FrancophonIA/ELRC3.0 huggingface dataset:
English: Demographics were well balanced (median age was 49-50 years, the majority were caucasian (71%))
Danish: Demografien var velbalanceret (median-alder 49-50 år, størstedelen var kaukasiere (71%)) og alle patienter var kvinder.
English: IDFS including second primary non-breast cancer
Danish: Invasiv sygdomsfri overlevelse inklusive anden primær kræft (ikke bryst)
English: METHOD OF ADMINISTRATION For intravenous use after dilution
Danish: ADMINISTRATIONSMETODE Til intravenøs anvendelse efter fortynding.
English: Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-drug antibodies (ADA) to Perjeta.
Danish: Patienter i det pivotale studie CLEOPATRA blev på flere tidspunkter testet for anti-terapeutiske antistoffer mod Perjeta.
English: Clinical response represents patients with a best overall response of CR or PR during the neoadjuvant period (in the primary breast lesion).
Danish: Klinisk respons repræsenteret af patienter, hvor bedste samlede respons var komplet respons eller partielt respons i den neoadjuverende behandlingsperiode (i den primære brystlæsion).
English: Nail problems
Danish: • Negleproblemer
English: For full instructions on assay performance and interpretation please refer to the package leaflets of validated HER2 testing assays.
Danish: Den fulde instruktion for udførelse af testen og tolkning af resultaterne findes i vejledningerne til de validerede HER2-test.
English: The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model.
Danish: Pertuzumabs farmakokinetiske resultater fra NEOSPHERE- og APHINITY-studiet var i overensstemmelse med det forventede ud fra den tidligere populationsfarmakokinetiske model.
English: Thereafter in both arms physical function and global health status scores returned to baseline levels during targeted treatment.
Danish: Herefter forbedredes scorer for såvel fysisk funktionsniveau som overordnet helbredsstatus til baseline niveau under forsøgsbehandlingen.
English: Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.
Danish: Indenfor hver frekvenskategori og systemorganklasse er bivirkningerne præsenteret efter faldende alvorlighedsgrad.
English: Tell your doctor straight away, if you get pregnant during treatment with Perjeta or during the 6 months after stopping treatment.
Danish: • Du skal straks kontakte lægen, hvis du bliver gravid under behandlingen med Perjeta eller inden for 6 måneder efter, behandlingen er afsluttet.
English: In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
Danish: I BERENICE var 4,1% (16/392) af patienterne i Perjeta-gruppen positive for anti-terapeutiske antistoffer.
English: Table 2 Summary of ADRs in patients treated with Perjeta in clinical trials^, and in the Postmarketing setting†
Danish: Tabel 2: Resumé af bivirkninger hos patienter behandlet med Perjeta i kliniske forsøg^, samt efter markedsføring†
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: At Caesarean section on GD100, oligohydramnios, decreased relative lung and kidney weights and microscopic evidence of renal hypoplasia consistent with delayed renal development were identified in all pertuzumab dose groups.
Danish: Ved kejsersnit på gestationsdag 100 blev der identificeret oligohydramnios, nedsat relativ lunge- og nyrevægt og mikroskopiverificeret bevis på renal hypoplasi konsistent med forsinket renal udvikling hos alle grupper behandlet med pertuzumab.
English: No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab.
Danish: Der er ikke gennemført specifikke studier med pertuzumab for at vurdere påvirkningen af fertilitet hos dyr.
English: For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package leaflet for these products.
Danish: Hvis du vil vide mere om doseringen af trastuzumab og kemoterapi (som også kan give bivirkninger), kan du læse indlægssedlerne for disse præparater.
English: The pCR rates as well as the magnitude of benefit with Perjeta (Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel) were lower in the subgroup of patients with hormone receptor-positive tumours (difference of 6% in pCR in the breast) than in patients with hormone receptor-negative tumours (difference of 26.4% in pCR in the breast).
Danish: Såvel pCR-raten som størrelsesordenen af fordelen ved Perjeta (Perjeta plus trastuzumab og docetaxel sammenlignet med trastuzumab og docetaxel) var lavere i undergruppen af patienter med hormonreceptor-positive tumorer (forskel på 6% i pCR i brystet) end hos patienter med hormonrecetor-negative tumorer (forskel på 26,4% i pCR i brystet).
