FrancophonIA/ELRC3.0 huggingface dataset:
English: The affected paediatric patients consequently treated are at high risk of acute anthracycline cardiotoxicity, as a consequence of the high doses of chemotherapy received; therefore, a treatment with a cardioprotective agent is needed in this very small number of patients.
Danish: Der er derfor behov for behandling med et kardioprotektivt middel hos dette meget lave antal patienter.
English: The infusion is given over two hours, three times daily.
Danish: Infusionen gives over et tidsrum på 2 timer, 3 gange dagligt.
English: Treatment usually lasts between 5 and 14 days, depending on the type of infection.
Danish: Behandlingen varer mellem 5 og 14 dage, afhængigt af infektionstypen.
English: Doses may need to be reduced and/or given less often in patients with severely reduced kidney function.
Danish: Dosis skal måske reduceres og/eller indgives mindre hyppigt i patienter med alvorligt reduceret nyrefunktion.
English: The full EPAR for Zavicefta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zavicefta 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 Zavicefta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zavicefta.
English: Other information about Zavicefta
Danish: Andre oplysninger om Zavicefta
English: It works by interfering with the production of certain molecules that bacteria need to build their protective cell walls.
Danish: Det virker ved at gribe ind i dannelsen af visse molekyler, som bakterierne behøver for at opbygge deres beskyttende cellevægge.
English: What measures are being taken to ensure the safe and effective use of Zavicefta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zavicefta?
English: Zavicefta is an antibiotic used in adults to treat the following infections:
Danish: Zavicefta er et antibiotikum, der anvendes hos voksne til behandling af følgende infektioner:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta'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 Zavicefta opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: • infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.
Danish: • infektioner forårsaget af gramnegative bakterier (speciel bakterietype), når andre behandlinger ikke virker.
English: The benefits of Zavicefta have been shown in four main studies.
Danish: Fordelene ved Zavicefta er blevet illustreret i fire store undersøgelser.
English: Zavicefta ceftazidime / avibactam
Danish: Zavicefta ceftazidim/avibactam
English: A study of Zavicefta in patients with hospital-acquired pneumonia has not yet been completed.
Danish: En undersøgelse af virkningen af Zavicefta i patienter med hospitalspådraget lungebetændelse er endnu ikke færdiggjort.
English: What is Zavicefta and what is it used for?
Danish: Hvad er Zavicefta, og hvad anvendes det til?
English: One of the main measures of effectiveness was based on eliminating the disease-causing bacteria.
Danish: Et hovedeffektmålene er baseret på elimineringen af den sygdomsfremkaldende bakterie.
English: Why is Zavicefta approved?
Danish: Hvorfor er Zavicefta blevet godkendt?
English: The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells).
Danish: De mest almindelige bivirkninger ved Zavicefta (som ramte mere end 5 ud af 100 personer) er kvalme (opkastning), diarré og et positivt resultat i en antiglobulintest (et tegn på udvikling af antistoffer, der angriber de røde blodceller).
English: It is not intended to provide practical advice on how to use Zavicefta.
Danish: Det er ikke en praktisk vejledning i, hvordan Zavicefta bør anvendes.
English: Zavicefta can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antibiotics.
Danish: Zavicefta fås kun på recept og den ordinerende læge skal følge den officielle vejledning om anvendelse af antibiotika.
English: The company that makes Zavicefta is carrying out a study to compare the effectiveness and safety of Zavicefta with meropenem (another antibiotic) for the treatment of hospital-acquired pneumonia.
Danish: Virksomheden der producerer Zavicefta udfører en undersøgelse til at sammenligne effektiviteten og sikkerheden af Zavicefta med meropenem (et andet antibiotikum) til behandling af hospitalspådraget lungebetændelse.
English: • complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
Danish: • komplicerede (svære at behandle) infektioner i mavevæv og -organer (intra-abdominale infektioner)
English: However, the CHMP considered that the data already available supported Zavicefta's activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work.
Danish: Dog tog CHMP i betragtning, at de allerede tilgængelige data understøttede Zaviceftas aktivitet under hospitalspådraget lungebetændelse og under behandling af infektioner som følge af aerobiske gramnegative organismer i voksne patienter, når andre behandlinger ikke viser sig effektive.
