FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
Danish: I dette fase 3 kliniske studie udviste palifermin-behandlede patienter signifikante fordele i patientrapporteret resultat af mund- og svælg-ømhed og dets indvirken på at synke, drikke, spise og tale.
English: Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Danish: Palifermin virker på samme måde som keratinocyt vækstfaktor (KGF), der produceres naturligt af kroppen i små mængder.
English: The study involved 281 adults who were receiving chemotherapy to treat multiple myeloma (a type of blood cancer), but without any radiotherapy.
Danish: I dette studie (n = 281) fik patienter med multipelt myelom konditionerende behandling med melphalan (200 mg/m2) inden autolog hæmatopoietisk stamcelletransplantation.
English: The main measure of effectiveness was the number of days during which patients experienced severe oral
Danish: Det vigtigste effektivitetsmål for studiet var antallet af dage, hvorunder patienterne oplevede alvorlig oral mucositis (grad 3/4 på Verdenssundhedsorganisationens (WHO) skala).
English: For the full list of all side effects reported with Kepivance, see the package leaflet.
Danish: For information om dosisbegrænsende toksiciteter, se pkt.
English: How does Kepivance work?
Danish: Når De får Kepivance
English: However, in the study of patients receiving chemotherapy without radiation, there was no difference in the severity of mucositis between the patients receiving placebo and those receiving either schedule of Kepivance.
Danish: Der var ingen tegn på forsinkelse i tid til hæmatopoietisk restitution hos patienter, der modtog palifermin, sammenlignet med patienter, der modtog placebo.
English: Kepivance is used in adults who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative chemotherapy (medicines to destroy the bone marrow) in combination with radiotherapy (treatment with radiation) and an autologous haematopoietic stem-cell transplant (a transplant of their own blood-producing cells).
Danish: For at behandle Deres blodkræft kan De få kemoterapi, strålebehandling og autolog knoglemarvstransplantation (celler fra Deres egen krop, som producerer blod).
English: The medicine can only be obtained with a prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘epithelial' cells that line the mouth and gastrointestinal tract to grow and develop.
Danish: Kepivance er en vækstfaktor, som stimulerer proliferation af epitelceller, som udtrykker KGFreceptor.
English: In the main study, the patients receiving chemotherapy and radiotherapy had severe oral mucositis for a shorter time if they received Kepivance (3.7 days, on average) than if they received placebo (10.4 days, on average).
Danish: Hertil kommer, at der var en højere forekomst af infektioner hos patienter, der fik palifemin før og efter kemoterapi (49,5%) sammenlignet med patienter, som fik placebo (24,6%).
English: The most common side effects with Kepivance (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), increased levels of lipase and amylase (enzymes used in digestion), hypertrophy (increase in the number or size of cells) or discoloration of the mouth and tongue, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (swelling), pain and pyrexia (fever).
Danish: Effektivitet og sikkerhed for palifermin blev fastslået i et randomiseret, dobbeltblindt, placebo kontrolleret studie, hvor patienterne modtog højdosis cytotoksisk behandling bestående af fraktioneret helkropsbestråling (12 Gy total dosis, dag -8 til -5), højdosis etoposid (60 mg/kg, dag -4) og højdosis cyclofosfamid (100 mg/kg, dag -2) efterfulgt af PBPC-understøtning til behandling af hæmatologiske maligniteter (Non-Hodgkins lymfom (NHL), Hodgkin's sygdom, Akut Myeloid Leukæmi (AML), Akut Lymfocytisk Leukæmi (ALL), Kronisk Myeloid Leukæmi (CML), Kronisk Lymfocytisk Leukæmi (CLL) eller multipelt myelom).
English: It contains the active substance
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: EMA/206629/2016 EMEA/H/C/000609
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/314/001
English: Kepivance is used to decrease the frequency, duration and severity of oral mucositis (inflammation of the lining of the mouth, ranging from soreness and redness to severe ulceration).
Danish: Kepivance er indiceret til at mindske forekomst, varighed og grad af oral mucositis hos voksne patienter med hæmatologiske maligniteter, der får myeloablativ radiokemoterapi forbundet med en høj forekomst af alvorlig mucositis, og som behøver autolog hæmatopoietisk stamcellestøtte.
English: Kepivance is a powder that is made up into a solution for injection.
Danish: Pulver til injektionsvæske, opløsning (pulver til injektionsvæske).
English: Palifermin is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Danish: Palifermin er en human keratinocyt vækstfaktor (KGF), produceret ved rekombinant DNA-teknologi i Escherichia coli.
