FrancophonIA/ELRC3.0 huggingface dataset:
English: However no more than two patches should be left in the patient as there has not been enough experience with larger quantities.
Danish: Der bør dog højst efterlades to enheder i patienten, da der ikke er tilstrækkelige erfaringer med større antal.
English: The CHMP concluded that the benefits of Evarrest outweigh its risks and recommended that it be granted marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Evarrest overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: A risk management plan has been developed to ensure that Evarrest is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Evarrest anvendes så risikofrit som muligt.
English: It should only be used in a single layer with an overlap of 1 to 2 cm on the surrounding non-bleeding tissue.
Danish: Det bør kun bruges i et enkelt lag og overlappe 1-2 cm af det omgivende ikke blødende væv.
English: What measures are being taken to ensure the safe and effective use of Evarrest?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Evarrest?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Evarrest was shown to be effective when used to stop bleeding in surgery and the product could be a suitable alternative to other products and techniques.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at Evarrest var påvist at være effektivt til at standse blødning ved operationer og kunne være et velegnet alternativ til andre produkter og teknikker.
English: Evarrest is made of absorbable material that can be left in the patients after surgery.
Danish: Evarrest er fremstillet af absorberbart materiale, som kan efterlades i patienten efter operationen.
English: Evarrest must not be used to repair the walls of large blood vessels, must not be applied to the inside of blood vessels and must not be used in closed spaces (such as openings in bones).
Danish: Evarrest må ikke anvendes til at reparere skader på store blodkar, må ikke påføres på indersiden af blodkar og må ikke anvendes i lukkede hulrum (såsom indvendigt i knoglerne).
English: Evarrest should therefore only be used when standard methods for controlling bleeding are not sufficient.
Danish: Evarrest bør derfor kun anvendes, når sædvanlige metoder til kontrol af blødning ikke er tilstrækkelige.
English: It is not intended to provide practical advice on how to use Evarrest.
Danish: Det er ikke en praktisk vejledning i, hvordan Evarrest bør anvendes.
English: What is Evarrest and what is it used for?
Danish: Hvad er Evarrest, og hvad anvendes det til?
English: Why is Evarrest approved?
Danish: Hvorfor er Evarrest blevet godkendt?
English: The active substances in Evarrest, fibrinogen and thrombin, are proteins extracted from the blood, which are involved in the natural clotting process.
Danish: De aktive stoffer i Evarrest, fibrinogen og trombin, er proteiner, der er udvundet af blod og medvirker ved blodets naturlige størkning.
English: Two studies compared Evarrest with commonly used surgical techniques considered to be standard care.
Danish: To undersøgelser sammenlignede Evarrest med kirurgiske teknikker, der sædvanligvis anvendes som standardbehandling.
English: What are the risks associated with Evarrest?
Danish: Hvilke risici er der forbundet med Evarrest?
English: For more information about treatment with Evarrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Evarrest, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Evarrest should only be used by experienced surgeons who will judge the amount to use based on the size and location of the bleeding area.
Danish: Evarrest bør kun anvendes af erfarne kirurger, som kan vurdere, hvor meget der skal bruges, alt efter hvor og hvor meget det bløder.
English: Evarrest is a surgical product used in adults to help stop bleeding during surgery when standard methods for controlling bleeding are not sufficient.
Danish: Evarrest er et kirurgisk produkt, der hos voksne anvendes til at standse blødning under operationer, hvor sædvanlige metoder til kontrol af blødning ikke er tilstrækkelige.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evarrest, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Evarrest er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: One study compared Evarrest with another product, Surgicel, in patients undergoing abdominal, thoracic and pelvic surgeries.
Danish: I én undersøgelse blev Evarrest sammenlignet med et andet produkt, Surgicel, hos patienter, der fik foretaget operationer i maven, brystkassen eller bækkenet.
English: Thrombin works by cutting fibrinogen up into smaller units called fibrin, which then stick together to form clots.
Danish: Trombin virker ved at spalte fibrinogen til mindre enheder, der kaldes fibrin, som derefter hæfter sammen og danner blodklumper.
English: When an Evarrest patch is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of clots.
Danish: Når en enhed af Evarrest lægges på det blødende område under operationen, bevirker fugten, at de aktive stoffer reagerer med hinanden, så der hurtigt dannes blodklumper.
English: For the full list of all side effects reported with Evarrest, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Evarrest fremgår af indlægssedlen.
English: The complications seen in studies with Evarrest were generally related the surgical procedure and the underlying conditions although there were cases of re-bleeding from the sites where Evarrest patches were used.
