FrancophonIA/ELRC3.0 huggingface dataset:
English: Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Rebetol.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti protiretrovirusnih zdravil, uporabljenih sočasno s terapijo za HCV, da bi se bolj zavedali in bi lahko obvladovali toksične učinke vsakega od teh zdravil ter potencialno prekrivanje njihovih toksičnih učinkov z zdravilom Rebetol.
English: Table 10 Predictive Value of In-Treatment Virologic Response while on peginterferon alfa-2b 1.5 µg/kg/Rebetol 800-1,400 mg Combination Therapy Negative
Slovenian: Preglednica 10 Napovedna vrednost virološkega odziva med kombiniranim zdravljenjem s peginterferonom alfa-2b 1,5 µg/kg in zdravilom Rebetol od 800 do 1.400 mg Negativna
English: In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/mL) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Slovenian: V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600.000 i.e./ml), prejemalo peginterferon alfa-2b v odmerku 1,5 mikrogramov/kg subkutano enkrat na teden, v kombinaciji z zdravilom Rebetol v odmerku, prilagojenem glede na telesno maso.
English: In clinical trials with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 x 200 mg capsules) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
Slovenian: V kliničnih preskušanjih z zdravilom Rebetol v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b je bilo največje preveliko odmerjanje skupni odmerek 10 g zdravila Rebetol (50 x 200 mg kapsul) in 39 mio i.e. interferona alfa-2b (13 subkutanih injekcij po 3 mio i.e. vsaka), ki ga je v enem dnevu vzel bolnik v poskusu samomora.
English: Table 8 Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Rebetol capsules when administered to paediatric patients with chronic hepatitis C PARAMETER
Slovenian: Preglednica 8 Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa-2b in zdravila Rebetol kapsule pediatričnim bolnikom s kroničnim hepatitisom C
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Slovenian: Sočasno okuženi bolniki z napredovalo cirozo, ki prejemajo kombinirano protivirusno terapijo (cART - combined anti-retroviral therapy), imajo lahko zvečano tveganje za nastanek jetrne dekompenzacije in smrti.
English: Rebetol Dose (daily)
Slovenian: Odmerek zdravila Rebetol (dnevni)
English: Any subject with missing data in and after the follow-up week 12 window was considered to be a non-responder at week 24 of follow-up.
Slovenian: Vsakega preiskovanca z manjkajočimi podatki v časovnem obdobju 12. tedna spremljanja bolnikov in po njem pa so ob obisku v 24. tednu spremljanja bolnikov šteli med bolnike brez virološkega odziva.
English: Reminder: Please read the “Other medicines" section of the Package Leaflet for the other medicines used in combination with Rebetol before you begin combination treatment with this medicine.
Slovenian: Opozorilo: Prosimo, preberite poglavje "Druga zdravila" v navodilih za uporabo za druga zdravila, uporabljena v kombinaciji z zdravilom Rebetol, preden začnete s kombiniranim zdravljenjem s tem zdravilom.
English: Rebetol oral solution 40 mg/mL
Slovenian: Rebetol peroralna raztopina 40 mg/ml
English: If you are aHCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicineand peginterferon alfa may increase your risk of worsening liver function (combined anti-retroviral therapy (cART))and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Slovenian: Če ste odrasel bolnik, ki jesočasno okužen z virusoma HCV in HIVin prejematerapijo proti virusu HIV, lahko dodatek tega zdravila in peginterferona alfa-2b k terapiji poveča tveganje za poslabšanje delovanja jeter (kombinirana protiretrovirusna terapija (cART)) in tudi tveganje za nastanek laktacidoze, jetrne odpovedi in krvnih motenj (npr. zmanjšanje števila rdečih krvnih celic, ki prenašajo kisik po telesu, zmanjšanje števila določenih belih krvnih celic, ki služijo za boj proti okužbam, in zmanjšanje števila krvnih celic, ki so odgovorne za strjevanje krvi in jim pravimo trombociti) (NRTI).
English: This medicine stops the multiplication of hepatitis C virus.
