FrancophonIA/ELRC3.0 huggingface dataset:
English: · the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
Danish: ● de hyppigste alvorlige bivirkninger (>0,5% af patienterne) var blødning, feber, trombocytopeni, dyspnø, abdominalsmerter, muskuloskeletale smerter og opkastning.
English: Your doctor will check your heart function before and regularly during treatment.
Danish: Lægen vil kontrollere din hjertefunktion, inden du starter behandling og jævnligt under behandlingen.
English: Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic (see section 5.3).
Danish: Dyrestudier med maytansin, et stof, som er tæt beslægtet med DM1 og af samme maytansinoidklasse, tyder på, at DM1, den mikrotubulærhæmmende cytotoksiske komponent i trastuzumabemtansin, kan forventes at være såvel teratogen som embryotoksisk (se pkt.
English: Kadcyla, as a single agent, is indicated for 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.
Danish: Kadcyla er, som enkeltstof, indiceret til adjuverende behandling af voksne patienter med HER2positiv tidlig brystkræft med invasiv residualsygdom i bryst og/eller lymfekirtler efter neoadjuverende taxan-baseret og HER2-targeteret behandling.
English: Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to infusion-related reactions (IRR); treatment is not recommended for these patients.
Danish: Behandling med trastuzumabemtansin er ikke undersøgt hos patienter, der har fået seponeret trastuzumab permanent på grund af infusionsrelaterede reaktioner; behandling af disse patienter frarådes.
English: In addition, trastuzumab emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
Danish: Derudover hæmmer trastuzumabemtansin, ligesom trastuzumab, afstødning af HER2-ECD, hæmmer signaler gennem fosfatidylinositol-3-kinase- (PI3-K) signalvejen og medierer antistof-afhængig, cellemedieret cytotoksicitet (ADCC) i humane brystkræftceller med overekspression af HER2.
English: Table 5 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study BO27938/KATHERINE
Danish: Tabel 5 Laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i studie BO27938/KATHERINE
English: A Phase III, randomised, multicentre, international, open-label clinical study was conducted in patients with HER2-positive unresectable locally advanced breast cancer (LABC) or MBC who had received prior taxane and trastuzumab-based therapy, including patients who received prior therapy with trastuzumab and a taxane in the adjuvant setting and who relapsed during or within six months of completing adjuvant therapy.
Danish: Der er gennemført et randomiseret, internationalt multicenter, åbent, klinisk fase III-studie med patienter med HER2-positiv, inoperabel, lokalt fremskreden brystkræft eller metastatisk brystkræft, som tidligere var behandlet med et taxan og trastuzumab, inklusive patienter tidligere behandlet med trastuzumab og et taxan som adjuverende behandling, og som oplevede recidiv under den adjuverende behandling, eller inden for seks måneder efter den adjuverende behandling var afsluttet.
English: Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases (Grade 1-4 transaminitis), has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.8).
Danish: Levertoksicitet, primært i form af asymptomatiske stigninger i aminotransferaser (grad 1-4 transaminitis), er observeret i kliniske studier med trastuzumabemtansin behandling (se pkt.
English: White to off-white lyophilised powder.
Danish: Hvidt/hvidligt, frysetørret pulver.
English: Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE.
Danish: Tabel 4 og 5 viser laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i de kliniske studier TDM4370g/BO21977/EMILIA og studie BO27938/KATHERINE.
English: The majority of the patients (76.9%) had received an anthracycline-containing neoadjuvant chemotherapy regimen.19.5% percent of patients received another HER2-targeted agent in addition to trastuzumab as a component of neoadjuvant therapy; 93.8% of these patients received pertuzumab.
Danish: 19,5% af patienterne havde fået andet HER2-rettet middel i tillæg til trastuzumab, som en del af et neoadjuverende behandlingsregime; 93,8% af disse patienter fik pertuzumab.
English: · When prepared as a solution for infusion Kadcyla is stable for up to 24 hours at 2°C to 8°C, and must be discarded thereafter.
