FrancophonIA/ELRC3.0 huggingface dataset:
English: Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with ropeginterferon alfa-2b.
Slovenian: Narkotike, hipnotike ali sedative je treba pri sočasni uporabi z ropeginterferonom alfa-2b uporabljati previdno.
English: • If you do not see the droplet after the seventh time, ask your doctor or pharmacist for advice.
Slovenian: • Če po sedmem poskusu kaplje še vedno ni videti, se posvetujte z zdravnikom ali farmacevtom.
English: 19 (10.7) 6.0 n.r.
Slovenian: 19 (10,7) 6,0 n.p.
English: Mean Cmax was 2.4 ng/mL (with a dose of 5080 micrograms) to 49 ng/mL (with a dose of 450 micrograms) and AUC0-t ranged from 28.5 ng.h/mL (with a dose of 50 - 80 micrograms) to 552.6 ng.h/mL (with a dose of 450 micrograms) in patients after subcutaneous multiple dose administration.
Slovenian: Pri bolnikih je po večkratnem subkutanem odmerjanju povprečni Cmax znašal 2,4 ng/ml (pri odmerku 50-80 mikrogramov) do 49 ng/ml (pri odmerku 450 mikrogramov), AUC0-t pa je znašal od 28,5 ng*h/ml (pri odmerku 5080 mikrogramov) do 552,6 ng*h/ml (pri odmerku 450 mikrogramov).
English: Mean % (± SD)
Slovenian: Povprečje % (±SD)
English: Patients should be closely monitored, in particular during the titration phase; complete blood counts including determination of haematocrit level, leukocyte and platelet counts should be performed regularly also after the individual optimal dose has been established.
Slovenian: redno je treba opravljati pregled celotne krvne slike, vključno z določanjem ravni hematokrita, številom levkocitov in trombocitov, tudi po tem, ko je bil individualni optimalni odmerek že določen.
English: Besremi contains benzyl alcohol
Slovenian: Zdravilo Besremi vsebuje benzilalkohol
English: The instructions for use in the package leaflet should be followed.
Slovenian: Slediti je treba navodilom za dajanje zdravila v navodilu za uporabo.
English: Then, tap the pen (cartridge holder) gently with your fingers to allow any air bubbles to rise to the top of the cartridge holder.
Slovenian: Nato s prsti narahlo potrkajte po peresniku (držalu vložka), da se morebitni zračni mehurčki dvignejo na vrh držala vložka.
English: You have to use a different injection site for each of the two pens.
Slovenian: Za vsakega od peresnikov morate uporabiti drugo mesto injiciranja.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Možna mesta injiciranja so področje popka (več kot pet centimetrov stran od popka) ali stegno.
English: If the pre-filled pen is used for the first time, the pen is prepared for injection by turning the dose knob until the symbol of a “drop” in the display window is seen.
Slovenian: Če napolnjen injekcijski peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
English: The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon alfa-2b is not known.
Slovenian: Vpletenost prenašalnih beljakovin v absorpcijo, distribucijo in izločanje ropeginterferona alfa-2b ni znana.
English: It is unknown whether the active substance of the medicinal product is excreted in human milk.
Slovenian: Ni znano, ali se učinkovina v tem zdravilu izloča v materino mleko.
English: The push button should be pressed in completely and held down for at least 10 seconds before removing the needle.
Slovenian: Potisni gumb je treba pritisniti do konca in pred umikom igle peresnik tiščati ob kožo vsaj 10 sekund.
English: Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite
Slovenian: Presnovne in prehranske motnje pogosti hipertrigliceridemija, zmanjšan apetit
English: This medicine contains 5 mg benzyl alcohol in each 0.5 mL.
Slovenian: To zdravilo vsebuje 5 mg benzilalkohola na vsakih 0,5 ml. Benzilalkohol lahko povzroči alergijske reakcije.
English: Gastrointestinal disorders have been reported with other interferon alfa medicinal products and have been reported in 15.2% of patients with ropeginterferon alfa-2b treatment.
Slovenian: 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.
English: Patients should have eye examinations before and during ropeginterferon alfa-2b therapy, specifically in those patients with retinopathy associated disease such as diabetes mellitus or hypertension.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: It is available in packs containing 1 pre-filled pen and 2 injection needles.
Slovenian: Na voljo je v pakiranju z 1 napolnjenim injekcijskim peresnikom in 2 injekcijskima iglama.
English: At doses up to 100 micrograms, the same pen can be used twice.
Slovenian: Pri odmerkih do 100 mikrogramov lahko peresnik uporabite dvakrat.
English: Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6.
Slovenian: Pokazali so, da interferon alfa vpliva na aktivnost izoencimov citokroma P450 (CYP) CYP1A2 in CYP2D6.
English: The pen can be adjusted to administer doses in 50 microgram intervals in the range of 50 to 250 micrograms or 50 to 500 micrograms.
Slovenian: Peresnik lahko nastavite v intervalih po 50 mikrogramov za dajanje odmerkov od 50 do 250 mikrogramov ali od 50 do 500 mikrogramov.
