FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Perjeta and trastuzumab may continue until disease progression or unmanageable toxicity even if treatment with docetaxel is discontinued.
Danish: Behandling med Perjeta og trastuzumab kan fortsætte indtil sygdomsprogression eller uacceptabel toksicitet selv hvis behandling med docetaxel seponeres.
English: Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms.
Danish: Patienterne bør evalueres og monitoreres omhyggeligt, indtil symptomerne er fuldstændigt forsvundet.
English: Additional supportive clinical trial information
Danish: Yderligere understøttende oplysninger fra kliniske studier
English: Patients' median LVEF at baseline was 65.0% (range 50% - 88%) in both groups.
Danish: Patienternes mediane LVEF ved baseline var 65,0% (interval 50% - 88%) for begge grupper.
English: Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of pertuzumab between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
Danish: Baseret på den populationsfarmakokinetiske analyse blev der ikke observeret nogen signifikant forskel i pertuzumabs farmakokinetik hos patienter < 65 år (n = 306) og patienter ≥ 65 år (n = 175).
English: The statistically significant OS benefit in favour of the Perjetatreated group, previously observed at an interim analysis of OS (performed one year after the primary analysis), was maintained (HR 0.68, p = 0.0002 log-rank test).
Danish: Den statistisk signifikante samlede overlevelse til fordel for Perjeta-gruppen, som tidligere var observeret ved en interimanalyse af samlet overlevelse (udført et år efter den primære analyse), blev fastholdt (hazard ratio 0,68, p = 0,0002 log-rank test).
English: With doses of 15 mg/kg and higher, intermittent mild treatment-associated diarrhoea was noted.
Danish: Ved doser på 15 mg/kg og derover bemærkedes intermitterende, let, behandlingsrelateret diarré.
English: In early stage breast cancer, tumor size, grade, hormone receptor status and lymph node metastases should be taken into account in the risk assessment.
Danish: For brystkræft i et tidlig stadie skal tumorstørrelsen, graden, hormonreceptorstatus og metastaser i lymfeknuderne inkluderes i risikovurderingen.
English: Perjeta recognises and attaches to a target called “human epidermal growth factor receptor 2” (HER2).
Danish: Perjeta genkender og binder sig et sted på cellerne, der hedder human epidermal vækstfaktor-receptor 2 (HER2).
English: The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.
Danish: De mest almindelige bivirkninger af NCI-CTCAE grad 3-4 (≥ 10%) var neutropeni og febril neutropeni.
English: The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies.
Danish: Forekomsten af dysfunktion af venstre ventrikel og kongestivt hjerteinsufficiens afspejler hvad der er indberettet (foretrukne MedDRA-termer) for de individuelle studier.
English: Decreases in LVEF have been reported with medicinal products that block HER2 activity, including Perjeta.
Danish: Der er rapporteret fald i LVEF med lægemidler, der blokerer HER2-aktivitet, inklusive Perjeta.
English: Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis.
Danish: Medicinsk gennemgang af disse 15 rapporter viste, at i 8 ud af 15 hændelser var det rapporterede udfald ikke en indikation af infusionsrelaterede reaktioner/ anafylaksi/overfølsomhed.
English: If you are given Perjeta with trastuzumab and chemotherapy at the same time, some side effects may also be due to these other medicines.
Danish: Hvis du får Perjeta sammen med trastuzumab og kemoterapi, kan nogle af bivirkningerne også skyldes disse andre lægemidler.
English: The primary endpoint of this study was cardiac safety during the neoadjuvant treatment period of the study.
Danish: Studiets primære endepunkt var kardiologisk sikkerhed i studiets neoadjuverende behandlingsperiode.
English: Pertuzumab displayed linear pharmacokinetics within the recommended dose range.
Danish: Pertuzumab udviste lineær farmakokinetik inden for det anbefalede dosisinterval.
English: The median time to death was 40.8 months in the placebo-treated group and 56.5 months in the Perjeta-treated group (see Table 3, Figure 2).
Danish: Mediantid til død var 40,8 måneder i placebo-gruppen og 56,5 måneder i Perjeta-gruppen (se tabel 3, figur 2).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC13
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC13.
English: No overall differences in efficacy and safety of Perjeta were observed in patients ≥65 and <65 years of age with the exception of diarrhoea, which had an increased incidence in patients ≥65 years of age.
