FrancophonIA/ELRC3.0 huggingface dataset:
English: The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Danish: Den farmakokinetiske populationsanalyse har vist, at kreatinin-clearance ikke påvirker trastuzumabemtansins farmakokinetik.
English: Patients should be observed during the infusion and for at least 90 minutes following the initial infusion for fever, chills, or other infusion-related reactions.
Danish: Patienterne skal observeres for feber, kulderystelser eller andre infusionsrelaterede reaktioner under infusionen og i mindst 90 minutter efter.
English: Do not use if the reconstituted solution contains visible particulates, or is cloudy or discoloured.
Danish: Hvis det rekonstituerede koncentrat indeholder synlige partikler eller er uklart eller misfarvet, må det ikke anvendes.
English: (ECD), as well as to Fcγ receptors and complement C1q.
Danish: ● Trastuzumabemtansin bindes ligesom trastuzumab til domæne IV i det HER2-ekstracellulære domæne (ECD) såvel som til Fcγ-receptorer og komplement-C1q.
English: · Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Danish: · Smerter, følelsesløshed, kløe og en snurrende, kriblende eller prikkende og stikkende fornemmelse i hænder og fødder.
English: Sodium chloride 4.5 mg/mL (0.45%) solution for infusion may be used without a polyethersulfone (PES) 0.20 or 0.22-μm in-line filter.
Danish: Natriumchlorid 4,5 mg/ml (0,45%) infusionsvæske kan anvendes uden 0,20 eller 0,22 mikron integrereret polyethersulfonfilter.
English: Trastuzumab emtansine exposure (AUC) at Cycle 3 after repeated dosing in patients with mild or moderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Danish: Efter gentagen dosering var trastuzumabemtansin-eksponeringen (AUC) ved tredje behandlingscyklus inden for det samme interval hos patienter med let og moderat nedsat leverfunktion som hos patienter med normal leverfunktion.
English: Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.
Danish: Trastuzumabemtansin er et antistof-lægemiddel-konjugat, som indeholder humaniseret antiHER2-IgG1-antistof trastuzumab og DM1, et mikrotubulærhæmmende maytansinoid.
English: The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm.
Danish: Median varigheden for samlet overlevelse var 29,9 måneder i trastuzumabemtansin-armen sammenlignet med 25,9 måneder for lapatinib plus capecitabin-armen.
English: For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4.
Danish: Vedrørende dosisændring i tilfælde af infusionsrelaterede reaktioner, se pkt.
English: Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical trials with trastuzumab emtansine and the incidence of severe haemorrhagic events (Grade ≥3) occurred in 2.2%.
Danish: Der er i kliniske studier med mBC-patienter indberettet blødningshændelser hos 34,8% af patienterne behandlet med trastuzumabemtansin, og forekomsten af svære blødningshændelser (grad ≥3) var 2,2%.
English: Upon diagnosis of NRH, trastuzumab emtansine treatment must be permanently discontinued.
Danish: Hvis nodulær regenerativ hyperplasi diagnosticeres, skal trastuzumabemtansin seponeres permanent.
English: Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Danish: Trastuzumabemtansin blev givet intravenøst, 3,6 mg/kg på dag 1 i en 21-dages serie.
English: Grade 3 (> 3 to ≤ 10´ the ULN)
Danish: Grad 3 (>3 til ≤10 ´ øvre normalgrænse)
English: LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Danish: LVEF 40% til ≤45% og fald er <10% point fra baseline
English: Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Danish: Der er i kliniske studier observeret stigning i serum-aminotransferase (grad 1-4) under behandling med trastuzumabemtansin (se pkt.
English: Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Danish: Behandling af patienter med nedsat leverfunktion skal ske med forsigtighed (se pkt.
English: Trastuzumab emtansine has not been studied in patients with severe hepatic impairment.
Danish: Trastuzumabemtansin er ikke undersøgt hos patienter med svær nedsat leverfunktion.
English: In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
Danish: Trastuzumabemtansin-metabolitterne MCC-DM1, Lys-MCC-DM1 og DM1 kunne spores i små mængder i humant plasma.
English: Glucose (5%) solution should not be used (see section 6.2).
Danish: Glucoseinfusionsvæske (5%) må ikke anvendes.
English: · the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
Danish: ● de hyppigste bivirkninger (≥25%) var kvalme, træthed, muskuloskeletale smerter, blødning, hovedpine, transaminaseforhøjelser, trombocytopeni og perifer neuropati.
English: Treatment should be interrupted in patients with a severe IRR until signs and symptoms resolve.
Danish: Hos patienter med svære infusionsrelaterede reaktioner bør behandlingen afbrydes, indtil symptomerne er forsvundet.
