FrancophonIA/ELRC3.0 huggingface dataset:
English: Read them before you start using Besremi.
Slovenian: Preberite jih pred začetkom uporabe zdravila Besremi.
English: Treatment should be initiated under supervision of a physician experienced in the management of the disease.
Slovenian: Zdravljenje mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s to boleznijo.
English: *Class label for interferon medicinal products, see below pulmonary arterial hypertension.
Slovenian: *Velja za skupino zdravil, ki vsebujejo interferone, glejte pljučno arterijsko hipertenzijo spodaj.
English: Ropeginterferon alfa-2b treatment was continued and the patients received appropriate medicinal products to treat these events.
Slovenian: Zdravljenje z ropeginterferonom alfa-2b so nadaljevali, bolniki pa so za zdravljenje teh dogodkov prejeli ustrezna zdravila.
English: • Unscrew the needle and dispose of it appropriately.
Slovenian: • Iglo odvijte in jo primerno odstranite.
English: To prevent passing on infectious diseases, you should never share Besremi pre-filled pen with anyone else, even when the needle is changed.
Slovenian: Za preprečevanje morebitnega prenosa okužb ne smete peresnika zdravila Besremi nikoli deliti s katero koli drugo osebo, tudi če je bila igla zamenjana.
English: • Immunosuppressed transplant recipients
Slovenian: • prejemniki presadka na imunosupresivnem zdravljenju,
English: • If you are unable to reach the required dose setting by turning the dose knob, your pen may not have sufficient medicine left.
Slovenian: • Če z vrtenjem odmernega gumba ne morete doseči zahtevane nastavitve odmerka, v vašem peresniku morda ni več dovolj zdravila.
English: Patients who experience dizziness, somnolence or hallucination (see section 4.8) during Besremi therapy should avoid driving or using machines.
Slovenian: Bolniki, ki se jim med zdravljenjem z zdravilom Besremi pojavijo omotica, somnolenca ali halucinacije (glejte poglavje 4.8), se morajo izogibati vožnji in upravljanju strojev.
English: • Do not touch the needle tip at any time.
Slovenian: • V nobenem primeru se ne dotikajte konice igle.
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).
Slovenian: Interferon alfa spada v skupino interferonov tipa I, ki svoje učinke na celice izražajo z vezavo na transmembranske receptorje, imenovane interferon alfa receptorji (IFNAR).
English: Ropeginterferon alfa-2b may inhibit the activity of CYP1A2 and CYP2D6 and thus may increase the blood concentrations of these medicinal products.
Slovenian: Ropeginterferon alfa-2b lahko zavira aktivnost CYP1A2 in CYP2D6 in tako povzroči zvečano koncentracijo teh zdravil v krvi.
English: If you stop using Besremi
Slovenian: Če ste prenehali uporabljati zdravilo Besremi
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.
Slovenian: - če se vam med uporabo zdravila Besremi pojavijo znaki hude alergijske reakcije (kot so oteženo dihanje, piskajoče dihanje ali koprivnica) - v tem primeru morate nemudoma poiskati zdravniško pomoč;
English: n.r.
Slovenian: n.p.
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).
Slovenian: Pri interferonu alfa so poročali o primerih pljučne arterijske hipertenzije (PAH), predvsem pri bolnikih z dejavniki tveganja za PAH (kot je portalna hipertenzija, okužba s HIV, ciroza).
English: Raynaud's phenomenon, hypertension, haematoma, flushing
Slovenian: Raynaudov fenomen, hipertenzija, hematom, zardevanje
English: Before use, the pre-filled pen should be brought to room temperature (15 °C - 25 °C) for up to 15 minutes.
Slovenian: Pred uporabo pustite napolnjen injekcijski peresnik do 15 minut na sobni temperaturi (15 °C - 25 °C).
English: Patients should be closely monitored for any symptoms of psychiatric disorders and therapeutic management should be considered by the treating physician if such symptoms emerge.
