FrancophonIA/ELRC3.0 huggingface dataset:
English: When trastuzumab binds to HER2 it can stop the cancer cells growth and cause them to die.
Danish: Når trastuzumab bindes til HER2, kan det stoppe væksten af kræftcellerne og forårsage deres død.
English: Use caution with these agents and consider additional monitoring when concomitant use is medically necessary.
Danish: Vær forsigtig ved samtidig brug af disse lægemidler og overvej yderligere monitorering, når samtidig anvendelse er medicinsk indiceret.
English: Pack of 1 vial.
Danish: Pakker med 1 hætteglas.
English: Some of these bleeding events resulted in fatal outcomes.
Danish: Nogle af disse blødninger var dødelige.
English: Your doctor will check your blood regularly for decreased platelets.
Danish: Din læge vil kontrollere dit blod regelmæssigt for nedsat antal blodplader.
English: · DM1 - an anti-cancer substance that becomes active once Kadcyla enters the cancer cell.
Danish: · DM1 - et middel mod kræft, som aktiveres, når Kadcyla trænger ind i en kræftcelle.
English: Dose to be administered
Danish: Dosis, der skal administreres
English: At retreatment a dose reduction may be considered according to the dose reduction schedule (see Table 1).
Danish: Ved genoptagelse af behandling kan dosisreduktion i overensstemmelse med dosisreduktionsskemaet overvejes (se tabel 1).
English: The key efficacy analyses were ORR based on independent radiologic review and duration of objective response.
Danish: De primære virkningsendepunkter var objektiv responsrate, baseret på uafhængig radiologisk vurdering, og varighed af objektivt respons.
English: The reconstituted product contains no preservative and is intended for single use only.
Danish: Det rekonstituerede produkt indeholder ikke konserveringsmiddel og er til éngangsbrug.
English: Trastuzumab Emtansine N = 743
Danish: Trastuzumabemtansin N = 743
English: The co-primary efficacy endpoints of the study were progression-free survival (PFS) as assessed by an independent review committee (IRC) and overall survival (OS) (see Table 7 and Figures 2 to 3).
Danish: De co-primære virkningsendepunkter i studiet var progressionsfri overlevelse, vurderet af en uafhængig bedømmelseskomité, og samlet overlevelse (se tabel 7 og figur 2 til 3).
English: Kadcyla is used to treat breast cancer in adults when: · the cancer cells have many HER2 proteins on them - your doctor will test your cancer cells for this.
Danish: Kadcyla bruges til at behandle brystkræft hos voksne, når: · kræftcellerne har mange HER2-proteiner på overfladen - lægen vil teste, om det er tilfældet hos dig.
English: Early Breast Cancer (EBC)
Danish: Tidlig brystkræft (eBC)
English: The initial dose should be administered as a 90 minute intravenous infusion.
Danish: Den første dosis administreres som 90-minutters intravenøs infusion.
English: The median age was approximately 49 years (range 23-80 years), 72.8% were White, 8.7% were Asian and 2.7% were Black or African American.
Danish: Medianalderen var ca. 49 år (23-80 år); 72,8% var hvide, 8,7% var asiater og 2,7% var sorte eller afroamerikaner.
English: This HCP educational pack shall consist of the following:
Danish: Pakken med uddannelsesmaterialet skal indeholde følgende:
English: If the prior infusion was well tolerated, subsequent doses of trastuzumab emtansine may be administered as 30 minute infusions.
Danish: Hvis den foregående infusion var veltolereret, kan efterfølgende doser af trastuzumabemtansin administreres som 30-minutters infusioner.
English: Results from in vitro cytotoxicity assays show that DM1 is 20-200 times more potent than taxanes and vinca alkaloids.
Danish: Resultater fra in vitro cytotoksiske analyser viser, at DM1 er 20-200 gange mere potent end taxaner og vincaalkaloider.
English: The subgroup of patients 75 years or above did not demonstrate a benefit for PFS or OS, but was too small (n=25) to draw any definitive conclusions.
Danish: Subgruppen af patienter over 75 år viste ingen gavn med hensyn til progressionsfri overlevelse og samlet overlevelse, men var for lille (n=25) til, at der kunne drages definitive konklusioner.
English: In general, the Grade ≥ 3 hepatic events were not associated with poor clinical outcome; subsequent follow-up values tended to show improvement to ranges allowing the patient to remain on study and continue to receive study treatment at the same or reduced dose.
Danish: Generelt var leverbivirkninger grad ≥3 ikke forbundet med et dårligt klinisk resultat; ved opfølgning havde efterfølgende værdier tendens til at vise forbedring til niveauer, der gjorde, at patienten kunne fortsætte i studiet og få studiemedicinen ved samme eller reduceret dosis.
