FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Take the long needle and place it firmly on to the tip of the syringe (2).
Croatian: ● Uzmite dugu iglu i čvrsto je postavite na vrh štrcaljke (2).
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.
Croatian: U literaturi su prijavljene pancitopenija i supresija koštane srži koje se javljaju unutar 3 do 7 tjedana nakon primjene peginterferona i ribavirina istodobno s azatioprinom.
English: The Pegasys pre-filled pen is intended to be used in a home-setting by patients who have been properly instructed.
Croatian: Pegasys napunjena brizgalica namijenjena je za primjenu kod kuće u bolesnika koji su odgovarajuće podučeni.
English: Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Croatian: Tablica 10: Nuspojave prijavljene u pedijatrijskih bolesnika zaraženih HCV-om koji su primali Pegasys plus ribavirin u ispitivanju NV17424
English: The interaction between theophylline and Pegasys is likely to be maximal after more than 4 weeks of Pegasys therapy.
Croatian: Najjača interakcija između teofilina i lijeka Pegasys očekuje se nakon 4. tjedna liječenja lijekom Pegasys.
English: The safety and efficacy of Pegasys and ribavirin treatment have not been established in patients with liver and other transplantations.
Croatian: Nije utvrđena sigurnost i djelotvornost liječenja lijekom Pegasys i ribavirinom u bolesnika s presađenom jetrom i drugim presađenim organima.
English: The following instructions explain how to use Pegasys single dose vials to inject yourself or your child.
Croatian: U nastavku ove upute nalazi se objašnjenje kako koristiti Pegasys jednodozne bočice da biste ubrizgali lijek sebi ili svome djetetu.
English: The device is for single use only and is then to be discarded.
Croatian: Brizgalica je samo za jednokratnu uporabu, nakon čega je treba baciti.
English: Infections: Lung infection, skin infections
Croatian: Infekcije: infekcija pluća, kožne infekcije
English: With both Pegasys monotherapy, and also the combined treatment with ribavirin, up to 2% of patients experienced increased ALT levels that led to dose modification or discontinuation of the treatment.
Croatian: Tijekom liječenja samo lijekom Pegasys, kao i u kombiniranoj primjeni s ribavirinom, do 2% bolesnika je imalo povišene razine ALT-a zbog čega su doze morale biti prilagođene ili liječenje prekinuto.
English: ● Do not try to use the pre-filled pen again
Croatian: ● ne pokušavajte ponovno upotrijebiti istu napunjenu brizgalicu.
English: ● use if pre-filled pen appears to be damaged.
Croatian: ● ne primjenjujte ako napunjena brizgalica izgleda oštećena.
English: HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Croatian: HBeAg serokonverzija HBV DNK < 20 000 IU/ml* HBV DNK < 2000 IU/ml Normalizacija ALT-a HBsAg serokonverzija
English: Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Croatian: Vaš je liječnik odredio točnu dozu lijeka Pegasys i reći će Vam koliko često ga trebate primiti.
English: The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 18).
Croatian: Podaci upućuju da je skraćivanje trajanja liječenja na 16 tjedana povezano s većim rizikom pojave relapsa (vidjeti tablicu 18).
English: Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Croatian: Pegasys se primjenjuje za liječenje kroničnog hepatitisa B ili kroničnog hepatitisa C u odraslih.
English: Treatment with Pegasys should be discontinued immediately in patients with hepatic decompensation.
Croatian: Liječenje lijekom Pegasys treba odmah prekinuti u bolesnika s dekompenzacijom jetre.
English: Skin disorder
Croatian: Kožni poremećaji
English: For children and adolescents 23 kg or greater, a dosing schedule using 200 mg ribavirin tablets is provided in Table 7.
Croatian: Raspored doziranja za djecu i adolescente tjelesne težine 23 kg ili više uz primjenu ribavirin tableta od 200 mg nalazi se u tablici 7.
English: Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alfa interferon therapies, including Pegasys.
Croatian: Hipertenzija, supraventrikularne aritmije, kongestivno zatajenje srca, bol u prsima i infarkt miokarda povezani su s liječenjem alfa interferonima, uključujući Pegasys.
