FrancophonIA/ELRC3.0 huggingface dataset:
English: No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Danish: Der er ikke set uforligeligheder mellem Herceptin og polyvinylchlorid-, polyethylen- eller polypropylenposer.
English: A single dose study in rabbits and a 13-week repeat dose toxicity study in Cynomolgus monkeys were conducted.
Danish: Der er udført et enkelt-dosis studie i kaniner og et 13-ugers toksicitetsstudie efter gentagne doser i cynomolgus aber.
English: These are very common (may affect more than 1 in 10 people).
Danish: Disse er meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter).
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P < 0.001).
Danish: De eksplorative analyser af kovarianter fra en patientundergruppe tydede på, at patienter med forhøjet niveau af shed HER2-ekstracellulære domæne havde en hurtigere ikke-lineær clearance (lavere Km) (p<0,001).
English: Herceptin contains the active substance trastuzumab, which is a monoclonal antibody.
Danish: Herceptin indeholder det aktive stof trastuzumab, som er et monoklonalt antistof.
English: Portsmouth, NH 03801 USA
Danish: Lonza Portsmouth 101 International Dr. Portsmouth, NH 03801 USA
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Danish: Denne tilstand kan være skadelig for dit foster og er blevet forbundet med, at lungerne ikke er fuldstændigt udviklede, hvilket kan resultere i fosterdød.
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Danish: • Du har metastatisk mavekræft med høje koncentrationer af HER2, når det er i kombination med de andre kræftlægemidler, capecitabin eller 5-fluoruracil og cisplatin.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 600 mg/5 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 600 mg/5 ml
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 en infusionsreaktion indtræffer, skal infusionen af Herceptin afbrydes, eller infusionshastigheden nedsættes, og patienten skal monitoreres, indtil alle observerede symptomer er forsvundet (se pkt.
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 Herceptin, or longer if a continuous decrease of LVEF is observed.
Danish: Yderligere monitorering anbefales hos patienter, som får antracyklin-baseret kemoterapi, og monitoreringen bør foregå årligt i op til 5 år efter sidste administration af Herceptin eller længere, hvis kontinuerligt fald i LVEF observeres.
English: Herceptin intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Danish: Herceptin intravenøs formulering gives som en intravenøs infusion (drop) direkte ind i dine blodårer.
English: If patients have been treated concurrently with a full course of low-dose anthracyclines and Herceptin in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery.
Danish: Hvis patienterne er blevet behandlet samtidigt med et fuldt forløb af lavdosis-antracykliner og Herceptin i et neoadjuverende behandlingsregime, bør yderligere cytotoksisk kemoterapi ikke gives efter operation.
English: • dry eyes
Danish: • tørre øjne
English: Total pathological complete response* (95 % CI)
Danish: Komplet patologisk response* (95 % konfidensinterval)
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH.
Danish: Studier af HER2-positivitetsrater ved ventrikelkræft ved brug af immunhistokemi (IHC) og fluorescens in situ hybridisering (FISH) eller kromogen in situ hybridisering (CISH) har vist, at der er udstrakt variation af HER2-positivitet, som rækker fra 6,8 % til 34,0 % for IHC og 7,1 % til 42,6 % for FISH.
English: Patients were treated with Herceptin until progression of disease.
Danish: Patienterne blev behandlet med Herceptin, indtil progression af sygdommen.
English: However, Herceptin plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Danish: Herceptin plus docetaxel var dog virkningsfuld hos patienterne, uanset om de tidligere havde fået adjuverende antracyklin eller ej.
English: Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (max. 30°C) in diffused daylight.
Danish: Når lægemidlet er overført fra hætteglasset til sprøjten er det fysisk og kemisk stabilt i 28 dage ved 28 °C og i 6 timer (samlet tid i hætteglasset og sprøjten) ved stuetemperatur (max 30 °C) i diffust dagslys.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in Section 4.4.
Danish: Detaljer omkring risikominimeringsaktiviteter, som er i overensstemmelse med EU's risikostyringsplan, er præsenteret i pkt.
English: Therefore you should tell your doctor, pharmacist or nurse that you have had Herceptin 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 Herceptin, hvis du begynder at anvende enhver form for nyt lægemiddel inden for 7 måneder efter ophør med Herceptin-behandlingen.
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 øvrige parametre blev der med kombinationsbehandlingen set følgende forbedringer: Samlet respons (16,5 % versus 6,7 %), klinisk benefit ratio (42,7 % versus 27,9 %), tid til progression (4,8 måneder versus 2,4 måneder).
