FrancophonIA/ELRC3.0 huggingface dataset:
English: • you have ever had any other treatment for cancer.
Danish: • du nogensinde har fået andre kræftbehandlinger.
English: Allow the vial to stand undisturbed for approximately 5 minutes.
Danish: Lad hætteglasset stå i ro i ca. 5 minutter.
English: Study BO15935
Danish: Studie BO15935
English: Determine the volume of the solution required:
Danish: Beregn det nødvendige volumen af opløsningen:
English: Before starting the treatment your doctor will determine the amount of HER2 in your tumour.
Danish: Inden din behandling påbegyndes, vil lægen bestemme mængden af HER2 i din tumor.
English: • Your doctor will advise you of the risks and benefits of taking KANJINTI during pregnancy.
Danish: • Lægen vil rådgive dig om risiko og fordele ved at tage KANJINTI under graviditet.
English: This could be more serious if you are already breathless.
Danish: Dette kan blive alvorligt, hvis du allerede har åndenød.
English: These tissues were fixed in formalin or Bouin's fixative.
Danish: Disse væv blev fikseret i formalin eller Bouin's fiksativ.
English: • you suffer from breathlessness, especially if you are currently using a taxane.
Danish: • du har åndenød, særligt hvis du i øjeblikket får et taxan.
English: • low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
Danish: • lavt antal røde blodceller og hvide blodceller (som hjælper med at bekæmpe infektion) nogle gange med feber
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Danish: Alle doser skal tages på det rigtige tidspunkt hver uge eller hver tredje uge (afhængigt af dit doseringsskema).
English: It is not known whether trastuzumab can affect reproductive capacity.
Danish: Det vides ikke, om trastuzumab kan påvirke reproduktionskapaciteten.
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Danish: Patienter skal advares om muligheden for dette sene frembrud og instrueres i at kontakte deres læge, hvis disse symptomer forekommer.
English: The majority of the deaths were due to events related to the underlying cancer.
Danish: Størstedelen af dødsfaldene skyldtes hændelser relateret til den grundliggende cancer.
English: KANJINTI should only be given by a doctor or nurse.
Danish: KANJINTI må kun gives af en læge eller sygeplejerske.
English: Due to non-linear elimination, total clearance increased with decreasing concentration.
Danish: Grundet ikke-lineær elimination steg den totale clearance ved faldende koncentration.
English: The primary endpoint was overall survival which was defined as the time from the date of randomisation to the date of death from any cause.
Danish: Det primære endepunkt var samlet overlevelse, som blev defineret som tiden fra datoen for randomiseringen til datoen for dødsfald uanset årsag.
English: Fatalities have occurred within hours and up to one week following infusion.
Danish: Dødsfald er forekommet inden for timer og op til en uge efter infusionen.
English: Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Danish: En initial forbedring efterfulgt af klinisk forværring og forsinkede reaktioner med hurtig klinisk forværring er også blevet rapporteret.
English: Sometimes, symptoms may improve and then get worse later.
Danish: Nogle gange kan symptomerne mindskes og senere igen blive værre.
English: The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects.
Danish: Den første dosis af din behandling gives over 90 minutter, og du vil blive observeret af sundhedspersonale, mens den indgives, i tilfælde af at du får nogle bivirkninger.
English: Trastuzumab is not genotoxic.
Danish: Trastuzumab er ikke genotoksisk.
English: The following information is intended for medical or healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale
English: A careful risk-benefit assessment should be made before deciding to treat with KANJINTI.
Danish: Der skal foretages en grundig risk-benefit vurdering før det besluttes, om der skal behandles med KANJINTI.
English: It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Danish: Det estimeres, at ca. 40 % af patienterne, som bliver behandlet med trastuzumab, vil opleve infusionsrelaterede reaktioner i en eller anden form.
English: All the terms included are based on the highest percentage seen in pivotal clinical trials.
Danish: Alle inkluderede termer er baseret på den højeste procent set i de pivotale kliniske studier.
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Danish: Der er observeret overekspression af HER2 i 20-30 % af primær brystkræft.
English: The clinical relevance of these antibodies is not known.
Danish: Den kliniske relevans af disse antistoffer er ukendt.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Danish: Den biologiske aktivitet af D7D og den kliniske betydning af øget eksponering for denne metabolit var uklar.
English: Use of other reconstitution solvents should be avoided.
