FrancophonIA/ELRC3.0 huggingface dataset:
English: An updated RMP should be submitted: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: ● når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Patients with dyspnoea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary events.
Danish: Patienter med hviledyspnø på grund af komplikationer fra fremskreden malignitet og/eller co-morbiditet, og som samtidig får strålebehandling af lungerne, kan have øget risiko for pulmonale bivirkninger.
English: The significance of reported adverse reactions such as fatigue, headache, dizziness and blurred vision on the ability to drive or use machines is unknown.
Danish: Betydningen af indberettede bivirkninger som fx træthed, hovedpine, svimmelhed og sløret syn på evnen til at føre motorkøretøj og betjene maskiner er ukendt.
English: Standard cardiac function testing (echocardiogram or multigated acquisition (MUGA) scanning) should be performed prior to initiation of treatment and also at regular intervals (e.g. every three months) during treatment.
Danish: Der bør udføres standardtest af hjertefunktion (ekkokardiogram eller isotopkardiografi (MUGAscanning)) inden behandlingsstart samt med jævne mellerum (fx hver 3. måned) under behandlingen.
English: Kadcyla should only be prescribed by a physician and administered as an intravenous infusion under the supervision of a healthcare professional who is experienced in the treatment of cancer patients (i.e. prepared to manage allergic/anaphylactic infusion reactions and in an environment where full resuscitation facilities are immediately available (see section 4.4)).
Danish: Kadcyla skal ordineres af en læge med erfaring i behandling af kræftpatienter og administreres som intravenøs infusion under supervision af erfarne sundhedspersoner (dvs. klar til at håndtere allergiske/anafylaktiske infusionsreaktioner og med umiddelbar adgang til komplette genoplivningsfaciliteter (se pkt.
English: Increased transaminases were reported in 32.4% of patients with EBC.
Danish: Forhøjede transaminaser var indberettet hos 32,4% af patienterne med eBC.
English: In case of overdose, the patient should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosis skal patienten monitoreres nøje for bivirkninger og relevant symptomatisk behandling institueres.
English: The recommended dose of trastuzumab emtansine is 3.6 mg/kg bodyweight administered as an intravenous infusion every 3 weeks (21-day cycle).
Danish: Anbefalet dosis trastuzumabemtansin er 3,6 mg/kg kropsvægt administreret som intravenøs infusion hver 3. uge (21-dages cyklus).
English: · If the Kadcyla infusion solution leaks into the area around the infusion site you may develop tenderness or redness of your skin, or swelling at the infusion site.
Danish: · Hvis Kadcyla-infusionsvæsken siver ud i vævet omkring infusionsstedet, kan du opleve ømhed, rødme eller hævelse af huden omkring infusionsstedet.
English: If you get any of the side effects after your treatment with Kadcyla has stopped, talk to your doctor or nurse and tell them that you have been treated with Kadcyla.
Danish: Hvis du oplever én eller flere af disse bivirkninger, efter du har afsluttet behandlingen med Kadcyla, skal du kontakte lægen eller sundhedspersonalet og fortælle dem, at du har fået Kadcyla.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/885/002
English: Grade 3 or 4 events were reported in 0.4% of patients with MBC.
Danish: Grad 3 eller 4 tilfælde indberettedes hos 0,4% af patienterne med mBC.
English: Table 1 Dose reduction schedule
Danish: Tabel 1 Skema for dosisreduktion
English: The median number of anti-cancer agents that patients had received in any setting was 8.5 (range, 5-19) and in the metastatic setting was 7.0 (range, 3-17), including all agents intended for the treatment of breast cancer.
Danish: Det mediane antal kræftmidler, som disse patienter havde fået, var 8,5 (5-19), og 7,0 (3-17) for metastatisk sygdom alene, inkluderende alle lægemidler anvendt til behandling af brystkræft.
English: If the LVEF remains < 50% and has not recovered to < 10% points from baseline, discontinue trastuzumab emtansine.
Danish: Hvis LVEF fortsat er <50% og ikke er forbedret til <10% point fra baseline, skal trastuzumabemtansin seponeres
English: · Breathing problems: Kadcyla can cause serious breathing problems such as shortness of breath (either at rest or while performing any type of activity) and cough.
Danish: · Vejrtrækningsproblemer: Kadcyla kan forårsage alvorlige vejrtrækningsproblemer som åndenød (i hvile eller ved aktivitet) og hoste.
