FrancophonIA/ELRC3.0 huggingface dataset:
English: If you need a dose of more than 250 micrograms, you require two Besremi 250 microgram pre-filled pens.
Danish: Hvis du har brug for en dosis på mere end 250 mikrogram, skal du bruge to fyldte penne med Besremi 250 mikrogram.
English: An abortifacient effect was reported in primates receiving other interferon alfa medicinal products.
Danish: Der blev rapporteret om en abortfremkaldende virkning hos primater, der fik andre interferon alfa-lægemidler.
English: The Besremi pre-filled pen comes with two needles.
Danish: Besremi fyldt pen leveres med to kanyler.
English: In the same study, a 25% increase in the AUC of theophylline (CYP1A2 substrate) was observed, demonstrating that pegylated interferon alfa-2a is an inhibitor of CYP1A2 activity.
Danish: Der blev i det samme studie observeret en stigning i AUC for theophyllin (CYP1A2-substrat) på 25 %, hvilket viser, at pegyleret interferon alfa-2a er en hæmmer af CYP1A2-aktivitet.
English: The use of ropeginterferon alfa-2b is associated with skin disorders (pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhydrosis).
Danish: Anvendelse af ropeginterferon alfa-2b er forbundet med hudsygdomme (kløe, alopeci, udslæt, erytem, psoriasis, xeroderma, akneiform dermatitis, hyperkeratose, hyperhidrose).
English: The pharmacokinetic profile in patients with moderate or severe renal impairment and in patients with end stage renal disease (ESRD) has been evaluated only for other pegylated interferon alfa medicinal products.
Danish: Den farmakokinetiske profil hos patienter med moderat eller svært nedsat nyrefunktion og hos patienter med nyresygdom i slutstadiet (ESRD) er kun blevet vurderet for andre pegylerede interferon alfa-lægemidler.
English: You should see a droplet of liquid appearing at the needle tip.
Danish: Du bør kunne se en dråbe væske komme til syne ved kanylespidsen.
English: Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons.
Danish: Besremi indeholder det aktive stof ropeginterferon alfa-2b, som tilhører gruppen af lægemidler kaldet interferoner.
English: These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera.
Danish: Disse virkninger er muligvis involveret i interferon alfas terapeutiske virkninger på polycytæmia vera.
English: Store the pen in the outer carton in the refrigerator.
Danish: Opbevar pennen i den ydre emballage i køleskabet.
English: Tell your doctor especially if you are taking any of the following medicines: - theophylline (a medicine used to treat respiratory diseases such as asthma) - methadone (a medicine used to treat pain or opioid dependence) - vortioxetine or risperidone (medicines used to treat mental disorders) - anti-cancer medicines such as those stopping or slowing the growth of blood-forming cells in the bone marrow (e.g. hydroxycarbamide) - medicines that work on the central nervous system to relieve pain, help you sleep, or have a calming effect (e.g. morphine, midazolam)
Danish: Fortæl det især til lægen, hvis du tager nogen af følgende lægemidler: - theophyllin (et lægemiddel til behandling af luftvejssygdomme såsom astma) - metadon (et lægemiddel til behandling af smerter eller narkotikaafhængighed) - vortioxetin eller risperidon (lægemidler til behandling af psykiske lidelser) - lægemidler mod kræft, såsom dem, der stopper eller bremser væksten af bloddannende celler i knoglemarven (f.eks. hydroxycarbamid) - lægemidler, der virker på centralnervesystemet for at lindre smerte, hjælpe dig med at sove eller har en beroligende virkning (f.eks. morfin, midazolam)
English: Then press the push button until the display window shows “0”.
Danish: Tryk derefter på trykknappen, indtil dosisvinduet viser "0".
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: At doses up to 250 micrograms, the same pen can be used twice.
Danish: Ved doser op til 250 mikrogram, kan den samme pen anvendes to gange.
English: • If you are using your pen for the first time, prepare the pen for injection by turning the dose knob until you see the symbol of a “drop”.
Danish: • Hvis du bruger pennen for første gang, skal du klargøre pennen til injektion ved at dreje dosisknappen, indtil du ser symbolet med "dråben".
English: - if you have or had an autoimmune disease (such as rheumatoid arthritis, psoriasis or inflammatory bowel disease).
Danish: - hvis du har eller har haft en autoimmun sygdom (såsom leddegigt, psoriasis eller inflammatorisk tarmsygdom).
