FrancophonIA/ELRC3.0 huggingface dataset:
English: What Rebetol is and what it is used for What you need to know before you use Rebetol How to use Rebetol
Slovenian: Kaj je zdravilo Rebetol in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Rebetol Kako uporabljati zdravilo Rebetol Možni neželeni učinki
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection = 125 IU/mL.
Slovenian: a: Odziv na zdravljenje je bil opredeljen kot nemerljiva vrednost HCV-RNA v 24. tednu po zdravljenju, spodnja meja detekcije = 125 i.e./ml.
English: It is possible that the decreased bioavailability in this study was due to delayed transit of Rebetol or modified pH.
Slovenian: Možno je, da je bila zmanjšana biološka uporabnost v tej študiji posledica zakasnjenega prehajanja zdravila Rebetol ali spremenjenega pH.
English: What Rebetol looks like and contents of the pack
Slovenian: Izgled zdravila Rebetol in vsebina pakiranja
English: Among patients with undetectable HCV-RNA at the end of treatment, the relapse rate was 24 %.
Slovenian: Med bolniki z nemerljivimi koncentracijami HCV-RNA ob koncu zdravljenja je bila pogostnost ponovnih izbruhov bolezni 24 %.
English: Patients with low CD4 counts
Slovenian: Bolniki z majhnim številom celic CD4
English: Genotype 2/3 88.9 (72/81)
Slovenian: Genotip 2/3 88,9 (72/81)
English: Hold the syringe to your mouth and release the dose into your mouth (or the mouth of the patient you are caring for) by pushing in the rod.
Slovenian: Brizgo držite pri ustih in s pritiskom na bat izpustite odmerek v usta (svoja ali bolnikova).
English: Transient rashes do not necessitate interruption of treatment.
Slovenian: Pri prehodnih izpuščajih zdravljenja ni treba prekiniti.
English: The plastic oral dosing syringe consists of two parts, an opaque barrel, and a white plunger rod that fits into the barrel.
Slovenian: Plastična brizga za peroralno odmerjanje je sestavljena iz dveh delov, neprozornega valjastega dela in belega bata, ki se tesno prilega valjastemu delu.
English: If the abnormality is reversed, Rebetol may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Slovenian: Če nepravilnost izgine, se lahko zdravilo Rebetol znova začne uporabljati v odmerku 600 mg na dan, katerega se nato po presoji lečečega zdravnika poveča na 800 mg na dan.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Slovenian: Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v anamnezi in/ali s predhodnimi ali obstoječimi motnjami srčnega ritma morate skrbno nadzorovati.
English: However, if a week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Slovenian: Če pa se je v 12. tednu pojavil odziv na zdravljenje, je bila razlika v trajnem virološkem odzivu (SVR) majhna, ne glede na predhodno zdravljenje ali bolnikov predhodni odziv na zdravljenje.
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Slovenian: Vmesna analiza je pokazala visoko stopnjo trajnega virološkega odziva v tej podskupini (n = 49), ki je bila tudi prospektivno potrjena (n = 48).
English: Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Slovenian: Bolnike, ki so med zdravljenjem utrujeni, zaspani ali zmedeni, morate opozoriti, da ne smejo voziti ali upravljati s stroji.
English: Rebetol oral solution 100 mL is packaged in 118 mL amber glass bottles (coloured EP Type IV glass, Ph Eur.
Slovenian: Rebetol peroralna raztopina 100 ml je pakirana v 118 ml stekleničke iz stekla jantarne barve (obarvano steklo tipa EP IV po Ph.Eur.)
English: The selection of Rebetol formulation is based on individual characteristics of the patient.
Slovenian: Farmacevtsko obliko zdravila Rebetol je treba izbrati glede na individualne lastnosti posameznega bolnika.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Slovenian: Zdravljenje je prejelo skupaj 107 bolnikov, od tega je bilo 52 % žensk, 89 % kavkazijcev, 67 % jih je imelo HCV genotipa 1 in 63 % jih je bilo starih < 12 let.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3 Genotype 4
Slovenian: Vsi genotipi Genotip 1 Genotip 2 Genotip 3 Genotip 4
English: Please refer to the SmPC of the corresponding DAA for a full description of the clinical data with such combination.
Slovenian: Prosimo, glejte povzetek glavnih značilnosti zadevnega DAA za celoten opis kliničnih podatkov v takšni kombinaciji.
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR) Treatment group
Slovenian: Preglednica 9 Virološki odziv v 12. tednu zdravljenja, odziv ob koncu zdravljenja, pogostnost ponovnih izbruhov bolezni* in trajni virološki odziv (SVR) Terapevtska skupina
English: It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Slovenian: Možno je, da je bila povečana biološka uporabnost v tej raziskavi posledica zakasnjenega prehajanja ribavirina ali spremenjenega pH.