Danish: De komplikationer, der sås i undersøgelser med Evarrest, skyldes sædvanligvis selve operationen og den underliggende sygdom, skønt der forekom tilfælde af fornyet blødning fra de områder, hvor der var påført Evarrest.
English: It is made of absorbable material coated on one side with two active substances, fibrinogen and thrombin, and is available as 10.2 cm x 10.2 cm patches.
Danish: Det er fremstillet af et absorberbart materiale, der på den ene side er belagt med to aktive stoffer, fibrinogen og trombin, og leveres i enheder på 10,2 cm x 10,2 cm. Under operationen klippes enhederne til i form og størrelse og anvendes til at lukke det blødende område.
English: For practical information about using Evarrest, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Evarrest, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: 98% of the patients in the Evarrest group (59 out of 60) had their bleeding stopped within 4 minutes (with no recurrence of bleeding during a 6-minute observation period) compared with 53% of patients in the Surgicel group (16 out of 30).
Danish: Hos 98 % (59 ud af 60) af patienterne i gruppen på Evarrest var blødningen standset inden for 4 minutter (og begyndte ikke igen i en 6minutters observationsperiode), sammenholdt med 53 % (16 ud af 30) af patienterne i gruppen på Surgicel.
English: The clots enable the patch to stick more firmly to the tissue thereby helping to stop the bleeding.
Danish: Blodklumperne får enheden at hæfte stærkere til vævet, hvilket er med til at standse blødningen.
English: Similar results were seen in a study in patients undergoing liver surgery: 83% of patients in the Evarrest group (33 out of 40) had their bleeding stopped within 4 minutes compared with 30% of the standard care group (13 out of 44).
Danish: Tilsvarende resultater sås i en undersøgelse hos patienter, der fik opereret leveren: 83 % (33 ud af 40) af patienterne i gruppen på Evarrest fik standset blødningen inden for 4 minutter, sammenholdt med 30 % (13 ud af 44) af dem, der fik standardbehandlingen.
English: Evarrest has been shown in studies to be effective in helping to stop bleeding during surgeries, with most patients having their bleeding stopped within 4 minutes.
Danish: Undersøgelserne viser, at Evarrest effektivt standser blødningen under operationer, idet blødningen ophører inden for 4 minutter hos de fleste patienter.
English: What benefits of Evarrest have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Evarrest?
English: In a study in patients undergoing abdominal, thoracic and pelvic surgeries, 84% of patients in the Evarrest group had their bleeding stopped within 4 minutes (50 out of 59) compared with 31% (10 out of 32) in the standard care group.
Danish: I en undersøgelse hos patienter, der blev opereret i maven, brystkassen eller bækkenet, fik 84 % (50 ud af 59) af patienterne i gruppen på Evarrest standset blødningen inden for 4 minutter, sammenholdt med 31 % (10 ud af 32) i gruppen på standardbehandlingen.
English: How is Evarrest used?
Danish: Hvordan anvendes Evarrest?
English: How does Evarrest work?
Danish: Hvordan virker Evarrest?
English: The complications that arise in patients being treated with Evarrest are generally related to the surgical procedure and the underlying conditions, and include post-surgery bleeding and increased fibrinogen levels in the blood.
Danish: De består i blødning efter operationen og øget indhold af fibrinogen i blodet.
English: Packaging Content Package sizeWithdrawal period
Danish: Emballage Indhold Pakningsstørrelse
English: Route of administration
Danish: Administrationsmåde
English: Strength Pharmaceutical form
Danish: EU-nummer Særnavn Styrke Lægemiddelform Dyrearter, som læge-midlet er beregnet til
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer (Særnavn) navn Styrke
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Pixuvri on 10 May 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pixuvri den 10. maj 2012.
English: The full EPAR for Pixuvri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pixuvri findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The side effects of the medicine were considered to be short term and manageable.
Danish: Bivirkningerne ved lægemidlet blev anset for at være kortvarige og kunne behandles.
English: This is a summary of the European public assessment report (EPAR) for Pixuvri.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pixuvri.
English: The recommended dose is 50 mg/m2 given as an infusion into a vein over at least 60 minutes on days 1, 8 and 15 of a 28-day cycle.
Danish: Den anbefalede dosis er 50 mg/m2, der gives som infusion i en vene i løbet af mindst 60 minutter på dag 1, 8 og 15 i en 28-dages kur (cyklus).
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Danish: Det virker ved at gribe ind i cellernes produktion af dna, så de ikke er i stand til at fremstille flere dna-kopier og producere proteiner.
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 conditions of use for Pixuvri.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Pixuvri.
English: The effects of Pixuvri were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Pixuvri blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness was the number patients who had a complete response to treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på det antal patienter, der opnåede fuldstændig bedring ved behandlingen.
