FrancophonIA/ELRC3.0 huggingface dataset:
English: Plavix has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease.
Danish: Plavix blev sammenlignet med aspirin i en undersøgelse kaldet CAPRIE, hvori der indgik ca. 19 000 patienter, som inden for den seneste tid havde haft et hjerteanfald eller et iskæmisk slagtilfælde, eller som havde påvist perifer arteriesygdom.
English: The patients were treated for an average of three years, and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a heart attack, ischaemic stroke or death.
Danish: Patienterne blev behandlet i gennemsnitligt tre år, og behandlingens virkning blev hovedsageligt bedømt på antallet af patienter, som oplevede en ‘hændelse' såsom hjerteanfald, iskæmisk slagtilfælde eller dødsfald.
English: The main measure of effectiveness was how many patients experienced a new ‘ischaemic event' (heart attack, ischaemic stroke or death) over one to three years.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor mange patienter der i løbet af et til tre år oplevede en ny ‘iskæmisk hændelse' (hjerteanfald, iskæmisk slagtilfælde eller dødsfald).
English: The active substance in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Plavix, clopidogrel, er en trombocytfunktionshæmmer.
English: In acute coronary syndrome, Plavix has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Danish: Ved akut koronart syndrom blev Plavix sammenlignet med placebo (en virkningsløs behandling) i en undersøgelse, som omfattede godt 12 000 patienter med non-ST-segment elevation, hvoraf 2 172 fik en stent indsat i løbet af undersøgelsen (CURE-undersøgelsen varede i op til et år).
English: What is Plavix?
Danish: Hvad er Plavix?
English: In atrial fibrillation, Plavix has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Danish: Plavix blev til atrieflimren sammenlignet med placebo (begge taget sammen med aspirin) i en hovedundersøgelse, som omfattede ca. 7 500 patienter, der havde mindst en risikofaktor for vaskulære hændelser, og som ikke kunne tåle vitamin K-antagonistterapi.
English: What is Plavix used for?
Danish: Hvad anvendes Plavix til?
English: How has Plavix been studied?
Danish: Hvordan blev Plavix undersøgt?
English: What benefit has Plavix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Plavix?
English: In acute coronary syndrome and atrial fibrillation, Plavix is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Plavix sammen med aspirin.
English: How is Plavix used?
Danish: Hvordan anvendes Plavix?
English: How does Plavix work?
Danish: Hvordan virker Plavix?
English: London, 25 September 2008 Doc.
Danish: London, den 25. september 2008 Dok.
English: International non-proprietary name (INN): satraplatin
Danish: Internationalt fællesnavn (INN): satraplatin
English: This means that the cancer does not respond to hormonal treatment.
Danish: Det betyder, at kræften ikke reagerer på hormonbehandling.
English: What is Orplatna?
Danish: Hvad er Orplatna?
English: Questions and answers on the withdrawal of the marketing application for Orplatna
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse Orplatna
English: These compounds are made from the metal platinum.
Danish: Disse forbindelser er fremstillet af metallet platin.
English: As a result, it is expected to stop the growth of tumour cells, which eventually die.
Danish: Som følge heraf forventes det at standse væksten i kræftcellerne, som til sidst vil dø.
English: The effects of Orplatna were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Orplatna blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Progression-free survival was measured using a ‘composite' method, which means that there was more than one symptom that could be used as a measure.
Danish: Den progressionsfrie overlevelse blev målt ved hjælp af en ‘sammensat' metode, hvilket betyder, at der var mere end et symptom, som kunne anvendes som målestok.
English: In this instance, progression could be measured as the appearance of new tumours as detected during a scan, the appearance of new bone problems, the progression of symptoms (such as pain, weight loss or problems with urination), or death.
Danish: I dette tilfælde kunne progressionen måles som forekomst af nye tumorer således som påvist under scanning, forekomst af nye knogleproblemer, symptomforværring (såsom smerter, vægttab eller vandladningsbesvær) eller død.
English: The company informed the CHMP that Orplatna will continue to be made available for patients included in ongoing clinical trials.
Danish: Virksomheden underrettede CHMP om, at Orplatna fortsat vil være til rådighed for patienter, som indgår i igangværende kliniske undersøgelser.
English: The main measure of effectiveness was ‘progression-free survival' (the time taken for the disease to get worse) as well as overall survival time.
Danish: Det primære effektmål var ‘progressionsfri overlevelse' (den tid, det tager, inden sygdommen forværres) og den samlede overlevelsestid.
English: In the body, satraplatin is expected to attach itself to the DNA within cells, stopping them reproducing.
Danish: Satraplatin forventes i kroppen at binde sig til dna'et i cellerne, hvorved de forhindres i at reproducere sig selv.
English: Orplatna is a medicine that contains satraplatin as the active substance.