English: 3-year event-free rate and 5-year survival rate derived from Kaplan-Meier estimates 3.
Danish: Andel der er hændelsesfri efter 3 år og 5 år er udledt af Kaplan-Meier-estimater 3.
English: · Allergic reactions can occur and most patients will have mild symptoms such as itching or tightness in the chest.
Danish: · Allergiske reaktioner kan forekomme, og de fleste patienter vil få lette symptomer såsom kløe eller trykken for brystet.
English: As with all therapeutic proteins, there is the potential for an immune response to trastuzumab emtansine.
Danish: Som med alle terapeutiske proteiner er der med trastuzumabemtansin risiko for immunrespons.
English: Nodular Regenerative Hyperplasia (NRH)
Danish: Nodulær regenerativ hyperplasi (NRH)
English: Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment.
Danish: Overordnet var størstedelen af overfølsomhedsreaktionerne lette eller moderate i sværhedsgrad og forsvandt ved behandling.
English: There are no data from the use of trastuzumab emtansine in pregnant women.
Danish: Der er ingen data fra anvendelse af trastuzumabemtansin til gravide kvinder.
English: In vitro, DM1 was a substrate of P-glycoprotein (P-gp).
Danish: In vitro var DM1 substrat for P-glykoprotein (P-gp).
English: The reconstituted Kadcyla solution should be diluted in polyvinyl chloride (PVC) or latex-free PVC-free polyolefin infusion bags.
Danish: Rekonstitueret Kadcyla-koncentrat skal fortyndes i polyvinylchlorid (PVC) eller latex-fri, PVC-fri polyolefin-infusionsposer.
English: Kadcyla will be given to you by a doctor or nurse in a hospital or clinic: · It is given by a drip into a vein (intravenous infusion).
Danish: Du får Kadcyla af en læge eller sygeplejerske på hospitalet: · Det gives i en vene via et drop (intravenøs infusion).
English: Do not freeze or shake the infusion during storage.
Danish: Infusionsvæsken må ikke fryses eller rystes under opbevaring.
English: · Kadcyla is available in packs containing 1 vial.
Danish: · Kadcyla fås i pakker med 1 hætteglas.
English: No dose relationship was observed in clinical studies.
Danish: Der sås ingen dosissammenhæng i de kliniske studier.
English: · If you do become pregnant during treatment with Kadcyla, tell your doctor straight away.
Danish: · Hvis du bliver gravid under behandling med Kadcyla, skal du straks kontakte lægen.
English: Patients received radiotherapy and/or hormonal therapy concurrent with study treatment as per local guidelines.
Danish: Patienterne fik strålebehandling og/eller hormonterapi samtidig med forsøgsbehandlingen i overensstemmelse med lokale retningslinjer.
English: The majority of events were asymptomatic Grade 1 or 2 decrease in LVEF.
Danish: I størstedelen af tilfældene var bivirkningen asymptomatisk grad 1 eller 2 fald i LVEF.
English: · The other ingredients are succinic acid, sodium hydroxide (see section 2 under ‘Important information about some of the ingredients of Kadcyla'), sucrose, and polysorbate 20.
Danish: · Øvrige indholdsstoffer: ravsyre, natriumhydroxid (se afsnit 2 under ”Vigtig information om nogle af indholdsstofferne i Kadcyla”), saccharose og polysorbat 20
English: Date of latest renewal: 17 September 2018
Danish: Dato for første markedsføringstilladelse: 15. november 2013 Dato for seneste fornyelse: 17. september 2018
English: Since many medicinal products are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should discontinue breast-feeding prior to initiating treatment with trastuzumab emtansine.
Danish: Da mange lægemidler udskilles i humanmælk, og da der er risiko for alvorlige bivirkninger hos det ammede barn, bør kvinder holde op med at amme, inden behandling med trastuzumabemtansin påbegyndes.
English: If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Danish: Hvis du udvikler en af disse reaktioner, vil de nedsætte infusionshastigheden eller stoppe infusionen, og de kan give dig behandling, som modvirker bivirkningerne.
English: (see section 4.2).
Danish: (angivet i afsnit 6).
English: In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: For at bedre sporbarheden af biologiske lægemidler skal det administrerede lægemiddels handelsnavn og batchnummer altid registreres (eller angives) tydeligt i patientjournalen.
English: Due to the low incidence of ADA, conclusions cannot be made on the impact of anti- trastuzumab emtansine antibodies on the pharmacokinetics, safety, and efficacy of trastuzumab emtansine.
