FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: PROUD-PV in 24-mesečno trajanje zdravljenja v podaljšani študiji) je znašal 363 (±149) mikrogramov ropeginterferona alfa-2b.
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)
Slovenian: - težave z dihanjem, vključno s kratko sapo, kašljem in bolečino v prsnem košu, ki jih lahko povzroči infiltracija pljuč, pljučnica (okužba pljuč), pljučna arterijska hipertenzija (visok krvni tlak v krvnih žilah, ki dovajajo kri iz srca v pljuča) in pljučna fibroza (bolezen pljuč, pri kateri v pljučnem tkivu nastajajo brazgotine).
English: What Besremi looks like and contents of the pack
Slovenian: Izgled zdravila Besremi in vsebina pakiranja
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#
Slovenian: žolčnika in žolčevodov zelo pogosti zvečana vrednost gama-glutamiltransferaze pogosti bolezen jeter, zvečana vrednost alanin-aminotransferaze, zvečana vrednost aspartat-aminotransferaze, zvečana vrednost alkalne fosfataze v krvi občasni hepatotoksičnost, toksični hepatitis, hepatomegalija redki odpoved jeter#
English: This leaflet was last revised in .
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: The European Medicines Agency has waived the obligation to submit the results of studies with Besremi in all subsets of the paediatric population in the treatment of polycythaemia vera (see section 4.2 for information on paediatric use).
Slovenian: Besremi za vse podskupine pediatrične populacije za zdravljenje prave policitemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, mialgija pogosti
English: If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy.
Slovenian: Če se psihiatrični simptomi poslabšajo, je priporočljivo zdravljenje z ropeginterferonom alfa-2b prekiniti.
English: • Raise a fold of skin between the thumb and forefinger.
Slovenian: • S palcem in kazalcem napravite kožno gubo.
English: In addition, dry mouth could damage teeth and the lining of the mouth during long-term treatment with Besremi.
Slovenian: Poleg tega lahko med dolgotrajnim zdravljenjem z zdravilom Besremi zaradi suhih ust pride do poškodb zob in ustne sluznice.
English: It is not known if Besremi is present in breast milk.
Slovenian: Ni znano, ali se zdravilo Besremi izloča v materino mleko.
English: • Needle
Slovenian: • iglo,
English: Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy.
Slovenian: Bolniki s sladkorno boleznijo, ki je ni mogoče učinkovito nadzorovati z zdravili, ne smejo začeti zdravljenja z ropeginterferonom alfa-2b.
English: The use of Besremi is not recommended during pregnancy.
Slovenian: Uporaba zdravila Besremi med nosečnostjo ni priporočljiva.
English: How to store Besremi 6.
Slovenian: Shranjevanje zdravila Besremi 6.
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).
Slovenian: Centralni živčni sistem (CŽS) V programu kliničnega razvoja zdravila so pri nekaterih bolnikih, zdravljenih z ropeginterferonom alfa-2b, opazili učinke na CŽS, še zlasti depresijo (glejte poglavje 4.8).
English: Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain
Slovenian: Sjögrenov sindrom, artritis, bolečina v okončinah, mišično-skeletna bolečina, bolečina v kosteh, mišični krči občasni mišična šibkost, bolečina v vratu, bolečina v dimljah
English: CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
Slovenian: Pri interferonu alfa so poročali o učinkih na CŽS, vključno s poskusom samomora, samomorilnimi mislimi, agresijo, bipolarno motnjo, manijo in zmedenostjo (glejte poglavje 4.4).
English: During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
Slovenian: V programu kliničnih študij so poročali o enemu primeru nenamernega prevelikega odmerjanja z ropeginterferonom alfa-2b.
English: • Check the solution through the inspection windows along the sides of the cartridge holder.
Slovenian: • Skozi kontrolna okenca, ki potekajo vzdolž držala vložka, preverite raztopino.
English: It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred.
Slovenian: Ne sme se ga injicirati v predele telesa, kjer je koža razdražena, pordela, podpluta, okužena ali brazgotinasta.
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.
