FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N: number of patients.
Danish: Forkortelser: CTCAE, Common Terminology Criteria for Adverse Events (generel terminologi vedrørende bivirkninger), n.r., not reported (ikke rapporteret); ADR, adverse drug reaction (bivirkning), PT, preferred term (foretrukket term) IR, Incidence rate (incidensrate) for gennemsnitlige bivirkninger pr. 100 patienter om året, N: antal patienter.
English: Respiratory system
Danish: Åndedrætssystemet
English: If you are a woman of childbearing potential, your doctor will discuss with you if effective birth control should be used during your treatment with Besremi.
Danish: Hvis du er en kvinde og kan få børn, vil lægen tale med dig om, hvorvidt du bør anvende effektiv prævention under behandlingen med Besremi.
English: • Hold the push button down and wait for at least 10 seconds before removing the needle.
Danish: • Hold trykknappen nede og vent mindst 10 sekunder, inden du fjerner kanylen.
English: Pharmacokinetics were not evaluated in patients with increased severity of hepatic impairment.
Danish: Farmakokinetikken blev ikke evalueret hos patienter med øget sværhedsgrad af nedsat leverfunktion.
English: It is not known if Besremi is present in breast milk.
Danish: Det vides ikke, om Besremi udskilles i modermælk.
English: Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.
Danish: Det kan være nødvendigt med flebotomi som redningsbehandling for at normalisere hyperviskositet.
English: In this case, place the pen back into the outer carton and store it in the refrigerator for the next use.
Danish: Du skal i så fald sætte pennen tilbage i yderemballagen og opbevare den i køleskabet indtil næste brug.
English: When the increase in liver enzyme levels is progressive and persistent, the dose should be reduced.
Danish: Når stigningen i leverenzymniveauer er tiltagende og vedvarende, skal dosen reduceres.
English: If you stop using Besremi
Danish: Hvis du holder op med at bruge Besremi
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Danish: Høje doser af lægemidlet bør anvendes med forsigtighed og kun hvis nødvendigt, især hos personer med nedsat lever- eller nyrefunktion på grund af risikoen for ophobning og toksicitet (metabolisk acidose).
English: Endocrine system
Danish: Det endokrine system
English: Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR).
Danish: Interferon alfa tilhører gruppen af type I interferoner, som udøver deres cellulære virkninger ved at binde sig til en transmembranreceptor betegnet interferon alfa receptor (IFNAR).
English: Patients were stratified by previous exposure to hydroxycarbamide, age at screening (≤60 or >60 years) and presence of thromboembolic events in the past.
Danish: tidligere eksponering for hydroxycarbamid, alder ved screening (≤ 60 eller > 60 år) og tilstedeværelse af tidligere tromboemboliske hændelser.
English: • Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt
Danish: • Tilstedeværelse eller tidligere forekomst af alvorlige psykiatriske lidelser, især alvorlig depression, selvmordstanker eller selvmordsforsøg
English: In case of appearance or worsening of this skin disorders, the stop of the treatment must be envisaged.
Danish: Hvis disse hudsygdomme forekommer eller forværres, skal det overvejes at seponere behandlingen.
English: Do not use Besremi if you are taking telbivudine (for treating hepatitis B) since the combination of these medicines increases the risk of peripheral neuropathy (numbness, tingling, or burning sensations in the arms and legs).
Danish: Hvis du tager telbivudin (til behandling af hepatitis B), må du ikke tage Besremi, da kombinationen af disse lægemidler øger risikoen for perifer neuropati (følelsesløshed, prikkende eller brændende fornemmelser i arme og ben).
English: - if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while using Besremi - if this is the case you will need to seek medical help immediately.
Danish: - hvis du udvikler tegn på en alvorlig allergisk reaktion (såsom åndedrætsbesvær, hvæsen eller nældefeber), mens du bruger Besremi, skal du straks søge lægehjælp.
English: • Unscrew the needle and dispose of it appropriately.
Danish: • Skru kanylen af og bortskaf den på korrekt vis.
English: System organ class Frequency
Danish: Systemorganklasse Hyppighed Bivirkning
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. ml, dvs. det er i det væsentlige natriumfrit.
English: Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse AOP Orphan Pharmaceuticals AG
English: Your doctor or pharmacist will explain to you how to use the two pens.