English: The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Slovenian: Jakost izraža količino dela interferona alfa-2b v ropeginterferonu alfa-2b, brez upoštevanja pegilacije.
English: 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.
Slovenian: 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.
English: Correct the dose if necessary by turning the dose knob.
Slovenian: odmerek popravite z vrtenjem gumba.
English: 19 (10.7) 6.3 n.r.
Slovenian: 19 (10,7) 6,3 n.p.
English: Female n (%) Male n (%)
Slovenian: Ženski n (%) Moški n (%)
English: - if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself).
Slovenian: - 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);
English: IR
Slovenian: SI
English: - if you have kidney problems.
Slovenian: - težave s spolnostjo,
English: Disposal of the pen:
Slovenian: Odstranjevanje peresnika:
English: The attachment of interferon alfa-2b to a high molecular weight (40 kDa) branched polyethylene glycol moiety is considered as the main reason for the differences in the elimination compared to unpegylated interferons.
Slovenian: 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.
English: - if you take telbivudine (a medicine used to treat hepatitis B infection).
Slovenian: - če jemljete telbivudin (zdravilo, ki se uporablja za zdravljenje okužbe z virusom hepatitisa B); - če imate napredovalo, nenadzorovano bolezen jeter;
English: Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons.
Slovenian: Zdravilo Besremi vsebuje učinkovino ropeginterferon alfa-2b, ki spada v skupino zdravil, imenovanih interferoni.
English: 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.
Slovenian: 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.
English: Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide.
Slovenian: 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.
English: JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study.
Slovenian: Breme alela JAK2V617F in spremembe od izhodišča v podaljšani študiji
English: Then press the push button until the display window shows “0”.
Slovenian: Nato pritisnite potisni gumb, dokler v okencu ni vidna »0«.
English: Most common adverse reactions
Slovenian: Najpogostejši neželeni učinki
English: Pharmacokinetic interaction studies in humans with pegylated interferon alfa-2a indicated a moderate inhibitory effect on substrates metabolised by CYP1A2 and CYP2D6 (see section 4.5).
Slovenian: 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).
English: The cartridge is sealed in a pen injector.
Slovenian: Vložek je zaprt v injekcijski peresnik.
English: (N=178) Leukopenia 34 (19.1) 27.2 3 (8.8)* 23 (67.6) 7 (20.6)
Slovenian: 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)
English: Dental and gum disorders, which may lead to loss of teeth, can occur with interferon medicines.
Slovenian: Pri zdravilih z interferoni lahko pride do bolezni zob in dlesni, ki lahko vodijo do izgube zob.
English: 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.
Slovenian: Pri bolnikih s kompenzirano cirozo (npr. Child-Pugh A) so pokazali, da je varno drugo zdravilo s pegiliranim interferonom alfa (pegiliran interferon alfa-2a).
English: At doses up to 250 micrograms, the same pen can be used twice.
Slovenian: Pri odmerkih do 250 mikrogramov lahko peresnik uporabite dvakrat.
English: 22 (12.4) 10.1 n.r.
Slovenian: 22 (12,4) 10,1 n.p.
English: Therefore, care should be taken when ropeginterferon alfa-2b is co-administered with CYP1A2 substrates notably those having a narrow therapeutic margin such as theophylline or methadone.
Slovenian: 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.
English: Inspect the solution before use.
Slovenian: Raztopino je treba pred uporabo pregledati.
English: CNS
Slovenian: CŽS
English: The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4.
Slovenian: Odziv na zdravljenje z ropeginterferonom alfa-2b je predstavljen v Preglednici 3 in Preglednici 4.
English: • Do not put the outer needle cap back on the needle until after you have injected the medicine.
Slovenian: • Zunanjega pokrovčka igle ne nameščajte nazaj na iglo,
English: 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.
Slovenian: 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.
English: The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms.
Slovenian: Zdravilo Besremi 250 mikrogramov napolnjen injekcijski peresnik lahko uporabite za injiciranje odmerkov po 50, 100, 150, 200 in 250 mikrogramov.
English: Let the area dry before you inject the medicine.
Slovenian: Preden zdravilo injicirate, počakajte, da se področje posuši.
English: • Do not use the pen if the solution is cloudy, has particles or flakes, or is any colour other than colourless to slightly yellow.
Slovenian: • Ne uporabite peresnika, če je raztopina motna, so v njej vidni delci ali kosmiči ali če ni brezbarvna ali rahlo rumena.
English: • If you are using your pen for the first time, prepare the pen for injection by turning the dose knob until you see the symbol of a “drop”.
Slovenian: • Če vaš peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
English: 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.
Slovenian: 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.
English: Regardless of the starting dose or degree of renal impairment, patients should be monitored.
Slovenian: Bolnike je treba spremljati ne glede na začetni odmerek ali stopnjo ledvične okvare.
English: Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol.
Slovenian: Vsebuje tudi natrijev klorid, polisorbat 80, brezvodni natrijev acetat, koncentrirano ocetno kislino, vodo za injekcije in benzilalkohol.
