FrancophonIA/ELRC3.0 huggingface dataset:
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with PegIntron in combination with ribavirin was 99 % (67/68; Study 1) (see section 5.1).
Slovenian: Negativna napovedna vrednost stalnega virološkega odziva pri bolnikih, ki so bili sočasno okuženi s HCV/HIV in so se zdravili z zdravilom PegIntron v kombinaciji z ribavirinom, je bila 99 % (67/68, študija 1) (glejte poglavje 5.1).
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron monotherapy compared to those treated with combination therapy (see Table 6).
Slovenian: Utrujenost, alopecija, pruritus, navzea, anoreksija, zmanjšanje telesne mase, razdražljivost in nespečnost se pojavljajo opazno redkeje pri bolnikih, zdravljenih z zdravilom PegIntron v monoterapiji, kot pa pri tistih, ki prejemajo kombinirano zdravljenje (glejte preglednico 6).
English: Paediatric population PegIntron can be used in combination with ribavirin in paediatric patients 3 years of age and older.
Slovenian: Zdravilo PegIntron se lahko uporablja v kombinaciji z ribavirinom pri pediatričnih bolnikih starih 3 leta in več.
English: Tritherapy (PegIntron with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Slovenian: Trojna terapija (zdravilo PegIntron ter ribavirin in boceprevir): velja za odrasle bolnike s CHC genotipa 1.
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 PegIntron (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 PegIntron skrbno spremljate (glejte poglavje 4.2).
English: PegIntron 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 PegIntron 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: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject PegIntron”).
Slovenian: Podrobna navodila za podkožno injiciranje so priložena na koncu teh navodil (glejte poglavje "Kako si sami injicirate zdravilo PegIntron").
English: In this trial, the combination of PegIntron (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 PegIntron (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: For disposal instructions, see section 5 “How to store PegIntron”.
Slovenian: Za navodila o odstranjevanju zdravila glejte poglavje 5 "Shranjevanje zdravila PegIntron".
English: - If you are also being treated for HIV (see section “Other medicines and PegIntron”).
Slovenian: - se zdravite tudi zaradi okužbe s HIV (glejte poglavje "Druga zdravila in zdravilo PegIntron").
English: PegIntron showed no genotoxic potential.
Slovenian: Zdravilo PegIntron ni pokazalo nikakršne genotoksičnosti.
English: Table 2b Two-step dose reduction of PegIntron in combination therapy in adults First dose reduction to PegIntron 1 µg/kg
Slovenian: Preglednica 2b Dvostopenjsko zmanjšanje odmerka zdravila PegIntron pri kombinirani terapiji pri odraslih bolnikih Prvo zmanjšanje odmerka zdravila PegIntron na 1 µg/kg
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with PegIntron (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to PegIntron 1 µg/kg dose.
Slovenian: Pri Afro-Američanih (kar je znan neugoden prognostični dejavnik za zatiranje HCV) je zdravljenje s kombinirano terapijo z zdravilom PegIntron (1,5 µg/kg) in ribavirinom vodilo do večjega deleža trajnega virološkega odziva v primerjavi z zdravilom PegIntron v odmerku 1 µg/kg.
English: Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SmPC).
Slovenian: Bolniki z očistkom kreatinina < 50 ml/minuto se ne smejo zdraviti z zdravilom PegIntron v kombinaciji z ribavirinom (glejte SmPC za ribavirin).
English: Table 13 Sustained virological response based on genotype after PegIntron in combination with Ribavirin in HCV/HIV Co-infected patients Study 1
Slovenian: Preglednica 13 Trajni virološki odziv glede na genotip po jemanju zdravila PegIntron v kombinaciji z ribavirinom pri bolnikih, sočasno okuženih s HCV / HIV Študija 1
English: PegIntron pre-filled pen is to be removed from the refrigerator before administration to allow the solvent to reach room temperature (not more than 25°C).