English: - if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine
Danish: - hvis du er allergisk over for ropeginterferon alfa-2b eller et af de øvrige indholdsstoffer i
English: The pen can be adjusted to administer doses in 50 microgram intervals in the range of 50 to 250 micrograms or 50 to 500 micrograms.
Danish: Pennen kan indstilles til administration af doser i intervaller på 50 mikrogram i området fra 50 til 250 mikrogram eller 50 til 500 mikrogram.
English: The mean dose after 12 months of treatment was 382 (±141) micrograms for ropeginterferon alfa-2b.
Danish: Den gennemsnitlige dosis efter 12 måneders behandling var 382 (± 141) mikrogram for ropeginterferon alfa-2b.
English: The attachment of interferon alfa-2b to a high molecular weight (40 kDa) branched polyethylene glycol moiety is considered as the main reason for the differences in the elimination compared to unpegylated interferons.
Danish: Bindingen af interferon alfa-2b til en forgrenet polyethylenglykoldel med høj molekylvægt (40 kDa) betragtes som hovedårsagen til forskellene i eliminationen sammenlignet med upegylerede interferoner.
English: Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Danish: Behandling med ropeginterferon alfa-2b bør seponeres, når stigningen på trods af dosisreduktion er tiltagende og klinisk signifikant.
English: Ropeginterferon alfa-2b treatment was continued and the patients received appropriate medicinal products to treat these events.
Danish: Behandlingen med ropeginterferon alfa-2b blev fortsat, og patienterne blev behandlet med passende lægemidler for denne hændelse.
English: One patient who experienced serious acute stress disorder (0.6%; incidence rate: 0.2 events/100 patients per year) with moderate intensity recovered completely after the dose of ropeginterferon alfa-2b was reduced.
Danish: En patient, som fik en alvorlig akut stresslidelse (0,6 %, incidensrate: 0,2 hændelser/100 patienter per år) med moderat intensitet, opnåede fuld bedring efterdosisreduktion af ropeginterferon alfa-2b.
English: The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days.
Danish: Absorptionen af ropeginterferon alfa-2b opretholdes hos patienter med maksimal serumkoncentration efter 3 til 6 dage.
English: • If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7.
Danish: • Hvis du allerede har brugt din Besremi 500 mikrogram fyldt pen én gang før, skal du fortsætte direkte med trin
English: No dose adaptions for ropeginterferon alfa-2b should be necessary when concomitantly administered with medicinal products metabolised via CYP2C9/19, CYP3A4 or by N-acetyltransferase.
Danish: Det bør ikke være nødvendigt at foretage dosisjusteringer af ropeginterferon alfa-2b ved samtidig administration med lægemidler, som metaboliseres af CYP2C9/19, CYP3A4 eller N-acetyltransferase.
English: Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly.
Danish: Når der ses en væskedråbe på kanylespidsen, fungerer den fyldte pen og kanylen korrekt.
English: Ninety-five patients continued to receive ropeginterferon alfa-2b (from 50 to 500 micrograms administered subcutaneously every two, three or four weeks).
Danish: 95 patienter fortsatte med at modtage ropeginterferon alfa-2b (fra 50 til 500 mikrogram subkutant hver anden, tredje eller fjerde uge).
English: Patients should have eye examinations before and during ropeginterferon alfa-2b therapy, specifically in those patients with retinopathy associated disease such as diabetes mellitus or hypertension.
Danish: Patienterne bør få foretaget en øjenundersøgelse før og under behandling med ropeginterferon alfa-2b, især patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
English: After subcutaneous multiple dose administration (dose range 50 - 450 micrograms), the terminal halflife of ropeginterferon alfa-2b in patients is approximately 6 to 10 days and the clearance of ropeginterferon alfa-2b is 0.023 to 0.061 L/h.
Danish: Efter subkutan administration af flere doser (fra 50-450 mikrogram) er den terminale halveringstid for ropeginterferon alfa-2b hos patienter ca. 6 til 10 dage, og clearance af ropeginterferon alfa-2b er 0,023 til 0,061 l/time.
English: Ropeginterferon alfa-2b must not be administered in patients with existence of or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt (see section 4.3).
Danish: Ropeginterferon alfa-2b må ikke gives til patienter med forud eksisterende eller tidligere forekomst af alvorlige psykiatriske lidelser, især alvorlig depression, selvmordstanker eller selvmordsforsøg (se pkt.
