FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon side effects (may affect up to 1 in 100 people): - infection and re-infection with herpes, bacterial infections - increase in the number of platelets - autoimmune disorder of the thyroid gland, sarcoidosis (areas of inflamed tissue in different parts of the body) - diabetes - panic attack, hallucination (seeing, hearing or feeling things that are not there), feeling stressed, feeling nervous, lack of interest in activities, nightmare, irritability, confusion - damage to the nervous system, migraine, mental disorder (health condition involving changes in thinking, emotion or behaviour), visual or sensory disturbances, shaky hands - eye discomfort, eyelid eczema - hearing loss, ringing in ears (tinnitus), spinning feeling (vertigo) - heart disorders such as heart block (a disorder in the heart´s electrical activity), blood clots in the blood vessels of the heart, leakage of the aortic valve - high blood pressure, reduced blood supply to certain parts of the body, haematoma (collection of blood under the skin), flushing - inflammation of lung tissue, coughing, nosebleed, sore throat - inflammation of the stomach, abdominal wall disorder, intestinal gas, indigestion, painful swallowing, bleeding gums - inflammation of the liver, damage to the liver, enlarged liver - sensitivity to sunlight, peeling of the skin, nail disorder - muscle weakness, neck pain, groin pain - inflammation of the bladder, painful urination, increased need to urinate, inability to urinate - sexual problems - pain or itching at the site of injection, sensitivity to weather change - loss of weight - in blood tests: increase of uric acid, antibodies produced by the body´s immune system against red blood cells
Danish: manglende interesse i aktiviteter, mareridt, irritabilitet, forvirring - skader på nervesystemet, migræne, psykisk lidelse (helbredtilstand, som involverer ændringer i tankegang, følelser eller adfærd), visuelle eller sensoriske forstyrrelser, rystende hænder - øjenubehag, øjenlågseksem - høretab, ringen for ørerne (tinnitus), følelse af, at det hele drejer rundt (svimmelhed) - hjertesygdomme såsom hjerteblok (en lidelse i hjertets elektriske aktivitet), blodpropper i hjertets blodkar, lækage fra aortaklappen - forhøjet blodtryk, nedsat blodtilførsel til visse dele af kroppen, hæmatom (samling af blod under huden), rødmen - betændelse i lungevæv, hoste, næseblod, ondt i halsen - betændelse i maven, lidelse i bugvæggen, luft i tarmene, fordøjelsesbesvær, smerter ved synkning, blødende tandkød - leverbetændelse, skader på leveren, forstørret lever - følsomhed over for sollys, afskalning af huden, negleproblemer - muskelsvaghed, nakkesmerter, lyskesmerter - blærebetændelse, smertefuld vandladning, øget vandladningstrang, manglende vandladning - seksuelle problemer - smerte eller kløe på injektionsstedet, følsomhed over for vejrændringer - vægttab - i blodprøver: forhøjet urinsyre, antistoffer som produceres af kroppens immunsystem mod røde blodlegemer
English: Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with ropeginterferon alfa-2b.
Danish: Der skal udvises forsigtighed ved samtidig administration af narkotika, hypnotika eller sedativa med ropeginterferon alfa-2b.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a grey push button and the strength “250 mcg/0.5 mL” highlighted in grey on the label.
Danish: Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Den fyldte pen er fremstillet af hvid polypropylen med en grå trykknap og styrken "250 mikrog/0.5ml" fremhævet med grå skrift på etiketten.
English: White n (%)
Danish: Hvid n (%)
English: A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3).
Danish: Kombinationsbehandling med telbivudin og ropeginterferon alfa-2b er kontraindiceret (se pkt.
English: Respiratory disorders such as lung infiltration, pneumonitis, pneumonia or pulmonary arterial hypertension have been observed rarely in patients treated with interferon alfa (see section 4.8).
Danish: Der er i sjældne tilfælde blevet observeret respiratoriske lidelser såsom lungeinfiltration, pneumonitis, lungebetændelse eller pulmonal arteriel hypertension hos patienter behandlet med interferon alfa (se pkt.
English: Severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness have been observed rarely in patients treated with interferon alfa (see section 4.8).
