FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Slovenian: Farmakokinetika ribavirina je pri bolnikih z motnjami delovanja ledvic spremenjena zaradi zmanjšanega navideznega očistka pri teh bolnikih.
English: * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
Slovenian: * Ker je bil ribavirin vedno predpisan skupaj z zdravili, ki vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na izkušnjah v obdobju trženja in ne omogočajo natančne opredelitve pogostnosti, so zgoraj navedene pogostnosti vzete iz kliničnih preskušanj z uporabo ribavirina v kombinaciji z interferonom alfa-2b (pegiliranim ali nepegiliranim).
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration, cardiac status and indirect bilirubin concentration.
Slovenian: Preglednica 2 prikazuje smernice za prilagoditev odmerka in prenehanje zdravljenja na podlagi bolnikove koncentracije hemoglobina, stanja srca in koncentracije indirektnega bilirubina.
English: Neoplasm unspecified
Slovenian: neopredeljene novotvorbe
English: Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2).
Slovenian: Za zmanjšanje odmerka glede na koncentracije hemoglobina veljajo pri pediatričnih bolnikih brez srčne bolezni enake smernice kot pri odraslih bolnikih brez srčne bolezni (preglednica 2).
English: Viral infection, pharyngitis
Slovenian: virusna okužba, faringitis
English: This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva Pharma B.V. may cause sleepiness, tiredness or confusion.
Slovenian: To zdravilo ne vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, medtem ko druga zdravila, uporabljena v kombinaciji z zdravilom Ribavirin Teva Pharma B.V., lahko povzročijo utrujenost, zaspanost ali zmedenost.
English: There are no data for paediatric patients with cardiac disease (see section 4.4).
Slovenian: Podatkov o pediatričnih bolnikih s srčno boleznijo ni na voljo (glejte poglavje 4.4).
English: All
Slovenian: vsi
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Slovenian: Glede na objavljene podatke je bila farmakokinetika ribavirina po enkratnem odmerku pri bolnikih z motnjami delovanja ledvic spremenjena (povečanje AUCtf in Cmax) v primerjavi s kontrolno skupino (očistek kreatinina > 90 ml/minuto).
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis
Slovenian: pljučnica, askarioza, enterobioza, herpes zoster, celulitis
English: If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Slovenian: Če se pri bolniku pojavijo resni neželeni učinki, ki bi lahko bili povezani z ribavirinom, je treba, če je to primerno, odmerek ribavirina prilagoditi ali uporabo zdravila prekiniti, dokler neželeni učinek ne izzveni oziroma se njegova izrazitost ne zmanjša.
English: Creatinine Clearance
Slovenian: Očistek kreatinina
English: Within the 5 years follow-up post-treatment period, the children had a mean height of 44th percentile, which was below the median of the normative population and less than their mean baseline height (48th percentile).
Slovenian: V obdobju 5-letnega spremljanja bolnikov po koncu zdravljenja je bila srednja višina otrok v 44. percentilu, kar je pod mediano vrednostjo normativne populacije in manj od srednje vrednosti njihove višine na začetku zdravljenja (48. percentil).
English: The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Slovenian: Glavna z zdravljenjem povezana sprememba v zvezi z zdravljenjem je bila reverzibilna, blaga do zmerna anemija, ki je bila hujša kot pri samostojni uporabi vsake od obeh učinkovin.
English: The use of pegylated alpha interferons and ribavirin concomitantly with azathioprine should be avoided.
Slovenian: Uporabi pegiliranega alfa interferona in ribavirina sočasno z azatioprinom se je treba izogibati.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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); not known.
Slovenian: Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥1/10), pogosti (od ≥1/100 do <1/10), občasni (od ≥1/1.000 do <1/100), redki (od ≥ 1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl.reverse transcriptase inhibitors, ATC code: J05AB04.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB04
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Slovenian: hiperglikemija, hiperurikemija, hipokalciemija, dehidracija, povečan apetit
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, ribavirin dose should be reduced to 600 mg/day (administered as one 200 mg tablet in the morning and two 200 mg tablets in the evening).
Slovenian: *Pri bolnikih, ki prejemajo odmerek 1.000 mg (< 75 kg) ali 1.200 mg (> 75 mg), je treba odmerek ribavirina zmanjšati na 600 mg/dan (uporabljen kot ena 200-mg tableta zjutraj in dve 200 mg tableti zvečer).
English: In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
Slovenian: V študiji toksičnosti zdravila na podganjih mladičih so pri mladičih, ki so jim od 7. do 63. dne po rojstvu dajali odmerke 10, 25 in 50 mg/kg ribavirina, so ugotovili od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti.