English: If a pregnant woman is treated with Herceptin, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, close monitoring by a multidisciplinary team is desirable.
Danish: Hvis en gravid kvinde behandles med Herceptin, eller hvis en patient bliver gravid under behandlingen med Herceptin eller indenfor 7 måneder efter den sidste dosis Herceptin, anbefales tæt monitorering af et tværfagligt hold.
English: Data from study JP16003, a single-arm study of Herceptin (4 mg/kg IV loading dose and 2 mg/kg IV
Danish: Data fra studie JP16003, et enkelt-arm-studie med Herceptin (4 mg/kg i.v.-støddosis og 2 mg/kg i.v.
English: This dose should be administered subcutaneously over 2-5 minutes every three weeks.
Danish: Denne dosis skal administreres subkutant over 2-5 minutter hver tredje uge.
English: The majority of patients experienced resolution of symptoms and subsequently received further infusions of Herceptin.
Danish: Størstedelen af patienterne oplevede, at symptomerne forsvandt, og fik efterfølgende flere infusioner med Herceptin.
English: Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you.
Danish: Din læge kan vælge at ændre din Herceptin-behandling fra intravenøs til subkutan behandling (eller omvendt), hvis det er hensigtsmæssigt for dig.
English: Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous formulation respectively).
Danish: Svære bivirkninger (defineret i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade > 3), version 3.0) var ligeligt fordelt mellem begge Herceptinformuleringer (52,3 % versus 53,5 % i henholdsvis intravenøs formulering og subkutan formulering).
English: Periodic Safety Update Reports 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
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel 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 europæiske webportal for lægemidler.
English: During the treatment course with Herceptin subcutaneous formulation other medicinal products for subcutaneous administration should preferably be injected at different sites.
Danish: Gennem behandlingsforløbet med Herceptin subkutan formulering skal andre lægemidler til subkutan administration så vidt muligt injiceres på forskellige steder.
English: After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection, chemical and physical stability of Herceptin has been demonstrated for up to 30 days at 2 oC - 8oC, and 24 hours at temperatures not exceeding 30°C.
Danish: Efter aseptisk fortynding i polyvinylchlorid-, polyethylen- eller polypropylenposer, som indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, er fysisk og kemisk stabilitet af Herceptin blevet påvist i op til 30 dage ved 2 °C - 8 °C og 24 timer ved temperaturer, som ikke overstiger 30 °C.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Danish: Opbevar altid dette lægemiddel i den lukkede originalpakning i køleskab ved 2 °C - 8 °C.
English: Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Danish: Størstedelen af de patienter (79 %), der udviklede kardiel dysfunktion i disse studier, oplevede en forbedring på standardbehandling af kongestiv hjerteinsufficiens.
English: In patients with lower body weights (<59 kg, the lowest body weight quartile) the fixed dose used in the Herceptin subcutaneous arm was not associated with an increased risk of cardiac events or significant drop in LVEF.
Danish: Hos patienter med lav kropsvægt (< 59 kg, den nedre kvartil for kropsvægt) var den faste dosis anvendt i Herceptin subkutan-armen ikke associeret med øget risiko for kardielle bivirkninger eller signifikant fald i LVEF.
English: These events have occasionally been fatal and may occur as part of an infusion-related reaction or with delayed onset.
Danish: Disse bivirkninger har nogle gange haft letal udgang og kan opstå som en del af en infusionsrelateret reaktion eller med forsinket frembrud.
English: • The active substance is trastuzumab.
Danish: • Aktivt stof: Trastuzumab.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Herceptin treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Danish: Trastuzumab kan fortsat være i cirkulationen i op til 7 måneder efter ophør af Herceptin-behandlingen, baseret på populationsfarmakokinetiske analyser af alle tilgængelige data (se pkt.
English: Herceptin intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Danish: Intravenøs infusion af Herceptin bør administreres af sundhedspersonale, som er forberedt på at håndtere anafylaksi, og nødudstyr skal være tilgængeligt.
English: • Administration-related reactions: 37.2 % versus 47.8 % for the intravenous formulation versus subcutaneous formulation, respectively during the treatment phase;
Danish: • Administrationsrelaterede reaktioner: 37,2 % versus 47,8 % i henholdsvis intravenøs formulering og subkutan formulering under behandlingsfasen.
English: An absolute benefit of 13 percentage points in favour of the Herceptin arm was estimated in terms of 3-year event-free survival rate (65 % versus.
Danish: En absolut gavnlig effekt på 13 procentpoint til fordel for Herceptin-armen blev estimeret, udtrykt i 3års hændelsesfri overlevelse (65 % versus 52 %).
