FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in
Slovenian: V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Slovenian: Pri vseh bolnikih je treba opraviti osnovni pregled očesa, pri tistih bolnikih, ki tožijo o poslabšanju vida ali o izgubi vida, pa je treba takoj opraviti celoten pregled očesa.
English: The pharmacokinetics of ribavirin (dose-normalized) in this trial was similar to those reported in a prior study of ribavirin in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Slovenian: Farmakokinetika ribavirina (pri uporabi normaliziranega odmerka) v tem preskušanju je bila podobna farmakokinetiki, ugotovljeni v prejšnji študiji uporabe ribavirina v kombinaciji z interferonom alfa-2b pri otrocih in mladostnikih ter pri odraslih bolnikih.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa2b (with or without ribavirin), respectively.
Slovenian: Dolgoročni podatki o učinkovitosti - Odrasli bolniki V dve veliki, dolgoročni študiji spremljanja bolnikov po zdravljenju v prejšnjih študijah so vključili skupaj 1071 bolnikov po končanem zdravljenju z nepegiliranim interferonom alfa-2b (z ribavirinom ali brez njega) ter 567 bolnikov po končanem zdravljenju s pegiliranim interferonom alfa-2b (z ribavirinom ali brez njega).
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Povidone
Slovenian: Vsebina kapsule: mikroristalna celuloza laktoza monohidrat kroskarmeloza natrij povidon
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration, cardiac status and indirect bilirubin concentration.
Slovenian: Preglednica 2 prikazuje smernice za prilagoditev odmerka in prenehanje zdravljenja na podlagi bolnikove koncentracije hemoglobina in koncentracije indirektnega bilirubina.
English: Dose modification for adverse reactions
Slovenian: Prilagajanje odmerka pri neželenih učinkih
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Slovenian: bakterijska okužba (vključno s sepso), glivična okužba, gripa, okužba zgornjih dihal, bronhitis, herpes simpleks, sinuzitis, otitis media, rinitis, okužbe sečil
English: This medicine 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 pain, loss of consciousness, loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, loss of vision.
Slovenian: To zdravilo v kombinaciji s ali peginterferonom alfa-2b ali interferonom alfa-2b lahko povzroči tudi: temen, moten ali nenormalno obarvan urin, težave z dihanjem, spremembe srčnega utripa, bolečine v prsih, bolečino, ki se širi navzdol po levi roki, bolečina v čeljusti, izgubo zavesti, nezmožnost premikanja, povešanje ali izgubo moči obraznih mišic, izgubo občutka za dotik, izgubo vida.
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Slovenian: Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem*
English: Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30% for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Slovenian: Za ribavirin so dokazali veliko inter- in intraindividualno farmakokinetično variabilnost po enkratnem peroralnem odmerku (variabilnost pri posamezniku je bila približno 30 % tako za AUC kot za Cmax).
English: Ribavirin Mylan 200 mg hard capsules ribavirin
Slovenian: Ribavirin Mylan 200 mg trde kapsule ribavirin
English: Response to the treatment was measured by Sustained Virologic Response (SVR) which is defined as undetectable HCV-RNA at 24 weeks post-treatment (see Table 9).
Slovenian: Odziv bolnikov na zdravljenje so merili na podlagi trajnega virološkega odziva (SVR - Sustained Virologic Response), ki je opredeljen kot nemerljiva koncentracija HCV-RNA v 24. tednu po koncu zdravljenja (glejte Preglednico 9).
English: Conditions or restrictions regarding supply and use imposed on the marketing authorisation holder
Slovenian: • Pogoji ali omejitve v zvezi z dobavo in uporabo, odrejeni imetniku dovoljenja za promet
English: In case of serious adverse reaction potentially related to medicinal products used in combination with Ribavirin Mylan, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the ribavirin dose modification and/or discontinuation guidelines as described in Table 2.
Slovenian: Če se med kombiniranim zdravljenjem z zdravilom Ribavirin Mylan pojavijo resni neželeni učinki, ki bi lahko bili povezani s katerimo od zdravil, uporabljenih v kombinaciji, prosimo glejte ustrezne SmPC-je posameznih zdravil, uporabljenih v kombiniranem zdravljenju, saj nekateri režimi odmerjanja ne sledijo prilagajanju odmerjanja ribavirina in/ali smernicam za ukinjanje zdravila, kot je opisano v Preglednici 2).
