FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children (see section 4.4).
Slovenian: Znižanje srednje vrednosti telesne mase opazovanih bolnikov (50. percentila) v enem letu po začetku spremljanja je bilo najbolj izrazito pri otrocih pred puberteto (glej poglavje 4.4).
English: The use of ribavirin is contraindicated in patients with severe hepatic impairment or decompensated cirrhosis (see section 4.3).
Slovenian: Uporaba ribavirina je kontraindicirana pri bolnikih s hudo jetrno okvaro ali dekompenzirano cirozo (glejte
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is
Slovenian: Pri bolnikih, pozitivnih na HIV, ki se zdravijo po shemi NRTI, mora zdravnik skrbno spremljati pokazatelje toksičnost za mitohondrije in laktacidoze pri sočasnem zdravljenju z ribavirinom, še posebej:
English: The safety and efficacy of this combination have been established only using ribavirin together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Slovenian: Varnost in učinkovitost te kombinacije je bila ugotovljena le pri uporabi ribavirina skupaj z raztopino za injiciranje peginterferona alfa-2b ali interferona alfa-2b.
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) are similar in adults and
Slovenian: Farmakokinetika zdravila Ribavirin BioPartners in interferona alfa-2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
English: Female partners of male patients must have a routine pregnancy test performed monthly during treatment and for seven months thereafter (see
Slovenian: Partnerke bolnikov morajo rutinsko opravljati nosečnostni test vsak mesec med zdravljenjem in še sedem mesecev po njem (glejte poglavje 4.6).
English: Ribavirin BioPartners film-coated tablets in combination with interferon alfa-2b:
Slovenian: Filmsko obložene tablete zdravila Ribavirin BioPartners v kombinaciji z interferonom alfa-2b:
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite Diabetes mellitus, hypertriglyceridemia*
Slovenian: hipotiroidizem, hipertiroidizem hiperglikemija, hiperurikemija, hipokalciemija, dehidracija, povečan tek, žeja sladkorna bolezen, hipertrigliceridemija*
English: Study 22
Slovenian: Preglednica 8.
English: Table 4 Adverse reactions reported during clinical trials or following the marketing use of Ribavirin with pegylated interferon alfa-2b or interferon alfa-2b System Organ Class
Slovenian: Preglednica 4 Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v okviru izkušenj v obdobju trženja z uporabo zdravila Ribavirin skupaj s pegiliranim interferonom alfa-2b ali interferonom alfa-2b Razvrstitev po organskih sistemih
English: • Ribavirin (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Slovenian: • Ribavirin (1.000/1.200 mg/dan) + interferon alfa-2b (3 mio i.e. trikrat na teden) (n = 505).
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition is observed, the reversibility of which is uncertain (see section 4.4).
Slovenian: V času kombinirane terapije s pegiliranim interferonom alfa-2b in ribavirinom, ki je trajala do 48 tednov, so opazili tudi zastoj rasti, katerega reverzibilnost ni gotova (glejte poglavje 4.4).
English: If you are self-administering treatment, or if you are the caregiver of a child taking Ribavirin BioPartners in combination with interferon alfa-2b, take/administer the missed dose as soon as possible during the same day.
Slovenian: Če ste pozabili vzeti zdravilo Ribavirin BioPartners Če si sami dajete kombinirano terapijo zdravila Ribavirin BioPartners z interferonom alfa-2b ali če dajete terapijo otroku, za katerega skrbite, vzemite/dajte pozabljeni odmerek čim prej v istem dnevu.
English: Patients with pre-existing eye disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic eye exams during combination therapy with ribavirin and an alpha interferon.
Slovenian: Bolniki z obstoječimi očesnimi boleznimi (npr. z diabetično ali hipertenzivno retinopatijo) pa morajo imeti med prejemanjem kombinirane terapije z ribavirinom in interferoni alfa periodične očesne preglede.
English: Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Slovenian: Bolezen se je ponovila pri dvanajstih od 492 bolnikov s trajnim virološkim odzivom iz prve skupine in le pri 3 od 366 bolnikov s trajnim virološkim odzivom iz druge skupine, ki so bili
English: Hepatic function: Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) are similar to those of normal controls.
Slovenian: Delovanje jeter: Pri bolnikih z blagimi, zmernimi ali hudimi motnjami delovanja jeter (A, B ali C po Child-Pughu) je farmakokinetika enkratnih odmerkov ribavirina podobna kot pri normalnih
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 sočasno okuženi s HCV in HIV, ki imajo število celic CD4 manjše od 200 celic/μl, je na voljo malo podatkov o učinkovitosti in varnosti zdravila (N = 25).
