FrancophonIA/ELRC3.0 huggingface dataset:
English: · Developed disease recurrence during or within six months of completing adjuvant therapy.
Danish: ● have udviklet sygdomsrecidiv under adjuverende behandling eller inden for seks måneder efter, den adjuverende behandling er afsluttet.
English: For patients randomised to trastuzumab emtansine, the median age was 53 years, most patients were female (99.8%), the majority were Caucasian (72%), and 57% had oestrogen-receptor and/or progesterone-receptor positive disease.
Danish: Medianalder for patienter randomiseret til trastuzumabemtansin var 53 år; de fleste patienter var kvinder (99,8%), størstedelen var kaukasere (72%), og 57% havde østrogen-receptor- og/eller progesteron-receptorpositiv sygdom.
English: The study compared the safety and efficacy of trastuzumab emtansine with that of lapatinib plus capecitabine.
Danish: Studiet sammenlignede trastuzumabemtansins sikkerhed og virkning med sikkerheden og virkningen af lapatinib plus capecitabin.
English: The majority of ADRs reported were of Grade 1 or 2 severity.
Danish: De fleste af de indberettede bivirkninger var af sværhedsgrad 1 eller 2.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Figure 3 Kaplan-meier curve of overall survival
Danish: Figur 3 Kaplan-Meier-kurver for samlet overlevelse
English: Treat at the same dose level
Danish: Giv samme dosisniveau
English: Blood alkaline phosphatase increased, blood bilirubin increased
Danish: Forhøjet alkalisk fosfatase i blodet, forhøjet bilirubin i blodet
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Danish: Opbevar altid lægemidlet i den lukkede originalpakke i køleskab, ved en temperatur på 2ºC - 8ºC.
English: Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%)
Danish: Trastuzumabemtansin (N=490) Alle grader (%) Grad 3 (%)
English: Kadcyla (trastuzumab emtansine) and Herceptin (trastuzumab) are two very different products with different active substances never to be used interchangeably.
Danish: Kadcyla (trastuzumabemtansin) og Herceptin (trastuzumab) er to meget forskellige lægemidler med forskellige aktive indholdsstoffer, og de må aldrig erstatte hinanden.
English: Grade 3 or 4 increased AST and ALT were reported in 4.2% and 2.7% of patients with MBC respectively and usually occurred in the early treatment cycles (1-6).
Danish: Der er indberettet ASAT- og ALAT-forhøjelser grad 3 og 4 hos henholdsvis 4,2% og 2,7% af patienterne med mBC; disse forekom sædvanligvis i de første behandlingscyklusser (1-6).
English: Your doctor or nurse will check to see whether you are having any of these side effects.
Danish: Lægen eller sundhedspersonalet vil holde øje med, om du får disse bivirkninger.
English: DM1 was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Danish: DM1 var ikke mutagent i en in vitro bakteriel mutationstest (Ames).
English: The median duration of response by IRC was not reached (95% CI, 4.6 months to not estimable).
Danish: Medianværdi for varighed af respons, vurderet af en uafhængig komité, blev ikke nået (95% konfidensinterval 4,6 måneder til ikke estimérbar).
English: No fertility studies in animals have been performed to evaluate the effect of trastuzumab emtansine.
Danish: Der er ikke udført fertilitetsstudier med dyr for at evaluere effekten af trastuzumabemtansin.
English: Tumor prognostic characteristics including hormone receptor status (positive: 72.3%, negative: 27.7%), clinical stage at presentation (inoperable: 25.3%, operable: 74.8%) and pathological nodal status after preoperative therapy (node positive: 46.4%, node negative or not evaluated: 53.6%) were similar in the study arms.
Danish: Tumorprognostiske karakteristika omfattede hormonreceptorstatus (positiv: 72,3%, negativ: 27,7%), klinisk stadie ved præsentation (inoperabel: 25,3%, operabel: 74,8%) og patologisk nodalstatus efter præ-operativ behandling (nodalpositiv: 46,4%, nodalnegativ eller ikke vurderet: 53,6%) var ensartet behandlingsarmene imellem.
English: In the post-marketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab.
Danish: Der er efter markedsføring indberettet tilfælde af oligohydramnios, nogle forbundet med dødelig lungehypoplasi, hos gravide kvinder behandlet med trastuzumab.
English: If not used immediately, the reconstituted vials can be stored for up to 24 hours at 2°C to 8°C, provided it was reconstituted under controlled and validated aseptic conditions, and must be discarded thereafter.
Danish: Hvis det ikke anvendes straks, kan de rekonstituerede hætteglas opbevares i op til 24 timer ved 2°C til 8°C, forudsat at rekonstituering fandt sted under kontrollerede og validerede aseptiske forhold.