Danish: · Efter tilberedning til infusionsvæske er Kadcyla holdbart i op til 24 timer ved 2°C - 8°C;
English: Increased Aspartate Transaminase (AST)
Danish: Forhøjet aspartattransaminase (ASAT)
English: Radiation pneumonitis
Danish: Stråle-pneumonitis
English: Do not substitute or combine trastuzumab emtansine with or for trastuzumab 4.
Danish: Trastuzumabemtansin må ikke substitueres eller kombineres med trastuzumab.
English: All but 5 patients were women; 3 men were included in the trastuzumab arm and 2 in the trastuzumab emtansine arm. 22.5 percent of patients were enrolled in North America, 54.2% in Europe and 23.3% throughout the rest of the world.
Danish: 22,5% af patienterne blev inkluderet i Nordamerika, 54,2% i Europa og 23,3% i resten af verden.
English: In patients with EBC, the overall incidence was 32.3% and 10.3% for
Danish: Hos patienter med eBC var den samlede forekomst af perifer neuropati 32,3% og
English: Specific treatment for trastuzumab emtansine extravasation is unknown at this time.
Danish: Der kendes endnu ingen specifik behandling af trastuzumabemtansinekstravasation.
English: Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Danish: Trastuzumabemtansin skal rekonstitueres og fortyndes af sundhedspersonale og administreres som intravenøs infusion.
English: The primary endpoint was investigator assessed Progression-Free Survival (PFS).
Danish: Det primære endepunkt var progressionsfri overlevelse vurderet af investigator.
English: Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Danish: IDFS efter 3 år blev estimeret til 88,3% og 77,0% i henholdsvis trastuzumabemtansin- og trastuzumabarmen.
English: The use of 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Danish: Der skal anvendes 0,20 eller 0,22 mikron integrereret polyethersulfonfilter til infusionen, når koncentratet til infusionsvæske fortyndes med natriumchlorid 9 mg/ml (0,9%) infusionsvæske.
English: Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine.
Danish: Der er identificeret tilfælde af nodulær regenerativ hyperplasi af leveren i leverbiopsier fra patienter behandlet med trastuzumabemtansin.
English: Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver.
Danish: Ikke almindelige bivirkninger: · En anden unormal tilstand, der kan forekomme i forbindelse med behandling med Kadcyla, er en tilstand, der kaldes nodulær regenerativ hyperplasi.
English: Dose Modifications for Patients with MBC Adverse reaction Severity
Danish: Dosisændringer hos patienter med mBC
English: Trastuzumab emtansine has minor influence on the ability to drive and use machines.
Danish: Trastuzumabemtansin påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to hypersensitivity; treatment with trastuzumab emtansine is not recommended for these patients.
Danish: Trastuzumabemtansin er ikke undersøgt hos patienter, hvor trastuzumab er seponeret permanent på grund af overfølsomhed; trastuzumabemtansin frarådes til disse patienter.
English: In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of >10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors.
Danish: I et observationsstudie (BO39807) oplevede ca. 22 % (7 patienter ud af 32) af mBC patienterne i begyndende behandling med trastuzumabentamsin et fald i LVEF på >10% fra baseline og/eller hjertesvigt.
English: Grade 4 at any time < 25,000/mm3
Danish: Grad 4 på hvilket som helst tidspunkt (<25.000/mm3)
English: Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia.
Danish: Infusionsrelaterede reaktioner karakteriseres ved en eller flere af følgende symptomer: ansigtsrødme, kulderystelser, feber, dyspnø, hypotension, hvæsende vejrtrækning, bronkospasme og takykardi.
English: Serious hepatobiliary disorders, including nodular regenerative hyperplasia (NRH) of the liver and some with a fatal outcome due to drug-induced liver injury have been observed in patients treated with trastuzumab emtansine.
Danish: Der er set svære lever- og galdeforstyrrelser, herunder nodulær regenerativ hyperplasi af leveren og nogle med dødelig udgang, på grund af lægemiddelinduceret leverskade hos patienter behandlet med trastuzumabemtansin.
