FrancophonIA/ELRC3.0 huggingface dataset:
English: In children and adolescent patients receiving body surface area-adjusted dosing of ViraferonPeg at 60 g/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 g/kg/week.
Slovenian: Pri otrocih in mladostnikih, ki so prejemali na telesno površino prilagojen odmerek zdravila ViraferonPeg 60 µg/m na teden, je bila napovedana logaritemska vrednost ocene 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: Collect the necessary items before you begin: - a vial of ViraferonPeg powder for injection; - an ampoule of water for injections solvent to prepare ViraferonPeg injection; - a 1 ml syringe; - a long needle (for example 0.8  40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the ViraferonPeg powder vial; - a short needle (for example 0.3  13 mm [30 gauge 0.5 inch]) for the subcutaneous injection; - a cleansing swab.
Slovenian: Pred začetkom si pripravite vse potrebne pripomočke: - vialo s praškom zdravila ViraferonPeg za injekcije; - ampulo vode za injekcije - vehikel oz. topilo za pripravo zdravila ViraferonPeg za injiciranje; - 1 ml brizgo; - dolgo iglo (npr. 0,8  40 mm 21 gauge 1,5 inch ), ki jo boste uporabili za dodajanje vode za injekcije v vialo s praškom ViraferonPeg; - kratko iglo (npr. 0,3  13 mm[30 gauge 0,5 inch]) za subkutano injiciranje; - čistilni tampon.
English: The safety and efficacy of ViraferonPeg alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Slovenian: Varnosti in učinkovitosti zdravila ViraferonPeg v monoterapiji ali v kombinirani terapiji z ribavirinom za zdravljenje hepatitisa C pri bolnikih s presajenimi jetri ali drugimi organi niso preučevali.
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Slovenian: Med farmakološke učinke ribavirina sodi tudi povečanje količine fosforiliranih presnovkov purinskih nukleozidov in vitro.
English: Chronic Hepatitis C Subjects (N=24)
Slovenian: preiskovanci s kroničnim hepatitisom C (n = 24)
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 je pravilni odmerek tega zdravila določil glede na vašo telesno maso ali telesno maso otroka, za katerega skrbite.
English: • Genotype 4:
Slovenian: • Genotip 4:
English: While pyrexia may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent pyrexia must be ruled out.
Slovenian: Čeprav je lahko povezana z gripi podobnim sindromom, o katerem pogosto poročajo med zdravljenjem z interferoni, morate izključiti druge vzroke za dolgotrajnejšo zvišano telesno temperaturo.
English: Thioridazine
Slovenian: tioridazin
English: - In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
Slovenian: -V podskupini bolnikov, ki so okuženi z virusom genotipa 1 in imajo majhno virusno obremenitev (< 600.000 i.e./ml) ter katerih izvidi na HCV-RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja, se zdravljenje lahko bodisi ukine po ciklu terapije v 24. tednu, ali pa se nadaljuje še dodatnih 24 tednov (tako da bo skupno trajanje zdravljenja 48 tednov).
English: Caffeine (CYP1A2 substrate)
Slovenian: kofein (substrat CYP1A2)
English: Neuropathy, neuropathy peripheral
Slovenian: nevropatija, periferna nevropatija
English: Description of selected adverse reactions in children and adolescents Most of the changes in laboratory values in the ViraferonPeg/ribavirin clinical trial were mild or moderate.
Slovenian: Opis izbranih neželenih učinkov pri otrocih in mladostnikih V kliničnem preskušanju z zdravilom ViraferonPeg/ribavirinom so bile spremembe v laboratorijskih vrednostih večinoma blage do zmerne.
English: Clinical efficacy and safety - paediatric population Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus ViraferonPeg 60 g/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Slovenian: Klinična učinkovitost in varnost - pediatrična populacija Otroke in mladostnike, stare od 3 do 17 let, s kompenziranim kroničnim hepatitisom C in merljivo HCV-RNA so vključili v multicentrično preskušanje in jih zdravili z ribavirinom 15 mg/kg na dan in zdravilom ViraferonPeg 60 µg/m2 enkrat na teden 24 ali 48 tednov, glede na genotip HCV in virusno breme na začetku preskušanja.
English: This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 8).
