FrancophonIA/ELRC3.0 huggingface dataset:
English: Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
Slovenian: V treh preskušanjih so raziskovali uporabo interferona pri predhodno nezdravljenih bolnikih in sicer v dveh z zdravilom Rebetol + interferonom alfa-2b (C95-132 in I95-143) in v eni z zdravilom Rebetol + peginterferonom alfa-2b (C/I98-580).
English: Other medicines with Rebetol
Slovenian: Druga zdravila in zdravilo Rebetol
English: If a patient has a serious adverse reaction potentially related to Rebetol, the Rebetol 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 zdravilom Rebetol, je treba, če je to primerno, odmerek zdravila Rebetol prilagoditi ali uporabo zdravila prekiniti, dokler neželeni učinek ne izzveni oziroma se njegova izrazitost ne zmanjša.
English: The study results are summarized in Table 13.
Slovenian: Izsledki študije so povzeti v preglednici 13.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa-2b (with or without Rebetol), 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 zdravila Rebetol) ter 567 bolnikov po končanem zdravljenju s pegiliranim interferonom alfa-2b (z ali brez zdravila Rebetol).
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast-feeding”).
Slovenian: • moški in je vaša partnerica v rodni dobi (glejte poglavje "Nosečnost in dojenje"),
English: p value
Slovenian: Vredn ost p
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.
Slovenian: Pri bolnikih, ki so prejeli > 10,6 mg/kg zdravila Rebetol (800 mg odmerek pri značilnem 75 kg težkem bolniku), je bil delež odziva bistveno višji kot pri tistih, ki so prejeli  10,6 mg/kg zdravila Rebetol, ne glede na genotip ali virusno obremenitev (preglednica 7), delež odziva pri tistih, ki so prejeli > 13,2 mg/kg zdravila Rebetol, pa je bil še višji.
English: Rebetol contains lactose
Slovenian: Zdravilo Rebetol vsebuje laktozo
English: In 3-and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm occurred at doses of 15 mg/kg and above.
Slovenian: V 3- in 6-mesečni študiji na miših za proučevanje učinkov ribavirina na testise in spermo so se anomalije sperme pojavile pri odmerku 15 mg/kg in več.
English: There is no evidence from toxicity studies that Rebetol induces liver enzymes.
Slovenian: Študije toksičnosti niso pokazale znakov, da zdravilo Rebetol inducira jetrne encime.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Slovenian: • ženska v rodni dobi (glejte poglavje "Nosečnost in dojenje"),
English: The capsule shell imprint contains shellac, propylene glycol, ammonium hydroxide, colouring agent (E 132).
Slovenian: Oznaka na ovojnici kapsule vsebuje šelak, propilenglikol, amonijev hidroksid, barvilo (E 132).
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.
Slovenian: Uporaba zdravila Rebetol v kombinaciji s peginterferonom alfa-2b ni imela opaznega negativnega vpliva na nadzor viremije HIV med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
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.
Slovenian: Čeprav zdravilo Rebetol nima neposrednih srčnožilnih učinkov, lahko anemija povezana z zdravilom Rebetol povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
English: attempted suicide and aggressive behaviour, etc.) - Growth inhibition in children and adolescents that may be irreversible in some patients - Increased thyroid stimulating hormone (TSH) in children and adolescents - Severe ocular disorders - Dental and periodontal disorders.
Slovenian: poskus samomora in agresivno vedenje itd.) - zastoj rasti pri otrocih in mladostnikih, ki je lahko pri nekaterih bolnikih ireverzibilen - zvišanje ščitnico stimulirajočega hormona (TSH) pri otrocih in mladostnikih - hude očesne bolezni - zobne in obzobne bolezni
English: SVR in patients with undetectable HCV-RNA at treatment week 12 *HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/mL
Slovenian: SVR pri bolnikih z nemerljivo koncentracijo HCV-RNA v 12. tednu zdravljenja *PCR test za določitev HCV-RNA s spodnjo mejo kvantifikacije 27 i.e./ml
English: Measure: You can measure the dose with the oral dosing syringe provided.
Slovenian: 1.Odmerjanje: Odmerek lahko odmerite s priloženo brizgo za peroralno odmerjanje.
English: Packs of 84, 112, 140 and 168 capsules.
Slovenian: Pakiranje po 84, 112, 140 in 168 kapsul.
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Slovenian: pljučnica, askarioza, enterobiaza, herpes zoster, celulitis Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogosti:
English: Dose reduction of Rebetol depends on the initial Rebetol posology which depends on the medicinal product that is used in combination with Rebetol.
