FrancophonIA/ELRC3.0 huggingface dataset:
English: By inhibiting tubulin polymerization, both DM1 and trastuzumab emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death.
Danish: Ved at hæmme tubulinpolymerisation bremser såvel DM1 og trastuzumabemtansin cellerne i G2/M-fasen af cellecyklus, hvilket i sidste ende medfører apoptotisk celledød.
English: Pharmacokinetic data in patients with severe renal impairment (CLcr 15 to 29 mL/min) are limited (n = 1), therefore no dosage recommendations can be made.
Danish: Der er begrænsede farmakokinetiske data (n=1) fra patienter med svært nedsat nyrefunktion (CLcr 15-29 ml/min), og der kan derfor ikke gives dosisanbefalinger.
English: PAES: In order to further investigate the efficacy of trastuzumab emtansine in the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy, the MAH should submit the final analysis of OS from the phase 3, randomised, open-label study KATHERINE (BO27938).
Danish: PAES: For yderligere at undersøge effekten af trastuzumabemtansin i adjuverende behandling af voksne patienter med HER2-positiv tidlig brystkræft, som har resterende invasiv sygdom, i bryst og/eller lymfekirtler, efter neoadjuverende taxan-baseret eller HER2-targeteret behandling, skal indehaveren af markedsføringstilladen indsende den finale analyse af samlet overlevelse fra det åbne, randomiserede fase IIIstudie KATHERINE (BO27938).
English: Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Danish: Symptomerne omfatter dyspnø, hoste, træthed og lungeinfiltrater.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given Kadcyla.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så spørg lægen eller apotekspersonalet inden du får Kadcyla.
English: · Infusion-related reactions or allergic reactions: Kadcyla can cause flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing during the infusion or after the infusion on the first day of treatment.
Danish: · Reaktioner i forbindelse med infusionen eller allergiske reaktioner: Kadcyla kan give anfaldsvis rødfarvning af ansigtet, kulderystelser, feber, åndedrætsbesvær, lavt blodtryk, hurtig hjerterytme, pludselig opsvulmen af ansigt og tunge samt synkebesvær under infusionen eller i løbet af den dag, infusionen er blevet givet.
English: The MAH shall ensure that in parallel to the launch of Kadcyla (trastuzumab emtansine), all health care professionals who may prescribe, dispense or administer Kadcyla (trastuzumab emtansine) and/or Herceptin (trastuzumab) are provided with a health care professional (HCP) educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal samtidig med lanceringen af Kadcyla (trastuzumabemtansin) sikre, at sundhedspersonale, som vil udskrive, udlevere eller administrere Kadcyla (trastuzumabemtansin) og/eller Herceptin (trastuzumab), får en pakke med uddannelsesmateriale til sundhedspersoner.
English: What you need to know before you are given Kadcyla
Danish: Det skal du vide, før du får Kadcyla
English: Patients should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
Danish: Patienterne skal behandles med i alt 14 behandlingsserier, med mindre der er sygdomsrecidiv eller toksicitet, der ikke kan behandles.
English: Do not administer trastuzumab emtansine at doses greater than 3.6 mg/kg once every 3 weeks 6.
Danish: Trastuzumabemtansin må ikke administreres i højere doser end 3,6 mg/kg én gang hver 3. uge.
English: You must not be given Kadcyla · if you are allergic to trastuzumab emtansine or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Kadcyla · hvis du er allergisk over for trastuzumabemtansin eller et af de øvrige indholdsstoffer i Kadcyla
English: The reconstituted Kadcyla solution diluted in infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for infusion, or sodium chloride 4.5 mg/mL (0.45%) solution for infusion, is stable for up to 24 hours at 2°C to 8°C, provided it was prepared under controlled and validated aseptic conditions.
Danish: Rekonstitueret Kadcyla-opløsning fortyndet i infusionsposer indeholdende natriumchlorid 9 mg/ml (0,9%) infusionsvæske eller natriumchlorid 4,5 mg/ml (0,45%) infusionsvæske er stabil i op til 24 timer ved 2°C til 8°C, forudsat tilberedningen fandt sted under kontrollerede og validerede aseptiske forhold.
English: Trastuzumab emtansine has not been studied in patients with platelet counts ≤ 100,000/mm3 prior to initiation of treatment.