Danish: På grund af den lave forekomst af ADA, kan der ikke konkluderes på antitrastuzumabemtansin-antistoffernes betydning for trastuzumabemtansins farmakokinetik, sikkerhed eller virkning.
English: · Your skin and whites of your eyes get yellow (jaundice) - these could be signs of severe liver damage.
Danish: · Gulfarvning af huden og det hvide i øjnene (gulsot) - dette kan være tegn på svær leverskade.
English: If you forget or miss your Kadcyla appointment, make another appointment as soon as possible.
Danish: Hvis du glemmer eller udebliver fra en behandling med Kadcyla, skal du lave en ny aftale så hurtigt som muligt.
English: Patients should be observed during the infusion and for at least 30 minutes after infusion.
Danish: Patienterne skal observeres under infusionen og i mindst 30 minutter efter infusionen.
English: The schedule of administration should be adjusted to maintain a 3-week interval between doses.
Danish: Herefter justeres behandlingsskemaet, så det igen passer med et 3-ugers interval mellem doserne.
English: In KATHERINE, consistent treatment benefit of trastuzumab emtansine for IDFS was seen in all the pre-specified subgroups evaluated, supporting the overall result.
Danish: I KATHERINE sås vedvarende behandlingsgavn af trastuzumabemtansin på IDFS i alle de præspecificerede subgrupper, der blev evalueret, hvilket understøtter det overordnede resultat.
English: If a patient requires 2 delays due to thrombocytopenia, consider reducing dose by one level.
Danish: Hvis en patient har behov for 2 udsættelser på grund af trombocytopeni, kan det overvejes at nedsætte dosis med 1 dosisniveau
English: Kadcyla will be stored by the health professionals at the hospital or clinic.
Danish: Kadcyla opbevares på hospitalet af sundhedspersonalet.
English: In the event of a true hypersensitivity reaction (in which severity of reaction increases with subsequent infusions), trastuzumab emtansine treatment must be permanently discontinued.
Danish: I tilfælde af en reel allergisk reaktion (hvor reaktionen bliver alvorligere ved efterfølgende infusioner), skal trastuzumabemtansin seponeres permanent.
English: · The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
Danish: ● MCC-linkeren er designet til at begrænse systemisk frigørelse og øger målrettet afgivelse af DM1, hvilket er påvist ved meget lave niveauer af frit DM1 i plasma.
English: Talk to your doctor about the best contraception for you.
Danish: Tal med lægen om, hvilken type prævention der vil være bedst for dig.
English: Patients were randomized (1:1) to receive trastuzumab or trastuzumab emtansine.
Danish: Patienterne blev randomiseret (1:1) til trastuzumab eller trastuzumabemtansin.
English: A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
Danish: I alt 991 patienter randomiseredes til trastuzumabemtansin eller lapatinib plus capecitabin:
English: METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution
Danish: ADMINISTRATIONSMETODE Til intravenøs anvendelse efter rekonstitution og fortynding
English: · medicine for depression called nefazodone
Danish: ● medicin mod depression, såsom nefazodon
English: Patients treated with trastuzumab emtansine are at increased risk of developing left ventricular dysfunction.
Danish: Patienter behandlet med trastuzumabemtansin har øget risiko for at udvikle dysfunktion af venstre ventrikel.
English: These reactions have been observed more frequently within 24 hours of infusion.
Danish: Reaktionerne forekommer hyppigst inden for 24 timer efter infusionen.
English: Trastuzumab emtansine dose should not be re-escalated after a dose reduction is made.
Danish: Dosis af trastuzumabemtansin bør ikke titreres op igen, når den først er reduceret.
English: The infusion site should be closely monitored for possible subcutaneous infiltration during administration (see section 4.8).
Danish: Infusionsstedet skal overvåges omhyggeligt for eventuel subkutan infiltration under administrationen (se pkt.
English: · you have any history of liver problems.
Danish: · du tidligere har haft leverproblemer.
English: · Unexpected bruising and bleeding (such as nose bleeds).
Danish: · Uventede blå mærker og blødning (fx næseblod).
English: Management of symptomatic adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of trastuzumab emtansine as per guidelines provided in text and Tables 1 and 2 .
Danish: Behandling af symptomgivende bivirkninger kan kræve midlertidig afbrydelse, dosisreduktion eller seponering af trastuzumabemtansin, som beskrevet i retningslinjerne i teksten samt i tabel 1 og 2.
English: Additional endpoints included IDFS including second primary non-breast cancer, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI).
