FrancophonIA/ELRC3.0 huggingface dataset:
English: ** Final analysis of overall survival, cutoff date 11
Danish: ** Endelig analyse af samlet overlevelse, cut-off den 11. februar 2014.
English: Overall 6% of patients had inflammatory breast cancer, 25% had locally advanced breast cancer and 69% had operable breast cancer.
Danish: Samlet set havde 6% af patienterne inflammatorisk brystkræft, 25% havde lokalt avanceret brystkræft, og 69% havde operabel brystkræft.
English: 3-year event-free rate derived from Kaplan-Meier estimates.
Danish: Antal patienter unden hændelse efter tre år er udledt fra Kaplan-Meier-estimater.
English: The safety of Perjeta has been evaluated in more than 6,000 patients in Phase I, II, and III trials in patients with various malignancies and predominantly treated with Perjeta in combination with other antineoplastic agents.
Danish: Perjetas sikkerhed er vurderet hos flere end 6000 patienter i fase I-, II- og III-studier hos patienter med forskellige former for malign sygdom og hovedsageligt behandlet med Perjeta i kombination med andre antineoplastiske midler.
English: For all following infusions, if the first infusion was well tolerated:
Danish: Ved de efterfølgende infusioner vil du, hvis du godt kunne tåle den første infusion,
English: Perjeta is for single use only.
Danish: Perjeta er beregnet til engangsbrug.
English: For docetaxel and other chemotherapy dose modifications, see relevant SmPC.
Danish: For dosisjustering af docetaxel og anden kemoterapi, se det relevante produktresumé.
English: If particulates or discoloration are observed, the solution should not be used.
Danish: Hvis der observeres partikler eller misfarvning, må infusionsvæsken ikke anvendes.
English: The primary endpoint of the study was pathological complete response (pCR) rate in the breast (ypT0/is).
Danish: Studiets primære endepunkt var patologisk komplet respons rate (pCR-rate) i brystet (ypT0/is).
English: Overall 7% of patients had inflammatory breast cancer, 32% had locally advanced breast cancer and 61% had operable breast cancer.
Danish: Samlet set havde 7% af patienterne inflammatorisk brystkræft, 32% havde lokalt avanceret brystkræft, og 61% havde operable brystkræft.
English: If you have inflammation of the digestive tract (e.g.sore mouth or diarrhoea) you may be more likely to develop this side effect.
Danish: Hvis du har inflammation (en betændelseslignende tilstand) i fordøjelseskanalen (fx mundbetændelse eller diarré), vil du måske have større risiko for at udvikle denne bivirkning.
English: pCR rates were similar in patients with operable and locally advanced disease.
Danish: pCR-raterne var sammenlignelige hos patienter med operabel og lokalt avanceret sygdom.
English: Following surgery all patients received trastuzumab to complete one year of therapy.
Danish: Efter operation fik alle patienter trastuzumab for at fuldføre 1 års behandling.
English: As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).
Danish: Som resultat heraf hæmmer pertuzumabligand-initierede intracellullære signalprocesser gennem to vigtige signalveje, mitogen-aktiveret protein-kinase og fosfoinositid 3-kinase.
English: The safety and efficacy of Perjeta in children and adolescents below 18 years of age have not been established.
Danish: Perjetas sikkerhed og virkning er ikke undersøgt hos børn og unge < 18 år.
English: Adjuvant Treatment
Danish: Adjuverende behandling
English: The population PK analysis suggested no PK differences based on age, gender and ethnicity (Japanese versus non-Japanese).
Danish: Den populationsfarmakokinetiske analyse tydede ikke på forskelle i farmakokinetikken på baggrund af alder, køn eller etnicitet (japanske patienter vs. ikke-japanske).
English: • CLEOPATRA, in which Perjeta was given in combination with docetaxel and trastuzumab to patients with metastatic breast cancer (n=453)
Danish: • CLEOPATRA, hvor Perjeta blev givet i kombination med docetaxel og trastuzumab til patienter med metastatisk brystkræft (n=453)
English: Patients with metastases, bilateral breast cancer, clinically important cardiac risk factors
Danish: Patienter med metastaser, bilateral brystkræft, klinisk signifikante kardielle risikofaktorer (se pkt.
English: The pCR rates were lower in the subgroup of patients with hormone receptor positive tumours (range 46.2% to 50.0%) than in patients with hormone receptor-negative tumours (range 65.0% to 83.8%).
Danish: pCR-raten var lavere i subgruppen af patienter med hormonreceptor-positive tumorer (interval 46,2% til 50,0%) end hos patienter med hormonreceptor-negative tumorer (interval 65,0% til 83,8%).