Slovenian: Pred uporabo vzemite napolnjeni injekcijski peresnik PegIntron iz hladilnika, da se bo vehikel ogrel na sobno temperaturo (ne več kot 25C).
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with PegIntron reported in adult patients.
Slovenian: Učinek, značilen za skupino zdravil, ki vsebujejo interferon-alfa - pri standardnem interferonskem zdravljenju so o njem poročali pri odraslih in pediatričnih bolnikih; pri zdravljenju z zdravilom PegIntron so o njem poročali pri odraslih bolnikih.
English: However, renal elimination may account for a minority (approximately 30 %) of PegIntron apparent clearance.
Slovenian: Vendar pa njegovo izločanje prek ledvic lahko predstavlja le manjši del (približno 30 %) celotnega očistka zdravila PegIntron.
English: Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Slovenian: Podatki, dobljeni pri starejših bolnikih, ki so jih zdravili z enkratnim odmerkom zdravila PegIntron, kažejo, da zaradi starosti ni potrebna sprememba odmerka zdravila PegIntron (glejte poglavje 5.2).
English: - The use of PegIntron in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Slovenian: - Uporaba zdravila PegIntron pri otrocih in mladostnikih, ki imajo hude psihiatrične motnje ali so jih kdaj imeli, je kontraindicirana (glejte poglavje 4.3).
English: PegIntron should be used with caution in patients with moderate to severe renal impairment.
Slovenian: Zdravilo PegIntron morate uporabljati previdno pri bolnikih z zmerno do hudo ledvično okvaro.
English: During combination therapy for up to 48 weeks with PegIntron and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Slovenian: V času kombinirane terapije z zdravilom PegIntron in ribavirinom, ki je trajala do 48 tednov, so opazili tudi zastoj rasti, ki je pri nekaterih bolnikih povzročil manjšo telesno višino (glejte poglavje 4.4).
English: If renal function decreases during treatment, PegIntron therapy should be discontinued.
Slovenian: Če se delovanje ledvic poslabša med zdravljenjem, zdravljenje z zdravilom PegIntron ukinite.
English: While changes in laboratory values were observed in some patients treated with PegIntron 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 PegIntron v kombinaciji z ribavirinom, opazili spremembe laboratorijskih vrednosti, pa so se le-te povrnile na začetne vrednosti v nekaj tednih po koncu zdravljenja.
English: PegIntron should be administered as a subcutaneous injection.
Slovenian: Zdravilo PegIntron se mora uporabljati v obliki subkutane injekcije.
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 PegIntron 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 PegIntron uporablja v kombinaciji z ribavirinom).
English: At the PegIntron 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Slovenian: Pri odmerku zdravila PegIntron 1,5 µg/kg z ribavirinom so bili deleži trajnega virološkega odziva nižji pri bolnikih s cirozo, pri bolnikih z normalnimi vrednostmi ALT, pri bolnikih z začetnim virusnim bremenom > 600.000 i.e./ml in pri bolnikih > 40 let.
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of PegIntron in combination with ribavirin (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]).
Slovenian: Med bolniki, zdravljenimi s priporočenimi odmerki zdravila PegIntron v kombinaciji z ribavirinom, je bilo nekaj primerov težje nevtropenije (3. stopnje po WHO: 39 od 182 [21 %] in 4. stopnje po WHO: 13 od 186 [7 %]).
English: In a clinical trial, approximately 1.2 % of patients treated with PegIntron or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Slovenian: V kliničnem preskušanju so pri približno 1,2 % bolnikov, zdravljenih z zdravilom PegIntron ali z interferonom alfa-2b v kombinaciji z ribavirinom med zdravljenjem poročali o smrtno nevarnih duševnih motnjah.
English: PegIntron Cmax and AUC measurements increase in a dose-related manner.
Slovenian: Vrednosti Cmax in AUC za zdravilo PegIntron naraščajo v odvisnosti od odmerka.