Slovenian: To zdravilo ustavi razmnoževanje virusa hepatitisa C. Zdravila Rebetol ne smete uporabljati samega.
English: Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after 6 to 12 months of therapy and 6 months of follow-up.
Slovenian: Peroralne pripravke zdravila Rebetol v monoterapiji so proučevali v več kliničnih preskušanjih kot možnost zdravljenja kroničnega hepatitisa C. Izsledki teh raziskav so pokazali, da monoterapija z zdravilom Rebetol ni imela nobenega učinka na uničenje virusa hepatitisa (HCV-RNA) ali na izboljšanje jetrnega histološkega izvida po 6 do 12 mesecih terapije in nadaljnjih 6 mesecih spremljanja bolnikov.
English: The bioavailability of Rebetol 600 mg was decreased by co-administration with an antacid containing magnesium, aluminium and simethicone; AUCtf decreased 14 %.
Slovenian: Biološka uporabnost zdravila Rebetol v odmerku 600 mg se je zmanjšala pri sočasni uporabi antacida z magnezijem, aluminijem in simetikonom.
English: 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: 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 začetne vrednosti).
English: Each capsule contains 200 mg of ribavirin.
Slovenian: Ena kapsula vsebuje 200 mg ribavirina.
English: Genotype 2/3 67.9 (74/109) 70.3 (52/74)
Slovenian: Genotip 2/3 67,9 (74/109)
English: Depression, anxiety, emotional lability, insomnia
Slovenian: depresija, tesnoba, čustvena labilnost, nespečnost
English: Table 5 Adverse reactions reported during clinical trials or following the marketing use of Rebetol with pegylated interferon alfa-2b or interferon alfa-2b System Organ Class
Slovenian: Preglednica 5 Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v obdobju trženja zdravila Rebetol skupaj s pegiliranim interferonom alfa-2b ali interferonom alfa-2b Organski sistem
English: Patients were randomized to receive either Rebetol (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or Rebetol (800 mg/day) plus interferon alfa-2b (3 MIU TIW) for 48 weeks with a follow-up period of 6 months.
Slovenian: Bolnike so naključno razporedili bodisi v skupino, ki bo prejemala zdravili Rebetol (800 mg/dan) in peginterferon alfa-2b (1,5 µg/kg/teden), ali pa v skupino, ki bo prejemala zdravili Rebetol (800 mg/dan) in interferon alfa-2b (3 milijone i.e. trikrat na teden) v času 48 tednov, s 6-mesečnim spremljanjem.
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for contraindications specific to these products.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z zdravilom Rebetol, za kontraindikacije, specifične za ta zdravila.
English: This solution is packaged in 118 mL size amber glass bottles containing 100 mL of oral solution.
Slovenian: Taraztopina je pakirana v 118ml stekleničke iz stekla jantarne barve, ki vsebujejo po 100ml peroralne raztopine.Priložena je tudi 10ml peroralna odmerna brizga za merjenje odmerka.
English: While changes in laboratory values were observed in some patients treated with Rebetol used in combination with peginterferon alfa-2b in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
Slovenian: Čeprav so v kliničnem preskušanju pri nekaterih bolnikih, ki so prejemali zdravilo Rebetol v kombinaciji s peginterferonom alfa-2b, opazili spremembe laboratorijskih vrednosti, pa so se le-te povrnile na začetne vrednosti že v nekaj tednih po koncu zdravljenja.
English: No interaction studies have been conducted with Rebetol and other medicinal products, except for interferon alfa-2b and antacids.
Slovenian: Ni bilo opravljenih nobenih študij medsebojnega delovanja zdravila Rebetol z drugimi zdravili, razen za interferon alfa-2b in antacide.
English: Warnings and precautions There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Slovenian: Opozorila in previdnostni ukrepi Kombinirano zdravljenje z zdravilom Rebetol in (peg)interferonom alfa je povezano z več resnimi neželenimi učinki.