English: Patients with substance use/abuse: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alfa interferon.
Croatian: Bolesnici koji uzimaju/zlorabe sredstva ovisnosti: Bolesnici zaraženi HCV-om koji istodobno uzimaju sredstva ovisnosti (alkohol, kanabis i sl.) izloženi su povećanom riziku za razvoj psihijatrijskih poremećaja ili pogoršanje postojećih psihijatrijskih poremećaja kad se liječe interferonom alfa.
English: When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Croatian: Kada je primjenjivan u kombinaciji s ribavirinom, Pegasys nije iskazao nikakve nove učinke kod majmuna koji već nisu bili zamijećeni u monoterapijskoj primjeni bilo koje od ove dvije djelatne tvari.
English: Side effects with unknown frequency:
Croatian: Nuspojave nepoznate učestalosti:
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Croatian: Bolesnici skloni razvoju autoimunih poremećaja izloženi su većem riziku.
English: Patients missing HCV RNA results at week 12 have been excluded from the analysis.
Croatian: Bolesnici u kojih su u 12. tjednu izostali rezultati HCV RNK isključeni su iz analize.
English: Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/mole of protein.
Croatian: Interferon alfa-2a konjugira se s bis-[monometoksipolietilenglikolom] u supstitucijskom omjeru od jednog mola polimera za jedan mol proteina.
English: Study NV15801
Croatian: Ispitivanje NV15801
English: There are no data on the effects of peginterferon alfa-2a on fertility in women.
Croatian: Nema podataka o učincima peginterferona alfa-2a na plodnost žena.
English: Patients who have detectable virus at week 12 should stop therapy.
Croatian: U bolesnika u kojih je virus u 12. tjednu mjerljiv, potrebno je prekinuti liječenje.
English: Dispose of the syringe and needle safely in a closed container.
Croatian: Štrcaljku i iglu odložite u zatvoreni spremnik na siguran način.
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.
Croatian: U bolesnika koji ranije nisu odgovorili na liječenje te se ponovno liječe 48 odnosno 72 tjedna, supresija virusa u 12. tjednu (nemjerljiva razina HCV RNK definirana kao < 50 IU/ml) pokazala se kao prediktivna za trajni virološki odgovor.
English: # p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Croatian: # p-vrijednost (u odnosu na lamivudin) < 0.01 (stratificirani Cochran-Mantel-Haenszel test)
English: ● if you have a problem with your liver other than hepatitis B or C.
Croatian: • ako osim hepatitisa B ili C imate neke druge poteškoće s jetrom.
English: Your other hand will be free to move the plunger of the syringe.
Croatian: Slobodnom drugom rukom moći ćete povući klip štrcaljke.
English: Pegasys 360/180 or 180 mcg
Croatian: Pegasys 360/180 ili
English: More frequent monitoring of hepatic function was recommended in all instances.
Croatian: U svim se slučajevima preporučuje češće praćenje jetrenih funkcija.
English: ● Clean the rubber top of the vial with a cleansing swab.
Croatian: Očistite gumeni vrh bočice vatom za čišćenje.
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Croatian: Ako se liječite kombiniranom terapijom s ribavirinom, obratite pažnju i na odgovarajući tekst u informacijama o lijekovima koji sadrže ribavirin.
English: Table 16: Relapse of virological response at the end of treatment for rapid virological response population
Croatian: Tablica 16: Relaps virološkog odgovora na kraju liječenja za populaciju s brzim virološkim odgovorom (RVR)
English: Serious infections (bacterial, viral, fungal) and sepsis have been reported during treatment with alfa interferons including Pegasys.
Croatian: Teške infekcije (bakterijske, virusne, gljivične) i sepsa primijećene su tijekom liječenja interferonima alfa, među kojima i lijekom Pegasys.
English: Skin disorders: Toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa)
Croatian: Poremećaji kože: toksična epidermalna nekroliza/Stevens Johnsonov sindrom/multiformni eritem (niz osipa različite težine, uključujući i smrtni ishod, koji mogu biti povezani s plikovima u ustima, nosu, očima i drugim sluznicama te kraste na zahvaćenim područjima kože), angioedem (oticanje kože i sluznica).