English: The selected dose must align with the dot and dose display window.
Danish: Den valgte dosis skal flugte med prikken og dosisvinduet.
English: Discontinuation of ropeginterferon alfa-2b should be considered in patients who develop new or worsening eye disorders.
Danish: Seponering af ropeginterferon alfa-2b bør overvejes hos de patienter, som udvikler nye eller forværrede øjensygdomme.
English: Other medicines and Besremi
Danish: Brug af anden medicin sammen med Besremi
English: Excipient with known effect Each pre-filled pen contains 10 mg benzyl alcohol per mL.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver fyldt pen indeholder 10 mg benzylalkohol pr. ml.
English: If the pre-filled pen is used for the first time, the pen is prepared for injection by turning the dose knob until the symbol of a “drop” in the display window is seen.
Danish: Når den fyldte pen anvendes for første gang, skal den klargøres til injektion ved at dreje dosisknappen, indtil symbolet med "dråben" vises i dosisvinduet.
English: Complete haematological responsea Complete haematological responsea and improvement in disease burdenb a defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 x 109/L and leukocytes <10 x 109/L.
Danish: Fuldstændigt hæmatologisk responsa Fuldstændigt hæmatologisk responsa og forbedring af sygdomsbyrdenb a defineret som hæmatokrit < 45 % uden flebotomi (mindst 3 måneder siden sidste flebotomi), trombocytter < 400 x 109/l og leukocytter < 10 x 109/l.
English: Do not use this medicine if you notice that the pre-filled pen appears damaged, the solution is cloudy, has particles or flakes, or has any colour other than colourless to slightly yellow.
Danish: Dette lægemiddel må ikke bruges, hvis den fyldte pen ser beskadiget ud, opløsningen er grumset, indeholder partikler eller flager eller har nogen anden farve end farveløs til svagt gul.
English: **e.g. urticaria, angioedema, bronchoconstriction or anaphylaxis.
Danish: **F.eks. urticaria, angioødem, bronkokonstriktion eller anafylaksi.
English: Besremi contains sodium
Danish: Besremi indeholder natrium
English: Interferon alfa was shown to be abortifacient in primates and ropeginterferon alfa-2b is expected to have a similar effect.
Danish: Interferon alfa har vist sig at have en abortfremkaldende virkning hos aber, og ropeginterferon alfa-2b forventes at have en lignende virkning.
English: Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6.
Danish: Det er blevet påvist, at interferon alfa påvirker aktiviteten af cytokrom P450 (CYP)-isozymerne CYP1A2 og CYP2D6.
English: In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred.
Danish: I det kliniske udviklingsprogram med ropeginterferon alfa-2b forekom der to tilfælde af alvorlig depression (1,1 %, incidensrate: 0,4 hændelser/100 patienter per år).
English: Patients who experience dizziness, somnolence or hallucination (see section 4.8) during Besremi therapy should avoid driving or using machines.
Danish: Patienter, som oplever svimmelhed, somnolens eller hallucinationer under behandling med Besremi, bør undgå at føre motorkøretøj eller betjene maskiner (se pkt.
English: The cartridge is sealed in a pen injector.
Danish: Cylinderampullen er forseglet i en injektionspen.
English: An open label, randomised phase III study (PROUD-PV) evaluated the efficacy and safety of ropeginterferon alfa-2b in comparison to hydroxycarbamide in 254 adult polycythaemia vera patients (randomisation 1:1).
Danish: Et åbent, randomiseret fase III-studie (PROUD-PV) evaluerede virkningen og sikkerheden af ropeginterferon alfa-2b sammenlignet med hydroxycarbamid hos 254 voksne patienter med polycytæmia vera (randomisering 1:1).
English: Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism.
Danish: Studier hos rotter med et tilsvarende interferon alfa-lægemiddel (pegyleret interferon alfa-2a) viste en primær elimination via hepatisk metabolisering.
English: The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh.
Danish: Det anbefalede injektionssted er i maveskindet, dog mindst 5 cm fra navlen, eller i låret.
English: • Put the cap back on the pen securely.
Danish: • Sæt forsvarligt hætten tilbage på pennen.