Danish: Brug af andre rekonstitueringsopløsninger bør undgås.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Danish: Det kan også være en god idé, at du selv noterer disse oplysninger for det tilfælde, at du i fremtiden bliver bedt om at udlevere dem.
English: Preparation should be:
Danish: Klargørelse skal:
English: KANJINTI can cause breathing difficulties, especially when it is first given.
Danish: KANJINTI kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får medicinen, da den indeholder vigtige oplysninger.
English: Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.
Danish: Derfor kan din læge beslutte at fortsætte med at undersøge din hjertefunktion, efter din behandling er stoppet.
English: In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
Danish: I andre situationer baseres beslutningen om behov for yderligere cytotoksisk kemoterapi på individuelle faktorer.
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Danish: Størstedelen af disse hændelser forekommer under eller inden for 2,5 timer efter påbegyndelse af den første infusion.
English: No formal drug interaction studies have been performed.
Danish: Der er ikke udført formelle lægemiddelinteraktionsstudier.
English: Study MO16419
Danish: Studie MO16419
English: Warnings and precautions Your doctor will closely supervise your therapy.
Danish: Advarsler og forsigtighedsregler Din læge vil nøje overvåge din behandling.
English: Cysts and polyps)
Danish: cyster og polypper)
English: Anaphylactoid reactions have been observed in isolated cases.
Danish: Der er observeret anafylaktoide reaktioner i isolerede tilfælde.
English: If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Danish: Hvis antracykliner bruges, skal patientens kardielle funktion monitoreres omhyggeligt.
English: HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth.
Danish: HER2 findes i store mængder på overfladen af nogle kræftceller, hvor det stimulerer deres vækst.
English: Only patients with a large amount of HER2 will be treated with KANJINTI.
Danish: Kun patienter med store mængder HER2 vil blive behandlet med KANJINTI.
English: Patients were treated with trastuzumab until progression of disease.
Danish: Patienterne blev behandlet med trastuzumab, indtil progression af sygdommen.
English: The frequency of occurrence of hypoprothrombinaemia is not known.
Danish: Hyppigheden af hypoprotrombinæmi er ikke kendt.
English: Docetaxel was administered as follows:
Danish: Docetaxel blev administreret som følger:
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation.
Danish: Effektresultaterne fra den interime effektanalyse krydsede protokollens præspecificerede statistiske grænse for sammenligningen af 1-år med trastuzumab versus observation.
English: Other side effects can occur at any time during treatment with trastuzumab, not just related to an infusion.
Danish: Andre bivirkninger kan indtræffe på ethvert tidspunkt under behandlingen med trastuzumab, og som ikke kun er relateret til en infusion.
English: Therefore, no constant value for half-life of trastuzumab can be deduced.
Danish: Der kan derfor ikke udledes en konstant værdi for trastuzumabs halveringstid.
English: Children and adolescents KANJINTI is not recommended for anyone under the age of 18 years.
Danish: Brug til børn og unge KANJINTI anbefales ikke til børn og unge under 18 år.
English: Some of the side effects you experience may be due to your underlying cancer.
Danish: Nogle af de bivirkninger, som du oplever, kan skyldes din underliggende kræftsygdom.
English: It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
Danish: Det er vigtigt at kontrollere præparatets etiket for at sikre, at der gives den korrekte formulering i henhold til ordinationen.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Danish: Mere end 70 % af de inkluderede patienter udviste en 3+ overekspression.
English: Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Danish: Sådanne metoder skal være præcise og nøjagtige nok til at vise overekspression af HER2 og skal være i stand til at skelne mellem moderat (kongruent med 2+) og stærk (kongruent med 3+) overekspression af HER2.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks).
Danish: Patienter, som udvikler asymptomatisk kardiel dysfunktion, kan have gavn af hyppigere monitorering (f.eks. hver 6.-8. uge).
English: The median overall survival was extended by 4.6 months for patients in the combination arm.
Danish: Den mediane samlede overlevelse blev forlænget med 4,6 måneder for patienter i armen med kombinationsbehandlingen.
English: In addition, terms reported in the post marketing setting are included in Table 1.
Danish: Termer rapporteret efter markedsføringen er ligeledes inkluderet i tabel 1.
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at bruge trastuzumab i den pædiatriske population.
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Danish: Disse hændelser kan optræde som en del af en infusionsrelateret reaktion eller med forsinket frembrud.
English: (L/day)
Danish: (l/dag)
English: SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology.