Danish: Yderligere endepunkter omfattede IDFS inklusive anden primær kræft (ikke bryst), sygdomsfri overlevelse (DFS), samlet overlevelse (OS) samt interval uden fjernrecidiv (DRFI).
English: Description of the key differences between trastuzumab emtansine and trastuzumab in relation to indication, dose, administration and packaging differences.
Danish: Beskrivelse af de vigtigste forskelle mellem trastuzumabemtansin og trastuzumab i henhold til indikation, dosering og administration samt forskelle i pakninger.
English: Table 3 shows pooled data from the overall treatment period in the MBC studies (N= 1871; median number of cycles of trastuzumab emtansine was 10) and in KATHERINE (N=740; median number of cycles was 14).
Danish: I tabel 3 præsenteres samlede data fra den overordnede behandlingsperiode i mBC-studierne (N= 1871; median for antal trastuzumabemtansin-serier var 10) og i KATHERINE (N=740; median for antal serier var 14).
English: A vial of Kadcyla reconstituted with water for injections (not supplied) is stable for 24 hours at 2ºC - 8 ºC after reconstitution and must not be frozen.
Danish: Et hætteglas med Kadcyla, rekonstitueret med vand til injektionsvæske (medfølger ikke) er stabilt i 24 timer ved 2ºC - 8ºC efter rekonstitution og må ikke fryses.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis og er dermed i det væsentlige ‘natriumfrit'.
English: Liver function should be monitored prior to initiation of treatment and each dose.
Danish: Leverfunktionen skal monitoreres inden behandlingsstart og inden hver enkelt dosis.
English: Transaminase elevations were generally transient.
Danish: Stigningen i aminotransferaser var generelt forbigående.
English: · you are receiving treatment with blood thinning medicines (e.g. warfarin, heparin).
Danish: · du får blodfortyndende medicin (fx warfarin eller heparin).
English: It is not known whether the ingredients in Kadcyla pass into breast-milk.
Danish: Det vides ikke, om indholdsstofferne i Kadcyla udskilles i mælken.
English: Patients (n = 110) received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks until disease progression or unacceptable toxicity.
Danish: Patienterne (n=110) fik 3,6 mg/kg trastuzumabemtansin intravenøst hver 3. uge indtil sygdomsprogression eller uacceptabel toksicitet.
English: In most patients, these reactions resolved over the course of several hours to a day after the infusion was terminated.
Danish: Hos de fleste patienter forsvandt disse reaktioner i løbet af adskillige timer til en dag efter, infusionen var afsluttet.
English: These may be signs of inflammation of your lung, which may be serious, and even fatal.
Danish: Dette kan være tegn på en inflammation (betændelseslignende reaktion) i lungerne, som kan være alvorlig og i værste fald dødelig.
English: Trastuzumab emtansine (N=740) All Grade % Grade 3 (%) Grade 4 (%)
Danish: Trastuzumabemtansin (N=740) Alle grader % Grad 3 (%) Grad 4 (%)
English: You should tell your doctor immediately if you notice any unexpected bruising or bleeding.
Danish: Du skal straks fortælle det til lægen, hvis du uventet oplever blå mærker eller blødning.
English: The decision to administer trastuzumab emtansine in MBC patients with low LVEF must be made only after careful benefit risk assessment and cardiac function should be closely monitored in these patients (see section 4.8).
Danish: Beslutningen om at administrere trastuzumabemtansin hos mBC patienter med lav LVEF bør kun foretages efter nøje risk/benefit-vurdering, og hjertefunktion hos disse patienter skal nøje overvåges (se pkt.
English: In addition, exploratory analysis showed that the impact of covariates (i.e., renal function, race and age) on the pharmacokinetics of total trastuzumab and DM1 was limited and was not clinically relevant.
Danish: Derudover har eksploratoriske analyser vist, at kovariaternes (dvs. nyrefunktion, etnicitet og alder) betydning for farmakokinetikken for totaltrastuzumab og -DM1 var begrænset og ikke klinisk relevant.
English: Transaminase elevations were generally transient with peak elevation at day 8 after administration of therapy and subsequent recovery to Grade 1 or less prior to the next cycle.
Danish: Aminotransferasestigninger var generelt forbigående med maksimal stigning på dag 8 efter administration og efterfølgende bedring til grad 1 eller mindre inden næste cyklus.
English: Cases of bleeding events with a fatal outcome have been observed in both MBC and EBC.
Danish: Der er observeret dødelige blødningshændelser i såvel mBC- som eBC-gruppen.