English: Studies with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) indicated that the kidney is a major organ for excretion of radiolabelled metabolic products (study in rats) and that the systemic clearance of pegylated interferon alfa-2a in humans is about 100-fold lower compared to the native, unpegylated interferon alfa-2a.
Danish: Studier med et tilsvarende interferon alfa-lægemiddel (pegyleret interferon alfa-2a) indikerede, at nyrerne spiller en væsentlig rolle i udskillelse af radioaktivt mærkede metaboliske produkter (studier hos rotter), og at den systemiske clearance af pegyleret interferon alfa-2a hos mennesker er ca. 100 gange lavere sammenlignet med nativ, upegyleret interferon alfa-2a.
English: Therefore, care should be taken when ropeginterferon alfa-2b is co-administered with CYP1A2 substrates notably those having a narrow therapeutic margin such as theophylline or methadone.
Danish: Der skal derfor udvises forsigtighed ved samtidig administration af ropeginterferon alfa-2b og CYP1A2-substrater, især dem, som har en snæver terapeutisk margin, såsom theophyllin eller metadon.
English: Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b.
Danish: Det menes, at enzymer af proteinkatabolismen er involveret i metaboliseringen af ropeginterferon alfa2b.
English: Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia
Danish: Det reproduktive system og mammae ikke almindelig Erektil dysfunktion, hæmospermi
English: How to store Besremi 6.
Danish: Sådan skal du bruge Besremi 4.
English: • If you have used your Besremi 250 microgram pre filled pen once before, continue directly with step 7.
Danish: • Hvis du allerede har brugt din Besremi 250 mikrogram fyldt pen én gang før, skal du fortsætte direkte med trin
English: No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 6089 mL/min) or moderate (GFR 30-59 mL/min) renal impairment.
Danish: Der kræves ingen dosisjustering af ropeginterferon alfa-2b til voksne patienter med let (GFR 6089 ml/min) eller moderat (GFR 30-59 ml/min) nedsat nyrefunktion.
English: The mean dose after 36 months of treatment (12-month treatment duration in the PROUD-PV Study and 24month treatment duration in the extension study) was 363 (±149) micrograms for ropeginterferon alfa2b.
Danish: Den gennemsnitlige dosis efter 36 måneders behandling (12 måneders behandling i PROUD-PV-studiet og 24 måneders behandling i forlængelsesstudiet) var 363 (± 149) mikrogram for ropeginterferon alfa-2b.
English: Each pack contains 1 pre-filled pen and 2 injection needles.
Danish: Hver pakning indeholder 1 fyldt injektionspen og 2 injektionskanyler
English: Interaction studies of other pegylated interferon alfa medicinal products Co-administration of pegylated interferon alfa-2a with telbivudine in patients with hepatitis B increased the risk of developing peripheral neuropathy.
Danish: Interaktionsstudier med andre pegylerede interferon alfa-lægemidler Samtidig administration af pegyleret interferon alfa-2a med telbivudin hos patienter med hepatitis B øgede risikoen for udvikling af perifer neuropati.
English: CNS effects, in particular depression, have been observed in some patients treated with ropeginterferon alfa-2b during the clinical development program (see section 4.8).
Danish: Der er observeret CNS-virkninger, især depression, hos nogle af patienterne i behandling med ropeginterferon alfa-2b i løbet af det kliniske udviklingsprogram (se pkt.
English: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Danish: Besremi er indiceret som monoterapi til behandling af polycytæmia vera uden symptomatisk splenomegali hos voksne patienter.
English: An open-label, phase IIIb extension study (CONTINUATION-PV) enrolled 171 adult polycythaemia vera patients who previously completed the PROUD-PV Study to evaluate the long-term efficacy and safety of ropeginterferon alfa-2b.
Danish: I et åbent, fase IIIb forlængelsesstudie (CONTINUATION-PV) blev der inkluderet 171 voksne patienter med polycytæmia vera, som tidligere havde gennemført PROUD-PV-studiet, for at evaluere virkningen og sikkerheden af langvarig behandling med ropeginterferon alfa-2b.
English: Besremi 500 micrograms/0.5 mL
Danish: Besremi 500 mikrogram/0,5 ml
English: Caution must be exercised when administering ropeginterferon alfa-2b in combination with other potentially myelosuppressive/chemotherapeutic agents.
Danish: Der skal udvises forsigtighed ved samtidig administration af ropeginterferon alfa-2b med andre potentielt myelosuppressive/kemoterapeutiske midler.