English: Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Danish: Hvert hætteglas indeholder 150 mg trastuzumab, som skal opløses i 7,2 ml vand til injektionsvæsker.
English: (µg.day/mL)
Danish: (mikrogram.dag/ml)
English: The highest rate of cardiac dysfunction was seen in patients receiving Herceptin concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %).
Danish: Den største hyppighed af kardiel dysfunktion blev set hos patienter, der fik Herceptin samtidigt med antracyklin/cyclophosphamid (27 %), og var signifikant højere end ved antracyklin/cyclophosphamid alene (7-10 %).
English: When Herceptin was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Danish: Når Herceptin blev administreret efter afslutning af adjuverende kemoterapi, blev NYHA-klasse IIIIV hjerteinsufficiens observeret hos 0,6 % af patienterne i 1-års armen efter en median opfølgning på 12 måneder.
English: In a method comparison study (study D008548) a high degree of concordance (>95 %) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Danish: I et studie (studie D008548), der sammenlignede metoder, blev der observeret en høj grad af overensstemmelse (>95 %) mellem SISH- og FISH-teknikker til detektion af HER2-genamplifikation hos patienter med ventrikelkræft.
English: Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”).
Danish: Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se punktet Advarsler og forsigtighedsregler).
English: The efficacy of Herceptin in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Danish: Effekten af Herceptin i kombination med paclitaxel hos patienter, som ikke tidligere havde fået adjuverende antracyklin, er ikke blevet undersøgt.
English: Patients assigned to receive Herceptin were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years.
Danish: Patienterne, der blev tildelt Herceptin-behandling, fik en initial støddosis på 8 mg/kg efterfulgt af 6 mg/kg hver 3. uge i enten et eller to år.
English: Herceptin 1 Year N = 1702***
Danish: Herceptin 1 år N=1.702***
English: Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients.
Danish: Kropsvægt og serum alanin aminotransferase (SGPT/ALAT) viste en statistik signifikant indflydelse på farmakokinetikken, dog viste simulationer, at dosisjustering ikke er nødvendig hos patienter med tidlig brystkræft.
English: Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herceptin 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 Herceptin og er blevet forbundet med letal udgang (se pkt 4.4).
English: • Post-operative wound infections (severe and/or serious): 1.7 % versus 3.0 % for the intravenous formulation versus subcutaneous formulation, respectively;
Danish: • Post-operative sår-infektioner (svære og/eller alvorlige): 1,7 % versus 3,0 % i henholdsvis den intravenøse formulering og den subkutane formulering.
English: The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without Herceptin, was immunohistochemistry.
Danish: Den testmetode, der hovedsageligt blev anvendt til bestemmelse af HER2-positivitet i det pivotale studie med docetaxel med eller uden Herceptin, var immunhistokemi.
English: It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed.
Danish: Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at det er den korrekte formulering i henhold til ordinationen (intravenøs eller subkutan fast-dosis), som administreres til patienten.
English: Trastuzumab washout period was assessed following subcutaneous administration using the population PK model.
Danish: Udvaskningsperioden for trastuzumab blev vurderet efter subkutan administration ved hjælp af den populationsfarmakokinetiske model.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Herceptin.
Danish: I meget sjældne tilfælde er det sket, at patienter, som havde alvorlige vejrtrækningsproblemer inden behandlingsstart døde, da de fik Herceptin.
English: Herceptin Subcutaneous
Danish: Herceptin subkutant
English: Herceptin Intravenous
Danish: Herceptin intravenøst
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of Herceptin and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p=0.004).
Danish: Hyppigheden af progression i leveren var signifikant lavere hos patienter, som blev behandlet med kombinationen af Herceptin og paclitaxel sammenlignet med paclitaxel alene (21,8 % versus 45,7 %, p = 0,004).
English: The pharmacokinetic results for the co primary endpoint, Ctrough pre dose Cycle 8, showed non-inferiority of the Herceptin subcutaneous compared to the Herceptin intravenous dose adjusted by body weight.
Danish: De farmakokinetiske resultater for det sammensatte primære endepunkt, Ctrough før dosis i serie 8, viste non-inferioritet af Herceptin subkutant sammenlignet med den intravenøse Herceptin dosis, der var tilpasset kropsvægt.
English: Do not breast-feed your baby during Herceptin therapy and for 7 months after the last dose of Herceptin as Herceptin may pass to your baby through your breast milk.
