FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is necessary for buprenorphine/naloxon e and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for buprenorphin/naloxon og dasabuvir med ombitasvir/ paritaprevir/ritonavir
English: global multicentre, open-label
Danish: randomiseret globalt multicenter studie, åbent
English: Breastfeeding
Danish: Smephenytoin
English: • Feeling very tired (fatigue)
Danish: • usædvanlig træthed
English: No dose adjustment needed for dolutegravir when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for dolutegravir ved samtidig administration med dasabuvir + ombitasvir/paritaprevir/ri tonavir.
English: No dose adjustment is necessary for raltegravir or dasabuvir ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for raltegravir eller dasabuvir med ombitasvir/paritaprevir/ ritonavir.
English: Apalutamide
Danish: Lansoprazol
English: Very common
Danish: Meget almindelig Pruritus
English: България АбВи ЕООД
Danish: АбВи ЕООД Тел.
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks
Danish: Dasabuvir og ombitasvir/paritaprevir/ritonavir (12 uger)
English: dasabuvir and ombitasvir/paritaprevir/ritonavir with or without RBV for 12 or 24 weeks
Danish: Behandling: dasabuvir og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin i 12 eller 24 uger
English: ANTICONVULSANTS carbamazepine dasabu vir +
Danish: ANTIKONVULSIVEMIDLER Carbamazepin
English: Clinical Comments tacrolimus is due to
Danish: Klinisk kommentar dosis tonavir
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Danish: De behandlede patienter (N = 631) havde en median alder på 52 år (interval: 18-70); 54,5 % var mænd; 5,4 % var sorte; 15,2 % havde depression eller bipolar lidelse i anamnesen; 79,1 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 %
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Danish: Dasabuvir og ombitasvir/paritaprevir/ritonavir i 12 uger Med RBV
English: Hepatic decompensation and hepatic failure
Danish: Leverdekompensation og leversvigt Leverdekompensation og leversvigt Hud og subkutane væv
English: Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Danish: Mekanisme: Paritaprevir, ritonavir og dasabuvirs hæmning af BCRP
English: • Vomiting
Danish: • kvalme
English: Тел.
Danish: I pkt.
English: a herbal medicine for anxiety and mild depression.
Danish: mod angst og mild depression (naturlægemiddel) - fås i håndkøb
English: TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Danish: Behandlingsnaive pegIFN/RBV-erfarne 100 % (91/91) Tidligere recidiv 100 % (33/33) Tidligere delvis respons Tidligere nul respons Andre typer af pegIFN/RBV svigt I ALT +Andre typer af pegIFN/RBV svigt inklusive mindre vel-dokumenteret non-respons, recidiv/virologisk gennembrud eller anden pegIFN svigt.
English: Atazanavir/ ritonavir 300/100 mg once daily
Danish: ANTIMYKOTIKA Ketoconazol 400 mg én gang dagligt
English: This medicine is available without a prescription
Danish: Lægemidlet tages/gives
English: GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks)
Danish: Dasabuvir og ombitasvir/paritaprevir/ritonavir (8 uger)
English: ↑ keto conazole
Danish: Dabigatran etexilat
English: dasabuvir and ombitasvir/paritaprevir/ritonavir with weight-based ribavirin for 12 weeks
Danish: dasabuvir og ombitasvir/paritaprevir/ritonavir med ribavirin baseret på vægt i 12 uger
English: (see also Table 2).
Danish: 4.5, tabel 2).
English: AUC Ctrough
Danish: KG Knollstrasse
English: ombitas vir/parit aprevir/ ritonavi r carbamaze pine 10, 11epoxide section 4.3).
Danish: ombitasvir/p aritaprevir/ri tonavir hydrokodon (1,14-1,40) (1,72-2,10)
English: SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks n/N (%)
Danish: Dasabuvir og ombitasvir/paritaprevir/ritonavir i 8 uger n/N (%)
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Danish: Mekanisme: Paritaprevir, ritonavir og dasabuvirs hæmning af BCRP og Pgp.
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r everolimus
Danish: Dasabuvir ombitasvir/ paritaprevi r/ritonavir everolimus
English: NA ombitasvir/paritaprevir/ ritonavir).
Danish: ombitasvir/ paritaprevir/ritonavir
English: Axumin fluciclovine (
Danish: Axumin fluciclovin (
English: The side effects seen with the product are mild and rare, and there are no serious safety risks.
Danish: De iagttagne bivirkninger med lægemidlet er sjældne og lette, og der er ingen alvorlige sikkerhedsrisici.
English: The full EPAR for Axumin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Axumin 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 Axumin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Axumin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Axumin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Axumin er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Axumin
Danish: Andre oplysninger om Axumin
English: What measures are being taken to ensure the safe and effective use of Axumin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Axumin?
English: The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection.
Danish: De hyppigste bivirkninger ved Axumin (som optræder hos mellem 1 og 10 patienter ud af 100) er smagsforstyrrelser, ændret lugtesans og smerter eller udslæt på injektionsstedet.
English: It is not intended to provide practical advice on how to use Axumin.
Danish: Det er ikke en praktisk vejledning i, hvordan Axumin bør anvendes.
English: All men enrolled in this study had already shown some signs that the cancer might have returned, such as increases in blood levels of PSA, a protein produced in the prostate glands.
Danish: Alle mænd i denne undersøgelse havde vist tegn på, at kræften kunne være vendt tilbage, såsom stigning i blodets indhold af proteinet PSA, der dannes i prostata.
English: Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.
Danish: Axumin afgiver en meget lille mængde stråling, som kan tænkes at medføre en minimal risiko for kræft eller arvelige defekter.
English: PET scans with Axumin are effective in detecting prostate cancer and can help exclude the presence of the cancer.
Danish: PET-skanninger med Axumin er effektive til at opspore prostatakræft og kan medvirke til at udelukke tilstedeværelse af kræften.
English: Axumin is a ‘radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.
Danish: Axumin er et radioaktivt lægemiddel: Det indeholder det aktive stof fluciclovin (18F), der udsender en lille smule stråling.
English: Axumin is a diagnostic medicine used with a body scan to check whether or not prostate cancer has returned.
Danish: Axumin er et diagnostisk lægemiddel, der anvendes sammen med en kropsskanning for at kontrollere, om prostatakræft er vendt tilbage eller ej.
English: The company that markets Axumin will ensure that all healthcare professional expected to use this product have access to education material to reduce errors in interpreting PET scan images.
Danish: Den virksomhed, der markedsfører Axumin, skal sørge for, at alle sundhedspersoner, som forventes at anvende produktet, modtager oplysningsmateriale, der nedsætter fejl i fortolkningen af PETskanninger.
English: What is Axumin and what is it used for?
Danish: Hvad er Axumin, og hvad anvendes det til?
English: For the full list of side effects and restrictions reported with Axumin, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger, der er indberettet med Axumin, fremgår af indlægssedlen.
English: Why is Axumin approved?
Danish: Hvorfor er Axumin blevet godkendt?
English: For more information about treatment with Axumin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Axumin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Once inside the cancer cells, it emits radiation which is detected on the PET scan, enabling doctors to see where the cancer is located.
Danish: Når det er kommet ind i kræftcellerne, afgiver det stråling, som ses på PETskanningen, så lægerne kan se, hvor der er kræft.
English: It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.
Danish: Det anvendes specielt i forbindelse med en kropsskanning, der betegnes positronemissionstomografi (PET), hos mænd, hos hvem blodprøven for prostataspecifikt antigen (PSA) viser, at der kan være kræft.
English: Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.
Danish: Axumin fås som en injektionsvæske, opløsning, der indgives i en vene ca. 3-5 minutter før patienten skal have foretaget en PET-skanning.
English: What are the risks associated with Axumin?
Danish: Hvilke risici er der forbundet med Axumin?
English: The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells.
Danish: Det aktive stof i Axumin, fluciclovin (18F), afgiver en lille smule stråling og virker ved at blive optaget i prostatakræftceller gennem strukturerne LAT-1 og ASCT2, der findes i stort antal på overfladen af sådanne celler.
English: For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Axumin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling).
Danish: I en hovedundersøgelse, der omfattede patientjournaler fra 115 mænd, var de PET-skanninger med Axumin, der viste, at kræften var vendt tilbage hos en patient, korrekte i 79 % af tilfældene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Axumin have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge med henblik på sikker og effektiv anvendelse af Axumin.
English: How is Axumin used?
Danish: Hvordan anvendes Axumin?
English: What benefits of Axumin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Axumin?
English: Furthermore, the risk from radiation is very low.
Danish: Desuden er risikoen fra strålingen meget lav, og lægerne bliver instrueret i at anvende de laveste nødvendige doser.
English: The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin.
Danish: Resultatet skal gennemses af en sundhedsperson, der er oplært i at fortolke PET-skanninger.
English: How does Axumin work?
Danish: Hvordan virker Axumin?
English: Axumin can only be obtained with a prescription.
Danish: Axumin udleveres kun mod recept, og PET-skanningen skal udføres af uddannet medicinsk personale.
English: Depending on the person reading the scans, only 17 to 54% of patients whose tissue samples did not show cancer had a negative scan result.
Danish: Når PET-skanningerne viste, at kræften ikke var vendt tilbage hos en patient, var skanningerne desuden korrekte i 92 % af tilfældene.
English: Pharmaceutical form Route of administration
Danish: Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultatet af en procedure i henhold til artikel 31 i direktiv 2001/83/EF, som ændret
English: EMA/673031/2013 rev1 EMEA/H/A-31/1267
Danish: Den 18. september 2013 EMA/422612/2012 rev1 EMEA/H/A-31/1267
English: What are the recommendations for patients and prescribers?
Danish: Hvilke anbefalinger gælder for patienter og ordinerende læger?
English: What are antifibrinolytics?
Danish: Hvad er antifibrinolytika?
English: • Patients with any question should speak to their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål, bør kontakte lægen eller apotekspersonalet.
English: The European Commission issued a decision for aprotinin on 18 September 2013.
Danish: Europa-Kommissionen traf en beslutning om aprotinin den 18. september 2013.
English: New analyses showed flaws in the way the study was carried out, which cast doubt on the previous conclusions.
Danish: Nye analyser viste fejl i undersøgelsernes udførelse, hvilket rejste tvivl om de foregående konklusioner.
English: Prescribers will be sent information on how to use the registry.
Danish: De ordinerende læger vil få tilsendt oplysninger om, hvordan de skal benytte registret.
English: Aprotinin had been approved in several EU countries for patients undergoing heart bypass surgery but was suspended in the EU by the European Commission in February 2008.
Danish: Aprotinin har været godkendt i flere EU-lande til patienter, der får foretaget bypassoperationer på hjertet, men blev af Europa-Kommissionen suspenderet i EU i februar 2008.
English: Why were antifibrinolytics reviewed?
Danish: Hvorfor blev antifibrinolytika vurderet igen?
English: The CHMP was informed of ongoing pharmacokinetic studies which are to be finalised and assessed by national authorities.
Danish: CHMP blev informeret om igangværende farmakokinetiske undersøgelser, som skal afsluttes og vurderes af de nationale myndigheder.
English: • A registry will be set up in EU monitor the pattern of use of aprotinin.
Danish: • Der skal oprettes et register i EU til at overvåge anvendelsesmønstret for aprotinin.
English: • When aprotinin becomes available again, prescribers are advised to note the revised indication and to adhere closely to the updated prescribing advice.
Danish: • Når aprotinin igen bliver tilgængeligt, anbefales de ordinerende læger at tage den reviderede anvendelse til efterretning og nøje overholde de ajourførte ordineringsoplysninger.