English: Kadcyla delayed patient-reported time to symptom progression for 7.1 months compared with 4.6 months for the control arm (Hazard Ratio 0.796 (0.667, 0.951); p-value 0.0121).
Danish: Kadcyla forsinkede patient-rapporteret tid til symptomprogression i 7,1 måned sammenlignet med 4,6 måned i kontrolarmen (hazard ratio 0,796 (0,667; 0,951); p-værdi 0,0121).
English: · If the first infusion is well tolerated, the infusion on your next visit may be given over 30 minutes.
Danish: · Hvis du tåler den første infusion godt, kan næste infusion gives i løbet af 30 minutter.
English: The MAH shall agree the content and format of the Kadcyla (trastuzumab emtansine) educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla (trastuzumab emtansine) is launched in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal aftale indholdet og formen af uddannelsesmateriale for Kadcyla (trastuzumabemtansin) og en kommunikationsplan med den relevante nationale myndighed før lancering af Kadcyla (trastuzumabemtansin) i hvert enkelt medlemsland.
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab emtansine in all subsets of the paediatric population in 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 trastuzumabemtansin i alle undergrupper af den pædiatriske population ved indikationen brystkræft (se pkt.
English: No accumulation of trastuzumab emtansine was observed after repeated dosing of intravenous infusion every 3 weeks.
Danish: Der er ikke set akkumulering af trastuzumabemtansin efter gentagen dosering ved intravenøs infusion hver 3. uge.
English: In study TDM4370g/BO21977, consistent treatment benefit of trastuzumab emtansine was seen in the majority of pre-specified subgroups evaluated, supporting the robustness of the overall result.
Danish: I studie TDM4370g/BO21977 sås vedvarende gavn af behandling med trastuzumabemtansin hos størstedelen af de evaluerede, præ-specificerede subgrupper, hvilket understøtter de overordnede resultaters robusthed.
English: Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated.
Danish: Infusionsrelaterede reaktioner forsvandt i løbet af adskillige timer til en dag, efter infusion var afsluttet.
English: Patients with baseline elevation of ALT (e.g. due to liver metastases) may be predisposed to liver injury with a higher risk of a Grade 3-5 hepatic event or liver function test increase.
Danish: Patienter med forhøjet baseline-ALAT (f.eks. pga. levermetastaser) kan være disponeret for leverskade med højere risiko for hepatiske bivirkninger af grad 3-5 eller forhøjede værdier af leverfunktionsundersøgelser.
English: Figure 1 Kaplan-Meier Curve of Invasive Disease-Free Survival in KATHERINE
Danish: Figur 1 Kaplan-Meier-kurver over overlevelse uden invasiv sygdom i KATHERINE
English: · Use effective contraception to avoid becoming pregnant while you are being treated with Kadcyla.
Danish: · Du skal bruge sikker prævention for at undgå at blive gravid, mens du er i behandling med
English: Women may begin breast-feeding 7 months after concluding treatment.
Danish: Amning kan påbegyndes 7 måneder efter, behandlingen er afsluttet.
English: It must be verified that the non-proprietary name is trastuzumab emtansine.
Danish: Det skal bekræftes, at det generiske navn er trastuzumabemtansin.
English: No relationship was observed between trastuzumab emtansine exposure (AUC), trastuzumab emtansine maximum serum concentration (Cmax), total trastuzumab exposure (AUC), or Cmax of DM1 and increases in transaminase.
Danish: Der sås ingen sammenhæng mellem trastuzumabemtansin-eksponering (AUC), maksimal serumkoncentration af trastuzumabemtansin (Cmax), total trastuzumab-eksponering (AUC) eller Cmax af DM1 og aminotransferase-stigninger.
English: A cumulative effect on transaminases has also been observed (the proportion of patients with Grade 1-2 ALT/AST abnormalities increases with successive cycles).
Danish: Der er også observeret en kumulativ effekt på aminotransferaser (andelen af patienter med grad 1-2 ALAT/ASATafvigelser øges med antallet af serier).
English: Tell your doctor or nurse straight away if you notice any of the following serious side effects while you are given Kadcyla:
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du oplever én eller flere af følgende alvorlige bivirkninger, mens du får Kadcyla:
English: In some of the observed cases the patients had thrombocytopenia, or were also receiving anti-coagulant therapy or antiplatelet therapy; in others there were no known additional risk factors.
Danish: I nogle af de observerede tilfælde havde patienterne trombocytopeni eller var også i antikoagulant eller antitrombotisk behandling, mens der i andre tilfælde ikke var yderligere kendte risikofaktorer.