Danish: Trastuzumabemtansin er ikke undersøgt hos patienter med trombocytværdier ≤100.000/mm3 inden behandlingsstart.
English: Following trastuzumab emtansine dosing, 5.1% (63/1243) of patients tested positive for anti-trastuzumab emtansine antibodies at one or more post-dose time points.
Danish: Efter dosering af trastuzumabemtansin blev 5,1% (63/1.243) af patienterne testet positive for anti-trastuzumabemtansin-antistoffer ved én eller flere målinger.
English: Events of LVEF drop of >10% from baseline and/or CHF were observed in an observational study (BO39807) of MBC patients with baseline LVEF of 40-49% in a real world setting.
Danish: Der blev observeret tilfælde af fald i LVEF >10 % fra baseline og/eller hjertesvigt i et observationsstudie (BO39807) med metastatiske brystkræft (mBC) patienter med LVEF på 40-49 % ved baseline i almindelig klinisk praksis.
English: The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Danish: Bivirkningerne angives i overensstemmelse med MedDRAs systemorganklasse og frekvenser.
English: Principal toxicities included liver (liver enzyme elevations) at ³ 20 mg/kg and ³ 10 mg/kg, bone marrow (reduced platelet and white blood cell count)/hematologic at ³ 20 mg/kg and ³ 10 mg/kg, and lymphoid organs at ³ 20 mg/kg and ³ 3 mg/kg, in rat and monkey, respectively.
Danish: Primære toksiciteter omfattede lever (leverenzymstigninger) ved ³20 mg/kg og ³10 mg/kg, knoglemarv (reducerede trombocyt- og leukocyttal)/blod ved ³20 mg/kg og ³10 mg/kg og lymfoidt væv ved ³20 mg/kg og ³3 mg/kg hos henholdsvis rotter og aber.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter rekonstitution og fortynding Læs indlægssedlen inden brug
English: Independent of race, the incidence of Grade 3 or 4 events (< 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Danish: Forekomst af grad 3 og 4 bivirkninger (<50.000/mm3) var 8,7% hos mBC-patienter behandlet med trastuzumabemtansin og 5,7% hos eBC-patienter, uafhængig af etnicitet.
English: Kadcyla must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Danish: Kadcyla skal rekonstitueres og fortyndes af sundhedspersonale og administreres som intravenøs infusion.
English: In more severe cases, swelling of your face or tongue, trouble swallowing or difficulty breathing may occur.
Danish: I alvorligere tilfælde kan der opstå hævelse af ansigt og tunge, synkebevær eller vejrtrækningsproblemer.
English: Ask your pharmacist how to dispose of medicines you no longer use.
Danish: · Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Trastuzumab emtansine has not been studied in patients with serum transaminases > 2.5 ´ ULN or total bilirubin > 1.5 ´ ULN prior to initiation of treatment.
Danish: Trastuzumabemtansin er ikke undersøgt hos patienter med serum-aminotransferaser >2,5 ´ øvre normalgrænse eller total-bilirubin >1,5 ´ øvre normalgrænse inden behandlingsstart.
English: The reconstituted solution should be free of visible particulates, clear to slightly opalescent.
Danish: Det rekonstituerede koncentrat må ikke indeholde synlige partikler og skal være klart til let opaliserende.
English: Very common (may affect more than 1 in 10 people): · Kadcyla may cause inflammation or damage to cells in the liver, resulting in elevated liver enzymes in blood tests.
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud 10 patienter): · Kadcyla kan forårsage inflammation (betændelseslignende reaktion) i leveren eller beskadige leverceller og dermed øge mængden af leverenzymer i blodet.
English: Patients with elevated transaminases improved to Grade 1 or normal within 30 days of the last dose of trastuzumab emtansine in the majority of the cases (see section 4.8).
Danish: Patienter med forhøjede aminotransferaser oplevede i størstedelen af tilfældene forbedring til grad 1 eller normalværdi inden for 30 dage efter sidste dosis trastuzumabemtansin (se pkt.
English: The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting).
Danish: Den farmakokinetiske populationsanalyse viste ingen forskelle i trastuzumabemtansin-optagelse afhængigt af sygdomsstatus (adjuverende vs. metastatisk regi).