Danish: Alvorlige oftalmologiske lidelse såsom retinopati, nethindehæmoragi, retinalt ekssudat, nethindeløsning og arterie- eller veneokklusion i nethinden, som kan resultere i blindhed, er i sjældne tilfælde blevet observeret hos patienterne efter behandling med interferon alfa (se pkt.
English: The elimination of ropeginterferon alfa-2b is not fully characterised.
Danish: Eliminationen af ropeginterferon alfa-2b er ikke fuldt klarlagt.
English: No n (%)
Danish: Nej n (%)
English: If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Danish: Hvis nyrefunktionen falder i løbet af behandlingen, skal behandlingen med ropeginterferon alfa-2b seponeres.
English: Description Besremi 500 micrograms pre-filled pen
Danish: Beskrivelse af Besremi 500 mikrogram fyldt pen
English: Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Danish: Der er observeret stigende leverenzymniveauer hos patienter, der behandles med ropeginterferon alfa2b.
English: Women of childbearing potential/Contraception in females Women of childbearing potential have to use effective contraception during the treatment with ropeginterferon alfa-2b, unless otherwise discussed with the physician.
Danish: Fertile kvinder skal anvende effektiv prævention under behandlingen med ropeginterferon alfa-2b, medmindre andet er diskuteret med lægen.
English: Description Besremi 250 micrograms pre-filled pen
Danish: Beskrivelse af Besremi 250 mikrogram fyldt pen
English: No ropeginterferon alfa-2b dose adjustment is required for adult patients with mild liver impairment.
Danish: Der kræves ingen dosisjustering af ropeginterferon alfa-2b til voksne patienter med let nedsat leverfunktion.
English: The metabolism of ropeginterferon alfa-2b is not fully characterised.
Danish: Metaboliseringen af ropeginterferon alfa-2b er ikke fuldt klarlagt.
English: Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite
Danish: Hypertriglyceridæmi, nedsat appetit
English: CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
Danish: Der er rapporteret om CNS-virkninger, herunder selvmordsforsøg, selvmordstanker, aggression, bipolar lidelse, mani og forvirring i forbindelse med behandling med interferon alfa (se pkt.
English: The dose will be set individually for you by your doctor for your condition.
Danish: Dosen vil blive indstillet af lægen, så den passer specielt til dig og din sygdom.
English: The 500 micrograms/0.5 mL pre-filled pen has a blue push button.
Danish: Den fyldte pen med 500 mikrogram/0,5 ml har en blå trykknap.
English: Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure#
Danish: Leversygdom, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk fosfatase i blodet ikke almindelig Hepatotoksicitet, toksisk hepatitis, hepatomegali sjælden
English: 250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
Danish: Den leverer doser på 50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, 450 μg og 500 μg.
English: Skin and subcutaneous tissue disorders common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation#
Danish: Kløe, alopeci, udslæt, erytem, psoriasis, xeroderma, akneiform dermatitis, hyperkeratose, hyperhidrose, tør hud ikke almindelig Lysfølsomhedsreaktion, hudafskalning, negledystrofi ikke kendt
English: The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweight patients.
Danish: Ropeginterferon alfa-2b's farmakokinetiske profil er ikke blevet fastlagt hos overvægtige og undervægtig patienter.
English: Package leaflet: Information for the user Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b Dette lægemiddel er underlagt supplerende overvågning.
English: Each cartridge contains 0.5 mL of solution.
Danish: Hver cylinderampul indeholder 0,5 ml opløsning.
English: Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Danish: Atrieflimren ikke almindelig Myokardieinfarkt#, atrioventrikulært blok, intrakardiel trombe, aortaklapinsufficiens, kardiovaskulær lidelse sjælden
English: Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3).
Danish: Enhver forud eksisterende thyroideasygdom skal behandles og kontrolleres med konventionel behandling (se pkt.
English: Over a dose range of 24 to 270 micrograms, ropeginterferon alfa-2b Cmax increased proportionally with dose in a pharmacokinetic study with healthy subjects.
