FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Croatian: Farmakokinetika lijeka Rebetol promijenjena je u bolesnika s disfunkcijom bubrega zbog smanjenog prividnog klirensa kreatinina u tih bolesnika (vidjeti dio 5.2).
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see section 4.5).
Croatian: Ova je mijelotoksičnost bila reverzibilna u roku od 4 do 6 tjedana nakon ukidanja istodobne primjene antivirusne terapije protiv HCV-a i azatioprina i nije se ponovila nakon ponovnog uvođenja bilo koje od te dvije terapije zasebno (vidjeti dio 4.5).
English: Patients who are treated with interferon alfa-2b and Rebetol after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Croatian: U bolesnika koji se liječe interferonom alfa-2b i lijekom Rebetol zbog relapsa nakon prethodnog liječenja interferonom te u onih koji se liječe kraće vrijeme veća je vjerojatnost da će imati bolji sigurnosni profil nego što je opisano u nastavku.
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Croatian: pneumonija, askarijaza, enterobijaza, herpes zoster, celulitis Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) često:
English: Excipient with known effect Each hard capsule contains 40 mg of lactose monohydrate.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 40 mg laktoze hidrata.
English: Co-administration of Rebetol and didanosine is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Rebetol i didanozina.
English: How to store Rebetol
Croatian: Kako čuvati Rebetol
English: Clear, colourless to pale or light yellow oral solution
Croatian: Bistra, bezbojna do blijedo ili svijetložuta oralna otopina.
English: Packs of 84, 112, 140 and 168 capsules.
Croatian: Pakiranja od 84, 112, 140 i 168 kapsula.
English: Rebetol Dose (daily)
Croatian: Doza lijeka Rebetol (dnevna)
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and Rebetol, 6 % discontinued therapy due to adverse reactions.
Croatian: U kliničkim ispitivanjima sa 118 djece i adolescenata dobi od 3 do 16 godina koji su liječeni kombiniranom terapijom interferona alfa-2b i lijeka Rebetol, 6% bolesnika prekinulo je liječenje zbog nuspojava.
English: Hepatomegaly, jaundice, hyperbilirubinemia*
Croatian: hepatomegalija, žutica, hiperbilirubinemija*
English: Most of the changes in laboratory values in the Rebetol/peginterferon alfa-2b clinical trial were mild or moderate.
Croatian: Promjene u laboratorijskim vrijednostima u kliničkom ispitivanju lijeka Rebetol/peginterferona alfa-2b bile su većinom blage ili umjerene.
English: The mechanism by which Rebetol in combination with other medicinal products exerts its effects against HCV is unknown.
Croatian: Nije poznat mehanizam putem kojega Rebetol u kombinaciji s drugim lijekovima djeluje na HCV.
English: Anaemia (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with Rebetol in combination with peginterferon alfa-2b.
Croatian: Anemija (hemoglobin <9,4 g/dl) je prijavljena u 12% (23/194) bolesnika liječenih lijekom Rebetol u kombinaciji s peginterferonom alfa-2b.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTRANJEM PAKIRANJU
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).
Croatian: Treba naglasiti da je prosječno smanjenje na percentilnoj krivulji rasta od početka ispitivanja do kraja dugotrajnog praćenja bilo najizraženije u djece pretpubertetske dobi (vidjeti dio 4.4).
English: In children and adolescent patients treated with Rebetol plus interferon alfa-2b, reduce Rebetol dose to 7.5 mg/kg/day.
Croatian: U djece i adolescenata koji se liječe lijekom Rebetol i interferonom alfa-2b smanjite dozu lijeka Rebetol na 7,5 mg/kg/dan.
English: oral solution 100 mL
Croatian: oralna otopina 100 ml
English: In those patients that received > 10.6 mg/kg Rebetol (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 Rebetol (Table 7), while response rates in patients that received > 13.2 mg/kg Rebetol were even higher.