English: Female: dysmenorrhoea
Slovenian: ženske: dismenoreja
English: In general, the adverse event profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of growth velocity of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Slovenian: Na splošno je bil profil neželenih učinkov v omejeni proučevani populaciji otrok in mladostnikov, ki je bila vključena v študije, podoben profilu pri odraslih, čeprav se je pri njih pojavila dodatna skrb glede zaviranja rasti, saj so med zdravljenjem opažali zmanjšanje percentila telesne višine (srednje odstotno zmanjšanje hitrosti rasti za 9 percentilov) in telesne mase (srednje odstotno zmanjšanje za 13 percentilov).
English: This should be discussed with your doctor (see “Do not take Ribavirin Teva Pharma B.V.”).
Slovenian: O tem se pogovorite s svojim zdravnikom (glejte poglavje “Ne jemljite zdravila Ribavirin Teva Pharma B.V.”).
English: The bioavailability of a single oral dose of ribavirin was increased by co-administration of a high fat meal (AUCtf and Cmax both increased by 70 %).
Slovenian: Biološka uporabnost enkratnega peroralnega odmerka ribavirina se je povečala ob sočasnem zaužitju zdravila z zelo mastnim obrokom (tako AUCtf kot Cmax sta se povečala za 70 %).
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Slovenian: Farmakokinetika ribavirina je pri bolnikih z motnjami delovanja ledvic spremenjena zaradi zmanjšanega navideznega očistka kreatinina pri teh bolnikih (glejte poglavje 5.2).
English: No data are available regarding dose modification for paediatric patients with renal impairment.
Slovenian: Podatkov o prilagoditvi odmerka pri pediatričnih bolnikih z okvaro ledvic ni na voljo.
English: Headache, dizziness, dry mouth, concentration impaired
Slovenian: glavobol, omotica, suha usta, motnje koncentracije
English: Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy.
Slovenian: Nekateri podatki kažejo, da se pri HIV/HCV bolnikih, ki prejemajo ART z abakavirom, lahko pojavi tveganje za nižjo stopnjo odzivnosti na zdravljenje s peginterferonom/ribavarinom.
English: A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Slovenian: Petletna dolgoročna opazovalna spremljevalna študija je zajela 94 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v multicentričnem preskušanju.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with nonpegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa2b (with or without ribavirin), respectively.
Slovenian: V dve veliki, dolgoročni študiji spremljanja bolnikov po zdravljenju v prejšnjih študijah so vključili skupaj 1.071 bolnikov po končanem zdravljenju z nepegiliranim interferonom alfa-2b (z ali brez ribavirina) ter 567 bolnikov po končanem zdravljenju s pegiliranim interferonom alfa-2b (z ali brez ribavirina).
English: Pigmentation disorder, dermatitis atopic, skin exfoliation
Slovenian: motnje pigmentacije, atopijski dermatitis, luščenje kože
English: The purpose of the studies was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Slovenian: Namen teh študij je bil oceniti dolžino trajnega virološkega odziva (SVR-sustained virologic response) in tudi vpliv nadaljnjega negativnega izvida testov na prisotnost virusa na klinični izid bolezni.
English: Rhabdomyolysis*, myositis*
Slovenian: rabdomioliza*, miozitis*
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Slovenian: V fazi zdravljenja v tej študiji so bili neželeni učinki z največjo prevalenco pri vseh preiskovancih zvišana telesna temperatura (80 %), glavobol (62 %), nevtropenija (33 %), utrujenost (30 %), anoreksija (29 %) in eritem na mestu injiciranja (29 %).
English: The use of ribavirin in combination treatment with interferon alfa-2b was evaluated in a number of clinical trials.
Slovenian: Uporabo ribavirina v kombinirani terapiji z interferonom alfa-2b so ovrednotili v številnih kliničnih preskušanjih.
English: In this trial, the combination of ribavirin and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of ribavirin and interferon alfa-2b, particularly in patients infected with Genotype 1.
Slovenian: V tem preskušanju je bila kombinacija ribavirina in peginterferona alfa-2b (1,5 mikrogramov/kg na teden) bistveno bolj učinkovita od kombinacije ribavirina in interferona alfa-2b, še posebej pri bolnikih, okuženih z genotipom 1.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of ribavirin therapy due to the long half-life (see section 5.2).
Slovenian: Zaradi dolge razpolovne dobe lahko do medsebojnega delovanja pride še do dva meseca (5 razpolovnih dob ribavirina) po koncu zdravljenja z ribavirinom (glejte poglavje 5.2).
