FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may continue therapy during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Danish: Patienter kan fortsætte behandling under perioder med reversibel, kemoterapi-induceret myelosuppression, men de skal i denne periode monitoreres omhyggeligt for komplikationer i forbindelse med neutropeni.
English: Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use.
Danish: Lægemidler til behandling af sådanne reaktioner såvel som akutudstyr skal være umiddelbart tilgængeligt.
English: There is limited amount of data from the use of pertuzumab in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af pertuzumab til gravide kvinder.
English: No specific dose recommendations can be made.
Danish: Der kan ikke gives specifikke dosisrekommandationer.
English: The median clearance (CL) of pertuzumab was 0.235 litres/day and the median half-life was 18 days.
Danish: Den gennemsnitlige clearance af pertuzumab var 0,235 liter/dag, og den gennemsnitlige halveringstid var 18 dage.
English: There is no relevant use of Perjeta in the paediatric population in the indication of breast cancer.
Danish: Der er ingen relevant anvendelse af Perjeta hos den pædiatriske population for indikationen brystkræft.
English: Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions.
Danish: Glucose (5%) infusionsvæske bør ikke anvendes til at fortynde Perjeta, da pertuzumab er kemisk og fysisk ustabilt i sådanne opløsninger.
English: < 6 weeks
Danish: < 6 uger
English: Treatment with Perjeta may affect the heart.
Danish: Behandling med Perjeta kan påvirke hjertet.
English: Based on modifications made to the study treatment, most reactions were assessed as secondary to docetaxel infusions.
Danish: På baggrund af ændringer i behandlingen i studiet vurderedes det, at de fleste reaktioner skyldtes infusion af docetaxel.
English: The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this.
Danish: • Brystkræften er bestemt til at være af typen ”HER2-positiv” brystkræft - lægen vil teste dig for dette.
English: Only chemotherapy-naive patients were treated and they received low cumulative doses of epirubicin (up to 300 mg/m2).
Danish: Kun kemoterapi-naive patienter blev behandlet, og de fik lave kumulative doser af epirubicin (op til 300 mg/m2).
English: Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration.
Danish: Parenterale lægemidler skal inspiceres visuelt for partikler og misfarvning inden administration.
English: Approximate 95% CI for difference of two response rates using Hauck-Anderson method.
Danish: Tilnærmet 95% konfidensinterval for forskel i de to responsrater beregnet efter Hauck-Andersons metode.
English: Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when:
Danish: Perjeta indeholder det aktive stof pertuzumab og bruges til at behandle voksne patienter med brystkræft, når:
English: There is very limited data available in patients with unresectable locally recurrent disease.
Danish: Der er meget begrænsede data tilgængelige hos patienter med lokalt recidiverende, ikke-resecerbar sygdom.
English: For recommendations on delayed or missed doses, please refer to Table 1 below.
Danish: For anbefalinger vedrørende forsinket eller manglende dosering, se tabel 1 nedenfor.
English: Perjeta is compatible with polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene.
Danish: Perjeta er forligelig med polyvinylchlorid (PVC) poser eller polyolefinposer uden PVC inklusive polyethylen.
English: Progression-Free Survival (independent review) - primary endpoint*
Danish: Progressionsfri overlevelse (uafhængigt vurderet)Primært endepunkt*
English: Loss of or altered taste
Danish: • Manglende eller ændret smagssans
English: In a subset of monkeys, chronic dosing (7 to 26 weekly doses) resulted in episodes of severe secretory diarrhoea.
Danish: I en subgruppe af aber medførte kronisk dosering (7-26 ugentlige doser) episoder med svær sekretorisk diarré.
English: Diarrhoea is most frequent during concurrent administration with taxane therapy.
Danish: Diarré er mest hyppig under samtidig administration med taxanbehandling.
English: If it has been 6 weeks or more since your last visit a higher Perjeta dose of 840 mg will be given to you.
Danish: Hvis der er gået mere end 6 uger siden din sidste behandling, vil du få en højere dosis Perjeta på 840 mg.