English: A large long-term follow-up study enrolled 567 patients after treatment in a prior study with PegIntron (with or without ribavirin).
Slovenian: Podatki o dolgoročni učinkovitosti zdravila - odrasli V veliko dolgoročno študijo spremljanja bolnikov je bilo vključenih 567 bolnikov, ki so zaključili zdravljenje z zdravilom PegIntron (z ali brez ribavirina) v okviru prejšnje študije.
English: PegIntron is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Slovenian: Zdravilo PegIntron je dobro opredeljen derivat interferona alfa-2b, modificiran s polietilenglikolom ("pegiliran"), in je sestavljen pretežno iz monopegiliranih vrst.
English: Use in children 3 years of age and older and adolescents PegIntron will be given in combination with ribavirin.
Slovenian: Uporaba pri otrocih, starih 3 leta ali več, in mladostnikih Zdravilo PegIntron se uporablja v kombinaciji z ribavirinom.
English: For HCV/HIV co-infected patients receiving PegIntron in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Slovenian: Pri bolnikih, ki so bili sočasno okuženi s HCV/HIV in so prejemali zdravilo PegIntron v kombinaciji z ribavirinom, so drugi neželeni učinki (o katerih niso poročali pri bolnikih s samo eno okužbo), o katerih so poročali v večjih študijah s pogostnostjo > 5 %, bili: oralna kandidiaza (14 %), pridobljena lipodistrofija (13 %), zmanjšano število limfocitov CD4 (8 %), zmanjšan apetit (8 %), zvišana vrednost gama glutamiltransferaze (9 %), bolečine v hrbtu (5 %), zvišana vrednost amilaze v krvi (6 %), zvišana koncentracija mlečne kisline v krvi (5 %), citolitični hepatitis (6 %), zvišana vrednost lipaze (6 %) in bolečine v udih (6 %).
English: The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Slovenian: Varnosti in učinkovitosti zdravila PegIntron v monoterapiji ali v kombinirani terapiji z ribavirinom za zdravljenje hepatitisa C pri bolnikih s presajenimi jetri ali drugimi organi niso preučevali.
English: Body weight(kg)
Slovenian: Telesna masa (kg)
English: Haematological abnormalities were more frequently reported in patients receiving PegIntron in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Slovenian: O nenormalnih hematoloških izvidih so poročali pogosteje pri bolnikih, ki so prejemali zdravilo PegIntron v kombinaciji z ribavirinom, kot pri tistih, ki so prejemali interferon alfa-2b v kombinaciji z ribavirinom.
English: Dose modification for all patients (monotherapy and combination therapy) If severe adverse reactions or laboratory abnormalities develop during treatment with PegIntron monotherapy or combination therapy, the dosages of PegIntron and/or ribavirin must be modified as appropriate, until the adverse reactions abate.
Slovenian: Prilagajanje odmerka pri vseh bolnikih (monoterapija in kombinirana terapija) Če se med zdravljenjem z zdravilom PegIntron v monoterapiji ali v kombinirani terapiji pojavijo resni neželeni učinki ali nenormalni laboratorijski izvidi, morate ustrezno prilagoditi odmerke zdravila PegIntron in/ali ribavirina, dokler neželeni učinki ne prenehajo.
English: - are being treated with telbivudine (see section “Other medicines and PegIntron”).
Slovenian: - če se zdravite s telbivudinom (glejte poglavje "Druga zdravila in zdravilo PegIntron").
English: Paediatric population (bitherapy only) - Dose to be administered Dosing for children 3 years of age and older and adolescent patients is determined by body surface area for PegIntron and by body weight for ribavirin.
Slovenian: Pediatrična populacija (samo dvojna terapija) - odmerek za injiciranje Odmerek za otroke, stare 3 leta in več, in mladostnike za zdravilo PegIntron se določi glede na bolnikovo telesno površino, za ribavirin pa glede na bolnikovo telesno maso.
