FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
Slovenian: V tem preskušanju je bila kombinacija zdravila ViraferonPeg (1,5 mikrogramov/kg/teden) in ribavirina pomembno bolj učinkovita od kombinacije interferona alfa-2b in ribavirina (preglednica 8), še posebej pri bolnikih, okuženih z genotipom 1 (preglednica 9).
English: Dysgeusia, syncope, disturbance in attention, somnolence, poor quality sleep
Slovenian: disgevzija, sinkopa, motnje pozornosti, somnolenca, slaba kakovost spanja
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Thyroid changes and section 4.8).
Slovenian: Bolnike z znaki in simptomi, ki kažejo na avtoimuno bolezen, morate skrbno pregledati in pri njih oceniti razmerje med koristmi in tveganji nadaljevanja zdravljenja z interferonom (glejte tudi poglavje 4.4 Spremembe delovanja žleze ščitnice in poglavje 4.8).
English: Tritherapy (ViraferonPeg with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Slovenian: Trojna terapija (zdravilo ViraferonPeg ter ribavirin in boceprevir): velja za odrasle bolnike s CHC genotipa 1.
English: This medicine contains sucrose.
Slovenian: To zdravilo vsebuje saharozo.
English: ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'-oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Slovenian: Farmakodinamiko zdravila ViraferonPeg so ocenjevali v preskušanju pri zdravih preiskovancih z uporabo naraščajočih enkratnih odmerkov in merjenjem sprememb temperature v ustih in koncentracije efektorskih proteinov, kot sta serumski neopterin ter 2'5'-oligoadenilatsintetaza (2'5'-OAS), ter določanjem števila levkocitov in nevtrofilcev.
English: Injection site infection, lower respiratory tract infection
Slovenian: okužba na mestu injiciranja, okužba spodnjih dihal
English: Periodic visual examinations are recommended during ViraferonPeg therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Slovenian: Med zdravljenjem z zdravilom ViraferonPeg so priporočljivi občasni pregledi vida, še posebej pri bolnikih z motnjami ali boleznimi, ki so lahko povezane z retinopatijo, kot sta sladkorna bolezen ali hipertenzija.
English: The safety and efficacy of ViraferonPeg therapy has not been evaluated in patients with severe hepatic dysfunction, therefore ViraferonPeg must not be used for these patients.
Slovenian: Varnost in učinkovitost zdravljenja z zdravilom ViraferonPeg pri bolnikih s hudo jetrno okvaro nista bili ovrednoteni, zato zdravila ViraferonPeg ne smete uporabljati pri teh bolnikih.
English: Thirty two percent (30/94) of subjects demonstrated > 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Slovenian: Dvaintrideset odstotkov (30/94) preiskovancev je imelo 5 let po koncu zdravljenja zmanjšanje percentila telesne višine za starost > 15 percentilov (glejte poglavji 4.8 in 5.1).
English: This may require combinations of various ViraferonPeg dose strengths and volumes.
Slovenian: To lahko zahteva kombiniranje različnih jakosti in volumnov zdravila ViraferonPeg.
English: In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
Slovenian: Študije in vitro in in vivo kažejo, da biološka aktivnost zdravila ViraferonPeg temelji na njegovem interferon alfa-2b delu molekule.
English: However, if HCV-RNA is still detectable at treatment week 24, discontinuation of therapy should be considered.
Slovenian: Če je koncentracija HCV-RNA v 24. tednu zdravljenja še vedno merljiva, premislite o ukinitvi zdravljenja.
English: Paediatric population ViraferonPeg can be used in combination with ribavirin in paediatric patients 3 years of age and older.
Slovenian: Zdravilo ViraferonPeg se lahko uporablja v kombinaciji z ribavirinom pri pediatričnih bolnikih starih 3 leta in več.
English: Upper limit of normal
Slovenian: zgornja meja normale (ZMN)
English: Cardiac ischaemia
Slovenian: srčna ishemija
English: Any unused material is to be discarded.
Slovenian: Vse neporabljene ostanke zavrzite.