English: Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SmPC).
Croatian: Stoga je pri uvođenju lijeka Pegasys i ribavirina HAART terapiji potreban oprez (vidjeti Sažetak opisa svojstava za ribavirin).
English: Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (i.e., 1260 micrograms/week) have been reported.
Croatian: Zabilježeni su slučajevi predoziranja lijekom Pegasys u kojima su bolesnici primili od dvije injekcije tijekom dva uzastopna dana (umjesto jedanput tjedno) pa sve do jedne injekcije dnevno tijekom cijelog tjedna (tj. 1260 mikrograma na tjedan).
English: Pegasys is administered subcutaneously in the abdomen or thigh.
Croatian: Pegasys se primjenjuje supkutano u abdomen ili bedro.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Croatian: No liječenje koje ukupno traje 24 tjedana može biti povezano s većim rizikom od relapsa nego 48-tjedno liječenje (vidjeti dio 5.1).
English: Table 18: Relapse of virological response after the end of treatment in genotype 2 or 3 patients with a rapid viral response
Croatian: Tablica 18: Relaps virološkog odgovora nakon završetka liječenja bolesnika s genotipom 2 ili 3 s brzim virološkim odgovorom
English: 7) Give injection
Croatian: 7) Dajte si injekciju
English: The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative CHB is 180 micrograms once weekly for 48 weeks.
Croatian: Preporučena doza i trajanje liječenja lijekom Pegasys kako HBeAg-pozitivnog tako i HBeAgnegativnog kroničnog hepatitisa B iznosi 180 mikrograma jedanput tjedno tijekom 48 tjedana.
English: ● if you are a woman of childbearing potential who is taking Pegasys in combination with ribavirin, you must have a negative pregnancy test before treatment, each month during therapy and for the 4 months after treatment is stopped.
Croatian: • Ako ste žena koja može zatrudnjeti i uzimate Pegasys u kombinaciji s ribavirinom, prije početka liječenja, svaki mjesec tijekom terapije i 4 mjeseca nakon nje morate imati negativan test na trudnoću.
English: Peripheral ischaemia
Croatian: vaskulitis periferna ishemija
English: Growth inhibition was observed in paediatric patients (see section 4.4).
Croatian: Primijećen je zastoj u rastu pedijatrijskih bolesnika (vidjeti dio 4.4).
English: After intravenous administration, the terminal half-life of peginterferon alfa2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
Croatian: Nakon intravenske primjene, terminalni poluvijek peginterferona alfa-2a kod zdravih ljudi iznosi oko 60 do 80 sati, dok za standardni interferon iznosi 3-4 sata.
English: ● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Croatian: Skinite poklopac s igle bez dodirivanja igle te štrcaljku s iglom zadržite u ruci.
English: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Croatian: Laktična acidoza i pogoršanje jetrenih funkcija su nuspojave vezane uz visokoaktivnu antiretroviralnu terapiju (HAART) HIV-a.
English: Table 12: Serological, virological and biochemical responses in chronic hepatitis B HBeAg positive Study WV16240
Croatian: Tablica 12: Serološki, virološki i biokemijski odgovor kod kroničnog hepatitisa B HBeAg pozitivni ispitivanje WV16240
English: Driving and using machines Do not drive or use machines if you feel drowsy, tired, or confused while taking Pegasys.
Croatian: Ne vozite niti upravljajte strojevima ako se tijekom liječenja lijekom Pegasys osjećate pospano, umorno ili smeteno.
English: The pharmacokinetics of Pegasys after single subcutaneous injections was comparable between male and female healthy subjects.
Croatian: Nakon jednokratne supkutane injekcije, farmakokinetika lijeka Pegasys bila je podjednaka kod zdravih muških i ženskih ispitanika.
English: Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 21).
Croatian: U ispitivanje NR15961 bili su uključeni samo bolesnici koinficirani HIV-om i HCV-om (vidjeti tablicu 21).
English: • In paediatric patients, the presence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.
Croatian: • u pedijatrijskih bolesnika postojeće ili teško psihijatrijsko stanje u anamnezi, osobito teška depresija, suicidalne ideje ili pokušaj samoubojstva.