English: Both studies showed that Zavicefta in combination with metronidazole was at least as effective as meropenem at curing the infection.
Danish: Begge undersøgelser viste, at Zavicefta i kombination med metronidazol var mindst lige så effektivt som meropenem til at helbrede infektionen.
English: What are the risks associated with Zavicefta?
Danish: Hvilke risici er der forbundet med Zavicefta?
English: • infections of the lungs that are caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe);
Danish: • lungeinfektioner, der er blevet pådraget i hospitalsmiljøet (HAP), inklusive ventilator-associeret lungebetændelse (lungebetændelse pådraget fra en ventilator, der hjælper patienten med at ånde)
English: For more information about treatment with Zavicefta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zavicefta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Danish: Zavicefta må ikke anvendes hos personer, som er overfølsomme (allergiske) over for aktivstofferne i Zavicefta eller nogen af dets andre indholdsstoffer, eller hos personer, som er hypersensitive over for andre antibiotika af cefalosporin-typen eller har haft en svær allergisk reaktion over for et andet betalaktam-antibiotikum.
English: Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams'.
Danish: Ceftazidim er et antibiotikum kaldet cefalosporin, der tilhører den bredere gruppe af "betalaktamer".
English: In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection.
Danish: I to undersøgelser blev virkningerne af kombinationen af Zavicefta og metronidazol (et andet antibiotikum) sammenlignet med virkningerne af antibiotikummet meropenem i 1 490 patienter med kompliceret intra-abdominal infektion.
English: The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections.
Danish: CHMP har vurderet, at undersøgelserne vedrørende Zavicefta viste, at lægemidlet er effektivt til behandling af komplicerede intra-abdominale infektioner og urinvejsinfektioner.
English: By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.
Danish: Ved at blokere virkningen af disse enzymer giver avibactam ceftazidim mulighed for at virke mod bakterier, der ellers ville være resistente.
English: Regarding Zavicefta's safety profile, side effects were those that can be expected for ceftazidime and a betalactamase inhibitor.
Danish: Hvad angår Zaviceftas sikkerhedsprofil er bivirkningerne de samme som dem, der kan forventes for ceftazidim og betalaktamase-hæmmere.
English: • complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
Danish: • komplicerede (svære at behandle) infektioner i urinvejene (urinvejsstrukturer), inklusiv pyelonephritis (nyreinfektion)
English: A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime).
Danish: En tredje undersøgelse omfattede 332 patienter med komplicerede intra-abdominale infektioner eller urinvejsinfektioner forårsaget af gramnegative bakterier, der var resistente over for ceftazidim (dvs. ikke kunne slås ned af ceftazidim).
English: In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem.
Danish: I en fjerde undersøgelse blev 1 020 patienter med kompliceret urinvejsinfektion (inklusive pyelonephritis) forårsaget af gramnegative bakterier behandlet med Zavicefta eller det antibiotiske lægemiddel doripenem.
English: Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic.
Danish: Zavicefta alene (for urinvejsinfektion) eller i kombination med metronidazol (for intra-abdominal infektion) gav resultater der lignede dem for andre antibiotika, hvad angår helbredelse af infektionen: 91 % af patienterne (140 ud af 154) blev helbredt efter behandling med Zavicefta sammenlignet med 91 % (135 ud af 148) efter behandling med det bedste alternative antibiotikum.
English: These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic's action.
Danish: Disse enzymer sætter bakterier i stand til at nedbryde betalaktam-antibiotika som ceftazidim, hvorved de bliver resistente over for den antibakterielle virkning.
English: Due to the design of this study, this evidence of Zavicefta's benefits is not as strong as for the other studies; however these results support Zavicefta's activity when combined with the other studies.
Danish: På grund af opbygningen af dette studie er dette bevis for Zaviceftas virkning ikke så stærkt som de andre undersøgelser.
English: For the full list of all side effects with Zavicefta, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkninger ved Zavicefta fremgår af indlægssedlen.
English: Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.