English: 10.8 months and not reached, respectively, compared with 5.7 months and 27.9 months, respectively, for the lapatinib plus capecitabine group.
Danish: Medianværdier for progressionfri overlevelse og samlet overlevelse var i trastuzumabemtansingruppen henholdsvis 10,8 måneder og ikke nået, sammenlignet med henholdsvis 5,7 måneder og 27,9 måneder i lapatinib plus capecitabin-gruppen.
English: · the most common National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 3 ADRs (> 2%) were thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
Danish: ● de hyppigste NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) grad ≥3 bivirkninger (>2%) var trombocytopeni, forhøjede aminotransferaser, anæmi, neutropeni, træthed og hypokaliæmi.
English: Dose reductions or discontinuation for increased serum transaminases and total bilirubin are specified in section 4.2.
Danish: Dosisreduktion eller seponering i forbindelse med stigning i aminotransferaser og total-bilirubin er specificeret i pkt.
English: Consider an alternate medicinal product with no or minimal potential to inhibit CYP3A4.
Danish: Alternativt lægemiddel uden eller med minimalt CYP3A4-hæmmende potentiale bør overvejes.
English: Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or
Danish: Symptomatisk hjertesvigt, Grad 3-4 LVSD eller Grad 3-4 hjertesvigt eller Grad 2 hjertesvigt ledsaget af LVEF <45%
English: A cumulative effect of trastuzumab emtansine on transaminases has been observed, and generally recovered when treatment was discontinued.
Danish: Der er observeret en kumulativ effekt af trastuzumabemtansin på aminotransferaser, som generelt rettede sig efter at behandling blev seponeret.
English: Randomization was stratified by clinical stage at presentation (operable vs. inoperable), hormone receptor status, preoperative HER2-directed therapy (trastuzumab, trastuzumab plus additional HER2-directed agent[s]), and pathological nodal status evaluated after preoperative therapy.
Danish: Randomiseringen var stratificeret efter klinisk stadie ved præsentation (operabel vs. inoperabel), hormonreceptor-status, præ-operativ HER2rettet behandling (trastuzumab, trastuzumab plus yderligere HER2-rettet stof(fer)) samt patologisk nodalstatus evalueret efter præ-operativ behandling.
English: The ADRs in 2,611 patients treated with trastuzumab emtansine are presented in Table 3.
Danish: De bivirkninger, der er indberettet fra de 2.611 patienter behandlet med trastuzumabemtansin, vises i tabel 3.
English: Dedicated embryo-foetal development studies have not been conducted in animals with trastuzumab emtansine.
Danish: Der er ikke gennemført specifikke embryo-føtale udviklingsstudier hos dyr med trastuzumabemtansin.
English: Permanently discontinue trastuzumab emtansine in the absence of another likely cause for the elevation of liver enzymes and bilirubin, e.g. liver metastasis or concomitant medication
Danish: Seponér trastuzumabemtansin permanent, hvis der ikke er anden sandsynlig årsag til stigningen i leverenzymer og bilirubin, fx levermetastaser eller anden samtidig behandling
English: Succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Danish: LISTE OVER HJÆLPESTOFFER Ravsyre, natriumhydroxid, saccharose, polysorbat 20.
English: Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are linked together: · trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2).
Danish: Kadcyla indeholder det aktive stof trastuzumabemtansin, som består af 2 dele, der er koblet sammen: · trastuzumab - et monoklonalt antistof, som bindes selektivt til et antigen (mål-protein), som kaldes human epidermal vækstfaktor receptor (HER2).
English: BO27938 (KATHERINE) was a randomized, multicenter, open-label trial of 1486 patients with HER2-positive, early breast cancer with residual invasive tumor (patients who had not achieved pathological complete response (pCR)) in the breast and/or axillary lymph nodes following completion of preoperative systemic therapy that included chemotherapy and HER2-targeted therapy.
Danish: BO27938 (KATHERINE) er et randomiseret, ublindet, multicenter-studie med 1486 patienter med HER2-positiv tidlig brystkræft med invasiv residualtumor (patienter som ikke havde opnået fuldstændigt patologisk respons (pCR)) i bryst og/eller de aksillære lymfekirtler efter færdiggørelse af præ-operativ systemisk behandling inkluderende kemoterapi og HER2-rettet behandling.