Slovenian: Ta raziskava je potrdila, da je zdravilo ViraferonPeg boljše od interferona alfa-2b (preglednica 8).
English: P 1.5/R ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Slovenian: P 1,5/R ViraferonPeg (1,5 mikrograma/kg) + ribavirin (800 mg) P 0,5/R ViraferonPeg (1,5 do 0,5 mikrograma/kg) + ribavirin (1.000/1.200 mg) I/R
English: LVL (≤600,000 IU/ml)
Slovenian: LVL (≤600.000 i.e./ml)
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Slovenian: Če bolezen napreduje do jetrne dekompenzacije, je treba pri njih nemudoma ukiniti zdravljenje hepatitisa in ponovno oceniti učinkovitost antiretrovirusnega zdravljenja.
English: For adult patients who use 0.5 g/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half as shown in Table 3b.
Slovenian: Za odrasle bolnike, ki uporabljajo 0,5 µg/kg zdravila ViraferonPeg v monoterapiji, zmanjšanje odmerka lahko dosežemo z zmanjšanjem predpisanega volumna za polovico, kot je prikazano v preglednici 3b.
English: Neuralgia, lethargy, paraesthesia, hypoaesthesia, psychomotor hyperactivity, tremor
Slovenian: nevralgija, letargija, parestezije, hipoestezija, psihomotorična hiperaktivnost, tremor
English: - Take the long needle and place it firmly on to the tip of the syringe.
Slovenian: - Vzemite dolgo iglo in jo trdno namestite na vrh brizge.
English: Device body
Slovenian: Telo pripomočka
English: ViraferonPeg Cmax and AUC measurements increase in a dose-related manner.
Slovenian: Vrednosti Cmax in AUC za zdravilo ViraferonPeg naraščajo v odvisnosti od odmerka.
English: This means that it is injected through a short injection needle into the fatty tissue just under the skin.
Slovenian: To pomeni, da se s kratko injekcijsko iglo injicira v maščevje tik pod kožo.
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis, urinary tract infection, gastroenteritis Blood and lymphatic system disorders Very common:
Slovenian: pljučnica, askariaza, enterobiaza, herpes zoster, celulitis, okužba sečil, gastroenteritis Bolezni krvi in limfatičnega sistema Zelo pogosti:
English: After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Slovenian: Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C - 8 °C).
English: In addition, 303 patients received interferon alfa-2b (3 million International Units [MIU] three times a week) as a comparator.
Slovenian: Poleg tega so za primerjavo vzeli 303 bolnike, ki so prejemali interferon alfa-2b v odmerku 3 milijone i.e. (mio i.e.) trikrat na teden.
English: Take the short needle and place it firmly on to the tip of the syringe.
Slovenian: Vzemite kratko iglo in jo trdno namestite na vrh brizge.
English: If renal function decreases during treatment, ViraferonPeg therapy should be discontinued.
Slovenian: Če se delovanje ledvic poslabša med zdravljenjem, zdravljenje z zdravilom ViraferonPeg ukinite.
English: Adults - Duration of treatment - Retreatment Tritherapy: Refer to the SmPC for boceprevir.
Slovenian: Odrasli - Trajanje zdravljenja - Ponovno zdravljenje Trojna terapija: glejte SmPC za boceprevir.
English: ViraferonPeg should be administered as a subcutaneous injection.
Slovenian: Zdravilo ViraferonPeg se mora uporabljati v obliki subkutane injekcije.
English: Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Slovenian: Interferon v monoterapiji, vključno z zdravilom ViraferonPeg, je indiciran predvsem v primeru, ko bolnik ne prenaša ribavirina ali je njegova uporaba kontraindicirana.
English: Aspartate aminotransferase (AST)
Slovenian: Alaninaminotransferaza (ALT) ali aspartataminotransferaza (AST)
English: Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking this medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste med zdravljenjem s tem zdravilom utrujeni, zaspani ali zmedeni, ne vozite in ne upravljajte z orodji ali stroji.
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative
Slovenian: Genotip 1* Do 4. tedna*** (n=950) Negativna HCV-RNA
English: ViraferonPeg combination therapy (bitherapy or tritherapy) Bitherapy (ViraferonPeg with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Slovenian: ViraferonPeg v kombinirani terapiji (dvojna ali trojna terapija) Dvojna terapija (zdravilo ViraferonPeg in ribavirin): velja za vse odrasle in pediatrične bolnike, stare 3 leta ali več.
