and 16.2% unknown, whilst 25.8% of patients were triple negative.
Danish: HER2-status for patienterne var: 15,3 % positive, 68,5 % negative og 16,2 % ukendte, mens 25,8 % af patienterne var trippelt negative.
English: Additionally, in vivo, concomitant administration of ketoconazole, a Pgp inhibitor, has no effect on eribulin exposure (AUC and Cmax).
Danish: Desuden har samtidig administration af ketoconazol in vivo ingen virkning på eksponeringen for eribulin (AUC og Cmax).
English: ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias or concomittant treatment with medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities.
Danish: Overvågning med EKG anbefales, hvis behandlingen påbegyndes hos patienter med kronisk hjerteinsufficiens, bradyarytmier eller samtidig behandling med lægemidler, der vides at forlænge QTintervallet, herunder Klasse Ia og III antiarytmika, og elektrolytforstyrrelser.
English: For all patients with renal impairment, caution and close safety monitoring is advised.
Danish: For alle patienter med nedsat nyrefunktion rådes der til forsigtighed og nøje sikkerhedsovervågning (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with eribulin in all subsets of the paediatric population in the indication of breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med eribulin i alle undergrupper af den pædiatriske population ved indikationen brystcancer (se pkt.
English: Slovenská republika Eisai GesmbH organizační složka Tel.: + 420 242 485 839 (Česká republika)
Danish: Eisai GesmbH organizační složka Tel.: + 420 242 485 839 (Česká republika)
English: They were randomized 2:1 to receive either HALAVEN, or treatment of physician's choice (TPC), which consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxane, 9% anthracycline, 10% other chemotherapy), or 3% hormonal therapy.
Danish: De blev randomiseret i forholdet 2:1 til at få enten HALAVEN eller bedste behandling efter lægens skøn (treatment of physician's choice, TPC), som bestod af 97 % kemoterapi (26 % vinorelbin, 18 % gemcitabin, 18 % capecitabin, 16 % taxan, 9 % antracyklin, 10 % anden kemoterapi) eller 3 % hormonbehandling.
English: Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age.
Danish: Ud af de 1.559 patienter med brystcancer, der blev behandlet med den anbefalede dosis eribulin, var 283 patienter (18,2 %) ≥ 65 år.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor hyppige de er.
English: Where Grade 3 or 4 reactions occurred, the actual total frequency and the frequency of Grade 3 or 4 reactions are given.
Danish: Hvor grad 3- eller grad 4-bivirkninger forekom, vises den totale hyppighed og hyppigheden af grad 3- og grad 4-bivirkninger.
English: HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.
Danish: HALAVEN må ikke anvendes under amning på grund af en mulig risiko for barnet.
English: Unless otherwise noted, the table shows the incidence rates of adverse reactions observed in breast cancer and soft tissue sarcoma patients who received the recommended dose in Phase 2 and Phase 3 studies.
Danish: Medmindre andet er angivet, viser nedenstående tabel hyppigheden af bivirkninger observeret hos patienter med brystcancer eller bløddelssarkom, som fik den anbefalede dosis i fase 2- og fase 3studier.
English: The pharmacokinetic properties are not dose or time dependent in the range of eribulin doses of 0.22 to 3.53 mg/m2.
Danish: De farmakokinetiske egenskaber er ikke dosis- eller tidsafhængige i dosisintervallet 0,22 til 3,53 mg/m2.
English: Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.
Danish: Andre bivirkninger omfatter træthed, alopeci, forhøjede leverenzymer, sepsis og muskuloskeletalt smertesyndrom.
English: The 762 patients in the pivotal Phase 3 EMBRACE study (Study 305) had locally recurrent or metastatic breast cancer, and had previously received at least two and a maximum of five chemotherapy regimens, including an anthracycline and a taxane (unless contraindicated).
Danish: De 762 patienter i det pivotale fase 3-studie (EMBRACE, studie 305) havde lokalt recidiverende eller metastaserende brystcancer og havde tidligere gennemgået mindst to og højst fem kemoterapi-kure, herunder en kur med antracyklin og en med taxan (medmindre det var kontraindiceret).
English: The HER2 status of the patients was: 16.1% positive, 74.2% negative and 9.7% unknown, whilst 18.9% of patients were triple negative.