Danish: Lægen eller apotekspersonalet vil forklare dig, hvordan du skal bruge de to penne.
English: Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp.
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) PharmaEssentia Corp.
English: • Besremi pre-filled pen
Danish: • Besremi fyldt pen
English: As ropeginterferon alfa-2b may have the same effect, this medicinal product is not recommended during pregnancy.
Danish: Da ropeginterferon alfa-2b kan have samme virkning, anbefales dette lægemiddel ikke under graviditet.
English: JAK2V617F allele burden (%)* 41.9±23.49
Danish: JAK2V617F allelbyrde (%)* 41,9 ± 23,49
English: The push button should be pressed in completely and held down for at least 10 seconds before removing the needle.
Danish: Trykknappen skal trykkes helt ind og holdes nede i mindst 10 sekunder, før kanylen fjernes.
English: Your doctor or pharmacist will show you how to use the pen.
Danish: Lægen eller apotekspersonalet vil vise dig, hvordan du skal bruge pennen.
English: Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.
Danish: Bindingen til IFNAR udløser en signal transduktion med intracellulære virkninger gennem aktivering af kinaser, især Janus kinase 1 (JAK1) og tyrosinkinase 2 (TYK2) samt transkriptionsaktivator (STAT)-proteiner.
English: • Combination with telbivudine (see section 4.5)
Danish: • Kombination med telbivudin (se pkt.
English: It is unknown if the active substance of the medicinal product is excreted into experimental animal or human milk (see section 4.6).
Danish: Det er uvist, om lægemidlets aktive stof udskilles i mælken hos forsøgsdyr eller mennesker (se pkt.
English: • Do not lift or move the pen during injection.
Danish: • Pennen må ikke løftes eller bevæges under injektionen.
English: Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis.
Danish: Interferon alfa har vist sig at have en hæmmende virkning på proliferationen af hæmatopoietiske og knoglemarvsfibroblast-progenitorceller og modvirkede effekt af vækstfaktorer og andre cytokiner, som spiller en rolle i udviklingen af myelofibrose.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Danish: Der er indberettet tilfælde af pulmonal arteriel hypertension (PAH) i forbindelse med interferon alfa, navnlig hos patienter med risikofaktorer for PAH (såsom portal hypertension, hiv-infektion og cirrose).
English: Characteristics of the study population are presented in Table 2.
Danish: Forsøgspopulationens karakteristika er angivet i tabel 2.
English: The most common adverse reactions (including number of patients, incidence rate, severity grade, necessity for dose adaptation and outcome) reported during the ropeginterferon alfa-2b clinical development program are summarised in Table 1.
Danish: De mest almindelige bivirkninger (herunder antal patienter, incidensrate, sværhedsgrad, nødvendigheden af dosisjustering og resultat), som blev rapporteret under det kliniske udviklingsprogram for ropeginterferon alfa-2b, er opsummeret i tabel 1.
English: Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC).
Danish: Variabiliteten mellem forsøgspersonerne for ropeginterferon alfa-2b var 35 % (Cmax) og 25 % (AUC).
English: • Set the dose your doctor told you by turning the dose knob.
Danish: • Indstil den dosis, din læge har angivet ved at dreje dosisknappen.
English: Complete haematological responsea Complete haematological responsea and improvement in disease burdenb
Danish: Fuldstændigt hæmatologisk responsa Fuldstændigt hæmatologisk responsa og forbedring i sygdomsbyrdeb
English: Adverse reactions are listed by system organ class and frequency (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) or not known (cannot be estimated from available data).
Danish: ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - if you have kidney problems.
Danish: - hvis du har nyreproblemer.
English: Contents of the pack and other information What Besremi contains
Danish: Pakningsstørrelser og yderligere oplysninger Besremi indeholder:
English: - if you have or had severe heart problems (such as heart attack or stroke).
Danish: - hvis du har eller har haft alvorlige hjerteproblemer (såsom hjerteanfald eller slagtilfælde).
English: • Do not put the outer needle cap back on the needle until after you have injected the medicine.
Danish: • Undgå at sætte den ydre kanylehætte tilbage på kanylen, før du har injiceret lægemidlet.
English: Ropeginterferon alfa-2b may inhibit the activity of CYP1A2 and CYP2D6 and thus may increase the blood concentrations of these medicinal products.