English: How to self-inject ViraferonPeg?
Slovenian: Kako si sami injicirate zdravilo ViraferonPeg?
English: Cerebrovascular haemorrhage, cerebrovascular ischaemia, encephalopathy
Slovenian: cerebrovaskularna krvavitev, cerebrovaskularna ishemija, encefalopatija
English: This medicine is a powder and solvent (liquid) for solution for injection in a pre-filled pen (CLEARCLICK).
Slovenian: To zdravilo je prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku (CLEARCLICK).
English: Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
Slovenian: V prvi (C/I97-010) je bilo zdravilo ViraferonPeg uporabljeno kot monoterapija, v drugi (C/I98-580) pa v kombinaciji z ribavirinom.
English: • Genotype 1:
Slovenian: • Genotip 1:
English: Twenty-four percent of subjects (11/46) treated for 24 weeks and 40 % of subjects (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of the 5 year long-term follow-up compared to pre-treatment baseline percentile.
Slovenian: Štiriindvajsetim odstotkom preiskovancev (11/46), zdravljenih 24 tednov, in 40 % preiskovancev (19/48), zdravljenih 48 tednov, se je od časa pred zdravljenjem do konca 5-letnega dolgoročnega spremljanja telesna višina za starost zmanjšala za > 15 percentilov v primerjavi z izhodiščnim percentilom pred zdravljenjem.
English: ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
Slovenian: Zdravilo ViraferonPeg je indicirano za zdravljenje odraslih bolnikov (18 let ali več) s CHC, ki imajo pozitiven izvid na RNA virusa hepatitisa C (HCV-RNA), vključno z bolniki z zdravljeno cirozo in/ali s sočasno klinično stabilno okužbo s HIV (glejte poglavje 4.4).
English: Uncommon side effects (may affect up to 1 in 100 people): - suicide, attempted suicide, thoughts about threatening the life of yourself, panic attack,
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - samomor, poskus samomora, misli kako ogroziti svoje življenje, panični napad, blodnje,
English: Undetectable HCVRNA at treatment week 12 End of treatment response Relapse SVR SVR in patients with undetectable HCVRNA at treatment week 12
Slovenian: Nemerljiva koncentracija HCV-RNA v 12. tednu zdravljenja Odziv ob koncu zdravljenja Ponovni izbruh bolezni SVR SVR pri bolnikih z nemerljivo koncentracijo HCVRNA v 12. tednu zdravljenja
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: - Remove the syringe from the wrapping and do not touch the tip of the syringe.
Slovenian: - Brizgo vzemite iz ovojnine in se ne dotikajte vrha brizge.
English: There are no apparent age-related effects on the pharmacokinetics of ViraferonPeg.
Slovenian: Starost nima opaznega vpliva na farmakokinetiko zdravila ViraferonPeg.
English: nd dose reduction of ribavirin is by an additional 200 mg/day.
Slovenian: Če je potrebno, lahko še drugič zmanjšate odmerek ribavirina za dodatnih 200 mg/dan.
English: The combination can also be used to treat adults who have already failed treatment with an interferon alpha or peginterferon alpha in combination with ribavirin or interferon alpha alone.
Slovenian: Ta kombinacija se lahko uporablja tudi za zdravljenje odraslih, ki se predhodno niso odzvali na kombinirano terapijo z interferonom alfa ali peginterferonom alfa in ribavirinom ali na monoterapijo z interferonom alfa.
English: ViraferonPeg should be administered as a once weekly subcutaneous injection.
Slovenian: Zdravilo ViraferonPeg se daje enkrat na teden v obliki subkutane injekcije.
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/HIV Čeprav se je hematološka toksičnost v obliki nevtropenije, trombocitopenije in anemije pogosteje pojavljala pri bolnikih, ki so bili sočasno okuženi s HCV/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: Adequate hydration must be maintained in patients undergoing ViraferonPeg therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom ViraferonPeg, morate ohranjati ustrezno hidracijo, saj so pri nekaterih bolnikih, zdravljenih z alfa interferoni, opazili hipotenzijo zaradi izgube tekočine.