Danish: HER2-status for patienterne var: 16,1 % positive, 74,2 % negative og 9,7 % ukendte, mens 18,9 % af patienterne var trippelt negative.
English: In some patients with normal/abnormal liver enzymes prior treatment with eribulin, increased levels of liver enzymes have been reported with initiation of eribulin treatment.
Danish: Hos nogle patienter med normale/unormale leverenzymer før behandling med eribulin er der blevet rapporteret forhøjede niveauer af leverenzymer, når behandlingen med eribulin blev påbegyndt.
English: In clinical trials, patients with pre-existing neuropathy greater than Grade 2 were excluded.
Danish: I kliniske studier blev patienter med allerede eksisterende neuropati over grad 2 ekskluderet.
English: Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects.
Danish: Gastrointestinal toksicitet i form af anoreksi, kvalme, opkastning, diarré, obstipation og stomatitis er blandt de rapporterede bivirkninger.
English: Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines.
Danish: Svær neutropeni kan håndteres med G-CSF eller lignende efter lægens skøn i henhold til relevante retningslinjer.
English: The safety and efficacy of HALAVEN in children from birth to 18 years of age have not yet been established in soft tissue sarcoma.
Danish: HALAVENs sikkerhed og virkning hos børn fra fødslen til 18 år er endnu ikke klarlagt ved bløddelssarkom.
English: Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
Danish: Neutropeni resulterede i seponering hos < 1 % af patienterne, der fik eribulin.
English: - The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.
Danish: - Øvrige indholdsstoffer: Ethanol og vand til injektionsvæsker, muligvis med meget små mængder saltsyre og natriumhydroxid.
English: Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concentrations.
Danish: Eribulin hæmmer ikke CYP-enzymerne 1A2, 2B6,2C8, 2C9, 2C19, 2D6 eller 2E1 ved relevante kliniske koncentrationer.
English: - Serious skin rashes with blistering of the skin, mouth, eyes and genitals.
Danish: - Alvorligt hududslæt med vabler på huden, i munden, øjnene og kønsdelene.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HALAVEN in one or more subsets of the paediatric population for the treatment of rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med HALAVEN i en eller flere undergrupper af den pædiatriske population ved behandling af rabdomyosarkom og ikke-rabdomyosarkom bløddelssarkom.
English: Administration of HALAVEN at a dose of 0.97 mg/m2 to patients with mild hepatic impairment and 0.62 mg/m2 to patients with moderate hepatic impairment resulted in a somewhat higher exposure than after a dose of 1.23 mg/m2 to patients with normal hepatic function.
Danish: Indgivelse af HALAVEN ved en dosis på 0,97 mg/m2 til patienter med let nedsat leverfunktion og 0,62 mg/m2 til patienter med moderat nedsat leverfunktion resulterede i en noget større eksponering end efter en dosis på 1,23 mg/m2 til patienter med normal leverfunktion.
English: Tél: + (33) 1 47 67 00 05
Danish: Eisai SAS Tél: + (33) 1 47 67 00 05
English: Adverse Reactions - all Grades Very Common (Frequency %)
Danish: Systemorganklasse Bivirkninger - alle grader Meget almindelig (Hyppighed %)
English: Neutropenia was reported as a Treatment Emergent Adverse Event (TEAE) in 151/404 (37.4% for all grades) in the sarcoma population, compared with 902/1559 (57.9% for all grades) in the breast cancer population.
Danish: Neutropeni blev rapporteret som en bivirkning, der opstod som følge af behandlingen (Treatment Emergent Adverse Event, TEAE) hos 151/404 (37,4 % for alle grader) i populationen med sarkom, sammenlignet med 902/1.559 (57,9 % for alle grader) i populationen med brystcancer.
English: In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
Danish: Hos brystcancerpatienter med allerede eksisterende grad 1 eller 2 perifer neuropati var hyppigheden af grad 3 perifer neuropati, der opstod under behandlingen, 14 %.
English: Eribulin exposure (AUC and Cmax) was unaffected by ketoconazole, a CYP3A4 and P glycoprotein (Pgp) inhibitor, and rifampicin, a CYP3A4 inducer.