English: However, the magnitude of effect of these covariates on trastuzumab emtansine exposure suggests that these covariates are unlikely to have any clinically meaningful effect on trastuzumab emtansine exposure.
Danish: Størrelsesordenen af disse kovariaters effekt på eksponeringen af trastuzumabemtansin antyder dog, at kovariaterne sandsynligvis ikke vil have klinisk relevant effekt på trastuzumabemtansin-eksponeringen.
English: · You should continue to take your contraception for at least 7 months after your last dose of
Danish: ● Du skal fortsætte med at bruge prævention i mindst 7 måneder efter din sidste dosis Kadcyla.
English: The primary efficacy endpoint of the study was Invasive Disease-Free Survival (IDFS).
Danish: Det primære endepunkt i studiet var overlevelse uden invasiv sygdom (IDFS).
English: Your doctor will monitor you for signs and symptoms of neurological problems.
Danish: Lægen vil undersøge dig for eventuelle symptomer på neurologiske problemer.
English: No significant difference was observed in the PK of trastuzumab emtansine among patients < 65 years (n = 577), patients between 65-75 years (n = 78) and patients > 75 years (n = 16).
Danish: Der sås ingen signifikant forskel i trastuzumabemtansins farmakokinetik hos patienter <65 år (n=577), patienter i aldersgruppen 65-75 år (n=78) eller patienter >75 år (n=16).
English: IDFS was defined as the time from the date of randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Danish: IDFS defineres som tid fra randomiseringsdato til første recidiv af ipsilateral invasiv brysttumor, recidiv af ipsilateral lokal eller regional brystkræft, fjernrecidiv, kontralateral invasiv brystkræft eller død af enhver årsag.
English: In patients with MBC, the overall incidence of peripheral neuropathy was 29.0% and 8.6% for Grade ≥ 2.
Danish: Hos patienter med mBC var den samlede forekomst af perifer neuropati 29,0% og 8,6% for grad ≥2.
English: · Swirl the vial gently until completely dissolved.
Danish: · Vend forsigtigt hætteglasset, indtil koncentratet er helt opløst.
English: The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies.
Danish: Sikkerhed af trastuzumabemtansin er evalueret hos 2.611 brystkræftpatienter i kliniske studier.
English: Metastatic Breast Cancer
Danish: Metastatisk brystkræft
English: Impairment of fertility and teratogenicity
Danish: Nedsat fertilitet og teratogenicitet
English: 3 weeks (n = 70).
Danish: intravenøst hver 3. uge (n=70).
English: Time to symptom progression, as defined by a 5-point decrease in the score derived from the Trials Outcome Index-Breast (TOI-B) subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life (FACT-B QoL) questionnaire was also assessed during the clinical study.
Danish: Tid til symptomprogression, defineret ved et fald på 5 point i TOI-B-score (Trials Outcome Index-Breast), der er en del af FACT-B QoL-spørgeskemaet (Functional Assessment of Cancer Therapy-Breast Quality of Life), blev også vurderet i løbet af det kliniske studie.
English: · DM1, the cytotoxic component of trastuzumab emtansine, binds to tubulin.
Danish: ● DM1, den cytotoksiske komponent i trastuzumabemtansin, bindes til tubulin.
English: Table 6 Summary of efficacy from study BO27938 (KATHERINE) Trastuzumab N = 743
Danish: Tabel 6 Resumé af effekt fra Studie BO27938 (KATHERINE) Trastuzumab N = 743
English: DM1 did not inhibit major CYP450 enzymes in vitro.
Danish: DM1 hæmmede ikke major CYP-enzymer in vitro.
English: These reactions were usually mild or moderate and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site.
Danish: Reaktionerne var sædvanligvis lette eller moderate og omfattede erytem, ømhed, hudirritation, smerter eller hævelse på infusionsstedet.
English: If you stop Kadcyla treatment Do not stop treatment with this medicine without talking to your doctor first.
Danish: Hvis du holder op med Kadcyla-behandlingen Du må ikke stoppe behandlingen med Kadcyla uden at have snakket med lægen først.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC14
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC14
English: An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Danish: I gennemsnit konjugeres 3,5 DM1-molekyler til ét trastuzumabmolekyle.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C.
Danish: Kemisk og fysisk holdbarhed af den rekonstituerede opløsning er dokumenteret at være op til 24 timer ved 2 °C til 8 °C.
English: The objective response rate (ORR) was 58.0% with trastuzumab plus docetaxel and 64.2% with trastuzumab emtansine.
Danish: Objektiv responsrate var 58,0% med trastuzumab plus docetaxel og 64,2% med trastuzumabemtansin.