Danish: Zavicefta var mindst lige så effektiv som doripenem: 77 % af patienterne (304 ud af 393) behandlet med Zavicefta viste et respons, sammenlignet med 71 % af patienterne (296 ud af 417) behandlet med doripenem.
English: The active substances in Zavicefta are ceftazidime and avibactam.
Danish: De aktive stoffer i Zavicefta er ceftazidim og avibactam.
English: For practical information about using Zavicefta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zavicefta, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Zavicefta fås som et pulver, der blandes til en opløsning til infusion (drop) i en vene.
English: Zavicefta contains the active substances ceftazidime and avibactam.
Danish: Zavicefta indeholder de aktive stoffer ceftazidim og avibactam.
English: In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic.
Danish: I tillæg hertil blev sygdomsfremkaldende bakterier elimineret i 82 % af patienterne (126 ud af 154) efter behandling med Zavicefta sammenlignet med 63 % (94 ud af 148) efter behandling med det bedste alternative antibiotikum.
English: This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Danish: Bakteriernes cellevæg bliver derved svag og tilbøjelig til at briste, så bakterierne til sidst dør.
English: In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem.
Danish: I den første undersøgelse viste en af de undersøgte patientgrupper, at 92 % af patienterne (376 ud af 410) behandlet med Zavicefta og metronidazol blev helbredt sammenlignet med 93 % (385 ud af 416) af patienterne behandlet med meropenem.
English: In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.
Danish: I den anden undersøgelse blev 94 % af patienterne (166 ud af 177) behandlet med Zavicefta og metronidazol helbredt, sammenlignet med 94 % (173 ud af 184) af patienterne behandlet med meropenem.
English: How is Zavicefta used?
Danish: Hvordan anvendes Zavicefta?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zavicefta have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Zavicefta.
English: Avibactam blocks the action of bacterial enzymes called beta-lactamases.
Danish: Avibactam hæmmer virkningen af bakterielle enzymer, der kaldes betalaktamaser.
English: How does Zavicefta work?
Danish: Hvordan virker Zavicefta?
English: What benefits of Zavicefta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zavicefta?
English: London, 18 October 2006 Doc.
Danish: London, den 18. oktober 2006 Dok.
English: International non-proprietary name (INN): abetimus
Danish: Internationalt fællesnavn (INN): abetimus
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for RIQUENT
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for RIQUENT
English: A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
Danish: Et specialudleveringsprogram er et program, hvorigennem læger kan anmode om et lægemiddel rettet mod en specifik sygdom til en af deres patienter, inden lægemidlet er fuldt godkendt.
English: What is Riquent?
Danish: Hvad er Riquent?
English: The effects of Riquent were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Riquent blev undersøgt i eksperimentelle modeller, før de blev undersøgt hos mennesker.
English: What was Riquent expected to be used for?
Danish: Hvad forventedes Riquent anvendt til?
English: There were two main studies involving a total of 529 patients with SLE, in which Riquent was compared with a placebo (a dummy treatment).
Danish: Der blev udført to hovedundersøgelser med i alt 529 patienter med SLE, i hvilke Riquent blev sammenlignet med placebo (en inaktiv behandling).
English: Abetimus is a small piece of double-stranded DNA that has been designed to reduce circulating levels of these antibodies.
Danish: Abetimus er et lille stykke dobbeltstrenget DNA, som er udviklet til at reducere cirkulationsniveauet af disse antistoffer.
English: Riquent is a solution for injection that contains 50 mg/ml of the active substance abetimus.
Danish: Riquent er en væske til injektion, som indeholder 50 mg/ml af det aktive stof abetimus.
English: How is Riquent expected to work?
Danish: Hvordan forventes Riquent at virke?
English: Riquent was expected to delay and to reduce the incidence of ‘flares' (increased signs of kidney disease).
Danish: Riquent forventedes at forsinke og reducere forekomsten af "flares" (tiltagende tegn på nyresygdom).
English: Abetimus, the active substance in Riquent, is a selective immunosuppressive agent (a compound that selectively dampens down the immune system).
Danish: Abetimus, det aktive stof i Riquent, er et selektivt immunosuppressivt stof (en substans, der selektivt dæmper immunsystemet).
English: The application was at day 114 when the company withdrew.