English: In the EMILIA study (TDM4370g/BO21977), 5.2% (24/466) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 13 were also positive for neutralizing antibodies.
Danish: I EMILIA-studiet (TDM4370g/BO21977) blev 5,2% (24/466) af patienterne testet positive for anti-trastuzumabemtansin-antistoffer, hvoraf 13 også var positive for neutraliserede antistoffer.
English: In particular, tell your doctor or pharmacist if you are taking: · any medicines to thin your blood such as warfarin or decrease the ability to form blood clot such as aspirin · medicines for fungal infections called ketoconazole, itraconazole or voriconazole · antibiotics for infections called clarithromycin or telithromycin · medicines for HIV called atazanavir, indinavir, nelfinavir, ritonavir or saquinavir.
Danish: Det er særligt vigtigt at fortælle lægen eller apotekspersonalet, hvis du tager: · blodfortyndende medicin, såsom warfarin, eller blodprophæmmende medicin, såsom aspirin · medicin for svampeinfektion, som indeholder ketoconazol, itraconazol eller voriconazol · antibiotika, som indeholder clarithromycin eller telithromycin · HIV-medicin, som indeholder atazanavir, indinavir, nelfinavir, ritonavir eller saquinavir
English: Important information about some of the ingredients of Kadcyla This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Vigtig information om nogle af indholdsstofferne i Kadcyla Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er i det væsentlige natriumfrit.
English: Patient demographics and baseline tumor characteristics were balanced between treatment arms.
Danish: Patientdemografi og tumorkarakteristika ved baseline var balanceret behandlingsarmene imellem.
English: If you experience flushing, shivering fits, fever, trouble breathing, low blood pressure or a rapid heartbeat (infusion-related reaction), blurred vision, tiredness, headache, or dizziness, do not drive, cycle, use tools or machines until these reactions stop.
Danish: Hvis du oplever ansigtsrødme, kulderystelser, feber, åndedrætsbesvær, lavt blodtryk eller hurtig hjerterytme (reaktioner på infusionen), sløret syn, træthed, hovedpine eller svimmelhed, må du ikke føre motorkøretøj, cykle, anvende værktøj eller betjene maskiner, før disse symptomer er forsvundet.
English: Volume (mL) = Total dose to be administered (body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Danish: Volumen (ml) = Totaldosis til administration (kropsvægt (kg) x dosis (mg/kg)) 20 (mg/ml, koncentration af rekonstitueret koncentrat)
English: Administration of trastuzumab emtansine to pregnant women is not recommended and women should be informed of the possibility of harm to the foetus before they become pregnant.
Danish: Administration af trastuzumabemtansin til gravide kvinder frarådes, og kvindelige patienter bør informeres om risikoen for fosterskader, inden de bliver gravide, og om straks at kontakte lægen, hvis de bliver gravide.
English: Continue treatment with trastuzumab emtansine.
Danish: Fortsæt behandling med trastuzumabemtansin.
English: Patients were randomised to receive trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks (n = 67) or trastuzumab 8 mg/kg intravenous loading dose followed by 6 mg/kg intravenously every 3 weeks plus docetaxel 75-100 mg/m2 intravenously every
Danish: Patienterne blev randomiseret til trastuzumabemtansin 3,6 mg/kg intravenøst hver 3. uge (n = 67) eller trastuzumab 8 mg/kg som intravenøs mætningsdosis efterfulgt af 6 mg/kg intravenøst hver 3. uge plus docetaxel 75-100 mg/m2
English: Kadcyla is not recommended if you are pregnant because this medicine may cause harm to the unborn baby.
Danish: Du må ikke få Kadcyla, hvis du er gravid, da lægemidlet kan skade fostret.
English: Cases of overdose have been reported with trastuzumab emtansine treatment, most associated with thrombocytopenia, and there was one death.
Danish: Der har været indberetninger om overdosering med trastuzumabemtansin, oftest forbundet med trombocytopeni, og der har været ét dødsfald.
English: Patients treated with trastuzumab emtansine should have HER2 positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device.
Danish: Patienter behandlet med trastuzumabemtansin skal have HER2-positiv tumorstatus, defineret som en score på 3+ ved immunhistokemi (IHC) eller en ratio ≥2,0 ved in situ-hybridisering (ISH) eller ved fluorescens in situ-hybridisering (FISH) vurderet ved CE-mærket in vitro-diagnostisk (IVD) medicinsk udstyr.