Danish: Ropeginterferon alfa-2b kan hæmme CYP1A2's og CYP2D6's aktivitet og kan således øge koncentration af disse lægemidler i blodet.
English: The most common gastrointestinal disorders reported in these studies were diarrhoea (5.1%; incidence rate: 2.8 [events/100 patients per year]) and nausea (4.5%; incidence rate: 1.6 events/100 patients per year]).
Danish: De mest almindelige gastrointestinale sygdomme, der blev rapporteret i disse studier, var diarré (5,1 %, incidensrate: 2,8 [hændelser/100 patienter per år]) og kvalme (4,5%, incidensrate: 1,6 [hændelser/100 patienter per år]).
English: - if you develop symptoms of a cold or other respiratory infection (such as difficulty in breathing, cough, fever and chest pain).
Danish: - hvis du udvikler symptomer på forkølelse eller anden luftvejssygdom (såsom åndedrætsbesvær, hoste, feber og brystsmerter).
English: not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#*
Danish: Lungefibrose#, pneumoni#, pulmonal arteriel hypertension#*
English: This medicinal product is contraindicated in patients with severe preexisting cardiovascular disease or patients who had recently suffered from a stroke or myocardial infarction (see section 4.3).
Danish: Dette lægemiddel er kontraindiceret til patienter med alvorlig forud eksisterende kardiovaskulær sygdom eller patienter, som for nylig har haft apopleksi eller myokardieinfarkt (se pkt.
English: JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study.
Danish: JAK2V617F-allelbyrden og ændringer fra baseline i CONTINUATION-PV forlængelsesstudiet.
English: Besremi is presented as a solution for injection (injection) in a pre-filled pen.
Danish: Besremi leveres som en injektionsvæske, opløsning (injektion) i en fyldt pen.
English: Talk to your doctor before using Besremi: - if you have thyroid disease.
Danish: Kontakt lægen, før du tager Besremi: - hvis du har en skjoldbruskkirtelsygdom.
English: Do not use the pen later than 30 days.
Danish: Pennen skal bruges inden 30 dage.
English: The effect of Besremi during pregnancy is not known.
Danish: Besremis virkning under graviditet er ikke kendt.
English: The most common adverse reactions are leukopenia (19.1%), thrombocytopenia (18.5%), arthralgia (12.9%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza like illness (10.7%), myalgia (10.7%), pyrexia (8.4%), pruritus (8.4%), increased alanine aminotransferase (8.4%), anaemia (7.9%), pain in extremity (6.7%), alopecia (6.7%), neutropenia (6.7%), increased aspartate aminotransferase (6.2%), headache (6.2%), diarrhoea (5.6%), chills (5.1%), dizziness (5.1%) and injection site reaction (5.1%).
Danish: De mest almindelige bivirkninger er leukopeni (19,1 %), trombocytopeni (18,5 %), artralgi (12,9 %), træthed (12,4 %), forhøjet gamma-glutamyltransferase (11,2 %), influenzalignende sygdom (10,7 %), myalgi (10,7 %), pyrexi (8,4 %), pruritus (8,4 %), forhøjet alaninaminotransferase (8,4 %), anæmi (7,9 %), smerter i ekstremitet (6,7 %), alopeci (6,7 %), neutropeni (6,7 %), forhøjet aspartataminotransferase (6,2 %) hovedpine (6,2 %), diarré (5,6), kuldegysninger (5,1 %), svimmelhed (5,1 %) og reaktion på injektionsstedet (5,1 %).
English: It may only be used if the solution is clear, colourless to pale yellow, with no particles visible.
Danish: Opløsningen må kun anvendes, hvis opløsningen er klar, farveløs til lysegul og uden synlige partikler.
English: Besremi contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free'.
Danish: Besremi indeholder mindre end 1 mmol (23 mg) natrium pr. ml, dvs. det er i det væsentlige natriumfrit.
English: • Click the needle onto the pen and make sure that it is firmly attached.
Danish: • Sæt kanylen på pennen med et klik, og kontrollér, at den sidder fast.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Besremi in all subsets of the paediatric population in the treatment of polycythaemia vera (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Besremi i alle undergrupper af den pædiatriske population i behandlingen af polycytæmia vera (se pkt.
