FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy with ribavirin in chronic hepatitis C In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.
Slovenian: Kombinirano zdravljenje z ribavirinom pri kroničnem hepatitisu C Pri kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom upoštevajte odmerjanje, ki vam ga je predpisal zdravnik.
English: In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration.
Slovenian: Pri teh bolnikih je pri odločanju o odstopanju od standardnega 24-tedenskega zdravljenja treba razmisliti o prenašanju kombiniranega zdravljenja in prisotnosti dodatnih kliničnih ali prognostičnih dejavnikov, kot je stopnja fibroze.
English: Chronic hepatitis B - adult patients
Slovenian: Odmerjanje Kronični hepatitis B - odrasli bolniki
English: 135 micrograms/0.5 ml
Slovenian: 135 μg/0,5 ml
English: Pegasys 180 mcg Ribavirin mg (N=453) 48 weeks
Slovenian: Pegasys 180 µg in ribavirin mg (n = 453) 48 tednov
English: Replace the needle guard and place the syringe in a horizontal position until ready for use.
Slovenian: Ponovno namestite igelno zaščito in dajte injekcijsko brizgo v vodoravno lego, dokler ne boste pripravljeni za injiciranje.
English: At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment).
Slovenian: Ob zaključku 2-letnega obdobja spremljanja bolnikov po zdravljenju so vrednosti večine bolnikov ponovno dosegale percentile telesne mase in višine normativne krivulje rasti izhodiščnih vrednosti (povprečnni percentil telesne mase je bil 64 % ob izhodišču in 60 % 2 leti po zdravljenju; povprečen percentil telesne višine je bil 54 % ob izhodišču in 56 % 2 leti po zdravljenju).
English: ● If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Confirmatory clinical trials in adult treatment-naïve patients All clinical trials recruited interferon-naïve patients with CHC confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
Slovenian: potrjen z merljivimi koncentracijami serumske HCV RNA, zvečane koncentracije ALT (z izjemo študije NR16071) in biopsijo jeter, ki ustreza kroničnemu hepatitisu.
English: 0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
Slovenian: 0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (silikonsko steklo tipa I) z zamaškom in batom ter pokrovom na vrhu (iz butilirane gume, prevlečene z laminatom in fluorescinom na strani, ki je obrnjena proti zdravilu), injekcijska igla.
English: HBsAg Seroconversion
Slovenian: HBsAg sero konverzija
English: Use with ribavirin
Slovenian: Uporaba z ribavirinom
English: Shortening the treatment duration in patients infected with genotype 2 or 3 with HVL (> 800,000 IU/ml) at baseline who become HCV negative by week 4 should be considered with more caution as this may significantly negatively impact the sustained virological response (see Table 1).
Slovenian: Pri skrajševanju zdravljenja pri bolnikih z genotipom 2 ali 3 in visokim virusnim bremenom pred začetkom zdravljenja (> 800.000 i.e./ml), katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja, je potrebna večja pozornost, saj lahko to signifikantno negativno vpliva na trajni virološki odziv (glejte preglednico 1).
English: All patients should have a baseline eye examination.
Slovenian: Pri vseh bolnikih je treba opraviti splošni oftalmološki pregled.
English: In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/or lactic acidosis was 3% (12/398).
Slovenian: V študiji NR15961 je bila incidenca pankreatitisa in/ali laktacidoze pri bolnikih, sočasno zdravljenih s stavudinom in interferonom z dodanim ribavirinom ali brez, 3 %
English: Response by week
Slovenian: Odziv do 12. tedna
English: For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%).
Slovenian: Za HBeAg pozitivne bolnike, okužene z virusom hepatitisa B genotipov B in C, HBsAg > 20.000 i.e./ml ali HBV DNA > 8 log10 i.e./ml v 12. tednu po začetku zdravljenja obstaja velika verjetnost nedoseganja serokonverzije HBeAg in HBV DNA < 2000 i.e./ml v 24. tednu po končanem zdravljenju (NPV > 90 %).
English: The recommended dosage for Pegasys, alone or in combination with ribavirin, is 180 micrograms once weekly subcutaneously for 48 weeks.
Slovenian: Priporočeni odmerek zdravila Pegasys, samega ali v kombinaciji z ribavirinom, je 180 mikrogramov enkrat na teden subkutano 48 tednov.
