FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with CLL is low, the disease is considered ‘rare', and Arzerra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Danish: Da antallet af patienter med kronisk lymfatisk leukæmi er lavt, betragtes sygdommen som "sjælden", og Arzerra blev udpeget som "lægemiddel til sjældne sygdomme" den 7. november 2008.
English: What are the risks associated with Arzerra?
Danish: Hvilke risici er der forbundet med Arzerra?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Arzerra can also be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Arzerra findes også på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The European Medicines Agency decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved lægemidlet opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Arzerra.
English: • in patients whose disease has come back after previous treatment (known as relapsed disease).
Danish: • til patienter, hvis sygdom er vendt tilbage efter tidligere behandling (kaldet recidiverende sygdom).
English: The response to treatment was assessed by looking at the patients' symptoms, the number of lymphocytes in their blood, results of blood and bone marrow tests and the size of their lymph nodes, liver and spleen.
Danish: Responsen på behandlingen blev vurderet ved at iagttage patienternes symptomer, antallet af lymfocytter i deres blod, resultater af blodprøver og knoglemarvsprøver samt størrelsen på deres lymfeknuder, lever og milt.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en særlig struktur (et antigen), som findes i visse celler i kroppen.
English: For practical information about using Arzerra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Arzerra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Before each infusion, the patient receives medicines, such as a corticosteroid, an antihistamine and paracetamol, to help to prevent infusion reactions (such as rash, fever, allergic reactions and difficulty breathing).
Danish: Inden hver infusion skal patienten have lægemidler som f.eks. et kortikosteroid, et antihistamin og paracetamol for at forebygge infusionsrelaterede reaktioner (såsom udslæt, feber, allergiske reaktioner og vejrtrækningsbesvær).
English: By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Danish: Ved at binde sig til CD20 stimulerer ofatumumab kroppens immunsystem til at angribe de maligne celler, hvorved sygdommen kan kontrolleres.
English: Arzerra can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in treating cancer and in a place where facilities for resuscitating patients are readily available.
Danish: Arzerra udleveres kun efter recept og bør kun administreres under tilsyn af en læge med erfaring i behandling af kræft og i omgivelser, hvor der er genoplivningsudstyr inden for rækkevidde.
English: The Agency noted that Arzerra was shown to be effective at treating patients with CLL (previously untreated patients, patients who had not responded to previous treatment with fludarabine and alemtuzumab and patients whose cancer had come back after previous treatment).
Danish: Agenturet bemærkede, at Arzerra havde vist sig effektivt til behandling af patienter med kronisk lymfatisk leukæmi (tidligere ubehandlede patienter, patienter, som ikke havde responderet på tidligere behandling med fludarabin og alemtuzumab, og patienter, hvis kræft var vendt tilbage efter tidligere behandling).
English: The most common side effects with Arzerra (seen in more than 1 patient in 10) are lower respiratory tract infection (infection of the lungs such as pneumonia), upper respiratory tract infection (nose and throat infection), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), nausea (feeling sick), fever, rash, dyspnoea (difficulty breathing), cough, diarrhoea and tiredness.
Danish: De hyppigste bivirkninger ved Arzerra (som optræder hos mere end én ud af 10 patienter) er infektioner i de nedre luftveje (infektioner i lungerne, f.eks. lungebetændelse), infektioner i de øvre luftveje (næse og hals), neutropeni (lavt niveau af neutrofiler, en type hvide blodlegemer), anæmi (lavt niveau af røde blodlegemer), kvalme, feber, udslæt, vejrtrækningsbesvær, hoste, diarré og træthed.
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Danish: Arzerra er et kræftlægemiddel til behandling af voksne med kronisk lymfatisk leukæmi (CLL), dvs. kræft i en type hvide blodlegemer, der kaldes lymfocytter.
English: For the full list of side effects and restrictions with Arzerra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger for Arzerra fremgår af indlægssedlen.
