FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets are given once a day at the same time every day, at a dose range of 1 - 2.4 mg per kg bodyweight depending on whether one or two tablets are required.
Danish: Tabletterne gives en gang om dagen på samme klokkeslæt hver dag med et dosisområde på 1 - 2,4 mg pr. kg kropsvægt afhængigt af, om der behøves en eller to tabletter.
English: The European Medicines Agency decided that Onsior's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Onsior opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats.
Danish: Efter afslutning af operationen sås tilstrækkelig smertekontrol op til 24 timer hos hunde og op til 52 timer (2 døgn) hos katte.
English: An overview of Onsior and why it is authorised in the EU
Danish: En oversigt over Onsior og hvorfor det er godkendt i EU
English: For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child.
Danish: For gravide kvinder, især de i de senere stadier af graviditeten, kan utilsigtet indtagelse eller selvinjektion af Onsior være farlig for det ufødte barn.
English: The solution for injection can also cause pain on injection.
Danish: Injektionsopløsningen kan desuden bevirke smerter ved injektion.
English: If the tablets are accidentally swallowed by a person, in particular by small children, or self-injection occurs with the solution for injection, the advice of a doctor should be sought immediately.
Danish: Hvis tabletterne ved et uheld indtages af en person, navnlig små børn, eller hvis der sker selvinjektion af injektionsopløsningen, bør der straks søge lægehjælp.
English: Pain was assessed by the veterinarian based on the animal's behaviour and responses to touching the inflamed area or moving the affected joint.
Danish: Smerter blev vurderet af dyrlægen baseret på dyrets adfærd og reaktioner på berøring af det betændte område eller bevægelse af det berørte led.
English: The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg bodyweight.
Danish: Injektionsopløsningen gives som en injektion under huden til katte eller hunde omkring 30 minutter før begyndelse af operationen, med en dosis på 2 mg/kg kropsvægt.
English: For more information about using Onsior, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelse af Onsior, kan du læse indlægssedlen, eller kontakte din dyrlæge eller dit apotek.
English: Why is Onsior authorised in the EU?
Danish: Hvorfor blev Onsior godkendt i EU?
English: The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Det aktive stof i Onsior, robenacoxib, tilhører lægemiddelgruppen ikke-steroide antiinflammatoriske lægemidler (NSAID).
English: Onsior is available as tablets in five different strengths (6 mg for cats and 5 mg, 10 mg, 20 mg, and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats).
Danish: Onsior fås som tabletter i fem forskellige styrker (6 mg til katte og 5 mg, 10 mg, 20 mg og 40 mg til hunde) og som injektionsvæske, opløsning (20 mg/ml, til hunde og katte).
English: Onsior contains the active substance robenacoxib.
Danish: Onsior indeholder det aktive stof robenacoxib.
English: Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs.
Danish: Onsior tabletter givet en gang om dagen reducerer smerter og bedrer bevægeligheden hos både katte og hunde.
English: What are the risks associated with Onsior?
Danish: Hvilke risici er der forbundet med Onsior?
English: In dogs, an increase in liver enzymes after long-term treatment with the tablets is common (which may affect up to 1 in 10 animals).
Danish: Hos hunde er en stigning i leverenzymer almindelig efter langvarig behandling med tabletterne (kan forekomme hos op til 1 ud af 10 dyr).
English: What is Onsior and what is it used for?
Danish: Hvad er Onsior, og hvad anvendes det til?
English: Onsior was as effective as the comparator NSAIDs and more effective than placebo.
Danish: Onsior var lige så effektivt som de NSAID, det blev sammenlignet med, og mere effektivt end placebo.
English: Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation.
Danish: Onsior er et antiinflammatorisk veterinærlægemiddel til behandling af katte og hunde mod smerter og betændelse.
English: Onsior must not be used with other NSAIDs or with glucocorticosteroids.
Danish: Onsior må ikke anvendes sammen med andre NSAID eller med binyrebarkhormoner.
English: Cats should be given a single dose by mouth prior to orthopaedic surgery.
Danish: Til katte gives en enkelt dosis gennem munden før ortopædisk operation.
English: Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems.
Danish: Der bør udvises forsigtighed ved behandling af katte eller hunde med kendt hjerte- eller nyresygdom, dehydrerede dyr og katte med leverproblemer.