English: As the solution fills the syringe, you will see the numbers on the rod go up, such as 1.5 mL, 2.0 mL, 2.5 mL, etc.
Slovenian: Ko bo raztopina postopoma polnila brizgo, bo številka na batu vedno višja, npr. 1,5 ml, 2,0 ml, 2,5 ml itd.
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.
Slovenian: Pri bolnikih, ki se zdravijo z interferonom alfa-2b in zdravilom Rebetol po predhodni ponovitvi bolezni po terapiji z interferonom, ali pri tistih, ki se zdravijo krajši čas, bo varnostni profil verjetno boljši od spodaj opisanega.
English: For patients with prior failure on therapy with non-pegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Slovenian: Pri bolnikih s predhodno neuspešnim zdravljenjem z nepegiliranim interferonom oziroma s pegiliranim interferonom in negativnim izvidom v 12. tednu sta bili pogostnosti trajnega virološkega odziva 59 % oziroma 50 %.
English: Any potential for interactions may persist for up to two months (five half-lives for Rebetol) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Slovenian: Zaradi dolge razpolovne dobe lahko do medsebojnega delovanja pride še do dva meseca (5 razpolovnih dob zdravila Rebetol) po koncu zdravljenja z zdravilom Rebetol (glejte poglavje 5.2).
English:  11 g/dL (females);  12 g/dL (males)
Slovenian:  11 g/dl (deklice);  12 g/dl (dečki)
English: • are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
Slovenian: • če ste noseči ali načrtujete nosečnost (glejte poglavje "Nosečnost in dojenje"),
English: Taking all your medicine: Take or give the prescribed dose by mouth in the morning and evening, with a meal.
Slovenian: Vzemite celoten odmerek zdravila: Predpisani odmerek zaužijte oziroma dajte bolniku peroralno s hrano, zjutraj in zvečer.
English: There is no evidence that Rebetol interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Slovenian: Ni dokazov o medsebojnem delovanju zdravila Rebetol z nenukleozidnimi zaviralci reverzne transkriptaze ali zaviralci proteaz.
English: Homicidal ideation*, mania*, mental status change
Slovenian: morilske misli *, manija*, spremembe duševnega stanja
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Slovenian: Študija 2 (P02080) je bila randomizirana, enocentrična študija, v katero so vključili 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi tudi z virusom HIV.
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Slovenian: Tmax (h) Cmax (ng/ml) AUC* Navidezni očistek l/h/kg ni bil določen
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.
Slovenian: Na splošno je bil profil neželenih učinkov v omejeni proučevani populaciji otrok in mladostnikov podoben kot pri odraslih, čeprav obstaja pri pediatričnih bolnikih še posebna skrb glede zastoja rasti, saj so med zdravljenjem opazili zmanjšanje percentila višine (srednje percentilno zmanjšanje za 9 percentilov) in percentila telesne mase (srednje percentilno zmanjšanje za 13 percentilov).
English: Antacid
Slovenian: Antacidi
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 %  12 years of age.
Slovenian: V študijo je bilo vključenih 118 bolnikov; od tega je bilo 57 % moških, 80 % kavkazijcev, 78 % bolnikov z genotipom 1 in 64 % otrok, starih  12 let.
English: However, as in younger patients, renal function must be determined prior to administration of Rebetol (see section 5.2).
Slovenian: Vendar je treba, enako kot pri mlajših bolnikih, pred začetkom uporabe zdravila Rebetol preveriti delovanje ledvic (glejte poglavje 5.2).
English: Patients who weigh > 47 kg and are able to swallow capsules may take the equivalent dose of ribavirin 200 mg capsules in two divided doses (Please see SmPC for Rebetol capsules).
Slovenian: Bolniki, ki tehtajo > 47 kg in lahko pogoltnejo kapsule, lahko zaužijejo enakovreden odmerek ribavirina v obliki 200 mg kapsul, v dveh deljenih odmerkih (glejte SmPC za Rebetol kapsule).
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Slovenian: Če se razvije akutna preobčutljivostna reakcija (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija), je treba uporabo zdravila Rebetol takoj prekiniti in uvesti ustrezno zdravljenje.
English: Genotype 1/4 59.7 (129/216) 51.2 (66/129)
Slovenian: Genotip 1/4 59,7 (129/216) 51,2 (66/129)
English: Dosing of Rebetol for children and adolescent patients is determined by the patient body weight.
