FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore Belgium and Sweden considered that the benefit/risk balance was negative for Tildren, as the efficacy of the product had not been sufficiently demonstrated.
Danish: Belgien og Sverige vurderede således, at benefit/risk-forholdet for Tildren var negativt, idet lægemidlets virkning ikke var blevet påvist med tilstrækkelig sikkerhed.
English: Assessment of the efficacy of Tildren
Danish: Vurdering af Tildrens virkning
English: The dose of 1 mg/kg was selected as the dose producing approximately 75 % inhibition of bone resorption.
Danish: Dosen på 1 mg/kg blev valgt som den dosis, der bevirkede en hæmning af knogleresorptionen på cirka 75 %.
English: Scientific conclusions and grounds for suspension or refusal of the granting of the marketing authorisation
Danish: Faglige konklusioner og begrundelse for suspendering af eller afslag på markedsføringstilladelse
English: Such lesions in the hock joint are responsible for varying degrees of lameness, often with an insidious onset, and leading to a complete ankylosis of the affected joints in the later stages of the disease.
Danish: Sådanne læsioner i haseleddet forårsager forskellige grader af halten, ofte med en snigende begyndelse, og kan føre til fuldstændig ankylose i de berørte led i sygdommens senere stadier.
English: Grounds for refusal of the granting of the marketing authorisation
Danish: Begrundelse for afslag på udstedelse af markedsføringstilladelse
English: There are considered to be significant deficiencies in the data provided by the Marketing Authorisation Holder in support of the efficacy of product.
Danish: Det vurderes, at der er betydelige mangler i de data, som indehaveren af markedsføringstilladelsen har indsendt til underbygning af lægemidlets virkning.
English: In the first study a number of criteria were chosen to evaluate efficacy, including lameness score, response to treatment, effect of pain on palpation or mobilisation of the limb, response to flexion test and level of activity.
Danish: I den første undersøgelse blev der udvalgt en række kriterier med henblik på at evaluere virkningen, herunder scoreværdien for halten, behandlingsrespons, smerteeffekt på leddets palpation eller mobilisation, respons på fleksionstest og aktivitetsniveau.
English: As bone resorption and bone formation are two coupled processes responsible for the integrity of bone mechanical properties, the inhibition of resorption secondarily leads to a slow-down in bone formation and, consequently, to a slow down in remodelling.
Danish: Idet knogleresorption og knogledannelse er to forbundne processer, der er ansvarlige for integriteten af knoglernes mekaniske egenskaber, medfører hæmning af knogleresorption sekundært en nedsat knogledannelse og, som følge heraf, nedsat remodellering.
English: On the other hand treatment with Tildren has been associated with abdominal disorders.
Danish: På den anden side er behandling med Tildren blevet associeret med mavesygdomme.
English: Tiludronate has anti-inflammatory and anti-arthritic properties by acting on macrophages.
Danish: Tiludronat har antiinflammatoriske og antiartritiske egenskaber, idet det virker på makrofager.
English: The CVMP was asked to assess if the efficacy of Tildren had been demonstrated and to conclude on the benefit/risk balance.
Danish: CVMP blev anmodet om at vurdere, hvorvidt Tildrens virkning var blevet påvist, og om at konkludere, hvorvidt lægemidlets benefit/risk-forhold er positivt eller negativt.
English: The data demonstrate a treatment effect on lameness whereas the role of exercise in connection with treatment was considered unresolved.
Danish: Dataene viser en behandlingseffekt på halten, mens det blev vurderet som uafklaret, hvilken rolle motion spillede i forbindelse med behandlingen.
English: Tiludronate is considered to reduce pain as bone disorders with increased osteoclastic bone resorption are frequently associated with pain.
Danish: Tiludronat betragtes som smertelindrende, idet knoglesygdomme med forøget osteoklastisk resorption ofte er forbundet med smerte.
English: Tiludronate is incorporated into the bone matrix and the osteoclasts where it affects ATP-dependent intracellular enzymes leading to apoptosis.
Danish: Tiludronat indarbejdes i knoglematricen og osteoklasterne, hvor det påvirker ATP-afhængige intracellulære enzymer, der forårsager apoptose.
English: With regard to the influence of exercise, the MAH concluded that the variation in exercise had been controlled to avoid any influence on the objective evaluation of the effect of the Tildren treatment.
Danish: Med hensyn til betydningen af motion konkluderede indehaveren af markedsføringstilladelsen, at variationen i motion var blevet kontrolleret for at undgå påvirkning af den objektive evaluering af virkningen af behandlingen med Tildren.
English: Bone spavin is a degenerative joint disease, characterized by bone modelling changes, articular cartilage destruction, and marginal osteophyte formation.