Croatian: U bolesnika koji su primali >10,6 mg/kg lijeka Rebetol (doza od 800 mg u bolesnika tjelesne težine 75 kg) je, bez obzira na genotip ili virusno opterećenje, stope odgovora bile značajno veće nego u onih koji su primali ≤ 10,6 mg/kg lijeka Rebetol (Tablica 7), dok je stopa odgovora u bolesnika koji su primali >13,2 mg/kg lijeka Rebetol bio još i veći.
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Croatian: U bolesnika bijele rase stopa trajnog virološkog odgovora bila je veća nego u afroameričkih bolesnika.
English: Gelatine Titanium dioxide
Croatian: Ovojnica kapsule želatina titanijev dioksid
English: A. Insert the assembled dosing syringe into the bottle of Rebetol oral solution.
Croatian: Stavite sastavljenu štrcaljku u bočicu s Rebetol oralnom otopinom.
English: Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Croatian: Rebetol je u kombinaciji s drugim lijekovima indiciran za liječenje kroničnog hepatitisa C u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Rebetol therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Croatian: Liječenje lijekom Rebetol ne smije se započeti dok se ne dobije negativan rezultat testa na trudnoću neposredno prije početka liječenja.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/mL), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Croatian: Bolesnici pogodni za ova ispitivanja imali su kronični hepatitis C potvrđen pozitivnim nalazom HCV-RNK pomoću testa lančane reakcije polimerazom (PCR) (>30 IU/ml), nalazom biopsije jetre koji je odgovarao patohistološkoj dijagnozi kroničnog hepatitisa bez nekog drugog mogućeg uzroka kroničnog hepatitisa i odstupanjem od normalnih vrijednosti ALT-a u serumu.
English: Contains Sorbitol liquid (crystallising), sucrose.
Croatian: Sadrži tekući sorbitol (kristalizirajući), saharozu.
English: Interferon alfa-2b 3 MIU/m 2 3 times a week (n = 54)
Croatian: Interferon alfa-2b 3 MIU/m 2 3 puta na tjedan (n=54)
English: The study results are summarized in Table 7.
Croatian: Rezultati ispitivanja sažeti su u Tablici 7.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Croatian: c: Bolesnici s genotipom 3 i malim virusnim opterećenjem (<600 000 IU/ml) liječeni su 24 tjedna, a bolesnici s genotipom 3 i velikim virusnim opterećenjem (≥600 000 IU/ml) 48 tjedana.
English: - The other ingredients are: sodium citrate, citric acid, anhydrous, sodium benzoate, glycerol, sucrose, sorbitol liquid (crystallising), propylene glycol, purified water, natural and artificial bubble gum flavouring
Croatian: - Drugi sastojci su: natrijev citrat, bezvodna citratna kiselina, natrijev benzoat, glicerol, saharoza, tekući sorbitol (kristalizirajući), propilenglikol, pročišćena voda, prirodna i umjetna aroma žvakaće gume.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze, sindromom malapsorpcije glukoze i galaktoze ili insuficijencijom saharoze-izomaltaze ne bi trebali uzimati ovaj lijek.
English: Very rarely reported side effects (may affect up to 1 in 10,000 people): suicide, stroke (cerebrovascular events).
Croatian: Vrlo rijetko prijavljene nuspojave (mogu se javiti u do 1 na 10 000 osoba): samoubojstvo, moždani udar (cerebrovaskularni događaji).
English: Rebetol may be used in paediatric patients (children 3 years of age and older and adolescents) who are not previously treated and without severe liver disease.
Croatian: Rebetol se može koristiti u pedijatrijskih bolesnika (djece u dobi od 3 ili više godina i adolescenata) koji prethodno nisu bili liječeni i nemaju tešku bolest jetre.
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/Rebetol combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Croatian: U bolesnika afroameričkog podrijetla (što je poznat slabi prognostički faktor za eradikaciju HCV-a) je liječenjem kombinacijom peginterferona alfa-2b (1,5 µg/kg) i lijeka Rebetol postignuta veća stopa trajnog virološkog odgovora u usporedbi s primjenom doze peginterferona alfa-2b od 1 µg/kg.
English: There is no evidence from toxicity studies that Rebetol induces liver enzymes.