English: The majority of cases of symptomatic heart failure reported in the adjuvant setting were in patients who received anthracyclinebased chemotherapy (see section 4.8).
Danish: De fleste tilfælde af symptomatisk hjerteinsufficiens rapporteret blandt patienter, der fik Perjeta som adjuverende behandling, var hos patienter, der fik antracyklin-baseret kemoterapi (se pkt.
English: No relationship between CLcr and pertuzumab exposure was observed over the range of CLcr (27 to 244 ml/min).
Danish: Der blev ikke observeret nogen sammenhæng mellem eksponeringen af pertuzumab og kreatininclearance i intervallet 27 til 244 ml/min.
English: In patients receiving an anthracycline-based regimen, Perjeta and trastuzumab should be administered following completion of the entire anthracycline regimen (see section 4.4).
Danish: Hos patienter i antracyklin-baseret regime, skal Perjeta og trastuzumab administreres efter hele antracyklin-regimet er afsluttet (se pkt.
English: Overall, 2 patients in the placebo-treated group and 4 patients in the Perjeta-treated group experienced events described as anaphylaxis by the investigator (see section
Danish: Ialt oplevede 2 patienter i placebo-gruppen og 4 patienter i Perjeta-gruppen bivirkninger, som af investigatorerne blev beskrevet som anafylaksi (se pkt.
English: After dilution, one ml of solution should contain approximately 3.02 mg of pertuzumab (840 mg/278 ml) for the initial dose where two vials are required and approximately 1.59 mg of pertuzumab (420 mg/264 ml) for the maintenance dose where one vial is required.
Danish: Efter fortynding skal 1 ml infusionsvæske indeholde ca. 3,02 mg pertuzumab (840 mg/278 ml) for initialdosis, hvor to hætteglas er påkrævet og ca. 1,59 mg (420 mg/264 ml) for vedligeholdelsesdosis, hvor et hætteglas er påkrævet.
English: • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
Danish: • Adjuverende behandling af voksne patienter med HER2-positiv tidlig brystkræft med høj risiko for tilbagefald (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Perjeta findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as oestrogen receptor (ER) positive and/or progesterone receptor (PgR) positive) and approximately half of the patients in each treatment group had received prior adjuvant or neoadjuvant therapy.
Danish: Ca. halvdelen af patienterne i hver behandlingsgruppe havde hormonreceptor-positiv sygdom (defineret som østrogenreceptor-positiv og/eller progesteronreceptor-positiv), og ca. halvdelen af patienterne i hver behandlingsgruppe havde tidligere fået adjuverende eller neoadjuverende behandling.
English: Patients treated with Perjeta, trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment (see section 4.8).
Danish: Patienter, behandlet med Perjeta, trastuzumab og docetaxel, har højere risiko for at få febril neutropeni sammenlignet med patienter, behandlet med placebo, trastuzumab og docetaxel, især under de første 3 behandlingsserier (se pkt.
English: A statistically significant improvement in IRF-assessed PFS was demonstrated in the Perjeta-treated group compared with the placebo-treated group.
Danish: En statistisk signifikant forbedring i den progressionsfrie overlevelse, vurderet af den uafhængige komite, blev påvist i Perjeta-gruppen sammenlignet med placebo-gruppen.
English: • APHINITY, in which adjuvant Perjeta was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n=2364)
Danish: • APHINITY, hvor adjuverende Perjeta blev givet i kombination med trastuzumab og antracyklinbaseret eller ikke-antracyklin-baseret, taxan-holdig kemoterapi til patienter med tidlig brystkræft(n=2364)
English: A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
Danish: Et multicenter, åbent, enkeltarms-studie med pertuzumab i kombination med trastuzumab og et taxan i første-linje-behandling af patienter med HER2-positiv avanceret (metastatisk eller lokalt recidiverende) brystkræft.
English: The incidence of symptomatic LVD was also lower in the Perjeta-treated group (1.8% in the placebo-treated group vs. 1.5% in the Perjeta-treated group) (see section 4.4).
