FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy results from the BCIRG 006 are summarised in Tables 9 and 10.
Danish: Virkningsresultaterne fra BCIRG 006-studiet er sammenfattet i tabel 9 og 10.
English: If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Danish: Hvis du under behandlingen får symptomer såsom kulderystelser eller feber, må du ikke føre motorkøretøj eller betjene maskiner, før symptomerne er forsvundet.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆ SBARE DATA
English: Instructions for reconstitution and dilution:
Danish: Instruktioner for rekonstitution og fortynding:
English: However, capecitabine itself showed higher concentrations and a longer half-life when combined with trastuzumab.
Danish: Capecitabin viste dog højere koncentrationer og læ ngere halveringstid, når det blev kombineret med trastuzumab.
English:  you have early breast cancer, with high levels of a protein called HER2.
Danish: • du har tidlig brystkræft med høje koncentrationer af et protein, som kaldes HER2.
English: Administration in combination with paclitaxel or docetaxel
Danish: Administration i kombination med paclitaxel eller docetaxel
English: When Herzuma binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når Herzuma bindes til HER2 stopper det væ ksten af sådanne celler, hvilket resulterer i, at de dør.
English: Pre-medication may be used to reduce risk of occurrence of these events.
Danish: Præ medicinering kan anvendes for at reducere risikoen for, at disse bivirkninger opstår.
English: Only patients with a large amount of HER2 will be treated with Herzuma.
Danish: Kun patienter med store mæ ngder HER2 vil blive behandlet med Herzuma.
English: The safety of continuation or resumption of Herzuma in patients who experience cardiac dysfunction has not been prospectively studied.
Danish: Sikkerheden ved fortsæ ttelse eller genoptagelse af Herzuma-behandling hos patienter, som oplever kardiel dysfunktion, er ikke undersøgt prospektivt.
English: Herzuma should be carefully handled during reconstitution.
Danish: Herzuma skal behandles forsigtigt under rekonstitutionen.
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske læ gemidler bør handelsnavnet og batchnummeret af det administrerede præ parat tydeligt registreres.
English: Each carton contains one vial.
Danish: Hvert karton indeholder ét hæ tteglas.
English: A study of trehalose, a major formulation excipient did not reveal any toxicities.
Danish: Et studie med trehalose, et hovedhjæ lpestof for formuleringen, afslørede ingen toksicitet.
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 væ re præ cise og nøjagtige nok til at vise overekspression af HER2 og skal væ re i stand til at skelne mellem moderat (kongruent med 2+) og stæ rk (kongruent med 3+) overekspression af HER2.
English: From a microbiological point of view, the reconstituted solution and Herzuma infusion solution should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsvæ sken med Herzuma anvendes med det samme.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læ ger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Danish: 1 time) med eller uden trastuzumab, havde 60 % af patienterne tidligere fået antracyklinbaseret adjuverende kemoterapi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette læ gemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæ iske webportal for læ gemidler.
English: Anaphylactoid reactions have been observed in isolated cases.
Danish: Der er observeret anafylaktoide reaktioner i isolerede tilfæ lde.
English: Herzuma is given as an intravenous infusion (“drip”) directly into your veins.
Danish: Herzuma gives som en intravenøs infusion (drop) direkte ind i dine blodårer.
English: The median overall survival was extended by 4.6 months for patients in the combination arm.
Danish: Den mediane samlede overlevelse blev forlæ nget med 4,6 måneder for patienter i armen med kombinationsbehandlingen.
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 Herzuma treatment.
Danish: Hvis du udvikler tegn på hjertesvigt (dårlig pumpefunktion af hjertet), kan det væ re, at din hjertefunktion vil blive kontrolleret oftere (hver 6. til hver 8. uge), at du vil få behandling for hjertesvigt eller at du må stoppe behandlingen med Herzuma.
English: This translates into an absolute benefit in terms of an 8 year disease free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
Danish: Dette overføres til en absolut gavnlig virkning udtrykt i en 8 års sygdomsfri overlevelsesrate på 6,4 procentpoint til fordel for 1 års trastuzumab-behandling.