English: It must not be used in patients with severe liver problems and in patients whose bone marrow produces abnormally low levels of blood cells.
Danish: Det må ikke anvendes til patienter med svære leverproblemer eller til patienter, hos hvem knoglemarven producerer unormalt få blodceller.
English: For more information about treatment with Pixuvri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pixuvri, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP concluded that the benefits of Pixuvri are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Pixuvri opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This means that there is more evidence to come about the medicine, in particular its benefits in patients who have previously been treated with rituximab.
Danish: Det betyder, at der forventes yderligere dokumentation om lægemidlet, navnlig dets fordele hos patienter, der tidligere er blevet behandlet med rituximab.
English: The dose of Pixuvri is based on the patient's body surface area (calculated using the patient's height and weight).
Danish: Dosis af Pixuvri afhænger af legemsoverfladen (beregnet efter patientens højde og vægt).
English: Other information about Pixuvri
Danish: Andre oplysninger om Pixuvri
English: In addition, patients treated with Pixuvri lived for longer without their disease getting worse.
Danish: Behandling med Pixuvri medførte desuden, at patienterne levede længere, uden at deres sygdom forværredes.
English: EPAR summary for the public pixantrone
Danish: EPAR sammendrag for offentligheden pixantron
English: The active substance in Pixuvri, pixantrone, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anthracyclines'.
Danish: Det aktive stof i Pixuvri, pixantron, er et cytotoksisk lægemiddel (et lægemiddel, der dræber celler, som deler sig, såsom kræftceller) i gruppen af ‘antracycliner'.
English: Pixuvri is a medicine that contains the active substance pixantrone.
Danish: Pixuvri er et lægemiddel, der indeholder det aktive stof pixantron.
English: In patients who develop side effects or who have very low blood levels of neutrophils (a type of white blood cell that fights infection) and platelets (components that help the blood to clot), the dose may have to be reduced or treatment may have to be delayed.
Danish: Hvis patienten får bivirkninger eller meget lavt niveau af neutrofile (en type hvide blodlegemer, der bekæmper infektioner) og blodplader (blodkomponenter, der medvirker ved blodets størkning), kan det være nødvendigt at sætte dosis ned eller udskyde behandlingen.
English: Pixuvri must be given by a doctor who has experience in the use of anticancer medicines and who has access to facilities for monitoring the patient.
Danish: Behandling med Pixuvri skal gives af en læge, der har erfaring i brug af lægemidler mod kræft og råder over faciliteter til overvågning af patienten.
English: However, the Committee noted that more data were needed on the benefits of Pixuvri in patients who have received previous treatment with rituximab (another medicine commonly used to treat lymphoma).
Danish: Udvalget bemærkede dog at der var behov for flere data om fordelene ved Pixuvri for patienter, der tidligere var behandlet med rituximab (et andet ofte anvendt lægemiddel til behandling af lymfom).
English: Patients were given either six cycles of Pixuvri or another approved anticancer medicine chosen by their doctor.
Danish: Patienterne fik enten seks kure med Pixuvri eller et andet godkendt kræftmiddel, der blev valgt af lægen.
English: The most common side effects with Pixuvri (seen in more than 1 patient in 10) are neutropenia, leucopenia and lymphopenia (low levels of different types of white blood cells), thrombocytopenia (low levels of platelets in the blood), anaemia (low levels of red blood cells), nausea (feeling sick), vomiting, skin discolouration, hair loss, chromaturia (abnormal colouration of the urine) and asthenia (weakness).
Danish: De hyppigste bivirkninger ved Pixuvri (som optræder hos flere end 1 ud af 10 patienter) er neutropeni, leukopeni og lymfopeni (for lavt antal af forskellige typer hvide blodlegemer), trombocytopeni (for lavt antal blodplader), anæmi (for lavt antal røde blodlegemer), kvalme, opkastning, misfarvning af huden, hårtab, misfarvning af urinen og asteni (kraftesløshed).
English: Pixuvri was shown to be beneficial in patients with aggressive non-Hodgkin's B cell lymphoma: 20% of patients responded completely to Pixuvri (14 out of 70 patients) compared with 5.7% of patients receiving other agents (4 out of 70 patients).
Danish: Det blev bevist, at Pixuvri er til fordel for patienter med aggressiv non-Hodgkins B-celle-lymfom: 20 % af patienterne fik fuldstændig bedring ved behandling med Pixuvri (14 ud af 70) i forhold til 5,7 % af de patienter, der fik anden medicin (4 ud af 70).
English: Pixuvri must not be used in patients who are hypersensitive (allergic) to pixantrone or any of the other ingredients.