Slovenian: Bolnike je treba skrbno spremljati glede pojava kakršnih koli simptomov psihiatričnih bolezni, če pa se taki simptomi pojavijo, mora lečeči zdravnik razmisliti o njihovem zdravljenju.
English: Basedow's disease, sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura#
Slovenian: Basedowova bolezen, sarkoidoza zelo redki idiopatska ali trombotična trombocitopenična purpura#
English: If you forget to use Besremi
Slovenian: Če ste pozabili uporabiti zdravilo Besremi
English: not known retinal detachment#
Slovenian: neznana odstop mrežnice#
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.
Slovenian: Odziv bolezni (določen kot hematokrit < 45 % brez flebotomije [najmanj 3 mesece od zadnje flebotomije], trombociti < 400 x 109/l in levkociti < 10 x 109/l po 12 mesecih zdravljenja) je bil 43,1 % [53/123 bolnikov] v skupini z ropeginterferonom alfa-2b po 12 mesecih zdravljenja.
English: Interferon alfa therapy has been associated with hepatotoxicity characterized by potentially significant increases in liver enzymes.
Slovenian: Zdravljenje z interferonom alfa je bilo povezano s hepatotoksičnostjo, za katero so značilna potencialno pomembna zvišanja jetrnih encimov.
English: What Besremi is and what it is used for
Slovenian: Kaj je zdravilo Besremi in za kaj ga uporabljamo
English: These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera.
Slovenian: Ta delovanja so lahko vpletena v terapevtske učinke interferona alfa pri pravi policitemiji.
English: This droplet is normal and does not mean that you underdosed.
Slovenian: To je normalno in ne pomeni, da ste prejeli premajhen odmerek.
English: Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly.
Slovenian: Ko se na konici igle pojavi kapljica tekočine, napolnjen injekcijski peresnik in igla delujeta pravilno.
English: • If you are using this pen for the first time, continue with preparation of the pen in step 5.
Slovenian: • Če ta peresnik uporabljate prvič, nadaljujte s pripravo peresnika, kot opisuje korak 5.
English: How to use Besremi
Slovenian: Kako uporabljati zdravilo Besremi
English: • Hold the pen so that the display window and the label are visible during the injection.
Slovenian: • Peresnik držite tako, da sta okence in nalepka med injiciranjem vidna.
English: not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#*
Slovenian: neznana pljučna fibroza#, pljučnica#, pljučna arterijska hipertenzija#*
English: Contact your doctor immediately if you notice any of the following serious side effects during your treatment with Besremi:
Slovenian: Nemudoma obvestite zdravnika, če med zdravljenjem z zdravilom Besremi opazite katerega koli od naslednjih resnih neželenih učinkov:
English: 250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
Slovenian: 200 μg in 250 μg, 300 μg, 350 μg, 400 μg, 450 μg in 500 μg.
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.
Slovenian: En bolnik, ki je doživel resno akutno stresno reakcijo (0,6 %; stopnja incidence: 0,2 dogodkov/100 bolnikov na leto) zmerne jakosti, je po zmanjšanju odmerka ropeginterferona alfa-2b popolnoma okreval.
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).
Slovenian: En napolnjen injekcijski peresnik vsebuje vložek (brezbarvno steklo tipa I) s sivim batom (bromobutilna guma) in prirobljeno zaporko (aluminij) z zamaškom (bromobutilna guma).
English: Obese or underweighted patients
Slovenian: Prekomerno prehranjeni ali podhranjeni bolniki
English: Based on data in monkeys, it is approx. 80%, similar to that seen for pegylated interferon alfa-2a.
Slovenian: Glede na podatke pri opicah je približno 80 %, podobno kot so opažali pri pegiliranem interferonu alfa-2a.
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.
Slovenian: Farmakokinetični profil pri bolnikih z zmerno ali hudo okvaro ledvic in pri bolnikih s končno ledvično odpovedjo so ovrednotili le za druga zdravila s pegiliranim interferonom alfa.
English: The dose can be set in steps of 50 micrograms by rotating the dose knob.
