FrancophonIA/ELRC3.0 huggingface dataset:
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 og efter behandlingen, men du skal straks fortælle lægen, hvis du bemærker et eller flere af ovenstående symptomer.
English: Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.
Danish: Der skal udvises forsigtighed ved pneumonitis, især hos patienter, der samtidig behandles med taxaner.
English: The median duration of follow-up in the trastuzumab arm was 3.8 years.
Danish: Den mediane varighed af opfølgning i trastuzumab-armen var 3,8 år.
English: Sites of progression
Danish: Steder med progression
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 kombinationsarmen.
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Danish: Studiet rekrutterede patienter med nyligt diagnosticeret lokalt fremskreden (stadie III) eller inflammatorisk EBC.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Danish: Infusionsrelaterede reaktioner, allergilignende reaktioner og overfølsomhed Det er estimeret, at ca. 40 % of patienterne, der behandles med trastuzumab, vil opleve en eller anden form for infusionrelateret reaktion.
English: Time to disease progression, median months
Danish: Tid til sygdomsprogression, median måneder
English: Women who become pregnant should be advised of the possibility of harm to the fetus.
Danish: Kvinder, der bliver gravide, skal informeres om muligheden for skade på fosteret.
English: Patients were treated with trastuzumab until progression of disease.
Danish: Patienterne blev behandlet med trastuzumab indtil sygdomsprogression.
English: A study of trehalose, a major formulation excipient, did not reveal any toxicities.
Danish: Et studie med trehalose, et vigtigt formuleringshjælpestof, viste ingen toksicitet.
English: For monotherapy, the rate was 6%-9%.
Danish: Ved monoterapi var hyppigheden 6 %-9 %.
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 på < 1 µg/ml (ca. 3 % af den populationsforudsagte Cmin,ss eller omkring 97 % udvaskning) i løbet af 7 måneder.
English: Table 13 Efficacy results from BO18225 Parameter
Danish: Virkningsresultater fra BO18225 Parameter
English: The loading dose should be administered as a 90-minute intravenous infusion.
Danish: Støddosis skal administreres som en 90 minutters intravenøs infusion.
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 (see section 2 under “Warnings and precautions”).
Danish: Den første dosis af din behandling gives over 90 minutter, og du vil blive observeret af en læge eller sundhedspersonale, mens den indgives, i tilfælde af at du får bivirkninger (se punkt 2 under ”Advarsler og forsigtighedsregler”).
English: Ontruzant is given as an infusion into a vein (intravenous infusion, “drip”).
Danish: Ontruzant gives som en infusion i en vene (intravenøs infusion, ”drop”).
English: The following information is intended for healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: Paediatric population There is no relevant use of Ontruzant in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende Ontruzant hos den pædiatriske population.
English: If the first dose is well tolerated the next doses may be given over 30 minutes.
Danish: Hvis den første dosis tåles godt, kan de efterfølgende doser gives over 30 minutter.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose.
Danish: Da human IgG1 udskilles i human mælk, og potentialet for skade på spædbarnet er ukendt, bør kvinder ikke amme under behandling med trastuzumab og i 7 måneder efter den sidste dosis.
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: 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 et dødeligt udfald.
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 sheddes til blodbanen og måles i serumprøver.
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The effects may be moderate to severe and could cause death.
Danish: Virkningerne kan være moderate til svære og kan føre til dødsfald.
English: It may take up to 7 months for Ontruzant to be removed from the body.
Danish: Det kan tage op til 7 måneder at udskille Ontruzant fra kroppen.
English: Interruption or slowing the rate of the infusion may help control such symptoms.
Danish: En afbrydelse eller nedsættelse af hastigheden af infusionen kan muligvis være en hjælp til at kontrollere sådanne symptomer.
English: Ontruzant may also be given once a week for metastatic breast cancer.
Danish: Ontruzant kan også gives én gang om ugen ved metastatisk brystkræft.
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 trastuzumabholdigt regime efter sygdomsprogression.
English: The cells are only stained in part of their membrane.
Danish: Cellerne er kun farvet i en del af deres membran
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Danish: Overvågning kan være en hjælp til at identificere patienter, der udvikler kardiel dysfunktion.
English: When Ontruzant binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når Ontruzant bindes til HER2 stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
English: If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Danish: Hvis en gravid kvinde behandles med trastuzumab, eller hvis en patient bliver gravid, mens hun får trastuzumab, eller inden for 7 måneder efter den sidste dosis af trastuzumab, anbefales tæt overvågning af et tværfagligt team.
English: All such patients should be referred for assessment by a cardiologist and followed up.
Danish: Alle sådanne patienter skal henvises til vurdering af en kardiolog og følges op.
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 koncentrationstidsprofil.
English: Patients with MBC or MGC should be treated with Ontruzant until progression of disease.