Danish: I et farmakokinetisk studie med raske forsøgspersoner øgedes Cmax for ropeginterferon alfa-2b proportionalt med dosis indenfor et dosisområde på 24 til 270 mikrogram.
English: Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Danish: Leverenzymer og leverfunktion bør kontrolleres jævnligt hos patienter, som er i langvarig behandling med ropeginterferon alfa-2b.
English: The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Danish: Ropeginterferon alfa-2b's farmakokinetiske profil er ikke blevet fastlagt hos overvægtige og undervægtige patienter.
English: Package leaflet: Information for the user Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b Dette lægemiddel er underlagt supplerende overvågning.
English: To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed.
Danish: Besremi fyldt pen må kun anvendes til én enkelt patient for at forhindre evt. overførsel af sygdom eller enhver form for kontaminering, selv med udskiftning af kanylen.
English: Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Danish: Der er rapporteret om leversvigt hos hepatitis Cinficerede patienter i behandling med andre interferon alfa-lægemidler (se pkt.
English: Regardless of the starting dose or degree of renal impairment, patients should be monitored.
Danish: Alle patienter skal overvåges uanset startdosis eller graden af nedsat nyrefunktion.
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years.
Danish: Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen 1,5 år.
English: • Remove the outer needle cap from the needle.
Danish: • Tag den ydre kanylehætte af kanylen.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
Danish: Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen
English: Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Danish: Ropeginterferon alfa-2b er kontraindiceret hos patienter med dekompenseret levercirrose (se pkt.
English: The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
Danish: Den fyldte pen med 250 mikrogram/0,5 ml har en grå trykknap.
English: • Do not touch the needle tip at any time.
Danish: • Undgå helt at berøre kanylespidsen.
English: Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease#
Danish: Diarré, kvalme, mavesmerter, forstoppelse, abdominal distension, mundtørhed ikke almindelig Gastritis, sygdom i abdominalvæggen, flatulens, hyppig afføring, odynofagi, gingival blødning ikke kendt
English: Uncommon side effects (may affect up to 1 in 100 people): - attempted suicide, thoughts about killing yourself - loss of vision which may be caused by bleeding in the retina (the retina is the light-sensitive layer in the eye), or by build-up of fat in or under the retina
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - selvmordsforsøg, selvmordstanker - synstab, som kan skyldes blødning i nethinden (nethinden er det lysfølsomme lag i øjet) eller ophobning af fedt i eller under nethinden
English: Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
Danish: Dyspnø ikke almindelig Pneumonitis, hoste, næseblødning, halsirritation meget sjælden Lungeinfiltration#
English: • Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Danish: • Du må ikke injicere i hud, som er irriteret, rødlig, forslået, betændt eller arret på nogen måde.
English: Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Danish: Ropeginterferon alfa-2b er kontraindiceret hos patienter med nyresygdom i slutstadiet (se pkt.
English: Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Danish: Der er rapporteret om leverproblemer hos patienter efter langvarig behandling med ropeginterferon alfa-2b (se pkt.
English: Most common adverse reactions during ropeginterferon alfa-2b treatment.
Danish: De mest almindelige bivirkninger under behandling med ropeginterferon alfa-2b.
English: Opened date:
Danish: Anbrudsdato:
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years.
Danish: Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen 3 år.
English: Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased uncommon platelet count increased, blood uric acid increased,
Danish: Positiv antithyroideaantistof, forhøjet niveau af thyreoideastimulerende hormon i blodet, forhøjet legemstemperatur, positiv antinukleært antistof, forhøjet laktatdehydrogenase i blodet ikke almindelig Forhøjet trombocyttal, forhøjet urinsyre i blodet, positiv Coombs test, vægttab #Rapporteret som bivirkninger under behandling med andre interferon alfa-lægemidler.
