FrancophonIA/ELRC3.0 huggingface dataset:
English: In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Danish: I TRYPHAENA-studiet forekom udslæt hos 36,8% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 20,0% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid.
English: Perjeta+ Trastuzuma b+ Docetaxel N=107
Danish: Perjeta + trastuzumab + docetaxel N=107
English: p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI] Overall Survival (OS)3
Danish: Invasiv sygdomsfri overlevelse Antal (%) patienter med hændelse Hazard ratio [95% konfidensinterval] p-værdi (Log-Rank-test, stratificeret1) Antal patienter uden hændelse efter tre år3 [95% konfidensinterval]
English: Due date
Danish: Figur 2
English: No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Danish: Ud fra et toksicitetsstudie med gentagen dosering hos cynomolgus-aber kan der ikke drages en endelig konklusion om påvirkningen af hanners reproduktionssystem.
English: Cytokine release syndrome°°
Danish: Anafylaktisk reaktionº, * Cytokinfrigivelsessyndromºº
English: 96.2% versus 96.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Danish: 91,2% efter 3 år og 91,0% vs. 88,7% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
English: What is in this leaflet:
Danish: Perjeta indeholder:
English: Difference in ORR:
Danish: Forskel i objektiv responsrate:
English: Secondary efficacy endpoints were clinical response rate, breast conserving surgery rate (T2-3 tumours only), disease-free survival (DFS), and PFS. Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
Danish: Sekundære virkningsendepunkter var klinisk respons rate, brystbevarende operationsrate (kun T2-3 tumorer), sygdomsfri overlevelse og progressionsfri overlevelse.
English: In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvant Perjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia,
Danish: I NEOSPHERE-studiet var hyppigheden af NCI-CTCAE (version 3) grad 3-4 neutropeni 74,5% hos patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel sammenlignet med 84,5% af patienter behandlet med trastuzumab og docetaxel inklusive henholdsvis 50,9% og 60,2% grad 4 neutropeni.I TRYPHAENA-studiet var hyppigheden af NCI-CTCAE (version 3) grad 3-4 neutropeni 85,3% hos patienter behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og 77,0% hos patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid, inklusive henholdsvis 66,7% og 59,5% grad 4 neutropeni.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Alopeci Udslæt
English: p-value (Log-Rank test, stratified1) 3 year event-free rate3 [95% CI] Secondary Endpoints1
Danish: Hazard ratio [95% konfidensinterval] p-værdi (Log-Rank-test, stratificeret1)
English: Infections and infestations Nasopharyngitis
Danish: Infektioner og parasitære sygdomme
English: Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer cells.
Danish: Perjeta tilhører en gruppe lægemidler, der kaldes monoklonale antistoffer.
English: Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly
Danish: • Feber forbundet med faretruende lave niveauer af hvide blodlegemer (neutrofilocytter)
English: Hepatic impairment
Danish: Opkastning Stomatitis Kvalme
English: Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.
Danish: Sekundære effektendepunkter var pCR-rate i brystet (ypT0/is), sygdomsfri overlevelse, progressionsfri overlevelse og samlet overlevelse.
English: Trastuzum ab +Docetaxel N=107
Danish: Trastuzumab + docetaxel N=107
English: Ask your doctor or nurse to give you information about these other medicines.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: (ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by Perjeta plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC
Danish: Hyppigheden af asymptomatisk LVD (ejektionsfraktionfald ifølge NCI-CTCAE version 4) var 7% i gruppen behandlet med kemoterapi (doxorubicin og cyclophosphamid) med kortere intervaller (dose-dense) efterfulgt af Perjeta plus trastuzumab og paclitaxel, og 3,5% i gruppen behandlet med 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel.
English: Hot flush
Danish: Tør hud
English: • 3 cycles of FEC followed by 3 cycles of docetaxel, all given concurrently with Perjeta and trastuzumab
Danish: • 3 serier bestående af 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af 3 serier docetaxel, alle givet sideløbende med Perjeta og trastuzumab
English: As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets.
Danish: Du kan finde information om disse lægemidler i de tilhørende indlægssedler.
English: The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD
Danish: Hyppigheden af symptomatisk LVD (kongestiv hjerteinsufficiens) var 1,3% i gruppen behandlet med Perjeta plus trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid (det er set bort fra en patient, som oplevede symptomatisk LVD under behandling med 5-fluoruracil, epirubicin og cyclophosphamid inden Perjeta plus trastuzumab og docetaxel blev givet) og ligeledes 1,3% i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab.
English: Dysgeusia
Danish: Nasopharyngitis
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Danish: Perjeta er et koncentrat til infusionsvæske, opløsning.
English: Perjeta+ Trastuzumab+ FEC Perjeta+ Trastuzumab
Danish: Perjeta + tras tuzumab + FEC Perjeta + tras tuzumab + docetaxel N=73
English: For details regarding trastuzumab, please refer to the summary of product characteristics (SmPC).
Danish: Der henvises til produktresumé for trastuzumab for yderligere oplysninger om dette produkt.
English: SC
Danish: (vs.