Danish: Patienter med MBC eller MGC bør behandles med Ontruzant indtil sygdomsprogression.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Danish: Reversibilitet af let symptomatisk og asymptomatisk venstre ventrikulær dysfunktion blev påvist hos 79,5 % af patienterne.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering præsenteres bivirkningerne efter faldende alvorlighed.
English: The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm.
Danish: Forekomsten af symptomatisk kardiel dysfunktion var 1,7 % i trastuzumab-armen.
English: (week)
Danish: (uge)
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 oxygen, beta-agonister og kortikosteroider.
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Danish: Patienter, der blev klassificeret med farvning 2+ eller 3+, blev inkluderet, mens patienter med farvning 0 eller 1+ blev udelukket.
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: Forekomsten af trastuzumab i serum hos spæde aber blev ikke forbundet med nogen bivirkninger på deres vækst eller udvikling fra fødsel til, de var 1 måned gamle.
English: Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Danish: En formel kardiologisk vurdering bør overvejes hos patienter, for hvem der er kardiovaskulære problemstillinger efter baseline-screening.
English: Slight foaming of the product upon reconstitution is not unusual.
Danish: Let skumdannelse af præparatet ved rekonstitution er ikke ualmindelig.
English: Your doctor may prescribe Ontruzant for the treatment of breast and gastric cancer when:
Danish: Din læge kan ordinere Ontruzant til behandling af bryst- og mavekræft, hvis:
English: Like all medicines, Ontruzant can cause side effects, although not everybody gets them.
Danish: Ontruzant kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Danish: Hjertefunktionen skal overvåges for alle patienter under behandlingen (f.eks. hver 12. uge).
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ontruzant.
Danish: Disse lægemidler (og ethvert andet antracyklin) kan skade hjertemusklen og øge risikoen for hjerteproblemer sammen med Ontruzant.
English: FP + H: fluoropyrimidine/cisplatin + trastuzumab FP: fluoropyrimidine/cisplatin a Odds ratio
Danish: FP + H: Fluoropyrimidin/cisplatin + trastuzumab FP: Fluoropyrimidin/cisplatin a Odds ratio
English: For instructions on reconstitution of Ontruzant intravenous formulation before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Ontruzant intravenøs formulering før administration, se pkt.
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Danish: Reversibilitet af svær CHF (defineret som en sekvens af mindst to på hinanden følgende LVEFværdier på ≥ 50 % efter hændelsen) var evident for 71,4 % af de trastuzumab-behandlede patienter.
English: Administration as an intravenous push or bolus is prohibited.
Danish: Administration som en intravenøs mætnings- eller bolusdosis er ikke tilladt.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ontruzant treatment.
Danish: Hvis du udvikler tegn på hjertesvigt (dårlig pumpning af blod fra hjertet), kan det være, at dit hjerte skal kontrolleres hyppigere (hver 6. til 8. uge), du skal have behandling for hjertesvigt, eller du må stoppe behandlingen med Ontruzant.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Danish: Størstedelen af de infusionsrelaterede reaktioner er dog lette til moderate i intensitet (NCI-CTC-klassificeringssystem) og har en tendens til at forekomme tidligt i behandlingen, d.v.s. under infusion ét, to og tre og mindske i hyppighed ved efterfølgende infusioner.
English: Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
Danish: Tidlig brystkræft er defineret som ikke-metastatisk primært invasivt karcinom i brystet.
English: • you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
Danish: • hvis du nogensinde har fået eller på nuværende tidspunkt får medicin kaldet doxorubicin eller epirubicin (medicin til at behandle kræft).
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D).
Danish: Trastuzumab kan dog øge den samlede eksponering af én doxorubicinmetabolit (7-deoxy-13dihydrodoxorubicinon, D7D).
English: Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Danish: De fleste af patienterne (79 %), der udviklede kardiel dysfunktion i disse studier, oplevede en forbedring efter at have fået standardbehandling for CHF.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Samsung Bioepis NL B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Samsung Bioepis NL B.V.
English: Treatment with Ontruzant (alone or with a taxane) may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Danish: Behandling med Ontruzant (alene eller sammen med et taxan) kan påvirke hjertet, især hvis du tidligere har fået et antracyklin (taxaner og antracykliner er to andre slags lægemidler, der anvendes til at behandle kræft).
English: Ontruzant is for intravenous use.
Danish: Ontruzant er til intravenøs anvendelse.
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Danish: 1 Bivirkninger, der overvejende er blevet rapporteret i forbindelse med infusionsrelaterede reaktioner.
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal development period was observed.
Danish: Der er observeret placentaoverførsel af trastuzumab i den tidlige (gestationsdag 20-50) og sene (gestationsdag 120-150) fosterudviklingsperiode.
English: Therefore you should tell your doctor, pharmacist or nurse that you have had Ontruzant if you start any new medicine in the 7 months after stopping treatment.
Danish: Du bør derfor fortælle din læge, apotekspersonalet eller sundhedspersonalet, at du har fået Ontruzant, hvis du begynder at anvende et hvilket som helst nyt lægemiddel indenfor 7 måneder efter ophør med Ontruzant-behandlingen.