English: Hyperbilirubinemia TBILI
Danish: Hyperbilirubinæmi
English: Trastuzumab emtansine has the mechanisms of action of both trastuzumab and DM1:
Danish: Trastuzumabemtansin har samme virkningsmekanisme som henholdsvis trastuzumab og DM1:
English: In order to prevent medicinal product errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab.
Danish: For at forhindre lægemiddelfejl er det vigtigt at gennemgå produktresuméet og kontrollere den ydre karton og hætteglassets etiket for at sikre, at lægemidlet, som blandes og administreres, er Kadcyla (trastuzumabemtansin) og ikke Herceptin (trastuzumab).
English: (flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia) should be advised not to drive and use machines until symptoms abate.
Danish: Patienter, der oplever infusionsrelaterede reaktioner (rødme, rysteanfald, feber, dyspnø, hypotension, hvæsen, bronkospasme og takykardi), bør informeres om ikke at føre motorkøretøj og betjene maskiner, før symptomerne er aftaget.
English: (> 5 to ≤ 20´ ULN on day of scheduled treatment)
Danish: (>5 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
English: Increased transaminases were reported in 24.2% of patients in MBC clinical studies.
Danish: Der er indberettet aminotransferase-stigninger hos 24,2% af patienterne i kliniske studier med mBC-patienter.
English: · Store in a refrigerator at (2°C - 8°C).
Danish: · Opbevares i køleskab (2°C - 8°C).
English: Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
Danish: Serumtransaminaser >3 ´ øvre normalgrænse og samtidigt total-bilirubin >2 ´ øvre normalgrænse
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/mL (0.45%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion.
Danish: Det relevante volumen koncentrat trækkes fra hætteglasset og tilsættes en infusionspose indeholdende 250 ml natriumchlorid 4,5 mg/ml (0,45%) infusionsvæske eller natriumchlorid 9 mg/ml (0,9%) infusionsvæske.
English: Haemorrhagic events were reported in 29% of patients with EBC and the incidence of severe haemorrhagic events (Grade ≥3) was 0.4%, including one Grade 5 event.
Danish: Blandt patienter med eBC blev der indberettet blødningshændelser hos 29% af patienterne og forekomsten af svære blødningshændelser (grad ≥3) var 0,4%, inklusive én hændelse af grad 5.
English: Infusion-related reactions (due to cytokine release), characterized by one or more of the following symptoms have been reported: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia.
Danish: Der er indberettet infusionsrelaterede reaktioner (på grund af cytokinfrigørelse), karakteriseret ved en eller flere af følgende symptomer: ansigtsrødme, kulderystelser, feber, dyspnø, hypotension, hvæsende vejrtrækning, bronkospasme samt takykardi.
English: Also you should not breast-feed for 7 months after your last infusion of Kadcyla.
Danish: Du må ikke amme, mens du er i behandling med Kadcyla eller i 7 måneder efter din sidste infusion.
English: What Kadcyla looks like and contents of the pack · Kadcyla is a white to off-white lyophilised powder for concentrate for solution for infusion supplied in glass vials.
Danish: Udseende og pakningsstørrelser · Kadcyla er et hvidt/hvidligt frysetørret pulver til koncentrat til infusionsvæske, opløsning, der leveres i hætteglas.
English: Dose modification
Danish: Dosisændringer
English: Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine.
Danish: Der er observeret alvorlige, anafylaktiske reaktioner i kliniske studier med trastuzumabemtansin.
English: Dose reduction schedule (Starting dose is 3.6 mg/kg)
Danish: Startdosis er 3,6 mg/kg
English: This abnormality causes the structure of the liver to change and can change how the liver functions.
Danish: Denne tilstand gør, at levercellerne ændres, og kan påvirke leverfunktionen.
English: Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Rekonstitueret koncentrat skal inden administration inspiceres visuelt for udfældning og misfarvning.
English: Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Danish: Trastuzumab blev givet intravenøst, 6 mg/kg på dag 1 i en 21-dages serie.