Slovenian: Odmerek zdravila Rebetol za otroke in mladostnike se določi na podlagi bolnikove telesne mase.
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/mL).
Slovenian: Skupaj je imelo v 12. tednu zdravljenja približno 36 % (821/2.286) bolnikov nezaznavne koncentracije HCV-RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i.e./ml).
English: The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Slovenian: Farmakokinetika zdravila Rebetol je pri bolnikih z motnjami delovanja ledvic spremenjena zaradi zmanjšanega navideznega očistka pri teh bolnikih.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SmPC for Rebetol 40 mg/mL oral solution.
Slovenian: Opomba: Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsule, prosimo, glejte Povzetek glavnih značilnosti zdravila Rebetol 40 mg/ml peroralna raztopina.
English: 15 mg/kg/day as 2 divided doses (n = 17)
Slovenian: Zdravilo Rebetol 15 mg/kg na dan v obliki 2 deljenih odmerkov (n = 17)
English: A. Insert the assembled dosing syringe into the bottle of Rebetol oral solution.
Slovenian: A. Sestavljeno brizgo za peroralno odmerjanje vstavite v stekleničko zdravila Rebetol peroralna raztopina.
English: Mitochondrial toxicity and lactic acidosis:
Slovenian: Mitohondrijska toksičnost in laktacidoza:
English: The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Slovenian: Neželeni učinki, ki so navedeni v preglednici 5, so povzeti iz izkušenj, zbranih v kliničnih preskušanjih pri odraslih bolnikih, ki se še niso zdravili s tem zdravilom in so jih z njim zdravili eno leto, ter iz obdobja trženja zdravila.
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µL.
Slovenian: Pri bolnikih, ki so sočasno okuženi s HCV in HIV, je na voljo malo podatkov o učinkovitosti in varnosti zdravila (N = 25) za tiste, ki imajo število celic CD4 manjše od 200 celic/μl.
English: Discontinue Rebetol if:
Slovenian: Zdravilo Rebetol prenehajte uporabljati, če:
English: The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Slovenian: Farmakokinetika zdravila Rebetol in interferona alfa-2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
English: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of Rebetol.
Slovenian: Izsledki študij in vitro z uporabo pripravkov človeških in podganjih jetrnih mikrosomov niso pokazali presnove zdravila Rebetol prek encimov citokroma P450.
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).
Slovenian: Farmakokinetika zdravila Rebetol je pri bolnikih z motnjami delovanja ledvic spremenjena zaradi zmanjšanega navideznega očistka kreatinina pri teh bolnikih (glejte poglavje 5.2).
English: How to use Rebetol
Slovenian: Kako uporabljati zdravilo Rebetol
English: The capsule shell contains gelatine, titanium dioxide.
Slovenian: Ovojnica kapsule vsebuje želatino, titanov dioksid.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy:
Slovenian: Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo zdravljenja z zdravilom Rebetol:
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.
Slovenian: Zaradi bistvenega zvišanja koncentracije ribavirina v plazmi pri bolnikih z zmerno in hudo okvaro ledvic je pri odraslih bolnikih z očistkom kreatinina < 50 ml/minuto odmerek zdravila Rebetol priporočljivo prilagoditi.
English: If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: Rebetol has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect.
Slovenian: Zdravilo Rebetol nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, druga zdravila uporabljena pri kombiniranem zdravljenju pa imajo lahko tovrsten učinek.
English: 84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
Slovenian: 84 trdih kapsul 112 trdih kapsul 140 trdih kapsul 168 trdih kapsul
English: You or your female partner must use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment.
Slovenian: Vi ali vaša partnerka morate uporabljati učinkovito kontracepcijo v času jemanja zdravila Rebetol in še 7 mesecev po zaključku zdravljenja.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Slovenian: V pivotnem kombiniranem preskušanju so bolniki bolje prenašali 6-mesečno kot enoletno terapijo; prekinitev zdravljenja 5 % v primerjavi s 14 %, prilagoditev odmerka 18 % v primerjavi z 49 %.
English: The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Slovenian: Glavna z zdravljenjem povezana sprememba je bila reverzibilna, blaga do zmerna anemija, ki je bila hujša kot pri samostojni uporabi vsake od obeh učinkovin.
English: Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at week 4 and week 24 of therapy.
Slovenian: 41 % preiskovancev (97/235) ni imelo merljivih koncentracij HCV-RNA v plazmi v 4. in 24. tednu zdravljenja.
English: REBETOL - 84, 112, 140, 168 hard capsules
Slovenian: REBETOL - 84, 112, 140, 168 trdih kapsul
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Slovenian: Odziv v 12. tednu so opredelili kot nezaznavno količino HCV-RNA po 12. tednih zdravljenja.