English: • Hold the pen with the needle pointing upwards.
Slovenian: • Peresnik držite tako, da je igla obrnjena navzgor.
English: *No CTCAE grade 4 (life-threating or disabling) or grade 5 (death) adverse reactions have been reported.
Slovenian: *O neželenih učinkih stopnje 4 (ogrožajo življenje ali povzročijo hudo prizadetost) ali stopnje 5 (smrtni izid) po
English: - The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections.
Slovenian: - Druge sestavine so natrijev klorid, polisorbat 80, benzilalkohol, brezvodni natrijev acetat, koncentrirana ocetna kislina in voda za injekcije.
English: No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.
Slovenian: Priporočila glede prilagajanja odmerka ropeginterferona alfa-2b pri teh bolnikih ni mogoče dati.
English: 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.
Slovenian: Ropeginterferon alfa-2b je kovalentni konjugat beljakovine interferon alfa-2b, pridobljene s tehnologijo rekombinantne DNK v celicah Escherichia coli, z metoksipolietilenglikolskim (mPEG) delom.
English: Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3).
Slovenian: Pred zdravljenjem z ropeginterferonom alfa-2b je treba s konvencionalnim zdravljenjem zdraviti in nadzorovati kakršno koli obstoječo bolezen ščitnice (glejte poglavje 4.3).
English: Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients.
Slovenian: 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.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: • Press the push button all the way down until the “0” mark is aligned with the dot in the display window.
Slovenian: • Pritisnite potisni gumb popolnoma navzdol, dokler oznaka »0« ni poravnana s piko v okencu.
English: - if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine
Slovenian: - če ste alergični na ropeginterferon alfa-2b ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6);
English: - if you have a liver or kidney disease.
Slovenian: - če ste noseči ali dojite, - če imate bolezen jeter ali ledvic.
English: 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.
Slovenian: 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.
English: Ropeginterferon alfa-2b clinical studies ADR >10%
Slovenian: Klinične študije ropeginterferona alfa-2b NU > 10 %
English: • History or presence of autoimmune disease
Slovenian: • prisotnost avtoimune bolezni ali avtoimuna bolezen v anamnezi,
English: The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans.
Slovenian: Absolutna biološka uporabnost subkutano danega ropeginterferona alfa-2b pri ljudeh ni bila preiskovana.
English: Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus#
Slovenian: Bolezni endokrinega sistema pogosti hipotiroidizem, hipertiroidizem, tiroiditis občasni sladkorna bolezen#
English: 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.
Slovenian: Ropeginterferon alfa-2b je rekombinantni interferon alfa-2b, konjugiran na dvoverižni metoksipolietilenglikol (mPEG) s stopnjo substitucije 1 mol polimera na 1 mol beljakovine.
English: 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.
Slovenian: NU, neželeni učinek; PI, priporočeni izraz; SI, povprečna stopnja incidence neželenih učinkov na 100 bolnikov na leto; n: število bolnikov.
English: Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija pogosti pancitopenija, nevtropenija, anemija
English: Each pack contains 1 pre-filled pen and 2 injection needles.
Slovenian: Eno pakiranje vsebuje 1 napolnjen injekcijski peresnik in 2 injekcijski igli.
English: 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%).
Slovenian: (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 %),
English: A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3).
Slovenian: Kombinirano zdravljenje s telbivudinom in ropeginterferonom alfa-2b je kontraindicirano (glejte poglavje 4.3).
English: Pharmacokinetics were not evaluated in patients with increased severity of hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter hujše jakosti farmakokinetike niso ovrednotili.
English: • Do not lift or move the pen during injection.
Slovenian: • Peresnika med injiciranjem ne dvigajte ali premikajte.
English: • Remove the outer needle cap from the needle.
Slovenian: • Odstranite zunanji pokrovček igle z igle.
English: Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura
Slovenian: Bolezni živčevja pogosti glavobol, omotica, hipestezija, somnolenca, parestezija občasni polinevropatija, periferna motorična nevropatija, radikulopatija, migrena, poslabšanje mentalnih sposobnosti, tremor, avra
English: - The active substance is ropeginterferon alfa-2b.
Slovenian: - Učinkovina je ropeginterferon alfa-2b.
English: The pre-filled pen label must always be checked before each injection to avoid medication errors between Besremi 250 micrograms/0.5 mL solution for injection and Besremi 500 micrograms/0.5 mL solution for injection.
Slovenian: 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.
English: A new, sterile needle as provided with the pre-filled pen must be carefully attached onto the pre-filled pen before each injection.
Slovenian: Pred vsakim injiciranjem je treba na napolnjen injekcijski peresnik skrbno namestiti novo, sterilno iglo, ki je priložena napolnjenem injekcijskem peresniku.
English: 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).
Slovenian: 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).
English: If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately.
Slovenian: Če se pojavi preobčutljivostna reakcija, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti in nemudoma uvesti ustrezno zdravljenje.
English: Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 napolnjen injekcijski peresnik + 2 injekcijski igli 0,5 ml raztopine
English: • Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis,
Slovenian: • 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,