English: The side effects of Onsior are similar to those seen with other NSAIDs.
Danish: Bivirkningerne af Onsior svarer til dem, der ses med andre NSAID.
English: The solution for injection caused a gradual decrease in pain scores in cats and dogs after surgery.
Danish: Injektionsopløsningen medførte et gradvist fald i smertescore hos katte og hunde efter operationen.
English: By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Danish: Ved at blokere produktionen af prostaglandiner reducerer robenacoxib smerter og betændelse som følge af muskuloskeletale sygdomme, operationer eller slidgigt.
English: It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients.
Danish: Det må ikke anvendes til dyr, der er drægtige, til diende hvalpe eller killinger, eller til dyr, der anvendes til avl eller er overfølsomme (allergiske) over for robenacoxib eller et af de øvrige indholdsstoffer.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Danish: Dette enzym medvirker ved dannelse af prostaglandiner, der er inddraget i smerter og betændelse.
English: After surgery in cats, a daily dose may be given for up to two further days.
Danish: Efter operationen kan katten gives en dosis om dagen i yderligere to dage.
English: In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.
Danish: Hos katte reducerede Onsior tabletter moderate smerter og betændelse i forbindelse med ortopædkirurgi i op til 2 dage efter operation i forhold til dyr, der fik placebo.
English: Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian.
Danish: Behandlingstiden er hos katte begrænset til seks dage for akutte muskuloskeletale sygdomme, og for kroniske muskuloskeletale sygdomme længere tid under dyrlægeovervågning.
English: For a full list of side effects of Onsior, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger af Onsior fremgår af indlægssedlen.
English: After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.
Danish: Efter operationen kan behandlingen af katte én gang dagligt fortsættes med samme dosis på samme klokkeslæt hver dag i op til 2 dage.
English: The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
Danish: De fleste bivirkninger af tabletterne og injektionsopløsningen er lette og forbigående virkninger på maven og tarmene, der viser sig som opkastning, blød afføring og diarré.
English: Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems.
Danish: Onsior tabletter må ikke anvendes til hunde eller katte med eksisterende mave-tarmlidelser såsom mavesår eller blødning, eller hos hunde med leverproblemer.
English: In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery.
Danish: Hos katte anvendes Onsior tabletter til behandling af smerter og betændelse ved kortvarige (akutte) og langvarige (kroniske) sygdomme i muskler og knogler (muskuloskeletale lidelser) og til at reducere moderate smerter og betændelse i forbindelse med knogleoperationer (ortopædkirurgi).
English: In a clinical study, Onsior tablets increased the activity in 10 of 35 cats with chronic musculoskeletal disorders (as measured by activity monitors on a neck collar) and scores of behaviour, quality of life, temperament and apparent happiness of cats compared to placebo (a dummy treatment).
Danish: Onsior var lige så effektivt som de NSAID, det blev sammenlignet med. I en klinisk undersøgelse øgede Onsior tabletterne aktiviteten hos 10 af 35 katte med kroniske muskuloskeletale sygdomme (målt med aktivitetsmonitorer på halsbåndet) og scoreværdier for adfærd, livskvalitet, temperament og tilsyneladende veltilpashed hos kattene, i forhold til virkningsløs behandling (placebo).
English: How does Onsior work?
Danish: Hvordan virker Onsior?
English: In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery.
Danish: Hos katte kan anvendes enten 6 mg tabletten eller injektionsopløsningen, når de bruges til at reducere smerte og betændelse ved ortopædkirurgi.
English: What benefits of Onsior have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Onsior?
English: In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain and inflammation in the joints).
Danish: Hos hunde anvendes Onsior tabletter til behandling af smerter og betændelse ved kronisk slidgigt (osteoartritis), der er en langvarig sygdom med smerter og betændelse i leddene.
English: How is Onsior used?
Danish: Hvordan anvendes Onsior?
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery.
Danish: Injektionsopløsningen anvendes til at behandle smerter og betændelse i forbindelse med ortopædiske operationer eller bløddelsoperationer.
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.
Danish: Injektionsopløsningen anvendes til at behandle smerter og betændelse i forbindelse med ortopædiske operationer eller bløddelsoperationer såsom kastrering.
English: Arzerra has been authorised since April 2010.
Danish: Arzerra har været godkendt siden april 2010.
English: The full European Public Assessment Report for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Arzerra findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is happening with Arzerra for the treatment of other diseases?