English: A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
Danish: I alt 1.243 patienter fra 7 kliniske forsøg er ved forskellige målepunkter testet for anti-lægemiddelantistofrespons (ADA) på trastuzumabemtansin.
English: All patients were previously treated with HER2-directed therapies (trastuzumab and lapatinib), and chemotherapy (anthracycline, taxane, and capecitabine) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting.
Danish: Alle patienter havde tidligere fået HER2-rettede behandlinger (trastuzumab og lapatinib) og kemoterapi (antracyklin, taxan og capecitabin) som neoadjuverende eller adjuverende behandling ved lokalt fremskreden eller metastatisk sygdom.
English: If the LVEF has not recovered to within 10% points from baseline, discontinue trastuzumab emtansine.
Danish: Hvis LVEF ikke forbedres til inden for 10% point fra baseline, seponeres trastuzumabemtansin.
English: If a prescription for Kadcyla (trastuzumab emtansine) is written electronically, it is important to ensure that the medicinal product prescribed is trastuzumab emtansine and not trastuzumab.
Danish: Hvis Kadcyla (trastuzumabemtansin) ordineres elektronisk, er det vigtigt at sikre, at det lægemiddel, som ordineres, er trastuzumabemtansin og ikke trastuzumab.
English: Common (may affect up to 1 in 10 people): · Flushing, shivering fits, fever, trouble breathing, low blood pressure or a rapid heartbeat during the infusion or up to 24 hours after the infusion - these are so-called infusion-related reactions.
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter): · Ansigtsrødme, kulderystelser, feber, åndedrætsbesvær, lavt blodtryk eller hurtig hjerterytme (puls) under infusionen eller i op til 24 timer efter infusionen - dette er såkaldte infusionsrelaterede reaktioner.
English: Based on population PK analysis, body weight, albumin, sum of longest diameter of target lesions by Response Evaluation Criteria In Solid Tumors (RECIST), HER2 shed extracellular domain (ECD), baseline trastuzumab concentrations, and aspartate aminotransferase (AST) were identified as statistically significant covariates for trastuzumab emtansine PK parameters.
Danish: Baseret på farmakokinetiske populationsanalyser kan kropsvægt, albumin, sum af mållæsions længste diameter vurderet ved RECIST (Response Evaluation Criteria In Solid Tumors), afstødning af HER2ekstracellulært domæne (ECD), trastuzumabkoncentrationer ved baseline og aspartataminotransferase (ASAT) identificeres som statistisk signifikante kovariater for farmakokinetiske parametre for trastuzumabemtansin.
English: Drug Induced Liver Injury (DILI)
Danish: Lægemiddelinduceret leverskade (DILI)
English: A clinically meaningful and statistically significant improvement in IDFS was observed in patients who received trastuzumab emtansine compared with trastuzumab (HR = 0.50, 95% CI [0.39, 0.64], p <0.0001.
Danish: Der sås klinisk betydningsfuldt og statistisk signifikant forbedring i IDFS hos patienter behandlet med trastuzumabemtansin sammenlignet med trastuzumab (HR = 0,50; 95% KI [0,39; 0,64], p <0,0001).
English: - Plasma concentrations of DM1 and DM1-containing catabolites (Lys-MCC-DM1 and MCC-DM1) were low and comparable between patients with and without hepatic impairment.
Danish: Plasmakoncentrationerne af DM1 og DM1-holdige katabolitter (Lys-MCC-DM1 og MCC-DM1) var lave og sammenlignelige for patienter med og uden nedsat leverfunktion.
English: Treatment with trastuzumab emtansine should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until symptoms resolve or improve to ≤ Grade 2.
Danish: Behandling med trastuzumabemtansin skal midlertidigt afbrydes hos patienter med grad 3 eller 4 perifer neuropati indtil symptomerne ophører eller forbedres til ≤ grad 2.
English: Patients in Study TDM4370g/BO21977 and Study BO29738 who received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks had a mean Cycle 1 maximum serum concentration (Cmax) of trastuzumab emtansine of 83.4 (± 16.5) mg/mL and 72.6 (± 24.3) mg/mL, respectively.