Danish: Orplatna er et lægemiddel, der indeholder satraplatin som aktivt stof.
English: What was Orplatna expected to be used for?
Danish: Hvad forventedes Orplatna anvendt til?
English: It was to be available as capsules to be taken by mouth containing 10 or 50 mg satraplatin.
Danish: Det skulle have været leveret som kapsler indeholdende 10 eller 50 mg satraplatin til oral anvendelse.
English: Orplatna was expected to be used to treat prostate cancer.
Danish: Orplatna forventedes anvendt til behandling af prostatacancer.
English: How is Orplatna expected to work?
Danish: Hvordan forventes Orplatna at virke?
English: The active substance in Orplatna, satraplatin, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘platinum compounds'.
Danish: Det aktive stof i Orplatna, satraplatin, er et cytotoksisk stof (et lægemiddel, som dræber celler, der deler sig såsom kræftceller), som tilhører gruppen af ‘platinforbindelser'.
English: Compared with placebo, Orplatna did not increase overall survival time, and the small improvement seen in progression-free survival was not considered relevant in the absence of a benefit in terms of overall survival time.
Danish: Sammenlignet med placebo øgede Orplatna ikke den samlede overlevelsestid, og de beskedne forbedringer i den progressionsfrie overlevelse ansås ikke for relevante i betragtning af den manglede effekt på den samlede overlevelsestid.
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Orplatna could not have been approved for the treatment of metastatic hormone-refractory prostate cancer.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Orplatna ikke kunne have været godkendt til behandling af metastaserende hormonresistent prostatacancer.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse med Orplatna?
English: However, the Committee was concerned that the patients in the main study who had previously treated been with docetaxel had more side effects when taking Orplatna than the patients who had received other medicines for their cancer before the study.
Danish: Udvalget havde imidlertid betænkeligheder ved, at patienterne i hovedundersøgelsen, som tidligere var blevet behandlet med docetaxel, havde flere bivirkninger, når de tog Orplatna, end patienter, som havde fået andre lægemidler for deres cancer inden undersøgelsen.
English: On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.
Danish: Den 1. august 2008 meddelte Pharmion Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Orplatna til behandling af patienter med metastaserende hormonresistent prostatacancer efter behandlingssvigt af tidligere kemoterapi.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Orplatna had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Orplatna ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
Danish: Det er en kræftform, som angriber prostata, der er den kirtel, som findes under blæren hos mænd, og som producerer sædvæsken.
English: The CHMP was concerned that the effectiveness of Orplatna had not been sufficiently shown.
Danish: CHMP fandt grund til betænkelighed ved, at effekten af Orplatna ikke var blevet tilstrækkeligt påvist.
English: The medicine was to be used with prednisone or prednisolone (anti-inflammatory medicines) in patients who had failed to respond to other anti-cancer medicines, when their cancer had spread from the original site to other parts of the body (metastatic) and had been shown to be ‘hormone-refractory'.
Danish: Dette lægemiddel skulle have været anvendt sammen med prednison eller prednisolon (antiinflammatoriske lægemidler) til patienter, som ikke havde haft effekt af andre lægemidler, når deres kræft havde bredt sig fra det oprindelige sted til andre dele af kroppen (metastaserende) og havde vist sig at være ‘hormonresistent'.
English: The Committee also noted that docetaxel is the standard first-line treatment for hormone-refractory prostate cancer, and that it is likely that most patients who would benefit from Orplatna treatment would have failed docetaxel treatment.
Danish: Udvalget bemærkede også, at docetaxel er en standard førstevalgsbehandling for hormonresistent prostatacancer, og at det er sandsynligt, at de fleste patienter, som ville have effekt af Orplatnabehandling, ikke ville have haft effekt af docetaxel.
English: In addition, the CHMP had concerns over the composite measure of progression-free survival which the Committed noted had not been sufficiently justified.
Danish: Endvidere var CHMP bekymret over den sammensatte målestok for progressionsfri overlevelse, der efter udvalgets opfattelse ikke var blevet tilstrækkeligt begrundet.
English: One main study compared the effectiveness of adding Orplatna or placebo (a dummy treatment) to prednisone in 950 patients with metastatic hormone-refractory prostate cancer in whom at least one previous treatment had failed.
Danish: Effekten af at tilføje Orplatna eller placebo (uvirksom behandling) til prednison blev sammenlignet i en hovedundersøgelse af 950 patienter med metastaserende hormonresistent prostatacancer, som ikke havde haft effekt af mindst en tidligere behandling.
English: 7.32 g 1 pre-filled syringe
Danish: 7,32g 1 forfyldt sprøjte
English: Invented Name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform
English: EU (MA) Number
Danish: EU Nummer
English: Withdrawal Period
Danish: Tilbageholde lsestid
English: Bottle (HDPE)
Danish: Oral anvendelse Tabletbeholder(H DPE)
English: One vial
Danish: N/A
English: (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage
English: France considered that the dosing regime of the product is not correct.