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10), and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10) in občasni (od ≥ 1/1.000 do < 1/100).
English: No data are available regarding dose modification for paediatric patients with renal impairment (see sections 4.2 and 5.2).
Slovenian: Podatkov o prilagoditvi odmerka pri pediatričnih bolnikih z okvaro ledvic ni na voljo (glejte poglavji 4.2 in 5.2).
English: Hepatomegaly, jaundice, hyperbilirubinemia*
Slovenian: hepatomegalija, zlatenica, hiperbilirubinemija*
English: In particular, decrease in mean height percentile from baseline to the end of the long-term follow-up was most prominent in prepubertal age children (see section 4.4).
Slovenian: Zmanjšanje srednjega percentila višine od začetka zdravljenja do konca dolgoročnega spremljanja bolnikov pa je bilo najbolj izrazito pri otrocih pred puberteto (glejte poglavje 4.4).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Slovenian: Pri zdravljenju bolnikov z majhnim številom celic CD4 je torej potrebna previdnost.
English: Two trials examined the use of ribavirin and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Slovenian: V dveh preskušanjih so raziskovali uporabo kombinacije ribavirina in interferona alfa-2b pri bolnikih s ponovitvijo bolezni (C95-144 in I95-145); 345 bolnikov s kroničnim hepatitisom, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom, so zdravili šest mesecev, in jih nato spremljali še šest mesecev.
English: Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Slovenian: Četudi se je hematološka toksičnost v obliki nevtropenije, trombocitopenije in anemije pogosteje pojavljala pri bolnikih, ki so bili sočasno okuženi s HCV in HIV, so lahko pri večini teh bolnikov toksične učinke odpravili s prilagoditvijo odmerka in je bila zaradi njih le redko potrebna predčasna ukinitev zdravila (glejte poglavje 4.4).
English: It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Slovenian: Pri bolnikih z obstoječimi motnjami delovanja srca je priporočljivo opravljati snemanje EKG pred in med zdravljenjem.
English: The response to treatment in both of these trials is presented in Table 8.
Slovenian: V preglednici 8 je predstavljen odziv bolnikov na zdravljenje pri obeh preskušanjih.
English: Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
Slovenian: Bolniki, zdravljeni z ribavirinom in zidovudinom, imajo zvečano tveganje za pojav anemije, zato pri njih sočasna uporaba ribavirina in zidovudina ni priporočljiva (glejte poglavje 4.5).
English: Enuresis, micturition disorder, urinary incontinence, proteinuria
Slovenian: enureza, motnje uriniranja, inkontinenca seča, proteinurija
English: Thus, ribavirin must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Slovenian: Zato morate ribavirin pri bolnikih z obstoječo boleznijo srca uporabljati previdno (glejte poglavje 4.3).
English: Most cases of anaemia, neutropenia, and thrombocytopenia were mild (WHO grades 1 or 2).
Slovenian: Večina primerov anemije, nevtropenije in trombocitopenije je bila blagih (1. ali 2. stopnje po WHO).
English: This medicinal product requires no special storage conditions.
Slovenian: Za shranjevanje tega zdravila niso potrebna posebna navodila.
English: Pneumonia*
Slovenian: pljučnica*
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg ribavirin (Table 7), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Slovenian: Pri bolnikih, ki so prejeli > 10,6 mg/kg ribavirina (800 mg odmerek pri tipičnem bolniku s telesno maso 75 kg), je bil delež odziva bistveno višji kot pri tistih, ki so prejeli ≤ 10,6 mg/kg ribavirina, ne glede na genotip ali virusno obremenitev (preglednica 7), delež odziva pri tistih, ki so prejeli > 13,2 mg/kg zdravila ribavirina, pa je bil še višji.
English: Co-infected patients with advanced liver disease receiving cART may be at increased risk of worsening liver function.
Slovenian: sočasno okuženi bolniki z napredovalo boleznijo jeter, ki prejemajo terapijo cART, imajo lahko povečano tveganje za poslabšanje delovanja jeter.
English: The mean AUCtf was threefold greater in subjects with creatinine clearance between 10 and 30 mL/min compared with control subjects.
Slovenian: Povprečna AUCtf je bila pri osebah z očistkom kreatinina med 10 in 30 ml/min trikrat večja kot pri kontrolnih preiskovancih.
English: Your doctor has determined the correct dose of this medicine based on how much you or the child you are caring for weighs.
Slovenian: Odmerek tega zdravila, ki vam ga je odmeril zdravnik, je določen na podlagi vaše telesne mase ali telesne mase otroka, za katerega skrbite.
English: Adult patients with moderate renal impairment (creatinine clearance of 30-50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg.