Danish: Pixuvri må ikke anvendes til patienter, der er overfølsomme (allergiske) over for pixantron eller andre af indholdsstofferne.
English: Pixuvri is used to treat adult patients with non-Hodgkin's B cell lymphoma.
Danish: Pixuvri anvendes til at behandle voksne patienter med non-Hodgkins B-celle-lymfom.
English: Patients receiving Pixuvri must not be given vaccines containing attenuated (weakened live) viruses.
Danish: Patienter i behandling med Pixuvri må ikke få vacciner, der indeholder svækkede levende vira.
English: This means that the cancer cells in non-Hodgkin's B cell lymphoma cannot divide and eventually die.
Danish: Dette forhindrer kræftcellerne i non-Hodgkins B-celle-lymfom i at dele sig, så de til sidst dør.
English: What is the risk associated with Pixuvri?
Danish: Hvilken risiko er der forbundet med Pixuvri?
English: It is available as a powder that is made up into a solution for infusion (a drip into a vein).
Danish: Det fås som et pulver, der efter opløsning indgives ved infusion (drop i en vene).
English: The company that makes Pixuvri will carry out a study to further investigate the effects of using Pixuvri in patients who had received prior treatment with rituximab.
Danish: Den virksomhed, der fremstiller Pixuvri, skal foretage en undersøgelse af virkningerne af Pixuvri hos patienter, der tidligere er behandlet med rituximab.
English: Pixuvri has been given ‘conditional approval'.
Danish: Der er udstedt en ‘betinget godkendelse' for Pixuvri.
English: What information is still awaited for Pixuvri?
Danish: Hvilke oplysninger afventes der stadig for Pixuvri?
English: Pixuvri is used when the lymphoma is aggressive and has come back or has not responded to other chemotherapy treatments (medicines to treat cancer).
Danish: Pixuvri anvendes, når lymfomet er aggressivt og er vendt tilbage, eller når anden kemoterapi (kræftmedicin) ikke har virket.
English: Why has Pixuvri been approved?
Danish: Hvorfor blev Pixuvri godkendt?
English: For the full list of all side effects reported with Pixuvri, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Pixuvri fremgår af indlægssedlen.
English: The CHMP concluded that patients with aggressive non-Hodgkin's B cell lymphoma had a better response to treatment with Pixuvri than other cancer treatments.
Danish: CHMP konkluderede, at patienter med aggressivt non-Hodgkins B-celle-lymfom reagerede bedre på Pixuvri end på anden kræftmedicin.
English: Pixuvri can be given for up to six cycles.
Danish: Der kan gives op til seks kure med Pixuvri.
English: What is Pixuvri?
Danish: Hvad er Pixuvri?
English: This is a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells.
Danish: Sygdommen udgår fra den type hvide blodlegemer, der kaldes B-lymfocytter eller B-celler.
English: The CHMP also considered the seriousness of the disease and the lack of suitable alternative treatments for patients whose non-Hodgkin's B cell lymphoma has come back or has not responded to other chemotherapy treatments.
Danish: CHMP tog desuden hensyn til sygdommens alvorlighed og manglen på andre behandlingsmuligheder for patienter, der har fået tilbagefald af Hodgkins Bcellelymfom, eller hos hvem anden kræftmedicin ikke virker.
English: What is Pixuvri used for?
Danish: Hvad anvendes Pixuvri til?
English: How has Pixuvri been studied?
Danish: Hvordan blev Pixuvri undersøgt?
English: How is Pixuvri used?
Danish: Hvordan anvendes Pixuvri?
English: What benefit has Pixuvri shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pixuvri?
English: How does Pixuvri work?
Danish: Hvordan virker Pixuvri?
English: Pixuvri was compared with other chemotherapy treatments in one main study involving 140 adults with aggressive non-Hodgkin's B cell lymphoma, who had previously received at least two other treatments, and whose cancer had come back or had not responded to treatment.
Danish: Patienterne havde aggressivt non-Hodgkins B-celle-lymfom, og havde tidligere fået mindst to kræftmidler.
English: The full EPAR and risk management plan summary for Pemetrexed medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pemetrexed medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed medac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed medac.
English: The Committee recommended that Pemetrexed medac be approved for use in the EU.
Danish: Udvalget anbefalede, at Pemetrexed medac godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Pemetrexed medac is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pemetrexed medac anvendes så sikkert som muligt.
English: This means that Pemetrexed medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Danish: Det betyder, at Pemetrexed medac er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Alimta.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Danish: • fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekarcinom, hvor det enten anvendes i kombination med cisplatin hos ikke tidligere behandlede patienter eller som eneste behandling hos patienter, der tidligere har fået kræftbehandling.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pemetrexed medac, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.