natgillin/translations-raw huggingface dataset:
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). 
Respiratorni poremećaji poput infiltracije pluća, pneumonitisa, pneumonije ili hipertenzije plućne arterije rijetko su zabilježeni u bolesnika liječenih interferonom alfa (vidjeti dio 4.8).
• Press the push button all the way down until the “0” mark is aligned with the dot in the display window. 
• Pritisnite potisni gumb do kraja, dok se oznaka „0“ ne poravna s točkom na prozorčiću za prikaz.
If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy. 
Ako se psihijatrijski simptomi pogoršaju, preporučuje se prekinuti terapiju ropeginterferonom alfa-2b.
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. 
Naljepnicu na napunjenoj brizgalici treba uvijek provjeriti prije svake primjene injekcije kako bi se izbjegle medikacijske pogreške između Besremi 250 mikrograma/0,5 ml otopine za injekciju i
No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients. 
Ne može se dati preporuka za prilagodbu doze ropeginterferona alfa-2b u tih bolesnika.
Severe eye problems may occur during Besremi therapy. 
Tijekom terapije lijekom Besremi mogu se pojaviti teški očni problemi.
- 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. 
- ako imate problema s jetrom - redovito ćete obavljati krvne pretrage za provjeru rada
Fertility There are no data on the effect of ropeginterferon alfa-2b therapy on the fertility of females or males. 
Nema podataka o učinku terapije ropeginterferonom alfa-2b na plodnost žena ili muškaraca.
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. 
U 13 bolesnika sa završnim stadijem bolesti bubrega, koji su zahtijevali kroničnu hemodijalizu, primjena 135 mikrograma pegiliranog interferona alfa-2a jedanput na tjedan rezultirala je u 34% nižoj izloženosti lijeku nego u bolesnika s normalnom funkcijom bubrega.
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). 
Farmakokinetički profil drugih lijekova koji sadrže interferon alfa (pegilirani interferon alfa-2a te pegilirani interferon alfa-2b) procijenjen je u bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8). 
Srčani događaji, uključujući kardiomiopatiju, infarkt miokarda, fibrilaciju atrija i koronarne ishemijske poremećaje povezani su s liječenjem interferonom alfa (vidjeti dio 4.8).
The use of interferon alfa has not been evaluated in patients with decompensated cirrhosis (i.e. ChildPugh B or C) and is contraindicated in these patients (see section 4.3). 
Primjena interferona alfa nije procijenjena u bolesnika s dekompenziranom cirozom jetre (tj. ChildPugh stadij B ili C) te je kontraindicirana u tih bolesnika (vidjeti dio 4.3).
The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms. 
Besremi 250 mikrograma napunjena brizgalica može se upotrijebiti za ubrizgavanje doza od 50, 100, 150, 200, i 250 mikrograma.
Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC). 
Varijabilnost između ispitanika za ropeginterferon alfa-2b iznosila je 35% (Cmax) i
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. 
U bolesnika s kompenziranom cirozom (tj. Child-Pugh stadij A), drugi lijek s pegiliranim interferonom alfa (pegilirani interferon alfa-2a) pokazao se sigurnim.
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. 
Porasti u razinama ALT (≥3 puta veći od gornje granice normale), AST (≥3 puta veći od gornje granice normael), GGT (≥3 puta veći od gornje granice normale) te bilirubin (>2 puta veći od gornje granice normale) uočeni su kod bolesnika liječenih ropeginterferonom alfa-2b.
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections. 
- Drugi sastojci su natrijev klorid, polisorbat 80, benzilni alkohol, bezvodni natrijev acetat, ledena acetatna kiselina i voda za injekcije.
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. 
Bolesnici s umjerenim ili teškim oštećenjem bubrega, koji primaju 180 mikrograma pegiliranog interferona alfa-2a jedanput na tjedan, pokazali su usporedivu odnosno za 60% višu izloženost lijeku u plazmi, u usporedbi s ispitanicima s normalnom funkcijom bubrega.
• Do not touch the needle tip at any time. 
• Nemojte nikada dodirivati vrh igle.
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). 
1 Bolesnici s 36 mjeseci liječenja ropeginterferonom alfa-2b (12-mjesečno trajanje liječenja u ispitivanju PROUD-PV i 24-mjesečnom trajanju liječenja u produžetku ispitivanja).
