FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have liver problems − you will have blood tests regularly to check how your liver is working if you are on a long-term Besremi therapy.
Danish: Hvis du er i langtidsbehandling med Besremi, vil du regelmæssigt få taget blodprøver for at kontrollere, hvordan din lever fungerer.
English: Besremi 250 micrograms/0.5 mL
Danish: Besremi 250 mikrogram/0,5 ml
English: Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients.
Danish: Der er blevet indberettet følgende behandlingsrelaterede bivirkninger med ropeginterferon alfa-2b i kliniske studier med 178 voksne patienter med polycytæmia vera.
English: Mean Cmax was 2.4 ng/mL (with a dose of 5080 micrograms) to 49 ng/mL (with a dose of 450 micrograms) and AUC0-t ranged from 28.5 ng.h/mL (with a dose of 50 - 80 micrograms) to 552.6 ng.h/mL (with a dose of 450 micrograms) in patients after subcutaneous multiple dose administration.
Danish: Efter subkutan administration af flere doser til patienterne varierede den gennemsnitlige Cmax fra 2,4 ng/ml (ved en dosis på 50-80 mikrogram) til 49 ng/ml (ved en dosis på 450 mikrogram) og AUC0-t varierede fra 28,5 ng.t/ml (ved en dosis på 50-80 mikrogram) til 552,6 ng.t/ml (ved en dosis på 450 mikrogram).
English: Comparable exposure and pharmacokinetic profile was reported for another interferon alfa medicinal product (pegylated interferon alfa-2a) in cirrhotic (Child-Pugh A) and non-cirrhotic patients.
Danish: Der blev rapporteret om en sammenlignelig eksponering og farmakokinetisk profil for et andet interferon alfa-lægemiddel (pegyleret interferon alfa-2a) hos cirrotiske (Child-Pugh A) og noncirrotiske patienter.
English: GGT (≥3 times the upper limit of normal) and bilirubin (>2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b.
Danish: Stigninger i niveauerne for ALAT (≥ 3 gange den øvre normalgrænse) ASAT (≥ 3 gange den øvre normalgrænse), GGT (≥ 3 gange den øvre normalgrænse) og bilirubin (>2 gange den øvre normalgrænse) er observeret hos patienter, der er behandlet med ropeginterferon alfa-2b.
English: Disease response after 24 and 36 months of ropeginterferon alfa-2b.
Danish: Sygdomsrespons efter 24 og 36 måneders behandling med ropeginterferon alfa-2b.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with ropeginterferon alfa-2b.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med ropeginterferon alfa-2b.
English: The Besremi 500 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200, 250, 300, 350, 400, 450 and 500 micrograms.
Danish: Besremi 500 mikrogram fyldt pen kan bruges til at injicere doser på 50, 100, 150, 200, 250, 300, 350, 400, 450 og 500 mikrogram.
English: The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4.
Danish: Behandlingsresponset på ropeginterferon alfa-2b er angivet i tabel 3 og tabel 4.
English: If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately.
Danish: Hvis en sådan reaktion forekommer, skal behandlingen med ropeginterferon alfa-2b seponeres, og passende medicinsk behandling skal omgående iværksættes.
English: • Needle
Danish: • Kanyle
English: Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol.
Danish: Indeholder også natriumchlorid, polysorbat 80, vandfrit natriumacetat, iseddikesyre, vand til injektionsvæsker og benzylalkohol.
English: Dental and periodontal disorders, which may lead to loss of teeth, have been reported with other interferon alfa medicinal products (see section 4.8).
Danish: Der er rapporteret om dentale og periodontale lidelser, som kan føre til tab af tænder, ved behandling med andre interferon alfa-lægemidler (se pkt.
English: Titration phase
Danish: Titreringsfasen
English: Following multiple dosing of pegylated interferon alfa-2b (1.0 micrograms/kg subcutaneously administered every week for four weeks), the clearance of pegylated interferon alfa-2b was reduced by a mean of 17% and 44% in patients with moderate or severe renal impairment, respectively, compared to subjects with normal renal function.
Danish: Efter gentagne doser af pegyleret interferon alfa-2b (1,0 mikrogram/kg indgivet subkutant hver uge i fire uger) reduceredes clearance af pegyleret interferon alfa-2b med gennemsnitlig 17 % og 44 % hos patienter med henholdsvis moderat og svært nedsat nyrefunktion sammenlignet med personer med normal nyrefunktion.
English: Solution for injection in pre-filled pen (injection).
Danish: Injektionsvæske, opløsning i fyldt pen (injektion).
English: Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy.
Danish: Patienter som lider af denne sygdom, og hvor sygdommen ikke kan kontrolleres effektivt med lægemidler, bør ikke påbegynde behandling med ropeginterferon alfa-2b.