English: If a carboplatin-based regimen is used, the recommended dose for docetaxel is 75 mg/m2 throughout (no dose escalation).
Danish: Hvis et carboplatin-baseret regime anvendes, er den anbefalede dosis af docetaxel 75 mg/m2 gennem hele forløbet (ingen optrapning af dosis).
English: Talk to your doctor or nurse before you are given Perjeta: If you have ever had heart problems (such as heart failure, treatment for serious irregular heartbeats, uncontrolled high blood pressure, recent heart attack), your heart function will be checked before and during treatment with Perjeta and your doctor will run tests to check if your heart is working properly.
Danish: • Hvis du nogensinde har haft hjerteproblemer (som for eksempel hjertesvigt, behandlingskrævende meget uregelmæssig hjerterytme, ukontrolleret forhøjet blodtryk, nyligt hjertetilfælde), vil din hjertefunktion derfor blive kontrolleret før og under behandlingen med Perjeta, og din læge vil lave undersøgelser for at kontrollere, om dit hjerte virker, som det skal.
English: The infusion rate may be slowed or interrupted if the patient develops an infusion reaction (see section 4.8).
Danish: Infusionshastigheden kan reduceres eller infusionen afbrydes, hvis patienten udvikler en infusionsreaktion (se pkt.
English: Table 2 summarizes the ADRs from the Perjeta-treated groups of the following pivotal clinical trials:
Danish: I tabel 2 opsummeres bivirkninger fra de Perjeta-behandlede grupper i følgende pivotale kliniske studier:
English: If you experience any of the above symptoms after treatment with Perjeta has been stopped, you should consult your doctor immediately and inform him or her that you have previously been treated with Perjeta.
Danish: Hvis du oplever en eller flere af ovennævnte bivirkninger, efter behandlingen med Perjeta er stoppet, skal du straks kontakte lægen og fortælle, at du tidligere har været i behandling med Perjeta.
English: The 420 mg dose of pertuzumab should be administered as soon as possible.
Danish: Dosis på 420 mg pertuzumab administreres så hurtigt som muligt.
English: Patients with clinically important cardiac risk factors were not included (see section 4.4).
Danish: Patienter med klinisk signifikante kardiale risikofaktorer blev ikke inkluderet (se pkt.
English: Inflammation of the nail bed where the nail and skin meet Condition in which the left ventricle of the heart is functionally impaired with or without symptoms
Danish: • Betændelse i neglevolden, der hvor negl og hud mødes • Tilstand, hvor det venstre hjertekammers funktion er nedsat, med eller uden symptomer
English: The majority of rash events were Grade 1 or 2.
Danish: Størstedelen af hændelserne var af grad 1 eller 2.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: Perjeta and trastuzumab may be resumed if the LVEF has recovered to > 45%, or to 40-45% associated with a difference of < 10% points below pre-treatment values.
Danish: Behandling med Perjeta og trastuzumab kan genoptages, hvis LVEF stiger til > 45% eller til 40-45% i forbindelse med en forskel på < 10% point under værdierne inden behandling.
English: Patients considered suitable for neoadjuvant treatment with trastuzumab plus anthracycline/taxane-based chemotherapy were allocated to receive one of the two following regimens prior to surgery as follows:
Danish: Patienter, som ansås for at egne sig til neoadjuverende behandling med trastuzumab plus antracyklin/taxan-baseret kemoterapi blev tildelt et af de to følgende regimer før operation:
English: If you get any serious reaction, your doctor may stop treatment with Perjeta.
Danish: Hvis du får en alvorlig bivirkning, kan lægen vælge at stoppe behandling med Perjeta.
English: The efficacy results are presented in Table 4.
Danish: Effektresultaterne er vist i tabel 4.
English: Perjeta and trastuzumab should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure.
Danish: Behandling med Perjeta og trastuzumab bør afbrydes i mindst 3 uger ved symptomer, der tyder på kongestiv hjerteinsufficiens.
English: Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet
Danish: Symptomer kan inkludere nyreproblemer (svaghed, åndenød, træthed og forvirring), hjerteproblemer (flakkende hjerte med et hurtigere eller langsommere hjerteslag), anfald, opkastning eller diarré og snurren i mund, hænder eller fødder.
English: • 6 cycles of docetaxel in combination with carboplatin
Danish: • 6 serier af docetaxel i kombination med carboplatin
English: Women of childbearing potential should use effective contraception while receiving Perjeta and for 6 months following the last dose of pertuzumab.
Danish: Kvinder i den fertile alder skal bruge sikker prævention, mens de er i behandling med Perjeta og i 6 måneder efter den sidste dosis af pertuzumab.