Croatian: Ispitivanja toksičnosti nisu pokazala da Rebetol inducira jetrene enzime.
English: It is not known whether Rebetol is excreted in human milk.
Croatian: Nije poznato izlučuje li se Rebetol u majčino mlijeko.
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 %).
Croatian: U fazi liječenja u sklopu ovoga ispitivanja nuspojave koje su se najčešće pojavljivale u svih ispitanika bile su pireksija (80%), glavobolja (62%), neutropenija (33%), umor (30%), anoreksija (29%) i eritem na mjestu injekcije (29%).
English: Blood and lymphatic system disorders Very common:
Croatian: Poremećaji krvi i limfnog sustava vrlo često:
English: Laboratory values for HCV/HIV co-infected patients 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).
Croatian: Laboratorijske vrijednosti u bolesnika s istodobnom infekcijom HCV-om i HIV-om Premda su se hematološki toksični učinci poput neutropenije, trombocitopenije i anemije javljali češće u bolesnika s istodobnom infekcijom HCV-om i HIV-om, većina ih se mogla zbrinuti prilagodbom doze, a rijetko je trebalo ranije obustaviti liječenje (vidjeti dio 4.4).
English: Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates
Croatian: retinalno krvarenje*, retinopatije (uključujući makularni edem)*, okluzija retinalne arterije*, okluzija retinalne vene*, optički neuritis*, edem papile*, gubitak oštrine vida ili vidnog polja*, retinalni eksudati
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving non-pegylated interferon alfa-2b (with or without Rebetol), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without Rebetol).
Croatian: Kaplan-Meierova procjena održivosti trajnog virološkog odgovora tijekom 5 godina iznosi 97% (uz 95% CI: 95-99%) za bolesnike koji su dobivali nepegilirani interferon alfa-2b (sa ili bez lijeka Rebetol) odnosno 99% (uz 95% CI: 98-100%) za bolesnike koji su dobivali pegilirani interferon alfa-2b (sa ili bez lijeka Rebetol).
English: Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Croatian: Virološki odgovor do 4. tjedna definira se kao smanjenje količine virusa za najmanje 1 log ili kao nemjerljiva razina HCV-RNK.
English: The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Croatian: Farmakokinetika lijeka Rebetol izmijenjena je u bolesnika s disfunkcijom bubrega zbog smanjenog prividnog klirensa u tih bolesnika.
English: The use of Rebetol in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Croatian: Primjena lijeka Rebetol u kombinaciji s peginterferonom alfa-2b nije imala vidljivih negativnih učinaka na kontrolu viremije HIV-a tijekom liječenja ili naknadnog praćenja bolesnika.
English: Combination therapy with Rebetol and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49 % vs 5 %, p < 0.0001).
Croatian: Kombinirana terapija lijekom Rebetol i interferonom alfa-2b povećala je trajan virološki odgovor 10 puta više nego liječenje samo interferonom alfa-2b (49% u odnosu na 5%, p <0,0001).
English: In clinical trials C95-132 and I95-143, Rebetol + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Croatian: U kliničkim ispitivanjima C95-132 i I95-143 se Rebetol u kombinaciji s interferonom alfa-2b pokazao značajno djelotvornijim od monoterapije interferonom alfa-2b (udvostručen trajan odgovor na liječenje).
English: Very rarely reported side effects(may affect up to 1 in 10,000people): suicide, stroke (cerebrovascular events).
Croatian: Vrlo rijetko prijavljene nuspojave(mogu se javiti u do 1 na10000osoba): samoubojstvo, moždani udar (cerebrovaskularni događaji).
English: The side effect profile was also similar at the lower incidences.
Croatian: Profil nuspojava bio je sličan i kod onih čija je učestalost bila manja.
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Croatian: Odgovor u 12. tjednu definiran je kao nemjerljiva razina HCV-RNK nakon 12 tjedana liječenja.
English: Tabulated list of adverse reactions in paediatric population
Croatian: Tablični prikaz nuspojava u pedijatrijskoj populaciji
English: Rebetol has been shown in preclinical studies to be teratogenic and genotoxic (see section 4.4 and 5.3).