Danish: Frankrig mente, at doseringsregimet for produktet ikke var korrekt.
English: BACKGROUND INFORMATION
Danish: Indledning og baggrund
English: It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Danish: Dette kan føre til manglende effektivitet og udvikling af modstandsdygtighed hos de patogene målorganismer, hvilket muligvis kan medføre risiko for menneskers helbred, når det drejer sig om zoonotiske bakterier.
English: The CVMP started the referral procedure during its meeting of 6-8 November 2007.
Danish: CVMP startede proceduren den 6. november 2007.
English: CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste.
Danish: Equibactin vet. oral pasta har vist sig at være grundlæggende magen til referenceproduktet, Tribrissen oral pasta.
English: In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products.
Danish: Som svar på spørgsmål 2 påpegede ansøgeren, at der ikke er nogen forskel overhovedet mellem de to produkter, der ville kunne retfærdiggøre forskellige konklusioner vedrørende produkternes sikkerhed og effektivitet.
English: The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.
Danish: I betragtning af Frankrigs betænkeligheder blev ansøgeren bedt om at angive og dokumentere, hvor det er nødvendigt, enhver forskel mellem Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste og referenceproduktet Tribrissen oral pasta (tilladt i Holland), der kan retfærdiggøre forskellige konklusioner vedrørende de to produkters sikkerhed og effektivitet.
English: Being aware of a referral ongoing at the time under Article 35 of Directive 2001/82/EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/V/023) should apply to the marketing authorisation of Equibactin vet.
Danish: Det anbefales at ændre Equibactin vet. oral pasta, i overensstemmelse med udfaldet af indbringelsesprocedure EMEA/V/023 i henhold til artikel 35 i direktivet 2001/82/EF med senere ændringer, for referencelægemidlet Tribrissen oral pasta, der er godkendt i Holland.
English: Therefore the same conclusions on efficacy and safety apply equally to both products and the objections raised by France should not prevent the granting of a marketing authorisation.
Danish: Derfor gælder de samme konklusioner vedrørende effektivitet og sikkerhed for begge produkter.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Danish: Lægemiddelform Styrke
English: Staphylococcus aureus.
Danish: Willeskop 212
English: Equibactin vet. is a paste for oral use containing trimethoprim and sulfadiazine as active ingredients and is indicated for treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly:
Danish: Da sammensætningen af de to aktive ingredienser, trimethoprim og sulfadiazin, er identiske, lægemiddelformen er den samme, og da der er bioækvivalens mellem Equibactin vet. oral pasta og Tribrissen oral pasta for både trimethoprim og sulfadiazin, kan produkterne betragtes som værende grundlæggende ens.
English: European Medicines Agency Veterinary Medicines and Inspections
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIBACTIN VET.
Danish: Ifølge Rådets direktiv 2001/82/EF, artikel 33, stk. 4, med senere ændringer blev sagen henvist til CVMP.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Danish: Som svar på spørgsmål 1 sendte ansøgeren en kopi af det originale dossier, der blev indleveret med ansøgningen i den decentraliserede procedure, samt alle supplementære data, der blev indsendt i løbet af den decentraliserede procedure som svar på fase I og fase II vurderingen og den efterfølgende indbringelsesprocedure i CMD(v).
English: and Staphylococcus aureus;
Danish: 3421 GW Oudewater Holland
English: The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 3 March 2008.
Danish: Den 16. november 2007 blev svar på spørgsmålene modtaget fra MAH, og proceduren blev startet igen.
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko for mennesker er ikke kendt.
English: − Your urine is darker than normal
Danish: − hvis din urin er mørkere end normalt
English: If you feel tired, do not drive or use machines.
Danish: Hvis du føler dig træt, må du ikke køre bil eller betjene maskiner.
English: -have diabetes.
Danish: - har diabetes.
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Danish: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
English: PEARL I was conducted in the US and Europe, M12536 in Japan.
Danish: PEARL I blev gennemført i USA og Europa, M12536 i Japan.
English: (administered 12 hours apart)
Danish: (administreret med 12 timers mellemrum)
English: The ritonavir exposures were comparable between Asians and non-Asians.
Danish: Ritonavir-eksponeringen er sammenlignelig for asiater og ikke-asiater.
English: Drug interaction studies have only been performed in adults.
Danish: Lægemiddelinteraktionsstudier er kun udført hos voksne.
English: SAPPHIRE I and II
Danish: SAPPHIRE I og II
English: Activity in cell culture and/or biochemical studies
Danish: Aktivitet i cellekulturanalyser og/eller biokemiske studier
English: The majority of these ALT elevations were transient and assessed as drug-related.
Danish: Størstedelen af disse ALAT-forhøjelser var forbigående og blev vurderet som lægemiddelrelaterede.
