natgillin/translations-raw huggingface dataset:
Seponér trastuzumabemtansin permanent, hvis der ikke er anden sandsynlig årsag til stigningen i leverenzymer og bilirubin, fx levermetastaser eller anden samtidig behandling
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
LISTE OVER HJÆLPESTOFFER Ravsyre, natriumhydroxid, saccharose, polysorbat 20.
Succinic acid, sodium hydroxide, sucrose, polysorbate 20.
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).
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).
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.
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.
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.
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.
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
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.
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.
Important information about some of the ingredients of Kadcyla This medicine contains less than 1 mmol sodium (23 mg) per dose.
Patientdemografi og tumorkarakteristika ved baseline var balanceret behandlingsarmene imellem.
Patient demographics and baseline tumor characteristics were balanced between treatment arms.
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.
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.
Volumen (ml) = Totaldosis til administration (kropsvægt (kg) x dosis (mg/kg)) 20 (mg/ml, koncentration af rekonstitueret koncentrat)
Volume (mL) = Total dose to be administered (body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
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.
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.
Fortsæt behandling med trastuzumabemtansin.
Continue treatment with trastuzumab emtansine.
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
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
Du må ikke få Kadcyla, hvis du er gravid, da lægemidlet kan skade fostret.
Kadcyla is not recommended if you are pregnant because this medicine may cause harm to the unborn baby.
Der har været indberetninger om overdosering med trastuzumabemtansin, oftest forbundet med trombocytopeni, og der har været ét dødsfald.
Cases of overdose have been reported with trastuzumab emtansine treatment, most associated with thrombocytopenia, and there was one death.
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.
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.
I alt 1.243 patienter fra 7 kliniske forsøg er ved forskellige målepunkter testet for anti-lægemiddelantistofrespons (ADA) på trastuzumabemtansin.
A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
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.
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.
Hvis LVEF ikke forbedres til inden for 10% point fra baseline, seponeres trastuzumabemtansin.
If the LVEF has not recovered to within 10% points from baseline, discontinue trastuzumab emtansine.
Hvis Kadcyla (trastuzumabemtansin) ordineres elektronisk, er det vigtigt at sikre, at det lægemiddel, som ordineres, er trastuzumabemtansin og ikke trastuzumab.
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.
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.
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.
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.
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.
Lægemiddelinduceret leverskade (DILI)
Drug Induced Liver Injury (DILI)
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).
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.
Plasmakoncentrationerne af DM1 og DM1-holdige katabolitter (Lys-MCC-DM1 og MCC-DM1) var lave og sammenlignelige for patienter med og uden nedsat leverfunktion.
- 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.
Behandling med trastuzumabemtansin skal midlertidigt afbrydes hos patienter med grad 3 eller 4 perifer neuropati indtil symptomerne ophører eller forbedres til ≤ grad 2.
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.
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.
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.
Infusionsvæsken skal administreres straks efter tilberedning.
Once the infusion is prepared it should be administered immediately.
· kræften ikke har spredt sig til andre steder i kroppen, og behandlingen gives efter operation
· 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
For dosisændringer i tilfælde af fald i LVEF, se tabel 2 i pkt.
For dose modifications in the event of LVEF decrease, see Table 2 in section 4.2 and section 4.4.
ALAT = alanintransaminase; ASAT = aspartattransaminase, LVEF = venstre ventrikels uddrivningsfraktion, LVSD = systolisk dysfunktion af venstre ventrikel *Inden påbegyndelse af behandling med trastuzumabemtansin.
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.
Tabel 3 Skema over bivirkninger hos patienter behandlet med trastuzumabemtansin i kliniske forsøg
Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical trials
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.
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.
· Inden du får Kadcyla, skal du fortælle lægen, hvis du er gravid, har mistanke om, at du er gravid,
· Tell your doctor before using Kadcyla if you are pregnant, think you may be pregnant or are planning to have a baby.
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.
The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
I de kliniske studier var forekomsten og sværhedsgraden af trombocytopeni højere hos patienter af asiatisk etnicitet.
In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients.
Justering af startdosis er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment.
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.