Danish: Ansøgningen var 114 dage inde i vurderingsperioden, da virksomheden trak den tilbage.
English: Most patients with SLE have antibodies in their blood that are directed against double-stranded DNA (deoxyribonucleic acid).
Danish: De fleste patienter med SLE har antistoffer i blodet, som er rettet mod dobbeltstrenget DNA (deoxyribonukleinsyre).
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP svarene og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180) til firmaet.
English: These antibodies are thought to be linked to the development of lupus kidney disease.
Danish: Disse antistoffer menes at være forbundet med udviklingen af lupus nyresygdom.
English: Riquent was expected to be used to treat lupus nephritis, an inflammation of the kidneys in patients with systemic lupus erythematosus (SLE, an auto-immune disease caused by the body's own defence system attacking normal tissue) who have a history of kidney disease and have been tested to check that they will benefit from the medicine.
Danish: Riquent forventedes at blive anvendt til behandling af lupus nephritis, en betændelsestilstand i nyrerne hos patienter med systemisk lupus erythematosus (SLE, en autoimmun sygdom, som forårsages af kroppens eget forsvarssystem, der angriber normalt væv), som har nyresygdom i anamnesen, og hos hvem det er kontrolleret, at de vil have gavn af lægemidlet.
English: The company informed the CHMP that it plans to continue the ongoing clinical trials in the treatment of lupus nephritis.
Danish: Firmaet meddelte CHMP, at det har planer om at fortsætte de igangværende kliniske undersøgelser vedrørende behandling af lupus nephritis.
English: When Riquent is injected, the levels of these antibodies in the blood are lowered and this is expected to help reduce the patient's likelihood of experiencing a ‘flare'.
Danish: Når Riquent injiceres, sænkes niveauerne af disse antistoffer i blodet, og dette forventes at være med til at reducere sandsynligheden for, at patienten oplever en flare.
English: Because the number of patients with lupus nephritis is low, the disease is rare, and Riquent was designated an orphan medicine (a medicine used in rare diseases) on 20 November 2001.
Danish: Eftersom antallet af patienter med lupus nephritis er lavt, er sygdommen sjælden, og Riquent blev udpeget som lægemiddel til sjældne sygdomme den 20. november 2001.
English: On 13 October 2006, La Jolla Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Riquent, for the treatment of lupus nephritis.
Danish: Den 13. oktober 2006 underrettede La Jolla Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse for Riquent, som er et lægemiddel til behandling af lupus nephritis, tilbage.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Danish: CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: The CHMP was evaluating the initial documentation provided by the Company and had not yet made any recommendations.
Danish: CHMP var i gang med at vurdere den indledende dokumentation, som virksomheden havde fremlagt, og havde endnu ikke afgivet en udtalelse.
English: The studies measured how many patients developed ‘flares' and the time to the development of the flares by measuring the levels of protein in the urine and of creatinine (an enzyme that is a marker of kidney function) in the blood.
Danish: I undersøgelserne blev det målt, hvor mange patienter der udviklede flares, samt hvor lang tid der gik, før disse flares opstod, ved måling af koncentrationen af protein i urinen og koncentrationen af kreatinin (et enzym, der er en markør for nyrefunktionen) i blodet.
English: The CHMP was evaluating the initial documentation provided by the company.
Danish: CHMP var i gang med at vurdere den indledende dokumentation, som virksomheden havde fremlagt.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Riquent?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Riquent eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The Company has no compassionate use programme.
Danish: Firmaet har ingen programmer for anvendelse med særlig udleveringstilladelse.
English: This means that cancer cells cannot divide and eventually die.
Danish: Det betyder, at kræftcellerne ikke kan dele sig og til sidst vil dø.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caelyx on 21 June 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Caelyx den 21. juni 1996.
English: ‘Metastatic' means the cancer has spread to other parts of the body.
Danish: Metastatisk betyder, at kræften har spredt sig til andre dele af kroppen.
English: The full EPAR for Caelyx can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Caelyx findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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 inaktivere dna'et inde i cellerne og forhindrer dem dermed i at lave flere kopier af dna'et og i at lave proteiner.
English: This is a summary of the European public assessment report (EPAR) for Caelyx.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Caelyx.