Slovenian: Odrasli bolniki z zmerno okvaro ledvic (očistek kreatinina od 30 do 50 ml/min) morajo izmenično prejemati dnevna odmerka 200 mg in 400 mg.
English: Table 4 Dosage Modification for Renal Impairment in Adult Patients
Slovenian: Preglednica 4 Prilagoditev odmerka v primeru okvare ledvic pri odraslih bolnikih
English: p valueb
Slovenian: p vrednostb
English: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Slovenian: V literaturi so poročali o pancitopeniji in supresiji kostnega mozga, ki sta se pojavili v 3 do 7 tednih po dajanju peginterferona in ribavirina sočasno z azatioprinom.
English: Three trials examined the use of interferon in naïve patients, two with ribavirin + interferon alfa-2b (C95-132 and I95-143) and one with ribavirin + peginterferon alfa-2b (C/I98-580).
Slovenian: V treh preskušanjih so raziskovali uporabo interferona pri predhodno nezdravljenih bolnikih in sicer z ribavirinom + interferonom alfa-2b (C95-132 in I95-143) in v eni z ribavirinom + peginterferonom alfa-2b (C/I98-580).
English: Film coating, composed of : polyvinyl alcohol - partly hydrolysed, macrogol / polyethylene glycol 3350, titanium dioxide (E171), talc, iron oxide red, iron oxide yellow, iron oxide black.
Slovenian: Obloga tablete: delno hidroliziran polivinilalkohol, makrogol/polietilenglikol 3350, titanov dioksid (E171), smukec, rdeči železov oksid, rumeni železov oksid, črni železov oksid.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Teva Pharma B.V. must be discontinued immediately and appropriate medical therapy instituted.
Slovenian: Če se razvije akutna preobčutljivostna reakcija (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksa), morate jemanje zdravila Ribavirin Teva Pharma B.V.
English: Genotype 1 ≤ 600,000 IU/mL
Slovenian: Genotip 1 ≤ 600.000 i.e./ml vsi
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 10.
Slovenian: Farmakokinetične lastnosti pri večkratnem odmerjanju kapsul ribavirina in interferona alfa-2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v preglednici 10.
English: Genotype 1 > 600,000 IU/mL
Slovenian: Genotip 1 > 600.000 i.e./ml vsi
English: Preclinical data: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section
Slovenian: - Plodnost: V študijah na živalih je ribavirin povzročil reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
English: Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Slovenian: Med druge osnovne dejavnike pri bolnikih, sočasno okuženih s HCV in HIV, ki bi lahko bili povezani z večjim tveganjem za jetrno dekompenzacijo, sodita tudi zdravljenje z didanozinom in zvišane serumske koncentracije bilirubina.
English: There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).
Slovenian: Ni podatkov o varnosti ali učinkovitosti uporabe ribavirina skupaj z drugimi oblikami interferona (to je ne alfa-2b).
English: Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Slovenian: Bolezen se je ponovila pri dvanajstih od 492 bolnikov s trajnim virološkim odzivom iz prve skupine in le pri 3 od 366 bolnikov s trajnim virološkim odzivom iz druge skupine, ki so bili vključeni v študijo.
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Slovenian: Približno 10 % radioaktivno označenega odmerka se izloči z blatom, vendar je absolutna biološka uporabnost zdravila približno 45 % do 65 %, verjetno zaradi presnove pri prvem prehodu skozi jetra.
English: Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Slovenian: Sočasno okuženi bolniki z napredovalo cirozo, ki prejemajo kombinirano protiretrovirusno terapijo (cART - combined anti-retroviral therapy), imajo lahko zvečano tveganje za nastanek jetrne dekompenzacije in smrti.
English: The use of ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Slovenian: Uporaba ribavirina v kombinaciji s peginterferonom alfa-2b ni imela opaznega negativnega vpliva na nadzor prisotnosti virusa HIV v krvi med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Slovenian: Glede fibroze v tej študiji niso opažali izboljšanja, steatoza pa je bila bistveno izboljšana pri bolnikih, okuženih z genotipom 3 virusa HCV.
English: peginterferon alfa-2b (1.5 µg /kg/ week)
Slovenian: peginterferon alfa-2b (1,5 µg /kg/ teden)
English: The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Slovenian: Seznam neželenih učinkov pri odraslih v preglednici Neželeni učinki, ki so navedeni v preglednici 5, so povzeti iz izkušenj, zbranih v kliničnih preskušanjih pri odraslih bolnikih, ki se še niso zdravili s tem zdravilom in so jih z njim zdravili eno leto, ter iz obdobja trženja zdravila.