English: The response rate was slightly lower in patients whose treatment with fludarabine had failed but who were not suitable for treatment with alemtuzumab (43%).
Danish: Responsen var en smule lavere for patienter, som ikke havde responderet på behandling med fludarabin, men som ikke var egnede til behandling med alemtuzumab (43 %).
English: Arzerra contains the active substance ofatumumab.
Danish: Arzerra indeholder det aktive stof ofatumumab.
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody.
Danish: Det aktive stof i Arzerra, ofatumumab, er et monoklonalt antistof.
English: In these patients Arzerra is used together with fludarabine and cyclophosphamide.
Danish: Hos disse patienter anvendes Arzerra sammen med fludarabin og cyclophosphamid.
English: What benefits of Arzerra have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Arzerra?
English: Arzerra has been investigated in one main study involving 223 patients with CLL whose disease had not responded to previous treatment.
Danish: Arzerra er blevet undersøgt i en hovedundersøgelse med 223 patienter med kronisk lymfatisk leukæmi, som ikke havde responderet på tidligere behandling.
English: If reactions occur, treatment is interrupted and may be restarted at a slower rate when the patient has recovered or stopped permanently if a serious allergic reaction occurs.
Danish: Den kan genstartes med lavere infusionshastighed, når patienten er kommet sig, eller helt stoppes, hvis der opstår alvorlige allergiske reaktioner.
English: Ofatumumab has been designed to attach to a protein called CD20 that is found on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Danish: Ofatumumab er udviklet til at binde sig til et protein kaldet CD20, som findes på overfladen af lymfocytter, herunder de maligne lymfocytter, der ses ved kronisk lymfatisk leukæmi.
English: One main study involving 447 previously untreated patients who could not be treated with fludarabinebased therapy compared a combination of Arzerra plus chlorambucil with chlorambucil given alone.
Danish: I en hovedundersøgelse med 447 ikke tidligere behandlede patienter, som ikke kunne behandles med fludarabin, blev en kombination af Arzerra og chlorambucil sammenlignet med chlorambucil taget alene.
English: One main study involving 365 patients whose cancer had come back compared the combination of Arzerra plus fludarabine and cyclophosphamide with fludarabine and cyclophosphamide used alone.
Danish: I en hovedundersøgelse med 365 patienter, hvis kræft var vendt tilbage, blev kombinationen af Arzerra plus fludarabin og cyclophosphamid sammenlignet med fludarabin og cyclophosphamid anvendt alene.
English: Arzerra is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Arzerra leveres som et koncentrat, der blandes til en infusionsvæske, opløsning, til indgivelse (drop) i en vene.
English: For more information on how Arzerra is used, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Arzerra fremgår af produktresuméet (også en del af denne EPAR).
English: How is Arzerra used?
Danish: Hvordan anvendes Arzerra?
English: For more information about treatment with Arzerra, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Arzerra fremgår af indlægssedlen (også en del af denne EPAR).
English: How does Arzerra work?
Danish: Hvordan virker Arzerra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arzerra have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Arzerra.
English: In 95 of these patients, the disease had not responded to both fludarabine and alemtuzumab, and in 112, treatment with fludarabine had failed but the patients had not been treated with alemtuzumab because this medicine was not suitable for them.
Danish: 112 patienter havde ikke responderet på behandling med fludarabin, men de var heller ikke blevet behandlet med alemtuzumab, da dette lægemiddel var uegnet til dem.
English: The Agency also noted that patients with CLL who had not responded to previous treatment have limited treatment options.
Danish: Agenturet bemærkede desuden, at der var begrænsede behandlingsmuligheder for patienter med kronisk lymfatisk leukæmi, som ikke havde responderet på tidligere behandling.
English: Arzerra plus fludarabine and cyclophosphamide was effective at increasing progression-free survival, with patients living on average for 28.9 months without their disease getting worse, compared with 18.8 months in patients given fludarabine and cyclophosphamide alone.