Slovenian: Pri bolnikih s hepatitisom B je sočasna uporaba pegiliranega interferona alfa-2a s telbivudinom povečala tveganje za nastanek periferne nevropatije.
English: Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija, hemospermija
English: Wilhelminenstrasse 91/IIf
Slovenian: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/IIf 1160 Dunaj
English: Besremi contains benzyl alcohol.
Slovenian: Pomožne snovi Zdravilo Besremi vsebuje benzilalkohol.
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.
Slovenian: Poleg tega imajo lahko suha usta med dolgotrajnim zdravljenjem z ropeginterferonom alfa-2b škodljive učinke na zobe in sluznice v ustni votlini.
English: Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Slovenian: Srčne bolezni pogosti atrijska fibrilacija občasni miokardni infarkt#, atrioventrikularni blok, intrakardialni krvni strdek, insuficienca aortne zaklopke, srčno-žilna bolezen redki kardiomiopatija#, angina pektoris#
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#
Slovenian: Psihiatrične motnje pogosti depresija, agresija#, nespečnost, anksioznost, spremembe razpoloženja, nihanje razpoloženja, ravnodušnost občasni poskus samomora#, samomorilne misli#, zmedenost#, akutna stresna reakcija, halucinacije, čustvena stiska,
English: Fertility There are no data on the effect of ropeginterferon alfa-2b therapy on the fertility of females or males.
Slovenian: Podatkov o vplivu ropeginterferona alfa-2b na plodnost pri ženskah ali moških ni na voljo.
English: The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy.
Slovenian: Bolnik je po zdravljenju s paracetamolom in začasni prekinitvi zdravljenja z ropeginterferonom alfa-2b popolnoma okreval.
English: Shelf life after first use: 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.
Slovenian: EXP Rok uporabnosti po prvi uporabi: shranjuje se lahko v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjeno z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Reproductive and developmental studies were not performed with ropeginterferon alfa-2b.
Slovenian: Študij vpliva na razmnoževanje in razvoj z ropeginterferonom alfa-2b niso opravili.
English: White n (%)
Slovenian: Bela n (%)
English: Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
Slovenian: Bolnike z obstoječimi srčno-žilnimi boleznimi ali anamnezo le-teh je treba med zdravljenjem z ropeginterferonom alfa-2b skrbno spremljati.
English: Do not drive or use machines if you feel dizzy, sleepy or confused while using Besremi.
Slovenian: Če se med uporabo zdravila Besremi počutite omotično, zaspano ali zmedeno, ne vozite in ne upravljajte strojev.
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.
Slovenian: Popoln hematološki odziva Popoln hematološki odziva in izboljšanje bremena boleznib a Določeno kot hematokrit < 45 % brez flebotomije (najmanj 3 mesece od zadnje flebotomije), trombociti
English: JAK2V617F allele burden JAK2V617F changes from baseline
Slovenian: Breme alela JAK2V617F
English: Thus, other products (e.g. hydroxycarbamide) may be preferred in patients for whom an early reduction in elevated blood counts is necessary to prevent thrombosis and bleeding.
Slovenian: Zato so pri bolnikih, pri katerih je nujno zgodnje zmanjšanje zvišanega števila krvnih celic za preprečevanje tromboze in krvavitev, morda ustreznejša druga zdravila (npr. hidroksikarbamid).
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
Slovenian: - izguba vida, ki jo lahko povzroči poškodba mrežnice (kot je oviranje pretoka v krvnih žilah v očesu) ali vidnega živca.
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.
Slovenian: 135 mikrogramov pegiliranega interferona alfa-2a enkrat na teden povzročilo 34 % manjšo izpostavljenost kot pri bolnikih z normalnim delovanjem ledvic.
English: Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued.
Slovenian: Bolnike, pri katerih se pojavijo simptomi na dihalih, je treba skrbno spremljati in njihovo zdravljenje z ropeginterferonom alfa-2b prekiniti, če je to potrebno.
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
Slovenian: 1 12-mesečno trajanje zdravljenja v študiji PROUD-PV in 12-mesečno trajanje zdravljenja v podaljšani študiji.
English: Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8).