English: If you forget to use Besremi
Danish: Hvis du har glemt at bruge Besremi
English: In addition, dry mouth could damage teeth and the lining of the mouth during long-term treatment with Besremi.
Danish: Derudover kan mundtørhed beskadige tænderne og mundens slimhinde under langtidsbehandling med Besremi.
English: The safety and efficacy of Besremi in children and adolescents has not been established.
Danish: Pædiatrisk population Besremis sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 x 109/L and leukocytes <10 x 109/L).
Danish: Dosen bør gradvist øges med 50 mikrogram hver anden uge (anden cytoreduktiv behandling bør sideløbende gradvist reduceres efter behov), indtil der opnås stabilisering af de hæmatologiske parametre (hæmatokrit < 45 %, trombocytter < 400 x 109/l og leukocytter < 10 x 109/l).
English: Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder
Danish: Alvorlige bivirkninger er depression (1,1 %), atrieflimren (1,1 %) og akut stresstilstand (0,6 %).
English: The dose can be set in steps of 50 micrograms by rotating the dose knob.
Danish: Dosen kan indstilles i trin på 50 mikrogram ved at dreje dosisknappen.
English: Ropeginterferon alfa-2b is found mainly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6.6 to 17 litres in patients after subcutaneous administration (dose range 50 - 450 micrograms).
Danish: Ropeginterferon alfa-2b findes fortrinsvis i blodet og ekstracellulærvæsken, som det fremgår af distributionsvolumenet ved steady-state (Vd) på 6,6 til 17 liter hos patienter efter subkutan administration (dosisområde 50-450 mikrogram).
English: Besremi contains benzyl alcohol.
Danish: Besremi indeholder benzylalkohol.
English: Cardiovascular system
Danish: Det kardiovaskulære system
English: Interferon alfa therapy has been associated with hepatotoxicity characterized by potentially significant increases in liver enzymes.
Danish: Behandling med interferon alfa er blevet forbundet med hepatotoksicitet, der er karakteriseret ved potentielt signifikante stigninger i leverenzymer.
English: Responder % (n/N)
Danish: Respondent % (n/N)
English: • Do not use the pen if the solution is cloudy, has particles or flakes, or is any colour other than colourless to slightly yellow.
Danish: • Brug ikke pennen, hvis opløsningen er grumset, indeholder partikler eller flager eller har nogen anden farve end farveløs til svagt gul.
English: What you need to know before you use Besremi 3.
Danish: Det skal du vide, før du begynder at bruge Besremi 3.
English: Side effects with frequency not known (cannot be estimated from the available data): - detachment of the retina (you may experience eye problems including changes in vision)
Danish: Bivirkninger, hvor hyppigheden ikke kendes (kan ikke beregnes ud fra tilgængelige data): - nethindeløsning (du kan få øjenproblemer, herunder ændringer i synet)
English: What you need to know before you use Besremi Do not use Besremi:
Danish: Det skal du vide, før du begynder at bruge Besremi Brug ikke Besremi:
English: Patients showed a statistically significant difference in the JAK2V617F allele burden (19.7%) and JAK2V617F allele change from baseline (-22.9%).
Danish: Patienterne opnåede en statistisk signifikant forskel i JAK2V617F-allelbyrden (19,7 %) og en JAK2V617F-allelændring fra baseline (-22,9 %).
English: It is available in packs containing 1 pre-filled pen and 2 injection needles.
Danish: Det findes i pakninger, der indeholder 1 fyldt pen og 2 injektionskanyler.
English: The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon alfa-2b is not known.
Danish: Involveringen af transportproteiner i absorptionen, fordelingen og eliminationen af ropeginterferon alfa-2b er ikke kendt.
English: Based on the results from the PROUD-PV and CONTINUATION-PV Study on drug exposure, pharmacodynamic response and tolerability, a dose adjustment for ropeginterferon alfa-2b is not considered necessary in the elderly population.
Danish: Baseret på resultaterne fra PROUD-PV- og CONTINUATION-PV-studierne vedrørende lægemiddeleksponering, farmakodynamisk respons og tolerabilitet, anses dosisjustering af ropeginterferon alfa-2b hos ældre ikke for at være nødvendig.
English: Based on single dose data, clearance was similar in patients with severe renal impairment not on haemodialysis and in patients who received haemodialysis.