English: Genotype 2-3
Slovenian: Genotip 2-3
English: Chronic hepatitis C in adult patients
Slovenian: Kronični hepatitis C pri odraslih bolnikih
English: ● if you have, so called autoimmune hepatitis.
Slovenian: • imate bolezen avtoimunski hepatitis,
English: Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Slovenian: Glejte tudi navodila za uporabo drugih zdravil, ki jih uporabljate v kombinaciji z zdravilom Pegasys.
English: Low viral load High viral load
Slovenian: Nizko virusno breme Visoko virusno breme
English: *These adverse reactions were common (≥1/100 to < 1/10) in CHB patients treated with Pegasys monotherapy § Class label for interferon products, see below Pulmonary arterial hypertension.
Slovenian: *Ti neželeni učinki so bili pogosti (≥ 1/100 do < 1/10) pri bolnikih, ki so imeli kronični hepatitis B in so bili zdravljeni le z zdravilom Pegasys.
English: 3 level reduction (mcg)
Slovenian: Zmanjšanje odmerka 3. stopnje (mikrogrami)
English: Anaemia (haemoglobin < 10 g/dl) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
Slovenian: O anemiji (hemoglobin < 10 g/dl) so poročali pri 7 % bolnikov, ki so se zdravili le z zdravilom Pegasys, in pri 14 % bolnikov, ki so prejemali kombinirano zdravljenje.
English: Infectious mononucleosis, pharyngitis streptococcal, influenza, gastroenteritis viral, candidiasis, gastroenteritis, tooth abscess, hordeolum, urinary tract infection, nasopharyngitis
Slovenian: Infekcijske in parazitske bolezni infekcijska mononukleoza, streptokokni faringitis, gripa, virusni gastroenteritis, kandidaza, gastroenteritis, zobni absces, hordeol, okužba sečil, nazofaringitis
English: Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Slovenian: Zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 so opazili pri 13 % bolnikih, ki so jemali zdravilo Pegasys samostojno, in pri 11 % bolnikov, ki so jemali zdravilo Pegasys v kombinaciji.
English: 180 micrograms/0.5 ml
Slovenian: 180 mikrogramov/0,5 ml
English: Choose a place on your stomach or thigh (see the picture).
Slovenian: 4) Izberite in pripravite mesto vboda Izberite mesto na trebuhu ali stegnih (glejte sliko).
English: ● Allow the solution to reach room temperature before injection or warm the syringe between your palms.
Slovenian: ● Pred injiciranjem naj ima raztopina sobno temperaturo, brizgo lahko ogrejete tudi med dlanmi.
English: Patients with moderate renal impairment receiving Pegasys 180 mcg once weekly exhibited similar peginterferon alfa-2a plasma exposures compared to patients with normal renal function.
Slovenian: Pri bolnikih z zmerno ledvično okvaro, ki so prejemali zdravilo Pegasys 180 µg enkrat na teden, so v primerjavi z bolniki z normalnim ledvičnim delovanjem opazili podobne izpostavljenosti peginterferonu alfa-2a v plazmi.
English: Dose increases to or towards the original dose may be considered when the adverse reaction abates (see sections 4.4 and 4.8).
Slovenian: Če neželeni učinki izzvenijo, razmislimo o ponovnem zvečanju odmerka proti prvotnemu ali na prvotni odmerek (glejte poglavji 4.4 in 4.8).
English: Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
Slovenian: Zdravilo Pegasys je v kombinaciji z ribavirinom indicirano za zdravljenje otrok in mladostnikov, starih 5 let ali več, ki imajo predhodno nezdravljen CHC in so pozitivni na ribonukleinsko kislino virusa hepatitisa C (HCV RNA) v serumu.
English: Pegasys 360/180 or 180 mcg
Slovenian: Pegasys 360/180
English: No biomarker can be identified with acceptable performance for HBeAg-negative patients with HBV genotype B or C infection.
Slovenian: Biološki označevalec s primernimi značilnostmi pri HBeAg negativnih bolnikih, okuženih z virusom hepatitisa B genotipov B in C, ni znan.
English: Genotype 1 or 4 without RVR*
Slovenian: Genotip 1 ali 4, brez hitrega virološkega odziva*
English: Common
Slovenian: Skupno
English: You are now back on your regularly scheduled day and should continue your injections every Monday.