Danish: Eksponeringen for eribulin (AUC og Cmax) blev ikke påvirket af ketoconazol, en CYP3A4- og Pglykoprotein- (Pgp-) hæmmer, eller rifampicin, en CYP3A4-induktor.
English: Women of childbearing age should use effective contraception during and up to 3 months after treatment with HALAVEN.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med HALAVEN og 3 måneder efter behandlingen.
English: The second Phase 3 study in earlier line metastatic breast cancer, Study 301, was an open-label, randomized, study in patients (n=1102) with locally advanced or metastatic breast cancer to investigate the efficacy of HALAVEN monotherapy compared to capecitabine monotherapy in terms of OS and PFS as co-primary endpoint.
Danish: Det andet fase 3-studie af metastatisk brystcancer i tidligere stadie, studie 301 var et open-label, randomiseret studie hos patienter (n=1.102) med lokalt fremskreden eller metastatisk brystcancer for at undersøge virkningen af HALAVEN-monoterapi i forhold til capecitabin-monoterapi med samlet overlevelse og PFS som sammensat primært endepunkt.
English: The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following: - Absolute neutrophil count (ANC) < 1 x 109/l - Platelets < 75 x 109/l - Grade 3 or 4 non-hematological toxicities.
Danish: Indgivelsen af HALAVEN bør udsættes på Dag 1 eller Dag 8 i følgende tilfælde: - Absolut neutrofiltal (ANC) < 1 x 109/l - Trombocytter < 75 x 109/l - Grad 3 eller 4 ikke-hæmatologiske toksiciteter.
English: P value (log rank)
Danish: P-værdi (log rank)
English: - Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion.
Danish: - Feber med en galoperende puls, hurtig overfladisk vejrtrækning, kold, bleg, klam eller spættet hud og/eller forvirring.
English: There is no study in patients with hepatic impairment due to cirrhosis.
Danish: Der foreligger ingen studier af patienter med nedsat leverfunktion på grund af cirrose.
English: Out of 1963 breast cancer and soft tissue sarcoma patients who received eribulin at the recommended dose in clinical trials there was one fatal event each of neutropenic sepsis (0.1%) and febrile neutropenia (0.1%).
Danish: Ud af 1.963 patienter med brystcancer eller bløddelssarkom, som fik eribulin i den anbefalede dosis i kliniske studier, var der et dødeligt tilfælde af neutropenisk sepsis (0,1 %) og et dødeligt tilfælde af febril neutropeni (0,1 %).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om HALAVEN findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Febrile neutropenia occurred in < 5% of patients treated with eribulin.
Danish: Febril neutropeni forekom hos < 5 % af patienter behandlet med eribulin.
English: How to use HALAVEN
Danish: Sådan skal du bruge HALAVEN
English: Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy.
Danish: Ud af de 404 sarkompatienter seponerede 2 patienter eribulin på grund af perifer neuropati.
English: Talk to your doctor or nurse before using HALAVEN: - if you have liver problems - if you have a fever or an infection - if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness - if you have heart problems
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger HALAVEN - hvis du har leverproblemer - hvis du har feber eller en infektion - hvis du oplever følelsesløshed, prikkende, stikkende fornemmelser, følsomhed over for berøring eller muskelsvaghed - hvis du har hjerteproblemer
English: Unchanged eribulin was the major circulating species in plasma following administration of 14C
Danish: Uomdannet eribulin var det hovedsagelige cirkulerende stof i plasma efter indgivelse af 14C-eribulin til patienter.
English: The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Danish: De hyppigst rapporterede bivirkninger i forbindelse med HALAVEN er knoglemarvssuppression i form af neutropeni, leukopeni, anæmi og trombocytopeni med tilhørende infektioner.
English: A study evaluated the pharmacokinetics of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=4) hepatic impairment due to liver metastases.
Danish: Et studie evaluerede eribulins farmakokinetik hos patienter med let (Child-Pugh A, n=7) og moderat (Child-Pugh B, n=4) nedsat leverfunktion på grund af levermetastaser.
English: Read the package leaflet before use.
Danish: Intravenøs anvendelse Læs indlægssedlen inden brug.
English: It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.
Danish: Det anvendes også hos voksne med fremskreden eller metastatisk liposarkom (en type cancer, der opstår fra fedtvævet), når tidligere behandling er prøvet, men ikke længere virker.
