FrancophonIA/ELRC3.0 huggingface dataset:
English: If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Danish: Hvis den initiale støddosis var veltolereret, kan de efterfølgende doser administreres som en 30 minutters infusion.
English: After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Danish: Efter rekonstituering med sterilt vand til injektionsvæsker er den rekonstituerede opløsning fysisk og kemisk stabil i 48 timer ved 2 °C-8 °C.
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 opfølgning på 3,5-3,8 år genbekræfter en analyse af sygdomsfri overlevelse størrelsen af den gavnlige virkning, der er vist i den endelige analyse af sygdomsfri overlevelse.
English: No incompatibilities between Ontruzant and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Ontruzant og poser af polyvinylchlorid, polyethylen eller polypropylen.
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 som en 8 års sygdomsfri overlevelsesrate på 6,4 procentpoint til fordel for 1 års trastuzumab-behandling.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til intravenøs anvendelse efter rekonstitution og fortynding.
English: Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
Danish: Efterfølgende vedligeholdelsesdoser skal administreres 7 eller 21 dage senere i henhold til planerne for administration henholdsvis ugentligt eller hver 3. uge.
English: To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Danish: For at sikre præcise og reproducerbare resultater skal testen udføres på et speciallaboratorium, der kan sikre validering af testprocedurerne.
English: There is no experience with overdose in human clinical trials.
Danish: Der er ingen erfaring med overdosering i kliniske studier med mennesker.
English: • You should use effective contraception during treatment with Ontruzant and for at least 7 months after treatment has ended.
Danish: • Du skal bruge sikker prævention under behandlingen med Ontruzant og i mindst 7 måneder efter, at behandlingen er stoppet.
English: On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for trastuzumab er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder trastuzumab, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Danish: Denne undersøgende kliniske studieanalyse, som blev udført på et centrallaboratorium, benyttede en 0 til 3+ skala.
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Danish: Data indikerer, at den gavnlige virkning var større blandt patienterne med højere niveauer af overekspression af HER2 (3+).
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Danish: På analysetidspunket var i alt 349 randomiserede patienter døde: 182 patienter (62,8 %) i kontrolarmen og 167 patienter (56,8 %) i behandlingsarmen.
English: Trastuzumab was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Danish: Trastuzumab blev administreret ugentligt med kemoterapi og hver 3. uge i totalt 52 uger.
English: Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Danish: Der er ikke observeret klinisk signifikante interaktioner mellem trastuzumab og de samtidigt anvendte lægemidler i kliniske studier.
English: Oligohydramnios
Danish: Oligohydramnion
English: EU/1/17/1241/001 EU/1/17/1241/002
Danish: EU/1/17/1241/002
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Danish: IHC anbefales som den første testmetode, og i tilfælde, hvor også HER2genamplifikationsstatus er påkrævet, skal der anvendes enten en sølvforstærket in situhybridisering (SISH) eller en FISH-teknik.
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to the trial MO16432.
Danish: Erfaring med samtidig administration af trastuzumab og regimer med lavdosisantracyklin er aktuelt begrænset til studiet MO16432.
English: Ontruzant is for single-use only, as the product contains no preservatives.
Danish: Ontruzant er kun til enkeltdosisbrug, idet lægemidlet ikke indeholder konserveringsmidler.
English: The efficacy results from Study MO16432 are summarized in Table 12.
Danish: Virkningsresultaterne fra studie MO16432 er sammenfattet i tabel 12.
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Danish: En mindre del af patienterne blev testet ved anvendelse af fluorescens-in situ-hybridisering (FISH).
English: Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Danish: Trastuzumab er blevet undersøgt i ét randomiseret, åbent fase III-studie ToGA (BO18255) i kombination med kemoterapi versus kemoterapi alene.
English: • swelling or bleeding at the back of the eyes
Danish: • hævelse eller blødning bagest i øjenene
English: Table 6 Efficacy results from Study BO16348 Median follow-up 12 months*
Danish: Virkningsresultater fra studie BO16348 Median opfølgning 12 måneder*
English: Ontruzant intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Danish: Ontruzant intravenøs formulering er ikke beregnet til subkutan administration og må kun administreres ved en intravenøs infusion.
English: Trastuzumab 1 Year N=1693
Danish: Trastuzumab 1 år N = 1693
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Danish: Der var ikke tegn på akut eller multipel dosis-relateret toksicitet i studier på op til 6 måneder og heller ikke tegn på reproduktionstoksicitet i studier af teratologi, fertilitet hos hunner eller sen gestationstoksicitet hhv. placentaoverførsel.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone.
Danish: I de metastatiske pivotale studier med intravenøs trastuzumab varierede forekomsten af kardiel dysfunktion mellem 9 % og 12 %, når det blev kombineret med paclitaxel, sammenlignet med 1 %-4 % for paclitaxel alene.
English: Do not breast-feed your baby during Ontruzant therapy and for 7 months after the last dose of Ontruzant as Ontruzant may pass to your baby through your breast milk.