English: 1 bottle of 100 mL 10 mL oral dosing syringe
Slovenian: peroralna raztopina ena 100 ml steklenička 10 ml brizga za peroralno odmerjanje
English: * Since Rebetol has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using Rebetol in combination with interferon alfa-2b (pegylated or non-pegylated).
Slovenian: * Ker je bilo zdravilo Rebetol vedno predpisano skupaj z zdravili, ki vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na izkušnjah v obdobju trženja in ne omogočajo natančne opredelitve pogostnosti, so zgoraj navedene pogostnosti vzete iz kliničnih preskušanj z uporabo zdravila Rebetol v kombinaciji z interferonom alfa-2b (pegiliranim ali nepegiliranim).
English: Genotype 1/4 23.0 (182/790) 51.6 (94/182)
Slovenian: Genotip 1/4 23,0 (182/790) 51,6 (94/182)
English: Table 3 Management of Adverse Reactions Laboratory values
Slovenian: Preglednica 3 Obvladovanje neželenih učinkov Laboratorijske vrednosti
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Slovenian: Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem* Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti:
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, Rebetol dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Slovenian: *Pri bolnikih, ki prejemajo odmerek 1.000 mg (< 75 kg) ali 1.200 mg (> 75 mg), je treba odmerek zdravila Rebetol zmanjšati na 600 mg/dan (uporabljen kot ena 200-mg kapsula zjutraj in dve 200 mg kapsuli zvečer).
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to non-pegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Slovenian: Pri bolnikih, ki se niso odzvali na predhodno zdravljenje s pegiliranim interferonom alfa/ribavirinom, je bila verjetnost, da se bodo odzvali na ponovno zdravljenje v 12. tednu, manjša kot pri tistih, ki se niso odzvali na zdravljenje z nepegiliranim interferonom alfa/ribavirinom (12,4 % v primerjavi z 28,6 %).
English: Excipient with known effect Each hard capsule contains 40 mg of lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 40 mg laktoze monohidrata.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Slovenian: Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Interferon alfa-2b 3 MIU/m 2 3 times a week (n = 54)
Slovenian: Interferon alfa-2b 3 mio i.e./m 2 3-krat na teden (n = 54)
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogosti:
English: - The active substance is ribavirin 200 mg. - The other ingredients are microcrystalline cellulose, lactose monohydrate (40 mg), croscarmellose sodium, magnesium stearate.
Slovenian: - Zdravilna učinkovina je ribavirin, 200 mg. -Druge sestavine so mikrokristalna celuloza, laktoza monohidrat (40mg), premrežen natrijev karmelozat, magnezijev stearat.
English: Conflicting findings are reported in literature on co-administration between abacavir and Rebetol.
Slovenian: V literaturi so poročali o nasprotujočih izsledkih pri sočasni uporabi abakavirja in zdravila Rebetol.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10) in občasni (od ≥ 1/1.000 do < 1/100).
English: 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.
Slovenian: c: Bolniki z genotipom 3 in majhnim virusnim bremenom (< 600.000 i.e./ml) so prejeli 24-tedensko zdravljenje, tisti z genotipom 3 in velikim virusnim bremenom (≥ 600.000 i.e./ml) so prejeli 48-tedensko zdravljenje.
English: Deliver:
Slovenian: Dajanje:
English: The purpose of the studies was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Slovenian: Namen teh študij je bil oceniti dolžino trajnega virološkega odziva (SVR) in tudi vpliv nadaljnjega negativnega izvida testov na prisotnost virusa na klinični izid bolezni.
English: Your doctor has determined the correct dose of this medicine based on how much you or the child you are caring for weighs.
Slovenian: Zdravnik vam je določil ustrezen odmerek tega zdravila na podlagi vaše telesne mase ali telesne mase otroka za katerega skrbite.
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).
Slovenian: Kaplan-Meierjeva ocena nadaljnjega neprekinjenega trajnega odziva v času 5 let je znašala 97 % (95 % IZ: 95-99 %) pri bolnikih, ki so prejemali nepegiliran interferon alfa-2b (z ali brez zdravila Rebetol), oziroma 99 % (95 % IZ: 98-100 %) pri tistih, ki so prejemali pegiliran interferon alfa-2b (z ali brez zdravila Rebetol).
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: * Number (%) of patients a. Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period.
Slovenian: * Število (%) bolnikov a. Opredeljeno kot vrednost HCV-RNA pod mejo detekcije z uporabo raziskovalnega testa RT-PCR ob koncu zdravljenja in v obdobju spremljanja bolnikov.