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Danish: I dette studie havde 87 % af de inkluderede patienter sygdom, der var IHC3+, og 95 % af de inkluderede patienter havde sygdom, der var IHC3+ og/eller FISH-positiv.
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 terapien i perioder med reversibel, kemoterapiinduceret knoglemarvssuppression, men de skal overvåges nøje for komplikationer i form af neutropeni i dette tidsrum.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ontruzant.
Danish: I meget sjældne tilfælde er det sket, at patienter, som havde svære vejrtrækningsproblemer inden behandlingsstart, døde, da de fik Ontruzant.
English: Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Danish: Patienter, der behandles med trastuzumab, har en øget risiko for at udvikle CHF (New York Heart Association [NYHA] klasse II-IV) eller asymptomatisk kardiel dysfunktion.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trastuzumab, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for trastuzumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: If you experience any of the above symptoms when your treatment with Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant.
Danish: Hvis du får et eller flere af ovenstående symptomer, når behandlingen med Ontruzant er stoppet, skal du kontakte din læge og fortælle, at du tidligere er blevet behandlet med Ontruzant.
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Danish: Der skal endvidere udvises forsigtighed ved behandling af patienter med øget kardiel risiko, f.eks. hypertension, dokumenteret koronararteriesygdom, CHF, LVEF på < 55 %, høj alder.
English: If you receive Ontruzant in combination with chemotherapy, some of them may also be due to the chemotherapy.
Danish: Hvis du får Ontruzant i kombination med kemoterapi, kan nogle af bivirkningerne også skyldes kemoterapien.
English: This helps your medicine work as well as it can.
Danish: Dette sikrer, at lægemidlet virker bedst muligt.
English: • you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Danish: • hvis du har svære problemer med at trække vejret i hvile på grund af din kræft, eller hvis du har behov for behandling med ilt.
English: Ontruzant should be carefully handled during reconstitution.
Danish: Ontruzant skal behandles forsigtigt under rekonstitutionen.
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Danish: Hormonreceptorpositive patienter skal endvidere have gennemgået hormonterapi uden virkning, medmindre patienterne er uegnede til disse behandlinger.
English: The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
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 af dyr for at fastslå trastuzumabs karcinogenicitet eller bestemme dets virkning på fertilitet hos hanner.
English: • pain in the arms and/or legs
Danish: • smerter i arme og/eller ben
English: These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Danish: Disse reaktioner indtræffer hovedsageligt i forbindelse med den første intravenøse infusion (”drop” i din vene) og i løbet af de første få timer, efter infusionen er påbegyndt.
English: Instructions for reconstitution:
Danish: Instruktioner til rekonstitution:
English: Trastuzumab 1 Year N=1702***
Danish: Trastuzumab 1 år N = 1702***
English: MBC EBC AGC
Danish: EBC AGC
English: Total pathological complete response* (95% CI)
Danish: Total patologisk komplet respons* (95 % CI)
English: If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF.
Danish: Hvis der udvikles symptomatisk hjerteinsufficiens under behandling med trastuzumab, skal den behandles med standardlægemidler mod CHF.
English: The majority of patients experienced resolution of symptoms and subsequently received further infusions of trastuzumab.
Danish: Størstedelen af patienterne oplevede, at symptomerne fortog sig, og fik efterfølgende yderligere infusioner af trastuzumab.
English: The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied.
Danish: Sikkerheden ved fortsat eller genoptaget behandling med trastuzumab hos patienter, der oplever kardiel dysfunktion, er ikke undersøgt prospektivt.
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Danish: Disse symptomer kan behandles med et analgetikum/antipyretikum, såsom meperidin eller paracetamol, eller et antihistamin, såsom diphenhydramin.
English: The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Danish: Hyppigheden af infusionsrelaterede reaktioner af alle grader varierede mellem studierne afhængig af indikation, dataindsamlingsmetode, og om trastuzumab blev givet samtidig med kemoterapi eller som monoterapi.
English: Hazard ratio versus observation *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Danish: Hazard ratio versus observation * Co-primært endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt den prædefinerede statistiske grænse ** Endelig analyse (herunder skift af 52 % af patienterne fra observations-armen til trastuzumab) *** Der er en uoverensstemmelse i den samlede prøvestørrelse på grund af et lille antal patienter, der blev randomiseret efter skæringsdatoen for analysen af den mediane 12 måneders opfølgning
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Danish: Generelt anses CISH for positiv, hvis der er mere end 5 kopier af HER2-genet pr. cellekerne i mere end 50 % af tumorcellerne.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Danish: Patienter, der tidligere havde fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m2 infusion over 3 timer) med eller uden trastuzumab.
English: You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions.
Danish: Du vil blive observeret af en læge eller sundhedspersonale under infusionen og i mindst 6 timer efter påbegyndelse af den første infusion og i 2 timer efter påbegyndelse af de efterfølgende infusioner.