natgillin/translations-raw huggingface dataset:
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 Bolniki s 36 meseci zdravljenja z ropeginterferonom alfa-2b (12-mesečno trajanje zdravljenja v študiji PROUD-PV in 24-mesečno trajanje zdravljenja v podaljšani študiji).
Your doctor will tell you where you have to inject it. Possible injection sites are the belly (more than five centimeters away from the belly button) or the thigh. 
Možna mesta injiciranja so področje popka (več kot pet centimetrov stran od popka) ali stegno.
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. 
Če napolnjen injekcijski peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon alfa-2b is not known. 
Vpletenost prenašalnih beljakovin v absorpcijo, distribucijo in izločanje ropeginterferona alfa-2b ni znana.
It is unknown whether the active substance of the medicinal product is excreted in human milk. 
Ni znano, ali se učinkovina v tem zdravilu izloča v materino mleko.
The push button should be pressed in completely and held down for at least 10 seconds before removing the needle. 
Potisni gumb je treba pritisniti do konca in pred umikom igle peresnik tiščati ob kožo vsaj 10 sekund.
Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite 
Presnovne in prehranske motnje pogosti hipertrigliceridemija, zmanjšan apetit
This medicine contains 5 mg benzyl alcohol in each 0.5 mL. 
To zdravilo vsebuje 5 mg benzilalkohola na vsakih 0,5 ml. Benzilalkohol lahko povzroči alergijske reakcije.
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. 
Pri drugih zdravilih z interferonom alfa so poročali o boleznih prebavil, prav tako pa so o njih poročali pri 15,2 % bolnikov, ki so se zdravili z ropeginterferonom alfa-2b.
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. 
Bolnikom je treba pred začetkom zdravljenja z ropeginterferonom alfa-2b in med zdravljenjem z njim pregledovati oči, še zlasti bolnikom z boleznimi, ki so povezane z retinopatijo, kot sta sladkorna bolezen ali hipertenzija.
While holding the pre-filled pen with the needle pointing upwards, tap the pre-filled pen gently with the fingers so that any air bubbles rise up towards the needle. 
Med tem, ko napolnjen injekcijski peresnik držite tako, da je igla obrnjena navzgor, narahlo potrkajte po njem s prsti, da se zračni mehurčki dvignejo navzgor proti igli.
It is available in packs containing 1 pre-filled pen and 2 injection needles. 
Na voljo je v pakiranju z 1 napolnjenim injekcijskim peresnikom in 2 injekcijskima iglama.
At doses up to 100 micrograms, the same pen can be used twice. 
Pri odmerkih do 100 mikrogramov lahko peresnik uporabite dvakrat.
Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6. 
Pokazali so, da interferon alfa vpliva na aktivnost izoencimov citokroma P450 (CYP) CYP1A2 in CYP2D6.
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. 
Peresnik lahko nastavite v intervalih po 50 mikrogramov za dajanje odmerkov od 50 do 250 mikrogramov ali od 50 do 500 mikrogramov.
The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation. 
Jakost izraža količino dela interferona alfa-2b v ropeginterferonu alfa-2b, brez upoštevanja pegilacije.
During ropeginterferon alfa-2b therapy, three cases of atrial fibrillation (1.1%; incidence rate: 0.5 events/100 patients per year) with intensity grade 1 to 3 occurred in two patients. 
Med zdravljenjem z ropeginterferonom alfa-2b je pri dveh bolnikih prišlo do treh primerov atrijske fibrilacije (1,1 %; stopnja incidence: 0,5 dogodka/100 bolnikov na leto) stopnje 1 do 3.
Correct the dose if necessary by turning the dose knob. 
odmerek popravite z vrtenjem gumba.
19 (10.7) 6.3 n.r. 
19 (10,7) 6,3 n.p.
Female n (%) Male n (%) 
Ženski n (%) Moški n (%)
- if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself). 
- če imate bolezen ščitnice, ki ni nadzorovana z zdravili; - če imate ali ste imeli hudo duševno motnjo (kot je depresija ali samomorilne misli ali če ste poskušali napraviti samomor);
IR 
SI
- if you have kidney problems. 
- težave s spolnostjo,
Disposal of the pen: 
Odstranjevanje peresnika:
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. 
Menijo, da je vezava interferona alfa-2b na razvejan polietilenglikol z visoko molekulsko maso (40 kDa) glavni razlog za razlike v izločanju v primerjavi z nepegiliranimi interferoni.