English: Reminder: Please read the “Do not take” section of the Package Leaflet for interferon alfa-2b before you begin used in combination with this medicine.
Slovenian: Opozorilo: Prosimo, preberite poglavje “Ne uporabljajte” v navodilih za uporabo za interferon alfa-2b, pred začetkom kombiniranega zdravljenja s tem zdravilom.
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Slovenian: ženske: amenoreja, menoragija, menstrualne motnje, bolezni nožnice moški: bolečine v testisih
English: The response to treatment in both of these trials is presented in Table 11.
Slovenian: V Preglednici 11 je predstavljen odziv bolnikov na zdravljenje pri obeh preskušanjih.
English: NR: Non-responder- defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Slovenian: NR: Neodzivni bolniki so opredeljeni kot tisti, ki imajo pozitiven izvid na serumsko ali plazemsko HCV-RNA ob koncu najmanj 12 tednov zdravljenja.
English: Ribavirin has been shown in preclinical studies to be teratogenic and genotoxic see section 4.4 and 5.3).
Slovenian: Predklinične študije so pokazale, da je zdravilo Ribavirin Mylan teratogeno in genotoksično (glejte poglavji 4.4 in 5.3)
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Ribavirin Mylan.
Slovenian: Zato je priporočljivo, da pri vseh bolnikih pred pričetkom jemanja zdravila Ribavirin Mylan ovrednotite delovanje ledvic.
English: There were some cases of more severe neutropenia in patients treated with ribavirin capsules in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21%]; and WHO grade 4: 13 of 186 [7%]); WHO grade 3 leukopenia was also reported in 7% of this treatment group.
Slovenian: Bilo je tudi nekaj primerov hujše nevtropenije (3. stopnje po WHO: 39 od 186 [21 %] in 4. stopnje po WHO: 13 od 186 [7 %]) med bolniki, zdravljenimi z zdravilom Ribavirin Mylan trde kapsule v kombinaciji s peginterferonom alfa-2b; pri 7 % bolnikov iz te terapevtske skupine so poročali tudi o levkopeniji 3. stopnje po WHO (SZO).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE OSKRBE IN UPORABE
English: Ribavirin Mylan has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
Slovenian: Zdravilo Ribavirin Mylan nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, peginterferon alfa-2b ali interferon alfa-2b uporabljen v kombinirani terapiji pa imata lahko tovrsten učinek.
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 zidovudinom, se lahko poveča verjetnost za razvoj anemije (majhno število rdečih krvnih celic).
English: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Slovenian: Biološka uporabnost ribavirina v odmerku 600 mg se je zmanjšala pri sočasni uporabi antacida z magnezijem, aluminijem in simetikonom.
English: Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa2b when compared to patients receiving ribavirin in combination with interferon alfa-2b.
Slovenian: O hematoloških motnjah so poročali pogosteje pri bolnikih, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b, kot pri tistih, ki so prejemali ribavirin v kombinaciji z interferonom alfa-2b.
English: Thyroid supplemental monitoring specific for children and adolescents: Approximately 12% to 21% of children treated with Ribavirin and interferon alfa-2b (pegylated and non-pegylated) developed increase in thyroid stimulating hormone (TSH).
Slovenian: Dodatno spremljanje žleze ščitnice pri otrocih in mladostnikih Pri približno 12 do 21 % otrok, zdravljenih, z ribavirinom in z interferon alfa-2b (pegiliranim in nepegiliranim) se je pojavilo povečanje vrednosti tiroidee stimulirajočega hormona (TSH ).
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Slovenian: izolirana aplazija eritrocitov, idiopatska trombocitopenična purpura, trombotska trombocitopenična purpura
English: If serum creatinine rises to > 2 mg/dl (Table 2) Ribavirin Mylan and interferon alfa-2b must be discontinued.
Slovenian: Če se vrednost kreatinina v serumu zviša nad 2,0 mg/dl (Preglednica 2), morate zdravljenje z zdravilom Ribavirin Mylan in interferonom alfa-2b prekiniti.
English: Cardiac murmur * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or non-pegylated).