Slovenian: Z odmerjanjem nadaljujete vsak ponedeljek.
English: For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Slovenian: Pri bolnikih, ki so okuženi s HIV in HCV in prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali tudi o drugih neželenih učinkih pri ≥ 1 % do ≤ 2 % bolnikov: hiperlaktacidemija/laktacidoza, gripa, pljučnica, čustvena labilnost, apatičnost, tinitus, bolečina v žrelu in grlu, heilitis, pridobljena lipodistrofija in kromaturija.
English: How to inject Pegasys
Slovenian: Kako injicirate zdravilo Pegasys
English: 2 level reduction (mcg)
Slovenian: Zmanjšanje odmerka 2. stopnje (mikrogrami)
English: Table 9 summarises the undesirable effects reported with Pegasys monotherapy in CHB or CHC adult patients and with Pegasys in combination with ribavirin in CHC patients.
Slovenian: Seznam neželenih učinkov v preglednici Preglednica 9 povzema neželene učinke, o katerih so poročali pri samostojnem zdravljenju z zdravilom Pegasys pri odraslih bolnikih s CHB ali CHC ter pri bolnikih s CHC, ki so prejemali zdravilo Pegasys v kombinaciji z ribavirinom.
English: The duration of treatment with Pegasys in combination with ribavirin in paediatric patients with CHC depends on viral genotype.
Slovenian: Trajanje zdravljenja z zdravilom Pegasys v kombinaciji z ribavirinom pri pediatričnih bolnikih s CHC je odvisno od virusnega genotipa.
English: Table 7: Ribavirin dosing recommendations for paediatric patients with chronic hepatitis C aged 5 to 17 years
Slovenian: Preglednica 7: Priporočila za odmerjanje ribavirina pri pediatričnih bolnikih s kroničnim hepatitisom C, starih od 5 do 17 let
English: A reduced dose of 135 mcg once weekly is recommended in adult patients with severe renal impairment or end stage renal disease (see section 5.2).
Slovenian: Pri odraslih bolnikih s hudo ledvično okvaro ali končno ledvično odpovedjo je priporočen zmanjšan odmerek 135 mikrogramov enkrat na teden (glejte poglavje 5.2).
English: ● Clean the rubber top of the vial with a cleansing swab.
Slovenian: ● Na viali pokrovček iz gume očistite z dezinfekcijsko krpico.
English: 1 level reduction (mcg)
Slovenian: Zmanjšanje odmerka 1. stopnje (mikrogrami)
English: Duration of treatment - dual therapy with Pegasys and ribavirin The duration of combination therapy with ribavirin for CHC depends on viral genotype.
Slovenian: Trajanje zdravljenja - dvojno zdravljenje z zdravilom Pegasys in ribavirinom Trajanje kombiniranega zdravljenja z ribavirinom pri CHC je odvisno od virusnega genotipa.
English: Digestive system disorders: Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums, inflammation of tongue and mouth, flatulence (excess amount of air or gases), dry mouth and loss of weight
Slovenian: Bolezni prebavil: bruhanje, slaba prebava, težave s požiranjem, razjede v ustih, krvavitev iz dlesni, vnetje jezika in ust, napenjanje (prevelika količina zraka ali plinov), suha usta in izguba telesne mase.
English: It is available in packs containing 1 or 4 single dose vials.
Slovenian: Pakiranje vsebuje 1 ali 4 enoodmerne viale.
English: The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
Slovenian: S konjugacijo reagenta PEG (bis-monometoksipolietilenglikol) z interferonom alfa-2a dobimo pegiliran interferon alfa-2a (zdravilo Pegasys).
English: The major treatment-related change was reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Slovenian: Glavni neželeni učinek, ki je bil povezan z zdravljenjem, je bila reverzibilna blaga do srednje huda anemija, ki pa je bila hujša kot v primeru vsake posamezne učinkovine.
English: HBsAg > 20,000 HBV DNA > 6.5 log10
Slovenian: HBV DNA > 6,5 log10
English: In chronic hepatitis B the duration of Pegasys treatment is 48 weeks.