English: AST/ALT recovers to Grade ≤ 2, and then reduce one dose level
Danish: ASAT/ALAT forbedres til Grad ≤2; herefter nedsættes dosis med 1 dosisniveau
English: Based on population pharmacokinetic (PK) analysis, following intravenous administration of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer, the clearance of trastuzumab emtansine was 0.68 L/day and the elimination half-life (t1/2) was approximately 4 days.
Danish: Baseret på farmakokinetiske populationsanalyser er clearance af trastuzumabemtansin 0,68 l/dag og halveringstiden (t1/2) ca. 4 dage efter intravenøs administration af trastuzumabemtansin til patienter med HER2-positiv metastatisk brystkræft.
English: The majority of the patients had Grade 1 or 2 events (≥ 50,000/mm3), with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥ 75,000/mm3) by the next scheduled dose.
Danish: Størstedelen af patienterne havde grad 1 eller 2 bivirkninger (≥50.000/mm3) med laveste værdi omkring dag 8.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 160 mg
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 160 mg
English: Patients develop multiple nodules in the liver that can change how the liver functions.
Danish: Denne tilstand gør, at levercellerne ændres, og der dannes mange små knuder i leveren, som kan ændre leverfunktionen.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 100 mg
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 100 mg
English: NRH is a rare liver condition characterised by widespread benign transformation of hepatic parenchyma into small regenerative nodules; NRH may lead to non-cirrhotic portal hypertension.
Danish: Nodulær regenerativ hyperplasi er en sjælden leversygdom karakteriseret ved udbredt benign omdannelse af leverparenkym til små regenerative noduli.
English: Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed with an aluminium seal with a white plastic flip-off cap.
Danish: Kadcyla leveres i type I-hætteglas, indeholdende 15 ml (100 mg), med fluororesinbelagt grå butylgummi-prop og forseglet med aluminium med hvidt flip-off-låg.
English: Trastuzumab emtansine is administered intravenously.
Danish: Absorption Trastuzumabemtansin administreres intravenøst.
English: · Kadcyla (trastuzumab emtansine) SPC · Health care professional information The HCP information shall contain the following key messages:
Danish: ● Kadcyla (trastuzumabemtansin) produktresumé ● Information til sundhedspersonale
English: Continue treatment with trastuzumab emtansine
Danish: Fortsæt behandling med trastuzumabemtansin
English: Do not administer trastuzumab emtansine in combination with chemotherapy 5.
Danish: Trastuzumabemtansin må ikke administreres i kombination med kemoterapi.
English: Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Danish: Grad 2-3 på dag for planlagt behandling (25.000 til <75.000/mm3)
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight (see section 4.2):
Danish: Beregn, hvor meget rekonstitueret koncentrat der er behov for, til en dosis på 3,6 mg trastuzumabemtansin/kg kropsvægt (se pkt.
English: Grade 3 (> 5 to ≤ 20´ the ULN)
Danish: Grad 3 (>5 til ≤20 ´ øvre normalgrænse)
English: Thrombocytopenia, or decreased platelet counts, was commonly reported with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation, dose reduction, and dose interruption (see section 4.8).
Danish: Trombocytopeni eller lave trombocytværdier var en hyppigt indberettet bivirkning ved behandling med trastuzumabemtansin og var i kliniske studier den bivirkning, der hyppigst medførte seponering, dosisreduktion og afbrydelse af dosis (se pkt.
English: Treatment must be permanently discontinued in the event of a life threatening infusionrelated reaction (see section 4.2).
Danish: Ved en livstruende infusionsrelateret reaktion skal behandlingen seponeres permanent (se pkt.
English: Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Danish: Hvis der anvendes 0,9% natriumchlorid til fortynding, kan der ved opbevaring fremkomme udfældning (se pkt.
English: TBILI > 2´ ULN at any time
Danish: Total bilirubin >2 ´ øvre normalgrænse på hvilket som helst tidspunkt
English: Patients should receive treatment until disease progression or unmanageable toxicity.
Danish: Metastatisk brystkræft (mBC) Patienterne skal behandles indtil der er sygdomsrecidiv eller toksicitet, der ikke kan behandles.
English: Thrombocytopenia, Anaemia
Danish: Blod og lymfesystem Trombocytopeni, anæmi
English: Increased Alanine Transaminase (ALT)
Danish: Forhøjet alanintransaminase (ALAT)
English: You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
Danish: Ved første infusion vil lægen eller sundhedspersonalet overvåge dig for eventuelle bivirkninger, mens du får infusionen og i mindst 90 minutter efter.
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1, and then treat at the same dose level.
Danish: Giv ikke trastuzumabemtansin før totalbilirubin forbedres til Grad ≤1; herefter behandles ved samme dosisniveau
English: In patients 65 to 74 years old (n=113), based on IRC assessments, the hazard ratios for PFS and OS were 0.88 (95% CI: 0.53, 1.45) and 0.74 (95% CI: 0.37, 1.47), respectively.