Danish: Der er ikke observeret overordnede forskelle med hensyn til effekt og sikkerhed af Perjeta hos patienter i aldersgruppen ≥ 65 og < 65 år bortset fra diarré, som forekom hyppigere hos patienter i aldersgruppen ≥ 65 år.
English: On the basis of reported adverse reactions, Perjeta has no or negligible influence on the ability to drive or use machines.
Danish: Baseret på de rapporterede bivirkninger har Perjeta ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see section 4.2).
Danish: Den kliniske vurdering bør baseres på sværhedsgraden af den forudgående reaktion og på respons på behandlingen givet for bivirkningen (se pkt.
English: Perjeta should be administered in combination with trastuzumab and docetaxel .
Danish: Perjeta skal administreres i kombination med trastuzumab og docetaxel.
English: Perjeta is unlikely to affect you being able to drive or use machines.
Danish: Det er usandsynligt, at Perjeta påvirker evnen til at køre bil eller betjene maskiner.
English: If you experience severe diarrhoea while receiving your anti-cancer treatment, your doctor may start you on anti-diarrhoeal treatment and may stop your treatment with Perjeta until the diarrhoea is under control.
Danish: Hvis du oplever svær diarré, mens du får din kræftmedicin, kan lægen give dig behandling mod diarré og lægen kan stoppe behandlingen med Perjeta indtil diarréen er under kontrol.
English: Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Danish: Perjeta er et humaniseret IgG1-monoklonalt antistof produceret i pattedyrsceller (ovarieceller fra kinesisk hamster) ved rekombinant DNA-teknologi.
English: Because human IgG is secreted in human milk and the potential for absorption and harm to the infant is unknown, a decision should be made to discontinue breast-feeding or to discontinue treatment, taking into account the benefit of breast-feeding for the child and the benefit of Perjeta therapy for the woman (see section 5.2).
Danish: Da humant IgG udskilles i human mælk, og da risikoen for absorption og skadelig virkning på spædbarnet er ukendt, skal det besluttes, om amning skal ophøre eller behandlingen seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til Perjeta-behandlingens fordele for moderen (se pkt.
English: The active substance is pertuzumab.
Danish: • Aktivt stof: pertuzumab.
English: An increased incidence of febrile neutropenia was observed among Asian patients in both treatment groups compared with patients of other races and from other geographic regions.
Danish: En øget forekomst af febril neutropeni blev observeret hos asiatiske patienter i begge behandlingsgrupper sammenlignet med patienter af anden race og fra andre geografiske regioner.
English: A feeling of numbness, prickling or tingling in feet or hands; sharp jabbing, throbbing, freezing or burning pain; feeling pain from something which should not be painful such as a light touch; less able to feel changes in heat or cold; loss of balance or coordination
Danish: • En følelse af følelsesløshed, prikkende eller snurren i fødder eller hænder; stærk stikkende, dunkende, frysende eller brændende smerte; føle smerte fra noget, der ikke bør være smertefuldt, såsom let berøring; dårligere til at mærke ændringer i varme eller kulde; tab af balance eller koordination
English: Perjeta and trastuzumab should be administered sequentially and not mixed in the same infusion bag.
Danish: Perjeta og trastuzumab skal administreres sekventielt og må ikke blandes i den samme infusionspose.
English: *** Patients with best overall response of confirmed CR or PR by RECIST.
Danish: *** Patienter med bedste samlede respons i form af RECIST-defineret komplet respons eller partielt respons.
English: Simes corr. for CMH test)
Danish: for CMH-test)
English: However sensitivity analyses performed at the recommended dose and schedule of Perjeta showed that at the extreme values of these two covariates, there was no significant impact on the ability to achieve target steady-state concentrations identified in preclinical tumour xenograft models.
Danish: Sensitivitetsanalyser udført med den anbefalede dosis og behandlingsskema for Perjeta har dog vist, at der ved ekstreme værdier af disse to kovariater ikke er signifikant påvirkning af evnen til at opnå målet for steady-state koncentrationer i prækliniske tumorxenograft-modeller.
English: The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency:
Danish: Bivirkninger angives nedenfor i henhold til MedDRA-systemsorganklasser og med følgende frekvenskategorier:
English: You will be given 840 mg of Perjeta over 60 minutes.
Danish: • Vil du få 840 mg Perjeta i løbet af 60 minutter.