English: Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Danish: Patienter med alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) >3 x den øvre normalgrænse (ULN) oplevede en højere forekomst af grad 4 neutropeni og febril neutropeni.
English: Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus assay.
Danish: Eribulin var positiv i en mutagenese-assay af muselymfom, og det var klastogent i en in vivo micronukleus-assay hos rotter.
English: The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively.
Danish: De kombinerede hyppigheder for TEAE og unormale neutrofiltal var hhv. 307/404 (76,0 %) og 1.314/1.559 (84,3 %).
English: Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 3-fold in patients with mild and moderate hepatic impairment, respectively.
Danish: Sammenlignet med patienter med normal leverfunktion (n=6), var eribulins eksponering forhøjet 1,8 gange og tre gange hos patienter med hhv. let og moderat nedsat leverfunktion.
English: Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic anion (OAT1, OAT3, OATP1B1, OATP1B3), multi-drug resistance-associated protein (MRP2, MRP4) and bile salt export pump (BSEP) transporters.
Danish: Eribulin er ikke substrat for brystcancer-resistensprotein(BCRP), organisk anion- (OAT1, OAT3, OATP1B1, OATP1B3), multidrug-resistensprotein- (MRP2, MRP4) og galdesalt-eksportpumpe- (BSEP) transportørerne .
English: Nominal P value (log rank)
Danish: Nominel P-værdi (log rank)
English: Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Danish: Behandling med eribulin skal kun påbegyndes hos patienter med absolut antal neutrofile ≥ 1,5 x 109/l og trombocytter > 100 x 109/l.
English: Platelets < 25 x 109/l thrombocytopenia Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion Non-haematological:
Danish: Trombocytter < 25 x 109/l trombocytopeni Trombocytter < 50 x 109/l trombocytopeni kompliceret af blødning eller som kræver blod- eller trombocyttransfusion
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis der er kontakt med slimhinder, skal slimhinderne skylles grundigt med vand.
English: Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Danish: Johnsons syndrom/ Toksisk epidermal nekrolyse b
English: Musculoskeletal pain Musculoskeletal chest pain
Danish: Muskuloskeletale smerter Muskuloskeletale brystsmerter
English: In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Danish: Hos de 1.559 brystcancerpatienter var den bivirkning, som hyppigst resulterede i seponering af eribulin, perifer neuropati (3,4 %).
English: However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
Danish: Patienter med allerede eksisterende neuropati grad 1 eller 2 var imidlertid ikke mere tilbøjelige til at udvikle nye eller forværrede neuropati symptomer end patienter, der indgik i studiet uden neuropati.
English: Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see section 5.1).
Danish: Svær neutropeni kan behandles med granulocyt-kolonistimulerende faktor (G-CSF) eller lignende efter lægens skøn i henhold til relevante retningslinjer (se pkt.
English: aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
Danish: b aCox proportional hazard bStratificeret af geografisk region, HER2/neu-status og tidligere capecitabinbehandling.
English: The positive effect on OS was seen both in capecitabine-naïve and in capecitabine pre-treated patient groups.
Danish: Den positive virkning på den samlede overlevelse blev set både hos capecitabin-naive og capecitabinforbehandlede patientgrupper.
English: HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1).
Danish: HALAVEN er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk brystcancer med sygdomsprogression efter mindst ét kemoterapiregime for fremskreden sygdom (se pkt.
English: Tél/Tel: + 32 (0)800 158 58 (Belgique/Belgien) Magyarország
Danish: Tél/Tel: + 32 (0)800 158 58 (Belgique/Belgien)
English: Despite reduction to 0.62 mg/m2
Danish: Trods reduktion til 0,62 mg/m2
English: In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age.
Danish: Ud af de 404 sarkompatienter, der blev behandlet med eribulin, var 90 patienter (22,3 %) ≥ 65 år.
English: Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
Danish: Eribulin er embryotoksisk, føtotoksisk og teratogent hos rotter.
English: In clinical trials, patients with pre-existing neuropathy were as likely to develop new or worsening symptoms as those who entered the study without the condition.
Danish: I de kliniske studier var det lige så sandsynligt, at patienter med allerede eksisterende neuropati udviklede nye eller forværrede symptomer end patienter, der indgik i studiet uden neuropati.