English: Common: · chills or flu like symptoms · decrease in your potassium levels (shown in a blood test) · skin rashes · decreased white blood cells (shown in a blood test) · dry eyes, watery eyes or blurred vision · eye redness or infection · indigestion · swelling of legs and/or arms · bleeding from the gums · increase in blood pressure · feeling dizzy · taste disturbances · itching · difficulty in remembering · hair loss · hand-and-foot skin reaction (Palmar-plantar erythrodysaesthesia syndrome) · nail disorder
Danish: Almindelige bivirkninger: · kulderystelser eller influenzalignende symptomer · nedsat kaliumindhold i blodet (påvises ved blodprøve) · hududslæt · nedsat antal hvide blodlegemer (påvises ved blodprøve) · tørre øjne, rindende øjne eller sløret syn · røde øjne eller øjeninfektion · fordøjelsesproblemer · hævede ben og arme · blødende tandkød/gummer · forhøjet blodtryk · svimmelhed · smagsforstyrrelser · kløe · hukommelsesbesvær · hårtab · hudreaktion på hænder og fødder (palmoplantar erytrodysæstesi) · negleproblemer
English: No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2).
Danish: Justering af startdosis er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: In addition, developmental toxicity of maytansine has been identified in non-clinical studies which suggests that DM1, the microtubule-inhibiting cytotoxic maytansinoid component of trastuzumab emtansine, will be similarly teratogenic and potentially embryotoxic.
Danish: Derudover er maytasin i ikke-kliniske studier vist at være udviklingstoksisk, hvilket taler for, at DM1, den mikrotubulærhæmmende cytotoksiske maytansin-komponent i trastuzumabemtansin, tilsvarende vil være teratogent og potentielt embryotoksisk.
English: DM1 was aneugenic or clastogenic in an in vivo single-dose rat bone marrow micronucleus assay at exposures that were comparable to mean maximum concentrations of DM1 measured in humans administered trastuzumab emtansine.
Danish: DM1 var aneugent eller klastogent i en in vivo enkeltdosis rottemarvs-mikronukleus-analyse ved eksponeringer, der var sammenlignelige med den gennemsnitlig maksimale koncentration af DM1 hos mennesker, der har fået trastuzumabemtansin.
English: The colour of the reconstituted solution should be colourless to pale brown.
Danish: Farven på det rekonstituerede koncentrat skal være farveløs til lysebrun.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 160 mg
English: Nervous system disorders Neuropathy peripheral, Headache
Danish: Perifer neuropati, hovedpine
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
Danish: I kliniske studier var forekomsten og sværhedsgraden af trombocytopeni højere hos asiatiske patienter (se pkt.
English: Grade 3 and 4 increased transaminases were reported in 1.5% of patients with EBC.
Danish: Transaminaseforhøjelser svarende til grad 3 og 4 var indberettet hos 1,5% af patienterne med eBC.
English: Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Danish: Tørre øjne, konjunktivitis, sløret syn, tåreflåd
English: The median duration of response was not reached with trastuzumab emtansine vs. 9.5 months in the control arm.
Danish: Medianvarigheden af respons blev ikke nået med trastuzumabemtansin, og var 9,5 måneder i kontrolarmen.
English: The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data and therefore patients with severe renal impairment should be monitored carefully.
Danish: På grund af utilstrækkelige data er det ikke klarlagt, om dosisjustering er nødvendig hos patienter med svært nedsat nyrefunktion, og patienter med svært nedsat nyrefunktion bør derfor monitoreres omhyggeligt.
English: The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated after the administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function (n=10), mild (Child-Pugh A; n=10) and moderate (Child-Pugh B; n=8) hepatic impairment.
Danish: Farmakokinetikken for trastuzumabemtansin og DM1-holdige katabolitter blev undersøgt efter administration af 3,6 mg/kg trastuzumabemtansin til patienter med HER2-positiv metastatisk brystkræft og normal (n=10), let nedsat (Child-Pugh A; n=10) og moderat nedsat (Child-Pugh B; n=8) leverfunktion.
English: Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Danish: En anden sjælden tilstand, der kan forekomme i leveren, er en tilstand, der kaldes nodulær regenerativ hyperplasi.