Danish: Incidensen af symptomatisk LVD var også lavere i Perjeta-gruppen (1,8% i placebo-gruppen vs.1,5% i Perjeta-gruppen) (se pkt.
English: As in the CLEOPATRA trial, a higher incidence of neutropenia and febrile neutropenia was observed among Asian patients compared with other patients in both neoadjuvant trials.
Danish: Som i CLEOPATRA-studiet var den observerede hyppighed af neutropeni og febril neutropeni højere blandt asiatiske patienter sammenlignet med andre patienter i begge neoadjuverende studier.
English: Swollen ankles or other body parts due to your body retaining too much water Not being able to sleep
Danish: • Hævede ankler eller andre kropsdele på grund af for meget væske i kroppen
English: The European Medicines Agency has waived the obligation to submit the results of studies with Perjeta in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Perjeta i alle undergrupper af den pædiatriske population med brystkræft i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) (se pkt.
English: There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group.
Danish: Der blev observeret et tilfælde af symptomatisk LVD i Perjeta plus trastuzumabgruppen.
English: What you need to know before you are given Perjeta
Danish: Det skal du vide, før du begynder at få Perjeta
English: Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).
Danish: Blandt de asiatiske patienter var forekomsten af febril neutropeni højere i Perjeta-gruppen (25,8%) end i placebo-gruppen (11,3%).
English: The amount of medicine you are given and how long the infusion will last are different for the first dose and following doses.
Danish: • Første gang vil mængden af medicin og længden af infusionen være en anden end de efterfølgende gange.
English: The type and severity of events were consistent with those observed in CLEOPATRA at the cycles when Perjeta was given on the same day as trastuzumab and docetaxel, with the majority of reactions being mild or moderate in severity.
Danish: Type og sværhedsgrad af hændelserne var i overensstemmelse med dem observeret i CLEOPATRA-studiet ved serierne, hvor Perjeta blev givet på den samme dag som trastuzumab og docetaxel.
English: In the neoadjuvant setting, Perjeta should be administered for 3 to 6 cycles in combination with trastuzumab and chemotherapy, as part of a complete treatment regimen for early breast cancer (see section 5.1).
Danish: Som neoadjuverende behandling skal Perjeta administreres i kombination med trastuzumab og kemoterapi i 3 til 6 serier, som led i et komplet behandlingsregime for tidlig brystkræft (se pkt.
English: Cough Epistaxis Dyspnoea
Danish: Hoste Epistaxis Dyspnø
English: In the CLEOPATRA trial in metastatic breast cancer, nadir neutrophil counts were similar in Perjeta-treated and placebo-treated patients.
Danish: I CLEOPATRA-studiet med metastatisk brystkræft var nadirneutrofiltallene ens hos Perjeta-behandlede patienter og placebo-behandlede patienter.
English: Perjeta may elicit severe diarrhoea.
Danish: Perjeta kan fremkalde svær diarré.
English: Hypersensitivity reactions/anaphylaxis
Danish: Overfølsomhedsreaktioner/anafylaksi
English: Patients with metastatic breast cancer
Danish: Patienter med metastatisk brystkræft
English: As in the CLEOPATRA, TRYPHAENA, and NEOSPHERE trials, a higher incidence of febrile neutropenia was observed among Perjeta-treated Asian patients compared with other races in the APHINITY trial (15.9% of Perjeta-treated patients and 9.9% of placebo-treated patients).
Danish: Som i CLEOPATRA-, TRYPHAENA- og NEOSPHEREstudierne blev der i APHINITY-studiet observeret en højere forekomst af febril neutropeni blandt Perjeta-behandlede asiatiske patienter sammenlignet med patienter af anden oprindelse (15,9% af Perjeta-behandlede patienter og 9,9% af placebo-behandlede patienter).
English: Perjeta has not been studied in patients with: a pre-treatment LVEF value of < 50%; a prior history of congestive heart failure (CHF); LVEF declines to < 50% during prior trastuzumab adjuvant therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m2 of doxorubicin or its equivalent.