English: Table 3 Summary of efficacy from CLEOPATRA study Parameter
Danish: Tabel 3: Resumé af effekt i CLEOPATRA-studiet Parameter
English: * ADRs with a fatal outcome have been reported.
Danish: * bivirkninger med dødelig udgang er rapporteret.
English: Early intervention with loperamide, fluids and electrolyte replacement should be considered, particularly in elderly patients, and in case of severe or prolonged diarrhoea.
Danish: Tidlig indgriben med loperamid, væsker og elektrolyt-genoprettelse skal overvejes, især hos ældre patienter og i tilfælde af svær eller forlænget diarré.
English: Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion.
Danish: I meget sjældne tilfælde er patienter døde af anafylaktiske reaktioner under Perjeta infusion.
English: Patients were treated with Perjeta and trastuzumab until disease progression, withdrawal of consent or unmanageable toxicity.
Danish: Patienterne blev behandlet med Perjeta og trastuzumab indtil sygdomsprogression, tilbagetrækning af samtykke eller ukontrollerbar toksicitet.
English: Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
Danish: Behandlingen skal omfatte antracyklin- og/eller taxan-baseret standard-kemoterapi.
English: Perjeta should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents.
Danish: Behandling med Perjeta bør kun initieres under supervision af læge med erfaring i administration af kræftlægemidler.
English: no. of patients with an event Median months
Danish: Antal patienter med en hændelse Median antal måneder
English: The addition of Perjeta to trastuzumab plus chemotherapy did not affect patients' overall role function over the course of the study.
Danish: Tillæg af Perjeta til trastuzumab plus kemoterapi påvirkede ikke patienternes overordnede funktionsniveau i løbet af studiet.
English: A decrease in the number or low amount of white blood cells (shown in a blood test), with or without fever, which may increase the risk of an infection.
Danish: • Et fald i antallet eller lavt antal af hvide blodlegemer (måles i en blodprøve) med eller uden feber, som kan øge risikoen for en infektion.
English: For the first infusion:
Danish: Ved den første infusion
English: Table 5 Overall Efficacy: ITT Population
Danish: Tabel 5 Samlet effekt: ITT-population
English: If you stop having Perjeta
Danish: Hvis du holder op med at få Perjeta
English: Most events were Grade 1 or 2 in severity, occurred in the first two cycles, and responded to standard therapies, such as topical or oral treatment for acne.
Danish: De fleste af tilfældene var af sværhedsgrad 1 eller 2, forekom i de første 2 serier og responderede på standardbehandling, såsom topikal eller oral behandling af acne.
English: Permanent discontinuation should be considered in patients with severe infusion reactions.
Danish: Permanent seponering bør overvejes hos patienter med svære infusionsreaktioner.
English: Use in children and adolescents
Danish: Børn og unge
English: If you forget to have Perjeta
Danish: Hvis du har glemt at få Perjeta
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pertuzumab, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en for pertuzumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: No events of febrile neutropenia were reported after cessation of docetaxel.
Danish: Der blev ikke rapporteret tilfælde af febril neutropeni efter seponering af docetaxel.
English: Thereafter, revert to the original planned schedule.
Danish: Herefter genoptages det oprindeligt planlagte doseringsskema.
English: Patients should be observed closely for hypersensitivity reactions.
Danish: Patienter bør observeres omhyggeligt for overfølsomhedsreaktioner.
English: Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Danish: Patienter, som oplever infusionsreaktioner, skal rådes til ikke at føre et motorkøretøj og betjene maskiner, før symptomerne er aftaget.
English: In both studies most events were mild to moderate in severity.
Danish: I begge studier var de fleste tilfælde lette til moderate i sværhedsgrad.
English: The indication in the neoadjuvant treatment of breast cancer is based on demonstration of an improvement in pathological complete response rate, and trends to improvement in disease-free survival that nevertheless do not establish or precisely measure a benefit with regard to long-term outcomes, such as overall survival or disease-free survival.