English: The observation period should be completed prior to any subsequent infusion of trastuzumab or chemotherapy (see section 4.4).
Danish: Observationsperioden skal afsluttes inden efterfølgende infusion af trastuzumab eller kemoterapi (se pkt.
English: Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of ≥ 50%.
Danish: Patienter skal inden behandling have en venstre ventrikels ejektionsfraktion (LVEF) ≥ 50%.
English: The higher incidence of febrile neutropenia in Perjeta-treated patients was associated with the higher incidence of mucositis and diarrhoea in these patients.
Danish: Den højere forekomst af febril neutropeni var hos de Perjeta-behandlede patienter associeret med den højere forekomst af mucositis og diarré hos disse patienter.
English: Secondary endpoints included the assessment of patient-reported global health status, role and physical function, and treatment symptoms using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
Danish: Sekundære endepunkter inkluderede vurdering af patient-rapporteret, overordnet helbredsstatus, dagligt fysisk funktionsniveau og behandlingssymptomer ved hjælp af EORTC QLQ-C30- og EORTC QLQ-BR23-spørgeskemaer.
English: Perjeta should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately available.
Danish: Perjeta bør administreres af sundhedspersonale, der er uddannet til at behandle anafylaksi, samt på hospitalsafdelinger, hvor genoplivningsudstyr er umiddelbart tilgængeligt.
English: The vial must not be shaken.
Danish: Hætteglasset må ikke rystes.
English: There were too few patients with inflammatory breast cancer to draw any firm conclusions but the pCR rate was higher in patients who received Perjeta plus trastuzumab and docetaxel.
Danish: Der var for få patienter med inflammatorisk brystkræft til at drage nogen klar konklusion, men pCR-raten var højere hos patienter, der fik Perjeta plus trastuzumab og docetaxel.
English: Figure 2 Kaplan-Meier Curve of Overall Survival
Danish: Kaplan-Meier-kurve over samlet overlevelse
English: When administered with Perjeta the recommendation is to follow a 3 weekly schedule for trastuzumab administered as either:
Danish: Ved administration sammen med Perjeta er anbefalingen for trastuzumab at følge en 3-ugers serie administreret som enten:
English: Tumour lysis syndrome (a condition which may happen when cancer cells die quickly, causing changes in blood levels of minerals and metabolites shown in a blood test).
Danish: • Tumorlyse syndrom (en tilstand, som kan forekomme, når kræftceller dør hurtigt, og forårsager ændringer i blodniveauer af mineraler og metabolitter måles i en blodprøve).
English: Based on the pharmacological actions of HER2-targeted agents and anthracyclines, the risk of cardiac toxicity might be expected to be higher with concomitant use of Perjeta and anthracyclines than with sequential use.
Danish: På baggrund af de farmakologiske virkningsmekanismer for HER2-lægemidler og antracykliner, må risiko for kardiel toksicitet forventes at være højere ved samtidigt brug af Perjeta og antracykliner end ved sekventielt brug.
English: The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review facility (IRF) and defined as the time from the date of randomisation to the date of disease progression or death (from any cause) if the death occurred within 18 weeks of the last tumour assessment.
Danish: Studiets primære endepunkt var progressionsfri overlevelse vurderet af en uafhængig komite og defineret som tid fra randomiseringsdato til dato for sygdomsprogression eller død (af enhver årsag), såfremt døden indtrådte inden for 18 uger efter sidste tumorvurdering.
English: Treatment with Perjeta may cause severe diarrhoea.
Danish: Behandling med Perjeta kan fremkalde svær diarré.
English: The PK of pertuzumab in these studies was comparable to those observed in single-agent studies.
Danish: Pertuzumabs farmakokinetik var i disse studier sammenlignelig med det, der var set i enkeltstof-studier.
English: This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.
Danish: Fraværet af lægemiddelinteraktion blev bekræftet af farmakokinetiske data fra NEOSPHEREog APHINITY-studiet.
English: Perjeta is administered as an intravenous infusion.
Danish: Perjeta administreres som intravenøs infusion.
English: Patients treated with Perjeta must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ hybridisation (ISH) assessed by a validated test.
Danish: Patienter, der behandles med Perjeta, skal have HER2-positiv-tumorstatus, defineret som en score på 3+ ved immunhistokemi (IHC) og/eller på > 2,0 ved in situ hybridisering (ISH) vurderet ved en valideret test.