English: In the GLP toxicity studies, with the exception of irreversible peripheral axonal toxicity (observed only in monkeys at ³ 10 mg/kg) and reproductive organ toxicity (observed only in rats at 60 mg/kg), partially or completely reversible dose dependent toxicities were identified in both animal models.
Danish: Med undtagelse af irreversibel perifer aksonal toksicitet (kun observeret hos aber ved ³10 mg/kg) og toksisk virkning på reproduktionsorganer (kun observeret hos rotter ved 60 mg/kg) er der i GLP-toksicitetsstudier set delvist eller fuldstændigt reversibel, dosisafhængig toksicitet i begge dyremodeller.
English: No formal pharmacokinetic study has been conducted and no population PK data was collected in patients with severe hepatic impairment (Child-Pugh class C).
Danish: Der er ikke udført formelt farmakokinetisk studie eller indsamlet farmakokinetiske populationsdata hos patienter med svært nedsat leverfunktion (Child-Pugh class C).
English: Some symptoms could be yellowing of your skin and whites of your eyes (jaundice).
Danish: Eventuelle symptomer kan være gulfarvning af huden og det hvide i øjet (gulsot).
English: You should tell your doctor immediately if you notice any of the above symptoms.
Danish: Du skal straks fortælle lægen, hvis du bemærker et af de symptomer, som er beskrevet ovenfor.
English: Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with trastuzumab emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity.
Danish: Samtidig brug af potente CYP3A4-hæmmere (fx ketoconazol, itraconazol, clarithromycin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) og trastuzumabemtansin bør undgås på grund af risiko for øget DM1-eksponering og toksicitet.
English: The median PFS was 9.2 months in the trastuzumab plus docetaxel arm and 14.2 months in the trastuzumab emtansine arm (hazard ratio, 0.59; p = 0.035), with a median follow-up of approximately 14 months in both arms.
Danish: Den mediane progressionsfri overlevelse var 9,2 måneder i trastuzumab plus docetaxel-armen og 14,2 måneder i trastuzumabemtansin-armen (hazard ratio 0,59; p=0,035) med en median opfølgningstid på ca. 14 måneder i begge arme.
English: The liver is a primary organ for eliminating DM1 and DM1-containing catabolites.
Danish: Leveren er det primære organ til eliminering af DM1 og DM1-holdige katabolitter.
English: Patients should be clinically monitored on an ongoing basis for signs/symptoms of neurotoxicity.
Danish: Patienter skal monitoreres løbende for tegn eller symptomer på neurotoksicitet.
English: Requirement for further dose reduction
Danish: Behov for yderligere dosisreduktion
English: · Neurological problems: Kadcyla can damage nerves.
Danish: · Nerve (neurologiske) problemer: Kadcyla kan beskadige nerverne.
English: · Liver problems: Kadcyla can cause inflammation or damage to cells in the liver that can stop the liver from functioning normally.
Danish: · Leverproblemer: Kadcyla kan forårsage inflammation i eller beskadige leverceller, som kan forårsage, at leveren holder op med at virke normalt.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC)
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2ºC - 8ºC)
English: There is no known antidote for trastuzumab emtansine overdose.
Danish: Der er ingen kendt antidot mod overdosering med trastuzumabemtansin.
English: If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying trastuzumab emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
Danish: Hvis samtidig brug af en potent CYP3A4-hæmmer ikke kan undgås, kan det overvejes at udsætte trastuzumabemtansin-behandlingen, indtil den potente CYP3A4-hæmmer er ude af blodet (ca. 3 halveringstider for hæmmeren), hvis dette er muligt.
English: Patients should be observed closely for hypersensitivity/allergic reactions, which may have the same clinical presentation as an IRR.
Danish: Patienterne skal observeres nøje for overfølsomheds-/allergiske reaktioner, som kan manifestere sig klinisk på samme måde som en infusionsrelateret reaktion.
English: Baseline patient and tumour characteristics were well balanced between treatment groups.
Danish: Patient- og tumorkarakteristika ved baseline var velafbalanceret mellem behandlingsgrupperne.
English: · Bleeding problems: Kadcyla can lower the number of platelets in your blood.
Danish: · Blødningsproblemer: Kadcyla kan få antallet af blodplader i blodet til at falde.
English: It is recommended that platelet counts are monitored prior to each trastuzumab emtansine dose.
Danish: Det anbefales at monitorere trombocytværdier inden hver dosis trastuzumabemtansin.