Danish: Indikationen for neoadjuverende behandling af brystkræft er baseret på en påvisning af forbedring i den patologiske komplette responsrate og en tendens til forbedring af sygdomsfri overlevelse, som dog alligevel ikke etablerer eller præcist måler fordelene med hensyn til langsigtede resultater, såsom samlet overlevelse og sygdomsfri overlevelse.
English: °° Infusion reaction includes a range of different terms within a time window, see “Description of selected adverse reactions” below.
Danish: ºº Infusionsreaktion inkluderer en række forskellige bivirkninger inden for et bestemt tidsrum, se ”Beskrivelse af udvalgte bivirkninger” nedenfor.
English: These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax.
Danish: Disse dosisniveauer resulterede i klinisk relevante eksponeringer 2,5 til 20 gange større end ved de anbefalede humane doser, baseret på Cmax.
English: Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Danish: Disse studier inkluderede de pivotale studier CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225) og APHINITY (n=4804) [poolet i tabel 2].
English: Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given).
Danish: Patienter skal inden behandling have en LVEF ≥ 55% (≥ 50% efter at have gennemført antracyklindelen af kemoterapien, hvis en sådan gives).
English: The number of infusions you will be given depends on how you respond to treatment and whether you are receiving treatment before or after surgery (neoadjuvant or adjuvant therapy) or for disease which has spread.
Danish: • Antallet af infusioner afhænger af hvordan du reagerer på behandlingen, og om du får behandling før eller efter operation (neoadjuverende eller adjuverende behandling) eller behandling for sygdom, som har spredt sig.
English: Table 4 NEOSPHERE (WO20697) and TRYPHAENA (BO22280): Overview of efficacy (Intent to Treat Population)
Danish: Tabel 4 NEOSPHERE (WO20697) og TRYPHAENA (BO22280): Oversigt over effekt (Intention-to-Treat-population)
English: Being given this medicine
Danish: Når du får medicinen
English: Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively.
Danish: Hæmning af disse signalveje kan henholdsvis stoppe cellevæksten og fremkalde apoptose.
English: When Perjeta attaches to the HER2 cancer cells, it may slow or stop the cancer cells from growing, or may kill them.
Danish: Når Perjeta binder sig til HER2, kan det bremse eller stoppe kræftcellernes vækst og måske slå dem ihjel.
English: Left ventricular dysfunction (including congestive heart failure)
Danish: Dysfunktion af venstre ventrikel (inklusive kongestiv hjerteinsufficiens)
English: The storage details are as follows:
Danish: Opbevaringsbetingelserne er:
English: When the diarrhoea is under control treatment with pertuzumab may be reinstated.
Danish: Når diarréen er under kontrol kan pertuzumab-behandling genoptages.
English: Pack of 1 vial.
Danish: Pakke med 1 hætteglas.
English: Treatment with Perjeta and trastuzumab resulted in a response rate of 24.2%, with a further 25.8% of patients experiencing stabilisation of disease lasting at least 6 months, indicating that Perjeta is active following progression on trastuzumab.
Danish: Behandling med Perjeta og trastuzumab resulterede i en responsrate på 24,2% , hvor yderligere 25,8% af patienterne oplevede en sygdomsstabilisering af mindst 6 måneders varighed, hvilket indikerer, at Perjeta er aktivt efter progression på trastuzumab.
English: Ask your doctor about whether you can breast-feed during or after treatment with Perjeta.
Danish: • Spørg lægen, om du kan amme under eller efter behandlingen med Perjeta.
English: The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group).
Danish: Den endelige analyse af samlet overlevelse blev udført, da 389 patienter var døde (221 i placebogruppen og 168 i Perjeta-gruppen).
English: Some of the side effects which you get may be due to your breast cancer.
Danish: Nogle bivirkninger kan skyldes brystkræften.
English: Perjeta is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Perjeta kan ikke anbefales under graviditet eller til kvinder i den fertile alder, som ikke anvender prævention.
English: If you forget or miss your appointment to receive Perjeta make another appointment as soon as possible.
Danish: Hvis du glemmer eller er forhindret i at møde til din aftale til en behandling med Perjeta, skal du lave en ny aftale så hurtigt som muligt.