Slovenian: Odmerek lahko nastavljate v korakih po 50 mikrogramov z vrtenjem odmernega gumba.
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.
Slovenian: V klinični študiji prave policitemije je bil konec povprečne individualne faze titracije za ropeginterferon alfa-2b dosežen po približno 3,7 mesecih, za hidroksikarbamid pa po približno 2,6 mesecih zdravljenja.
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).
Slovenian: To zdravilo je kontraindicirano pri bolnikih s hudo obstoječo srčno-žilno boleznijo ali pri bolnikih z nedavno možgansko kapjo ali miokardnim infarktom (glejte poglavje 4.3).
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.
Slovenian: Odprta podaljšana študija faze IIIb (CONTINUATION-PV) je vključevala 171 odraslih bolnikov s pravo policitemijo, ki so pred tem zaključili študijo PROUD-PV, in je ocenjevala dolgoročno učinkovitost in varnost ropeginterferona 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.
Slovenian: Raziskave masnega ravnovesja, porazdelitve v tkiva in raziskave avtoradioluminografije celega telesa pri podganah so pokazale, da se podobno zdravilo z interferonom alfa (pegiliran interferon alfa-2a) porazdeli v jetra, ledvice in kostni mozeg poleg tega, da je visoko koncentriran v krvi.
English: Ninety-five patients continued to receive ropeginterferon alfa-2b (from 50 to 500 micrograms administered subcutaneously every two, three or four weeks).
Slovenian: Petindevetdeset bolnikov je nadaljevalo s prejemanjem ropeginterferona alfa-2b (od 50 do 500 mikrogramov subkutano, danih vsaka dva, tri ali štiri tedne).
English: Patients showed a statistically significant difference in the JAK2V617F allele burden (19.7%) and JAK2V617F allele change from baseline (-22.9%).
Slovenian: Bolniki so imeli statistično pomembno razliko v bremenu alela JAK2V617F (19,7 %) in spremembi od izhodišča alela JAK2V617F (−22,9 %).
English: The selected dose must align with the dot and dose display window.
Slovenian: Izbrani odmerek mora biti poravnan s piko v odmernem okencu.
English: unstable angina) or recent stroke or myocardial infarction
Slovenian: nestabilna angina pektoris) ali nedavna možganska kap ali miokardni infarkt,
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.
Slovenian: Pokazali so, da ima interferon alfa zaviralni učinek na proliferacijo fibroblastnih hematopoetskih matičnih celic in fibroblastnih matičnih celic v kostnem mozgu ter preprečuje delovanje rastnih dejavnikov in drugih citokinov, ki imajo vlogo v razvoju mielofibroze.
English: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Slovenian: Zdravilo Besremi je indicirano kot monoterapija pri odraslih za zdravljenje prave policitemije brez simptomatske splenomegalije.
English: not known
Slovenian: neznana
English: • If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7.
Slovenian: • Če ste vaš napolnjen injekcijski peresnik zdravila Besremi 500 mikrogramov pred tem že enkrat uporabili, nadaljujte neposredno s korakom 7.
English: Do not use this medicine after the expiry date which is stated on the label and the outer carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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.
Slovenian: Ne uporabljajte tega zdravila, če je peresnik videti poškodovan ali je raztopina motna ali so v njej vidni delci ali kosmiči ali je katere koli druge barve kot brezbarvna ali rahlo rumena.
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]).
Slovenian: V teh študijah so bile najpogostejše bolezni prebavil diareja (5,1 %; stopnja incidence: 2,8 dogodkov/100 bolnikov na leto) in navzea (4,5 %; stopnja incidence: 1,6 dogodkov/100 bolnikov na leto).
English: Based on single dose data, clearance was similar in patients with severe renal impairment not on haemodialysis and in patients who received haemodialysis.
Slovenian: Glede na podatke za enkratni odmerek je bil očistek pri bolnikih s hudo ledvično okvaro, ki niso na hemodializi, podoben kot pri tistih na hemodializi.