English: Rebetol 40 mg/mL oral solution ribavirin
Slovenian: Rebetol 40 mg/ml peroralna raztopina ribavirin
English: The concomitant use of Rebetol with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Slovenian: Zaradi povečanega tveganja za anemijo torej sočasna uporaba zdravila Rebetol z zidovudinom ni priporočljiva (glejte poglavje 4.4).
English: Immune system disorders Uncommon:
Slovenian: Bolezni imunskega sistema Občasni:
English: Table 1 Rebetol oral solution - Children and adolescents dosage to be administered with interferon alfa-2b or peginterferon alfa-2b Body Weight (kg)
Slovenian: Preglednica 1 Rebetol peroralna raztopina - Odmerjanje za otroke in mladostnike pri uporabi z interferonom alfa-2b ali peginterferonom alfa-2b Telesna masa (kg)
English: Endocrine disorders Common:
Slovenian: Bolezni endokrinega sistema Pogosti:
English: Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Slovenian: Preprečitvi zanositve bolnice med zdravljenjem je treba posvetiti posebno skrb (glejte poglavje 5.3).
English: The recommended dose of Rebetol combined with interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Slovenian: Priporočeni odmerek zdravila Rebetol v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b je prikazan v spodnji preglednici.
English: Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates
Slovenian: mrežnične krvavitve*, retinopatije (vključno z edemom makule)*, zapora mrežnične arterije*, zapora mrežnične vene*, nevritis vidnega živca*, edem papile*, zmanjšanje ostrine vida ali zmanjšanje vidnega polja*, eksudati na mrežnici
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m 3 times a week for 1 year followed by 6 months follow-up after treatment.
Slovenian: Zdravilo Rebetol v kombinaciji z interferonom alfa-2b Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV-RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT-PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo Rebetol prejemali v odmerku 15 mg/kg na dan skupaj z interferonom alfa-2b v odmerku 3 mio i.e./m2 trikrat na teden v času enega leta, čemur je sledilo 6-mesečno spremljanje po zdravljenju.
English: For example, the body weight dosing used in conjunction with interferon alfa-2b or peginterferon alfa-2b is shown in Table 1.
Slovenian: Kot primer je odmerjanje glede na telesno maso med souporabo z interferonom alfa-2b ali peginterferonom alfa-2b prikazano v preglednici 1.
English: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Slovenian: psoriaza, poslabšanje psoriaze, ekcem, preobčutljivostna reakcija za svetlobo, makulopapulozni izpuščaj, eritematozni izpuščaj, nočno potenje, hiperhidroza, dermatitis, akne, furunkuloza, eritem, urtikarija, kožne bolezni, podplutbe, povečano potenje, nenormalna tekstura las, bolezni nohtov*
English: Haemolysis: Rebetol can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Slovenian: Poleg tega so se pri bolnikih, ki so jemali zdravilo Rebetol, pojavili naslednji učinki: Hemoliza: Zdravilo Rebetol lahko povzroči razgradnjo rdečih krvnih celic in posledično anemijo, kar lahko poslabša delovanje srca ali poslabša simptome bolezni srca.
English: Table 1 Rebetol dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in paediatric patients Patient weight (kg)
Slovenian: Preglednica 1 Odmerek zdravila Rebetol na podlagi telesne mase, ko se pri pediatrični populaciji uporablja v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b Telesna masa bolnika (kg)
English: Cardiomyopathy, arrhythmia*
Slovenian: kardiomiopatija, aritmije*
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Slovenian: Zdravilo Rebetol v kombinaciji z interferonom alfa-2b V petletno dolgoročno opazovalno študijo za spremljanje bolnikov so vključili 97 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v dveh prej omenjenih multicentričnih preskušanjih.
English: Enuresis, micturition disorder, urinary incontinence, proteinuria Reproductive system and breast disorders Common:
Slovenian: enureza, motnje uriniranja, inkontinenca seča, proteinurija
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of Rebetol capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, two trials studied Rebetol in combination with peginterferon alfa-2b.