English: At Week 48 of Pegasys treatment, a height or weight percentile decrease of more than 15 percentiles on the normative growth curves was observed in 6% of patients for height and 11% of patient for weight, whereas in the untreated group it was 2% of patients for height and 9% for weight.
Croatian: U 48. tjednu liječenja lijekom Pegasys, na normativnim krivuljama rasta primijećeno je smanjenje tjelesne visine za 15 percentila ili više u 6% bolesnika te smanjenje tjelesne težine za 15 percentila ili više u 11% bolesnika, dok je u neliječenoj skupini isto primijećeno u 2% bolesnika za visinu odnosno 9% bolesnika za težinu.
English: In approximately half the cases of flares exceeding 10x ULN, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
Croatian: U otprilike pola slučajeva naglog porasta koji je deseterostruko premašivao GGN, doza lijeka Pegasys je smanjena ili izostavljena sve do normalizacije razina transaminaza, dok je u drugoj polovici terapija nastavljena bez promjena.
English: In patients with cardiovascular disease, anaemia may necessitate dose reduction or discontinuation of ribavirin (see section 4.2).
Croatian: U bolesnika s kardiovaskularnim bolestima, pojava anemije može zahtijevati smanjenje doze odnosno prekid primjene ribavirina (vidjeti dio 4.2).
English: 180 micrograms <75 kg = 1000 mg ≥75 kg = 1200 mg
Croatian: 180 mikrograma < 75 kg = 1000 mg
English: Platelet <25,000 cells/mm3: discontinue treatment.
Croatian: Trombociti < 25 000 stanica/mm 3: obustaviti liječenje.
English: Blood disorders: Aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets)
Croatian: Poremećaji krvi: aplastična anemija (nemogućnost koštane srži da stvara crvene krvne stanice, bijele krvne stanice i trombocite).
English: Acute and chronic toxicity studies have been carried out in cynomolgus monkeys, and the findings observed in peginterferon dosed animals were similar in nature to those produced by interferon alfa-2a.
Croatian: Ispitivanja akutne i kronične toksičnosti u cynomolgus majmuna ukazala su na sličnosti u nalazima u životinja izloženih peginterferonu i onih izloženih interferonu alfa-2a.
English: In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/97) and 59% (58/99), respectively.
Croatian: U bolesnika koji su bili liječeni samo lijekom Pegasys u ispitivanju WV16241, stopa HBV DNK odgovora i normalizacija ALT-a u razdoblju od 12 mjeseci nakon završetka liječenja iznosile su 42% (41/97) odnosno 59% (58/99).
English: Both chronic hepatitis B and C are viral infections of the liver.
Croatian: I kronični hepatitis B i kronični hepatitis C su virusne infekcije jetre.
English: Dose increases to or towards the original dose may be considered when the adverse reaction abates (see sections 4.4 and 4.8).
Croatian: Ponovno povećanje doze prema ili na početnu dozu treba razmotriti kada nuspojave oslabe (vidjeti dijelove 4.4 i 4.8).
English: Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
Croatian: Liječenje lijekom Pegasys povezano je s klinički značajnim promjenama laboratorijskih nalaza štitnjače, koji zahtijevaju kliničku intervenciju (vidjeti dio 4.4).
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).
Croatian: Pegasys nije ispitivan u bolesnika s dekompenziranom cirozom (Child-Pugh stadij B ili C, ili krvarenje varikoziteta jednjaka) (vidjeti dio 4.3).
English: Do not use Pegasys
Croatian: Nemojte primjenjivati Pegasys
English: Ask your healthcare provider any questions you may have.
Croatian: Sva pitanja koja budete imali postavite zdravstvenom radniku.
English: Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
Croatian: Među bolesnicima iz ispitivanja WV16240, koji su liječeni samo lijekom Pegasys i bili uključeni u ispitivanje dugotrajnog praćenja, stopa održane HBeAg serokonverzije u razdoblju od 12 mjeseci nakon završetka liječenja iznosila je 48% (73/153).
English: Push the plunger up slowly to the correct dose.
Croatian: Polako potiskujte klip do odgovarajuće doze.