Danish: Du må ikke amme dit barn, mens du behandles med Ontruzant og i 7 måneder efter, du har fået den sidste dosis Ontruzant, da Ontruzant kan overføres til dit barn gennem mælken.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Danish: Opbevar altid dette lægemiddel i den lukkede originalpakning i køleskab ved 2 °C-8 °C.
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed.
Danish: Hos patienter, der får antracyklinholdig kemoterapi, anbefales yderligere overvågning, som skal ske årligt til 5 år efter den sidste administration af trastuzumab eller længere, hvis der observeres et kontinuerligt fald i LVEF.
English: Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody.
Danish: Ontruzant indeholder det aktive stof trastuzumab, som er et monoklonalt antistof.
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 med behandlingen uden yderligere kliniske kardielle hændelser.
English: So far, no results are available which compare the efficacy of trastuzumab administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting.
Danish: Der er indtil videre ingen tilgængelige resultater, der sammenligner virkningen af trastuzumab administreret med kemoterapi i den adjuverende behandling med virkningen i den neoadjuverende/adjuverende behandling.
English: Approximately 17% of cardiac dysfunction related events occurred after completion of trastuzumab.
Danish: Ca. 17 % af hændelserne relateret til kardiel dysfunktion forekom efter gennemførelse af trastuzumab-behandling.
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 sjældne tilfælde har patienter oplevet fremkomst af infusionsrelaterede symptomer og lungesymptomer mere end 6 timer efter start på trastuzumab-infusionen.
English: Occasionally, symptoms start later than six hours after the infusion begins.
Danish: Lejlighedsvis kan der indtrække symptomer senere end 6 timer, efter infusionen er påbegyndt.
English: The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
Danish: Samtidig administration af anastrozol syntes ikke at påvirke farmakokinetikken af trastuzumab.
English: Ontruzant is given every 3 weeks for early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Danish: Ontruzant gives hver 3. uge ved tidlig brystkræft, metastatisk brystkræft og metastatisk mavekræft.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping trastuzumab treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Danish: Trastuzumab kan blive i kredsløbet i op til 7 måneder efter behandling med trastuzumab er stoppet, baseret på en populationsfarmakokinetisk analyse af alle tilgængelige data (se pkt.
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Danish: * Observeret med kombinationsterapi efter antracykliner og kombineret med taxaner.
English: In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as statistically significant covariates affecting the exposure of trastuzumab.
Danish: I den endelige populationsfarmakokinetiske model blev udover primær tumortype kropsvægt, serumaspartataminotransferase og -albumin identificeret som statistisk signifikante kovarianter med indvirkning på trastuzumabs eksponering.
English: Progression free survival was doubled in the trastuzumab plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months).
Danish: Progressionsfri overlevelse blev fordoblet i armen med trastuzumab plus anastrozol sammenlignet med anastrozol alene (4,8 måneder versus 2,4 måneder).
English: Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Danish: Neutraliserende anti-trastuzumab-antistoffer blev fundet i prøver efter baseline hos 2 ud af 30 patienter i armen behandlet med intravenøs trastuzumab.
English: Do not use with glucose-containing solutions.
Danish: Der må ikke anvendes glukoseholdige opløsninger.
English: However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Danish: Trastuzumab plus docetaxel var dog virkningsfuld hos patienterne, hvad enten de tidligere havde fået adjuverende antracykliner eller ej.
English: Total CL range from Cmax,ss to Cmin,ss
Danish: Samlet CL-interval fra Cmax,ss til Cmin,ss
English: For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Danish: For eventuelle andre metoder, der kan anvendes til bestemmelse af HER2-protein eller genekspression, bør analyserne kun udføres af laboratorier, der tilbyder tilstrækkeligt avanceret udførelse af validerede metoder.
English: • jaundice (yellowish discoloration of the skin or eyes)
Danish: • gulsot (gulfarvning af hud eller øjne)
English: More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm (16.3%).
Danish: Flere patienter oplevede mindst én grad 3 eller 4-bivirkning i 2 års-behandlingsarmen (20,4 %) sammenlignet med 1 årsbehandlingsarmen (16,3 %).
English: To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Danish: For at sikre validering af testprocedurer og frembringelse af nøjagtige og reproducerbare resultater skal HER2-testen udføres på et laboratorium med et trænet personale.
English: Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Danish: Hvis der skulle forekomme en infusionsrelateret reaktion, skal infusionen afbrydes, eller infusionshastigheden reduceres, og patienten skal overvåges, indtil alle observerede symptomer har fortaget sig (se pkt.
English: Primary tumour type
Danish: Primær tumortype
English: Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Danish: Binding af trastuzumab til HER2 hæmmer ligand-uafhængig HER2-signalering og forhindrer den proteolytiske spaltning af dens ekstracellulære domæne, en aktiveringsmekanisme for HER2.
English: If you receive Ontruzant with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Danish: Hvis du får Ontruzant sammen med andre lægemidler til at behandle kræft, såsom paclitaxel, docetaxel, en aromatasehæmmer, capecitabin, 5-fluoruracil eller cisplatin, skal du også læse indlægssedlerne for disse lægemidler.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (>50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Danish: Risikofaktorer for en kardiel hændelse identificeret i fire store adjuverende studier omfattede høj alder (> 50 år), lav LVEF (< 55 %) ved baseline, før eller efter initiering af paclitaxel-behandling, fald i LVEF på 10-15 point og tidligere eller samtidig anvendelse af antihypertensiva.