Danish: Perjeta er ikke undersøgt hos patienter med LVEF-værdier < 50% inden behandling, kongestivt hjerteinsufficiens (CHF) i anamnesen, LVEF-fald til < 50% under tidligere adjuverende behandling med trastuzumab eller tilstande, der kan nedsætte venstre ventrikel funktionen, fx ukontrolleret hypertension, nyligt myokardieinfarkt, alvorlig behandlingskrævende hjertearytmi eller tidligere antracyklin-behandling til kumuleret dosis > 360 mg/m2 doxorubicin eller tilsvarende behandling ækvivalent hermed.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 420 mg/14 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 420 mg/14 ml
English: † Evaluated in patients with Best Overall Response of CR or PR. ^ Objective response rate and duration of response are based on IRF-assessed tumour assessments.
Danish: † Evalueret hos patienter, hvor bedste samlede respons var komplet respons eller partielt respons ^ Objektiv responsrate og varighed af respons er baseret på den uafhængige vurdering af tumor.
English: Reproductive toxicology studies have been conducted in pregnant cynomolgus monkeys (Gestational Day (GD) 19 through to GD 50) at initial doses of 30 to 150 mg/kg followed by bi-weekly doses of 10 to 100 mg/kg.
Danish: Der er gennemført reproduktions-toksikologiske studier med drægtige cynomolgus-aber (fra gestationsdag 19 til og med gestationsdag 50) med initialdoser på 30 til 150 mg/kg efterfulgt af doser på 10 til 100 mg/kg to gange om ugen.
English: Perjeta should be discontinued if symptomatic heart failure is confirmed (see section 4.4 for more details).
Danish: Perjeta bør seponeres, hvis symptomatisk hjerteinsufficiens bekræftes (se pkt.
English: During the second cycle when all medicinal products were administered on the same day, the most common infusion reactions in the Perjeta-treated group (≥ 1.0%) were fatigue, dysgeusia, drug hypersensitivity, myalgia and vomiting (see section 4.4).
Danish: I den anden serie, hvor alle lægemidlerne blev administreret samme dag, var de hyppigste infusionsreaktioner (≥ 1,0%) i Perjeta-gruppen: træthed, smagsforstyrrelser, lægemiddeloverfølsomhed, myalgi og opkastning (se pkt.
English: Tumour lysis syndrome†
Danish: Tumorlyse syndrom†
English: The fixed dose of 600mg trastuzumab SC should be administered as soon as possible.
Danish: Fast dosis af 600 mg trastuzumab subkutan administreres så hurtigt som muligt.
English: HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
Danish: HR = hazard ratio, CI = konfidensinterval, Pla = placebo, Ptz = pertuzumab (Perjeta), T = trastuzumab (Herceptin), D = docetaxel.
English: From the global safety database of the MAH a total of 15 case reports were retrieved inculding MedDRA PTs potentially indicative of an IRR or hypersensitivity/anaphylaxis which were associated with fatal outcome.
Danish: Fra den globale sikkerhedsdatabase tilhørende indehaveren af markedsføringstilladelsen er i alt indhentet 15 sagsrapporter inklusive MedDRA PT's potentielt indikerende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed, hvilket var associeret med dødeligt udfald.
English: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Danish: Perjeta er i kombination med trastuzumab og docetaxel indiceret til voksne patienter med HER2positiv, metastatisk eller lokalt recidiverende, ikke-resecérbar brystkræft og som ikke tidligere har fået anti-HER2-behandling eller kemoterapi for deres metastatiske sygdom.
English: Based on the results of the population pharmacokinetic analysis, pertuzumab exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Danish: Baseret på den populationsfarmakokinetiske analyse var eksponeringen af pertuzumab hos patienter med let nedsat nyrefunktion (kreatininclearance 60-90 ml/min, n = 200) og hos patienter med moderat nedsat nyrefunktion (kreatinclearance 30-60 ml/min, n = 71) sammenlignelig med eksponeringen hos patienter med normal nyrefunktion (kreatininclearance større end 90 ml/min, n = 200).
