FrancophonIA/ELRC3.0 huggingface dataset:
English: • In paediatric patients, the presence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.
Slovenian: • pediatrični bolniki s hudimi psihičnimi stanji ali hudimi psihičnimi stanji v anamnezi, zlasti s hudo depresijo, razmišljanjem o samomoru ali poskusom samomora.
English: When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy.
Slovenian: Pri odločanju o tem, ali boste z zdravljenjem pričeli v otroštvu ali ga odložili na odraslo obdobje, je pomembno upoštevati, da kombinirano zdravljenje povzroča zastoj rasti.
English: HBeAg-negative(a)
Slovenian: HBeAg-negativni
English: You should use a different place each time you give yourself an injection.
Slovenian: Vsakič, ko si date injekcijo, izberite drugo mesto.
English: At 2 years posttreatment, 16% (6 of 38) of patients remained 15 percentiles or more below their baseline weight curve and 11% (4 of 38) remained 15 percentiles or more below their baseline height curve.
Slovenian: Dve leti po zdravljenju je 16 % (6 od 38) bolnikov ostalo 15 percentilov ali več pod svojo izhodiščno krivuljo telesne mase.
English: Pegasys treatment has been associated with decreases in platelet count, which returned to pretreatment levels during the post-treatment observation period (see section 4.8).
Slovenian: Zdravljenje z zdravilom Pegasys je bilo povezano z zmanjšanjem števila trombocitov, ki pa se je v opazovanem obdobju po zdravljenju vrnilo na število pred zdravljenjem (glejte poglavje 4.8).
English: Consideration should be given to continuing treatment with more frequent monitoring of liver function during ALT flares.
Slovenian: Med nihanji vrednosti ALT je vredno premisliti o nadaljevanju zdravljenja s pogostejšimi kontrolami jetrne funkcije.
English: ● Remove the protective cap from the Pegasys vial (1).
Slovenian: Merjenje odmerka zdravila Pegasys ● Z viale zdravila Pegasys odstranite zaščitni pokrovček (1).
English: Study NV15495
Slovenian: Študija NV15495
English: From the YV25718 study, 31 paediatric patients 3 to 17 years of age with CHB participated in the PK sub-study and received Pegasys according to a BSA category dosing regimen.
Slovenian: Iz študije YV25718 je skupno 31 pediatričnih bolnikov s CHB, starih od 3 do 17 let, sodelovalo v farmakokinetični podštudiji in prejemalo zdravilo Pegasys z režimom odmerjanja glede na telesno površino.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Slovenian: Sočasno jemanje ribavirina in zidovudina ni priporočljivo zaradi povečanega tveganja za nastanek anemije (glejte poglavje 4.4).
English: 180 micrograms/1 ml
Slovenian: 180 mikrogramov/1 ml
English: Alcohol pad
Slovenian: Alkoholni zloženec
English: ● an injection needle Not included in the pack:
Slovenian: V ovojnini ni vključeno:
English: (N=701) 48 weeks
Slovenian: (n = 701) 48 tednov
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be re-assessed (see also Endocrine system in sections 4.4 and 4.8).
Slovenian: Ponovno je treba ovrednotiti korist in tveganje nadaljevanja zdravljenja z interferoni (glejte tudi Endokrini sistem poglavji 4.4 in 4.8).
English: General
Slovenian: Splošni
English: Pegasys is intended for subcutaneous use (under the skin).
Slovenian: Zdravilo Pegasys dajemo subkutano (pod kožo).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Adult chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
Slovenian: V študiji MV17150 so bolnike, ki se niso odzvali na prejšnje zdravljenje s pegiliranim interferonom alfa-2b in ribavirinom, randomizirali v štiri različna zdravljenja:
English: 25,000 to cells/mm3
Slovenian: < 25.000 celic/mm3.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Nemčija Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: HBV genotype A subgroup size was insufficient to be analyzed.
Slovenian: Za virus hepatitisa B genotipa A je bila velikost podskupine za analizo nezadostna.
English: 0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a fixed needle (stainless steel), plunger stopper (butyl rubber laminated with fluororesin) and a needle shield (polyisoprene) in a pre-filled pen.