English: None of these patients experienced anaphylactic/hypersensitivity reactions that were clearly related to ADA.
Danish: Ingen af patienterne oplevede anafylaktiske/overfølsomheds-reaktioner, som entydigt var relateret til de anti-terapeutiske antistoffer.
English: Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4.
Danish: Pertuzumab er et rekombinant humaniseret monoklonalt antistof specifikt rettet mod det ekstracellulære dimeriseringsdomæne (sub-domæne II) i det humane epidermale vækstfaktorreceptor 2-protein (HER2) og blokerer derved ligand-afhængig heterodimerisering af HER2 med andre HERfamiliemedlemmer, inklusive EGFR, HER3 og HER4.
English: Dose adjustments of pertuzumab are not needed in patients with mild or moderate renal impairment.
Danish: Dosisjustering af pertuzumab er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: The metabolism of pertuzumab has not been directly studied.
Danish: Metabolismen af pertuzumab er ikke umiddelbart undersøgt.
English: Most of these patients had received prior anthracycline therapy and 11% of all patients had received prior trastuzumab.
Danish: De fleste af disse patienter havde tidligere fået antracyklinbehandling, 11% havde tidligere fået trastuzumab.
English: Assess LVEF prior to initiation of Perjeta and at regular intervals during treatment with Perjeta (e.g. once during neoadjuvant treatment and every 12 weeks in the adjuvant or metastatic setting) to ensure that LVEF is within normal limits.
Danish: LVEF skal vurderes, inden behandling med Perjeta påbegyndes og i jævnlige intervaller under behandling med Perjeta (fx én gang under neoadjuverende behandling og hver 12. uge ved adjuverende eller metastatisk behandling) for at sikre, at LVEF ligger inden for normalområdet.
English: If the LVEF has declined as indicated in section 4.2 and has not improved, or has declined further at the subsequent assessment, discontinuation of Perjeta and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Danish: 4.2 og ikke er forbedret eller er faldet yderligere ved efterfølgende undersøgelser, skal seponering af Perjeta og trastuzumab kraftigt overvejes, medmindre fordelene for den enkelte patient vurderes at opveje risici.
English: Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional.
Danish: Det er derfor vigtigt at sikre sterilitet af den tilberedte infusionsvæske, og infusionsvæsken bør fremstilles af sundhedspersonale.
English: It is given by a drip into a vein (intravenous infusion) once every three weeks.
Danish: • Medicinen gives i et drop i en vene (intravenøs infusion) hver tredje uge.
English: See section 4 “Serious side effects” for more details about infusion reactions to look out for during the infusion and thereafter.
Danish: Se punkt 4 “Alvorlige bivirkninger” for mere information om, hvad du skal holde øje med under og efter infusionen.
English: Perjeta and trastuzumab were given at standard doses in a 3-weekly regimen.
Danish: Perjeta og trastuzumab blev givet i standarddoser hver 3. uge.
English: The primary endpoint of the BERENICE trial is cardiac safety in the neoadjuvant period of the trial.
Danish: BERENICE-studiets primære endepunkt er kardiologisk sikkerhed i den neoadjuverende behandlingsperiode.
English: The efficacy results from the APHINITY trial are summarised in Table 5 and in Figure 3.
Danish: Effektresultater fra APHINITY-studiet opsummeres i tabel 5 og i figur 3.
English: As Perjeta was used with trastuzumab and chemotherapy in these trials, it is difficult to ascertain the causal relationship of an adverse event to a particular medicinal product.
Danish: Da Perjeta blev anvendt sammen med trastuzumab og kemoterapi i disse studier, er det svært at fastslå årsagssammenhæng mellem en bivirkning og det specifikke lægemiddel.
English: Consistent results were observed across pre-specified patient subgroups including the subgroups based on stratification factors of geographic region and prior adjuvant/neoadjuvant therapy or de novo metastatic breast cancer (see Figure 1).
Danish: Tilsvarende resultater sås på tværs af præspecificerede patient-subgrupper, inklusive de subgrupper, der var stratificeret på baggrund af geografisk region og tidligere adjuverende/neoadjuverende behandling eller de novo metastatisk brystkræft (se figur 1).
English: Following surgery all patients received Perjeta and trastuzumab intravenously every 3 weeks to complete 1 year of therapy.