Danish: Patienterne overlevede gennemsnitligt i 28,9 måneder uden sygdomsforværring, sammenholdt med 18,8 måneder for patienter, der fik fludarabin og cyclophosphamid alene.
English: In patients whose previous treatment with both fludarabine and alemtuzumab had failed, 49% (47 out of 95) responded to treatment with Arzerra.
Danish: 49 % (47 ud af 95) af de patienter, som ikke havde responderet på behandling med både fludarabin og alemtuzumab, responderede på behandlingen med Arzerra.
English: Previously untreated CLL
Danish: Kronisk lymfatisk leukæmi, der ikke tidligere er blevet behandlet
English: Refractory CLL
Danish: Refraktær kronisk lymfatisk leukæmi
English: Arzerra plus chlorambucil was effective at increasing progression-free survival (how long the patients lived without their disease getting worse), with patients living on average for 22.4 months without their disease getting worse, compared with 13.1 months in patients given chlorambucil alone.
Danish: Her overlevede patienterne gennemsnitligt i 22,4 måneder uden sygdomsforværring, sammenlignet med 13,1 måneder for patienter, der fik chlorambucil alene.
English: • in previously untreated patients who cannot be treated with fludarabine; in these patients it is used together with chlorambucil or bendamustine (other cancer medicines);
Danish: Hos disse patienter anvendes det i kombination med chlorambucil eller bendamustin (andre lægemidler mod kræft)
English: • in patients whose disease has not responded to previous treatment (known as refractory disease)
Danish: • til patienter, der ikke har reageret på tidligere behandling (kaldet refraktær sygdom) med fludarabin og et lægemiddel kaldet alemtuzumab
English: Relapsed CLL
Danish: Tilbagevendt kronisk lymfatisk leukæmi
English: Keep children away from treated animals during that time.
Danish: Hold børn væk fra behandlede dyr i denne periode.
English: The potential clinical consequences of such interactions have not been investigated.
Danish: Eventuelle kliniske konsekvenser af sådanne interaktioner er ikke undersøgt.
English: Wash hands after use.
Danish: Vask hænder efter brugen.
English: Highest concentration levels are found in the fat.
Danish: Det højeste koncentrationsniveau blev fundet i fedt.
English: Maximum concentrations were reached 2 hours after treatment for both active substances.
Danish: De maksimale koncentrationer blev nået 2 timer efter behandling for begge aktive stoffer.
English: The symptoms were completely reversible.
Danish: Symptomerne var fuldstændig reversible.
English: No food should be given until 4 hours after treatment.
Danish: Der bør ikke gives foder før 4 timer efter behandling.
English: Remove one pipette from package.
Danish: Tag en pipette ud af pakningen.
English: For example: Overnight fasting if the dog is to be treated in the morning.
Danish: For eksempel: faste natten over, hvis hunden skal behandles den efterfølgende morgen.
English: Echinococcosis represents a hazard for humans.
Danish: Echinococcosis udgør en fare for mennesker.
English: Allow the application site to dry before permitting contact with such materials.
Danish: Lad derfor behandlingsstedet tørre, inden der opstår mulighed for kontakt med sådanne materialer.
English: The excretion of emodepside has not been investigated in dogs.
Danish: Udskillelsen af emodepsid er ikke undersøgt hos hunde.
English: Treated animals therefore should not be bathed until the solution has dried.
Danish: Behandlede dyr bør derfor ikke bades før opløsningen er tørret.
English: Date of first authorisation: 27/07/2005.
Danish: Dato for første markedsføringstilladelse: 27/07/2005.
English: Do not administer orally or parenterally.
Danish: Må ikke gives oralt eller parenteralt.
English: Clear yellow to brown solution.
Danish: Klar gul til brun opløsning.
English: Studies in many different species show that praziquantel is rapidly metabolised in the liver.
Danish: Afprøvninger på mange forskellige dyrearter viser, at praziquantel hurtigt metaboliseres i leveren.
English: Remove screw cap (2).
Danish: Fjern skruelåget (2).