Slovenian: Zmanjšanje odmerka zdravila Rebetol je odvisno od začetnega odmerjanja zdravila Rebetol, ki pa je odvisno od zdravila, uporabljenega v kombinaciji z zdravilom Rebetol.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults.
Slovenian: Populacija je vključevala predvsem otroke z blagim do zmernim hepatitisom C. V dveh multicentričnih študijah je bil delež trajnega virološkega odziva pri otrocih in mladostnikih podoben tistemu pri odraslih.
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of Rebetol to the foetus (see section 4.4).
Slovenian: Če bolnica med zdravljenjem ali v roku štirih mesecev po koncu zdravljenja kljub temu zanosi, jo morate opozoriti na veliko teratogenost zdravila Rebetol za plod (glejte poglavje 4.4).
English: Rebetol (800 mg/day)
Slovenian: Zdravilo Rebetol (800 mg/dan)
English: Table 6 Sustained virological response rates (n a,b
Slovenian: Preglednica 6 Pogostnosti trajnega virološkega odziva (n a,b
English: 4 % (8/194) of patients receiving Rebetol in combination with peginterferon alfa-2b.
Slovenian: 3 pri 4 % (8/194) bolnikov, ki so prejemali zdravilo Rebetol v kombinaciji s peginterferonom alfa-2b.
English: The child-resistant cap has inner and outer polypropylene shells.
Slovenian: Za otroke varna zaporka ima notranjo in zunanjo polipropilensko plast.
English: Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Slovenian: Kapsule zdravila Rebetol naj bolnik jemlje peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
English: Usual daily Rebetol dose
Slovenian: Običajni dnevni odmerek zdravila Rebetol
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate
Slovenian: Vsebina kapsule mikrokristalna celuloza laktoza monohidrat premrežen natrijev karmelozat magnezijev stearat
English: Clear, colourless to pale or light yellow oral solution
Slovenian: peroralna raztopina bistra, brezbarvna do bleda ali svetlo rumena peroralna raztopina
English: Pigmentation disorder, dermatitis atopic, skin exfoliation Musculoskeletal and connective tissue disorders Very common:
Slovenian: motnje pigmentacije, atopijski dermatitis, luščenje kože Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti:
English: Anaemia (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with Rebetol in combination with peginterferon alfa-2b.
Slovenian: O anemiji (hemoglobin < 9,4 g/dl) so poročali pri 12 % (23/194) bolnikov, zdravljenih z zdravilom Rebetol v kombinaciji s peginterferonom alfa-2b.
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.3, 4.4 and 5.3).
Slovenian: Preprečitvi zanositve pri partnerkah moških bolnikov, ki jemljejo zdravilo Rebetol, je treba posvetiti posebno pozornost (glejte poglavja 4.3, 4.4 in 5.3).
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, 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: Contains Sorbitol liquid (crystallising), sucrose.
Slovenian: Vsebuje: tekoči sorbitol (kristalizirajoč), saharozo.
English: Rebetol has been shown in preclinical studies to be teratogenic and genotoxic (see section 4.4 and 5.3).
Slovenian: Predklinične študije so pokazale, da je zdravilo Rebetol teratogeno in genotoksično (glejte poglavji 4.4 in 5.3).
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.
Slovenian: V tem preskušanju je bila kombinacija zdravila Rebetol in peginterferona alfa-2b (1,5 mikrogramov/kg na teden) bistveno bolj učinkovita od kombinacije zdravila Rebetol in interferona alfa-2b, še posebej pri bolnikih, okuženih z genotipom 1.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase insufficiency should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: In children and adolescent patients treated with Rebetol plus interferon alfa-2b, reduce Rebetol dose to 7.5 mg/kg/day.
Slovenian: Pri otrocih in mladostnikih, zdravljenih z zdravilom Rebetol in interferonom alfa-2b, pa odmerek zdravila Rebetol zmanjšajte na 7,5 mg/kg na dan.
English: Thus, Rebetol must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Slovenian: Zato morate zdravilo Rebetol pri bolnikih z obstoječo boleznijo srca uporabljati previdno (glejte poglavje 4.3).
English: Paediatric patients (children 3 years of age and older and adolescents) Rebetol may be used in combination with peginterferon alfa-2b or interferon alfa-2b (see section 4.4).
Slovenian: Pediatrični bolniki (otroci, stari 3 leta ali več, in mladostniki) Zdravilo Rebetol se lahko uporablja v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b (glejte poglavje 4.4).