English: Drug interrupted
Danish: Lægemiddel afbrudt
English: Influenza like illness
Danish: Influenzalignende sygdom
English: Patients with renal impairment receiving a single dose of 1.0 micrograms/kg pegylated interferon alfa-2b showed an increased relation of Cmax, AUC, and half-life to the degree of renal impairment.
Danish: Hos patienter med nedsat nyrefunktion, som fik en enkelt dosis på 1,0 mikrogram/kg pegyleret interferon alfa-2b, steg Cmax, AUC og halveringstiden i forhold til graden af nedsat nyrefunktion.
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products.
Danish: Der er i sjældne tilfælde observeret alvorlige, akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) ved behandling med andre interferon alfa-lægemidler.
English: During ropeginterferon alfa-2b therapy, three cases of atrial fibrillation (1.1%; incidence rate: 0.5 events/100 patients per year) with intensity grade 1 to 3 occurred in two patients.
Danish: Under behandling med ropeginterferon alfa-2b forekom der tre tilfælde af atrieflimren (1,1 %, incidensrate: 0,5 hændelser/100 patienter per år) med intensitetsgrad 1-3 hos to patienter.
English: Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo
Danish: Øre og labyrint ikke almindelig Døvhed, tinnitus, svimmelhed
English: Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued.
Danish: Patienter, som udvikler respiratoriske symptomer, bør overvåges nøje, og behandling med ropeginterferon alfa-2b bør om nødvendigt seponeres.
English: 1 Patients with 36 months of ropeginterferon alfa-2b treatment (12-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study).
Danish: 1 Patienter som blev behandlet med ropeginterferon alfa-2b i 36 måneder (12 måneders behandling i PROUDPV-studiet og 24 måneders behandling i forlængelsesstudiet).
English: • Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis,
Danish: • Alvorlig forud eksisterende kardiovaskulær sygdom (dvs. ukontrolleret hypertension, kongestiv hjerteinsufficiens (≥ NYHA klasse 2), alvorlig kardiel arytmi, signifikant koronararteriestenose, ustabil angina) eller nylig apopleksi eller myokardieinfarkt
English: (listed in section 6).
Danish: Besremi (angivet i afsnit 6).
English: A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment.
Danish: Der anbefales en reduceret startdosis af ropeginterferon alfa-2b på 50 mikrogram til patienter med svært nedsat nyrefunktion (GFR 15-29 ml/min).
English: Co-administration of pegylated interferon alfa-2b showed no significant interaction with tolbutamide (CYP2C9 substrate), midazolam (CYP3A4 substrate), dapsone (N-acetyltransferase substrate) and modestly increased the exposure of caffeine (CYP1A2 substrate) and desipramine (CYP2D6 substrate).
Danish: Der sås ingen signifikant interaktion ved samtidig administration af pegyleret interferon alfa-2b og tolbutamid (CYP2C9-substrat), midazolam (CYP3A4-substrat), dapson (N-acetyltransferasesubstrat) og kun en beskeden øget eksponering for coffein (CYP1A2-substrat) og desipramin (CYP2D6substrat).
English: The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms.
Danish: Besremi 250 mikrogram fyldt pen kan bruges til at injicere doser på 50, 100, 150, 200 og 250 mikrogram.
English: If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
Danish: Hvis der opstår bivirkninger under behandlingen, skal den administrerede dosis reduceres eller behandlingen midlertidigt seponeres, indtil bivirkningerne aftager.
English: How to use Besremi
Danish: Sådan skal du bruge Besremi
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752 .docVed at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans.
Danish: Den absolutte biotilgængelighed af subkutant administreret ropeginterferon alfa-2b blev ikke undersøgt hos mennesker.
English: Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm methoxypolyethylene glycol (mPEG) at a degree of substitution of 1 mole of polymer/mole of protein.
Danish: Ropeginterferon alfa-2b er et rekombinant interferon alfa-2b konjugeret med to-armet methoxypolyethylenglycol (mPEG) med en substitutionsgrad på 1 mol polymer/mol protein.
English: Ropeginterferon alfa-2b clinical studies ADR >10%
Danish: Kliniske studier med ropeginterferon alfa-2b ADR > 10 %
English: Mean % (± SD)
Danish: Gennemsnit % (± SD)
English: Ropeginterferon alfa-2b treatment arm1 (n=94)
Danish: Ropeginterferon alfa-2bbehandlingsarm1 (n = 94)
English: - The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections.
Danish: - Øvrige indholdsstoffer: natriumchlorid, polysorbat 80, benzylalkohol, vandfrit natriumacetat, iseddikesyre og vand til injektionsvæsker.
English: Dental and gum disorders, which may lead to loss of teeth, can occur with interferon medicines.