English: For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Danish: For de andre parametre var forbedringer, der sås for kombinationen, for samlet respons (16,5 % versus 6,7 %), hyppighed af klinisk fordel (42,7 % versus 27,9 %), tid til progression (4,8 måneder versus 2,4 måneder).
English: Ontruzant may affect your ability to drive a car or operate machines.
Danish: Ontruzant kan påvirke din evne til at køre bil, motorcykel, cykle eller betjene maskiner.
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Danish: efterfulgt af • CMF på dag 1 og 8 hver 4. uge i 3 cyklusser efterfulgt efter operation af • yderligere cyklusser af adjuverende trastuzumab (til fuldførelse af 1 års behandling).
English: • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Danish: • Svær hviledyspnø som følge af komplikationer af fremskreden malignitet eller behov for supplerende oxygenbehandling.
English: If patients have been treated concurrently with a full course of low-dose anthracyclines and trastuzumab in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery.
Danish: Hvis patienterne er blevet behandlet samtidig med et fuldt forløb af lavdosisantracykliner og trastuzumab i den neoadjuverende behandling, bør der ikke gives yderligere cytoksisk kemoterapi efter operation.
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Danish: Studie JP19959 var et delstudie af BO18255 (ToGA) udført hos mandlige og kvindelige japanske patienter med fremskreden ventrikelkræft til undersøgelse af farmakokinetikken af capecitabin og cisplatin ved anvendelse med eller uden trastuzumab.
English: See section 5.1 for chemotherapy combination dosing.
Danish: 5.1 for dosering ved kombinationsdosering med kemoterapi.
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Danish: Det anvendes også i kombination med medicin, som kaldes aromatasehæmmere, til patienter med høje koncentrationer af HER2 samt hormonreceptor-positiv metastatisk brystkræft (brystkræft der er følsom over for tilstedeværelsen af kvindelige kønshormoner).
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in fetal death.
Danish: Denne tilstand kan være skadelig for fosteret og er blevet forbundet med ufuldstændig udvikling af lungerne, som resulterede i fosterdød.
English: Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents
Danish: Virkning af trastuzumab på farmakokinetikken af andre antineoplastiske midler
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 køre bil, motorcykel, cykle eller betjene maskiner, før symptomerne er forsvundet.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7%-10%).
Danish: Den højeste hyppighed af kardiel dysfunktion sås hos patienter, der fik trastuzumab samtidig med antracyklin/cyclophosphamid (27 %), og den var signifikant højere end for antracyklin/cyclophosphamid alene (7 %-10 %).
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Danish: Patienter med MBC og EBC havde sammenlignelige farmakokinetiske parametre (f.eks. clearance (CL), fordelingsvolumen for det centrale kompartment (Vc)) og populationsforudsagte steady-state-eksponeringer (Cmin, Cmax og AUC).
English: Studies indicate that breast cancer patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2.
Danish: Studier indikerer, at brystkræftpatienter, hvis tumorer har en overekspression af HER2, har en kortere sygdomsfri overlevelse sammenlignet med patienter, hvis tumorer ikke har en overexpression af HER2.
English: If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Danish: Hvis LVEF-procenten falder ≥ 10 point fra baseline OG til under 50 %, skal behandlingen seponeres og en ny LVEF-vurdering udføres inden for ca. 3 uger.
English: +Lung infiltration
Danish: +Lungeinfiltration
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs.
Danish: A: doxorubicin, C: cyclophosphamid, P: paclitaxel, H: trastuzumab * Ved en median varighed af opfølgningen på 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH-armen ** p-værdien for OS krydsede ikke den præspecificerede statistiske grænse for sammenligning af AC→PH vs. AC→P
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Danish: I det pivotale studie med docetaxel (100 mg/m2 infusion over 1 time) med eller uden trastuzumab havde 60 % af patienterne tidligere fået antracyklinbaseret adjuverende kemoterapi.
English: Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC2+/FISH+ or IHC3+).
Danish: Post-hoc subgruppeanalyser indikerer, at de positive behandlingseffekter er begrænset til målrettet behandling af tumorer med højere niveauer af HER2-protein (IHC2+/FISH+ eller IHC3+).
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) >25 kg/m2.
Danish: Hos patienter, der fik trastuzumab efter afsluttet adjuverende kemoterapi, var risikoen for kardiel dysfunktion forbundet med en højere kumulativ dosis af antracyklin, der blev givet før initiering af trastuzumab, og et kropsmasseindeks (BMI) på > 25 kg/m2.
English: Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Danish: Selvom der er visse begrænsninger ved brug af Cairo-Bishop kriterierne som diagnose, som fører til underestimering af antallet af tilfælde, så bifaldes det at opdatere produktinformationen med tilføjelse af tumorlyse syndrom med ukendt hyppighed grundet at trastuzumab er en potent mediator af antistofafhængig cellemedieret cytotoksicitet.