English: Paraesthesia
Danish: • Forstoppelse
English: In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta,
Danish: I det neoadjuverende studie TRYPHAENA var hyppigheden af LVD (i den samlede behandlingsperiode) 8,3% i gruppen behandlet med Perjeta plus trastuzumab og 5-fluoruracil,
English: On 8 March 2010, Mylan S.A.S.
Danish: Den 8. marts 2010 meddelte Mylan S.A.S.
English: It was to be used on its own or with other anticancer medicines.
Danish: Det skulle anvendes alene eller i kombination med andre lægemidler mod kræft.
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP har vurderet den oprindelige dokumentation fremlagt af virksomheden og opstillet en liste med spørgsmål.
English: The company had not yet responded to the questions at the time of the withdrawal.
Danish: Virksomheden havde endnu ikke besvaret spørgsmålene på tidspunktet for tilbagetrækningen af ansøgningen.
English: The company provided data on docetaxel from the published literature.
Danish: Virksomheden har fremlagt data om docetaxel fra den offentliggjorte litteratur.
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Danish: Når celleskelettet hele tiden er intakt, kan cellerne ikke dele sig og vil til sidst dø.
English: Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection.
Danish: Andre stoffer blev føjet til docetaxel for at hjælpe det med at danne små kugleformede strukturer kaldet 'miceller', som er egnet til injektion.
English: This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Danish: Det betyder, at det var hensigten, at Docetaxel Mylan skulle være identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Taxotere.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Danish: Docetaxel påvirker også andre celler end kræftcellerne, f.eks. blodcellerne, hvilket kan medføre bivirkninger.
English: Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety.
Danish: Derfor og på grund af micellernes komplekse karakter besluttede udvalget, at det var nødvendigt at foretage yderligere undersøgelser af Docetaxel Mylan, herunder blandt andet undersøgelser af, hvordan kroppen ville reagere på lægemidlet, og af dets sikkerhed.
English: However, the substances added in Docetaxel Mylan and Taxotere to form the micelles are not the same.
Danish: De stoffer, der blev føjet til Docetaxel Mylan og Taxotere for at danne miceller, er dog ikke de samme.
English: Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules.
Danish: Da Docetaxel Mylan indeholder det samme aktive stof som Taxotere og skulle indgives direkte i en vene, anså virksomheden, at det i overensstemmelse med bestemmelserne i EU ikke var nødvendigt med yderligere undersøgelser af Docetaxel Mylan.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Docetaxel Mylan ikke kunne være blevet godkendt.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Docetaxel Mylan, som er beregnet til behandling af brystkræft, ikke-småcellet lungekræft, prostatakræft, kirtelkræft i maven og kræft i hoved- og halsregionen.
English: What is Docetaxel Mylan?
Danish: Hvad er Docetaxel Mylan?
English: It was to be available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Danish: Det fås som et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Docetaxel Mylan is a medicine that contains the active substance docetaxel.
Danish: Docetaxel Mylan er et lægemiddel, der indeholder det aktive stof docetaxel.
English: Docetaxel Mylan was developed as a ‘generic medicine'.
Danish: Docetaxel Mylan blev udviklet som et generisk lægemiddel.
English: The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Mylan, docetaxel, tilhører en gruppe kræftlægemidler, der kaldes taxaner.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Danish: Docetaxel blokerer cellens evne til at nedbryde det indvendige celleskelet, der gør det muligt for cellerne at dele og formere sig.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Mylan.
Danish: CHMP var derfor af den opfattelse, at virksomheden på tidspunktet for tilbagetrækningen ikke havde forelagt tilstrækkelig dokumentation til at understøtte brugen af Docetaxel Mylan.
English: Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer.
Danish: Docetaxel Mylan forventedes anvendt til behandling af brystkræft, ikke-småcellet lungekræft, prostatakræft, kirtelkræft i maven og kræft i hoved- og halsregionen.
English: What was Docetaxel Mylan expected to be used for?
Danish: Hvad forventedes Docetaxel Mylan anvendt til?
English: How is Docetaxel Mylan expected to work?
Danish: Hvordan forventes Docetaxel Mylan at virke?
English: The application was withdrawn at ‘day 120'.
Danish: Ansøgningsproceduren var ved dag 180, da virksomheden trak sin ansøgning tilbage..
English: The full European Public Assessment Report for Javlor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Javlor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Danish: Virksomheden kan anmode om, at udtalelsen tages op til fornyet overvejelse inden for 15 dage efter modtagelsen af underretningen om denne negative udtalelse.
English: What is Javlor?
Danish: Hvad er Javlor?
English: Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Danish: Javlor er et lægemiddel mod kræft, som har været godkendt i EU siden september 2009.
English: The company that applied for the change to the authorisation is Pierre Fabre Médicament.
Danish: Den virksomhed, som ansøgte om ændringen, er Pierre Fabre Médicament.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 September 2014
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Although there was an improvement in progression-free survival, this was considered to be small.
Danish: Der var bedring i den progressionsfrie overlevelse, men bedringen blev anset for at være lille.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Javlor og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival (how long patients lived).
Danish: Desuden var der ingen fordel bedømt på andre vigtige mål for virkningen, herunder den totale overlevelse (hvor længe patienterne levede).