Danish: Patienterne i Studie TDM4370g/BO21977 og Studie BO29738, der fik 3,6 mg/kg trastuzumabemtansin intravenøst hver 3. uge, havde en gennemsnitlig maksimal serumkoncentration (Cmax) af trastuzumabemtansin på henholdsvis 83,4 (±16,5) mg/ml og 72,6 (± 24,3) mg/ml.
English: Once the infusion is prepared it should be administered immediately.
Danish: Infusionsvæsken skal administreres straks efter tilberedning.
English: · the cancer has spread to areas near the breast or to other parts of your body (metastasized) · the cancer has not spread to other parts of the body and treatment is going to be given after surgery
Danish: · kræften ikke har spredt sig til andre steder i kroppen, og behandlingen gives efter operation
English: For dose modifications in the event of LVEF decrease, see Table 2 in section 4.2 and section 4.4.
Danish: For dosisændringer i tilfælde af fald i LVEF, se tabel 2 i pkt.
English: ALT = alanine transaminase; AST = aspartate transaminase, CHF = congestive heart failure, LVEF = left ventricular ejection fraction, LVSD = left ventricular systolic dysfunction, TBILI = Total Bilirubin, ULN = upper limit of normal * Prior to starting trastuzumab emtansine treatment.
Danish: ALAT = alanintransaminase; ASAT = aspartattransaminase, LVEF = venstre ventrikels uddrivningsfraktion, LVSD = systolisk dysfunktion af venstre ventrikel *Inden påbegyndelse af behandling med trastuzumabemtansin.
English: Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical trials
Danish: Tabel 3 Skema over bivirkninger hos patienter behandlet med trastuzumabemtansin i kliniske forsøg
English: NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis.
Danish: Nodulær regenerativ hyperplasi bør overvejes hos alle patienter med kliniske symptomer på portal hypertension og/eller cirrose-lignende mønster ved CTscanning af leveren, men med normale aminotransferaser og ingen andre cirrose-manifestationer.
English: · Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: · Inden du får Kadcyla, skal du fortælle lægen, hvis du er gravid, har mistanke om, at du er gravid,
English: The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
Danish: Objektiv responsrate var 32,7% (95% konfidensinterval 24,1; 42,1), n=36 respondenter, ved såvel vurdering fra en uafhængig komité som vurdering fra investigator.
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients.
Danish: I de kliniske studier var forekomsten og sværhedsgraden af trombocytopeni højere hos patienter af asiatisk etnicitet.
English: No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment.
Danish: Justering af startdosis er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: Patients with a history of congestive heart failure (CHF), serious cardiac arrhythmia requiring treatment, history of myocardial infarction or unstable angina within 6 months of randomization, or current dyspnoea at rest due to advanced malignancy were excluded from clinical studies.
Danish: Patienter med hjertesvigt i anamnesen, alvorlig, behandlingskrævende kardiel arytmi, myokardieinfarkt i anamnesen eller ustabil angina inden for 6 måneder efter randomisering eller aktuel hviledyspnø på grund af fremskreden malignitet blev udelukket fra de kliniske studier.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel
English: Other medicines and Kadcyla Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Kadcyla Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Based on population PK analysis, following intravenous administration, the central volume of distribution of trastuzumab emtansine was (3.13 L) and approximated that of plasma volume.
Danish: Baseret på farmakokinetiske populationsanalyser svarede det centrale fordelingsvolumen af trastuzumabemtansin efter intravenøs administration (3,13 l) nogenlunde til plasmavoluminet.
English: MBC patients with Grade ³ 3 and EBC patients with Grade ³ 2 peripheral neuropathy at baseline were excluded from clinical studies.
Danish: Metastatiske brystkræft-patienter med grad ³ 3 og tidlig brystkræftpatienter med grad ³ 2 perifer neuropati ved baseline blev ekskluderet fra de kliniske studier.
English: Grade 4 (< 25,000/mm3)
Danish: Grad 4 (<25.000/mm3)
English: Discontinue trastuzumab emtansine if not resolving with standard treatment
Danish: Seponér trastuzumabemtansin, hvis tilstanden ikke forsvinder ved standardbehandling
English: If you miss a Kadcyla treatment
Danish: Hvis du ikke får en behandling med Kadcyla
English: What Kadcyla is used for
Danish: Hvad bruges Kadcyla til?
English: It is not known whether trastuzumab emtansine is excreted in human milk.
Danish: Det vides ikke, om trastuzumabemtansin udskilles i humanmælk.