Slovenian: 0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (silikonsko steklo tipa I) s pritrjeno iglo (nerjaveče jeklo), zamaškom in batom (iz butilirane gume, laminirane s fluororesinom) ter ščitnikom za iglo (poliizopren) v napolnjenem injekcijskem peresniku.
English: Ocular changes
Slovenian: Spremembe na očeh
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon re-introduction of either treatment alone (see section 4.5).
Slovenian: Mielotoksičnost je bila reverzibilna v 4 do 6 tednih po prekinitvi protivirusne terapije za HCV in sočasnega azatioprina in se po ponovni uvedbi enega od obeh zdravljenj ni ponovila (glejte poglavje 4.5).
English: Must not be given to premature babies, neonates or children up to 3 years old.
Slovenian: Ne smemo ga dajati nedonošenčkom, novorojenčkom ali otrocih do 3. leta starosti.
English: Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Slovenian: Na voljo je pakiranje z 1 ali 4 in skupno pakiranje z 12 (2 pakiranji po 6) napolnjenimi injekcijskimi brizgami.
English: Aggression, mood alteration, emotional disorders, nervousness, libido decreased
Slovenian: agresivnost, spremembe razpoloženja, čustvene motnje,
English: Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
Slovenian: Povečanje izpostavljenosti zdravila Pegasys v odvisnosti od odmerka so opazili tako pri zdravih ljudeh kot tudi pri bolnikih s kroničnim hepatitisom B ali C po odmerjanju enkrat na teden.
English: Patients with these conditions who cannot be effectively controlled by medication should not begin Pegasys monotherapy or Pegasys/ribavirin combination therapy.
Slovenian: Bolniki s temi stanji, ki jih ne moremo ustrezno uravnavati z zdravili, naj ne začnejo samostojnega zdravljenja z zdravilom Pegasys ali kombiniranega zdravljenja z zdravilom Pegasys in ribavirinom.
English: It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Slovenian: Za zdaj še ni jasno, če večji odmerek ribavirina (npr. 1000/1200 mg na dan glede na telesno maso) povzroči višji delež trajnega virološkega odziva kot odmerek 800 mg na dan, kadar je zdravljenje skrajšano na 16 tednov.
English: In patients with cardiovascular disease, anaemia may necessitate dose reduction or discontinuation of ribavirin (see section 4.2).
Slovenian: Pri bolnikih z motenim srčnim delovanjem je zaradi anemije treba zmanjšati odmerek ribavirina ali zdravljenje z ribavirinom prekiniti (glejte poglavje 4.2).
English: 500 to < 750 cells/mm3
Slovenian: 500 do < 750 celic/
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Slovenian: Pri zdravljenju bolnikov z nizkim številom celic CD4+ je zato potrebna previdnost.
English: The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Slovenian: Vrednost se nanaša na vsebnost interferona alfa-2a v molekuli peginterferona alfa-2a, brez upoštevanja polietilenglikolnih verig.
English: The clinical significance of this finding is unknown; nonetheless, patients should be monitored for the signs and symptoms of methadone toxicity.
Slovenian: Pri bolnikih je vseeno potrebno spremljati znake in simptome toksičnosti metadona.
English: In CHB or CHC patients, peginterferon alfa-2a serum concentrations accumulate 2 to 3 fold after 6 to 8 weeks of once weekly dosing compared to single dose values.
Slovenian: Pri bolnikih s CHB ali CHC prihaja po 6 do 8 tednih zdravljenja do 2- do 3-kratne kumulacije serumskih koncentracij peginterferona alfa-2a po odmerjanju enkrat na teden v primerjavi z vrednostmi enkratnega odmerka.
English: Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (or black, tarry stools); severe nosebleed; fever or chills; problems with your eyesight.
Slovenian: Če opazite katerega koli izmed naslednjih neželenih učinkov, takoj obvestite svojega zdravnika: huda bolečina v prsih, trdovraten kašelj, nepravilen srčni utrip, težave z dihanjem, zmedenost, depresija, huda bolečina v želodcu, kri v blatu (ali črno, katranasto blato), huda krvavitev iz nosu, zvišana telesna temperatura ali mrzlica, težave z vidom.
English: Pegasys has not been evaluated in patients with decompensated cirrhosis (e.g., Child-Pugh B or C or bleeding oesophageal varices) (see section 4.3).