Danish: Baseret på resultater med enkeltdosis var clearance den samme hos patienter med svært nedsat nyrefunktion uden dialyse som hos patienter, som fik hæmodialyse.
English: - if you have thyroid disease that is not controlled with medicines.
Danish: - hvis du har en skjoldbruskkirtelsygdom, der ikke er kontrolleret med medicin.
English: In a clinical study in polycythaemia vera, the end of the mean individual titration phase for ropeginterferon alfa-2b was reached after approximately 3.7 months, for hydroxycarbamide after approximately 2.6 months of treatment.
Danish: I et klinisk studie med polycytæmia vera, blev slutningen af den gennemsnitlige individuelle titreringsfase for ropeginterferon alfa-2b nået efter ca. 3,7 måneder, for hydroxycarbamid efter ca. 2,6 måneders behandling.
English: At doses up to 100 micrograms, the same pen can be used twice.
Danish: Ved doser op til 100 mikrogram, kan den samme pen anvendes to gange.
English: - if you have a liver or kidney disease.
Danish: - hvis du har en lever- eller nyresygdom.
English: Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide.
Danish: Hydroxycarbamidbehandlingsnaive (n = 160) eller hydroxycarbamidbehandlede patienter (n = 94) blev randomiseret til at få enten ropeginterferon alfa-2b eller hydroxycarbamid.
English: Severe eye problems may occur during Besremi therapy.
Danish: Der kan opstå alvorlige øjenproblemer under behandling med Besremi.
English: Common side effects (may affect up to 1 in 10 people): - changes in your heart beat (when the heart beats very fast and uneven)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): - ændringer i dit hjerteslag (når hjertet slår meget hurtigt og ujævnt)
English: Further, it was demonstrated that interferon alfa is able to decrease the mutated JAK2V617F allele burden in patients with polycythaemia vera (a V617F point mutation in the JAK2 kinase is a hallmark of polycythaemia vera and is present in approximately 95% of patients).
Danish: Det blev endvidere påvist, at interferon alfa er i stand til at reducere den muterede JAK2V617F allelbyrde hos patienter med polycytæmia vera (en V617F-punktmutation i JAK2-kinasen er et kendetegn på polycytæmia vera og er til stede hos ca. 95 % af patienterne).
English: Besremi is used as monotherapy for the treatment of polycythaemia vera in adults.
Danish: Besremi anvendes som monoterapi til behandling af polycytæmia vera hos voksne.
English: If the increase in liver enzymes is progressive and clinically significant despite dose reduction, or if there is evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Danish: Hvis stigningen i leverenzymer er tiltagende og klinisk betydningsfuld på trods af dosisreduktion, eller hvis der er tegn på leverdekompensation, skal behandlingen seponeres (se pkt.
English: A new, sterile needle as provided with the pre-filled pen must be carefully attached onto the pre-filled pen before each injection.
Danish: Den fyldte pen leveres sammen med en ny steril kanyle, som skal fastgøres omhyggeligt på den fyldte pen før hver injektion.
English: The disease response (defined as haematocrit <45% without phlebotomy [at least 3 months since last phlebotomy], platelets <400 x 109/L and leukocytes <10 x 109/L after 12 months of treatment) was 43.1% [53/123 of patients] in the ropeginterferon alfa-2b arm after 12 months of treatment.
Danish: Sygdomsresponset (defineret som hæmatokrit < 45 % uden flebotomi [mindst 3 måneder siden sidste flebotomi], trombocytter < 400 x 109/l og leukocytter < 10 x 109/l efter 12 måneders behandling) var på 43,1 % [53/123 af patienterne] i ropeginterferon alfa-2b-armen efter 12 måneders behandling.
English: Based on data in monkeys, it is approx. 80%, similar to that seen for pegylated interferon alfa-2a.
Danish: Baseret på data fra aber er den på ca. 80 %, hvilket svarer til det, der ses for pegyleret interferon alfa-2a.
English: The use of interferon alfa has not been evaluated in patients with decompensated cirrhosis (i.e. ChildPugh B or C) and is contraindicated in these patients (see section 4.3).
Danish: Anvendelsen af interferon alfa er ikke blevet evalueret hos patienter med dekompenseret cirrose (dvs. Child-Pugh B eller C) og er kontraindiceret hos disse patienter (se pkt.