English: Depression, anxiety, hallucination, abnormal behaviour, aggression, anger, attention deficit / hyperactivity disorder
Croatian: Psihijatrijski poremećaji nesanica depresija, anksioznost, halucinacije, abnormalno ponašanje, agresivnost, bijes, poremećaj pozornosti s hiperaktivnošću
English: Your doctor has determined the exact dose of Pegasys for your child and will tell you how often to use it.
Croatian: Liječnik će odrediti točnu dozu lijeka Pegasys za Vaše dijete i reći Vam koliko često lijek morate primjenjivati.
English: The following instructions explain how to use Pegasys pre-filled syringes to inject yourself or your child.
Croatian: U nastavku ove upute nalazi se objašnjenje kako koristiti Pegasys napunjene štrcaljke da biste ubrizgali lijek sebi ili svome djetetu.
English: Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
Croatian: Teške nuspojave prijavljene su u 2 bolesnika u skupini liječenoj kombinacijom Pegasys plus ribavirin (hiperglikemija i kolecistektomija).
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.
Croatian: Trenutno nije jasno rezultira li viša doza ribavirina (npr. 1000/1200 mg/dan temeljena na tjelesnoj težini) povećanim stopama trajnog virološkog odgovora (SVR) u odnosu na dozu od 800 mg/dan, kada je liječenje skraćeno na 16 tjedana.
English: Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 16).
Croatian: Podaci, premda ograničeni, pokazuju da skraćivanje trajanja liječenja na 24 tjedna može biti povezano s većim rizikom pojave relapsa (vidjeti tablicu 16).
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.
Croatian: Vjerojatnost da se trajni virološki odgovor neće postići liječenjem u trajanju od 48 odnosno 72 tjedna, ako se supresija virusa ne postigne u 12. tjednu, bila je 96% (363 od 380) odnosno 96% (324 od 339).
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.
Croatian: Vjerojatnost da će se trajni virološki odgovor postići liječenjem u trajanju od 48 odnosno 72 tjedna, ako se supresija virusa postigne u 12. tjednu, bila je 35% (20 od 57) odnosno 57% (57 od 100).
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%).
Croatian: U pedijatrijskom su ispitivanju najčešće nuspojave u bolesnika liječenih kombiniranom terapijom lijekom Pegasys i ribavirinom tijekom 48 tjedana bile bolest nalik gripi (91%), glavobolja (64%), gastrointestinalni poremećaj (56%) i reakcije na mjestu injekcije (45%).
English: Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Croatian: Liječenje lijekom Pegasys povezano je sa smanjenjem hematoloških vrijednosti (leukopenija, neutropenija, limfopenija, trombocitopenija i smanjenje hemoglobina) koje su se uglavnom popravljale nakon prilagodbe doze i vraćale na razine koje su zabilježene prije liječenja unutar 4-8 tjedana po prestanku liječenja (vidjeti dijelove 4.2 i 4.4).
English: ● if you are a man who is taking Pegasys in combination with ribavirin, do not have sex with a pregnant woman unless you use a condom.
Croatian: • Ako ste muškarac koji uzima Pegasys u kombinaciji s ribavirinom, nemojte imati spolne odnose s trudnom ženom bez korištenja kondoma.
English: See section 4.
Croatian: (pogledajte dio 4.).
English: Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
Croatian: Tablica 24: Stope HBeAg serokonverzije (%) prema sniženju razine HBV DNK od početka ispitivanja do 12. tjedna liječenja lijekom Pegasys u pedijatrijskih bolesnika
English: ● Check for air bubbles in the syringe.
Croatian: Provjerite da u štrcaljki nema mjehurića zraka.
English: The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 17).
Croatian: Mogućnost skraćivanja trajanja terapije na 16 tjedna u bolesnika s genotipom 2 ili 3 na temelju trajnog virološkog odgovora opaženog u bolesnika s brzim virološkim odgovorom do 4. tjedna ispitivana je u ispitivanju NV17317 (vidjeti tablicu 17).
English: Therefore, the combination of Pegasys with telbivudine is contraindicated (see section 4.3).
Croatian: Stoga je kombinacija lijeka Pegasys i telbivudina kontraindicirana (vidjeti dio 4.3).