English: Please refer to the respective Summary of Product Characteristics 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 ribavirin in combination with peginterferon alfa-2b.
Slovenian: Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se bolj zavedali toksičnih učinkov vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z zdravilom Ribavirin BioPartners v kombinaciji s peginterferonom alfa-2b.
English: Ribavirin BioPartners in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: - dark, cloudy or abnormally coloured urine, - difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw
Slovenian: Zdravilo Ribavirin BioPartners v kombinaciji s peginterferonom alfa-2b ali z interferonom alfa-2b temen, moten ali nenormalno obarvan seč, težave z dihanjem, spremembe srčnega utripa, bolečine v prsih, bolečine navzdol po levi roki,
English: Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells).
Slovenian: Pri bolnikih, zdravljenih s kombinirano terapijo interferonov alfa z ribavirinom v kombinaciji z zidovudin se lahko poveča verjetnost za razvoj anemij (majhno število rdečih krvnih celic).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ribavirin BioPartners film-coated tablet contains 200 mg of ribavirin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta zdravila Ribavirin BioPartners vsebuje 200 mg ribavirina.
English: If severe adverse reactions or laboratory abnormalities develop during therapy with ribavirin and interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Slovenian: Če se med zdravljenjem z zdravilom ribavirin in interferonom alfa-2b pojavijo hudi neželeni učinki ali nenormalni izvidi laboratorijskih preiskav, odmerek vsakega zdravila po potrebi prilagajajte, dokler neželene reakcije ne izginejo.
English: Please refer to the respective Summary of Product Characteristics 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 Ribavirin
Slovenian: Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se zavedali toksičnih učinke vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z ribavirinom v kombinaciji s
English: - Haemoglobinopathies (e.g., thalassemia, sickle-cell anaemia).
Slovenian: − hemoglobinopatije (npr. talasemija, anemija srpastih celic);
English: Ribavirin BioPartners in combination with an alpha interferon product may also cause: - aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy,
Slovenian: Zdravilo Ribavirin BioPartners v kombinaciji z zdravili, ki vsebujejo alfa interferon, lahko povzroči aplastično anemijo, čisto eritrocitno aplazijo (stanje, kjer telo preneha proizvajati eritrocite ali jih proizvaja manj); to povzroči hudo anemijo, katere simptomi običajno vključujejo neobičajno utrujenost ali pomanjkanje energije, privide, vnetje zgornjega in spodnjega respiratornega trakta, vnetje trebušne slinavke,
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Slovenian: Med farmakološke učinke zdravil Ribavirin BioPartners sodi tudi zvečanje količine fosforiliranih presnovkov purinskih nukleozidov in vitro.
English: Number of 200 mg tablets 1 tablet in the morning and 2 tablets in the evening
Slovenian: 1 tableta zjutraj in 2 tableti zvečer
English: Dosing for children and adolescent patients is determined by body weight for Ribavirin BioPartners and by body surface area for interferon alfa-2b.
Slovenian: Odmerek za otroke in mladostnike se za zdravilo Ribavirin BioPartners določi na podlagi bolnikov telesne mase in za interferon alfa-2b na podlagi bolnikove telesne površine.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin therapy:
Slovenian: Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred
English: ** Refer to the SPC for interferon alfa-2b for dose modification and discontinuation.
Slovenian: ** Glejte povzetek glavnih značilnosti zdravila za interferon alfa-2b za prilagajanje odmerka in prekinitev zdravljenja.
English: NAME OF THE MEDICINAL PRODUCT Ribavirin BioPartners 200 mg film-coated tablets
Slovenian: IME ZDRAVILA Ribavirin BioPartners 200 mg filmsko obložene tablete
English: - Co-infected patients with advanced liver disease receiving HAART may be at increased risk of worsening liver function.
Slovenian: - sočasno okuženi bolniki z napredovalo jetrno boleznijo, ki prejemajo močno aktivno protiretrovirusno terapijo (HAART), imajo lahko povečano tveganje za pojav poslabšane jetrne funkcije.
English: Adult patients: Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Slovenian: Odrasli bolniki: Zdravilo Ribavirin BioPartners je indicirano v kombinaciji s interferonom alfa-2b za zdravljenje odraslih bolnikov kroničnega hepatitisa C katerekoli vrste razen genotipa 1, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alanin-aminotransferaze (ALT) in so pozitivni na ribonukleinsko kislino virusa hepatitisa C RNA-HCV (glejte poglavje 4.4).