English: See section 4 “Serious side effects” for more details about signs of heart problems to look out for.
Danish: Se punkt 4 ”Alvorlige bivirkninger” for yderligere information om, hvad du skal holde øje med.
English: Due to the exclusion of patients with brain metastases no data are available on Perjeta activity on brain metastases.
Danish: Da patienter med hjernemetastaser blev udelukket fra studiet, er der ingen data for Perjetas aktivitet på hjernemetastaser.
English: Data available for Infusion Related Reactions (IRR) and anaphylaxis/hypersensitivity with fatal outcome for patients treated with Perjeta in clinical trials, data from published literature, and relevant data from the Roche global safety database showed that there were no cases of confirmed IRRs or anaphylaxis/hypersensitivity with a fatal outcome in pivotal clinical trials in patients treated with pertuzumab.
Danish: Data tilgængelig vedrørende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed med dødeligt udfald for patienter behandlet med Perjeta i kliniske studier, publicerede data og relevante data fra Roche's globale sikkerhedsdatabase viste ingen bekræftede sager vedrørende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed med dødeligt udfald i de afsluttende kliniske studier hos patienter behandlet med pertuzumab.
English: In the adjuvant setting, Perjeta should be administered in combination with trastuzumab for a total of one year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first) as part of a complete regimen for early breast cancer and regardless of the timing of surgery.
Danish: Som adjuverende behandling skal Perjeta administreres i kombination med trastuzumab i ialt ét år (op til 18 serier eller indtil sygdomsrecidiv eller uacceptabel toksicitet, afhængigt af hvad der opstår først), som led i et komplet behandlingsregime for tidlig brystkræft og uanset operationstidspunkt.
English: Intravenous administration of pertuzumab from GD19 through GD50 (period of organogenesis) was embryotoxic, with dose-dependent increases in embryo-foetal death between GD25 to GD70.
Danish: Intravenøs administration af pertuzumab fra gestationsdag 19 til og med gestationsdag 50 (perioden for organogenese) var embryotoksisk med en dosisafhængig stigning i embryoføtale dødsfald mellem gestationsdag 25 og 70.
English: Lacrimation increased
Danish: Øget tåresekretion
English: Treatment Perjeta+Trastuzumab+Docetaxel and Perjeta+Trastuzumab are compared to Trastuzumab+ Docetaxel while Perjeta+Docetaxel is compared to Perjeta+Trastuzumab+Docetaxel.
Danish: Behandling med Perjeta + trastuzumab + docetaxel og Perjeta + trastuzumab er sammenlignet med trastuzumab + docetaxel, mens Perjeta + docetaxel er sammenlignet med Perjeta + trastuzumab + docetaxel.
English: Secondary efficacy endpoints were overall survival (OS), PFS (investigator-assessed), objective response rate (ORR), duration of response, and time to symptom progression according to the FACT B Quality of Life questionnaire.
Danish: Sekundære virkningsendepunkter var samlet overlevelse, progressionsfri overlevelse (vurderet af investigator), objektiv responsrate, varighed af respons samt tid til symptomprogression vurderet i henhold til FACT B spørgeskemaet om livskvalitet.
English: HER2 overexpression was determined at a central laboratory and defined as a score of 3+ by IHC or an ISH amplification ratio ≥2.0 in the trials outlined below.
Danish: HER2-overekspression blev bestemt på centralt laboratorium og defineret som en score på 3+ ved IHC- eller ISH-amplifikationsratio ≥ 2,0 i nedenfor beskrevne studier.
English: In addition, consistent with foetal growth restrictions, secondary to oligohydramnios, lung hypoplasia (1 of 6 in 30 mg/kg and 1 of 2 in100 mg/kg groups), ventricular septal defects (1 of 6 in 30 mg/kg group), thin ventricular wall (1 of 2 in 100 mg/kg group) and minor skeletal defects (external - 3 of 6 in 30 mg/kg group) were also noted.
Danish: I overensstemmelse med reduktion i føtal vækst blev der yderligere, sekundært til oligohydramnios, også noteret lungehypoplasi (1 af 6 i 30 mg/kg og 1 af 2 i 100 mg/kg gruppen), ventrikel-septum-defekt (1 af 6 i 30 mg/kg gruppen), tynd ventrikelvæg (1 af 2 i 100 mg/kg gruppen) og mindre skeletale misdannelser (eksterne - 3 af 6 i 30 mg/kg gruppen).
English: No dose adjustment is necessary in the elderly population ≥ 65 years of age.
Danish: Dosisjustering er ikke nødvendig hos patienter ≥ 65 år.
English: Most events were mild to moderate in severity and occurred in the first few cycles of treatment.