English: The use of pegylated alpha interferons and Rebetol concomitantly with azathioprine should be avoided.
Slovenian: Uporabi pegiliranega alfa interferona in zdravila Rebetol sočasno z azatioprinom se je treba izogibati.
English: - Genotoxicity: Rebetol induces genotoxicity (see section 5.3).
Slovenian: - Genotoksičnost: Zdravilo Rebetol povzroča genotoksične učinke (glejte poglavje 5.3).
English: * Any subject with an undetectable HCV-RNA level at the follow-up week 12 visit and missing data at the follow-up week 24 visit was considered a sustained responder.
Slovenian: *Vsakega preiskovanca z nemerljivo koncentracijo HCV-RNA ob obisku v 12. tednu spremljanja bolnikov ali z manjkajočimi podatki ob obisku v 24. tednu spremljanja bolnikov so šteli med bolnike s trajnim virološkim odzivom.
English: Rebetol therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Slovenian: Rebetol ne smete uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja.
English: These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2 log10 decrease from baseline, patients to stop therapy.
Slovenian: V protokolu so bili uporabljeni naslednji kriteriji: Če je izvid določanja HCV-RNA v 12. tednu pozitiven in se je virusno breme zmanjšalo za < 2 log10 glede na začetne vrednosti, naj bolnik preneha z zdravljenjem.
English: Table 13 Sustained virological response rates (n a,b
Slovenian: Preglednica 13 Pogostnosti trajnega virološkega odziva (n a,b
English: peginterferon alfa-2b (1.5 µg/kg/ week)
Slovenian: peginterferon alfa-2b (1,5 µg/kg/ teden)
English: Co-administration of Rebetol and didanosine is not recommended.
Slovenian: Sočasna uporaba zdravila Rebetol in didanozina ni priporočljiva.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
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.
Slovenian: Zdravilo Rebetol se lahko uporablja pri pediatričnih bolnikih (otrocih, starih 3 leta ali več, in mladostnikih), ki predhodno še niso bili zdravljeni in nimajo hude bolezni jeter.
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.
Slovenian: Pri Afroameričanih (kar je znan neugoden prognostični dejavnik za izkoreninjenje HCV) je zdravljenje s kombinirano terapijo z peginterferonom alfa-2b (1,5 µg/kg) in zdravilom Rebetol vodilo do večje pogostnosti trajnega virološkega odziva kot pri odmerku peginterferona alfa-2b 1 µg/kg.
English: Calibrations are marked at 0.5 mL increments from 1.5 mL to 10 mL.
Slovenian: Oznake na batu brizge so z razmiki po 0,5 ml, v razponu od 1,5 ml do 10 ml.
English: No pharmacokinetic interaction appears between Rebetol and hepatic function (see section 5.2).
Slovenian: Med zdravilom Rebetol in delovanjem jeter ni farmakokinetičnih interakcij (glejte poglavje 5.2).
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.
Slovenian: V te klinične raziskave so vključili bolnike s kroničnim hepatitisom C, potrjenim s pozitivnim izvidom testa polimerazne verižne reakcije (PCR) na HCV-RNA (> 30 i.e./ml), izvid jetrne biopsije pa je bil v skladu s histološko diagnozo kroničnega hepatitisa brez drugih vzrokov za kronični hepatitis, poleg tega pa so imeli bolniki tudi nenormalne serumske vrednosti ALT.
English: EU/1/99/107/001 (84 hard capsules) EU/1/99/107/005 (112 hard capsules) EU/1/99/107/002 (140 hard capsules) EU/1/99/107/003 (168 hard capsules)
Slovenian: EU/1/99/107/001 (84 trdih kapsul) EU/1/99/107/005 (112 trdih kapsul) EU/1/99/107/002 (140 trdih kapsul) EU/1/99/107/003 (168 trdih kapsul)
English: Gelatine Titanium dioxide
Slovenian: Ovojnica kapsule želatina titanov dioksid
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.
Slovenian: V kliničnem preskušanju pri 107 otrocih in mladostnikih (starih od 3 do 17 let), zdravljenih s kombinirano terapijo s peginterferonom alfa-2b in zdravilom Rebetol, je bila potrebna prilagoditev odmerka pri 25 % bolnikov, najpogosteje zaradi anemije, nevtropenije in izgube telesne mase.
English: Patients treated with Rebetol and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of Rebetol with zidovudine is not recommended (see section 4.5).