Slovenian: Pri bolnikih z dekompenzirano cirozo (npr. stopnja Child-Pugh B ali C ali krvavitev iz varic požiralnika) zdravila Pegasys niso uporabljali (glejte poglavje 4.3).
English: The probabilities of not achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was not achieved at week 12 were 96% (363 of 380) and 96% (324 of 339), respectively.
Slovenian: Če bolniki v 12. tednu zdravljenja niso dosegli virusne supresije, je bila verjetnost, da ne bodo dosegli trajnega virološkega odziva, pri 48-tedenskem zdravljenju 96 % (363 od 380), pri 72-tedenskem pa 96 % (324 od 339).
English: Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm compared to administration in the abdomen and thigh.
Slovenian: Izpostavljenost zdravilu Pegasys je bila v raziskavah, kjer so zdravilo Pegasys dajali v roko v primerjavi z dajanjem v trebuh in stegna, nižja.
English: Depression, anxiety, hallucination, abnormal behaviour, aggression, anger, attention deficit / hyperactivity disorder
Slovenian: Psihiatrične motnje nespečnost depresija, anksioznost, halucinacija, nenormalno vedenje, agresija, jeza, motnja pomanjkanja pozornosti
English: Patients who develop these conditions during treatment and cannot be controlled with medication should discontinue Pegasys or Pegasys/ribavirin therapy.
Slovenian: Bolniki, pri katerih se ta stanja razvijejo med zdravljenjem in jih ne moremo ustrezno uravnati z zdravili, morajo zdravljenje z zdravilom Pegasys ali kombinirano zdravljenje z zdravilom Pegasys in ribavirinom prekiniti.
English: StevensJohnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme
Slovenian: toksična epidermalna nekroliza, angioedem, multiformni eritem
English: Each vial should be used by one person only and is for single use.
Slovenian: Vsako vialo mora prejeti le ena oseba in je le za enkratno uporabo.
English: When increases in ALT levels are progressive despite dose reduction, or are accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Slovenian: progresivna kljub zmanjšanju odmerka ali če jih spremlja zvišan bilirubin ali znaki jetrne dekompenzacije, zdravljenje prekinemo (glejte poglavje 4.4).
English: • Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na zdravilno učinkovino, interferone alfa ali katero koli pomožno snov,
English: Lamivudine 100 mg (N=271)
Slovenian: 100 mg (n = 271)
English: Psychiatric and nervous system disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning), peripheral neuropathy (disorder of the nerves affecting the extremities)
Slovenian: Psihiatrične motnje in bolezni živčevja: misli o samomoru, halucinacije (hude težave z osebnostjo in poslabšanje normalnega socialnega obnašanja), periferna nevropatija (bolezen živcev, ki prizadane ude).
English: Hormone system disorders: Diabetes (high blood sugar) Metabolic disorders: Dehydration
Slovenian: Bolezni endokrinega sistema: diabetes (visok krvni sladkor).
English: ● if you have ever had depression or symptoms associated with depression (e.g. feelings of sadness, dejection, etc.).
Slovenian: • če ste kdaj imeli hude živčne ali duševne motnje, • če ste kdaj imeli depresijo (npr. občutek žalosti, potrtosti itd.) ali simptome, povezane z depresijo,
English: The Pegasys prefilled pens do not allow for appropriate adjustment of dosing in these patients.
Slovenian: Zdravilo Pegasys v obliki napolnjenih injekcijskih peresnikov pri teh bolnikih ne omogoča ustreznega uravnavanja odmerka.
English: Table 21: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in HIV-HCV co-infected patients Study NR15961 Interferon alfa-2a 3 MIU
Slovenian: Preglednica 21: Trajni virološki odziv v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih, okuženih s HIV in HCV Študija NR15961 Interferon alfa-2a
English: For patients with ANC < 500 cells/mm3 treatment should be suspended until ANC
Slovenian: Pri bolnikih z absolutnim številom nevtrofilcev (ANCAbsolute Neutrophil Count) < 500 celic/mm3 moramo zdravljenje prekiniti, dokler se vrednosti ANC
English: Patients with severe renal impairment receiving Pegasys 180 mcg once weekly showed a 60% higher peginterferon alfa-2a exposure than patients with normal renal function, therefore a reduced dose of Pegasys 135 mcg once weekly is recommended in patients with severe renal impairment.