English: There is no experience with overdose in human clinical trials.
Danish: Der er ikke rapporteret tilfæ lde af overdosering i humane kliniske studier.
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Danish: Monitorering kan muligvis hjæ lpe med til at identificere de patienter, som udvikler kardiel dysfunktion.
English: The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples.
Danish: Det ekstracellulæ re domæ ne af receptoren (ECD, p105) kan spredes til blodet og måles i serumprøver.
English:  you have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
Danish: • du har metastatisk brystkræft (brystkræft, som har spredt sig ud over den oprindelige tumor) med høje koncentrationer af HER2.
English: Therefore, from the mechanism of action there is evidence that trastuzumab can cause tumour lysis syndrome.
Danish: Der er fra virkningsmekanismen derfor bevis for at trastuzumab kan forårsage tumorlyse syndrom.
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.
English: Talk to your doctor, pharmacist or nurse before using Herzuma if:
Danish: Kontakt læ gen, apotekspersonalet eller sundhedspersonalet, før du bruger Herzuma, hvis:
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt læ gemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væ sentlig æ ndring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæ l (læ gemiddelvoervågning eller risikominimering) er nået.
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 lineæ r og ikke-lineæ r elimination fra det centrale kompartment beskrev trastuzumabs koncentrations-tids profil.
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 forvæ rring og forsinkede reaktioner med hurtig klinisk forvæ rring er også blevet rapporteret.
English: No formal medicinal product interaction studies have been performed.
Danish: Der er ikke udført formelle læ gemiddelinteraktionsstudier.
English: Patients treated with Herzuma are at increased risk for developing CHF (New York Heart Association [NYHA] Class II - IV) or asymptomatic cardiac dysfunction.
Danish: Patienter, som behandles med Herzuma, har en øget risiko for at udvikle kongestiv hjerteinsufficiens (New York Heart Association [NYHA] klasse II - IV) eller asymptomatisk kardiel dysfunktion.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Danish: Opbevar altid dette læ gemiddel i den lukkede originalpakning i køleskab ved 2 °C - 8 °C.
English: Sometimes, symptoms may improve and then get worse later.
Danish: Nogle gange kan symptomerne mindskes og senere igen blive væ rre.
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30ºC).
Danish: Hvis den er fortyndet aseptisk, kan den opbevares i 24 timer (må ikke opbevares ved temperaturer over 30 C).
English: After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 7 days at 2ºC - 8ºC.
Danish: Efter rekonstitution med sterilt vand til injektionsvæ sker er den rekonstituerede opløsning fysisk og kemisk stabil i 7 dage ved 2 °C - 8 °C.
English: Hepatocellular injury
Danish: Hepatocellulæ r skade
English: During a Herzuma infusion, chills, fever and other flu like symptoms may occur.
Danish: Under en Herzuma-infusion kan der forekomme kulderystelser, feber og andre influenzalignende symptomer.
English: Administration in combination with an aromatase inhibitor
Danish: Administration i kombination med en aromatasehæ mmer
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne æ ndres.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in Table 6:
Danish: Virkningsresultaterne fra studie BO16348 efter 12 måneders* og 8 års** median opfølgning er sammenfattet i tabel 6:
English: However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates are unlikely to have a clinically meaningful effect on trastuzumab concentrations.
Danish: På grund af størrelsen af disse kovarianters virkning på trastuzumabs eksponering er det dog ikke sandsynligt, at disse kovarianter har nogen klinisk relevant virkning på koncentrationen af trastuzumab.
English: Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herzuma and has been associated with a fatal outcome (see section 4.4).
Danish: Kongestiv hjerteinsufficiens (NYHA-klasse II-IV) er en almindelig bivirkning forbundet med anvendelse af Herzuma og er blevet forbundet med letal udgang (se pkt 4.4).