English: There are no or limited amount of data from the use of interferon alfa in pregnant women.
Slovenian: Podatkov o uporabi interferona alfa pri nosečih ženskah ni oziroma so omejeni.
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.
Slovenian: V isti študiji so opazili tudi 25-odstotno zvečanje AUC teofilina (substrat CYP1A2), kar dokazuje, da je pegiliran interferon alfa-2a zaviralec aktivnosti CYP1A2.
English: If TSH levels can be controlled within the normal range, the therapy can be continued.
Slovenian: Z zdravljenjem se lahko nadaljuje, če je mogoče ravni TSH ohranjati v normalnem območju.
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).
Slovenian: Nadalje so dokazali, da je interferon alfa pri bolnikih s pravo policitemijo zmožen zmanjšati breme mutiranega alela JAK2V617F (točkovna mutacija V617F v kinazi JAK2, ki je znak prave policitemije in je prisotna pri približno 95 % bolnikov).
English: The mean dose after 12 months of treatment was 382 (±141) micrograms for ropeginterferon alfa-2b.
Slovenian: Povprečni odmerek po 12 mesecih zdravljenja je znašal 382 (±141) mikrogramov ropeginterferona alfa-2b.
English: If you need a dose of more than 250 micrograms, you require two Besremi 250 microgram pre-filled pens.
Slovenian: Če potrebujete odmerek, ki je večji od 250 mikrogramov, boste potrebovali dva napolnjena injekcijska peresnika zdravila Besremi 250 mikrogramov.
English: The use of ropeginterferon alfa-2b is associated with skin disorders (pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhydrosis).
Slovenian: Uporaba ropeginterferona alfa-2b je povezana z boleznimi kože (pruritus, alopecija, izpuščaj, eritem, psoriaza, kseroderma, akneiformni dermatitis, hiperkeratoza, hiperhidroza).
English: • Disinfect your skin in the injection area using an alcohol swab before the injection.
Slovenian: • Kožo na mestu injiciranja pred injiciranjem razkužite z alkoholnim zložencem.
English: Caution must be exercised when administering ropeginterferon alfa-2b in combination with other potentially myelosuppressive/chemotherapeutic agents.
Slovenian: Previdnost je potrebna pri dajanju ropeginterferona alfa-2b v kombinaciji z drugimi morebitno mielosupresivnimi/kemoterapevtskimi učinkovinami.
English: Besremi is presented as a solution for injection (injection) in a pre-filled pen.
Slovenian: Zdravilo Besremi je raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku.
English: Talk to your doctor before using Besremi: - if you have thyroid disease.
Slovenian: Pred začetkom uporabe zdravila Besremi se posvetujte z zdravnikom: - če imate bolezen ščitnice;
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.
Slovenian: Po večkratnem subkutanem odmerjanju (razpon odmerkov 50-450 mikrogramov) je končni razpolovni čas ropeginterferona alfa-2b pri bolnikih znašal približno 6 do 10 dni, očistek ropeginterferona alfa-2b pa je znašal od 0,023 do 0,061 l/h.
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.
Slovenian: Ženske v rodni dobi/kontracepcija pri ženskah Ženske v rodni dobi morajo med zdravljenjem z ropeginterferonom alfa-2b uporabljati učinkovito metodo kontracepcije, razen če jim je zdravnik svetoval drugače.
English: Besremi 500 micrograms/0.5 mL
Slovenian: Besremi 500 mikrogramov/0,5 ml
English: Interferon alfa was shown to be abortifacient in primates and ropeginterferon alfa-2b is expected to have a similar effect.
Slovenian: Ugotovili so, da interferon alfa deluje abortivno pri primatih in pričakujejo, da ima ropeginterferon alfa-2b podoben učinek.
English: **e.g. urticaria, angioedema, bronchoconstriction or anaphylaxis.
Slovenian: **Npr. koprivnica, angioedem, bronhokonstrikcija ali anafilaksija.