Slovenian: Pri bolnikih s hudo ledvično okvaro, ki so prejemali zdravilo Pegasys 180 µg enkrat na teden, so opazili za 60 % večjo izpostavljenost peginterferonu alfa-2a kot pri bolnikih z normalnim ledvičnim delovanjem, zato se pri bolnikih s hudo ledvično okvaro priporoča zmanjšan odmerek zdravila Pegasys 135 µg enkrat na teden.
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with CHC treated with interferon.
Slovenian: Pri bolnikih s CHC, ki so se zdravili z interferonom, so poročali o primerih Vogt-Koyanagi-Harada (VKH) sindroma.
English: Patients receiving zidovudine in combination with ribavirin and alfa interferons are at increased risk of developing anaemia.
Slovenian: Pri bolnikih, ki jemljejo zidovudin skupaj z ribavirinom in interferoni alfa, obstaja povečano tveganje za nastanek anemije.
English: Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalization at 6 months posttreatment.
Slovenian: Odziv na zdravljenje za HBeAg pozitivne bolnike je bil določen kot HBeAg serokonverzija (opredeljena kot izguba HBeAg in prisotnost anti-HBe) + HBV DNA < 2.000 i.e./ml po 6 mesecih po končanem zdravljenju; odziv na zdravljenje za HbeAg negativne bolnike je bil določen kot HBV DNA < 2.000 i.e./ml + normalizacija ALT po
English: Heart and blood vessel disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle, bleeding in the brain and inflammation in the vessels
Slovenian: Srčne in žilne bolezni: srčni napad, srčna odpoved, bolečina v srcu, hiter srčni ritem, motnje ritma in vnetje poprsnice ter srčne mišice, krvavitev v možganih in vnetje žil.
English: In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/week and ribavirin 800 milligrams/day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
Slovenian: V študiji NR16071 so randomizirani bolniki s HCV, ki so imeli normalne vrednosti ALT, prejemali zdravilo Pegasys v odmerku 180 mikrogramov na teden in 800 miligramov ribavirina na dan 24 ali 48 tednov, ki jim je sledilo 24-tedensko obdobje sledenja brez zdravljenja ali 72 tednov brez zdravljenja.
English: Ask your healthcare provider any questions you may have.
Slovenian: Nanj se obrnite, če imate vprašanja.
English: Breathing disorders: Shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat
Slovenian: Bolezni dihal: zasoplost pri telesni aktivnosti, krvavitev iz nosu, vnetje nosu in grla, okužbe nosu in sinusov (v kosteh obraza in glave so našli prostore, napolnjene z zrakom), izcedek iz nosu, vnetje grla.
English: Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
Slovenian: O hudih neželenih učinkih so poročali pri 2 bolnikih v skupini, ki je bila zdravljena s kombinacijo zdravila Pegasys in ribavirina (hiperglikemija in holecistektomija).
English: Comprehensive instructions for the preparation and administration of Pegasys in pre-filled pen are given in the package leaflet.
Slovenian: Natančna navodila za pripravo in dajanje zdravila Pegasys v napolnjenem injekcijskem peresniku so v navodilu za uporabo.
English: Study NV15942
Slovenian: Študija NV15942
English: In non-responder patients re-treated for 48 or 72 weeks, viral suppression at week 12 (undetectable HCV RNA defined as <50 IU/ml) has been shown to be predictive for sustained virological response.
Slovenian: Pri bolnikih, ki se na zdravljenje niso odzvali in so jih ponovno zdravili 48 ali 72 tednov, je bila virusna supresija v 12. tednu (nemerljiva koncentracija HCV RNA, definirana kot < 50 i.e./ml)
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Slovenian: Če opazite, da postajate depresivni, imate samomorilske misli ali opažate spremembe v svojem vedenju, takoj poiščite zdravniško pomoč.
English: Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
Slovenian: Med kliničnimi preskušanji so pri karcinomu ledvic dajali tedenske odmerke do 540 mikrogramov, pri kronični mieloični levkemiji pa do 630 mikrogramov.