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. 
Ropeginterferon alfa-2b je kovalentni konjugat proteina interferon alfa-2b, proizvedenog u stanicama bakterije Escherichia coli tehnologijom rekombinantne DNK, i metoksipolietilenglikola (mPEG).
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. 
Bolesnici s oštećenjem bubrega koji su primili jednokratnu dozu od 1,0 mikrograma/kg pegiliranog interferona alfa-2a pokazali su povećanu povezanost između Cmax, AUC te poluvijeka sa stupnjem oštećenja bubrega.
Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution 
Otopina za injekciju u napunjenoj brizgalici 1 napunjena brizgalica + 2 igle za injekciju 0,5 ml otopine
The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation. 
Jačina se odnosi na kvantitativni sadržaj interferon alfa-2b dijela ropeginterferona alfa-2b, dakle bez pegilacije.
including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products. 
Drugi učinci na SŽS uključujući suicidalnu ideaciju, pokušaj suicida, agresiju, bipolarni poremećaj, maniju i konfuznost uočeni su kod primjene drugih lijekova koji sadrže interferon alfa.
• Remove the outer needle cap from the needle. 
• Skinite vanjsku kapicu s igle.
Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3). 
Prije terapije ropeginterferonom alfa-2b, potrebno je svaku postojeću bolest štitnjače liječiti i kontrolirati standardnom terapijom (vidjeti dio 4.3).
- if you develop symptoms of a cold or other respiratory infection (such as difficulty in breathing, cough, fever and chest pain). 
- ako razvijete simptome prehlade ili drugih respiratornih infekcija (poput otežanog disanja,
Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia 
Poremećaji krvi i limfnog sustava vrlo često leukopenija, trombocitopenija često pancitopenija, neutropenija, anemija
- The active substance is ropeginterferon alfa-2b. 
- Djelatna tvar je ropeginterferon alfa-2b.
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) 
Recite svom liječniku posebno ako uzimate bilo koje od sljedećih lijekova: - teofilin (lijek koji se koristi za liječenje bolesti dišnog sustava poput astme) - metadon (lijek koji se koristi za liječenje boli ili ovisnosti o opioidima) - vortioksetin ili risperidon (lijekovi koji se koriste za liječenje psihičkih poremećaja)
A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3). 
Kombinirana terapija s telbivudinom i ropeginterferonom alfa-2b je kontraindicirana (vidjeti dio 4.3).
Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain 
Sjogrenov sindrom, artritis, bol u ekstremitetima, bol u mišićno-koštanom sustavu, bol u kostima, grčevi u mišićima manje često slabost mišića, bol u vratu, bol u preponama
Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients. 
Tablični popis nuspojava Sljedeće nuspojave povezane s liječenjem prijavljene su s ropeginterferonom alfa-2b u kliničkim ispitivanjima u 178 odraslih bolesnika s policitemijom verom.
Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus# 
Endokrini poremećaji često hipotiroidizam, hipertiroidizam, tiroiditis manje često dijabetes melitus#
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. 
Poremećaji probavnog sustava prijavljeni su kod drugih lijekova koji sadrže interferon alfa te su zabilježeni u 15,2% bolesnika koji se liječe ropeginterferonom alfa-2b.
Common side effects (may affect up to 1 in 10 people): - changes in your heart beat (when the heart beats very fast and uneven) 
- promjene u srčanom ritmu (kada srce kuca vrlo brzo i neujednačeno)
The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy. 
Bolesnik se u potpunosti oporavio nakon primjene paracetamola te privremenog prekida terapije ropeginterferonom alfa-2b.
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 
- bipolarni poremećaji (promjene raspoloženja s epizodama tuge i uzbuđenja), manija (pretjerano uzbuđenje ili nerazumni entuzijazam) - kardiomiopatija (bolesti koje zahvaćaju srčani mišić), angina pektoris (teška bol u prsištu kao rezultat začepljenja krvnih žila srca) - zatajenje jetre
The 500 micrograms/0.5 mL pre-filled pen has a blue push button. 
Napunjena brizgalica 500 mikrograma/0,5 ml ima plavi potisni gumb.
Ropeginterferon alfa-2b treatment arm1 (n=94) 
Skupina koja je primala ropeginterferon alfa-2b1 (n=94)
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients. 