English: · If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Danish: Efter binding til HER2 gennemgår trastuzumabemtansin en receptor-medieret internalisering og efterfølgende lysosomnedbrydning, hvorved DM1-holdige cytotoksiske katabolitter (primært lysin-MCC-DM1) frigives.
English: Treatment in patients with serum transaminases > 3 ´ ULN and concomitant total bilirubin > 2 ´ ULN should be permanently discontinued.
Danish: Hos patienter med serum-aminotransferaser >3 ´ øvre normalgrænse og samtidigt total-bilirubin >2 ´ øvre normalgrænse skal behandlingen seponeres permanent.
English: If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Danish: Hvis LVEF <45% bekræftes, skal trastuzumabemtansin seponeres
English: Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival
Danish: Figur 2 Kaplan-Meier-kurver for progressionsfri overlevelse vurderet af uafhængig komité
English: Diagnosis of NRH can be confirmed only by histopathology.
Danish: Diagnosen nodulær regenerativ hyperplasi kan kun bekræftes histologisk.
English: When the heart muscle is weak, patients may develop symptoms such as shortness of breath at rest or when sleeping, chest pain, swollen legs or arms, and a sensation of rapid or irregular heartbeats.
Danish: Når hjertemusklen er svækket, kan man udvikle symptomer som åndenød i hvile eller under søvn, brystsmerter, hævede ben eller arme samt en følelse af hurtige eller uregelmæssige hjerteslag.
English: - Systemic exposures (AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairment were approximately 38% and 67% lower than that of patients with normal hepatic function, respectively.
Danish: Den systemiske trastuzumabemtansin-eksponering (AUC) ved første behandlingscyklus var henholdsvis ca. 38% og 67% lavere hos patienter med let og moderat nedsat leverfunktion end hos patienter med normal leverfunktion.
English: In the event of decreased platelet count to Grade 3 or greater (< 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
Danish: Hvis trombocyttallet er faldet svarende til trombocytopeni grad 3 eller derover (<50.000/mm3), må trastuzumabemtansin ikke administreres, før trombocyttallet er forbedret til grad 1 (≥75.000/mm3) (se pkt.
English: Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
Danish: Reaktioner sekundært til ekstravasation er observeret i kliniske studier med trastuzumabemtansin.
English: What Kadcyla is
Danish: Hvad er Kadcyla?
English: Musculoskeletal pain, Arthralgia, Myalgia
Danish: Smerter i bevægeapparatet, artralgi, myalgi
English: If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Danish: Hvis fortyndet under aseptiske forhold, kan infusionsvæsken opbevares i op til 24 timer ved 2°C - 8°C.
English: Uncommon (may affect up to 1 in 100 people): · Inflammation of your lungs can cause breathing problems such as shortness of breath (either at rest or while performing any type of activity), coughing or coughing spells with a dry coughthese are signs of inflammation of your lung tissue.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter): · Inflammation i lungerne kan forårsage vejrtrækningsproblemer som åndenød (i hvile eller ved aktivitet), hoste eller hosteanfald med tør hoste - dette kan være tegn på inflammation i lungerne.
English: Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine.
Danish: Dysfunktion af venstre ventrikel indberettedes hos 2,2% af patienterne i kliniske mBC-studier med trastuzumabemtansin.
English: In vitro metabolism studies in human liver microsomes suggest that DM1, a small molecule component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and to a lesser extent by CYP3A5.
Danish: In vitro metaboliseringsstudier i humane levermikrosomer antyder, at DM1, en lille molekylekomponent i trastuzumabemtansin, primært metaboliseres af CYP3A4 og i mindre grad af CYP3A5.
English: If you are not sure, talk to your doctor or nurse before you are given Kadcyla.
Danish: Hvis du er i tvivl, så spørg lægen eller sundhedspersonalet, inden du får Kadcyla.
English: In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to a lesser extent, by CYP3A5.
Danish: In vitro metaboliseringsstudier med humane levermikrosomer tyder på, at DM1, en komponent i trastuzumabemtansin, primært metaboliseres af CYP3A4 og i mindre omfang af CYP3A5.
English: In nonclinical studies, trastuzumab emtansine catabolites including DM1, Lys-MCC-DM1, and MCC-DM1 are mainly excreted in the bile with minimal elimination in urine.
Danish: I ikke-kliniske studier udskiltes trastuzumabemtansin-katabolitter, inklusive DM1, Lys-MCC-DM1 og MCC-DM1, primært i galden med minimal udskillelse i urinen.