Slovenian: Dvojno zdravljenje s peginterferonom alfa-2b ali interferonom alfa-2b Varnost uporabe zdravila Rebetol kapsule so ovrednotili na podlagi izsledkov štirih kliničnih preskušanj pri bolnikih, ki še niso bili izpostavljeni interferonu (predhodno nezdravljeni bolniki).
English: Suicidal ideation, aggression, confusion, affect liability, behaviour disorder, agitation, somnambulism, anxiety, mood altered, restlessness, nervousness, sleep disorder, abnormal dreaming, apathy
Slovenian: samomorilne misli, agresija, zmedenost, občutek odgovornosti, vedenjske motnje, vznemirjenost, somnambulizem, tesnoba, spreminjajoče razpoloženje, nemir, živčnost, motnje spanja, nenormalne sanje, apatija
English: Uncommonly reported side effects (may affect up to 1 in 100 people): hearing or seeing images that are not present, heart attack, panic attack, hypersensitivity reaction to the medication, inflammation of pancreas, pain in bone, diabetes mellitus, muscle weakness.
Slovenian: Občasno poročani neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): slišati ali videti neobstoječe podobe, srčni napad, napad panike, preobčutljivostna reakcija na zdravilo, vnetje trebušne slinavke, bolečine v kosteh, sladkorna bolezen, mišična šibkost.
English: In addition, injection site disorders, pyrexia, anorexia, vomiting and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Slovenian: Poleg tega so se pri otrocih in mladostnikih pogosteje kot pri odraslih bolnikih pojavile težave na mestu injiciranja, zvišana telesna temperatura, anoreksija, bruhanje in čustvena labilnost.
English: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophoageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence
Slovenian: ulcerozni stomatitis, stomatitis, razjede v ustih, kolitis, bolečine v zgornjem desnem kvadrantu trebuha, dispepsija, gastroezofagealni refluks*, glositis, heilitis, napihnjenost trebuha, krvavitve iz dlesni, gingivitis, mehko blato, zobne bolezni, zaprtje, napenjanje
English: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour,nervousness, sleep disorder, decreased libido, apathy, abnormal dreams, crying
Slovenian: samomorilne misli, psihoza, agresivno vedenje, zmedenost, vznemirjenost, jeza, spremembe razpoloženja, nenormalno vedenje, živčnost, motnje spanja, zmanjšana spolna sla, apatičnost, nenormalne sanje, jok
English: For weight, pre-treatment to end of long-term follow-up, weight-for-age percentiles decreased 1.3 and 5.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Slovenian: Za telesno maso se je percentil telesne mase za starost od časa pred zdravljenjem do konca dolgoročnega spremljanja otrokom, zdravljenim 24 tednov, zmanjšal za 1,3 percentila in otrokom, zdravljenim 48 tednov, za 5,5 percentila.
English: Abdominal pain, abdominal pain upper, vomiting , diarrhoea, nausea
Slovenian: bolečine v trebuhu, bolečine v zgornjem delu trebuha, bruhanje, diareja, navzea
English: Rebetol in combination with peginterferon alfa-2b 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 Rebetol 15 mg/kg per day plus pegylated interferon alfa-2b 60 µg/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Slovenian: Zdravilo Rebetol v kombinaciji s peginterferonom alfa-2b Otroke in mladostnike, stare od 3 do 17 let, s kompenziranim kroničnim hepatitisom C in merljivimi koncentracijami HCV-RNA so vključili v multicentrično preskušanje in jih zdravili z zdravilom Rebetol 15 mg/kg na dan in pegiliranim interferonom alfa-2b 60 µg/m2 enkrat na teden v času 24 ali
English: What Rebetol contains
Slovenian: Kaj vsebuje zdravilo Rebetol
English: Patients were randomized to receive either Rebetol (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or Rebetol (800-1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Slovenian: Bolnike so naključno razporedili bodisi v skupino, ki bo prejemala zdravili Rebetol (800-1.200 mg/dan glede na telesno maso) in peginterferon alfa-2b (100 ali 150 µg/teden glede na telesno maso) ali pa zdravili Rebetol (800-1.200 mg/dan glede na telesno maso) in interferon alfa-2b (3 milijone i.e. trikrat na teden).