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.
Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel
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.
Brug af anden medicin sammen med Kadcyla Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Other medicines and Kadcyla Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Baseret på farmakokinetiske populationsanalyser svarede det centrale fordelingsvolumen af trastuzumabemtansin efter intravenøs administration (3,13 l) nogenlunde til plasmavoluminet.
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.
Metastatiske brystkræft-patienter med grad ³ 3 og tidlig brystkræftpatienter med grad ³ 2 perifer neuropati ved baseline blev ekskluderet fra de kliniske studier.
MBC patients with Grade ³ 3 and EBC patients with Grade ³ 2 peripheral neuropathy at baseline were excluded from clinical studies.
Grad 4 (<25.000/mm3)
Grade 4 (< 25,000/mm3)
Seponér trastuzumabemtansin, hvis tilstanden ikke forsvinder ved standardbehandling
Discontinue trastuzumab emtansine if not resolving with standard treatment
Hvis du ikke får en behandling med Kadcyla
If you miss a Kadcyla treatment
Hvad bruges Kadcyla til?
What Kadcyla is used for
Det vides ikke, om trastuzumabemtansin udskilles i humanmælk.
It is not known whether trastuzumab emtansine is excreted in human milk.
Ved at hæmme tubulinpolymerisation bremser såvel DM1 og trastuzumabemtansin cellerne i G2/M-fasen af cellecyklus, hvilket i sidste ende medfører apoptotisk celledød.
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.
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.
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.
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).
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).
Symptomerne omfatter dyspnø, hoste, træthed og lungeinfiltrater.
Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så spørg lægen eller apotekspersonalet inden du får Kadcyla.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given Kadcyla.
· 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.
· 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.
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.
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.
Det skal du vide, før du får Kadcyla
What you need to know before you are given Kadcyla
Patienterne skal behandles med i alt 14 behandlingsserier, med mindre der er sygdomsrecidiv eller toksicitet, der ikke kan behandles.
Patients should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
Trastuzumabemtansin må ikke administreres i højere doser end 3,6 mg/kg én gang hver 3. uge.
Do not administer trastuzumab emtansine at doses greater than 3.6 mg/kg once every 3 weeks 6.
Du må ikke få Kadcyla · hvis du er allergisk over for trastuzumabemtansin eller et af de øvrige indholdsstoffer i Kadcyla
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).
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.
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.
Trastuzumabemtansin er ikke undersøgt hos patienter med trombocytværdier ≤100.000/mm3 inden behandlingsstart.
Trastuzumab emtansine has not been studied in patients with platelet counts ≤ 100,000/mm3 prior to initiation of treatment.
Efter dosering af trastuzumabemtansin blev 5,1% (63/1.243) af patienterne testet positive for anti-trastuzumabemtansin-antistoffer ved én eller flere målinger.
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.
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.
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.
Bivirkningerne angives i overensstemmelse med MedDRAs systemorganklasse og frekvenser.
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
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.
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.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter rekonstitution og fortynding Læs indlægssedlen inden brug
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use
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.
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.
Kadcyla skal rekonstitueres og fortyndes af sundhedspersonale og administreres som intravenøs infusion.
Kadcyla must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
I alvorligere tilfælde kan der opstå hævelse af ansigt og tunge, synkebevær eller vejrtrækningsproblemer.
In more severe cases, swelling of your face or tongue, trouble swallowing or difficulty breathing may occur.
· Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your pharmacist how to dispose of medicines you no longer use.
Trastuzumabemtansin er ikke undersøgt hos patienter med serum-aminotransferaser >2,5 ´ øvre normalgrænse eller total-bilirubin >1,5 ´ øvre normalgrænse inden behandlingsstart.
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.
Det rekonstituerede koncentrat må ikke indeholde synlige partikler og skal være klart til let opaliserende.
The reconstituted solution should be free of visible particulates, clear to slightly opalescent.
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.
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.
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.
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).
Den farmakokinetiske populationsanalyse viste ingen forskelle i trastuzumabemtansin-optagelse afhængigt af sygdomsstatus (adjuverende vs. metastatisk regi).
The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting).