FrancophonIA/ELRC3.0 huggingface dataset:
English: Olysio is used in combination with other medicines.
Danish: Olysio anvendes i kombination med andre
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Danish: Denne undersøgelse gennemføres på baggrund af data, der indikerer, at patienter, som behandles med disse lægemidler, og som har haft leverkræft, kan risikere, at deres kræft vender hurtigt tilbage.
English: The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Olysio opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Danish: Hvad sikkerheden angår, tåltes Olysio godt, og bivirkningerne kunne behandles.
English: It is not intended to provide practical advice on how to use Olysio.
Danish: Det er ikke en praktisk vejledning i, hvordan Olysio bør anvendes.
English: What are the risks associated with Olysio?
Danish: Hvilke risici er der forbundet med Olysio?
English: Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Danish: Olysio udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
English: The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio.
Danish: Virksomheden, der markedsfører Olysio, vil gennemføre en undersøgelse blandt patienter, der tidligere har haft leverkræft, for at vurdere risikoen for, at leverkræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Olysio.
English: How does Olysio work?
Danish: Hvordan virker Olysio?
English: For the full list of side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger
English: Olysio is an antiviral medicine that contains the active substance simeprevir.
Danish: Olysio er et lægemiddel mod virus (et antiviralt lægemiddel), der indeholder det aktive stof simeprevir.
English: An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.
Danish: En analyse af disse undersøgelser viste, at Olysio var mindre effektivt hos den undergruppe, der var smittet med hepatitis C-virus af genotype 1a med Q80K-mutationen.
English: The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Danish: De hyppigste bivirkninger ved Olysio (som optræder hos mere end 1 ud af 10 patienter) er kvalme, udslæt, kløe og vejrtrækningsbesvær.
English: Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Danish: Olysio skal anvendes i kombination med andre lægemidler til behandling af kronisk hepatitis C, såsom peginterferon alfa og ribavirin eller sofosbuvir.
English: It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Danish: Det anvendes til behandling af voksne med kronisk hepatitis C, der er en smitsom sygdom, som angriber leveren og forårsages af hepatitis C-virus.
English: Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Danish: Eliminationen nåede op på over 90 %, når behandlingen blev forlænget til 24 uger.
English: Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Danish: Tre hovedundersøgelser med 1 178 patienter, som havde hepatitis C-virus af genotype 1, så nærmere på kombinationen med peginterferon alfa og ribavirin.
English: Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
Danish: Før behandlingen med Olysio påbegyndes, bør patienter med genotype 1a have taget en blodprøve for at se, om den virus, de er smittet med, indeholder en forandring (mutation) kaldet Q80K, da Olysio vides at være mindre effektivt hos disse patienter.
English: The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
Danish: I undersøgelsen deltog patienter med og uden skrumpelever og patienter, hos hvem den tidligere behandling ikke
English: For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olysio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Danish: En række undersøgelser viser, at Olysio i kombination med peginterferon alfa og ribavirin eller med sofosbuvir var effektivt til at eliminere hepatitis C-virusset fra blodet efter 12 eller 24 ugers
English: The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Danish: Det aktive stof i Olysio, simeprevir, blokerer virkningen af enzymet NS3/4A serinprotease i hepatitis Cvirusset.
English: Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Danish: Yderligere undersøgelser med kombinationen af peginterferon alfa og ribavirin hos patienter med hepatitis C-virus af genotype 4 og patienter, der desuden var smittet med hiv, gav de lignende resultater som hos patienter med
English: What benefits of Olysio have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Olysio?
English: In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
Danish: I to yderligere undersøgelser med 413 patienter, som fik simeprevir i kombination med sofosbuvir, var eliminationen hos patienterne uden skrumpelever, som fik Olysio sammen med sofosbuvir, 97 % efter 12 uger, mens eliminationen hos patienterne med skrumpelever var 83 % efter 12 uger.
English: Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
Danish: En undersøgelse med 167 patienter så nærmere på kombinationen af Olysio og sofosbuvir, og resultaterne viste, at denne kombination (med eller uden ribavirin) har elimineret infektionen med hepatitis C af genotype 1 hos over 90 % af patienterne 12 uger efter afslutningen af behandlingen.
English: In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
Danish: I den tredje undersøgelse med patienter, hvis infektion var vendt tilbage efter interferonbaseret behandling, var omkring 80 % (206 ud af 260) af de patienter, der fik Olysio, hepatitis C-negative 12 uger efter afslutningen af behandlingen sammenlignet med 37 % (49 ud 133) af dem, der fik placebo.
English: In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Danish: I to undersøgelser med ikke tidligere behandlede patienter var omkring 80 % (419 ud af 521) af de patienter, der fik Olysio, hepatitis Cnegative 12 uger efter afslutningen af behandlingen sammenlignet med 50 % (132 ud 264) af dem,
English: For practical information about using Olysio, patients should read the package leaflet or contact their
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Olysio, kan du læse indlægssedlen eller
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Olysio.
English: The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Danish: Agenturet konkluderede, at betydeligt flere patienter var uden tegn på infektion, når de fik Olysio som tillægsbehandling til peginterferon alfa og ribavirin, og at dette gælder både tidligere ubehandlede og tidligere behandlede patienter.
English: Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Danish: Olysio anbefales til patienter med virus af genotype 1 og 4.
English: The required dose is determined using the following formula:
Danish: Den nødvendige dosis bestemmes ved hjælp af følgende formel:
English: Date of first authorisation: 04 January 2017
Danish: Dato for første markedsføringstilladelse: 04 januar 2017
English: Your doctor should inform you of the early signs of allergic reactions.
Danish: Din læge vil oplyse dig om de tidlige tegn på allergiske reaktioner.
English: The regimen may be adjusted based on patient response.
Danish: Regimet kan justeres ud fra patientens respons.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning skal lægemidlet anvendes straks.
English: Paediatric population <12 years of age
Danish: Pædiatrisk population <12 år
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: Med henblik på forbedring af sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede produkt angives tydeligt.
English: Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
Danish: Ældre Kliniske studier med AFSTYLA har ikke inkluderet personer over 65 år.
English: ATC code: B02BD02
Danish: ATC-kode: B02BD02
English: • the severity of your disease
Danish: • hvor alvorlig din sygdom er
English: VWF stabilizes factor VIII and protects it from degradation.
Danish: VWF stabiliserer faktor VIII og beskytter den mod nedbrydning.
English: The amount of AFSTYLA you need to take and the duration of treatment depend on:
Danish: Hvor meget AFSTYLA, du skal have, samt behandlingens varighed afhænger af:
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Danish: Dette kan enten gøres ved at lade hætteglassene stå ved stuetemperatur i en times tid eller ved at holde dem i hænderne i nogle få minutter.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Danish: Faktor VIII bør derfor kun anvendes under graviditet og amning, hvis det er klart indiceret.
English: Osmolality: 500 - 600 mOsm/kg
Danish: Osmolalitet: 500-600 mOsm/kg
English: The product contain traces of hamster proteins (see also “Do not use AFSTYLA”).
Danish: Præparatet indeholder spor af hamsterproteiner (se også afsnittet "Brug ikke AFSTYLA").
English: Like all medicines, AFSTYLA can cause side effects, although not everybody gets them.
Danish: AFSTYLA kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
English: More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
Danish: Hyppigere eller højere doser kan være nødvendige hos børn <12 år for at opveje den højere clearance i denne aldersgruppe.
English: No paediatric subjects <18 years of age were included in the surgery population.
Danish: Der blev ikke inkluderet nogen pædiatriske patienter < 18 år i kirurgi-populationen.
English: Monitoring laboratory tests
Danish: Monitorering ved hjælp af laboratorieprøver
English: Repeat injection every 12 to 24 hours.
Danish: Injektion gentages hver 12. til 24. time.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Dosering baseret på kropsvægt kan nødvendiggøre justering hos under- og overvægtige patienter.
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 48 hours at room temperature (below 25 °C).
Danish: Efter rekonstitution er der påvist kemisk og fysisk i-brug-stabilitet på 48 timer ved stuetemperatur (under 25 °C).
English: The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
Danish: Den specifikke aktivitet af AFSTYLA er 7.400-16.000 IE/mg protein.
English: Do not use AFSTYLA
Danish: Brug ikke AFSTYLA
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Danish: Det noteres at den årlige blødningsrate (ABR) ikke kan sammenlignes mellem forskellige faktorkoncentrater eller mellem kliniske studier.
English: No patient developed an inhibitor or experienced an anaphylactic reaction.
Danish: Ingen patienter udviklede inhibitorer eller oplevede anafylaktiske reaktioner.
English: Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Danish: Mangel på denne faktor betyder, at blodet ikke koagulerer så hurtigt, som det bør, hvorved tendensen til blødninger øges.
English: AFSTYLA can be used for all age groups.
Danish: AFSTYLA kan bruges til alle aldersgrupper.
English: Do not expose the vials to direct heat.
Danish: Udsæt ikke hætteglassene for direkte varme.
English: • pain at the injection site
Danish: • smerter på injektionsstedet
English: Frequencies have been evaluated on a per patient basis according to the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er vurderet i henhold til følgende konvention: 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), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not stop using AFSTYLA without consulting your doctor.
Danish: Hold ikke op med at bruge AFSTYLA uden først at rådføre dig med din læge.
English: Hemostatic efficacy of rVIII-SingleChain in surgical prophylaxis was rated as excellent or good in all surgeries.
Danish: Den hæmostatiske virkning af rVIII-SingleChain til kirurgisk profylakse blev vurderet som fremragende eller god ved alle kirurgiske indgreb.
English: Frequency of doses (hours) / Duration of therapy (days)
Danish: Doseringsfrekvens (timer) / behandlingsvarighed (dage)
English: However depending on your body weight and your dose of AFSTYLA, you could receive more than one vial.
Danish: Afhængigt af din legemsvægt og af AFSTYLA-dosis kan du få mere end ét hætteglas.
English: Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
Danish: Tag straks den næste dosis og fortsæt som anvist af lægen eller apotekspersonalet.
English: • AFSTYLA must not be mixed with other medicines or solvents except those mentioned in section 6.
Danish: • AFSTYLA må ikke blandes med andre lægemidler eller solvenser end dem, der er nævnt i afsnit
English: In children below the age of 12 higher doses or more frequent injections may be needed.
Danish: Børn under 12 år kan have brug for højere doser eller hyppigere injektioner.
English: If you stop using AFSTYLA you may no longer be protected against bleeding or a current bleed may not stop.
Danish: Hvis du holder med at bruge AFSTYLA, kan det være, at du ikke er beskyttet mod blødning længere, eller at en eventuel blødning ikke stopper.
English: All patients had been diagnosed with severe haemophilia A with <1% factor VIII.
Danish: Alle patienter havde fået diagnosticeret svær hæmofili A med <1 % faktor VIII.
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Danish: • Udvikling af inhibitorer (antistoffer) er en kendt komplikation, som kan opstå under behandling med alle faktor VIII-lægemidler.
English: • Store in a refrigerator (2 °C to 8 °C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: 2.5 ml [for reconstitution of strengths 250/500/1000 IU] 5 ml [for reconstitution of strengths 1500/2000/2500/3000 IU]
Danish: 2.5 ml [til rekonstitution af styrkerne 250/500/1000 IU] 5 ml [til rekonstitution af styrkerne 1500/2000/2500/3000 IU]
English: IR and Cmax were baseline corrected while the remaining parameters were not baseline corrected.
Danish: IR og Cmax blev baseline-korrigeret, hvorimod de andre parametre ikke blev baseline-korrigeret.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Danish: Faktor VIII/von Willebrand-faktor-komplekset består af to molekyler (faktor VIII og von Willebrand-faktor) med forskellige fysiologiske funktioner.
English: Inject every 24 hours, at least 1 day, until healing is achieved.
Danish: Injektion hver 24. time, mindst 1 dag, indtil heling er opnået.