English: Mechanism: Unknown
Danish: Mekanisme: Ikke kendt
English: Patients should be instructed not to take a double dose.
Danish: Patienterne skal have at vide, at de ikke må tage en dobbelt dosis.
English: Mechanism: Increase in
Danish: Mekanisme: Øget
English: Q2 2023
Danish: 2. kvartal 2023
English: The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks.
Danish: Kombinationen blev ikke forbundet med nævneværdige sikkerhedsproblemer hos en begrænset gruppe patienter, der blev behandlet i 12-24 uger.
English: Pharmacokinetic steady state for the combination is achieved after approximately 12 days of dosing.
Danish: Farmakokinetisk steady state for kombinationen opnås efter ca. 12 dages dosering.
English: Medicinal products that inhibit transport proteins
Danish: Lægemidler, der hæmmer transportproteiner
English: Caution is advised due to the expected increase in paritaprevir exposures.
Danish: Forsigtighed tilrådes på grund af forventet øget eksponering af paritaprevir.
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: NA Decrease amlodipine dose by 50% and monitor patients for clinical effects.
Danish: Reducér amlodipin-dosen med 50 %, og overvåg patienten for kliniske virkninger.
English: paritaprevir ANTIBIOTICS (SYSTEMIC ADMINISTRATION)
Danish: ANTIBIOTIKA (SYSTEMISK ADMINISTRATION)
English: • If you or your partner becomes pregnant during treatment with Viekirax and ribavirin or in the months that follow, you must contact your doctor immediately.
Danish: • Hvis du eller din partner bliver gravide under behandlingen med Viekirax og ribavirin eller i de efterfølgende måneder, skal du straks kontakte din læge.
English: There are very limited data from the use of Viekirax in pregnant women.
Danish: Der er meget begrænsede data fra anvendelse af Viekirax til gravide kvinder.
English: • Decide what other medicines you should take with Viekirax and for how long.
Danish: • beslutte, hvilke andre lægemidler du skal tage sammen med Viekirax, og i hvor lang tid
English: NA Clinical monitoring of patients is recommended.
Danish: Klinisk overvågning af patienten anbefales.
English: Your doctor will test your blood before, during and after your treatment with Viekirax.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Viekirax.
English: • Anaemia (low number of red blood cells)
Danish: • anæmi (nedsat antal røde blodlegemer)
English: ANGIOTENSIN RECEPTOR BLOCKER Valsartan
Danish: ANGIOTENSIN RECEPTOR BLOKKER Valsartan
English: − Notice yellowing of your skin or eyes
Danish: − hvis du bemærker gulfarvning af huden eller øjnene
English: Medicinal products transported by the OATP family and OCT1
Danish: Lægemidler, der transporteres af OATP-familien og OCT1
English: C12:= concentration at 12 hours following single dose of everolimus.
Danish: C12: = koncentration ved 12 timer efter en enkelt dosis af everolimus.
English: These metabolites are not expected to have antiviral activity.
Danish: Disse metabolitter forventes ikke at have antiviral aktivitet.
English: You will take Viekirax for 8, 12 or 24 weeks.
Danish: Du skal tage Viekirax i 8, 12 eller 24 uger.
English: Viekirax tablets are packed into foil blisters containing 2 tablets.
Danish: Viekirax-tabletterne er pakket i blisterpakninger, der indeholder 2 tabletter.
English: NA Patients should be monitored for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Danish: Patienten bør overvåges for kliniske virkninger; det kan være nødvendigt at reducere furosemid-dosen med op til 50 %.
English: Do not stop taking Viekirax unless your doctor tells you to.
Danish: Stop ikke behandlingen med Viekirax, medmindre lægen siger, du skal.
English: 14 film-coated tablets Component of a multipack, can't be sold separately.
Danish: 14 filmovertrukne tabletter Delpakning af multipakning, må ikke sælges separat.
English: Nausea, Diarrhoea
Danish: Kvalme, Diarré
English: See Table 2 for guidance regarding potential interactions with other medicinal products and dosing recommendations.
Danish: Se tabel 2 for vejledning vedrørende mulige interaktioner med andre lægemidler og doseringsanbefalinger.
English: • Take the tablets in the morning with food.
Danish: • Tag tabletterne om morgenen sammen med noget mad.
English: Table 16 shows SVR rates for these subjects.
Danish: Tabel 16 viser SVR-raterne for disse patienter.
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Danish: ALFA 1-ANTAGONIST Alfuzosin
English: The recommended dose is two tablets taken together in the morning.
Danish: Den anbefalede dosis er 2 tabletter, der tages samlet om morgenen.
English: Ombitasvir + paritaprevir + ritonavir* for 12 weeks Treatment-naïve
Danish: Ombitasvir + paritaprevir + ritonavir* i 12 uger Behandlingsnaive