Farmakokinetički profil ropeginterferona alfa-2b nije utvrđen u pretilih i pothranjenih bolesnika.
If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately. 
U tom slučaju, terapiju ropeginterferonom alfa-2b treba prekinuti te odmah započeti s odgovarajućim liječenjem.
• If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7. 
500 mikrograma napunjenu brizgalicu, nastavite izravno s korakom 7.
Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy. 
Bolesnici s dijabetes melitusom, koji se ne mogu učinkovito kontrolirati lijekovima, ne smiju započinjati terapiju ropeginterferonom alfa-2b.
Reproductive and developmental studies were not performed with ropeginterferon alfa-2b. 
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti s ropeginterferonom alfa-2b.
Disposal of the pen: 
Zbrinjavanje brizgalice:
CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4). 
uključujući pokušaj samoubojstva, suicidalnu ideaciju, agresiju, bipolarni poremećaj, maniju i konfuziju, zabilježeni su kod interferona alfa (vidjeti dio 4.4).
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. 
Ropeginterferon alfa-2b je rekombinantni interferon alfa-2b, konjugiran s metoksipolietilenglikolom (mPEG) s dva kraka, uz stupanj supstitucije od 1 mola polimera/mol proteina.
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). 
Ozbiljni poremećaji oka zabilježeni su kod primjene interferona alfa,poput retinopatije, krvarenja u mrežnicu, eksudata u mrežnici, ablacije mrežnice i okluzije mrežnične arterije ili vene (vidjeti dio 4.4).
No ropeginterferon alfa-2b dose adjustment is required for adult patients with mild liver impairment. 
Nije potrebna prilagodba doze ropeginterferona alfa-2b u odraslih bolesnika s blagim oštećenjem jetre.
During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b. 
Tijekom programa kliničkog ispitivanja, zabilježen je jedan slučaj nehotičnog predoziranja s ropeginterferonom alfa-2b.
Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia 
Poremećaji reproduktivnog sustava i dojki manje često erektilna disfunkcija, hematospermija
Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy. 
Bolesnike s postojećim kardiovaskularnim poremećajima ili njihovom anamnezom treba pomno nadzirati tijekom terapije ropeginterferonom alfa-2b.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (GFR <15 mL/min) (see section 4.3). 
Ropeginterferon alfa-2b je kontraindiciran u bolesnika sa završnim stadijem bolesti bubrega (GFR <15 ml/min) (vidjeti dio 4.3).
The elimination of ropeginterferon alfa-2b is not fully characterised. 
Eliminacija ropeginterferona alfa-2b nije u potpunosti određena.
Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8). 
Zatajenje jetre u bolesnika zaraženih virusom hepatitisa C zabilježeno je kod primjene drugih lijekova koji sadrže interferon alfa (vidjeti dio 4.8).
Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8). 
Poremećaji jetre uočeni su u bolesnika nakon dugotrajne terapije ropeginterferonom alfa-2b (vidjeti dio 4.8).
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. 
a definirano kao hematokrit <45% bez flebotomije (najmanje 3 mjeseca od posljednje flebotomije), trombociti <400 x 109/l i leukociti <10 x 109/l.
It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg. 
50 μg, 100 μg, 150 μg, 200 μg i 250 μg.
• Besremi pre-filled pen 
• Besremi napunjenu brizgalicu
White n (%) 
Bijelci n (%)
JAK2V617F allele burden JAK2V617F changes from baseline 
Opterećenje alelom JAK2V617F
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. 
Rok valjanosti nakon prve uporabe: Može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
• If you have used your Besremi 250 microgram pre filled pen once before, continue directly with step 7. 
250 mikrograma napunjenu brizgalicu, nastavite izravno s korakom 7.
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 
- Vogt-Koyanagi-Harada bolest (rijetka bolest koja može dovesti do gubitka vida, sluha te pigmentacije kože), teška alergijska reakcija
Clear, colourless to pale yellow solution. 
Bistra, bezbojna do blijedožuta otopina.
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. 
Nakon otvaranja, napunjena brizgalica može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
Almost 50% of patients showed a complete haematological response with an improvement in disease burden after 36 months of treatment. 