English: In neoadjuvant and adjuvant trials, Perjeta was administered on the same day as other study treatments in all cycles.
Danish: I de neoadjuverende og adjuverende studier blev Perjeta administreret på samme dag som andre studiebehandlinger i alle serier.
English: If a significant infusion reaction occurs, the infusion should be slowed down or interrupted and appropriate medical therapies should be administered.
Danish: Hvis der opstår en signifikant infusionsreaktion, skal infusionshastigheden nedsættes eller infusionen afbrydes og relevant behandling administreres.
English: It should not be administered as an intravenous push or bolus.
Danish: Det må ikke administreres som intravenøs stød- eller bolusdosis.
English: If the first infusion is well tolerated, subsequent infusions may be administered over a period of 30 minutes to 60 minutes (see section 4.4).
Danish: Hvis den første infusion er veltolereret, kan efterfølgende infusioner administreres over en periode på 30 til 60 minutter (se pkt.
English: Cardiac failure congestive**
Danish: Kongestiv hjerteinsufficiens**
English: Figure 3 Kaplan-Meier Curve of Invasive Disease Free Survival
Danish: Figur 3 Kaplan-Meier-kurve over invasiv sygdomsfri overlevelse
English: BO17929 - single-arm trial in metastatic breast cancer
Danish: BO17929 - enkelt-arm-studie med metastatisk brystkræft
English: Perjeta will be given to you by a doctor or nurse in a hospital or clinic.
Danish: Du vil få Perjeta af en læge eller sygeplejerske på hospitalet.
English: Interruption of treatment with pertuzumab should be considered if no improvement in the patient's condition is achieved.
Danish: Seponering af pertuzumab-behandling bør overvejes, hvis patientens tilstand ikke er forbedret.
English: If you are allergic to pertuzumab, or to any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for pertuzumab eller et af de øvrige indholdsstoffer i Perjeta (angivet i punkt 6).
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 agreeed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: A consistent pattern of results was observed regardless of pCR definition used.
Danish: Der blev observeret et konsistent mønster for resultaterne uanset den anvendte pCR-definition.
English: Treat diarrhoea according to standard practice and guidelines.
Danish: Diarré skal behandles i henhold til klinisk praksis og vejledninger.
English: BO17929 was a phase II, non-randomised study in patients with metastatic breast cancer whose tumours had progressed during treatment with trastuzumab.
Danish: BO17929 var et ikke-randomiseret fase II-studie med patienter med metastatisk brystkræft, hvor tumorerne var progredieret under behandling med trastuzumab.
English: An observation period of 30 - 60 minutes is recommended after completion of each infusion.
Danish: Der anbefales en observationsperiode på 30-60 minutter efter hver Perjeta-infusion er afsluttet.
English: Patients' physical function, global health status and diarrhoea scores showed a clinically meaningful change during chemotherapy in both treatment arms.
Danish: Patientens fysiske funktionsniveau, overordnede helbredsstatus og diarré-score viste en klinisk betydningsfuld ændring under kemoterapien i begge behandlingsarme.
English: All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.
Danish: Alle analyser er stratificeret efter lymfeknudestatus, protokol version, central hormonreceptor-status samt adjuverende kemoterapi-regime.
English: The majority of patients had node-positive (63%) and/or hormone receptor-positive disease (64%), and were Caucasian (71%).
Danish: Størstedelen af patienterne havde lymfeknude-positiv (63%) og/eller hormonreceptor-positiv sygdom (64%) og var af kaukasisk afstamning (71%).
English: In conclusion, administration of Pertuzumab may cause Infusion Related Reactions (IRR) and hypersensitivity/anaphylaxis reactions that can be associated with fatal outcome and the Product Information should be updated to reflect such outcome.
Danish: Som konklusion kan administration af pertuzumab forårsage infusionsrelaterede reaktioner og anafylaksi/overfølsomhed, der kan associeres med dødeligt udfald og produktinformationen skal opdateres så den afspejler et sådant udfald.
English: Perjeta and trastuzumab should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.