Danish: De fleste tilfælde var lette til moderate i sværhedsgrad og forekom i de første få behandlingsserier.
English: Diarrhoeal events responded well to proactive management with anti-diarrhoeal agents.
Danish: Der var god respons på proaktiv behandling med midler mod diarré.
English: • NEOSPHERE (n=309) and TRYPHAENA (n=218), in which neoadjuvant Perjeta was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory, or early breast cancer
Danish: • NEOSPHERE (n=309) og TRYPHAENA (n=218), hvor neoadjuverende Perjeta blev givet i kombination med trastuzumab og kemoterapi til patienter med med lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft.
English: 95% CI for one sample binomial using Pearson-Clopper method.
Danish: 95% konfidensinterval for binomial fordeling for en prøve (one sample binomial) beregnet efter PearsonClopper-metoden.
English: In the adjuvant setting, based on data from the APHINITY study, HER2-positive early breast cancer patients at high risk of recurrence are defined as those with lymph node-positive or hormone receptornegative disease.
Danish: I den adjuverende behandling, baseret på data fra APHINITY-studiet, er patienter med HER2-positiv tidlig brystkræft med høj risiko for tilbagefald defineret som dem med lymfeknude-positiv eller hormonreceptor-negativ sygdom.
English: No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer.
Danish: Der er ikke set nogen farmakokinetiske interaktioner mellem pertuzumab og trastuzumab eller mellem pertuzumab og docetaxel i et sub-studie med 37 patienter i det randomiserede pivotale studie CLEOPATRA med metastatisk brystkræft.
English: The incidence of symptomatic left ventricular systolic dysfunction (LVD) [congestive heart failure] was higher in patients treated with Perjeta in combination with trastuzumab and chemotherapy compared with trastuzumab and chemotherapy .
Danish: Forekomst af symptomatisk systolisk dysfunktion af venstre ventrikel (LVD [kongestiv hjerteinsufficiens]) var højere blandt patienter behandlet med Perjeta i kombination med trastuzumab og kemoterapi sammenlignet med trastuzumab og kemoterapi.
English: When administered with Perjeta in the adjuvant setting, the recommended dose of paclitaxel is 80 mg/m2 once weekly for 12 weekly cycles.
Danish: Ved administration sammen med Perjeta som adjuverende behandling, er den anbefalede dosis af paclitaxel 80 mg/m2 en gang om ugen i 12 ugentlige serier.
English: The diarrhoea was managed (with the exception of euthanasia of one animal, 50 mg/kg/dose) with supportive care including intravenous fluid replacement therapy.
Danish: Diarréen blev behandlet (med undtagelse af aflivning i et tilfælde, 50 mg/kg/dosis) med støttende behandling inklusive intravenøs væskesubstitution.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan påvirke flere end 1 ud af 10 patienter):
English: Alternatively, docetaxel can be given at 100 mg/m2 on a 3 weekly schedule from the start, again depending on the chosen regimen.
Danish: Alternativt, kan en dosis af docetaxel på 100 mg/m2 gives i en 3-ugers serie fra starten af, igen afhængig af det valgte regime.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS-ETIKET
English: Perjeta in combination with trastuzumab and docetaxel CLEOPATRA (WO20698) is a multicentre, randomised, double-blind, placebo-controlled phase III clinical trial conducted in 808 patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
Danish: Perjeta i kombination med trastuzumab og docetaxel CLEOPATRA (WO20698) er et multicenter, randomiseret, dobbeltblindet, placebo-kontrolleret, klinisk fase III-studie med 808 patienter med HER2-positiv, metastatisk eller lokalt recidiverende, ikke-resecerbar brystkræft.
English: pCR rates were similar in patients with operable versus locally advanced disease.
Danish: pCR-raterne var sammenlignelige mellem patienter med operabel versus lokalt avanceret sygdom.
English: • a drop in LVEF to less than 50% associated with a fall of ≥ 10% points below pre-treatment values.
Danish: • LVEF falder til mindre end 50% i forbindelse med et fald på ≥ 10% point i forhold til værdierne inden behandling.
English: The efficacy of Perjeta in HER2-positive breast cancer is supported by a randomised phase III trial and a single-arm phase II trial in metastatic breast cancer, two randomised neoadjuvant phase II trials in early breast cancer (one controlled), a non-randomised neoadjuvant phase II trial, and a randomised phase III trial in the adjuvant setting.
Danish: Perjetas virkning ved HER2-positiv brystkræft understøttes af et randomiseret fase III-studie og et enkeltarmet fase II-studie med metastatisk brystkræft, to randomiserede neoadjuverende fase II-studier med tidlig brystkræft (ét kontrolleret), et ikke-randomiseret neoadjuverende fase II-studie samt et adjuverende randomiseret fase III-studie.