Danish: Behandling med interferon kan medføre tand- og tandkødssygdomme, som kan medføre tab af tænder.
English: Your doctor will tell you where you have to inject it. Possible injection sites are the belly (more than five centimeters away from the belly button) or the thigh.
Danish: Mulige injektionssteder er i maven (mere end fem centimeter fra navlen) eller i låret.
English: While holding the pre-filled pen with the needle pointing upwards, tap the pre-filled pen gently with the fingers so that any air bubbles rise up towards the needle.
Danish: Hold den fyldte pen med kanylen pegende opad, og bank forsigtigt på den fyldte pen med fingeren, så alle luftbobler stiger op mod kanylen.
English: - The active substance is ropeginterferon alfa-2b.
Danish: - Aktivt stof: ropeginterferon alfa-2b.
English: • Press the push button with your thumb until the “0” mark is aligned with the dot in the display window.
Danish: • Tryk på trykknappen med tommelfingeren, indtil markeringen "0" flugter med prikken i dosisvinduet.
English: Please read this leaflet carefully before using the Besremi 250 micrograms pre-filled pen.
Danish: Læs venligst denne indlægsseddel grundigt, inden du bruger Besremi 250 mikrogram fyldt pen.
English: It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Danish: Den leverer doser på 50 μg, 100 μg, 150 μg, 200 μg og 250 μg.
English: Patients with moderate or severe renal impairment receiving 180 micrograms of pegylated interferon alfa-2a once weekly showed a comparable or 60% higher drug plasma exposure, respectively, compared to subjects with normal renal function.
Danish: Patienter med moderat eller svært nedsat nyrefunktion, som fik 180 mikrogram pegyleret interferon alfa-2a én gang om ugen, havde en sammenlignelig eller 60 % højere lægemiddeleksponering i plasma, sammenlignet med personer med normal nyrefunktion.
English: The pharmacokinetic profile of other interferon alfa medicinal products (pegylated interferon alfa-2a and pegylated interferon alfa-2b) was evaluated in renal impaired patients (see section 5.2).
Danish: Den farmakokinetiske profil for andre interferon alfa lægemidler (pegyleret interferon alfa-2a og pegyleret interferon alfa-2b) er blevet evalueret hos patienter med nedsat nyrefunktion (se pkt.
English: Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, listless uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, apathy, nightmare, irritability rare bipolar disorder#, mania#
Danish: Depression, aggression#, søvnløshed, angst, humørændring, sløvhed ikke almindelig Selvmordforsøg#, selvmordstanker#, forvirring#, akut stresstilstand, hallucinationer, følelsesmæssige forstyrrelser, nervøsitet, apati, mareridt, irritabilitet sjælden
English: Reproductive and developmental studies were not performed with ropeginterferon alfa-2b.
Danish: Der er ikke udført reproduktions- og udviklingsstudier med ropeginterferon alfa-2b.
English: Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8).
Danish: Kardielle hændelser, herunder kardiomyopati, myokardieinfarkt, atrieflimren og iskæmisk koronararteriesygdom er blevet forbundet med interferon alfa-behandling (se pkt.
English: In patients with compensated cirrhosis (i.e. Child-Pugh A), another pegylated interferon alfa medicinal product (pegylated interferon alfa-2a) has been shown to be safe.
Danish: Hos patienter med kompenseret cirrose (dvs. Child-Pugh A) har et andet pegyleret interferon alfalægemiddel (pegyleret interferon alfa-2a) vist sig at være sikkert.
English: - if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself).
Danish: - hvis du har eller har haft alvorlige psykiske lidelser (såsom depression eller selvmordstanker,
English: Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
Danish: Patienter med forud eksisterende eller tidligere kardiovaskulære sygdomme bør overvåges nøje under behandling med ropeginterferon alfa-2b.
English: Fertility There are no data on the effect of ropeginterferon alfa-2b therapy on the fertility of females or males.
Danish: Der foreligger ingen data om indvirkning af behandling med ropeginterferon alfa-2b på fertiliteten hos mænd eller kvinder.
English: Basedow's disease, sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura#
Danish: Immunsystemet ikke almindelig Basedows sygdom, sarkoidose# meget sjælden Idiopatisk eller trombotisk trombocytopenisk purpura#
English: Ropeginterferon alfa-2b is a covalent conjugate of the protein interferon alpha-2b, produced in Escherichia coli cells by recombinant DNA technology, with a methoxypolyethylene glycol (mPEG) moiety.
Danish: Ropeginterferon alfa-2b er en covalent konjugering af proteininterferon alfa-2b med en methoxypolyethylenglycol (mPEG)-del produceret ved hjælp af rekombinant DNA-teknologi i Escherichia coli-celler.
English: If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy.