Danish: Perjeta og trastuzumab skal påbegyndes på dag 1 i den første taxan-holdige serie og fortsætte selv hvis kemoterapien seponeres.
English: Table 6 Efficacy results in subgroups by nodal status and hormone receptor status1 Population
Danish: Tabel 6 Effektsresultater i subgrupper ved lymfeknude-status og hormonreceptor-status1
English: The primary endpoint of cardiac safety, i.e. the incidence of NYHA Class III/IV LVD and LVEF declines, was consistent with previous data in the neoadjuvant setting (see section 4.4. and 4.8).
Danish: Det primære endepunkt for kardiologisk sikkerhed, dvs. hyppigheden af NYHA klasse III/IV LVD og LVEF-fald, var i overensstemmelse med tidligere data fra den neoadjuverende behandlingsperiode (se pkt.4.4 og 4.8).
English: The majority of the reported events were Grade 1 or 2
Danish: Størstedelen af de rapporterede hændelser var af sværhedsgrad 1 eller 2.
English: Overall, the majority of hypersensitivity reactions were mild or moderate in severity and resolved upon treatment.
Danish: Overordnet var størstedelen af overfølsomhedsreaktionerne af let eller moderat sværhedsgrad og forsvandt ved behandling.
English: • a fixed subcutaneous dose of trastuzumab by injection (600 mg) every 3 weeks irrespective of the patient's body weight.
Danish: • En subkutan injektion af trastuzumab i fast dosis (600 mg) uafhængigt af patientens kropsvægt hver 3. uge.
English: In patients receiving a taxane, Perjeta and trastuzumab should be administered prior to the taxane.
Danish: Hos patienter der behandles med taxaner, skal Perjeta og trastuzumab administreres inden taxan.
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosis skal patienten monitoreres tæt for tegn og symptomer på bivirkninger og relevant symptomatisk behandling påbegyndes.
English: In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter.
Danish: I begge behandlingsgrupper var andelen af patienter, der oplevede febril neutropeni, højest i den første behandlingsserie og faldt derefter.
English: Patients were then randomised to receive Perjeta or placebo, in combination with adjuvant trastuzumab and chemotherapy.
Danish: Herefter blev patienterne randomiseret til at få Perjeta eller placebo i kombination med adjuverende trastuzumab og kemoterapi.
English: Investigators selected one of the following anthracyclinebased or non-anthracycline-based chemotherapy regimens for individual patients:
Danish: Investigatorerne valgte én af følgende antracyklin-baserede eller ikke-antracyklin-baserede kemoterapi-regimer til de individuelle patienter:
English: Perjeta will be stored by the health professionals at the hospital or clinic.
Danish: Perjeta opbevares af sundhedspersonalet på hospitalet.
English: However, only limited safety data are available on concurrent use of Perjeta and an anthracycline.
Danish: Der er dog begrænsede sikkerhedsdata vedrørende samtidig brug af Perjeta og antracyklin.
English: It is supplied in a glass vial containing 14 ml concentrate.
Danish: Det fås i hætteglas indeholdende 14 ml koncentrat.
English: The majority of the events were reported in anthracycline-treated patients.
Danish: Størstedelen af hændelserne blev indberettet hos antracyklin-behandlede patienter.
English: A consistent pattern of results was observed regardless of pCR definition.
Danish: Der blev observeret et konsistent mønster for resultaterne uafhængigt af pCR-definitionen.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Infusion reactions occurred in 18.6% - 25.0% of patients on the first day of Perjeta administration (in combination with trastuzumab and chemotherapy).
Danish: Infusionsreaktioner forekom hos 18,6-25,0% af patienterne på den første dag med Perjeta-administration (i kombination med trastuzumab og kemoterapi).
English: On the basis of the scientific conclusions for pertuzumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pertuzumab is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for pertuzumab er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder pertuzumab, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: After completion of chemotherapy, patients received radiotherapy and/or hormone therapy as per local clinical standard.
Danish: Efter gennemført kemoterapi fik patienterne strålebehandling og/eller hormonbehandling, i overensstemmelse med lokal klinisk praksis.