English: Pertuzumab exposure was reported in offspring from all treated groups, at levels of 29% to 40% of maternal serum levels at
Danish: Pertuzumabeksponering blev rapporteret hos afkommet fra alle behandlede grupper i niveauer fra 29% til 40% af den maternale serumkoncentration på gestationsdag 100.
English: The infusion should be discontinued immediately and permanently if the patient experiences a NCICTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).
Danish: Infusionen bør straks og permanent afbrydes, hvis patienten udvikler en NCI-CTCAE grad 4-reaktion (anafylaksi), bronkospasme eller akut lungesvigt (se pkt.
English: Perjeta is administered intravenously by infusion.
Danish: Perjeta administreres ved intravenøs infusion.
English: When administered with Perjeta, docetaxel can be started at 75 mg/m2, and subsequently escalated to 100 mg/m2 depending on the chosen regimen and tolerability of the initial dose.
Danish: Ved administration sammen med Perjeta, kan dosis af docetaxel startes på 75 mg/m2 og efterfølgende optrappes til 100 mg/m2 afhængig af det valgte regime og tolerabilitet af den initiale dosis.
English: Standard doses of 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamide, docetaxel, paclitaxel and carboplatin were administered.
Danish: Der blev givet standarddoser af 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamid, docetaxel, paclitaxel og carboplatin.
English: ° Hypersensitivity/anaphylactic reaction is based on a group of terms.
Danish: º Overfølsomhed/anafylaktisk reaktion består af en række bivirkninger inden for samme kategori.
English: Patients were randomised to receive one of three neoadjuvant regimens prior to surgery as follows:
Danish: Patienterne blev randomiseret til at få én af tre følgende neoadjuverende behandlingsregimer inden operation:
English: Tell a doctor or nurse straight away, if you notice any of the side effects above.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du oplever en eller flere af ovenstående bivirkninger.
English: After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6).
Danish: Efter fortynding indeholder 1 ml infusionsvæske ca. 3,02 mg pertuzumab for den initiale dosis og ca. 1,59 mg pertuzumab for vedligeholdelsesdosis (se pkt.
English: In the APHINITY trial, febrile neutropenia occurred in 12.1% of Perjeta-treated patients and 11.1% of placebo-treated patients.
Danish: I APHINITY-studiet forekom febril neutropeni hos 12,1% af de Perjeta-behandlede patienter og hos 11,1% af de placebo-behandlede patienter.
English: In TRYPHAENA, the incidence of febrile neutropenia was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given.
Danish: I TRYPHAENA var hyppigheden af febril neutropeni højere hos patienter, som fik 6 serier Perjeta sammenlignet med patienter, der fik 3 serier Perjeta uafhængig af, hvilken kemoterapi, der var givet.
English: Infusion reactions with symptoms that can either be mild or more severe and may include feeling sick (nausea), fever, chills, feeling tired, headache, loss of appetite, joint and muscle pains, and hot flushes.
Danish: • Infusionsreaktioner med symptomer, som enten kan være lette eller svære og kan inkludere kvalme, feber, kulderystelser, træthed, hovedpine, appetitløshed, led- og muskelsmerter og hedeture.
English: Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Danish: Der kan opstå allergiske og anafylaktiske (mere alvorlige allergiske) reaktioner, når du får infusionen.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively).
Danish: I det pivotale studie CLEOPATRA med metastatisk brystkræft var incidensen af LVD under studiebehandling højere i placebo-gruppen end i Perjeta-gruppen (henholdsvis 8,6% og 6,6%).
English: No adverse reactions were observed in sexually mature female cynomolgus monkeys exposed to pertuzumab (see section 5.3).
Danish: Der blev ikke observeret nogen bivirkninger hos seksuelt kønsmodne hun-cynomolgus aber, der havde fået pertuzumab (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter fortynding Må ikke rystes
English: In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Danish: Derudover medierer pertuzumab antistofafhængig cellemedieret cytotoksicitet.
English: Grade ≥ 3 diarrhoea was reported in 9.8% of patients in the Perjeta arm vs. 3.7% in the placebo arm.
Danish: Der blev rapporteret diarré grad ≥ 3 hos 9,8% af patienterne i Perjeta-armen vs. 3,7% i placebo-armen.