English: · Trastuzumab emtansine arm: trastuzumab emtansine 3.6 mg/kg intravenously over 30-90 minutes on Day 1 of a 21-day cycle · Control arm (lapatinib plus capecitabine): lapatinib 1250 mg/day orally once per day of a 21-day cycle plus capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle
Danish: ● Kontrolarm (lapatinib plus capecitabin): lapatinib 1250 mg/dag oralt 1 gang dagligt i en 21-dages cyklus plus capecitabin 1000 mg/m2 oralt 2 gange dagligt på Dag 1-14 i en 21-dages cyklus
English: Breast tumor samples were required to show HER2 overexpression defined as 3+ IHC or ISH amplification ratio ≥ 2.0 determined at a central laboratory.
Danish: Der blev taget biopsier fra brysttumoren med henblik på at påvise HER2-overekspression, defineret som et 3+ IHC- eller ISH-amplifikationsratio ≥2,0, bestemt ved centralt laboratorium.
English: Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported.
Danish: Der sås infusionsrelaterede reaktioner hos 1,6% af patienterne med eBC; ingen af hændelserne var af grad 3 eller 4.
English: In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
Danish: I den deskriptive opfølgningsanalyse af samlet overlevelse var hazard ratio 0,75 (95% konfidensinterval 0,64; 0,88).
English: In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82).
Danish: I en følsomhedsanalyse hvor patienterne blev censureret på tidspunktet for overkrydsning, var hazard ratio 0,69 (95% konfidensinterval 0,59; 0,82).
English: Patients who discontinued trastuzumab emtansine could complete the duration of their intended study treatment up to 14 cycles of HER2-directed therapy with trastuzumab if appropriate based on toxicity considerations and investigator discretion.
Danish: Patienter som fik seponeret trastuzumabemtansin kunne gennemføre den planlagte forsøgsbehandling med op til 14 serier af HER2-rettet behandling med trastuzumab, hvis investigator vurderede, at det var hensigtsmæssigt i forhold til toksicitet.
English: Inflamed or injured liver cells may leak higher than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated liver enzymes in blood tests.
Danish: Inflammerede eller beskadigede leverceller kan sende bestemte stoffer (leverenzymer) ud i blodet i større mængde end normalt.
English: Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine.
Danish: Fertile kvinder skal anvende sikker prævention under behandlingsforløbet med trastuzumabemtansin og i 7 måneder efter sidste dosis.
English: Prior to enrolment, breast tumour samples were required to be centrally confirmed for HER2-positive status defined as a score of 3 + by IHC or gene amplification by ISH.
Danish: Inden inklusion skulle HER2-positiv status for brysttumorbiopsier bekræftes centralt, defineret som en score på 3+ ved IHC eller genamplifikation ved ISH.
English: Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells.
Danish: Når DM1 konjugeres til trastuzumab, opnås selektivitet for den cytotoksiske agent for tumorceller med HER2-overekspression, hvilket øger den intracellulære afgivelse af DM1 direkte til de maligne celler.
English: Trastuzumab emtansine when administered intravenously every 3 weeks exhibited linear PK across doses ranging from 2.4 to 4.8 mg/kg; patients who received doses less than or equal to 1.2 mg/kg had faster clearance.
Danish: Trastuzumabemtansin udviste lineær farmakokinetik på tværs af doser spændende fra 2,4 til 4,8 mg/kg ved intravenøs administration hver 3. uge; hos patienter, der fik doser svarende til 1,2 mg/kg eller derunder, var clearance hurtigere.
English: Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
Danish: Udslæt, pruritus, alopeci, negleproblemer, palmoplantar erytrodysæstesi, urticaria
English: If LVEF <40% is confirmed, discontinue trastuzumab emtansine
Danish: Hvis LVEF <40% bekræftes, seponeres trastuzumabemtansin
English: Because most of the patients in trastuzumab emtansine clinical studies were females, the effect of gender on the PK of trastuzumab emtansine was not formally evaluated.
Danish: Da de fleste af patienterne i de kliniske studier med trastuzumabemtansin var kvinder, er det ikke formelt evalueret, om køn spiller en rolle for farmakokinetikken af trastuzumabemtansin.