Danish: Hos patienter i alderen 65-74 år (n=113) var hazard ratio for progressionsfri overlevelse og samlet overlevelse, baseret på vurderinger fra en uafhængig komité, henholdsvis 0,88 (95% konfidensinterval 0,53; 1,45) og 0,74 (95% konfidensinterval 0,37; 1,47).
English: · 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial.
Danish: ● Hætteglas med 160 mg trastuzumabemtansin: Brug en steril sprøjte og injicér langsomt 8 ml sterilt vand til injektionsvæsker i hætteglasset.
English: Thrombocytopenia was reported in 28.5% of patients in EBC clinical studies with trastuzumab emtansine and was the most common reported adverse reaction for all grades and grades ≥ 3, as well as the most common adverse reaction leading to treatment discontinuation (4.2%), dose interruptions, and dose reductions.
Danish: Trombocytopeni blev indberettet hos 28,5% af patienterne med eBC i kliniske forsøg med trastuzumabemtansin og var den hyppigst indberettede bivirkning i alle grader samt grad ≥3.
English: Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. > 1), and visceral vs. non-visceral disease.
Danish: Primært endepunkt Overlevelse uden invasiv sygdom (IDFS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (log-ranktest, ustratificeret) Andel der er hændelsesfri efter 3 år2,% [95% konfidensinterval] Sekundære endepunkter Samlet overlevelse (OS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 5 år 2,% [95% konfidensinterval] IDFS inklusive anden primær kræft (ikke bryst) Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (log-rank-test, ustratificeret) Andel der er hændelsesfri efter 3 år konfidensinterval] Sygdomsfri overlevelse (DFS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 3 år 2,% [95% konfidensinterval] Interval uden fjernrecidiv (DRFI) Antal (%) patienter uden hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 3 år konfidensinterval] Data fra første interimanalyse 25 juli 2018 1.
English: Kadcyla is not recommended for anyone under the age of 18 years.
Danish: Kadcyla frarådes til patienter under 18 år, da der ikke er tilstrækkelig information om, hvordan det virker i denne aldersgruppe.
English: For patients 75 years or above, based on IRC assessments, the hazard ratios for PFS and OS were 3.51 (95% CI: 1.22, 10.13) and 3.45 (95% CI: 0.94, 12.65), respectively.
Danish: For patienter over 75 år var hazard ratio for progressionsfri overlevelse og samlet overlevelse, baseret på vurderinger fra en uafhængig komité, henholdsvis 3,51 (95% konfidensinterval 1,22; 10,13) og 3,45 (95% konfidensinterval 0,94; 12,65).
English: A randomised, multicentre, open-label phase II study evaluated the effects of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with HER2-positive MBC who had not received prior chemotherapy for metastatic disease.
Danish: Effekten af trastuzumabemtansin versus trastuzumab plus docetaxel hos patienter med HER2-positiv metastatisk brystkræft, som ikke tidligere havde fået kemoterapi for metastatisk sygdom, blev evalueret i et randomiseret, ublindet fase II-multicenterstudie.
English: · Male patients or their female partners should also use effective contraception.
Danish: · Hvis du er mand, skal du eller din eventuelle kvindelige partner bruge sikker prævention.
English: Kadcyla 160 mg powder for concentrate for solution for infusion Kadcyla is provided in 20 mL (160 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro resin laminate, and sealed with an aluminium seal with a purple plastic flip-off cap.
Danish: Kadcyla leveres i type I-hætteglas, indeholdende 20 ml (160 mg), med fluororesinbelagt grå butylgummi-prop og forseglet med aluminium med lilla flip-off-låg.
English: Succinic acid Sodium hydroxide Sucrose
Danish: Natriumhydroxid Saccharose Polysorbat 20
English: · If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: · Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine.
Danish: Efter rekonstitution indeholder et hætteglas med 8 ml opløsning 20 mg/ml trastuzumabemtansin.
English: Increased bilirubin Increased AST Increased ALT Haematologic Decreased platelet count Decreased haemoglobin Decreased neutrophils Potassium
Danish: Fald i trombocytter Fald i hæmoglobin Fald i neutrofilocytter Kalium
English: Transaminases increased (AST/ALT)
Danish: Forhøjede transaminaser (ASAT/ALAT)
English: In the subgroup of patients with hormone receptor-negative disease (n=426), the hazard ratios for PFS and OS were 0.56 (95% CI: 0.44, 0.72) and 0.75 (95% CI: 0.54, 1.03), respectively.
Danish: I subgruppen med patienter med hormonreceptor-negativ sygdom (n=426) var hazard ratio for progressionsfri overlevelse og samlet overlevelse henholdsvis 0,56 (95% konfidensinterval 0,44; 0,72) og 0,75 (95% konfidensinterval 0,54; 1,03).