Slovenian: Pri drugih zdravilih z interferonom alfa so opazili sladkorno bolezen (glejte poglavje 4.8).
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.
Slovenian: V farmakokinetični študiji zdravih preskušancev se je pri razponu odmerkov od 24 do 270 mikrogramov Cmax ropeginterferona alfa-2b zvečevala sorazmerno z odmerkom.
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).
Slovenian: Sočasna uporaba pegiliranega interferona alfa-2b ni pokazala pomembnih medsebojnih delovanj s tolbutamidom (substrat CYP2C9), midazolamom (substrat CYP3A4) in dapsonom (substrat
English: You should see a droplet of liquid appearing at the needle tip.
Slovenian: Na konici igle se mora pojaviti kaplja tekočine.
English: • Put the cap back on the pen securely.
Slovenian: • Pokrovček namestite nazaj na peresnik.
English: Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja občasni pnevmonitis, kašelj, epistaksa, draženje žrela zelo redki infiltracija pljuč#
English: Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
Slovenian: Prav tako je priporočljiva previdnost pri kombinaciji ropeginterferona alfa-2b s substrati CYP2D6 (npr. vortioksetinom, risperidonom).
English: The elimination of ropeginterferon alfa-2b is not fully characterised.
Slovenian: Izločanje ropeginterferona alfa-2b ni popolnoma opredeljeno.
English: The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy).
Slovenian: Odmerek se titrira individualno, priporočeni začetni odmerek je 100 mikrogramov (oziroma
English: Ropeginterferon alfa-2b treatment arm1 (n=94)
Slovenian: Skupina, zdravljenja z ropeginterferonom alfa-2b1 (n = 94)
English: Your doctor will reduce your starting dose to 50 microgram if you have severe kidney problems.
Slovenian: Če imate hude težave z ledvicami, bo zdravnik vaš začetni odmerek zmanjšal na 50 mikrogramov.
English: Besremi contains sodium
Slovenian: Zdravilo Besremi vsebuje natrij
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).
Slovenian: Pri interferonu alfa so poročali o resnih boleznih oči, kot so retinopatija, mrežnična krvavitev, mrežnični eksudati, odstop mrežnice in zapora mrežnične arterije ali vene (glejte poglavje 4.4).
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
Slovenian: Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg,
Slovenian: Možni odmerki so 50 μg, 100 μg, 150 μg,
English: Once opened, the pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Slovenian: Po odprtju lahko napolnjen injekcijski peresnik shranjujete v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjen z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Each cartridge contains 0.5 mL of solution.
Slovenian: En peresnik vsebuje 0,5 ml raztopine.
English: An abortifacient effect was reported in primates receiving other interferon alfa medicinal products.
Slovenian: Pri primatih, ki so prejemali druga zdravila z interferonom alfa, so poročali o abortivnem učinku.
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).
Slovenian: Pri drugih zdravilih z interferonom alfa so poročali o boleznih zobnih in obzobnih tkiv, ki lahko vodijo do izgube zob (glejte poglavje 4.8).
English: Adjustments in the recommended dose for ropeginterferon alfa-2b are not necessary when starting therapy in elderly patients (see section 5.2).
Slovenian: Pri uvajanju zdravljenja pri starejših bolnikih prilagajanje priporočenega odmerka ropeginterferona alfa-2b ni potrebno (glejte poglavje 5.2).
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.
Slovenian: Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik je izdelan iz belega polipropilena in ima siv potisni gumb, na nalepki pa ima s sivo označeno jakost “250 mcg/0,5 ml”.
English: Store the pen in the outer carton in the refrigerator.
Slovenian: Peresnik shranjujte v zunanji ovojnini in ga hranite v hladilniku.
English: Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Slovenian: Ropeginterferon alfa-2b je kontraindiciran pri bolnikih z dekompenzirano cirozo jeter (glejte poglavje 4.3).
English: If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Slovenian: Če se delovanje ledvic med zdravljenjem poslabša, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
English: Common side effects (may affect up to 1 in 10 people): - changes in your heart beat (when the heart beats very fast and uneven)
Slovenian: - spremembe srčnega ritma (kadar srce bije zelo hitro ali neenakomerno).