Danish: Hvis psykiatriske symptomer forværres, anbefales det at seponere behandlingen med ropeginterferon alfa-2b.
English: Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - bipolare lidelser (humørsygdomme med episoder af tristhed og opstemthed), mani (ekstrem opstemthed eller overdreven entusiasme) - kardiomyopati (sygdomme, som påvirker hjertemusklen), angina pectoris (alvorlige brystsmerter som følge af blokering af hjertets blodkar) - leversvigt
English: Very rare side effects (may affect up to 1 in 10,000 people): - blindness - breathing problems including shortness of breath, cough and chest pain which may be caused by lung infiltration, pneumonia (lung infection), pulmonary arterial hypertension (high blood pressure in the blood vessels bringing blood from the heart to the lungs) and pulmonary fibrosis (a lung disease where scars are formed in the lung tissue)
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): - blindhed - åndedrætsbesvær, herunder åndenød, hoste og brystsmerter, som kan være forårsaget af lungeinfiltrater, pneumoni (lungebetændelse), pulmonal arteriel hypertension (højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne) og lungefibrose (en lungesygdom, hvor der dannes ar i lungevæv)
English: Serious eye disorders have been reported with interferon alfa such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion (see section 4.4).
Danish: Der er rapporteret om alvorlige oftalmologiske lidelser under behandling med interferon alfa, såsom retinopati, nethindehæmoragi, retinalt ekssudat, nethindeløsning og arterie- eller veneokklusion i nethinden (se pkt.
English: Adjustments in the recommended dose for ropeginterferon alfa-2b are not necessary when starting therapy in elderly patients (see section 5.2).
Danish: Der kræves ingen justeringer af den anbefalede dosis af ropeginterferon alfa-2b ved behandlingsstart hos ældre patienter (se pkt.
English: • Hold the pen with the needle pointing upwards.
Danish: • Hold pennen med kanylen pegende opad.
English: Each pre-filled pen contains 0.5 mL of solution.
Danish: Hver fyldt pen indeholder 0,5 ml opløsning.
English: Infections and infestations common respiratory tract infection, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis
Danish: Luftvejsinfektion, rhinitis, svampeinfektion i huden, ikke almindelig Oral herpes, herpes zoster, oral candidiasis, bihulebetændelse, øsofageal candidiasis, vulvovaginal mykotisk infektion, bygkorn, onykomykose
English: • Press the push button all the way down until the “0” mark is aligned with the dot in the display window.
Danish: • Pres trykknappen helt i bund, indtil markeringen "0" flugter med prikken i dosisvinduet.
English: Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8).
Danish: Der er observeret diabetes mellitus under behandling med andre interferon alfa-lægemidler (se pkt.
English: Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (GFR <15 mL/min) (see section 4.3).
Danish: Ropeginterferon alfa-2b er kontraindiceret hos patienter med nyresygdom i slutstadiet (GFR < 15 ml/min) (se pkt.
English: Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution
Danish: Injektionsvæske, opløsning i fyldt pen 1 fyldt pen + 2 injektionskanyler 0,5 ml opløsning
English: including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products.
Danish: Andre CNS-virkninger, herunder selvmordstanker, selvmordsforsøg, aggression, bipolar lidelse, mani og forvirring er blevet observeret ved behandling med andre interferon alfa-lægemidler.
English: The pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Danish: 30 dage i køleskabet (2 °C - 8 °C), når den opbevares med påsat penhætte og opbevares i den ydre karton for at beskytte mod lys.
English: • Remove the cap from the pen.
Danish: • Tag hætten af pennen.
English: Each pre-filled pen contains a cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber).
Danish: Hver fyldt pen indeholder en cylinderampul (type 1 farveløst glas) med et gråt stempel
English: The dose was gradually increased depending on disease response and tolerability (for ropeginterferon alfa-2b, from 50 to
Danish: Dosen blev gradvist øget afhængigt af sygdomsrespons og tolerabilitet (fra 50 til 500 mikrogram subkutant hver anden uge for ropeginterferon alfa-2b).
English: No interaction studies have been performed with ropeginterferon alfa-2b.
Danish: Der er ikke udført interaktionsstudier med ropeginterferon alfa-2b.
English: Rare side effects (may affect up to 1 in 1,000 people): - loss of vision which may be caused by damage to the retina (such as obstruction of the blood vessels in the eye) or the optic nerve
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - synstab, som kan skyldes beskadigelse af nethinden (f.eks. blokering af blodkarrene i øjet) eller synsnerven
English: Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura
Danish: Hovedpine, svimmelhed, hypæstesi, somnolens, paræstesi ikke almindelig Polyneuropati, perifer motorisk neuropati, radikulopati, migræne, mental svækkelse, tremor, aura