Croatian: Pretklinička su ispitivanja pokazala da je Rebetol teratogen i genotoksičan (vidjeti dijelove 4.4 i 5.3).
English: 4 % (8/194) of patients receiving Rebetol in combination with peginterferon alfa-2b.
Croatian: 3 također u 4% (8/194) bolesnika koji su primali Rebetol u kombinaciji s peginterferonom alfa-2b.
English: peginterferon alfa-2b (100 or c µg/week)
Croatian: peginterferon alfa-2b (100 ili c µg/tjedan
English: Psychiatric disorders Very common:
Croatian: Psihijatrijski poremećaji vrlo često:
English: Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/mL.
Croatian: Nakon peroralne primjene 600 mg dvaput na dan stanje dinamičke ravnoteže postiže se nakon približno 4 tjedna, uz prosječnu koncentraciju u plazmi u stanju dinamičke ravnoteže od oko 2200 ng/ml.
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, Rebetol dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Croatian: Zbog značajnih povećanja koncentracije ribavirina u plazmi u bolesnika s umjerenim i teškim oštećenjem funkcije bubrega, preporučuje se prilagoditi dozu lijeka Rebetol u odraslih bolesnika s klirensom kreatinina <50 ml/min.
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of peginterferon alfa-2b and Rebetol, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Croatian: U kliničkom ispitivanju sa 107 djece i adolescenata (3 do 17 godina) liječenih kombiniranom terapijom peginterferona alfa-2b i lijeka Rebetol bilo je potrebno prilagoditi dozu u 25% bolesnika, najčešće zbog anemije, neutropenije i gubitka tjelesne težine.
English: At the peginterferon alfa-2b 1.5 µg/kg plus Rebetol 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.
Croatian: Kod primjene peginterferona alfa-2b u dozi od 1,5 µg/kg uz Rebetol, stopa trajnog virološkog odgovora bila je manja u bolesnika s cirozom, bolesnika s normalnim koncentracijama ALT-a, bolesnika s početnim virusnim opterećenjem >600 000 IU/ml i u bolesnika starijih od 40 godina.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-Rebetol for co-HCV infection (see section 4.4).
Croatian: Mitohondrijska toksičnost i laktacidoza prijavljene su u HIV-pozitivnih bolesnika koji su primali NRTI i dodatnu terapiju lijekom Rebetol zbog istodobne infekcije HCV-om (vidjeti dio 4.4).
English: Rebetol oral solution is supplied in a concentration of 40 mg/mL.
Croatian: Rebetol oralna otopina dostupna je u koncentraciji od 40 mg/ml.
English: Twenty-four percent of children (11/46) treated for 24 weeks and 40 % of children (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of 5 year long-term follow-up compared to pre-treatment baseline percentiles.
Croatian: U 24% djece (11/46) liječene 24 tjedna i 40% djece (19/48) liječene 48 tjedana zabilježen je pad za >15 percentila na percentilnoj krivulji visine za dob od razdoblja prije početka liječenja do kraja 5-godišnjeg dugotrajnog praćenja u usporedbi s percentilima prije početka liječenja.
English: Although Rebetol has no direct cardiovascular effects, anaemia associated with Rebetol may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Croatian: Iako Rebetol nema izravnih kardiovaskularnih učinaka, anemija povezana s lijekom Rebetol može dovesti do slabljenja srčane funkcije ili pogoršanja simptoma koronarne bolesti, ili oboje.
English: - Breast-feeding.
Croatian: - Dojenje.
English: The concomitant use of Rebetol with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Rebetol i zidovudina zbog povećanog rizika za razvoj anemije (vidjeti dio 4.4).
English: The combination of Rebetol and other medicines is used to treat adult patients who have chronic hepatitis C (HCV).
Croatian: Kombinacija lijeka Rebetol i drugih lijekova koristi se za liječenje odraslih bolesnika s kroničnim hepatitisom C (HCV).
English: Haemolysis: Rebetol can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Croatian: Hemoliza: Rebetol može uzrokovati raspad crvenih krvnih stanica uzrokujući anemiju koja može oštetiti funkciju srca ili pogoršati simptome bolesti srca.