English: There were also problems with the way data from some patients were excluded from the initial analyses and with the lack of appropriate monitoring of blood-thinning medicines the patients were taking.
Danish: Andre problemer var den måde, hvorpå dataene fra visse patienter blev udelukket af de indledende analyser, og den manglende passende overvågning af de blodfortyndende lægemidler, som patienterne fik.
English: Which data has the CHMP reviewed?
Danish: Hvilke data gennemgik CHMP?
English: The suspension in Germany led to an EU-wide review by the CHMP which recommended the suspension of aprotinin throughout the EU on 21 November 2007.
Danish: Suspenderingen i Tyskland førte til, at CHMP foretog en EU-dækkende gennemgang og anbefalede suspendering af aprotinin i hele EU den 21. november 20071.
English: The Committee also looked at data from other clinical studies, the published literature, spontaneous reports of side effects and data submitted by companies that market antifibrinolytics.
Danish: Udvalget så desuden på data fra andre kliniske undersøgelser, den videnskabelige litteratur, spontane bivirkningsindberetninger og data indsendt af virksomheder, der markedsfører antifibrinolytika.
English: On 5 November 2007, the German medicines regulatory authority (BfArM) suspended the marketing authorisations for aprotinin-containing medicines in Germany.
Danish: Den 5. november 2007 suspenderede den tyske lægemiddelstyrelse (BfArM) markedsføringstilladelserne for lægemidler indeholdende aprotinin i Tyskland.
English: The way additional blood-thinning treatments (such as heparin) were used in the study was inconsistent and sometimes inappropriate, and this could have contributed to higher than expected rates of deaths in patients on aprotinin.
Danish: Den måde, hvorpå der i undersøgelsen blev anvendt supplerende blodfortyndende medicin (såsom heparin), var inkonsekvent og undertiden uhensigtsmæssig, og dette kan have været medvirkende til, at dødeligheden hos patienter på aprotinin var højere end forventet.
English: During the review, the CHMP took advice from a scientific advisory group, consisting of experts in cardiovascular and bleeding disorders.
Danish: Under gennemgangen konsulterede CHMP en videnskabelig rådgivende gruppe af eksperter i hjerte-karsygdomme og blødningsforstyrrelser.
English: They have been used for several decades in patients undergoing certain dental or surgical operations as well as other patients at risk of complications from bleeding.
Danish: De har været anvendt i adskillige årtier hos patienter, der får foretaget tandbehandling og kirurgiske indgreb, samt andre patienter med risiko for blødningskomplikationer.
English: The CHMP's review of aminocaproic acid and tranexamic acid, which are currently on the market in the EU, did not reveal any new safety concerns.
Danish: CHMP's gennemgang af aminocapronsyre og tranexamsyre, der begge er på markedet i EU, afslørede ingen nye sikkerhedsproblemer.
English: The Committee has agreed with the companies marketing these medicines on a letter to be sent out to relevant healthcare professionals in the EU explaining the changes to the prescribing information.
Danish: Udvalget besluttede sammen med de virksomheder, der markedsfører disse lægemidler, at udsende et brev til de pågældende sundhedspersoner i EU med forklaring af ændringerne i ordineringsoplysningerne.
English: As these medicines have been authorised since the 1960s, the CHMP reviewed the available evidence on their benefits in various conditions and made recommendations to harmonise the conditions for which these medicines should be used in the EU.
Danish: Da disse lægemidler har været godkendt siden 1960'erne, gennemgik CHMP de foreliggende vidnesbyrd om deres fordele ved forskellige sygdomme og fremsatte anbefalinger til harmonisering af betingelserne for anvendelse af disse lægemidler i EU.
English: On 19 June 2012, following a re-examination, the CHMP confirmed its initial conclusions but decided to remove a requirement for a pharmacokinetic study with tranexamic acid.
Danish: Den 19. juni 2012 bekræftede CHMP efter fornyet overvejelse sine oprindelige konklusioner, men besluttede at slette et krav om en farmakokinetisk undersøgelse med tranexamsyre.