English: SVR after treatment of chronic HCV with non-pegylated interferon alfa-2b with ribavirin results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Slovenian: SVR po zdravljenju kronične okužbe s HCV z nepegiliranim interferonom alfa-2b z ribavirinom vodi do dolgoročnega očistka virusa, s čimer zagotovimo odpravo jetrne okužbe in klinično 'ozdravitev' kronične okužbe s HCV.
English: Because of co-administration with peginterferon alfa-2b or interferon alfa-2b: - Autoimmune hepatitis; or history of autoimmune disease.
Slovenian: Zaradi sočasne uporabe peginterferona alfa-2b ali interferona alfa-2b pa še: − avtoimunski hepatitis ali avtoimunska bolezen v anamnezi.
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 9.
Slovenian: Ribavirin v kombinirani terapiji z interferonom alfa-2b Farmakokinetične lastnosti pri večkratnem odmerjanju ribavirina in interferona alfa-2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 9.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Slovenian: Otroke in mladostnike morate spremljati na vsake 3 mesece glede morebitnih znakov motenj delovanja žleze
English: Only 1 subject discontinued therapy as the result of an adverse reaction (thrombocytopenia).
Slovenian: Zaradi neželenih učinkov je bilo zdravljenje ukinjeno le pri enem preizkušancu (po pojavu trombocitopenije).
English: Combination therapy with ribavirin and an alpha interferon should be discontinued in patients who develop new or worsening eye disorders.
Slovenian: Kombinirano terapijo z ribavirinom in interferoni alfa je treba ukiniti pri tistih bolnikih, ki se jim na novo pojavi očesna bolezen ali se jim poslabša obstoječa očesna bolezen.
English: - decrease in blood clotting cells called platelets (that may result in easy bruising and spontaneous
Slovenian: Pogosti neželeni učinki: zmanjšanje števila krvničk, odgovornih za strjevanje krvi, ki jim pravimo trombociti (kar lahko vodi do nagnjenosti k nastanku podplutb in spontanih krvavitev),
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of Ribavirin BioPartners and peginterferon alfa-2b may increase your risk of worsening liver function highly active anti-retroviral therapy (HAART) 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 odrasli bolnik, ki je sočasno okužen z virusoma HCV in HIV in prejema terapijo proti virusu HIV, lahko dodajanje zdravila Ribavirin BioPartners in peginterferona alfa-2b zviša tveganje za motnje delovanja jeter, močno aktivna protiretrovirusna terapija (HAART) in zviša tveganje za pojav laktacidoze, jetrne odpovedi in nastanek krvne motnje (zmanjšanje števila eritrocitov, ki prenašajo kisik, nekaterih belih krvnih celic, ki se borijo proti okužbam ter krvnih celic za strjevanje krvi, ki se imenujejo trombociti) (NRTI).
English: The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Slovenian: Kadar je bil zidovudin vključen v shemo zdravljenja okužbe s HIV, so poročali o poslabšanju anemije zaradi jemanja ribavirina, čeprav natančen mehanizem tega pojava ni znan.
English: Children 3 years of age and older and adolescents: Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.
Slovenian: Otroci stari 3 leta ali več in mladostniki: Zdravilo Ribavirin BioPartners je namenjeno za uporabo v kombinirani terapiji z interferonom alfa-2b za zdravljenje otrok, starih 3 leta ali več in mladostnikov, ki imajo predhodno nezdravljen kronični hepatitis C katerekoli vrste razen genotipa 1, brez jetrne dekompenzacije in pozitiven izvid na RNA-HCV.
English: Reminder: Please read the “Taking other medicines” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment.
Slovenian: Opozorilo: Prosimo, prebrati morate tudi poglavje „Jemanje drugih zdravil“ v navodilih za uporabo za interferona alfa-2b, preden začnete s kombiniranim zdravljenjem.
English: Read all of this leaflet carefully before you start taking this medicine - Keep this leaflet.
Slovenian: Pred začetkom jemanja natančno preberite navodilo!
English: Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during combination therapy with alpha interferons.
Slovenian: Bolniki z obstoječimi očesnimi boleznimi (npr. diabetična ali hipertenzivna retinopatija) bi morali imeti med kombinirano terapijo z interferoni alfa občasno oftalmološki pregled.
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Slovenian: Ženske: amenoreja, menoragija, menstrualne motnje, dismenoreja, bolečine v dojkah, bolezni jajčnikov, bolezni nožnice.