Danish: SISH-teknologi anbefales dog for at tillade den parallelle vurdering af tumorhistologien og -morfologien.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du får dette lægemiddel.
English: (day)
Danish: (dag)
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Danish: Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se punkt 2 under punktet ”Advarsler og forsigtighedsregler”).
English: The median duration of follow-up in the trastuzumab arm was 3.8 years.
Danish: Den mediane opfølgningstid i trastuzumab-armen var 3,8 år.
English: 30-60 minutes repeated every 3 weeks for a total of six cycles
Danish: 30-60 minutter gentaget hver 3. uge i samlet 6 serier.
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Danish: Derudover blev en sammenligning af 2-års versus 1-års trastuzumab-behandling udført.
English: Women who become pregnant should be advised of the possibility of harm to the foetus.
Danish: Kvinder, som bliver gravide, skal informeres om muligheden for, at fosteret kan tage skade.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are < 1 µg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Danish: Resultaterne af disse simuleringer indikerer, at mindst 95 % af patienterne vil nå koncentrationer < 1 µg/ml (ca. 3 % af den populationsforudsagte Cmin,ss, eller omkring 97 % udvaskning) i løbet af 7 måneder.
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Danish: Forskellen var ikke statistisk signifikant, men mere end halvdelen af patienterne i armen med anastrozol alene skiftede til et regime indeholdende trastuzumab efter sygdomsprogression.
English: Some of these side effects may be serious and may lead to hospitalisation.
Danish: Nogle af bivirkningerne kan være alvorlige og føre til hospitalsindlæggelse.
English: A study of trehalose, a major formulation excipient did not reveal any toxicities.
Danish: Et studie med trehalose, et hovedhjælpestof for formuleringen, afslørede ingen toksicitet.
English: The dose of KANJINTI depends on your body weight.
Danish: KANJINTI-dosis afhænger af din legemsvægt.
English: However, capecitabine itself showed higher concentrations and a longer half-life when combined with trastuzumab.
Danish: Capecitabin viste dog højere koncentrationer og længere halveringstid, når det blev kombineret med trastuzumab.
English: It is important for you to keep all your appointments to receive KANJINTI.
Danish: Det er vigtigt, at du overholder alle dine aftaler om at få KANJINTI.
English: The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16).
Danish: T1/2 falder med faldende koncentrationer inden for et doseringsinterval (se tabel 16).
English: KANJINTI may also be given once a week for metastatic breast cancer
Danish: KANJINTI kan også gives én gang om ugen ved metastatisk brystkræft.
English: The cells are only stained in part of their membrane.
Danish: Cellerne farves kun i dele af membranen.
English: Malignant neoplasm progression Not known Neoplasm progression
Danish: Progression af malign neoplasma Ikke kendt Neoplasma progression
English: The presence of trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 1 month of age.
Danish: Tilstedeværelsen af trastuzumab i serum hos spæde aber var ikke ledsaget af uønskede virkninger på vækst eller udvikling fra fødslen til 1-månedsalderen.
English: Aseptic preparation, handling and storage:
Danish: Aseptisk klargørelse, håndtering og opbevaring:
English: Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.
Danish: Der skal udvises forsigtighed ved pneumonitis specielt hos patienter, der samtidig bliver behandlet med taxaner.
English: The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples.
Danish: Det ekstracellulære domæne af receptoren (ECD, p105) kan spredes til blodet og måles i serumprøver.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in “Warnings and precautions” (see section 4.4).
Danish: Detaljer omkring risikominimeringsaktiviteter, som er i overensstemmelse med EU's risikostyringsprogrammet, er præsenteret i ”Advarsler og forsigtighedsregler” (se pkt.
English: Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Danish: Lægen vil kontrollere dit hjerte regelmæssigt under behandlingen, men du skal øjeblikkeligt fortælle lægen, hvis du får nogle af ovenstående symptomer.
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Danish: Patienter, som blev klassificeret som farvning 2+ eller 3+, blev inkluderet, mens patienter, som scorede 0 eller 1+, blev ekskluderet.
English: Infusion solutions should be used immediately after dilution.
Danish: Infusionsopløsninger skal anvendes umiddelbart efter fortynding.
English: It is not known whether trastuzumab is secreted in human milk.
Danish: Det vides ikke om trastuzumab udskilles i human mælk.
English: 9744 AP Groningen The Netherlands
Danish: 9744 AP Groningen Holland
English: Slight foaming of the product upon reconstitution is not unusual.