English: - a pre-filled pen (CLEARCLICK) - a needle ("Push-On Needle") - 2 alcohol swabs
Slovenian: - napolnjeni injekcijski peresnik (CLEARCLICK) - iglo ("igla na potisk") - 2 alkoholna tampona
English: Healthy Subjects (N=13)
Slovenian: zdravi preiskovanci (n = 13)
English: Table 2a Dose modification guidelines for combination therapy based on laboratory parameters
Slovenian: Preglednica 2a Smernice za prilagoditev odmerka za kombinirano terapijo, ki temeljijo na laboratorijskih vrednostih
English: - The use of ViraferonPeg in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Slovenian: - Uporaba zdravila ViraferonPeg pri otrocih in mladostnikih, ki imajo hude psihiatrične motnje ali so jih kdaj imeli, je kontraindicirana (glejte poglavje 4.3).
English: 3 was observed in 4 % (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
Slovenian: 3 pri 4 % (8/194) bolnikov, ki so prejemali zdravilo ViraferonPeg v kombinaciji z ribavirinom.
English: It may be used in adults who have not been previously treated for HCV infection or who have previously used medicines called interferons and pegylated interferons.
Slovenian: Lahko se uporablja pri odraslih, ki se predhodno niso zdravili zaradi okužbe z virusom hepatitisa C ali so predhodno uporabljali zdravila, imenovana interferoni in pegilirani interferoni.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with ViraferonPeg or interferon alfa-2b.
Slovenian: Vendar pa se je pokazalo, da je bila stopnja odziva v tem preskušanju odvisna tudi od odmerka ribavirina, prejetega v kombinaciji z zdravilom ViraferonPeg ali interferonom alfa-2b.
English: However, renal elimination may account for a minority (approximately 30 %) of ViraferonPeg apparent clearance.
Slovenian: Vendar pa njegovo izločanje prek ledvic lahko predstavlja le manjši del (približno 30 %) celotnega očistka zdravila ViraferonPeg.
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Slovenian: To je granulomatozna vnetna bolezen, ki prizadene oči, slušni sistem, možganske ovojnice in kožo.
English: ViraferonPeg should therefore not be used as long term maintenance monotherapy.
Slovenian: Zdravila ViraferonPeg torej ne smete uporabljati za dolgoročno vzdrževalno monoterapijo.
English: These reactions are listed in Table 7 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Slovenian: Ti učinki so našteti v preglednici 7 po organskih sistemih in po pogostnosti (zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Additionally, patients treated with this medicine and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Slovenian: Poleg tega se pri bolnikih, zdravljenih s kombinacijo tega zdravila in ribavirina skupaj z zidovudinom, lahko poveča tveganje za pojav anemije (majhno število rdečih krvnih celic).
English: Dose modification guidelines for adult patients who use ViraferonPeg monotherapy are shown in Table 3a.
Slovenian: Smernice za prilagoditev odmerka pri odraslih bolnikih, ki zdravilo ViraferonPeg uporabljajo v monoterapiji, so podane v preglednici 3a.
English: *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Slovenian: *izdelan s tehnologijo rekombinantne DNA na celicah E.coli, v katere so z genskim inženiringom vstavili plazmidni hibrid z genom za interferon alfa-2b iz človeških levkocitov
English: Suicidal ideation §, suicide attempt
Slovenian: §, poskus samomora
English: Patients with existence of, or history of severe psychiatric conditions If treatment with peginterferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Slovenian: Bolniki, ki imajo ali so kdaj imeli hude psihiatrične motnje Če ocenite, da je potrebno zdravljenje s peginterferonom alfa-2b pri odraslih bolnikih, ki imajo ali so kdaj imeli hude psihiatrične motnje, ga lahko uvedete šele potem, ko ste zagotovili ustrezno posamezniku prilagojeno diagnostično in terapevtsko obravnavo psihiatrične motnje.
English: Therefore, you should not breast-feed an infant if you are taking this medicine.
Slovenian: Zato ne smete dojiti, če uporabljate to zdravilo.