Slovenian: Zdravljenje z zdravilom Pegasys pri kroničnem hepatitisu B traja 48 tednov.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB11
Slovenian: Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC:
English: In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
Slovenian: V drugem kliničnem preskušanju so neodzivne bolnike z napredovalo fibrozo ali cirozo (stopnja 3 do 6 po Ishaku) in izhodiščno koncentracijo trombocitov tudi tako majhno, kot je 50.000 celic/mm3,
English: Some children and adolescents treated with Pegasys for chronic hepatitis B for 48 weeks did not grow or gain weight as much as expected for their age.
Slovenian: nekateri otroci in mladostniki s kroničnim hepatitisom C niso zrastli oziroma pridobili toliko telesne mase kot pričakovano.
English: Influenza-like illness, injection site reaction, irritability, fatigue
Slovenian: Bolezen, podobna gripi, reakcija na mestu injiciranja, razdražljivost,
English: Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or
Slovenian: 24-tedensko zdravljenje lahko vpeljemo pri bolnikih, ki so okuženi: - z genotipom 1 in imajo nizko virusno breme pred začetkom zdravljenja (≤ 800.000 i.e./ml) ali
English: The recommended dose for Pegasys is 180 micrograms once weekly given in combination with oral ribavirin or as monotherapy.
Slovenian: Priporočeni odmerek zdravila Pegasys je 180 mikrogramov enkrat na teden , ki je dan v kombinaciji s peroralnim ribavirinom ali kot monoterapija.
English: Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Slovenian: Histološko izboljšanje pa se je značilno pojavilo z večjo verjetnostjo pri bolnikih, ki so po 24 tednih po zaključku zdravljenja pokazali trajen odziv.
English: At the end of treatment, 43% of patients experienced a weight percentile decrease of 15 percentiles or more, and 25% (13 of 53) experienced a height percentile decrease of 15 percentiles or more on the normative growth curves.
Slovenian: Po koncu zdravljenja se je pri 43 % bolnikov percentil telesne mase zmanjšal za 15 percentilov ali več glede na normativne krivulje rasti.
English: Absent Slight Moderate
Slovenian: Ascites odsoten blag močan
English: In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
Slovenian: Pri 13 bolnikih s končno ledvično odpovedjo, pri kateri je potrebna kronična hemodializa, je bila pri dajanju zdravila Pegasys 135 µg enkrat na teden izpostavljenost peginterferonu alfa-2a 34 % manjša kot pri bolnikih z normalnim delovanjem ledvic.
English: All patients
Slovenian: Bolnike,
English: Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Slovenian: Še posebej je treba tveganje za podaljšanje QTc intervala upoštevati pri bolnikih, ki prejemajo velike odmerke metadona.
English: Immune system disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders: Loss of vision
Slovenian: Bolezni imunskega sistema: idiopatična (ali trombotična) trombocitopenična purpura (povečano nastajanje modric, krvavitev, zmanjšano število trombocitov, anemija in ekstremna šibkost).
English: For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalization at Week 24 post treatment.
Slovenian: Pri HBeAg negativnih bolnikih, okuženih z virusom hepatitisa B genotipa D, HBsAg > 20.000 i.e./ml ali HBV DNA > 6,5 log10 i.e./ml v 12. tednu po začetku zdravljenja obstaja velika verjetnost nedoseganja HBV-DNA < 2000 i.e./ml in normalizacije ALT v 24. tednu po končanem zdravljenju.
English: There is limited experience with Pegasys in treating paediatric patients with CHC aged 3 to 5 years, or who have failed to be adequately treated previously.
Slovenian: Pri zdravljenju pediatričnih bolnikov s CHC, starih od 3 do 5 let, ali bolnikov, ki predhodno niso prejeli ustreznega zdravljenja, so na voljo le omejene izkušnje z zdravilom Pegasys.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Slovenian: Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Na injekcijski brizgi so oznake za odmerke 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg in 10 mcg.
English: Table 1: Dosing recommendations for combination therapy for adult patients with chronic hepatitis C
Slovenian: Preglednica 1: Priporočila odmerjanja pri kombiniranem zdravljenju odraslih bolnikov s kroničnim hepatitisom C
English: ● Remove the needle guard.
Slovenian: ● Snemite igelno zaščito.
English: Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B
Slovenian: Preglednica 22: Serološki, virološki in biokemijski odzivi pri pediatričnih bolnikih s CHB
English: ● if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
Slovenian: • če opazite spremembo vida, • če se pri vas razvijejo simptomi, povezani s prehladom ali drugo okužbo dihal (kot so kašelj,
English: A prolongation of the menstrual cycle has been seen with peginterferon alfa-2a in female monkeys (see section 5.3).