English: Trastuzumab 1 Year N = 1693
Danish: Trastuzumab 1 år N = 1.693
English:  CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by
Danish: • CMF på dag 1 og 8 hver 4. uge i 3 serier, som efter operation blev efterfulgt af:
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Læ gemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjæ lpe med at fremskaffe mere information om sikkerheden af dette læ gemiddel.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette læ gemiddel, skal du henvende dig til den lokale repræ sentant for indehaveren af markedsføringstilladelsen:
English: In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
Danish: I sjæ ldne tilfæ lde er disse reaktioner forbundet med et klinisk forløb, der kulminerer med letal udgang.
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 at væ re positiv, hvis der er mere end 5 kopier af HER2-genet per cellekerne i mere end 50 % af tumorcellerne.
English: The effects may be moderate to severe and could cause death.
Danish: Påvirkningen kan væ re moderat til alvorlig, og kan væ re dødelig.
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a: Odds ratio
Danish: FP+H: Fluoropyrimidin/cisplatin + trastuzumab FP: Fluoropyrimidin/cisplatin a Sandsynslighedsratio
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Danish: En absolut gavnlig effekt på 13 procentpoint til fordel for trastuzumab-armen blev estimeret, udtrykt i 3-års hæ ndelsesfri overlevelse (65 % versus 52 %).
English: There is no relevant use of Herzuma in the paediatric population.
Danish: Det er ikke relevant at anvende Herzuma hos den pæ diatriske population.
English: If you experience any of the above symptoms when your treatment with Herzuma has finished, you should see your doctor and tell them that you have previously been treated with Herzuma.
Danish: Hvis du får nogle af ovenstående symptomer, når behandlingen med Herzuma er stoppet, skal du kontakte din læ ge og fortæ lle, at du tidligere er blevet behandlet med Herzuma.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gæ lder også mulige bivirkninger, som ikke er medtaget i denne indlæ gsseddel.
English: The reconstituted Herzuma results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Danish: Det rekonstituerede Herzuma resulterer i en farveløs til svagt gul, klar opløsning, som hovedsaglig skal væ re fri for synlige partikler.
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 indtræ ffer hovedsageligt i forbindelse med første intravenøse infusion (”drop”i din blodåre) og i løbet af de første få timer efter, infusionen er påbegyndt.
English: For intravenous use only after reconstitution and dilution.
Danish: Kun til intravenøs anvendelse efter rekonstitution og fortynding.
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: Virkningsresultaterne fra den interime virkningsanalyse krydsede protokollens præ specificerede statistiske græ nse for sammenligningen af 1-år med trastuzumab versus observation.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆ RKNING PÅ SMÅ INDRE EMBALLAGER
English: Table 6 Efficacy results from study BO16348
Danish: Virkningsresultater fra studie BO16348
English: Occasionally, symptoms start later than six hours after the infusion begins.
Danish: Lejlighedsvis kan symptomerne indtræ ffe senere end 6 timer efter, infusionen er påbegyndt.
English: Tell a doctor or nurse straight away, if you notice any of the following side effects:
Danish: Fortæ l øjeblikkeligt din læ ge eller sygeplejerske, hvis du oplever en af følgende bivirkninger:
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Danish: Disse hæ ndelser kan optræ de som en del af en infusionsrelateret reaktion eller med forsinket frembrud.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Herzuma treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Danish: Trastuzumab kan fortsat væ re i cirkulationen i op til 7 måneder efter ophør af Herzuma-behandlingen, baseret på populationsfarmakokinetiske analyser af alle tilgæ ngelige data (se pkt.
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Danish: Alvorlige anafylaktiske reaktioner, som kræ ver øjeblikkelig yderligere intervention, kan forekomme normalt under enten den første eller anden infusion af trastuzumab (se pkt 4.4) og er blevet forbundet med letal udgang.
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 kræ ft).
English: • You should use effective contraception during treatment with Herzuma and for at least 7 months after treatment has ended.
Danish: • Du skal anvende sikker prævention under behandlingen med Herzuma og i mindst 7 måneder efter, at behandlingen er stoppet.
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: Læ gen vil kontrollere dit hjerte regelmæ ssigt under og efter behandlingen, men du skal øjeblikkeligt fortæ lle læ gen, hvis du får nogle af ovenstående symptomer.