English: • Discard the pen after use as instructed by your doctor or pharmacist.
Slovenian: • Po uporabi peresnik odstranite, kot vam je naročil zdravnik ali farmacevt.
English: Contents of the pack and other information What Besremi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Besremi
English: Besremi 250 micrograms/0.5 mL
Slovenian: Besremi 250 mikrogramov/0,5 ml
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).
Slovenian: Porazdelitev Ropeginterferon alfa-2b najdemo predvsem v krvnem obtoku in zunajcelični tekočini, kar je razvidno tudi iz volumna porazdelitve, ki v stanju dinamičnega ravnovesja (Vd) pri bolnikih po subkutanem dajanju znaša 6,6 do 17 litrov (razpon odmerka 50-450 mikrogramov).
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.
Slovenian: Zdravilo Besremi 500 mikrogramov napolnjen injekcijski peresnik lahko uporabite za injiciranje odmerkov po 50, 100, 150, 200, 250, 300, 350, 400, 450 in 500 mikrogramov.
English: Reuse of the pen:
Slovenian: Ponovna uporaba peresnika:
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).
Slovenian: Ropeginterferona alfa-2b se ne sme dati bolnikom z obstoječimi hudimi psihiatričnimi boleznimi ali anamnezo takih bolezni, še zlasti hude depresije, samomorilnih misli ali poskusa samomora (glejte poglavje 4.3).
English: - if you develop symptoms of a cold or other respiratory infection (such as difficulty in breathing, cough, fever and chest pain).
Slovenian: - če se vam pojavijo simptomi prehlada ali druge okužbe dihal (kot so oteženo dihanje, kašelj,
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).
Slovenian: V odprti, randomizirani študiji III. faze (PROUD-PV) so ovrednotili učinkovitost in varnost ropeginterferona alfa-2b v primerjavi s hidroksikarbamidom pri 254 odraslih bolnikih s pravo policitemijo (randomizacija 1:1).
English: Inter-subject variability was observed with 25% and 35% for AUC and Cmax, respectively, in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih so bile razlike med preskušanci opažene pri 25 % in 35 % za AUC in Cmax.
English: The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days.
Slovenian: Absorpcija ropeginterferona alfa-2b pri bolnikih je trajna, največje serumske koncentracije pa so dosežene po 3 do 6 dneh.
English: Find a well-lit area without significant distraction for the injection.
Slovenian: Za injiciranje poiščite dobro osvetljen prostor, kjer ne boste deležni pretiranega odvračanja pozornosti.
English: Dental and periodontal disorders
Slovenian: Bolezni zobnih in obzobnih tkiv
English: • If you have used your Besremi 250 microgram pre filled pen once before, continue directly with step 7.
Slovenian: • Če ste vaš napolnjen injekcijski peresnik zdravila Besremi 250 mikrogramov pred tem že enkrat uporabili, nadaljujte neposredno s korakom 7.
English: Besremi is used as monotherapy for the treatment of polycythaemia vera in adults.
Slovenian: Zdravilo Besremi se uporablja kot monoterapija za zdravljenje prave policitemije pri odraslih.
English: Severe eye problems may occur during Besremi therapy.
Slovenian: Med zdravljenjem z zdravilom Besremi lahko pride do hudih težav z očmi.
English: Besremi contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Besremi vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni »brez natrija«.
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.
Slovenian: Prilagajanje odmerka ropeginterferona alfa-2b pri odraslih bolnikih z blago (GFR 60-89 ml/min) ali zmerno (GFR 30-59 ml/min) okvaro ledvic ni potrebno.
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.
Slovenian: Študije s podobnim zdravilom z interferonom alfa (pegiliran interferon alfa-2a) so pokazale, da so ledvice glavni organ za izločanje radioaktivno označenih presnovkov (študija na podganah) in da je sistemski očistek pegiliranega interferona alfa-2a pri ljudeh približno 100-krat manjši v primerjavi z nespremenjenim, nepegiliranem interferonom alfa-2a.