English: It is given as an injection into a vein for a total of six doses.
Danish: Denne dosis vil De få som en intravenøs injektion (i en blodåre).
English: At the request of the CHMP, the company carried out a further study comparing two schedules of Kepivance with placebo.
Danish: Ingen af de to dosisregimer viste statistisk signifikante resultater versus placebo.
English: This summary was last updated in 03-2016.
Danish: Denne indlægsseddel blev senest ændret
English: What benefit has Kepivance shown during the studies?
Danish: Indholdet bør slynges forsigtigt under opløsningen.
English: The replacement palifermin acts in the same way as naturally produced KGF.
Danish: Hæmatologiske maligniteter udtrykker ikke KGF receptoren.
English: The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem-cell transplant.
Danish: Palifermin blev indgivet som en daglig intravenøs injektion af 60 mikrogram/kg i 3 på hinanden følgende dage forud for initiering af den cytotoksiske behandling og i 3 på hinanden følgende dage efter infusion af perifere blodstamceller med ni dage mellem den sidste dosis før og den første dosis efter.
English: Epithelial cells in the mouth are normally replaced by the body every few days.
Danish: Normalt tager opløsning af Kepivance mindre end 5 minutter.
English: What is the risk associated with Kepivance?
Danish: Der findes ingen adækvate data vedrørende anvendelse af Kepivance til gravide kvinder.
English: In patients receiving chemotherapy and radiotherapy, the cells are not replaced as quickly, which leads to the development of mucositis.
Danish: Patienter behandlet med kemoterapi og/eller strålingsterapi er dog udsat for højere risiko for at udvikle sekundære tumorer, hvoraf visse kan udtrykke KGF-receptorer og teoretisk kan stimuleres af KGF-receptorligander.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the
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: The full EPAR for Kepivance can be found here.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Kepivance has been compared with placebo (a dummy treatment) in one main study in 212 adults receiving chemotherapy and radiotherapy for a blood cancer (mostly non-Hodgkin's lymphoma).
Danish: Der blev udført et randomiseret placebokontrolleret dobbeltblindt studie efter godkendelsen for at vurdere virkningen af palifermin administreret før kemoterapi eller før og efter kemoterapi (CT).
English: This document is a summary of the European Public Assessment Report (EPAR) for Kepivance.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: This study is still ongoing.
Danish: Undersøgelsen er stadig i gang.
English: With regard to its safety, the data do not reveal any unacceptable concerns.
Danish: Hvad sikkerheden angår, viste dataene ingen uacceptable problemer.
English: The treatment can continue for as long as the patient benefits from it.
Danish: Behandlingen kan fortsætte, så længe det er til fordel for patienten.
English: The studies will include children below 2 years of age, for whom there are currently no data.
Danish: Undersøgelserne vil omfatte børn over to år, som der på nuværende tidspunkt ikke findes data om.
English: What measures are being taken to ensure the safe and effective use of Brineura?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Brineura?
English: This is a summary of the European public assessment report (EPAR) for Brineura.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Brineura.
English: Brineura has been authorised under ‘exceptional circumstances'.
Danish: Brineura er godkendt under "særlige omstændigheder".
English: In a study in which 23 children (average age of 4 years) were treated with Brineura for almost a year, 20 of them (87%) did not experience the 2-point decline in movement and language skills seen historically in patients not receiving treatment.
Danish: I en undersøgelse, hvor 23 børn (gennemsnitsalder 4 år) blev behandlet med Brineura i næsten et år, fik 20 af dem (87 %) ikke den forringelse på 2 point i motoriske og sproglige færdigheder, som tidligere er set hos patienter, der ikke får behandling.
English: The rating was done by doctors who gave patients individual scores for movement and language skills (where 0 means most severe and 3 is normal).
Danish: Vurderingen blev foretaget af læger, som tildelte patienterne individuelle scoreværdier for motoriske og sproglige færdigheder (hvor 0 er sværest og 3 er normalt).
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Brineura or the infusion may be slowed down.
Danish: For at mindske risikoen for infusionsbetingede reaktioner kan patienten få andre lægemidler før eller efter behandlingen med Brineura, eller infusionen kan gives langsommere.
English: The infusions are given once every two weeks by a healthcare professional knowledgeable about giving medicines into the brain.
Danish: Infusionerne gives en gang hver anden uge af en sundhedsperson, der er kyndig i at indgive medicin i hjernen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Brineura's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Brineura opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because the number of patients with CLN2 is low, the disease is considered ‘rare', and Brineura was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 March 2013.