English: You will be observed by a doctor or nurse while it is being given and for at least 30 minutes following the dose, in case you have any side effects.
Danish: Lægen og sundhedspersonalet vil overvåge dig for eventuelle bivirkninger mens du får infusionen og i mindst 30 minutter efter.
English: No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Danish: Der er ikke gennemført studier af reproduktions- eller udviklingstoksicitet med trastuzumabemtansin.
English: Tell your doctor or nurse straight away if you notice any of the side effects above.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du oplever én eller flere af ovenstående bivirkninger.
English: Instructions for reconstitution · Kadcyla 100mg: using a sterile syringe, slowly inject 5 mL of sterile water for injection into the
Danish: Rekonstitutionsvejledning · Kadcyla 100 mg: Brug en steril sprøjte og injicér langsomt 5 ml sterilt vand til injektionsvæsker i hætteglasset med 100 mg trastuzumabemtansin.
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine.
Danish: Efter rekonstitution indeholder et hætteglas med 5 ml opløsning 20 mg/ml trastuzumabemtansin.
English: · Kadcyla 160mg: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Danish: · Kadcyla 160 mg: Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 160 mg trastuzumabemtansin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 100 mg trastuzumabemtansin.
English: In the subgroup of patients with hormone receptor-positive disease (n=545), the hazard ratios for PFS and OS were 0.72 (95% CI: 0.58, 0.91) and 0.62 (95% CI: 0.46, 0.85), respectively.
Danish: I subgruppen af patienter med hormonreceptor-positiv sygdom (n=545) var hazard ratio for progressionsfri overlevelse og samlet overlevelse henholdsvis 0,72 (95% konfidensinterval 0,58; 0,91) og 0,62 (95% konfidensinterval 0,46; 0,85).
English: For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Danish: Vedørende dosisændring i tilfælde af overfølsomhedsreaktioner, se pkt.
English: Do not administer trastuzumab emtansine until resolution £ Grade 2
Danish: Giv ikke trastuzumabemtansin før forbedring til £Grad 2
English: · Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Danish: · Kadcyla 100 mg: Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 100 mg trastuzumabemtansin.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever følgende alvorlige bivirkninger, skal du straks kontakte lægen eller sundhedspersonalet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Kadcyla 160 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumabemtansin
English: Do not administer trastuzumab emtansine until AST recovers to Grade £ 1, and then treat at the same dose level
Danish: Giv ikke trastuzumabemtansin før ASATforhøjelse er forbedret til Grad £1; herefter behandles ved samme dosisniveau
English: Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Danish: Behandling af patienter med nedsat leverfunktion bør ske med forsigtighed, da det er observeret, at trastuzumabemtansin er levertoksisk (se pkt.
English: Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or a fatal outcome, have been reported in clinical studies with trastuzumab emtansine (see section 4.8).
Danish: Der er i kliniske studier med trastuzumabemtansin indberettet tilfælde af interstitiel lungesygdom, herunder pneumonitis, hvoraf nogle har medført akut lungesvigt eller haft dødelig udgang (se pkt.
English: Very common: · decreased red blood cells (shown in a blood test) · being sick (vomiting) · diarrhoea · dry mouth
Danish: Meget almindelige bivirkninger: · nedsat antal røde blodlegemer (påvises ved blodprøve) · opkastning · diarré · tør mund · blærebetændelse · forstoppelse · mavesmerter · hoste · vejrtrækningsproblemer · inflammation i munden · søvnbesvær · muskel- eller ledsmerter · feber · hovedpine · træthed · svaghed
English: LVEF 40% to ≤ 45% and decrease is ≥ 10%
Danish: LVEF 40% til ≤45% og fald er ≥10% point fra baseline
English: Grade 4 (> 10´ the ULN)
Danish: Grad 4 (>10 ´ øvre normalgrænse)
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level.
Danish: Giv ikke trastuzumabemtansin før totalbilirubin forbedres til Grad ≤1; herefter nedsættes dosis med 1 dosisniveau
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Kadcyla 100 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumabemtansin
English: Do not administer trastuzumab emtansine until total bilirubin recovers to ≤ 1.0× ULN, and then reduce one dose level
Danish: Giv ikke trastuzumabemtansin før total bilirubin forbedres til ≤1,0 × øvre normalgrænse; herefter nedsættes dosis med 1 dosisniveau
English: The infusion rate of trastuzumab emtansine should be slowed or interrupted if the patient develops infusion-related symptoms (see sections 4.4 and 4.8).
Danish: Hvis patienten udvikler infusionsrelaterede symptomer, skal infusionshastigheden af trastuzumabemtansin nedsættes eller infusionen afbrydes (se pkt.
English: Discontinue treatment
Danish: Behandlingen seponeres