English: Collect the necessary items before you begin: - a vial of PegIntron powder for injection; - an ampoule of water for injections solvent to prepare PegIntron injection; - a 1 ml syringe; - a long needle (for example 0.8  40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the PegIntron powder vial; - a short needle (for example 0.3  13 mm [30 gauge 0.5 inch]) for the subcutaneous injection; - a cleansing swab.
Slovenian: Pred začetkom si pripravite vse potrebne pripomočke: - vialo s praškom zdravila PegIntron za injekcije; - ampulo vode za injekcije - vehikel oz. topilo za pripravo zdravila PegIntron za injiciranje; - 1 ml brizgo; - dolgo iglo (npr. 0,8  40 mm 21 gauge 1,5 inch ), ki jo boste uporabili za dodajanje vode za injekcije v vialo s praškom PegIntron; - kratko iglo (npr. 0,3  13 mm[30 gauge 0,5 inch]) za subkutano injiciranje; - čistilni tampon.
English: The dose of PegIntron is determined by a calculation accounting for both height and weight.
Slovenian: Odmerek zdravila PegIntron se določi z izračunom, ki upošteva telesno višino in telesno maso.
English: PegIntron should be administered as a once weekly subcutaneous injection.
Slovenian: Zdravilo PegIntron se daje enkrat na teden v obliki subkutane injekcije.
English: Dose reduction of PegIntron 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 PegIntron pri odraslih lahko dosežete z zmanjšanjem predpisanega volumna ali z uporabo manjše jakosti, kot je prikazano v preglednici 2b.
English: Clinical efficacy and safety - Adults Tritherapy with PegIntron, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Slovenian: Klinična učinkovitost in varnost - odrasli Trojna terapija z zdravilom PegIntron, ribavirinom in boceprevirjem: glejte SmPC za boceprevir.
English: Alanine aminotransferase (ALT)
Slovenian: Alaninaminotransferaza (ALT) ali aspartataminotransferaza (AST)
English: P 1.5/R PegIntron (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Slovenian: P 1,5/R PegIntron (1,5 mikrograma/kg) + ribavirin (800 mg) P 0,5/R PegIntron (1,5 do 0,5 mikrograma/kg) + ribavirin (1.000/1.200 mg) I/R
English: In children and adolescent patients receiving body surface area-adjusted dosing of PegIntron at 60 g/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 g/kg/week.
Slovenian: Pri otrocih in mladostnikih, ki so prejemali na telesno površino prilagojen odmerek zdravila PegIntron 60 µg/m na teden, je bila napovedana logaritemska vrednost ocene izpostavljenosti zdravilu v času odmernega intervala za 58 % (90 % IZ: 141-177 %) večja od ugotovljene vrednosti pri odraslih, ki so prejemali odmerek 1,5 µg/kg na teden.
English: Description of selected adverse reactions in children and adolescents Most of the changes in laboratory values in the PegIntron/ribavirin clinical trial were mild or moderate.
Slovenian: Opis izbranih neželenih učinkov pri otrocih in mladostnikih V kliničnem preskušanju z zdravilom PegIntron/ribavirinom so bile spremembe v laboratorijskih vrednostih večinoma blage do zmerne.
English: Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.
Slovenian: Interferon v monoterapiji, vključno z zdravilom PegIntron, je indiciran predvsem v primeru, ko bolnik ne prenaša ribavirina ali je njegova uporaba kontraindicirana.
English: Adequate hydration must be maintained in patients undergoing PegIntron therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom PegIntron, morate ohranjati ustrezno hidracijo, saj so pri nekaterih bolnikih, zdravljenih z alfa interferoni, opazili hipotenzijo zaradi izgube tekočine.
English: Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Slovenian: V prvi (C/I97-010) je bilo zdravilo PegIntron uporabljeno kot monoterapija, v drugi (C/I98-580) pa v kombinaciji z ribavirinom.