English: Do not administer trastuzumab emtansine until
Danish: Giv ikke trastuzumabemtansin før
English: Grade 4 (> 20 ´ ULN at any time)
Danish: Grad 4 (>20 ´ øvre normalgrænse på hvilket som helst tidspunkt)
English: Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla (trastuzumab emtansine) to patients.
Danish: Både særnavnet Kadcyla og det generiske navn (trastuzumabemtansin) skal anvendes og bekræftes, når lægemidlet ordineres og fremstilles som infusionsvæske, og når Kadcyla (trastuzumabemtansin) administreres til patienter.
English: Hypersensitivity was reported in 2.7% of patients with EBC, with Grade 3 or 4 in 0.4% of patients.
Danish: Overfølsomhed var indberettet hos 2,7% af patienterne med eBC; 0,4% af patienterne havde hændelser svarende til grad 3 eller 4.
English: (> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
Danish: (>3,0 til ≤5´ øvre normalgrænse på dag for planlagt behandling)
English: LVEF 45% to < 50% and decrease is < 10% points from baseline*
Danish: LVEF 45% til <50% og fald er <10% point fra baseline*
English: In the fatal case, the patient incorrectly received trastuzumab emtansine 6 mg/kg and died approximately 3 weeks following the overdose; a causal relationship to trastuzumab emtansine was not established.
Danish: I dette tilfælde fik patienten ved en fejl trastuzumabemtansin 6 mg/kg og døde ca. 3 uger efter overdoseringen.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Germany
Danish: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
English: (> 3.0 to ≤ 20´ ULN on day of scheduled treatment)
Danish: (>3,0 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
English: Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Danish: Metastatisk brystkræft (mBC) Kadcyla er, som enkeltstof, indiceret til behandling af voksne patienter med HER2-positiv, inoperabel, lokalt fremskreden eller metastatisk brystkræft, som tidligere har været behandlet med trastuzumab og et taxan, separat eller i kombination.
English: Table 7 Summary of efficacy from study TDM4370g/BO21977 (EMILIA)
Danish: Tabel 7 Oversigt over virkningsresultater i Studie TDM4370g/BO21977 (EMILIA)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: How you are given Kadcyla
Danish: Sådan får du Kadcyla
English: Peripheral neuropathy, mainly Grade 1 and predominantly sensory, has been reported in clinical studies with trastuzumab emtansine.
Danish: Der er indberettet perifer neuropati, primært i grad 1 og mest sensorisk, i kliniske studier med trastuzumabemtansin.
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight:
Danish: Beregn, hvor meget rekonstitueret koncentrat der er behov for, til en dosis på 3,6 mg trastuzumabemtansin/kg kropsvægt:
English: Dizziness, Dysgeusia, Memory impairment
Danish: Svimmelhed, smagsforstyrrelser, svækket hukommelse
English: Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Danish: Tabel 4 Laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i studie TDM4370g/BO21977/EMILIA
English: Your doctor will check your blood to test your liver function before and regularly during treatment.
Danish: Lægen vil kontrollere din leverfunktion med en blodprøve, inden du starter behandling og jævnligt under behandlingen.
English: Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Danish: Populationsfarmakokinetiske analyser tyder på, at alder ikke har klinisk relevant effekt på trastuzumabemtansins farmakokinetik (se pkt.
English: A treatment benefit was seen in the subgroup of patients who had relapsed within 6 months of completing adjuvant treatment and had not received any prior systemic anti-cancer therapy in the metastatic setting (n=118); hazard ratios for PFS and OS were 0.51 (95% CI: 0.30, 0.85) and 0.61 (95% CI: 0.32, 1.16), respectively.
Danish: Der sås gavn af behandling i subgruppen af patienter, der havde haft recidiv inden for 6 måneder efter afsluttet adjuverende behandling, og som ikke tidligere havde fået systemisk kræftbehandling efter udvikling af metastaser (n=118); hazard ratio for progressionfri overlevelse og samlet overlevelse var henholdsvis 0,51 (95% konfidensinterval 0,30; 0,85) og 0,61 (95% konfidensinterval 0,32; 1,16).