- if you take telbivudine (a medicine used to treat hepatitis B infection). 
- če jemljete telbivudin (zdravilo, ki se uporablja za zdravljenje okužbe z virusom hepatitisa B); - če imate napredovalo, nenadzorovano bolezen jeter;
Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons. 
Zdravilo Besremi vsebuje učinkovino ropeginterferon alfa-2b, ki spada v skupino zdravil, imenovanih interferoni.
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. 
Bolniki z zmerno ali hudo okvaro ledvic, ki so prejemali 180 mikrogramov pegiliranega interferona alfa-2a enkrat na teden, so imeli primerljivo ali 60 % večjo izpostavljenost zdravilu v plazmi v primerjavi s preskušanci z normalnim delovanjem ledvic.
Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide. 
Bolnike, ki predhodno niso prejeli zdravljenja s hidroksikarbamidom (n = 160) ali pa so zdravljenje s hidroksikarbamidom prejeli (n = 94), so randomizirali, da so prejeli ropeginterferon alfa-2b ali hidroksikarbamid.
JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study. 
Breme alela JAK2V617F in spremembe od izhodišča v podaljšani študiji
Then press the push button until the display window shows “0”. 
Nato pritisnite potisni gumb, dokler v okencu ni vidna »0«.
Most common adverse reactions 
Najpogostejši neželeni učinki
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). 
Študije farmakokinetičnih medsebojnih delovanj s pegiliranim interferonom alfa-2a pri ljudeh so pokazale zmeren zaviralni učinek na substrate, ki se presnavljajo preko CYP1A2 in CYP2D6 (glejte poglavje 4.5).
The cartridge is sealed in a pen injector. 
Vložek je zaprt v injekcijski peresnik.
(N=178) Leukopenia 34 (19.1) 27.2 3 (8.8)* 23 (67.6) 7 (20.6) 
34 (19,1) 27,2 3 (8,8)* 23 (67,6) 7 (20,6) n.p. Trombocitopenija 33 (18,5) 15,0 4 (12,1)* 13 (39,4) 3 (9,1)
Dental and gum disorders, which may lead to loss of teeth, can occur with interferon medicines. 
Pri zdravilih z interferoni lahko pride do bolezni zob in dlesni, ki lahko vodijo do izgube zob.
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. 
Pri bolnikih s kompenzirano cirozo (npr. Child-Pugh A) so pokazali, da je varno drugo zdravilo s pegiliranim interferonom alfa (pegiliran interferon alfa-2a).
At doses up to 250 micrograms, the same pen can be used twice. 
Pri odmerkih do 250 mikrogramov lahko peresnik uporabite dvakrat.
22 (12.4) 10.1 n.r. 
22 (12,4) 10,1 n.p.
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. 
Zato je potrebna previdnost pri sočasni uporabi ropeginterferona alfa-2b s substrati CYP1A2, še zlasti tistimi z ozkim terapevtskim oknom, kot sta teofilin ali metadon.
Inspect the solution before use. 
Raztopino je treba pred uporabo pregledati.
CNS 
CŽS
The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4. 
Odziv na zdravljenje z ropeginterferonom alfa-2b je predstavljen v Preglednici 3 in Preglednici 4.
• Do not put the outer needle cap back on the needle until after you have injected the medicine. 
• Zunanjega pokrovčka igle ne nameščajte nazaj na iglo,
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. 
Bolniki z okvaro ledvic, ki so prejeli enkraten odmerek 1,0 mikrograma/kg pegiliranega interferona alfa-2b, so imeli Cmax, AUC in razpolovni čas povečan skladno s stopnjo ledvične okvare.
The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms. 
Zdravilo Besremi 250 mikrogramov napolnjen injekcijski peresnik lahko uporabite za injiciranje odmerkov po 50, 100, 150, 200 in 250 mikrogramov.
Let the area dry before you inject the medicine. 
Preden zdravilo injicirate, počakajte, da se področje posuši.
• Do not use the pen if the solution is cloudy, has particles or flakes, or is any colour other than colourless to slightly yellow. 
• Ne uporabite peresnika, če je raztopina motna, so v njej vidni delci ali kosmiči ali če ni brezbarvna ali rahlo rumena.
• 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”. 
• Če vaš peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide. 