English: Measuring the dose of PegIntron from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Slovenian: Merjenje odmerka zdravila PegIntron iz rekonstituiranega praška za injekcije Vialo in brizgo držite obrnjeno narobe v eni roki.
English: There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Slovenian: Starost nima opaznega vpliva na farmakokinetiko zdravila PegIntron.
English: This study showed that PegIntron was superior to interferon alfa-2b (Table 8).
Slovenian: Ta raziskava je potrdila, da je zdravilo PegIntron boljše od interferona alfa-2b (preglednica 8).
English: What PegIntron looks like and contents of the pack
Slovenian: Izgled zdravila PegIntron in vsebina pakiranja
English: Discontinue PegIntron if:
Slovenian: Ukinite zdravilo PegIntron v primeru:
English: Clinical efficacy and safety - paediatric population Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus PegIntron 60 g/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Slovenian: Klinična učinkovitost in varnost - pediatrična populacija Otroke in mladostnike, stare od 3 do 17 let, s kompenziranim kroničnim hepatitisom C in merljivo HCV-RNA so vključili v multicentrično preskušanje in jih zdravili z ribavirinom 15 mg/kg na dan in zdravilom PegIntron 60 µg/m2 enkrat na teden 24 ali 48 tednov, glede na genotip HCV in virusno breme na začetku preskušanja.
English: PegIntron combination therapy (bitherapy or tritherapy) Bitherapy (PegIntron with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Slovenian: PegIntron v kombinirani terapiji (dvojna ali trojna terapija) Dvojna terapija (zdravilo PegIntron in ribavirin): velja za vse odrasle in pediatrične bolnike, stare 3 leta ali več.
English: Table 3a Dose modification guidelines for PegIntron monotherapy in adults based on laboratory parameters
Slovenian: Preglednica 3a Smernice za prilagoditev odmerka za monoterapijo z zdravilom PegIntron pri odraslih bolnikih, ki temeljijo na laboratorijskih vrednostih
English: Reconstituting PegIntron powder for injection
Slovenian: Rekonstitucija praška PegIntron za injekcije
English: Solvent for PegIntron Water for injections
Slovenian: Vehikel za PegIntron voda za injekcije
English: SVR % (n/N) 99% CI
Slovenian: SVR % (n/N) 99 % IZ
English: PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
Slovenian: Zdravilo PegIntron je indicirano za zdravljenje odraslih bolnikov (18 let ali več) s CHC, ki imajo pozitiven izvid na RNA virusa hepatitisa C (HCV-RNA), vključno z bolniki z zdravljeno cirozo in/ali s sočasno klinično stabilno okužbo s HIV (glejte poglavje 4.4).
English: - Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1; - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4); - Severe, debilitating medical conditions; - Autoimmune hepatitis or a history of autoimmune disease; - Severe hepatic dysfunction or decompensated cirrhosis of the liver; - Pre-existing thyroid disease unless it can be controlled with conventional treatment; - Epilepsy and/or compromised central nervous system (CNS) function; - HCV/HIV patients with cirrhosis and a Child-Pugh score ≥ 6.
Slovenian: - preobčutljivost na učinkovino, katerega od interferonov ali katero koli pomožno snov, navedeno v poglavju 6.1, - anamneza hude obstoječe bolezni srca, vključno z nestabilno ali nenadzorovano boleznijo srca v preteklih šestih mesecih (glejte poglavje 4.4), - hude bolezni, ki bolnika izčrpavajo, - avtoimuni hepatitis ali avtoimuna bolezen v anamnezi, - huda jetrna okvara ali dekompenzirana jetrna ciroza, - obstoječa bolezen ščitnice, razen če jo je mogoče nadzorovati s konvencionalno terapijo, - epilepsija in/ali motnje delovanja osrednjega živčevja (CŽS), - bolniki, okuženi s HCV/HIV in s cirozo jeter ter z oceno ≥ 6 po Child-Pughu, - kombinacija zdravila PegIntron s telbivudinom.