English: In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
Slovenian: V isti študiji so opazili tudi 25-% povečanje AUC za teofilin (označevalec aktivnosti citokroma P450
English: Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon.
Slovenian: Zdravilo Pegasys vsebuje zdravilno učinkovino peginterferon alfa-2a, ki je interferon z dolgotrajnim delovanjem.
English: A subsequent study (NV18209) in patients co-infected with HCV genotype 1 and HIV compared treatment using Pegasys 180 mcg/week and either ribavirin 800 mg or 1000 mg (<75 kg)/1200 mg (≥75 kg) daily for 48 weeks.
Slovenian: Kasnejša študija (NV18209) pri bolnikih, sočasno okuženih s HCV genotipom 1 ter HIV, je primerjala zdravljenje z zdravilom Pegasys 180 µg/teden v kombinaciji bodisi z 800 mg ribavirina bodisi s 1000 mg (bolniki < 75 kg)/1200 mg ribavirina (bolniki ≥ 75 kg) na dan, 48 tednov.
English: List of subsections on how to proceed:
Slovenian: Seznam korakov postopka:
English: Chronic hepatitis C in prior non-responder patients
Slovenian: Kronični hepatitis C pri bolnikih, ki se na prejšnje zdravljenje niso odzvali
English: HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Slovenian: HBV DNA < 20.000 i.e./ml* HBV DNA < 2.000 i.e./ml ALT normalizacija
English: *The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
Slovenian: *Zdravilna učinkovina peginterferon alfa-2a je kovalentni konjugat beljakovine interferona alfa-2a, pridobljene iz celične kulture Escherichia coli s tehnologijo rekombinantne DNA, z molekulo bis[monometoksipolietilenglikol].
English: In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), and injection-site reaction (45%).
Slovenian: V pediatrični študiji so bili pri bolnikih, zdravljenih s kombinacijo zdravila Pegasys in ribavirina do 48 tednov, prevladujoči neželeni učinki gripi podobna bolezen (91 %), glavobol (64 %), gastrointestinalne motnje (56 %), in reakcije na mestu injiciranja (45 %).
English: From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
Slovenian: Iz študije NR16141 je 14 otrok, starih od 2 do 8 let, s kroničnim hepatitisom C prejemalo zdravilo Pegasys z odmerkom: 180 µg/1,73 m2 x telesna površina (TP) otroka.
English: Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C Genotype
Slovenian: Preglednica 2: Napovedna vrednost virološkega odziva v 12. tednu pri priporočenem odmerjanju med kombiniranim zdravljenjem z zdravilom Pegasys pri odraslih bolnikih s kroničnim hepatitisom C
English: Patient ‘weight for age' and ‘height for age' percentiles of the normative population decreased during treatment.
Slovenian: Med zdravljenjem so se bolnikovi percentili telesne mase in višine bolnikov za njihovo starost glede na normativno populacijo zmanjšali.
English: The probabilities of achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was achieved at week 12 were 35% (20 of 57) and 57% (57 of 100), respectively.
Slovenian: Če so bolniki v 12. tednu zdravljenja dosegli virusno supresijo, pa je bila verjetnost, da bodo dosegli trajen virološki odziv, pri 48-tedenskem zdravljenju 35 % (20 od 57), pri 72-tedenskem pa 57 % (57 od 100).
English: During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Slovenian: Med zdravljenjem z zdravilom Pegasys v kombinaciji z ribavirinom ali brez, ki je trajalo do 48 tednov, sta bila pri bolnikih, starih od 3 do 17 let, izguba telesne mase in zastoj rasti pogosta (glejte poglavji 4.8 in 5.1).
English: In a clinical trial with 114 paediatric patients (5 to 17 years of age) treated with Pegasys alone or in combination with ribavirin (see section 5.1), dose modifications were required in approximately onethird of patients, most commonly for neutropenia and anaemia.
Slovenian: zdravljenih z zdravilom Pegasys samim ali v kombinaciji z ribavirinom (glejte poglavje 5.1), je bilo treba prilagoditi odmerke pri približno eni tretjini bolnikov, najpogosteje zaradi nevtropenije in anemije.
English: Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
Slovenian: Zdravilo Pegasys ima enake protivirusne in protiproliferativne značilnosti in vitro kot interferon alfa-2a.