Faza titracije odmerka Priporočeno odmerjanje v fazi titracije ropeginterferona alfa-2b (glejte poglavje 4.2) v primerjavi s hidroksikarbamidom povzroči podaljšanje časa za doseganje individualnega optimalnega odmerka.
Regardless of the starting dose or degree of renal impairment, patients should be monitored. 
Bolnike je treba spremljati ne glede na začetni odmerek ali stopnjo ledvične okvare.
Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol. 
Vsebuje tudi natrijev klorid, polisorbat 80, brezvodni natrijev acetat, koncentrirano ocetno kislino, vodo za injekcije in benzilalkohol.
• Hold the pen with the needle pointing upwards. 
• Peresnik držite tako, da je igla obrnjena navzgor.
*No CTCAE grade 4 (life-threating or disabling) or grade 5 (death) adverse reactions have been reported. 
*O neželenih učinkih stopnje 4 (ogrožajo življenje ali povzročijo hudo prizadetost) ali stopnje 5 (smrtni izid) po
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections. 
- Druge sestavine so natrijev klorid, polisorbat 80, benzilalkohol, brezvodni natrijev acetat, koncentrirana ocetna kislina in voda za injekcije.
No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients. 
Priporočila glede prilagajanja odmerka ropeginterferona alfa-2b pri teh bolnikih ni mogoče dati.
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 beljakovine interferon alfa-2b, pridobljene s tehnologijo rekombinantne DNK v celicah Escherichia coli, z metoksipolietilenglikolskim (mPEG) delom.
Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3). 
Pred zdravljenjem z ropeginterferonom alfa-2b je treba s konvencionalnim zdravljenjem zdraviti in nadzorovati kakršno koli obstoječo bolezen ščitnice (glejte poglavje 4.3).
Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients. 
O naslednjih z zdravljenjem povezanih neželenih učinkih so poročali v kliničnih študijah z ropeginterferonom alfa-2b, ki so jih opravili pri 178 odraslih bolnikih s pravo policitemijo.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
• Press the push button all the way down until the “0” mark is aligned with the dot in the display window. 
• Pritisnite potisni gumb popolnoma navzdol, dokler oznaka »0« ni poravnana s piko v okencu.
- if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine 
- če ste alergični na ropeginterferon alfa-2b ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6);
- if you have a liver or kidney disease. 
- če ste noseči ali dojite, - če imate bolezen jeter ali ledvic.
Following multiple dosing of pegylated interferon alfa-2b (1.0 micrograms/kg subcutaneously administered every week for four weeks), the clearance of pegylated interferon alfa-2b was reduced by a mean of 17% and 44% in patients with moderate or severe renal impairment, respectively, compared to subjects with normal renal function. 
Po večkratnem odmerjanju pegiliranega interferona alfa-2b (1,0 mikrograma/kg subkutano enkrat na teden štiri tedne) se je očistek pegiliranega interferona alfa-2b pri bolnikih z zmerno ledvično okvaro in hudo ledvično okvaro zmanjšal za povprečno 17 % in povprečno 44 % v primerjavi s preskušanci z normalnim delovanjem jeter.
Ropeginterferon alfa-2b clinical studies ADR >10% 
Klinične študije ropeginterferona alfa-2b NU > 10 %
• History or presence of autoimmune disease 
• prisotnost avtoimune bolezni ali avtoimuna bolezen v anamnezi,
The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans. 
Absolutna biološka uporabnost subkutano danega ropeginterferona alfa-2b pri ljudeh ni bila preiskovana.
Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus# 
Bolezni endokrinega sistema pogosti hipotiroidizem, hipertiroidizem, tiroiditis občasni sladkorna bolezen#
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 na dvoverižni metoksipolietilenglikol (mPEG) s stopnjo substitucije 1 mol polimera na 1 mol beljakovine.
Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N: number of patients. 
NU, neželeni učinek; PI, priporočeni izraz; SI, povprečna stopnja incidence neželenih učinkov na 100 bolnikov na leto; n: število bolnikov.
Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia 
Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija pogosti pancitopenija, nevtropenija, anemija
Each pack contains 1 pre-filled pen and 2 injection needles. 
Eno pakiranje vsebuje 1 napolnjen injekcijski peresnik in 2 injekcijski igli.