English: What ViraferonPeg is and what it is used for What you need to know before you use ViraferonPeg How to use ViraferonPeg
Slovenian: Kaj je zdravilo ViraferonPeg in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ViraferonPeg Kako uporabljati zdravilo ViraferonPeg Možni neželeni učinki
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Slovenian: V primeru ponovnega pojava ali razvoja psihiatričnih motenj in uživanja opojnih substanc je priporočljivo zgodnje ukrepanje.
English: By extrapolation from clinical data on combination therapy with standard interferon in paediatric patients (negative predictive value 96 % for interferon alfa-2b/ribavirin), patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders.
Slovenian: Na podlagi ekstrapolacije podatkov iz kliničnih študij kombinirane terapije s standardnim interferonom pri pediatričnih bolnikih (negativna napovedna vrednost za uporabo interferona alfa-2b in ribavirina je 96 %) lahko sklepamo, da je pri tistih bolnikih, ki niso dosegli virološkega odziva do 12. tedna, zelo majhna verjetnost, da bodo kdaj dosegli trajen virološki odziv.
English: Your doctor will test your blood before you begin therapy and throughout the treatment to make sure that the therapy you are getting is safe and effective.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem bo zdravnik pregledal kri, da se prepriča, da je zdravljenje varno in učinkovito.
English: Boceprevir must not be administered in the absence of ViraferonPeg and ribavirin.
Slovenian: Boceprevirja se ne sme uporabiti brez zdravila ViraferonPeg in ribavirina.
English: Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Slovenian: Zdi se, da sta takojšnja ukinitev interferona alfa in zdravljenje s kortikosteroidi povezana z odpravo neželenih učinkov na pljuča.
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Slovenian: Bolniki s sočasno okužbo s HIV, ki prejemajo močno aktivno antiretrovirusno terapijo (Highly Active Anti-Retroviral Therapy HAART), imajo lahko večje tveganje za pojav laktacidoze.
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject ViraferonPeg”).
Slovenian: Podrobna navodila za podkožno injiciranje so priložena na koncu teh navodil (glejte poglavje "Kako si sami injicirate zdravilo ViraferonPeg").
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV-infection, cirrhosis).
Slovenian: Pri uporabi zdravil, ki vsebujejo interferon alfa, so poročali o primerih pljučne arterijske hipertenzije (PAH), zlasti pri bolnikih z dejavniki tveganja zanjo (to so na primer portalna hipertenzija, okužba z virusom HIV ali ciroza).
English: A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Slovenian: Dolgoročni podatki o učinkovitosti - pediatrična populacija Petletna dolgoročna opazovalna spremljevalna študija je zajela 94 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v multicentričnem preskušanju.
English: Table 8 Sustained virological response (% patients HCV negative) ViraferonPeg monotherapy ViraferonPeg + ribavirin
Slovenian: Preglednica 8 Trajni virološki odziv (% HCV negativnih bolnikov) ViraferonPeg monoterapija ViraferonPeg + ribavirin
English: Interferon neutralising factors
Slovenian: Dejavniki, ki nevtralizirajo interferon
English: Class label for interferon products, see below Pulmonary arterial hypertension.
Slovenian: Velja za skupino zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj.
English: The combination of this medicine and ribavirin is recommended for adults 18 years of age and older who have not previously been treated with these medicines.
Slovenian: Kombinirano zdravljenje s tem zdravilom in ribavirinom je priporočljivo pri odraslih, starih 18 let ali več, ki predhodno niso bili zdravljeni s tema zdraviloma.
English: Be sure to discuss this with your doctor.
Slovenian: Pogovorite se o tem z zdravnikom.
English: If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Slovenian: Če se med zdravljenjem z zdravilom ViraferonPeg pojavi taka reakcija, morate takoj prekiniti zdravljenje in uvesti ustrezno zdravljenje.
English: In general, the adverse events seen in overdose cases involving ViraferonPeg are consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
Slovenian: Na splošno so neželeni učinki, ki so jih opazili v primerih prevelikega odmerjanja zdravila ViraferonPeg, doslej ustrezali znanemu profilu varnosti zdravila ViraferonPeg, vendar so lahko močnejši.
English: Interstitial lung disease
Slovenian: intersticijska pljučna bolezen
English: Chronic Hepatitis C Subjects (N=22)
Slovenian: preiskovanci s kroničnim hepatitisom C (n = 22)
English: Among children and adolescents treated with interferon alfa-2b in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs 1 %) during treatment and during the 6-month follow-up after treatment.