Slovenian: Pri uporabi peginterferona alfa-2a pri samicah opic so opazili podaljšanje menstrualnega cikla (glejte poglavje 5.3).
English: Hormone system disorders: Overactive and underactive thyroid gland
Slovenian: Bolezni endokrinega sistema: preveč aktivna in premalo aktivna žleza ščitnica.
English: All genotypes (N=101) Responder
Slovenian: Vsi genotipi (n = 101)
English: Available in packs of 1 or 4 vials.
Slovenian: Na voljo je pakiranje z 1 ali 4
English: Serum concentrations of theophylline should be monitored and appropriate dose adjustments of theophylline made for patients taking theophylline and Pegasys concomitantly.
Slovenian: Pri bolnikih, ki jemljejo teofilin sočasno z zdravilom Pegasys, moramo meriti serumske koncentracije teofilina in odmerek teofilina ustrezno prilagoditi.
English: Increases in ALT levels above baseline (BL) have been observed in patients treated with Pegasys, including patients with a virological response.
Slovenian: zdravljenih z zdravilom Pegasys, so opazili zvečanje koncentracij ALT nad izhodiščnimi vrednostmi (BL - baseline), vključno z bolniki z virološkim odzivom.
English: Ribavirin daily dose (Approx. 15 mg/kg/day)
Slovenian: Celoten odmerek (približno 15 mg/kg/dan)
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 36 weeks
Slovenian: • zdravilo Pegasys 360 mikrogramov/teden 12 tednov, čemur je sledilo 180 mikrogramov/teden naslednjih 36 tednov,
English: In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
Slovenian: Zdravljenje je skupaj potekalo 48 tednov, po njegovem zaključku pa so bolnike še 24 tednov spremljali.
English: The posology of Pegasys in paediatric patients is based on the Body Surface Area (BSA).
Slovenian: Odmerjanje zdravila Pegasys pri pediatričnih bolnikih je odvisno od njihove telesne površine.
English: Table 15: Sustained virological response based on rapid viral response at week 4 for genotype 1 and 4 after Pegasys combination therapy with ribavirin in CHC patients
Slovenian: Preglednica 15: Trajni virološki odziv v povezavi s hitrim virološkim odzivom v 4. tednu za genotipa 1 in 4 po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s CHC
English: Table 13: Virological response in CHC patients Pegasys monotherapy
Slovenian: Preglednica 13: Virološki odziv pri bolnikih s CHC Samostojno zdravljenje z zdravilom Pegasys
English: Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Slovenian: Podatki o varnosti pri bolnikih, okuženih z obema virusoma in s številom celic CD4+, manjšim od 200/μl, so omejeni.
English: Psychiatric and nervous system disorders: Feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep, headache, difficulty concentrating and dizziness Breathing disorders: Cough, shortness of breath
Slovenian: Psihiatrične motnje in bolezni živčevja: depresija (občutek potrtosti, slab občutek o sebi ali občutek brezupa), tesnoba, nespečnost, glavobol, težave s koncentracijo in omotica.
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 180 micrograms/0.5 ml
Slovenian: Skupno pakiranje: 12 (2 pakiranji po 6) napolnjenih injekcijskih brizg + 12 injekcijskih igel 180 mikrogramov/0,5 ml
English: Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAgnegative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).
Slovenian: Chronic Hepatitis B), ki so HBeAg (Hepatitis B envelope Antigen) pozitivni ali negativni, imajo kompenzirano jetrno bolezen, dokazano virusno replikacijo, zvišane vrednosti alanin-aminotransferaze (ALT) ali histološko potrjeno vnetje jeter in/ali fibrozo (glejte poglavji 4.4 in 5.1).
English: Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
Slovenian: Bolnike, okužene s HCV z genotipom 2 ali 3, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo 24 tednov, ne glede na virusno breme pred začetkom zdravljenja.
English: # p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Slovenian: # p-vrednost (v primerjavi z lamivudinom) < 0,01 (stratificiran Cochran-Mantel-Haenszelov test) Histološki odziv je bil v vseh treh zdravljenih skupinah podoben v vseh študijah.