Danish: Efter operation fik alle patienter Perjeta og trastuzumab intravenøst hver 3. uge for at fuldføre 1 års behandling.
English: On the first day when only Perjeta was administered, the overall frequency of infusion reactions was 9.8% in the placebo-treated group and 13.2% in the Perjeta-treated group, with the majority of infusion reactions being mild or moderate.
Danish: På den første dag, hvor der kun blev administreret Perjeta, var den overordnede hyppighed af infusionsreaktioner 9,8% i placebo-gruppen og 13,2% i Perjeta-gruppen, og størstedelen af infusionsreaktionerne var lette eller moderate.
English: In clinical trials, single doses higher than 25 mg/kg (1727 mg) have not been tested.
Danish: Enkeltdoser over 25 mg/kg (1727 mg) er ikke afprøvet i kliniske studier.
English: No dose recommendations can be made for patients with severe renal impairment because of the limited pharmacokinetic data available (see section 5.2).
Danish: Der kan ikke gives dosisanbefalinger for patienter med svært nedsat nyrefunktion på grund af begrænsede farmakokinetiske data (se pkt.
English: No differences in pertuzumab PK were observed in patients with early breast cancer compared to patients with metastatic breast cancer.
Danish: Der er ikke observeret forskelle i pertuzumabs farmakokinetik hos patienter med tidlig brystkræft sammenlignet med patienter med metastatisk brystkræft.
English: Febrile neutropenia (Low white blood cells with fever) When Perjeta is given with other cancer treatments (trastuzumab and chemotherapy), the number of white blood cells may drop and fever (raised temperature) may develop.
Danish: Febril neutropeni (lavt antal hvide blodlegemer med feber) Når Perjeta gives sammen med anden medicin mod kræft (trastuzumab og kemoterapi), kan antallet af hvide blodlegemer falde, og du kan få feber.
English: Reduced appetite
Danish: • Nedsat appetit
English: At the time of the primary analysis, the benefits of Perjeta were more apparent in subgroups of patients a high risk of recurrence: patients with node-positive or hormone receptor-negative disease (see table
Danish: På tidspunktet for den primære analyse, var fordelene ved Perjeta mere åbenlyse i subgrupper af patienter med høj risiko for tilbagefald: patienter med lymfeknude-positiv eller hormonreceptornegativ sygdom (se tabel 6).
English: While pertuzumab alone inhibited the proliferation of human tumour cells, the combination of pertuzumab and trastuzumab significantly augmented antitumour activity in HER2-overexpressing xenograft models.
Danish: Mens pertuzumab alene kan hæmme proliferationen af humane tumorceller, forstærker kombinationen af pertuzumab og trastuzumab i betydelig grad antitumor-aktiviteten i xenograft-modeller af HER2overekspression.
English: The primary endpoint of the study was invasive disease-free survival (IDFS), defined as the time from randomisation to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Danish: Studiets primære endepunkt var invasiv sygdomsfri overlevelse, defineret som tid fra randomisering til første forekomst af ipsilateral lokal eller regional invasiv brystkræft recidiv, fjernrecidiv, kontralateral invasiv brystkræft eller død af enhver årsag.
English: 14 ml of Perjeta concentrate should be withdrawn from the vial and diluted into a 250 ml PVC or non-PVC polyolefin infusion bag of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: 14 ml af Perjeta-koncentratet skal udtages fra hætteglasset og fortyndes i en 250 ml PVC- eller PVC-fri polyolefin-infusionspose med natriumchlorid 9 mg/ml (0,9%) infusionsvæske.
English: Neoadjuvant Treatment
Danish: Neoadjuverende behandling
English: Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of LVEF declines.
Danish: Patienter, som tidligere er behandlet med antracykliner eller har fået strålebehandling af brystkassen, kan have øget risiko for LVEF-fald.
English: Do not use this medicine if you notice any particles in the liquid or it is the wrong colour (please see section 6).
Danish: • Brug ikke Perjeta, hvis du bemærker partikler i infusionsvæsken, eller infusionsvæsken ikke har den rigtige farve (se punkt 6).
English: In the neoadjuvant setting, locally advanced and inflammatory breast cancers are considered as highrisk irrespective of hormone receptor status.
Danish: I rammerne af neoadjuverende behandling vurderes lokalt avanceret og inflammatorisk brystkræft at indebære høj risiko, uafhængig af hormonreceptorstatus.