Danish: Spat er en degenerativ ledsygdom, som er kendetegnet ved ændringer i knoglemodelleringen, nedbrydelse af ledbrusken og marginal osteofytdannelse.
English: TILDREN 500 mg, lyophilisate for solution for infusion (Tiludronic acid) is a product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age.
Danish: TILDREN 500 mg, lyofilisat til infusionsvæske, opløsning, (tiludronsyre) er et lægemiddel, der indiceres som en hjælp i behandlingen af de kliniske tegn på halten i forbindelse med spat kombineret med et kontrolleret motionsprogram hos heste på over tre år.
English: The efficacy of Tildren for the treatment of bone spavin in horses should be demonstrated through the provision of appropriate field data clearly demonstrating that the administration of the product at an adequate dose shows a specific benefit unrelated to the concomitant use of NSAIDs or horse specific exercise programs.
Danish: Virkningen af Tildren i behandlingen af spat hos heste skal påvises gennem forelæggelse af relevante data fra feltundersøgelser, som tydeligt påviser, at indgivelse af lægemidlet i tilstrækkelig dosis viser en specifik fordel uden relation til den samtidige behandling med NSAID'er eller specifikke motionsprogrammer for den enkelte hest.
English: With regard to the concomitant NSAID treatment, the MAH concluded there were no statistical differences between the treated and placebo groups having received NSAID treatment and therefore had not included this treatment in the statistical analysis.
Danish: Med hensyn til den samtidige behandling med NSAID'er konkluderede indehaveren af markedsføringstilladelsen, at der ikke var nogen statistiske forskelle mellem behandlingsgruppen og placebogruppen under NSAID-behandling, og havde derfor ikke medtaget denne behandling i den statistiske analyse.
English: A number of further questions were addressed to the Marketing Authorisation Holder (MAH) relating to the dosage, clarification of the statistical analyses, the concomitant NSAID treatment and the influence of exercise.
Danish: En række andre spørgsmål blev rettet til indehaveren af markedsføringstilladelsen vedrørende dosering, præciseringer i forbindelse med de statistiske analyser, samtidig behandling med NSAID'er og betydningen af motion.
English: The CVMP, however, concluded that the arguments presented by the MAH were not adequate to demonstrate efficacy given the data presented and concerns remained with regard to the influence of the variable exercise programmes and the concomitant use of NSAIDs.
Danish: CVMP konkluderede imidlertid, at de argumenter, der blev fremført af indehaveren af markedsføringstilladelsen, ikke var tilstrækkelige til at påvise lægemidlets virkning på baggrund af de fremsendte data, og der var fortsat betænkeligheder med hensyn til betydningen af de variable motionsprogrammer og den samtidige behandling med NSAID'er.
English: The first clinical study was carried out in accordance with GCP to assess the efficacy and tolerance of tiludronic acid in the treatment of 3 clinical conditions including bone spavin and to compare two dosage regimes with treatment administering a placebo (vehicle only).
Danish: Den første kliniske undersøgelse blev foretaget i overensstemmelse med god klinisk praksis (GCP) for at vurdere virkningen og tolerancen af tiludronsyre i behandlingen af tre kliniske tilstande, herunder spat, og sammenligne to doseringsregimer med behandling med placebo (kun vehikel).
English: Further tiludronate inhibits the enzyme secretion by chondrocytes or synovial cells.
Danish: Tiludronat hæmmer endvidere enzymsekretionen af kondrocytter eller synovialceller.
English: These enzymes are responsible for the degradation of the joint cartilage matrix.
Danish: Disser enzymer er ansvarlige for nedbrydelsen af ledbruskmatricen.
English: With regard to dosage the MAH responded that there is no existing model in the horse to mimic bone spavin and the dose was extrapolated from a model of bone resorption in rats using an allometric extrapolation.
Danish: Med hensyn til dosering svarede indehaveren af markedsføringstilladelsen, at der ikke findes nogen eksisterende model hos heste til at imitere spat, og at dosis var ekstrapoleret fra en model for knogleresorption hos rotter gennem anvendelse af allometrisk ekstrapolering.
English: Overall summary of the scientific evaluation of TILDREN 500 mg lyophilisate for solution for infusion
Danish: Samlet resumé af den faglige vurdering af TILDREN 500 mg lyofilisat til infusionsvæske, opløsning
English: Tildren 500 mg lyophilisate for solution for infusion
Danish: Tildren 500 mg lyofilisat til infusionsv æske, opløsning
English: They considered that the selected dose was shown to produce concentrations in bone that are in the range of concentrations shown to inhibit bone resorption in vitro systems and that PK/PD modelling used was adequate to derive a pharmacologically active dose using a marker of bone resorption.