English: For patients with previous hypersensitivity reactions appropriate pre-medication may be considered.
Danish: Hos patienter, der tidligere har oplevet overfølsomhedsreaktioner, kan passende præmedicinering overvejes.
English: The solvent will automatically flow into the powder vial.
Danish: Solvensen løber automatisk over i hætteglasset med pulver.
English: Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Danish: Når præparatet er taget ud af køleskab, må det ikke sættes tilbage i køleskab.
English: Factor VIII level required (%) (IU/dl)
Danish: Nødvendigt faktor VIII-niveau (%) (IE/dl)
English: The chromogenic assay result most accurately reflects the clinical hemostatic potential of AFSTYLA and is preferred.
Danish: Kromogenanalysen giver den mest præcise afspejling af det kliniske hæmostatiske potentiale af AFSTYLA og er at foretrække.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity studies, local tolerability and thrombogenicity assessments.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkeltdosis og gentagne doser, lokal tolerabilitet og trombogenicitet.
English: Activated AFSTYLA has an amino acid sequence identical to endogenous FVIIIa.
Danish: Aktiveret AFSTYLA har samme aminosyresekvens som endogen FVIIIa.
English: May be stored at room temperature up to 25 °C for a single 3 months period.
Danish: Kan opbevares ved stuetemperatur ved højst 25 °C i en enkelt 3-måneders periode.
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Danish: Aktiveret faktor VIII virker som en kofaktor for aktiveret faktor IX, hvilket accelererer omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili A hos kvinder er der ingen tilgængelige data fra brug af faktor VIII under graviditet og amning.
English: What AFSTYLA contains
Danish: AFSTYLA indeholder
English: Please stop using the medicine immediately and contact your doctor if:
Danish: Stop omgående med at bruge dette lægemiddel og kontakt lægen, hvis:
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Danish: Især ved større kirurgiske indgreb er korrekt monitorering af substitutionsbehandlingen ved hjælp af koagulationsanalyse (faktor VIII-aktivitet i plasma) uundværlig.
English: • During pregnancy and breast-feeding, AFSTYLA should be given only if it is clearly needed.
Danish: • Gravide kvinder og kvinder, der ammer, må kun få AFSTYLA, hvis det er absolut nødvendigt.
English: Children above 12 years of age can use the same dose as adults.
Danish: Børn over 12 år kan bruge samme doser som voksne.
English: Study 3002 enrolled a total of 84 previously treated patients <12 years of age (35 <6 years of age and 49 6 to <12 years of age).
Danish: I studie 3002 blev der inkluderet i alt 84 tidligere behandlede patienter < 12 år (35 var <6 år, og 49 var 6 til <12 år).
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Danish: Dosis og substitutionsbehandlingens varighed afhænger af, hvor alvorlig faktor VIII-manglen er, af blødningsstedet og blødningsomfanget samt af patientens kliniske tilstand.
English: Allergic type hypersensitivity reactions are possible with AFSTYLA.
Danish: Der kan forekomme allergiske overfølsomhedsreaktioner med AFSTYLA.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Danish: Mindst 1 dag, indtil blødningsepisoden er forsvundet vurderet ud fra smerter, eller indtil heling er opnået.
English: Reconstitution and administration
Danish: Rekonstitution og administration
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are in the responsibility of the user.
Danish: • Hvis den fremstillede injektionsvæske ikke anvendes med det samme, er opbevaringstiden og opbevaringsforholdene før brug brugerens ansvar.
English: The study participants accumulated a total of 5,239 EDs with rVIIISingleChain.
Danish: Studiedeltagerne akkumulerede i alt 5.239 ED med rVIII-SingleChain.
English: No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem præparater indeholdende human koagulationsfaktor VIII og andre lægemidler.
English: The active substance in AFSTYLA is lonoctocog alfa.
Danish: Det aktive stof i AFSTYLA er lonoctocog alfa.
English: AFSTYLA can be used in children and adolescents of all ages.
Danish: AFSTYLA kan bruges til børn og unge i alle aldre.