The most common adverse reactions are leukopenia (19.1%), thrombocytopenia (18.5%), arthralgia (12.9%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza like illness (10.7%), myalgia (10.7%), pyrexia (8.4%), pruritus (8.4%), increased alanine aminotransferase (8.4%), anaemia (7.9%), pain in extremity (6.7%), alopecia (6.7%), neutropenia (6.7%), increased aspartate aminotransferase (6.2%), headache (6.2%), diarrhoea (5.6%), chills (5.1%), dizziness (5.1%) and injection site reaction (5.1%). 
(10,7 %), mialgija (10,7 %), pireksija (8,4 %), pruritus (8,4 %), zvečana vrednost alaninaminotransferaze (8,4 %), anemija (7,9 %), bolečina v okončinah (6,7 %), alopecija (6,7 %),
A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3). 
Kombinirano zdravljenje s telbivudinom in ropeginterferonom alfa-2b je kontraindicirano (glejte poglavje 4.3).
Pharmacokinetics were not evaluated in patients with increased severity of hepatic impairment. 
Pri bolnikih z okvaro jeter hujše jakosti farmakokinetike niso ovrednotili.
• Do not lift or move the pen during injection. 
• Peresnika med injiciranjem ne dvigajte ali premikajte.
• Remove the outer needle cap from the needle. 
• Odstranite zunanji pokrovček igle z igle.
Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura 
Bolezni živčevja pogosti glavobol, omotica, hipestezija, somnolenca, parestezija občasni polinevropatija, periferna motorična nevropatija, radikulopatija, migrena, poslabšanje mentalnih sposobnosti, tremor, avra
- The active substance is ropeginterferon alfa-2b. 
- Učinkovina je ropeginterferon 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. 
Pred vsakim injiciranjem je treba preveriti nalepko napolnjenega injekcijskega peresnika, da se izognemo nenamerni zamenjavi zdravil Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje in Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje.
A new, sterile needle as provided with the pre-filled pen must be carefully attached onto the pre-filled pen before each injection. 
Pred vsakim injiciranjem je treba na napolnjen injekcijski peresnik skrbno namestiti novo, sterilno iglo, ki je priložena napolnjenem injekcijskem peresniku.
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). 
Pri bolnikih z dekompenzirano cirozo (npr. Child-Pugh B ali C) uporabe interferona alfa niso ovrednotili, zato je pri teh bolnikih uporaba kontraindicirana (glejte poglavje 4.3).
If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately. 
Če se pojavi preobčutljivostna reakcija, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti in nemudoma uvesti ustrezno zdravljenje.
Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution 
raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 napolnjen injekcijski peresnik + 2 injekcijski igli 0,5 ml raztopine
• Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, 
• obstoječa huda psihiatrična bolezen ali huda psihiatrična bolezen v anamnezi, še zlasti huda depresija, samomorilne misli ali poskus samomora • huda obstoječa srčno-žilna bolezen (npr. nenadzorovana hipertenzija, kongestivno srčno popuščanje (≥ NYHA razred 2), resna srčna aritmija, pomembna stenoza koronarnih arterij,
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. 
PROUD-PV in 24-mesečno trajanje zdravljenja v podaljšani študiji) je znašal 363 (±149) mikrogramov ropeginterferona alfa-2b.
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) 
- 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).
What Besremi looks like and contents of the pack 
Izgled zdravila Besremi in vsebina pakiranja
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# 
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#
This leaflet was last revised in . 
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
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). 
Besremi za vse podskupine pediatrične populacije za zdravljenje prave policitemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common 
Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, mialgija pogosti
If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy. 
Če se psihiatrični simptomi poslabšajo, je priporočljivo zdravljenje z ropeginterferonom alfa-2b prekiniti.
• Raise a fold of skin between the thumb and forefinger. 
• S palcem in kazalcem napravite kožno gubo.
In addition, dry mouth could damage teeth and the lining of the mouth during long-term treatment with Besremi. 
Poleg tega lahko med dolgotrajnim zdravljenjem z zdravilom Besremi zaradi suhih ust pride do poškodb zob in ustne sluznice.
It is not known if Besremi is present in breast milk. 
Ni znano, ali se zdravilo Besremi izloča v materino mleko.
• Needle 
• iglo,
Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy. 
Bolniki s sladkorno boleznijo, ki je ni mogoče učinkovito nadzorovati z zdravili, ne smejo začeti zdravljenja z ropeginterferonom alfa-2b.
The use of Besremi is not recommended during pregnancy. 
Uporaba zdravila Besremi med nosečnostjo ni priporočljiva.
How to store Besremi 6. 
Shranjevanje zdravila Besremi 6.
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). 
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).