Danish: Man mente, at den valgte dosis havde vist sig at danne koncentrationer i knoglerne, som lå inden for de koncentrationer, som havde vist sig at hæmme knogleresorption in vitro, og at den anvendte farmakokinetiske og farmakodynamiske model var tilstrækkelig til at fastsætte en farmakologisk aktiv dosis ved anvendelse af en markør for knogleresorption.
English: In the second study, efficacy was judged on the criteria of lameness score, level of exercise, assessed according to the type of animals and the combination of changes in lameness score and exercise level.
Danish: I den anden undersøgelse blev virkningen bedømt på baggrund af kriterierne for scoreværdien for halten og aktivitetsniveau vurderet i henhold til dyretype og kombinationen af ændringer i scoreværdi for halten og aktivitetsniveau.
English: In the view of Belgium and Sweden the clinical trial performed according to the recommended dosage failed to show a statistical significant effect of the product.
Danish: Ifølge Belgien og Sverige blev der ikke påvist en statistisk signifikant virkning af lægemidlet i den kliniske undersøgelse foretaget i henhold til den anbefalede dosering.
English: The second clinical study was performed in accordance with GCP to assess the efficacy and the safety of tiludronic acid administered as a single infusion at the dose of 1 mg/kg bw in the treatment of bone spavin in horses.
Danish: Den anden kliniske undersøgelse blev foretaget i overensstemmelse med god klinisk praksis (GCP) for at vurdere virkningen og sikkerheden af tiludronsyre givet som enkeltinfusion med en dosis på 1 mg/kg legemsvægt i behandlingen af spat hos heste.
English: By inhibiting bone resorption, tiludronate acts as a regulator of bone metabolism in situation where there is extensive bone resorption.
Danish: Ved at hæmme knogleresorption har tiludronat en regulerende virkning på knoglemetabolismen i situationer med omfattende knogleresorption.
English: The resulting effect of osteoclast inhibition is inhibition of bone resorption.
Danish: Hæmning af osteoklasterne medfører hæmning af knogleresorptionen.
English: Its main cellular target is the mature osteoclast, the cell responsible for bone resorption.
Danish: Det virker ved primært at hæmme de modne osteoklaster, som er de celler, der resorberer knoglerne.
English: Lyophilisate for solution for infusion
Danish: Lyofilisat til infusionsvæske, opløsning
English: This summary was last updated in 12-2010.
Danish: Dette sammendrag blev sidst ajourført i 12-2010.
English: There was also a reduction in the patients who had a stent inserted.
Danish: Der var også en reduktion hos patienter, der havde fået indsat en stent.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Plavix to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Plavix med gyldighed i hele Den Europæiske Union til Sanofi Pharma Bristol-Myers Squibb SNC den 15. juli 1998.
English: The full EPAR for Plavix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Plavix 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 Plavix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Plavix.
English: Plavix is converted into its active form in the body.
Danish: Plavix omdannes til sin aktive form i kroppen.
English: In CAPRIE, there were 939 events in the Plavix group, and 1,020 in the aspirin group.
Danish: I CAPRIEundersøgelsen var der 939 hændelser i Plavix-gruppen og 1 020 i aspirin-gruppen.
English: Other information about Plavix
Danish: Andre oplysninger om Plavix
English: Plavix was more effective than aspirin at preventing new ischaemic events.
Danish: Plavix var mere effektivt end aspirin til forebyggelse af nye iskæmiske hændelser.
English: This showed that Plavix reduces the risk of an event.
Danish: Dette viser, at Plavix mindsker risikoen for en hændelse.
English: Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up.
Danish: Nogle af disse patienter kan have fået en stent (et kort rør) anbragt i en arterie for at forhindre denne i at indsnævre sig.
English: • recently had a myocardial infarction (heart attack).
Danish: • for nylig har haft et myokardieinfarkt (hjertetilfælde).
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 Plavix.
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 Plavix.
English: Plavix is used to prevent problems caused by blood clots in adults who have:
Danish: Plavix anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne, som
English: For more information about treatment with Plavix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Plavix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that fewer patients will have new ischaemic events if they receive Plavix than if they receive aspirin.
Danish: Dette betyder, at færre patienter vil opleve nye iskæmiske hændelser, når de får Plavix, end hvis de får aspirin.
English: The CHMP decided that Plavix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Plavix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Danish: Plavix bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for clopidogrel eller andre af indholdsstofferne.
English: It is available as pink tablets (round: 75 mg; oblong: 300 mg).
Danish: Det fås som lyserøde tabletter (runde: 75 mg, aflange: 300 mg).
English: • peripheral arterial disease (problems with blood flow in the arteries);
Danish: • har perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne),
English: For genetic reasons, some patients may not be able to convert Plavix as effectively as others, which could reduce their response to the medicine.