Danish: Du må ikke amme dit barn under behandling med Herceptin og i de første 7 måneder efter, du har fået den sidste dosis Herceptin, da Herceptin kan overføres til dit barn gennem modermælken.
English: Severe pulmonary adverse reactions occur in association with the use of Herceptin and have been associated with a fatal outcome.
Danish: Alvorlige pulmonale bivirkninger forekommer i forbindelse med anvendelse af Herceptin og er blevet forbundet med letal udgang.
English: It may take up to 7 months for Herceptin to be removed from your body.
Danish: Det kan tage op til 7 måneder at udskille Herceptin fra kroppen.
English: For non-inferiority of the PK co-primary endpoint, steady-state trastuzumab Ctrough value at the end of treatment Cycle 7, refer to section 5.2.
Danish: Angående non-inferiøritet af det co-primære farmakokinetiske endepunkt, steady-state trastuzumab Ctrough-værdi ved slutningen af behandlingen ved serie 7, henvises til pkt.
English: (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Danish: AC→DH (AC→TH)-armen og 217/1.073 patienter i AC→D (AC→T)-armen en Karnofsky performance status ≤ 90 (enten 80 eller 90).
English: A vial of Herceptin aseptically reconstituted with sterile water for injections (not supplied) is chemically and physically stable for 48 hours at 2ºC - 8 ºC after reconstitution and must not be frozen.
Danish: Et hætteglas Herceptin aseptisk rekonstitueret med sterilt vand til injektionsvæsker (følger ikke med) er kemisk og fysisk stabilt i 48 timer efter rekonstitueringen ved 2 °C - 8 °C, og det må ikke nedfryses.
English: If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herceptin therapy has been seen.
Danish: Hvis patienten har vedvarende nedsat venstre ventrikelfunktion, men forbliver asymptomatisk, bør lægen overveje at seponere Herceptin, hvis der ikke ses nogen klinisk fordel.
English: 1 Denotes adverse reactions that are reported largely in association with administration-related reactions.
Danish: Angiver bivirkninger, som er rapporteret i stor udstrækning i forbindelse med administrationsrelaterede reaktioner.
English: The rate was highest in patients who were administered Herceptin concurrently with a taxane (2.0 %).
Danish: Hyppigheden var højest hos patienter, der fik administreret Herceptin samtidig med et taxan (2,0 %).
English: In the clinical study comparing these two formulations, infections and cardiac events leading to hospitalisation were more frequent with the subcutaneous formulation.
Danish: I det kliniske studie, hvor disse to formuleringer blev sammenlignet, opstod der oftere infektioner og bivirkninger, der påvirkede hjertet og medførte indlæggelse ved den formulering, der blev givet under huden.
English: In the pivotal metastatic trials of intravenous Herceptin, 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 pivotale metastatiske studier med intravenøst Herceptin varierede incidensen af kardiel dysfunktion mellem 9 % og 12 %, når Herceptin blev givet i kombination med paclitaxel sammenlignet med 1-4 %, når paclitaxel blev givet alene.
English: The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial in EBC was overall similar to the known safety profile of the intravenous formulation.
Danish: Sikkerhedsprofilen af Herceptin subkutan formulering (evalueret i 298 og 297 patienter behandlet med henholdsvis intravenøs og subkutan formulering) fra det pivotale studie i tidlig brystkræft var overordnet sammenlignelig med den kendte sikkerhedsprofil af den intravenøse formulering.
English: After aseptic reconstitution with sterile water for injection, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C.
Danish: Efter aseptisk rekonstituering med sterilt vand til injektionsvæsker er fysisk og kemisk stabilitet af den rekonstituerede opløsning blevet påvist i 48 timer ved 2 °C - 8 °C.
English: Herceptin may have a minor influence on the ability to drive or use machines (see section 4.8).
Danish: Herceptin kan have en mindre påvirkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: Median months Overall Response Rate, % 34.5 % 47.3 % 1.70a (1.22, 2.38) 0.0017
Danish: 34,5 % 47,3 % 1,70a (1,22-2,38)
English: Your doctor may prescribe Herceptin for the treatment of breast cancer when:
Danish: Din læge kan ordinere Herceptin til behandling af brystkræft, hvis:
English: The systemic reactions included hypersensitivity, hypotension, tachycardia, cough, and dyspnoea.
Danish: De systemiske reaktioner inkluderede overfølsomhed, hypotension, takykardi, hoste og dyspnø.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13
Danish: Trastuzumab kan dog øge den samlede eksponering for en af doxorubicins metabolitter (7-deoxy-13dihydro-doxorubicinon, D7D).