Danish: Let skumdannelse ved rekonstitueringen er ikke ualmindelig.
English: In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
Danish: I sjældne tilfælde er disse reaktioner forbundet med et klinisk forløb, der kulminerer med letal udgang.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Danish: Din læge vil ordinere en dosis og en behandlingsmåde, som passer til dig.
English: • you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
Danish: • du nogensinde har fået eller på nuværende tidspunkt får medicin kaldet doxorubicin eller epirubicin (medicin til at behandle kræft).
English: KANJINTI is a biosimilar medicinal product.
Danish: KANJINTI er et biosimilært lægemiddel.
English: Administration as an intravenous push or bolus is prohibited.
Danish: Den må ikke administrateres som intravenøs push eller bolus.
English: A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Danish: En to-kompartment model med parallel lineær og ikke-lineær elimination fra det centrale kompartment beskrev trastuzumabs koncentrations-tids profil.
English: Pre-medication may be used to reduce risk of occurrence of these events.
Danish: Præmedicinering kan anvendes for at reducere risikoen for, at disse bivirkninger opstår.
English: AUCss, 0-21days
Danish: AUCss 0-21 dage
English: AUC0-21days
Danish: AUC0-21 dage
English: *Cmin,ss - Cmin at steady-state **Cmax,ss = Cmax at steady-state *** time to 90% of steady-state
Danish: ved steady state **Cmax,ss = Cmax ved steady state ***Tid til 90 % af steady state
English: No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Danish: Der er ikke set uforligeligheder mellem KANJINTI og polyvinylchlorid-, polyethylen- eller polypropylenposer.
English: Volume of sterile water for injections
Danish: Mængde sterilt vand til injektionsvæsker
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Danish: For at forbedre sporbarheden af dette lægemiddel bør din læge eller apotekspersonalet registrere handelsnavnet og lotnummeret på det produkt, du har fået, i din patientjournal.
English: The effects may be moderate to severe and could cause death.
Danish: Virkningerne kan være moderate til alvorlige og kan være dødelige.
English: Each carton contains one vial.
Danish: Hvert karton indeholder ét hætteglas.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Danish: Alvorlige reaktioner er blevet behandlet succesfuldt med understøttende behandling såsom ilt, beta-agonister og kortikosteroider.
English: As animal reproduction studies are not always predictive of human response, KANJINTI should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Da reproduktionsstudier på dyr ikke altid er prædiktive for mennesker, bør KANJINTI undgås under graviditet med mindre den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Danish: Patienterne kan fortsætte behandlingen i perioder med reversibel, kemoterapi-induceret suppression af knoglemarven, men de skal monitoreres omhyggeligt for komplikationer relateret til neutropeni i denne periode.
English: No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Danish: Der er ikke foretaget langtidsstudier på dyr for at fastslå trastuzumabs carcinogene potentiale eller bestemme dets virkning på fertilitet hos hanner.
English: Median follow-up 8 years**
Danish: Median opfølgning 8 år**
English: t1/2 range from
Danish: t1/2-interval fra
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Danish: Hvis den første dosis tåles godt, kan de efterfølgende doser gives over 30 minutter (se punkt 2 under ”Advarsler og forsigtighedsregler”).
English: • you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Danish: • du har alvorlige problemer med at trække vejret på grund af din cancer eller hvis du har behov for behandling med ilt.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with KANJINTI.
Danish: Disse lægemidler (og ethvert andet antracyklin) kan skade hjertet og øge risikoen for hjerteproblemer sammen med KANJINTI.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Danish: Reversibilitet af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel blev påvist hos 79,5 % af patienterne.
English: Long term follow-up efficacy analysis**
Danish: Effektanalyse af længerevarende opfølgning**
English: Therefore, these patients should not be treated with KANJINTI (see section 4.3).
Danish: Disse patienter bør derfor ikke behandles med KANJINTI (se pkt.
English: When trastuzumab binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når trastuzumab bindes til HER2 stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
English: For monotherapy, the rate was 6% - 9%.
Danish: Ved monoterapi var frekvensen 6-9 %.
English: KANJINTI should not be diluted with glucose solutions since these cause aggregation of the protein.
Danish: KANJINTI må ikke fortyndes med glukoseopløsninger, da disse kan forårsage aggregation af proteinet.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, inden du tager nogen form for medicin.
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: • udføres under aseptiske betingelser af trænet personale i henhold til god klinisk praksis, især i forhold til aseptisk klargørelse af parenterale produkter.