English: Pulmonary Toxicity Interstitial lung disease (ILD) or pneumonitis
Danish: Interstitiel lungesygdom (ILD) eller pneumonitis
English: ADRs were reported using NCI-CTCAE for assessment of toxicity.
Danish: NCI-CTCAE er anvendt til vurdering af toksicitet i forbindelse med indberetning af bivirkningerne.
English: Left Ventricular Dysfunction
Danish: Dysfunktion af venstre ventrikel
English: Neutropenia, Leucopoenia
Danish: Neutropeni, leukopenia
English: Patients with thrombocytopenia (≤ 100,000/mm3) and patients on anti-coagulant treatment (e.g. warfarin, heparin, low molecular weight heparins) should be monitored closely while on trastuzumab emtansine treatment.
Danish: Patienter med trombocytopeni (≤100.000/mm3) og patienter i antikoagulansbehandling (fx warfarin, heparin, lavmolekylære hepariner) skal monitoreres tæt under behandling med trastuzumabemtansin.
English: However, in most cases during Kadcyla treatment, liver enzyme levels are elevated mildly and temporarily, do not cause any symptoms, and do not affect liver function.
Danish: I de fleste tilfælde er mængden af leverenzymer dog kun let og kun midlertidigt forhøjet; der er ingen symptomer, og leverfunktionen påvirkes ikke.
English: Table 2 Dose Modification Guidelines Dose Modifications for Patients with EBC Adverse reaction Severity
Danish: Tabel 2 Vejledning i dosisændring Dosisændringer hos patienter med eBC
English: In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
Danish: I fase I- og fase II-studier blev 6,4% (24/376) af patienterne testet positive for antitrastuzumabemtansin-antistoffer.
English: · Heart problems: Kadcyla can weaken the heart muscle.
Danish: · Hjerteproblemer: Kadcyla kan svække hjertemusklen.
English: What Kadcyla contains · The active substance is trastuzumab emtansine.
Danish: Kadcyla indeholder: · Aktivt stof: trastuzumabemtansin.
English: Patients were treated with trastuzumab emtansine or trastuzumab for a total of 14 cycles unless there was recurrence of disease, withdrawal of consent, or unacceptable toxicity, whichever occurred first.
Danish: Patienterne blev behandlet med trastuzumabemtansin eller trastuzumab ved i alt 14 serier, med mindre der var sygdomsrecidiv, samtykket blev trukket tilbage eller der opstod uacceptabel toksicitet, alt efter hvad der forekom først.
English: Hepatotoxicity, Hepatic failure, Nodular regenerative hyperplasia, Portal hypertension
Danish: Levertoksicitet, leversvigt, nodulær regenerativ hyperplasi, portal hypertension
English: Kadcyla (trastuzumab emtansine) is NOT a generic version of Herceptin (trastuzumab) and has different properties, indications and dose.
Danish: Kadcyla (trastuzumabemtansin) er IKKE en generisk version af Herceptin (trastuzumab), og de 2 lægemidler har forskellige egenskaber, indikationer og doseringer.
English: Left ventricular ejection fraction (LVEF) < 40% has been observed in patients treated with trastuzumab emtansine, and therefore symptomatic congestive heart failure (CHF) is a potential risk (see section 4.8).
Danish: Der er set venstre ventrikel uddrivningsfraktion (LVEF) <40% hos patienter behandlet med trastuzumabemtansin, og symptomatisk hjertesvigt er derfor en potentiel risiko (se pkt.
English: How much you will be given · You will be given 3.6 mg of Kadcyla for every kilogram of your body weight.
Danish: · Du vil få 3,6 mg Kadcyla for hvert kilo, du vejer.
English: Patients with treated brain metastases were eligible for enrollment if they did not require therapy to control symptoms.
Danish: Patienter behandlet for hjernemetastaser kunne inkluderes, hvis de ikke havde behov for symptomkontrollerende behandling.
English: Biotransformation (trastuzumab emtansine and DM1) Trastuzumab emtansine is expected to undergo deconjugation and catabolism by means of proteolysis in cellular lysosomes.
Danish: Biotransformation (trastuzumabemtansin og DM1) Trastuzumabemtansin forventes at dekonjugeres og kataboliseres ved proteolyse i cellulære lysosomer.
English: Left ventricular dysfunction occurred in 3.0% of patients with EBC, with Grade 3 or 4 in 0.5% of patients.
Danish: Dysfunktion af venstre ventrikel sås hos 3,0% af patienterne med eBC, i grad 3 eller 4 hos 0,5% af patienterne.
English: Trastuzumab, a component of trastuzumab emtansine, can cause foetal harm or death when administered to a pregnant woman.