English: Table 7 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Slovenian: Preglednica 7 Stalni virološki odziv glede na genotip po jemanju ribavirina v kombinaciji s peginterferonom alfa-2b pri bolnikih, sočasno okuženih s HCV in HIV Študija 22
English: Retreatment of relapse patients with ribavirin and interferon alfa-2b combination treatment Two trials examined the use of ribavirin and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Slovenian: V dveh preskušanjih so raziskovali uporabo kombinacije ribavirina in interferona alfa-2b pri bolnikih s ponovitvijo bolezni (C95-144 in I95-145); 345 bolnikov s kroničnim hepatitisom, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom, so zdravili šest mesecev, in jih nato spremljali še šest mesecev.
English: Table 6 Sustained response rates with Ribavirin + peginterferon alfa-2b (by ribavirin dose [mg/kg], genotype and viral load) P 1.5/R
Slovenian: Preglednica 6 Trajni virološki odziv pri uporabi zdravila Ribavirin + peginterferon alfa-2b (po odmerku zdravila Ribavirin [mg/kg], genotipu in virusni obremenitvi)
English: For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Slovenian: pridobljena lipodistrofija (13 %), zmanjšano število limfocitov CD4 (8 %), zmanjšan tek (8 %), zvišana vrednost gama glutamiltransferaze (9 %), bolečine v hrbtu (5 %), zvišana vrednost amilaze v krvi (6 %), zvišana koncentracija mlečne kisline v krvi (5 %), citolitični hepatitis (6 %), zvišana vrednost lipaze (6 %) in bolečine v udih (6 %).
English: Based on interim data from the long-term follow-up portion of this study, 22 % (16/74) of children had a > 15 percentile decrease in height percentile, of whom 3 (4 %) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Slovenian: Vmesni podatki, pridobljeni na podlagi dolgoročnega spremljanja bolnikov kažejo, da se je tudi več kot eno leto po zaključku zdravljenja počasnejša telesna rast nadaljevala, saj se je telesna višina pri 22 % (16/74) otrok zmanjšala za več kot 15 percentilov, od tega pri treh (4 %) za več kot 30 percentilov.
English: A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4.
Slovenian: V Preglednici 4 je za primerjavo podano tudi nekaj neželenih učinkov, ki so jih običajno pripisovali zdravljenju z interferoni, vendar so jih prijavili tudi med zdravljenjem hepatitisa C (v kombinaciji z ribavirinom).
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: − Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: • Ribavirin (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514).
Slovenian: • Ribavirin (1.000/1.200 mg/dan) + peginterferon alfa-2b (1,5 mikrogramov/kg na teden en mesec, potem pa 0,5 mikrogramov/kg na teden 11 mesecev) (n = 514).
English: (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) (affects less than 1 user in 10,000) Not known (frequency cannot be estimated from the available data) The following side effects have been reported with the combination of ribavirin and an alpha
Slovenian: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) (pojavijo se pri 1 do 10 od 100 bolnikov) (pojavijo se pri 1 do 10 od 1.000 bolnikov) (pojavijo se pri 1 do 10 od 10.000 bolnikov) (pojavijo se pri manj kot 1 od 10.000 bolnikov) Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: • Ribavirin (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511).
Slovenian: • Ribavirin (800 mg/dan) + peginterferon alfa-2b (1,5 mikrogramov/kg na teden) (n = 511).
English: Interferon alfa-2b: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Slovenian: Interferon alfa-2b: V farmakokinetični študiji večkratnih odmerkov niso beležili nobenih farmakokinetičnih interakcij med ribavirinom in peginterferonom alfa-2b ali interferonom alfa-2b.
English: Seek medical advice immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Ribavirin BioPartners Če se med zdravljenjem pojavijo simptomi hude alergijske reakcije, nemudoma poiščite zdravniški nasvet (npr. težave z dihanje, piskanje v pljučih ali koprivnica).
English: Dose to be administered for the combination therapy with interferon alfa-2b:
Slovenian: Odmerki za dajanje pri kombinirani terapiji z interferonom alfa-2b:
English: Ribavirin BioPartners must be used in combination with interferon alfa-2b.
Slovenian: Zdravilo Ribavirin BioPartners morate uporabljati v kombinaciji z interferonom alfa 2-b.
English: Laboratory values for HCV/HIV co-infected patients:
Slovenian: Laboratorijske vrednosti pri bolnikih, sočasno okuženih s HCV in HIV:
English: < 25 x 109/l (adults) < 50 x 109/l (children and adolescents) 2.5 x ULN* > 4 mg/dl (adults) > 5 mg/dl (for > 4 weeks) (children and adolescents treated with interferon alfa-2b),
Slovenian: > 4 mg/dl (odrasli) > 5 mg/dl (za > 4 tedne) (otroci in mladostniki, zdravljeni z interferonom alfa2b)
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, pierksija, anoreksija, bruhanje in čustvena labilnost.