English: Sequential use of Perjeta (in combination with trastuzumab and a taxane) has been evaluated following the epirubicin or doxorubicin component of many anthracycline-based regimens in the APHINITY and BERENICE studies.
Danish: Sekventielt brug af Perjeta (i kombination med trastuzumab og et taxan) er i APHINITY- og i BERENICE-studiet undersøgt efter administration af epirubicin- eller doxorubicin-komponenten i flere antracyklin-baserede regimer.
English: Patients were randomised 1:1 to receive placebo + trastuzumab + docetaxel or Perjeta + trastuzumab + docetaxel.
Danish: Patienterne blev randomiseret i forholdet 1:1 til placebo + trastuzumab + docetaxel eller Perjeta + trastuzumab + docetaxel.
English: The incidences of embryo-foetal loss were 33, 50, and 85% for pregnant female monkeys treated with bi-weekly pertuzumab doses of 10, 30, and 100 mg/kg, respectively (2.5 to 20-fold greater than the recommended human dose, based on Cmax).
Danish: Forekomsten af embryoføtalt tab var 33, 50 og 85% for drægtige hun-aber behandlet med doser på henholdsvis 10, 30 og 100 mg/kg pertuzumab to gange om ugen (2,5 til 20 gange større end de anbefalede humane doser baseret på Cmax).
English: The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment.
Danish: Perjetas sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion.
English: A statistically significant improvement in pCR rate (ypT0/is) was observed in patients receiving Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel (45.8% vs 29.0%, p value = 0.0141).
Danish: Der blev observeret en statistisk signifikant forbedring i pCR-raten (ypT0/is) hos patienter, der fik Perjeta plus trastuzumab og docetaxel sammenlignet med patienter, der fik trastuzumab og docetaxel (45,8% vs. 29,0%, p = 0,0141).
English: The cancer has spread to other parts of the body such as the lungs or liver (metastasised) and has not previously been treated with anticancer medicines (chemotherapy) or other medicines designed to attach to HER2, or else the cancer has come back in the breast after previous treatment.
Danish: • Kræften har spredt sig til andre dele af kroppen, for eksempel lungerne eller leveren (dannet metastaser) og ikke tidligere er behandlet med kræftmedicin (kemoterapi) eller anden medicin designet til at binde sig til HER2, eller hvis kræften er kommet tilbage til brystet efter tidligere behandling.
English: 3.3% (13/389 patients) of Perjeta-treated patients and 6.7% (25/372 patients) of placebo-treated patients tested positive for ADA.
Danish: 3,3% (13/389 patienter) i Perjeta-gruppen og 6,7% (25/372 patienter) i placebo-gruppen var positive for anti-terapeutiske antistoffer.
English: However, if you get any infusion reactions, allergic or anaphylactic reactions, wait until these have gone away before driving or using machines.
Danish: Hvis du får en infusionsreaktion, en allergisk eller anafylaktisk reaktion, skal du vente med at køre bil og betjene maskiner, indtil den er forsvundet.
English: The safety of Perjeta was generally consistent across studies, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether Perjeta was administered as monotherapy or with concomitant anti-neoplastic agents.
Danish: Perjetas sikkerhed var generelt konsistent på tværs af studier, dog varierede hyppighed og de mest almindelige bivirkninger afhængigt af, om Perjeta blev administreret som monoterapi eller i kombination med antineoplastiske midler.
English: You will be given 420 mg of Perjeta over 30 to 60 minutes.
Danish: • Få 420 mg Perjeta i løbet af 30 til 60 minutter.
English: The median duration of the longest episode was 18 days in Perjeta-treated patients and 8 days in placebotreated patients.
Danish: Den gennemsnitlige varighed af den længste episode var 18 dage i Perjeta-gruppen og 8 dage i placebo-gruppen.
English: The efficacy results from the CLEOPATRA study are summarised in Table 3.
Danish: Effektresultaterne fra CLEOPATRA-studiet er vist i tabel 3.
English: Allergic and anaphylactic (more severe allergic) reactions with symptoms that may include swelling of your face and throat, with difficulty in breathing.
Danish: • Allergiske og anafylaktiske (mere alvorlige allergiske) reaktioner med symptomer, som kan inkludere hævelser i ansigtet og svælget, der gør det svært at trække vejret.
English: Sore throat, red, sore or runny nose, flu-like symptoms and fever Producing more tears
Danish: • Ondt i halsen, rød, øm eller løbende næse, influenza lignende symptomer og feber