Danish: Visse patienter er af genetiske årsager måske ikke i stand til at omdanne Plavix lige så effektivt som andre og reagerer måske ikke lige så godt på lægemidlet.
English: The standard dose of Plavix is one 75-mg tablet once a day.
Danish: Standarddosis af Plavix er en tablet a 75 mg en gang dagligt.
English: In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Plavix instead of aspirin.
Danish: Ca. 10 patienter ud af 1 000 vil med andre ord undgå en ny iskæmisk hændelse to år efter, at de er begyndt at tage Plavix i stedet for aspirin.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Danish: Dette efterfølges så af en standarddosis på 75 mg en gang dagligt i mindst fire uger (ved myokardieinfarkt med ST-segment elevation) eller i op til 12 måneder (ved ustabil angina eller ‘non-Q-tak' myokardieinfarkt).
English: It must not be used in patients who have severe liver disease or a disease that may cause bleeding such as a stomach ulcer or bleeding in the brain.
Danish: Det må ikke anvendes til patienter, som har en svær leversygdom eller en sygdom, som kan give blødninger såsom mavesår eller blødning i hjernen.
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen).
English: In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Danish: Ved akut koronart syndrom med non-ST-segment elevation var den samlede relative reduktion af risikoen for en hændelse 20 % sammenlignet med placebo.
English: Plavix can be started between a few days and 35 days after the attack;
Danish: Behandling med Plavix kan indledes få dage efter anfaldet og indtil 35 dage efter,
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Danish: • har en sygdom kaldet ‘akut koronart syndrom', når det skal gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper).
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Danish: akut koronart syndrom er en samlebetegnelse for hjerteproblemer, som omfatter hjerteanfald og ustabil angina (en svær form for brystsmerter).
English: Plavix is a medicine that contains the active substance clopidogrel.
Danish: Plavix er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Danish: Når blodet koagulerer, skyldes det, at de særlige celler i blodet kaldet blodplader (trombocytter) klæber sammen (aggregerer).
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Danish: • har atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre, når det skal gives sammen med aspirin.
English: Plavix can be started between seven days and six months after the stroke;
Danish: Behandling med Plavix kan indledes syv dage efter slagtilfældet og indtil seks måneder efter,
English: In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Danish: Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på en 300-mg tablet eller fire 75- mg tabletter.
English: What is the risk associated with Plavix?
Danish: Hvilken risiko er der forbundet med Plavix?
English: The most common side effects with Plavix (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Danish: De hyppigste bivirkninger ved Plavix (der optræder hos mellem 1 og 10 patienter af 100) er hæmatom (blodsamling under huden), epistaksis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, dyspepsi (halsbrand), blå mærker og blødning på punkturstedet.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Danish: Det anvendes til patienter, som har mindst en risikofaktor for vaskulære hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin Kantagonister (andre lægemidler, der forebygger blodpropper), og som har en lille blødningsrisiko.
English: In ST segment elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Danish: Ved myokardieinfarkt med forhøjelse af ST-segmentet havde færre af de Plavix-behandlede patienter hændelser end de placebo-behandlede patienter (262 mod 377 i CLARITY-undersøgelsen og 2 121 mod 2 310 i COMMIT-undersøgelsen).
English: For the full list of all side effects reported with Plavix, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Plavix fremgår af indlægssedlen.
English: In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a blocked artery, another heart attack or death during the study.
Danish: I undersøgelserne af akut koronart syndrom tog alle patienterne også aspirin, og behandlingens virkning blev hovedsagelig bedømt på, hvor mange patienter, der oplevede en ‘hændelse' såsom en blokeret arterie, et nyt hjertetilfælde eller dødsfald i løbet af undersøgelsen.
English: Why has Plavix been approved?
Danish: Hvorfor blev Plavix godkendt?
English: Plavix has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Plavix with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Danish: Plavix blev også sammenlignet med placebo i to undersøgelser, der omfattede patienter med forhøjelse af STsegmentet: CLARITY, som omfattede over 3 000 patienter, og som varede i op til otte dage, og COMMIT, som omfattede næsten 46 000 patienter, og i løbet af hvilken patienterne fik Plavix med eller uden metoprolol (et andet lægemiddel anvendt ved hjerteproblemer eller forhøjet blodtryk) i op til fire uger.
English: In the study in atrial fibrillation patients, Plavix taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Danish: I undersøgelsen af atrieflimren nedsatte Plavix taget sammen med aspirin risikoen for nye hændelser med 11 % sammenlignet med placebo taget sammen med aspirin, idet slagtilfælde tegnede sig for den største nedsættelse (28 %).