Danish: Da antallet af patienter med CLN2 er lavt, betragtes sygdommen som "sjælden", og Brineura blev udpeget som "lægemiddel til sjældne sygdomme" den 13. marts 2013.
English: Other information about Brineura
Danish: Andre oplysninger om Brineura
English: This is because it has not been possible to obtain complete information about Brineura due to the rarity of the disease.
Danish: Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Brineura, fordi sygdommen er sjælden.
English: A patient's final score was the sum of the two scores.
Danish: Slutscoreværdien for en patient var de to scoreværdier lagt sammen.
English: The active substance in Brineura, cerliponase alfa, is a copy of TPP1 and is used as a replacement for the missing enzyme.
Danish: Det aktive stof i Brineura, cerliponase alfa, er en kopi af TPP1 og anvendes som erstatning for det manglende enzym.
English: Since Brineura has been approved under exceptional circumstances, the company that markets it will provide further data from studies on the safety of Brineura, including the risk of allergic reactions when used long-term, and on its long-term effectiveness in delaying or stopping worsening of movement and language skills.
Danish: Eftersom Brineura er blevet godkendt under ekstraordinære omstændigheder, skal virksomheden, der markedsfører det, fremlægge yderligere data fra undersøgelser om sikkerheden af Brineura, herunder risikoen for allergiske reaktioner ved længere tids anvendelse, og om dets effektivitet på længere sigt mht. at bremse eller standse forringelsen af motoriske og sproglige færdigheder.
English: The full EPAR for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Brineura findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In a follow-up study the benefits of Brineura lasted for another year, with the results showing the disease could be delayed in the majority of patients.
Danish: I en opfølgende undersøgelse vedvarede fordelene ved Brineura i endnu et år, og resultaterne viste, at sygdommen kunne forsinkes hos størstedelen af patienterne.
English: The most common side effects with Brineura (which may affect more than 1 in 5 people) are fever, low levels of protein in CSF (the fluid in the brain and spinal cord), abnormalities in ECG (a test of the heart's activity), vomiting, upper respiratory tract infections (nose and throat infections), and hypersensitivity (allergic) reactions.
Danish: De hyppigste bivirkninger med Brineura (som kan forekomme hos mere end 1 ud af 5 personer) er feber, lavt proteinindhold i væsken i hjernen og rygmarven (cerebrospinalvæsken), abnormt EKG (undersøgelse af hjertets aktivitet), opkastning, næse- og halsinfektioner (øvre luftvejsinfektioner) og overfølsomhedsreaktioner (allergiske reaktioner).
English: Brineura contains the active substance cerliponase alfa.
Danish: Brineura indeholder det aktive stof cerliponase alfa.
English: Brineura is infused directly into the brain.
Danish: Brineura gives som infusion direkte i hjernen.
English: Brineura is a medicine for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease), an inherited condition in children that leads to progressive brain damage.
Danish: Brineura er et lægemiddel til behandling af neuronal ceroid lipofuscinose type 2 (CLN2-sygdom), som er en arvelig sygdom, der hos børn fører til fremadskridende hjerneskade.
English: Why is Brineura approved?
Danish: Hvorfor blev Brineura godkendt?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Brineura findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine is infused directly into the brain in order to bypass the blood-brain barrier, a protective barrier that separates the blood stream from the brain, and prevents substances such as medicines, from entering brain tissue.
Danish: Lægemidlet gives som infusion direkte i hjernen for at omgå den beskyttende blod-hjernebarriere, som adskiller blodbanen fra hjernen og forhindrer stoffer såsom lægemidler i at komme ind i hjernevævet.
English: Finally, patients must not be given Brineura while there are any problems with the device, such as leakage or infection.
Danish: Endelig må patienten ikke få Brineura, når der er problemer med den indopererede enhed såsom utæthed eller infektion.
English: For more information about treatment with Brineura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Brineura, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Brineura must not be given to patients who have experienced life-threatening hypersensitivity (allergic) reactions with Brineura and whose symptoms re-occurred when Brineura was given again.
Danish: Brineura må ikke gives til patienter, der har haft livstruende overfølsomhedsreaktioner (allergiske reaktioner) i forbindelse med Brineura, og hos hvem symptomerne kom igen, når patienterne fik Brineura igen.
English: The company that markets Brineura will ensure that all healthcare professionals expected to use this medicine are provided with training material on how to use it and how to avoid problems with the device such as infection or blockage.
Danish: Virksomheden, der markedsfører Brineura, skal sikre, at alle sundhedspersoner, der forventes at bruge dette lægemiddel, forsynes med oplysningsmateriale om, hvordan de skal bruge det, og hvordan de skal undgå problemer med enheden såsom infektion eller tilstopning.