English: The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
Slovenian: Bel prašek je v 2 ml stekleni viali, bister in brezbarven vehikel pa v 2 ml stekleni ampuli.
English: In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of ViraferonPeg subcutaneously for 4 weeks increased R-methadone AUC by approximately 15 % (95 % Cl for AUC ratio estimate 103 - 128 %).
Slovenian: Pri bolnikih s kroničnim hepatitisom C, ki so bili na vzdrževalnem zdravljenju s stalnimi odmerki metadona in še niso prejemali peginterferona alfa-2b, se je pri dodatku zdravila ViraferonPeg v odmerku 1,5 mikrograma/kg/teden subkutano v času 4 tednov, povečala vrednost AUC za R-metadon za približno 15 % (95 % IZ za oceno razmerja AUC 103 - 128 %).
English: • Choose an injection site on your stomach area (abdomen) or thigh.
Slovenian: • Izberite mesto za injiciranje v predelu trebuha ali na stegnu.
English: Add needle • Turn the dial to number 2 (see Figure 3).
Slovenian: Namestitev igle • Obrnite gumb za nastavitev do številke 2 (glejte sliko 3).
English: It is recommended that patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Slovenian: Pri bolnikih z obstoječimi motnjami delovanja srca je priporočljivo opraviti snemanje EKG pred uvedbo zdravljenja in med zdravljenjem.
English: Hyperbilirubinemia, hepatomegaly Skin and subcutaneous tissue disorders Very common:
Slovenian: hiperbilirubinemija, hepatomegalija Bolezni kože in podkožja Zelo pogosti:
English: * (HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/ml) Lack of early virologic response by Treatment week 12 (detectable HCV-RNA with a < 2 log10 reduction from baseline) was a criterion for discontinuation of treatment.
Slovenian: *(PCR test za določitev HCV-RNA s spodnjo mejo kvantifikacije 27 i.e./ml) Kriterij za ukinitev zdravljenja je bila odsotnost zgodnjega virološkega odziva do 12. tedna zdravljenja (merljiva koncentracija HCV-RNA z zmanjšanjem za < 2 log10 glede na začetno vrednost).
English: Bitherapy: Predictability of sustained virological response - Patients infected with virus genotype 1 who fail to achieve undetectable HCV-RNA or demonstrate adequate virological response at week 4 or 12 are highly unlikely to become sustained virological responders and should be evaluated for discontinuation (see also section 5.1).
Slovenian: Napoved trajnega virološkega odziva - Pri bolnikih, okuženih z virusom genotipa 1, ki ne dosežejo nemerljive koncentracije HCV-RNA ali ne dosežejo ustreznega virološkega odziva v 4. ali 12. tednu zdravljenja, je zelo malo verjetno, da bodo razvili trajen virološki odziv, zato je treba oceniti možnost ukinitve zdravljenja (glejte tudi poglavje 5.1).
English: Leukocytes
Slovenian: Levkociti
English: What ViraferonPeg looks like and contents of the pack
Slovenian: Izgled zdravila ViraferonPeg in vsebina pakiranja
English: Following multiple dosing of ViraferonPeg (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of ViraferonPeg is reduced by a mean of 17 % in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44 % in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Slovenian: Po večkratnem odmerjanju zdravila ViraferonPeg (1,0 mikrogram/kg, subkutano enkrat na teden štiri tedne) se očistek zdravila ViraferonPeg pri bolnikih z zmerno ledvično okvaro (očistek kreatinina od 30 do 49 ml/minuto) zmanjša za povprečno 17 %, pri bolnikih s hudo ledvično okvaro (očistek kreatinina od 15 do 29 ml/minuto) pa za povprečno 44 % v primerjavi s preiskovanci z normalnim delovanjem jeter.
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two ViraferonPeg/ribavirin regimens [ViraferonPeg 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Slovenian: V velikem randomiziranem preskušanju so primerjali varnost in učinkovitost 48-tedenskega zdravljenja z dvema režimoma zdravljenja z zdravilom ViraferonPeg v kombinaciji z ribavirinom [zdravilo ViraferonPeg v odmerku 1,5 µg/kg in 1 µg/kg subkutano enkrat na teden, oboje v kombinaciji z ribavirinom od 800 do 1.400 mg peroralno na dan (v dveh deljenih odmerkih)] in zdravljenja s peginterferonom alfa-2a v odmerku 180 µg subkutano enkrat na teden v kombinaciji z ribavirinom v odmerku od 1.000 do 1.200 mg peroralno na dan (v dveh deljenih odmerkih) pri 3.070 odraslih s kroničnim hepatitisom C genotipa 1, ki se še niso zdravili.