Slovenian: Bolniki, zdravljeni z zdravilom Rebetol in zidovudinom, imajo zvečano tveganje za pojav anemije, zato sočasna uporaba zdravila Rebetol in zidovudina ni priporočljiva (glejte poglavje 4.5).
English: Propylene glycol Ammonium hydroxide Colouring agent (E 132)
Slovenian: Napis na kapsuli šelak propilenglikol amonijev hidroksid barvilo (E 132)
English: Pharmacologically, Rebetol increases phosphorylated metabolites of purine nucleosides in vitro.
Slovenian: Med farmakološke učinke zdravila Rebetol sodi tudi povečanje količine fosforiliranih presnovkov purinskih nukleozidov in vitro.
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.
Slovenian: Pri odmerku peginterferona alfa-2b 1,5 µg/kg z odmerkom zdravila Rebetol pa so bile pogostnosti trajnega virološkega odziva nižje pri bolnikih s cirozo, pri tistih z normalnimi vrednostmi ALT, pri tistih z začetnim virusnim bremenom > 600.000 i.e./ml in pri tistih, ki so bili starejši od 40 let.
English: Predictability of sustained virological response in naïve patients Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.
Slovenian: Predvidljivost trajnega virološkega odziva pri predhodno nezdravljenih bolnikih Virološki odziv do 12. tedna je opredeljen kot najmanj 2-log zmanjšanje virusne obremenitve ali nemerljive koncentracije HCV-RNA.
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).
Slovenian: Pri kombinirani terapiji z zdravilom Rebetol in interferonom alfa-2b je bil trajni virološki odziv kar desetkrat večji kot pri monoterapiji z interferonom alfa-2b (49 % proti 5 %, p < 0,0001).
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Slovenian: Neuspešnost predhodnega zdravljenja so opredelili kot ponovitev bolezni (relaps) ali odsotnost odziva na zdravljenje (bolniki so imeli pozitiven izvid na HCV-RNA ob koncu najmanj 12-tedenskega zdravljenja).
English: Table 12 Rates of Response to retreatment in prior treatment failures Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatement interferon alpha/ribavirin peginterferon alpha/ribavirin
Slovenian: Preglednica 12 Stopnje odziva na ponovno zdravljenje v primeru, da je bilo predhodno zdravljenje neuspešno Bolniki, pri katerih je bila vrednost HCV-RNA nemerljiva v 12. tednu zdravljenja in SVR pri ponovnem zdravljenju interferon alfa/ribavirin peginterferon alfa/ribavirin
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 zvišana serumska koncentracija bilirubina.
English: CD4 lymphocytes decrease
Slovenian: Zmanjšanje števila limfocitov CD4
English: Tabulated list of adverse reactions in paediatric population
Slovenian: Seznam neželenih učinkov pri pediatrični populaciji v preglednici
English: This medicine does not affect your ability to drive or use machines; however, other medicines used in combination with Rebetol may affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, medtem ko druga zdravila, uporabljena v kombinaciji z zdravilom Rebetol, lahko vplivajo na vašo sposobnost za vožnjo ali upravljanje s stroji.
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).
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: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Slovenian: Pri otrocih in mladostnikih, ki so prejemali odmerek peginterferona alfa-2b 60 µg/m na teden, prilagojen glede na telesno površino, je bila napovedana logaritemska vrednost ocene razmerja izpostavljenosti zdravilu v času odmernega intervala za 58 % (90 % IZ: 141-177 %) večja od ugotovljene vrednosti pri odraslih, ki so prejemali odmerek 1,5 µg/kg na teden.
English: Anti-thyroid antibody positive Injury, poisoning and procedural complications Common:
Slovenian: pozitivna protitelesa anti-TSH Poškodbe in zastrupitve in zapleti pri posegih Pogosti:
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).
Slovenian: V kliničnih preskušanjih C95-132 in I95-143 se je kombinirana terapija z zdravilom Rebetol in interferonom alfa-2b izkazala za statistično značilno bolj učinkovito od monoterapije z interferonom alfa-2b (podvojen trajni odziv).
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).
Slovenian: Laboratorijske vrednosti pri bolnikih, sočasno okuženih s HCV in HIV 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: Not known side effects(frequency cannot be estimated from the available data): thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself], change in colour of the tongue.
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): misli, kako ogroziti življenja drugih, manija (pretirano in nerazumno navdušenje), perikarditis (vnetje osrčnika), perikardno iztekanje nabiranje tekočine med perikardom (osrčnikom) in srcem, sprememba barve jezika.