Danish: Hvad sker der med Arzerra til behandling af andre sygdomme?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
Danish: 1 Den 10. november 2016 vedtog CHMP en positiv udtalelse med anbefaling af en forlængelse af denne indikation: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
English: The main measure of effectiveness was based on the number of patients who showed a partial or complete response to treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på antallet af patienter, der udviste delvis eller fuldstændig respons på behandlingen.
English: What is Arzerra?
Danish: Hvad er Arzerra?
English: There are no consequences on the use of Arzerra in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for brugen af Arzerra i de godkendte indikationer.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Danish: Efter CHMP havde vurderet virksomhedens svar på spørgsmålene, var der fortsat visse uafklarede punkter.
English: What was Arzerra expected to be used for?
Danish: Hvad forventedes Arzerra anvendt til?
English: Additionally, although some patients (39 out of 53) responded to the combination Arzerra plus bendamustine, only a few patients (6 out of 53) had a complete response, and these data were not supported by further study results.
Danish: Selvom en række patienter (39 ud af 53) reagerede på kombinationen af Arzerra plus bendamustin, var der desuden kun nogle få patienter (6 ud af 53), som oplevede fuldstændig respons, og disse data var ikke understøttet af andre forsøgsresultater.
English: It can also be used in patients whose disease has not responded to previous treatment with fludarabine and a medicine called alemtuzumab1.
Danish: Det kan desuden anvendes hos patienter, der ikke har responderet på tidligere behandling med fludarabin og et lægemiddel kaldet alemtuzumab1.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter CHMP havde vurderet den dokumentation, som virksomheden havde fremlagt, og udarbejdet en liste med spørgsmål.
English: The company presented the results from a study involving 53 patients with relapsed CLL.
Danish: Virksomheden fremlagde resultaterne af en undersøgelse omfattende 53 patienter med recidiverende CLL.
English: All patients received Arzerra plus bendamustine; Arzerra was not compared with any other treatment in this study.
Danish: Alle patienter blev behandlet med Arzerra; Arzerra blev ikke sammenlignet med nogen anden behandling i denne undersøgelse.
English: On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).
Danish: Den 8. november 2016 meddelte Novartis Europharm Ltd. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Arzerra til anvendelse i en ny kombination med bendamustin til behandling af recidiverende kronisk lymfatisk leukæmi (CLL).
English: The CHMP was concerned that the study did not compare Arzerra with any other medicine and only included 53 patients with relapsed CLL.
Danish: CHMP var betænkelig ved, at undersøgelsen ikke sammenlignede Arzerra med noget andet lægemiddel, og at undersøgelsen kun omfattede 53 patienter med recidiverende CLL.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Arzerra could not have been approved for the treatment of relapsed CLL in combination with bendamustine.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Arzerra ikke kunne være blevet godkendt til behandling af recidiverende CLL i kombination med bendamustin.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not considered to be robust and the CHMP concluded that the medicine could not have been approved based on the data presented by the company.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at undersøgelsens resultater ikke ansås for pålidelige, og konkluderede, at lægemidlet ikke kunne være blevet godkendt på baggrund af de oplysninger, som virksomheden havde fremlagt.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the objections raised by the CHMP with regard to the design of the study and its patient population.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes CHMP's betænkeligheder vedrørende forsøgsdesignet og patientpopulationen.
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 kræftmiddel til behandling af voksne med kronisk lymfatisk leukæmi (CLL), dvs. kræft i en type hvide blodlegemer der kaldes lymfocytter.
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called CD20 on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Danish: Det aktive stof i Arzerra, ofatumumab, er et monoklonalt antistof, dvs. et protein, der er designet til at genkende og binde til et andet protein ved navn CD20 på overfladen af lymfocytter, herunder de maligne lymfocytter, der ses ved CLL.
English: Arzerra was also expected to be used in combination with bendamustine to treat adults with relapsed CLL (CLL that came back after previous treatment).
Danish: Arzerra forventedes anvendt i kombination med bendamustin til behandling af voksne med recidiverende CLL (dvs. CLL, der vender tilbage efter behandling).
English: Arzerra was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 7 November 2008 for CLL.
Danish: Arzerra blev den 7. november 2008 udpeget som "lægemiddel til sjældne sygdomme" til behandling af CLL.