Slovenian: Pri otrocih in mladostnikih, ki so se zdravili s kombinacijo interferona alfa-2b in ribavirina, so o samomorilnih mislih in poskusih samomora med samim zdravljenjem in 6 mesecev po končanem zdravljenju poročali bolj pogosto kot pri odraslih (2,4 % vs. 1 %).
English: These reactions are listed in table 6 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Slovenian: Ti učinki so našteti v preglednici 6 po organskih sistemih in po pogostnosti (zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: - If you are also being treated for HIV (see section “Other medicines and ViraferonPeg”).
Slovenian: - se zdravite tudi zaradi okužbe s HIV (glejte poglavje "Druga zdravila in zdravilo ViraferonPeg").
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Slovenian: c: Bolniki z genotipom 3 in majhnim virusnim bremenom (< 600.000 i.e./ml) so prejeli 24-tedensko zdravljenje, tisti z genotipom 3 in velikim virusnim bremenom (≥ 600.000 i.e./ml) so prejeli 48- tedensko zdravljenje.
English: - Clean the rubber top of the vial with a cleansing swab.
Slovenian: - Očistite gumijasto zgornjo površino viale s čistilnim tamponom.
English: One ampoule of solvent contains 0.7 ml of water for injections.
Slovenian: Ena ampula vehikla vsebuje 0,7 ml vode za injekcije.
English: Use in adults - ViraferonPeg in combination treatment This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week.
Slovenian: Uporaba pri odraslih - zdravilo ViraferonPeg v kombiniranem zdravljenju Kadar uporabljate to zdravilo skupaj s kapsulami ribavirina, je odmerek običajno 1,5 mikrograma na kilogram telesne mase enkrat na teden.
English: Interferon neutralising factor assays were performed on serum samples of patients who received ViraferonPeg in the clinical trial.
Slovenian: Preiskave za določanje dejavnikov, ki nevtralizirajo interferon, so opravili na serumskih vzorcih bolnikov, ki so prejemali zdravilo ViraferonPeg v kliničnem preskušanju.
English: - Then insert the needle through the rubber top of the ViraferonPeg vial.
Slovenian: Nato zabodite iglo skozi gumijasti zgornji del viale zdravila ViraferonPeg.
English: Dose reduction of ViraferonPeg in adults may be accomplished by reducing the prescribed volume or by utilizing a lower dose strength as shown in Table 2b.
Slovenian: Zmanjšanje odmerka zdravila ViraferonPeg pri odraslih lahko dosežete z zmanjšanjem predpisanega volumna ali z uporabo manjše jakosti, kot je prikazano v preglednici 2b.
English: Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SmPC).
Slovenian: Bolniki z očistkom kreatinina < 50 ml/minuto se ne smejo zdraviti z zdravilom ViraferonPeg v kombinaciji z ribavirinom (glejte SmPC za ribavirin).
English: • Genotype 2 or 3:
Slovenian: • Genotip 2 ali 3:
English: Colitis ulcerative
Slovenian: ulcerozni kolitis
English: For disposal instructions, see section 5 “How to store ViraferonPeg”.
Slovenian: Za navodila o odstranjevanju zdravila glejte poglavje 5 "Shranjevanje zdravila ViraferonPeg".
English: Patients who were HCV-RNA negative at treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Slovenian: Bolniki, ki so imeli negativen izvid HCV-RNA v 12. tednu zdravljenja, so nadaljevali z zdravljenjem še 48 tednov, po zdravljenju pa so jih spremljali še 24 tednov.
English: For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Slovenian: Pri bolnikih s predhodno neuspešnim zdravljenjem z nepegiliranim interferonom oziroma s pegiliranim interferonom in negativnim izvidom v 12. tednu sta bila deleža trajnega virološkega odziva 59 % oziroma 50 %.
English: You can save the swab to clean the skin area where you will inject the dose.
Slovenian: Tampon lahko spravite, da boste z njim očistili še kožo, kamor boste injicirali odmerek.