English: Since Besremi is a solution, it does not require resuspension before use.
Slovenian: Ker je zdravilo Besremi raztopina, resuspendiranje pred injiciranjem ni potrebno.
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#
Slovenian: suha usta občasni gastritis, bolezen trebušne stene, flatulenca, pogosto odvajanje blata, odinofagija, krvavitev iz dlesni neznana bolezni zob#, bolezen obzobnega tkiva#
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
Slovenian: zadebelitev zunanjega sloja kože, povečano znojenje, - bolezen, imenovana Sjögrenov sindrom, pri kateri telesni imunski sistem napade žleze, v katerih nastaja tekočina (kot so solzne žleze in žleze slinavke), artritis, bolečina v rokah in nogah, bolečina v kosteh, nenadno boleče krčenje mišice, - vročina, šibkost, mrzlica, splošne zdravstvene težave, razdražena ali pordela koža na mestu injiciranja,
English: Administration of 180 micrograms of pegylated interferon alfa-2a once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that pegylated interferon alfa-2a has no effect on in vivo metabolic activity of cytochrome P450 (CYP) 3A4, 2C9, 2C19 and 2D6 isozymes.
Slovenian: Dajanje 180 mikrogramov pegiliranega interferona alfa-2a enkrat na teden 4 tedne pri zdravih moških preskušancih ni vplivalo na farmakokinetični profil mefenitoina, dapsona, debrisokina in tolbutamida.
English: It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Slovenian: Možni odmerki so 50 μg, 100 μg, 150 μg, 200 μg in
English: • Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Slovenian: • Nikakor ne injicirajte v kožo, ki je razdražena, pordela, podpluta, okužena ali brazgotinasta.
English: • Set the dose your doctor told you by turning the dose knob.
Slovenian: • Z vrtenjem odmernega gumba nastavite odmerek, ki vam ga je določil zdravnik.
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,
Slovenian: Preiskave pogosti prisotnost protiteles proti ščitnici, zvečana vrednost tirotropina v krvi, zvišana telesna temperatura, prisotnost antinuklearnih protiteles, zvečana vrednost laktatdehidrogenaze v krvi občasni zvečano število trombocitov, zvečana vrednost sečne kisline v krvi, pozitiven Coombsov test, zmanjšanje telesne mase
English: Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Slovenian: Pri drugih zdravilih z interferonom alfa so pri bolnikih z okužbo z virusom hepatitisa C poročali o odpovedi jeter (glejte poglavje 4.8).
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years.
Slovenian: Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 1,5 leta
English: No interaction studies have been performed with ropeginterferon alfa-2b.
Slovenian: Študij medsebojnega delovanja z ropeginterferonom alfa-2b niso opravili.
English: Only limited pharmacokinetic data are available from the use of ropeginterferon alfa-2b in the elderly.
Slovenian: Iz uporabe ropeginterferona alfa-2b pri starejših so na voljo le omejeni farmakokinetični podatki.
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)
Slovenian: - zdravila proti raku, kot so tista, ki ustavijo ali upočasnijo rast krvotvornih celic v kostnem mozgu (npr. hidroksikarbamid), - zdravila, ki delujejo na centralni živčni sistem in lajšajo bolečino, delujejo uspavalno ali imajo pomirjujoč učinek (npr. morfin, midazolam).
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).
Slovenian: V povezavi z zdravljenjem z interferonom alfa so poročali o srčnih dogodkih, vključno s kardiomiopatijo, miokardnim infarktom, atrijsko fibrilacijo in ishemičnimi boleznimi koronarnih arterij (glejte poglavje 4.8).
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).
Slovenian: Pri bolnikih, zdravljenih z interferonom alfa, so redko poročali o boleznih dihal, kot so infiltracija pljuč, pnevmonitis, pljučnica ali pljučna arterijska hipertenzija (glejte poglavje 4.8).
English: Most common adverse reactions during ropeginterferon alfa-2b treatment.
Slovenian: Najpogostejši neželeni učinki med zdravljenjem z ropeginterferonom alfa-2b