English: It contains the active substance ofatumumab and is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Det indeholder det aktive stof ofatumumab og leveres som et koncentrat, der blandes til en infusionsvæske, opløsning, som indgives i en vene (med drop).
English: The company informed the CHMP that there are no consequences for patients currently included in or who may be joining clinical trials using Arzerra.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke har nogen konsekvenser for patienter, der i øjeblikket deltager eller vil deltage i kliniske undersøgelser med Arzerra.
English: It is used together with the cancer medicines chlorambucil or bendamustine in previously untreated patients who cannot be given treatment based on another medicine, fludarabine.
Danish: Det anvendes i kombination med kræftlægemidlerne chlorambucil eller bendamustin hos tidligere ubehandlede patienter, der ikke kan behandles med fludarabin (et andet lægemiddel).
English: Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Danish: Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
English: • have cancer.
Danish: • har kræft.
English: It must be used within this 30 days period.
Danish: Produktet skal anvendes inden for dette tidsrum på 30 dage.
English: Before you begin
Danish: Inden du går i gang
English: It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat.
Danish: Det er vigtigt at forsøge at undgå, at der opstår ONJ, da det kan være en smertefuld tilstand, som kan være svær at behandle.
English: These cases were predominantly cellulitis.
Danish: Disse tilfælde var fortrinsvis cellulitis.
English: • hair loss (alopecia).
Danish: • hårtab (alopeci).
English: Your doctor will discuss this with you.
Danish: Din læge vil fortælle dig mere om dette.
English: Long-term antiresorptive treatment
Danish: Antiresorptiv langtidsbehandling
English: Always wash your hands before every injection.
Danish: Vask altid dine hænder inden hver injektion.
English: For safety reasons: Do not grasp the plunger.
Danish: Af sikkerhedsmæssige grunde: Hold ikke på stemplet.
English: • are a smoker (as this may increase the risk of dental problems).
Danish: • er ryger (da det kan forhøje risikoen for at få problemer med tænderne).
English: These effects were sustained with continued treatment.
Danish: Disse effekter blev opretholdt i takt med den fortsatte behandling.
English: To give an injection, you will need:
Danish: For at kunne give en injektion skal du bruge:
English: Although this imbalance was identified via a pooled analysis, it was not identified via a stratified analysis.
Danish: Selvom denne ubalance blev påvist i en poolet analyse, blev den ikke påvist i en stratificeret analyse.
English: These events have also occurred without antiresorptive therapy.
Danish: Disse hændelser er også opstået uden antiresorptiv behandling.
English: Bone is a living tissue and is renewed all the time.
Danish: Knogler er levende væv og fornys hele tiden.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
Danish: Følgende risikofaktorer bør tages i betragtning, når man vurderer en patients risiko for at udvikle ONJ:
English: There is no experience with overdose in clinical studies.
Danish: Der er ingen erfaring med overdosering i kliniske studier.
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Danish: Det er vigtigt at fortælle det til din læge, hvis du er gravid; mener, at du kan være gravid eller planlægger at blive gravid.
English: Wash your hands thoroughly with soap and water.
Danish: Vask dine hænder grundigt med vand og sæbe.
English: Administration should be performed by an individual who has been adequately trained in injection techniques.
Danish: Indgivelse skal udføres af en person, der har fået fyldestgørende undervisning i injektionsteknikker.
English: It allows continued monitoring of the benefit-risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: Check the appearance of Prolia.
Danish: Kontrollér Prolias udseende.
English: Please talk to your doctor before you consider stopping the treatment.
Danish: Tal med din læge, inden du overvejer at standse behandlingen.
English: Thereafter, injections should be scheduled every 6 months from the date of the last injection.
Danish: Efterfølgende skal injektionerne gives hver 6. måned fra den seneste injektion.
English: These changes were partially reversible in this model when dosing with RANKL inhibitors was discontinued.
Danish: Disse ændringer var delvist reversible i denne model, når doseringen af RANKL-hæmmere ophørte.
English: To get the most benefit from your treatment, it is important to use Prolia for as long as your doctor prescribes it for you.
Danish: For at opnå den største fordel af din behandling er det vigtigt at bruge Prolia så længe, som din læge har ordineret det til.
English: Specific radiographic findings characterise these events.
Danish: Disse hændelser er kendetegnet ved specifikke radiografiske fund.