English: Do not smoke, eat or drink during application.
Danish: Spis, drik og ryg ikke under påføringen.
English: Appropriate combination of volumes
Danish: Passende kombination af volumen
English: Lot: {number}
Danish: Lot: {nummer}
English: Unused half tablets must not be stored for future use and should be disposed of in accordance with local requirements.
Danish: Ubrugte halve tabletter må ikke gemmes til fremtidig brug, og skal destrueres i overensstemmelse med de lokale krav.
English: Avoid direct contact with application area while it is wet.
Danish: Undgå direkte kontakt med påføringsstedet, mens det er vådt.
English: Incompatibilities: None known.
Danish: Uforligeligheder: Ingen kendte.
English: ATCvet code: QP52AA51.
Danish: ATCvet-kode: QP52AA51.
English: Volume (ml)
Danish: Volumen (ml)
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: Pharmacotherapeutic group: therapeutic antiparasitic agent.
Danish: Farmakoterapeutisk gruppe: Antiparasitikum.
English: (1 blister strip)
Danish: (1 blisterkort)
English: Emodepside is a substrate for P-glycoprotein.
Danish: Emodepsid er et substrat for P-glycoprotein.
English: Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product.
Danish: Børn bør ikke have langvarig tæt kontakt (f.eks. under søvn) med behandlede katte i de første 24 timer efter påføring af præparatet.
English: Each tablet of Profender contains:
Danish: Hver Profender-tablet indeholder:
English: Renal elimination predominates.
Danish: Renal udskillelse dominerer.
English: There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Danish: Der er begrænset erfaring med brug af præparatet til syge og svækkede dyr, derfor må det kun anvendes til sådanne dyr efter en risk-benefit vurdering.
English: Profender should not be allowed to enter water courses as emodepside has shown harmful effects on aquatic organisms.
Danish: Profender må ikke udledes i vandløb, da emodepsid har vist skadelig virkning på organismer i vandet.
English: No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function.
Danish: Der har ikke været udført studier med alvorligt svækkede hunde, eller hunde med alvorlig nedsat nyreeller leverfunktion.
English: Salivation and vomiting may occur in very rare cases.
Danish: Savlen og opkastning kan forekomme i meget sjældne tilfælde.
English: Both active substances were then eliminated from the plasma with a half-life of 1.4 to 1.7 hours.
Danish: Begge aktive stoffer blev udskilt fra plasma med en halveringstid på 1,4 til 1,7 timer.
English: For the lungworm Aelurostrongylus abstrusus, two treatments administered two weeks apart are effective.
Danish: For lungeorm Aelurostrongylus abstrusus er to behandlinger, administreret med to ugers mellemrum, tilstrækkeligt.
English: Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides.
Danish: Emodepsid er en semisyntetisk forbindelse, der tilhører den nye kemiske gruppe af depsipeptider.
English: Either calculate the exact dose based on the individual body weight, or use the following dose volumes recommended for the different weight ranges:
Danish: Beregn enten nøjagtig dosis ud fra individuel legemsvægt eller brug følgende dosis størrelse, som anbefales til forskellige vægtgrupper.
English: The tablets can be divided into equal halves.
Danish: Tabletten kan deles i 2 lige store halvdele.
English: It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.
Danish: Det virker på den neuromuskulære endeplade ved at stimulere presynaptiske receptorer, som tilhører secretin-receptor-gruppen, hvilket resulterer i parasitternes lammelse og død.
English: Avoid the treated cat or other cats in the household licking the site of application while it is wet.
Danish: Undgå at den behandlede kat eller andre katte i huset slikker på påføringsstedet, mens det er vådt.
English: Date of last renewal: 01/07/2010.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 01/07/2010.
English: The main metabolites are monohydroxycyclohexyl derivatives of praziquantel.
Danish: Hovedmetabolitterne er monohydroxycyklohexyl-derivater af praziquantel.
English: The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces.