English: Side effects with frequency not known (cannot be estimated from the available data): - Vogt-Koyanagi-Harada disease (a rare disease that can lead to loss of vision, hearing and skin pigmentation), severe allergic reaction - discolouration of the skin
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke beregnes ud fra tilgængelige data): - Vogt-Koyanagi-Harada syndrom (en sjælden sygdom, der kan føre til synstab, høretab og tab af hudpigmentering), alvorlig allergisk reaktion - misfarvning af huden - tandkøds- og tandsygdomme, farveændring af tungen
English: Gastrointestinal disorders have been reported with other interferon alfa medicinal products and have been reported in 15.2% of patients with ropeginterferon alfa-2b treatment.
Danish: Der er rapporteret om gastrointestinale sygdomme ved behandling med andre interferon alfalægemidler samt hos 15,2 % af patienterne i behandling med ropeginterferon alfa-2b.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ropeginterferon alfa-2b therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med ropeginterferon alfa2b seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In 13 patients with ESRD requiring chronic haemodialysis, administration of 135 micrograms pegylated interferon alfa-2a once weekly resulted in a 34% lower drug exposure than in patients with normal renal function.
Danish: Hos 13 patienter med ESRD, som krævede kronisk hæmodialyse, resulterede administration af 135 mikrogram pegyleret interferon alfa-2a én gang om ugen i en 34 % lavere lægemiddeleksponering end hos patienter med normal nyrefunktion.
English: JAK2V617F allele burden JAK2V617F changes from baseline
Danish: JAK2V617F-allelbyrden JAK2V617F-ændringer fra basisline
English: The pre-filled pen label must always be checked before each injection to avoid medication errors between Besremi 250 micrograms/0.5 mL solution for injection and Besremi 500 micrograms/0.5 mL solution for injection.
Danish: Etiketten på den fyldte pen skal altid kontrolleres før hver injektion for at undgå medicineringsfejl mellem Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning og Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning.
English: Besremi contains benzyl alcohol
Danish: Besremi indeholder benzylalkohol
English: Then, tap the pen (cartridge holder) gently with your fingers to allow any air bubbles to rise to the top of the cartridge holder.
Danish: Bank forsigtigt på pennen (cylinderampulholderen) med fingrene så alle eventuelle luftbobler stiger op mod toppen af cylinderampulholderen.
English: Female n (%) Male n (%)
Danish: Kvinde n (%) Mand n (%)
English: Please read this leaflet carefully before using the Besremi 500 micrograms pre-filled pen.
Danish: Læs venligst denne indlægsseddel grundigt, inden du bruger Besremi 500 mikrogram fyldt pen.
English: Only limited pharmacokinetic data are available from the use of ropeginterferon alfa-2b in the elderly.
Danish: Der findes kun begrænsede farmakokinetiske data om anvendelse af ropeginterferon alfa-2b hos ældre.
English: The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy.
Danish: Patienten opnåede fuld bedring efter administration af paracetamol og midlertidig seponering af behandling med ropeginterferon alfa-2b.
English: From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, it was shown that a similar interferon alfa medicinal product (pegylated interferon alfa-2a) was distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Danish: I henhold til studier på rotter af massebalance, vævsdistribution og helkropsautoradioluminografi fordeltes et tilsvarende interferon alfa-lægemiddel (pegyleret interferon alfa-2a) til lever, nyrer og knoglemarv, udover at blive stærkt koncentreret i blodet.
English: No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.
Danish: Der kan ikke gives nogen anbefalinger om dosisjustering af ropeginterferon alfa-2b for disse patienter.
English: Pharmacokinetic interaction studies in humans with pegylated interferon alfa-2a indicated a moderate inhibitory effect on substrates metabolised by CYP1A2 and CYP2D6 (see section 4.5).
Danish: Farmakokinetiske interaktionsstudier hos mennesker med pegyleret interferon alfa-2a indikerede en moderat hæmmende virkning på substrater metaboliseret af CYP1A2 og CYP2D6 (se pkt.
English: The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Danish: Styrken indikerer mængden af interferon alfa-2b-delen af ropeginterferon alfa-2b uden hensyntagen til pegyleringen.
English: Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus#
Danish: Hypothyroidisme, hyperthyroidisme, thyroiditis ikke almindelig Diabetes mellitus#