English: The maximum daily dose reported is 1,200 µg for one day.
Slovenian: Največji prijavljeni dnevni odmerek je bil 1200 mcg.
English: Preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3 of Rebetol SmPC if ViraferonPeg is to be administered in combination with ribavirin).
Slovenian: Rezultati predklinične študije toksičnosti za mladiče so pokazali manjše, od odmerka odvisno zmanjšanje rasti pri novorojenih podganah, ki so jim dajali odmerke ribavirina (glejte poglavje 5.3 v SmPC-ju za zdravilo Rebetol, če se zdravilo ViraferonPeg uporablja v kombinaciji z ribavirinom).
English: No statistically significant effect on the time to development of the first clinical event (liver decompensation, hepatocellular carcinoma, death and/or liver transplantation) was observed as compared to the absence of treatment.
Slovenian: Pri teh bolnikih namreč niso opazili nikakršnega statistično značilnega učinka zdravljenja na čas do nastanka prvega kliničnega dogodka (dekompenzacija jeter, hepatocelularni karcinom, smrt in/ali presaditev jeter) v primerjavi z nezdravljenimi bolniki.
English: Table 2b Two-step dose reduction of ViraferonPeg in combination therapy in adults First dose reduction to ViraferonPeg 1 µg/kg
Slovenian: Preglednica 2b Dvostopenjsko zmanjšanje odmerka zdravila ViraferonPeg pri kombinirani terapiji pri odraslih bolnikih Prvo zmanjšanje odmerka zdravila ViraferonPeg na 1 µg/kg
English: Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with ViraferonPeg (see section 4.2)
Slovenian: Zaradi očitnih razlik v farmakokinetiki interferona med posameznimi preiskovanci priporočamo, da bolnike s hudo ledvično okvaro med zdravljenjem z zdravilom ViraferonPeg skrbno spremljate (glejte poglavje 4.2).
English: ViraferonPeg is likely to also cause this effect.
Slovenian: Tudi zdravilo ViraferonPeg ima verjetno enak učinek.
English: st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Slovenian: Opomba 1: Pri odraslih bolnikih je prvo zmanjšanje odmerka ribavirina za 200 mg/dan (razen pri bolnikih, ki prejemajo 1.400 mg - pri njih odmerek zmanjšajte za 400 mg/dan).
English: Note: The needle shield will automatically SNAP UP as you dial (see Figure 9).
Slovenian: Opomba: Ščitnik igle se bo med obračanjem gumba samodejno namestil (glejte sliko 9).
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with ViraferonPeg (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to ViraferonPeg 1 µg/kg dose.
Slovenian: Pri Afro-Američanih (kar je znan neugoden prognostični dejavnik za zatiranje HCV) je zdravljenje s kombinirano terapijo z zdravilom ViraferonPeg (1,5 µg/kg) in ribavirinom vodilo do večjega deleža trajnega virološkega odziva v primerjavi z zdravilom ViraferonPeg v odmerku 1 µg/kg.
English: Inspect visually the reconstituted solution prior to administration: do not use if discolouration (change in the original colour of the solution) or particulate matter is present.
Slovenian: Rekonstituirano raztopino pred uporabo vizualno preglejte: ne uporabite je, če je spremenila barvo ali če so v njej delci.
English: These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2log10 decrease from baseline, patients to stop therapy.
Slovenian: V protokolu so bili uporabljeni naslednji kriteriji: Če je HCV-RNA v 12. tednu pozitivna in se je virusno breme zmanjšalo za < 2 log10 glede na začetno vrednost, naj bolnik preneha z zdravljenjem.
English: While changes in laboratory values were observed in some patients treated with ViraferonPeg used in combination with ribavirin in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
Slovenian: Čeprav so v kliničnem preskušanju pri nekaterih bolnikih, ki so jemali zdravilo ViraferonPeg v kombinaciji z ribavirinom, opazili spremembe laboratorijskih vrednosti, pa so se le-te povrnile na začetne vrednosti v nekaj tednih po koncu zdravljenja.
English: ≥ 8.5 g/dl, and < 10 g/dl
Slovenian: ≥ 8,5 g/dl in < 10 g/dl