English: - diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase
Danish: - tørre øjne - skade på kapillærerne (meget små blodkar) i kroppen - åndedrætsbesvær - diarré, kvalme, mavesmerter eller ubehag i maven, forstoppelse, mundtørhed - leversygdom, stigning i visse leverenzymer (ses i blodprøver) - kløe, hårtab, udslæt, hudrødme, psoriasis, tør og skællende hud, akne, fortykkelse af det ydre lag af huden, øget svedtendens - en sygdom, som kaldes Sjögrens syndrom, hvor kroppens immunsystem angriber de kirtler, som producerer væske (såsom tåre- og spytkirtler), leddegigt, smerter i arme og ben, knoglesmerter,
English: Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
Danish: Der skal ligeledes udvises forsigtighed med CYP2D6-substrater (f.eks. vortioxetin,
English: 112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study
Danish: 112 måneders behandling i PROUD-PV-studiet og 12 måneders behandling i forlængelsesstudiet).
English: Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred.
Danish: Undgå at injicere i et område, hvor huden er irriteret, rød, forslået, inficeret eller arret.
English: Ropeginterferon alfa-2b treatment arm
Danish: Ropeginterferon alfa-2bbehandlingsarmen
English: The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
Danish: 4.2) resulterer i en forlængelse af den tid, det tager at nå den individuelle optimale dosis sammenlignet med hydroxycarbamid.
English: Raynaud's phenomenon, hypertension, haematoma, flushing
Danish: Mikroangiopati ikke almindelig Raynauds fænomen, hypertension, hæmatom, rødme
English: Patients with 24 months of ropeginterferon alfa-2b treatment1
Danish: Patienter ned 24 måneders behandling med ropeginterferon alfa 2b1
English: Details on how to prepare and inject Besremi are given in the Instructions for Use.
Danish: I brugsanvisningen finder du yderligere oplysninger om, hvordan du klargør og injicerer Besremi.
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred.
Danish: Undgå at injicere i et område på kroppen, hvor huden er irriteret, rødlig, forslået, betændt eller arret.
English: Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Danish: Du må ikke injicere i hud, som er irriteret, rødlig, forslået, betændt eller arret på nogen måde.
English: Most common adverse reactions
Danish: Mest almindelige bivirkninger
English: Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Danish: Hvis en patient under behandling med ropeginterferon alfa-2b udvikler symptomer, der kan tyde på nedsat thyroideafunktion, bør TSH-værdierne fastlægges.
English: Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Danish: Besremi 250 mikrog/0,5 ml injektion ropeginterferon alfa-2b s.c.
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label.
Danish: Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Den fyldte pen er fremstillet af hvid polypropylen med en blå trykknap og styrken "500 mikrog/0.5
English: Patients with 36 months of ropeginterferon alfa-2b treatment2
Danish: Patienter ned 36 måneders behandling med ropeginterferon alfa 2b2
English: General disorders and administration site conditions very common influenza like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known:
Danish: Pyreksi, reaktion på injektionsstedet, asteni, kuldegysninger, generel forringelse af fysisk helbred, erytem på injektionsstedet ikke almindelig Smerte på injektionsstedet, kløe på injektionsstedet, følsomhed over for vejrforandringer ikke kendt
English: Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Danish: Besremi 500 mikrog/0,5 ml injektion ropeginterferon alfa-2b s.c.
English: During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
Danish: Der er rapporteret om ét tilfælde af uforsætlig overdosering med ropeginterferon alfa-2b under det kliniske studieprogram.
English: If you use more Besremi than you should
Danish: Hvis du har brugt for meget Besremi
English: Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
Danish: Benzylalkohol Polysorbat 80
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Danish: Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Hver fyldt pen med 0,5 ml opløsning indeholder 500 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 1.000 mikrogram/ml.
English: Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Danish: Hver fyldt pen med 0,5 ml opløsning indeholder 500 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 1.000 mikrogram/ml.
English: Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#,
Danish: Øjentørhed ikke almindelig Nethindehæmoragi#, nethindeekssudater#, synssvækkelse, nedsat synsskarphed, uklart syn, ubehag i øjnene, eksem på øjenlåg sjælden
English: Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Danish: Hver fyldt pen med 0,5 ml opløsning indeholder 250 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 500 mikrogram/ml.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Danish: Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Hver fyldt pen med 0,5 ml opløsning indeholder 250 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 500 mikrogram/ml.
English: very rare myocardial ischemia#
Danish: Kardiomyopati#, angina pectoris# meget sjælden Myokardieiskæmi#
English: not known retinal detachment#
Danish: Nethindeløsning#