English: Aminocaproic acid and tranexamic acid are the commonly used antifibrinolytics in the EU.
Danish: Aminocapronsyre og tranexamsyre er de oftest anvendte antifibrinolytika i EU.
English: Antifibrinolytics are medicines used to prevent excessive blood loss.
Danish: Antifibrinolytika er lægemidler til forebyggelse af for stort blodtab.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines outweigh their risks and recommended that the EU-wide suspension of the marketing authorisation for aprotinin-containing medicines that has been in place since 2008 be lifted.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved disse lægemidler er større end risiciene, og anbefalede ophævelse af den suspendering af markedsføringstilladelsen i EU for lægemidler indeholdende aprotinin, der har været i kraft siden 2008.
English: In patients at risk of significant bleeding, antifibrinolytics ensure that blood clots are not broken down too rapidly, which helps to reduce blood loss.
Danish: Hos patienter med risiko for betydelig blødning sikrer antifibrinolytika, at blodpropperne ikke nedbrydes for hurtigt, hvorved blodtabet mindskes.
English: This decision was triggered by the early results of a study (the BART study) that showed a higher number of deaths 30 days after heart surgery among patients given aprotinin compared with patients given other antifibrinolytic treatments (aminocaproic acid and tranexamic acid).
Danish: Denne afgørelse blev foranlediget af de indledende resultater af en undersøgelse (BART-undersøgelsen), der viste et højere antal dødsfald 30 dage efter hjerteoperation hos patienter, der fik aprotinin, end hos patienter, der fik andre antifibrinolytiske midler (aminocapronsyre og tranexamsyre).
English: On 12 March 2010, the German medicines agency asked the CHMP to carry out a full assessment of the benefits and risks of aprotinin, as well as those of aminocaproic acid and tranexamic acid, and to issue an opinion on their authorisation in the EU.
Danish: Den 12. marts 2010 anmodede den tyske lægemiddelstyrelse CHMP om at foretage en fuldstændig vurdering af fordelene og risiciene ved aprotinin samt af aminocapronsyre og tranexamsyre og afgive en udtalelse om deres godkendelse i EU.
English: The results from the BART study were not replicated in other studies, and when data from several studies (excluding BART) were analysed together, the results did not show that aprotinin is linked to a higher risk of death compared with other antifibrinolytics.
Danish: Resultaterne af BART-undersøgelsen gentog sig ikke i andre undersøgelser, og når dataene fra adskillige undersøgelser (bortset fra BART) blev analyseret samlet, viste resultaterne ikke højere dødsrisiko med aprotinin end med andre antifibrinolytika.
English: • Prescribers should follow the new harmonised recommendations for the use of aminocaproic acid and tranexamic acid.
Danish: • De ordinerende læger bør overholde de nye harmoniserede anbefalinger for anvendelse af aminocapronsyre og tranexamsyre.
English: They work by reducing the activity of an enzyme called plasmin that is responsible for breaking up the fibres in blood clots.
Danish: Virkningen skyldes, at de nedsætter aktiviteten af enzymet plasmin, der er ansvarligt for nedbrydning af fibrene i blodpropperne.
English: The CHMP also recommended important changes to the prescribing information for aprotinin medicines, including restricting their use to isolated heart bypass surgery in adults at high risk of major blood loss and the inclusion of a warning on the risk of giving patients too little heparin (‘under heparinisation').
Danish: CHMP anbefalede desuden vigtige ændringer i produktinformationen for lægemidler indeholdende aprotinin, herunder, at deres anvendelse skal begrænses til isoleret bypassoperation på hjertet hos voksne med høj risiko for større blodtab, og at der skal indsættes en advarsel om risikoen ved at give for lille heparindosis (“underheparinisering”).
English: The CHMP reviewed data from the BART study, including additional data and analyses that became available since 2007.
Danish: CHMP gennemgik data fra BART-undersøgelsen, herunder supplerende data og analyser, der var blevet tilgængelige siden 2007.