Gotovo 50% bolesnika liječenih ropeginterferonom alfa-2b pokazalo je potpuni hematološki odgovor s poboljšanjem u opterećenju bolesšću nakon 36 mjeseci liječenja.
JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study. 
Tablica 4. Opterećenje alelom JAK2V617F i promjene od početne vrijednosti u produljenom ispitivanju CONTINUATION-PV
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. 
Napunjena brizgalica može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy. 
Potrebno je redovito nadzirati jetrene enzime i funkciju jetre u bolesnika s dugotrajnom terapijom ropeginterferonom alfa-2b.
Most common adverse reactions 
Najčešće nuspojave
The dose was gradually increased depending on disease response and tolerability (for ropeginterferon alfa-2b, from 50 to 
Doza se postupno povećavala ovisno o odgovoru na bolest te podnošljivosti (za ropeginterferon alfa-2b od 50 do 500 mikrograma primijenjeno supkutano svaka 2 tjedna).
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, 
Pretrage često pozitivna antitiroidna protutijela, povišena vrijednost TSH u krvi, povišena tjelesna temperatura, pozitivan nalaz na anti-nuklearna protutijela, povišena laktat dehidrogenaza u krvi manje često smanjen broj trombocita, povišena mokraćna kiselina u krvi, pozitivan Coombsov test, smanjena tjelesna težina
If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued. 
Ako se bubrežna funkcija smanji tijekom liječenja, potrebno je prekinuti terapiju ropeginterferonom alfa-2b.
Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#, 
Poremećaji oka često suhe oči manje često krvarenje u mrežnicu#, eksudat u mrežnici#, poremećaj vida, smanjena oštrina vida, zamućeni vid, neugoda u oku, ekcemi na očnim kapcima rijetko retinopatija#, optička neuropatija#, okluzija mrežnične arterije#, okluzija mrežnične vene#
Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris# 
Srčani poremećaji često fibrilacija atrija manje često infarkt miokarda#, atrioventrikularni blok, intrakardijalni tromb, inkompetencija aortalnog zalistka,
Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b. 
Povišene razine jetrenih enzima uočene su u bolesnika liječenih ropeginterferonom alfa-2b.
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). 
(supstrat CYP2C9), midazolamom (supstrat CYP3A4), dapsonom (supstratom N-acetiltransferaze) te je umjereno povećala izloženost kofeinu (supstrat CYP1A2) i dezipraminu (supstrat CYP2D6).
Excipient with known effect Each pre-filled pen contains 10 mg benzyl alcohol per mL. 
Jedna napunjena brizgalica sadrži 10 mg benzilnog alkohola po ml.
• Before you begin, check that the product has not expired. 
• Prije početka provjerite rok valjanosti lijeka.
The 250 micrograms/0.5 mL pre-filled pen has a grey push button. 
Napunjena brizgalica 250 mikrograma/0,5 ml ima sivi potisni gumb.
No interaction studies have been performed with ropeginterferon alfa-2b. 
Nisu provedena ispitivanja interakcija s ropeginterferonom alfa-2b.
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. 
Oštećenje jetre Usporediva izloženost i farmakokinetički profil zabilježen je za druge lijekove koji sadrže interferon alfa (pegilirani interferon alfa-2a) u bolesnika s cirozom (Child-Pugh stadij A) te u bolesnika bez ciroze.
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]). 
događaja/100 bolesnika po godini) i mučnina (4,5%; stopa incidencije: 1,6 [događaja/100 bolesnika po godini]).
Severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness have been observed rarely in patients treated with interferon alfa (see section 4.8). 
Teški poremećaji oka kao što su retinopatija, krvarenje u mrežnici, eksudati u mrežnici, ablacija mrežnice i okluzija mrežnične arterije ili vene koja može rezultirati gubitkom vida, rijetko su prijavljeni u bolesnika liječenih interferonom alfa (vidjeti dio 4.8).
It is unknown if the active substance of the medicinal product is excreted into experimental animal or human milk (see section 4.6). 
Nije poznato izlučuje li se djelatna tvar lijeka u majčino mlijeko eksperimentalnih životinja ili ljudi
Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued. 
Bolesnike koji razviju respiratorne simptome treba pomno nadzirati te ako je potrebno prekinuti primjenu ropeginterferona alfa-2b.