English: What was Javlor expected to be used for?
Danish: Hvad forventedes Javlor anvendt til?
English: There are no consequences on the use of Javlor in its authorised indication.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Javlor til den godkendte indikation.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Danish: At kræften er metastatisk vil sige, at den har bredt sig til andre dele af kroppen.
English: Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Danish: Afslag på ansøgningen om ændring af markedsføringstilladelsen for Javlor (vinflunin) EMA/587197/2014
English: How is Javlor expected to work?
Danish: Hvordan forventes Javlor at virke?
English: Refusal of a change to the marketing authorisation for Javlor (vinflunine)
Danish: Afslag på ansøgningen om ændring af markedsføringstilladelsen for Javlor (vinflunin)
English: The change concerned an extension of indication to add treatment of breast cancer.
Danish: Ændringen vedrørte udvidelse af anvendelsen til også at omfatte behandling af brystkræft.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Danish: Virksomheden informerede CHMP om, at beslutningen ikke ville få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Javlor.
English: EMA/587197/2014
Danish: Den 26. september 2014 EMA/587197/2014
English: On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
Danish: Den 25. september 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlet Javlor.
English: Therefore, at that point in time, the CHMP was of the opinion that the modest effect of Javlor in the treatment of breast cancer did not outweigh the additional risks observed.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Javlor til behandling af brystkræft ikke opvejede de ekstra risici, der var iagttaget.
English: The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Danish: Det aktive stof i Javlor, vinflunin, tilhører en gruppe af kræftlægemidler kaldet vinkaalkaloider.
English: Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Danish: Javlor forventedes også anvendt i kombination med kræftlægemidlet capecitabin til at behandle voksne med lokalt fremskreden eller metastatisk brystkræft.
English: It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
Danish: Det bindes i cellerne til proteinet tubulin, der er vigtigt for dannelsen af cellernes indvendige »skelet«, som cellerne behøver for at kunne dele sig.
English: Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
Danish: I forhold til behandling med capecitabin alene var der flere patienter på Javlor plus capecitabin, der fik bivirkninger i form af et abnormt lavt antal hvide blodceller (neutropeni), bivirkninger fra mave-tarm-systemet i form af forstoppelse, kvalme, opkastning og mavesmerter, træthed og symptomer fra nervesystemet, såsom beskadigelse af nerverne i arme og ben.
English: The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
Danish: CHMP bemærkede, at virkningen af Javlor i kombination med capecitabin ikke var tilstrækkeligt påvist.
English: By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Danish: Når vinflunin bindes til tubulin i kræftcellerne, blokerer det dannelsen af dette skelet og forhindrer derved kræftcellerne i at dele sig og spredes.
English: The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 770 patienter, der havde fremskreden brystkræft og tidligere var behandlet med, eller ikke havde oplevet noget virkning af, et antracyclinderivat, og hos hvem taxaner heller ikke virkede.
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelsen?
English: The main measure of effectiveness was progression-free survival (how long patients lived without their disease getting worse).
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen (progressionsfri overlevelse).
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Danish: CHMP anbefalede derfor et afslag på ansøgningen om ændring af markedsføringstilladelsen.
English: In the study, Javlor given together with capecitabine was compared with capecitabine alone.
Danish: I undersøgelsen blev Javlor i kombination med capecitabin sammenlignet med capecitabin alene.
English: It was to be used in patients previously treated with, or resistant to, another type of cancer medicine called an anthracycline and who are also resistant to a third type of cancer medicines called taxanes.
Danish: Det skulle anvendes hos patienter, der tidligere var blevet behandlet med, eller ikke havde oplevet nogen virkning af, et kræftlægemiddel i gruppen antracyclinderivater, og som heller ikke havde oplevet nogen virkning af en tredje type kræftlægemidler kaldet taxaner.
English: Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Danish: Javlor indeholder det aktive stof vinflunin og fås som et koncentrat til infusionsvæske, opløsning, der gives med drop i en vene.
English: What is happening with Javlor for the treatment of transitional-cell carcinoma of the urothelial tract?
Danish: Hvad sker der med Javlor til behandling af voksne med overgangscellekarcinom i urinvejene?
English: It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Danish: Det bruges i forvejen til behandling af voksne med fremskreden eller metastatisk kræft i slimhinden i blæren og resten af urinvejene (overgangscellekarcinom).
English: Strength Pharmaceutical Form
Danish: Særnavn Navn Styrke Lægemiddelform
English: Route of Administration
Danish: Administration
English: 1 Previously known as DuoCover.
Danish: 1 Tidligere kendt som DuoCover.
English: Both active substances have been available in the European Union (EU) for a number of years.
Danish: Begge aktive stoffer har i en årrække været tilgængelige i Den Europæiske Union (EU).
English: It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Danish: Det fås som tabletter, der indeholder 75 mg clopidogrel, enten med 75 mg eller 100 mg acetylsalicylsyre.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Danish: Det kan anvendes til følgende patientgrupper, som har en sygdom, der kaldes "akut koronarsyndrom":
English: The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clopidogrel/Acetylsalicylsyre Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.