Danish: Trastuzumab, en komponent i trastuzumabemtansin, kan forårsage fosterskader eller fosterdød, hvis det administreres til en gravid kvinde.
English: In the KATHERINE (BO27938) study, 3.7% (15/401) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 5 were also positive for neutralizing antibodies.
Danish: I KATHERINE-studiet (BO27938) blev 3,7% (15/401) af patienterne testet positive for anti-trastuzumabemtansin-antistoffer, hvoraf 5 også var positive for neutraliserende antistoffer.
English: Administration of trastuzumab emtansine was well tolerated in rats and monkeys at doses up to 20 and 10 mg/kg, respectively, corresponding to 2040 mg DM1/m2 in both species, which is approximately equivalent to the clinical dose of trastuzumab emtansine in patients.
Danish: Administration af trastuzumabemtansin er veltolereret hos rotter og aber i doser op til henholdsvis 20 og 10 mg/kg, svarende til 2.040 mg DM1/m2 i begge arter, hvilket nogenlunde svarer til den kliniske dosis af trastuzumabemtansin til patienter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/885/001
English: Pharmacokinetics of trastuzumab emtansine in patients with mild (creatinine clearance CLcr 60 to 89 mL/min, n = 254) or moderate (CLcr 30 to 59 mL/min, n = 53) renal impairment were similar to those in patients with normal renal function (CLcr ³ 90 mL/min, n = 361).
Danish: Trastuzumabemtansins farmakokinetik hos patienter med let (kreatinin-clearance CLcr 60-89 ml/min, n=254) eller moderat (CLcr 30-59 ml/min, n=53) nedsat nyrefunktion svarede til det, der sås hos patienter med normal nyrefunktion (CLcr ³90 ml/min, n=361).
English: General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age (> 50 years), low baseline LVEF values (< 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI (> 25 kg/m2).
Danish: Generelle risikofaktorer for kardiale bivirkninger, og de, der er identificeret i brystkræftstudier med trastuzumab som adjuverende behandling, inkluderer stigende alder (>50 år), lav LVEF ved baseline (<55%), lav LVEF inden eller efter adjuverende behandling med paclitaxel, tidligere eller samtidig brug af antihypertensiva, tidligere behandling med et antracyklin og højt BMI (>25 kg/m2).
English: Platelets help your blood to clot so you might get unexpected bruising or bleeding (such as nose bleeds, bleeding from gums).
Danish: Blodplader får dit blod til at størkne, så du kan opleve uventede blå mærker eller blødninger (fx næseblod eller blødning fra tandkødet).
English: Over time, this may lead to symptoms such as a bloated sensation or swelling of the abdomen due to fluid accumulation or bleeding from abnormal blood vessels in the gullet or rectum.
Danish: Over tid kan dette give symptomer som oppustethed eller opsvulmet mave på grund væskeophobning eller blødning fra unormale blodkar i spiserøret eller endetarmen.
English: Observed cases may have been confounded by comorbidities and/or concomitant medicinal products with known hepatotoxic potential.
Danish: De observerede tilfælde kan have været påvirket af co-morbiditet og/eller samtidig behandling med andre lægemidler med kendt levertoksisk potentiale.
English: If a strong CYP3A4 inhibitor is coadministered and trastuzumab emtansine treatment cannot be delayed, patients should be closely monitored for adverse reactions.
Danish: Hvis en potent CYP3A4-hæmmer administreres samtidig, og trastuzumabemtansin ikke kan udsættes, skal patienten monitoreres omhyggeligt for bivirkninger.
English: It is recommended that treatment with trastuzumab emtansine be permanently discontinued in patients who are diagnosed with ILD or pneumonitis, except for radiation pneumonitis in the adjuvant setting, where trastuzumab emtansine should be permanently discontinued for ³ Grade 3 or for Grade 2 not responding to standard treatment.
Danish: Det anbefales at seponere behandlingen med trastuzumabemtansin permanent hos patienter, der diagnosticeres med interstitiel lungesygdom eller pneumonitis, bortset fra strålepneumonitis ved adjuverende behandling, hvor trastuzumabemtansin skal seponeres permanent ved ³Grad 3 eller ved Grad 2, hvis der ikke er respons på standardbehandling (se pkt.
English: Epistaxis, Cough, Dyspnoea
Danish: Epistaxis, hoste, dyspnø
English: Developmental toxicity of trastuzumab has been identified in the clinical setting although it was not predicted in the non-clinical program.
Danish: Det er i kliniske rammer vist, at trastuzumab er udviklingstoksisk, selvom det ikke var forudset i det præ-kliniske program.