English: When the total amount of solvent is combined with the full amount of ViraferonPeg powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Slovenian: Ko se bo celotna količina vehikla pomešala s celotno količino ViraferonPeg praška, bo dosežena pravilna koncentracija za merjenje odmerka (t.j.
English: HCV/HBV Coinfection
Slovenian: Sočasna okužba s HCV/HBV
English: Myalgia, arthralgia, musculoskeletal pain
Slovenian: mialgija, artralgija, mišičnoskeletne bolečine
English: Infrequently, adult patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Slovenian: Redko se lahko pri odraslih bolnikih, zdravljenih z interferonom alfa zaradi kroničnega hepatitisa C, pojavijo motnje delovanja žleze ščitnice - hipertiroza ali hipotiroza.
English: The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
Slovenian: Bel prašek ter bister in brezbarven vehikel sta oba v dvokomornem steklenem vložku, ki je vgrajen v napolnjen injekcijski peresnik za enkratno uporabo.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Slovenian: O resnih neželenih učinkih so poročali pri 7 % (8/107) vseh preiskovancev in med te neželene učinke so sodili bolečina na mestu injiciranja (1 %), bolečina v udih (1 %), glavobol (1 %), nevtropenija (1 %) in zvišana telesna temperatura (4 %).
English: Prior to initiation of ViraferonPeg therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Slovenian: Pred uvedbo zdravljenja z zdravilom ViraferonPeg je treba oceniti vrednosti TSH, morebitne motnje delovanja žleze ščitnice, ki jih pri tem ugotovite, pa je treba zdraviti z običajno terapijo.
English: The powder is contained in a 2 ml vial (Type I flint glass) with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet.
Slovenian: Prašek je na voljo v 2 ml vialah (iz kristalnega stekla tipa I) z zamaškom iz butilne gume v aluminijasti zaporki z odmično ploščico in polipropilenskim pokrovčkom.
English: Table 10 Virologic response at end of treatment, Sustained Virologic Response and relapse by HCV Genotype and viral load* ViraferonPeg 1.5 g/kg once weekly plus Ribavirin 800-1,400 mg/day End of treatment response
Slovenian: Preglednica 10 Virološki odziv ob koncu zdravljenja, trajni virološki odziv in ponovitev bolezni glede na HCV genotip in virusno breme* ViraferonPeg v odmerku 1,5 g/kg enkrat na teden plus Ribavirin v odmerku 800 do 1.400 mg/dan odziv ob koncu zdravljenja trajni virološki odziv ponovitev bolezni
English: Most cases of neutropenia and thrombocytopenia were mild (WHO grades 1 or 2).
Slovenian: V večini primerov nevtropenije in trombocitopenije je šlo za blažjo obliko (1. ali 2. stopnje po WHO).
English: The decline of height, weight and BMI Z scores observed during the treatment phase in comparison to a normative population did not fully recover at the end of long-term follow-up period for children treated with 48 weeks of therapy (see section 4.4).
Slovenian: Pri otrocih, zdravljenih 48 tednov, se zmanjšanje Z vrednosti telesne višine, telesne mase in ITM, ki so ga opazili v času zdravljenja, v primerjavi z normativno populacijo na koncu dolgoročnega spremljanja ni povsem popravilo (glej poglavje 4.4).
English: Eleven percent of subjects (5/46) treated for 24 weeks and 13 % of subjects (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline of > 30 height-for-age percentiles to the end of the 5 year long-term follow-up.
Slovenian: Pri enajstih odstotkih preiskovancev (5/46), zdravljenih 24 tednov, in 13 % preiskovancev (6/48), zdravljenih 48 tednov, so od časa pred zdravljenjem do konca 5-letnega dolgoročnega spremljanja opazili zmanjšanje > 30 percentilov telesne višine za starost.