English: > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b), or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b) * In children and adolescent patients treated with Rebetol plus peginterferon alfa-2b, 1
Slovenian: > 5 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b) ali > 4 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b) * Pri otrocih in mladostnikih, zdravljenih z zdravilom Rebetol in peginterferonom alfa-2b, naj bo prvo zmanjšanje odmerka zdravila Rebetol na 12 mg/kg na dan, drugo zmanjšanje odmerka zdravila Rebetol pa na 8 mg/kg na dan.
English: For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Slovenian: Za indeks telesne mase (ITM) se je percentil ITM za starost od časa pred zdravljenjem do konca dolgoročnega spremljanja otrokom, zdravljenim 24 tednov, zmanjšal za 1,8 percentila in otrokom, zdravljenim 48 tednov, za 7,5 percentila.
English: Also, refer to peginterferon alfa-2b and interferon alfa-2b SmPCs for adverse reactions that may be attributable to interferons monotherapy.
Slovenian: Prosimo, glejte tudi povzetek glavnih značilnosti zdravila za peginterferon alfa-2b ali interferon alfa-2b za neželene učinke, ki jih pripisujejo monoterapiji z interferoni.
English: Rebetol in combination with interferon alfa-2b
Slovenian: Kombinirana terapija z interferonom alfa-2b
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-Rebetol for co-HCV infection (see section 4.4).
Slovenian: Pri HIV-pozitivnih bolnikih, ki so prejemali shemo NRTI skupaj z zdravilom Rebetol zaradi sočasne okužbe s HCV, so poročali o mitohondrijski toksičnosti in o laktacidozi (glejte poglavje 4.4).
English: Each mL of oral solution contains 40 mg of ribavirin.
Slovenian: En ml peroralne raztopine vsebuje 40 mg ribavirina.
English: Amnesia, memory impairment, syncope, migraine, ataxia, paresthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Slovenian: amnezija, motnje spomina, sinkopa, migrena, ataksija, parestezije, disfonija, izguba okusa, hipoestezija, hiperestezija, hipertonija,somnolenca, motnje pozornosti, tremor, disgevzija
English: - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease,
Slovenian: - Huda obstoječa srčna bolezen v anamnezi, vključno z nestabilno ali nenadzorovano srčno boleznijo v preteklih šestih mesecih (glejte poglavje 4.4).
English: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Slovenian: amnezija, motnje spomina, sinkopa, migrena, ataksija, parestezije, disfonija, izguba okusa, hipoestezija, hiperestezija, hipertonija, somnolenca, motnje pozornosti, tremor, disgevzija
English: Respiratory, thoracic and mediastinal disorders Very common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti:
English: HCV-RNA negative or ≥ 2 log decrease in viral load
Slovenian: Negativen izvid testa na HCV-RNA ali zmanjšanje virusnega bremena za ≥ 2 log
English: *Genotype 1 receive 48 weeks treatment **Genotype 2, 3 receive 24 weeks treatment ***The presented results are from a single point of time.
Slovenian: ** Genotipa 2 in 3 naj prejmeta 24 tednov zdravljenja.
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z zdravilom Rebetol.
English: Previously treated patients - Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa-2b in combination with Rebetol:
Slovenian: Predhodno zdravljeni bolniki - Ponovno zdravljenje s peginterferonom alfa-2b v kombinaciji z zdravilom Rebetol v primeru neuspešnega predhodnega zdravljenja (za bolnike s ponovitvijo bolezni in tiste, ki se niso odzvali na predhodno terapijo):
English: Multiple-dose pharmacokinetic properties for Rebetol capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 8.
Slovenian: Rebetol v kombinirani terapiji z interferonom alfa-2b Farmakokinetične lastnosti pri večkratnem odmerjanju zdravila Rebetol kapsule in interferona alfa-2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v preglednici 8.