English: Available data show that Brineura helps slow the decline in movement and language skills in patients with CLN2, a condition for which there are no other treatments.
Danish: De foreliggende data viser, at Brineura bremser forringelsen af motoriske og sproglige færdigheder hos patienter med CLN2, som er en sygdom uden andre behandlingsmuligheder.
English: Brineura can only be obtained with a prescription.
Danish: Lægemidlet Brineura udleveres kun efter recept.
English: It is not intended to provide practical advice on how to use Brineura.
Danish: Det er ikke en praktisk vejledning i, hvordan Brineura bør anvendes.
English: What information is still awaited for Brineura?
Danish: Hvilke oplysninger afventes der stadig for Brineura?
English: It must also not be given to patients who have had a shunt implanted to drain extra fluid from the brain.
Danish: Det må heller ikke gives til patienter, der har fået indopereret et dræn til at fjerne overskydende væske fra hjernen.
English: Patients with CLN2 lack an enzyme required for normal brain development called tripeptidyl-peptidase1 (TPP1).
Danish: Patienter med CLN2 mangler enzymet tripeptidylpeptidase-1 (TPP1), der er nødvendigt for hjernens normale udvikling.
English: What is Brineura and what is it used for?
Danish: Hvad er Brineura, og hvad anvendes det til?
English: What are the risks associated with Brineura?
Danish: Hvilke risici er der forbundet med Brineura?
English: Before the first infusion, the patient will need to have surgery to implant a device, which runs from the outside of the skull through to the fluid cavity in the brain where the medicine is delivered to.
Danish: Før den første infusion skal patienten have indopereret en enhed, der fra ydersiden af kraniet fører til det væskefyldte hulrum i hjernen, hvor lægemidlet tilføres.
English: Brineura has been shown in early studies to reduce the rate at which the disease worsens as measured with standard rating scale.
Danish: Tidlige undersøgelser har vist, at Brineura nedsætter den hastighed, som sygdommen forværres med, målt på en standardskala.
English: For the full list of all side effects reported with Brineura, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Brineura fremgår af indlægssedlen.
English: How is Brineura used?
Danish: Hvordan anvendes Brineura?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brineura have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Brineura.
English: For practical information about using Brineura, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Brineura, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Brineura have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Brineura?
English: This summary was last updated in January 2018.
Danish: Dette sammendrag blev sidst ajourført i januar 2018.
English: As a result, the cells cannot divide and eventually die.
Danish: Som følge heraf kan cellerne ikke dele sig og vil til sidst dø.
English: In both cases, treatment is for five consecutive days.
Danish: I begge tilfælde skal behandlingen gives i fem dage i træk.
English: The withdrawal period for eggs is zero days.
Danish: Tilbageholdelsestiden for æg er nul dage.
English: The full EPAR for Panacur AquaSol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Panacur AquaSol findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The medicine is effective against the worms and their eggs.
Danish: Lægemidlet er effektivt mod orm og æg.
English: The European Commission granted a marketing authorisation valid throughout the EU, for Panacur AquaSol on 09/12/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Panacur AquaSol den 9.12.2011.
English: It works by interfering with the formation of tube-like structures called ‘microtubules' inside the cells of the worm that are needed to perform vital functions such as growth and cell division.
Danish: Det virker ved at forstyrre dannelsen af de rørlignende strukturer ("mikrotubuli") i ormens celler, der er nødvendige for livsvigtige funktioner som f.eks. vækst og celledeling.
English: The medicine should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Danish: Lægemidlet må ikke hældes ud i overfladevand, da det har skadelige virkninger på vandorganismer.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Panacur AquaSol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Panacur AquaSol opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is also the time required after administration of the medicine before eggs can be used for human consumption.
Danish: Det er også den tid, der skal gå efter administration af et lægemiddel, før æggene kan anvendes til menneskeligt konsum.
English: This is a summary of the European public assessment report (EPAR) for Panacur AquaSol.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Panacur AquaSol.
English: Before allowing the animals to access the medicated water, the water delivery system should be drained and flushed with the medicated water.
Danish: Før dyrene får adgang til det medicinerede vand, bør vandingssystemet drænes og gennemskylles med det medicinerede vand.
English: In case of skin or eye contact, the affected area should be rinsed immediately with water and any contaminated clothes should be removed.
Danish: I tilfælde af hud- eller øjenkontakt skal det berørte område omgående skylles med vand, og hvis der spildes på tøjet, skal det tages af.