English: NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Croatian: Bez odgovora: definirano kao pozitivan nalaz HCV-RNK u serumu/plazmi na kraju liječenja u trajanju od najmanje 12 tjedana.
English: Genotype 2/3 88.9 (72/81)
Croatian: Genotip 2/3 88,9 (72/81) 73,6 (53/72)
English: Only 1 subject discontinued therapy as the result of an adverse reaction (thrombocytopenia).
Croatian: Samo je jedan ispitanik prekinuo liječenje zbog nuspojave (trombocitopenija).
English: Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with Rebetol may increase your risk of developing severe blood disorders.
Croatian: Obavijestite liječnika ili ljekarnika ako Vi ili dijete o kojem skrbite uzimate, nedavno ste uzeli ili biste mogli uzeti: - azatioprin, lijek koji suprimira Vaš imunološki sustav, čija primjena u kombinaciji s lijekom Rebetol može povećati rizik od razvoja teških poremećaja krvi. - lijekove protiv virusa humane imunodeficijencije (HIV) [nukleozidni inhibitor reverzne transkriptaze (NRTI) i/ili kombiniranu antiretrovirusnu terapiju (cART)]:
English: In females of childbearing potential, Rebetol must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Croatian: U žena reproduktivne dobi liječenje lijekom Rebetol ne smije se započeti dok se ne dobije negativan rezultat testa na trudnoću neposredno prije početka liječenja.
English: Enuresis, micturition disorder, urinary incontinence, proteinuria Reproductive system and breast disorders Common:
Croatian: enureza, poremećaj mokrenja, urinarna inkontinencija, proteinurija Poremećaji reproduktivnog sustava i dojki često:
English: In general, the adverse reaction 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 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Croatian: Profil nuspojava zabilježenih u malobrojnoj ispitivanoj populaciji djece i adolescenata općenito je bio sličan onome u odraslih, uz problem specifičan za pedijatrijsku populaciju koji se odnosi na zastoj u rastu, jer su tijekom liječenja zabilježena smanjenja percentila tjelesne visine (prosječno smanjenje za 9 percentila) i percentila tjelesne težine (prosječno smanjenje za 13 percentila).
English: In this trial, the combination of Rebetol and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of Rebetol and interferon alfa-2b, particularly in patients infected with Genotype 1.
Croatian: U ovom je ispitivanju kombinacija lijeka Rebetol i peginterferona alfa-2b (1,5 mikrograma/kg/tjedan) bila značajno djelotvornija od kombinacije lijeka Rebetol i interferona alfa-2b, osobito u bolesnika inficiranih genotipom
English: Hypertriglyceridemia, hyperuricemia
Croatian: hipertrigliceridemija, hiperuricemija
English: Use in children and adolescents If the child is weighing less than 47 kg or unable to swallow an oral solution of Rebetol is available.
Croatian: Ako dijete teži manje od 47 kg ili ako ne može gutati, dostupna je i Rebetol oralna otopina.
English: LVL (≤600,000 IU/mL)
Croatian: Nisko (≤ 600 000 IU/ml)
English: The study results are summarized in Table 13.
Croatian: Rezultati ispitivanja sažeti su u Tablici 13.
English: Table 3 Management of Adverse Reactions Laboratory values
Croatian: Tablica 3 Zbrinjavanje nuspojava Laboratorijske vrijednosti
English: - Men:
Croatian: - Muškarci:
English: Discontinue Rebetol if:
Croatian: Prekinuti primjenu lijeka Rebetol ako je:
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 Rebetol concomitantly with azathioprine.
Croatian: U literaturi je prijavljena pojava pancitopenije i supresije koštane srži unutar 3 do 7 tjedana nakon primjene peginterferona i lijeka Rebetol istodobno s azatioprinom.
English: The haemolytic anaemia associated with Rebetol therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Croatian: Hemolitička anemija povezana s terapijom lijekom Rebetol može dovesti do slabljenja funkcije srca i/ili pogoršanja postojeće bolesti srca.