Danish: Opløsningsmidlet i dette præparat kan give pletter på visse materialer såsom læder, tekstiler, plast og polerede overflader.
English: After oral application in the rat, emodepside is distributed to all organs.
Danish: Efter oral administration til rotter fordeler emodepsid sig til alle organer.
English: [Single-dose pipettes]
Danish: [Enkeltdosispipetter]
English: The symptoms were completely self-resolving without any treatment.
Danish: Symptomerne forsvandt fuldstændigt uden behandling.
English: Dosage and Treatment Schedule
Danish: Dosis og behandlingstabel
English: For user safety warnings - read the package leaflet before use.
Danish: Advarsler for brugeren - Læs indlægssedlen inden brug.
English: 0.35 (1 pipette) >2.5 - 5 Profender for Medium Cats 0.70 (1 pipette) >5 - 8 Profender for Large Cats
Danish: 0,35 (1 pipette) >2,5 - 5 Profender til mellemstore katte 0,70 (1 pipette) >5 - 8 Profender til store katte
English: Profender tablets are meat flavoured and usually dogs will accept them without any food.
Danish: Profender-tabletter er tilsat kødsmag, og hunde indtager dem normalt uden føde.
English: Special precautions for use in animals: Apply only to the skin surface and on intact skin.
Danish: Særlige forholdsregler til brug hos dyr: Kun til brug på hudoverfladen og på uskadt hud.
English: Administer only to fasted dogs.
Danish: Gives kun til fastende hunde.
English: Emodepside
Danish: Emodepsid
English: This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.
Danish: Dette fører til alvorlig skade på parasittens integument, sammentrækning og paralyse, hæmning af metabolismen hvilket til sidst medfører parasittens død.
English: For oral use in dogs from 12 weeks of age and weighing at least 1 kg. Profender tablets are meat flavoured and usually dogs will accept them without any food.
Danish: Til oral brug til hunde over 12 uger og som vejer mere end 1 kg. Profender-tabletter er tilsat smag, og hunde indtager dem normalt uden føde.
English: Then turn bottle up-side down, and withdraw the necessary volume (4).
Danish: Vend bunden i vejret på flasken og træk den nødvendige mængde ud (4).
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Danish: Parasitær resistens over for en bestemt gruppe antihelmintika kan opstå ved hyppig og gentagen brug af antihelmintika af denne gruppe.
English: Both active substances are then slowly eliminated from the serum with a half-life of 9.2 ± 3.9 days for emodepside and 4.1 ± 1.5 days for praziquantel.
Danish: Begge aktive stoffer blev derefter langsomt udskilt fra serum med en halveringstid på 9,2 ± 3,9 dage for emodepsid og på 4,1 ± 1,5 dage for praziquantel.
English: Butylhydroxyanisole Isopropylidene glycerol Lactic acid
Danish: Butylhydroxyanisol Isopropyliden glycerol Mælkesyre
English: Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.
Danish: Hold pipetten opret, drej og træk hætten af og brug den modsatte ende af hætten til at bryde forseglingen.
English: Maximum concentrations were reached for emodepside 3.2 ± 2.7 days after application and 18.7 ± 47 hours for praziquantel.
Danish: De maksimale koncentrationer blev for emodepsid nået 3,2 ± 2,7 dage efter påføring og for praziquantel 18,7 ± 47 timer efter.
English: Volume Emodepside Praziquantel
Danish: Volumen Emodepsid Praziquantel
English: When D. caninum infection is present, concomitant treatment against intermediate hosts such as fleas and lice should be considered to prevent reinfection.
Danish: Ved behandling af D. caninum-infektioner bør samtidig behandling af mellemværter såsom lopper og lus overvejes, for at forhindre geninfektion.
English: Non compliance with fasting requirements tended to be a feature of those cases.
Danish: Manglende efterlevelse af anbefalingen om faste ser ud til at være medvirkende til disse tilfælde.
English: If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
Danish: Hvis præparatet kommer i øjnene ved et uheld, skylles de grundigt med vand.