English: Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with trastuzumab emtansine, with one Grade 3 and one Grade 4 events reported.
Danish: Der er indberettet overfølsomhed hos 2,6% af patienterne i kliniske mBC-studier med trastuzumabemtansin; der er indberettet en grad 3 og en grad 4-reaktion.
English: You may experience tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Danish: Du kan opleve smerter, følelsesløshed, kløe og en snurrende, kriblende eller prikkende og stikkende fornemmelse i hænder og fødder.
English: Grade 2 (> 2.5 to ≤ 5´ the ULN)
Danish: Grad 2 (>2,5 til ≤5 ´ øvre normalgrænse)
English: In order to prevent medicinal product errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Danish: For at undgå lægemiddelfejl er det vigtigt at kontrollere hætteglasetiketten for at sikre, at det lægemiddel, der tilberedes og administreres, er Kadcyla (trastuzumabemtansin) og ikke Herceptin (trastuzumab).
English: No formal PK study has been conducted in patients with renal impairment.
Danish: Der er ikke gennemført formelle farmakokinetiske studier med patienter med nedsat nyrefunktion.
English: Permanently discontinue trastuzumab emtansine
Danish: Seponér trastuzumabemtansin permanent
English: If symptoms do occur, cough shortness of breath at rest or when sleeping flat, chest pain and swollen ankles or arms, a sensation of rapid or irregular heartbeats may be observed.
Danish: Hvis der er symptomer, opleves de som hoste/åndenød ved hvile eller ved søvn i liggende position, brystsmerter og hævede ankler og arme, følelse af hurtige eller uregelmæssige hjerteslag.
English: Symptomatic CHF Discontinue trastuzumab emtansine LVEF <40%
Danish: Symptomatisk hjertesvigt Seponér trastuzumabemtansin LVEF <40%
English: In patients ≥ 65 years old (n=138 across both treatment arms) the hazard ratios for progression-free survival (PFS) and Overall Survival (OS) were 1.06 (95% CI: 0.68, 1.66) and 1.05 (95% CI: 0.58, 1.91), respectively.
Danish: Hos patienter ≥65 år (n=138 for begge behandlingsgrupper) var hazard ratio for progressionsfri overlevelse og samlet overlevelse henholdsvis 1,06 (95% konfidensinterval 0,68; 1,66) og 1,05 (95% konfidensinterval 0,58; 1,91).
English: Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
Danish: Grad 3 (25.000 til <50.000/mm3)
English: The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2).
Danish: I tilfælde af dysfunktion af venstre ventrikel bør dosering udsættes eller behandlingen seponeres, hvis nødvendigt (se pkt.
English: Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Danish: Trastuzumabemtansin er et antistof-lægemiddel-konjugat, der indeholder trastuzumab, et humaniseret IgG1-monoklonalt antistof fremstillet ud fra en cellekultursuspension fra pattedyr (ovarier fra kinesiske hamstre), der via den stabile thioether-linker MCC (4-[N-maleimidomethyl] cyclohexan-1-carboxylat) er kovalent bundet til DM1, en mikrotubulær hæmmer.
English: Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Danish: Kadcyla, trastuzumabemtansin, er et HER-2-antistof-lægemiddel-konjugat, der indeholder det humaniserede anti-HER2-IgG1, trastuzumab, der via den stabile thioether-linker MCC (4-[N-maleimidomethyl]-cyclohexan-1-carboxylat) er kovalent bundet til den mikrotubulære hæmmer DM1 (et maytansinderivat).
English: DATE OF REVISION OF THE TEXT
Danish: Rekonstitutionsvejledning
English: If sodium chloride 9 mg/mL (0.9%) solution for infusion is used for infusion, a 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required.
Danish: Hvis infusionsvæsken fremstilles med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, skal der anvendes et 0,20 eller 0,22 mikron integrereret polyethersulfonfilter.