English: Overexpression of HER2 is observed in 20% - 30% of primary breast cancers.
Danish: Der er observeret overekspression af HER2 i 20 - 30 % af primæ r brystkræ ft.
English: Read the package leaflet before use.
Danish: Læ s indlæ gssedlen inden brug.
English: If you receive Herzuma in combination with chemotherapy, some of them may also be due to the chemotherapy.
Danish: Hvis du får Herzuma i kombination med kemoterapi, kan nogle af bivirkningerne skyldes kemoterapien.
English: Combination treatment with trastuzumab and anastrozole
Danish: Kombinationsbehandling med trastuzumab og anastrozol
English: Herzuma contains the active substance trastuzumab, which is a monoclonal antibody.
Danish: Herzuma indeholder det aktive stof trastuzumab, som er et monoklonalt antistof.
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Danish: Trastuzumab er desuden en potent mediator af antistofafhæ ngig cellemedieret cytotoksicitet (ADCC).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkræ vede aktiviteter og foranstaltninger vedrørende læ gemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlæ gsseddel blev senest æ ndret <{MM/Å Å Å Å }>.
English: The efficacy results from study BO18225 are summarised in Table 13:
Danish: Virkningsresultaterne fra studie BO18255 er sammenfattet i tabel 13:
English: Total pathological complete response* (95% CI)
Danish: Komplet patologisk response* (95 % konfidensinterval)
English: AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Danish: AC→PH (versus AC→P) (NSABP B31 og NCCTG N9831)*
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Danish: Studiet rekrutterede patienter med nyligt diagnostiseret lokalt avanceret (stadium III) eller inflammatorisk tidlig brystkræ ft.
English: Placental transfer of trastuzumab during the early (days 20 - 50 of gestation) and late (days 120 - 150 of gestation) foetal development period was observed.
Danish: Der blev observeret, at trastuzumab træ ngte igennem placentabarrieren i den tidlige (dag 20 - 50 af dræ gtighedsperioden) og sene (dag 120 - 150 af dræ gtighedsperioden) føtale udviklingsperiode.
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events.
Danish: Størstedelen af patienterne med kardielle symptomer og evidens på en klinisk fordel af trastuzumab-behandling fortsatte behandlingen uden yderligere kliniske kardielle hæ ndelser.
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: Tilstedevæ relsen af trastuzumab i serum hos spæ de aber var ikke ledsaget af uønskede virkninger på væ kst eller udvikling fra fødslen til 1-månedsalderen.
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Danish: Data tyder på, at den gavnlige virkning var højere hos patienter med højere HER2-overekspression (3+).
English: The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Danish: Virkningen af trastuzumab i kombination med paclitaxel hos patienter, som ikke tidligere havde fået adjuverende antracyklin, er ikke blevet undersøgt.
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
Danish: I meget sjæ ldne tilfæ lde har patienter oplevet frembrud af infusionssymptomer og pulmonale symptomer mere end 6 timer efter påbegyndelse af trastuzumab-infusionen.
English: Table 13 Efficacy results from BO18225
Danish: Virkningsresultater fra BO18225
English: At the time of a safety update after a median of 3.5 - 3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Danish: På tidspunktet for en sikkerhedsopdatering efter en median opfølgningstid på 3,5 - 3,8 år genbekræ fter en analyse af sygdomsfri overlevelse størrelsen af den gavnlige effekt vist i den endelige analyse af sygdomsfri overlevelse.
English: Approximately 17% of cardiac dysfunction related events occurred after completion of trastuzumab.
Danish: Ca. 17 % af de bivirkninger, der repræ senterede kardiel dysfunktion, indtraf efter afslutning af 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 læ ge eller sygeplejerske under infusionen og i mindst 6 timer efter påbegyndelse af den første infusion og i 2 timer efter påbegyndelse af de efterfølgende infusioner.
English: Clinically significant interactions between Herzuma and the concomitant medicinal products used in clinical trials have not been observed.
Danish: Der er ikke observeret klinisk signifikante interaktioner mellem Herzuma og de andre læ gemidler, der blev anvendt samtidigt i de kliniske studier.