Slovenian: * Ker se ribavirin vedno predpisuje skupaj z zdravili, ki vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na izkušnjah v obdobju trženja in ne omogočajo natančne opredelitve pogostnosti, so zgoraj navedene pogostnosti povzete na osnovi kliničnih preskušanj z uporabo ribavirina v kombinaciji z interferonom alfa-2b (pegiliranim ali nepegiliranim).
English: Discontinue Ribavirin Mylan if:
Slovenian: Ribavirin Mylan, če*:
English: Genotype 1/4 23.0 (182/790)
Slovenian: Genotip 1/4 23,0 (182/790) 51,6 (94/182)
English: Use in children and adolescents If the child is weighing less than 47 kg or unable to swallow an oral solution of Ribavirin is available.
Slovenian: Če otrok tehta manj kot 47 kg ali ne more požirati je na voljo peroralna raztopina ribavirina.
English: If week 12 HCV-RNA is positive and decreased ≥ 2 log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Slovenian: Če pa je izvid določanja HCVRNA v 12. tednu pozitiven in za ≥ 2 log10 manjši od začetne vrednosti, pa v 24. tednu ponovno opravite določanje vrednosti HCV-RNA in če je izvid pozitiven, naj bolnik preneha z zdravljenjem.
English: Standard haematologic tests, blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Slovenian: Pred pričetkom zdravljenja morate pri vseh bolnikih opraviti standardne hematološke in biokemične preiskave krvi (celotno krvno sliko in diferencialno krvno sliko, število trombocitov, določanje vrednosti elektrolitov in serumskega kreatinina, jetrne funkcijske teste, določanje vrednosti sečne kisline) in test nosečnosti.
English: However, as in younger patients, renal function must be determined prior to administration of Ribavirin Mylan (see section 5.2).
Slovenian: Pri mlajših bolnikih, je potrebno pred začetkom dajanja zdravial Ribavirin Mylan določiti stopnjo delovanja ledvic (glejte poglavje section 5.2).
English: If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Slovenian: Če ocenite, da je pri takšnih bolnikih potrebno zdravljenje z interferonom alfa, morate pri njih skrbno preveriti, ali imajo morda kakšno sočasno psihiatrično motnjo in če obstaja nevarnost uživanja opojnih substanc.V tem primeru jih je treba skrbno obravnavati in ustrezno zdraviti še pred uvedbo zdravila.
English: Please refer to the corresponding SmPC of medicinal products that are used in combination with ribavirin for additional undesirable effects reported with these products.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z ribavirinom, za dodatne neželene učinke, poročane pri teh zdravilih.
English: In children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce Ribavirin Mylan dose to 7.5 mg/kg/day.
Slovenian: Pri otrocih in mladostnikih, ki se zdravijo z zdravilom Ribavirin Mylan v kombinaciji z interferonom alfa-2b, se odmerek zdravila Ribavirin Mylan zmanjša na 7,5 mg/kg/dan.
English: Propylene glycol Ammonia solution, concentrated Yellow iron oxide (E172) Indigotine (E132) Titanium dioxide (E171)
Slovenian: Ovoj kapsule: želatina titanov dioksid (E171) Napis na kapsuli: šelak propilenglikol koncentrirana raztopina amonijaka rumen železov oksid (E172) indigotin (E132) titanov dioksid (E171)
English: Ribavirin Mylan 200 mg hard capsules
Slovenian: Ribavirin Mylan 200 mg trde kapsule
English: Other medicines and Ribavirin Mylan
Slovenian: Druga zdravila in zdravilo Ribavirin Mylan
English: No interaction studies have been conducted with ribavirin and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Slovenian: Ni bilo opravljenih nobenih študij medsebojnega delovanja ribavirina z drugimi zdravili, razen za peginterferon alfa-2b, interferon alfa-2b in antacide.
English: Adult Patients (18 years of age or older): Ribavirin Mylan 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 serum HCV-RNA (see section 4.4).
Slovenian: Odrasli bolniki (stari 18 let ali več): Zdravilo Ribavirin Mylan je indicirano v kombinaciji z interferonom alfa-2b za zdravljenje odraslih bolnikov z vsemi tipi kroničnih hepatitisov C, z izjemo genotipa 1, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alanin-aminotransferaze (ALT) in so pozitivni na serumsko RNA-HCV (glejte poglavje 4.4).
English: Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Slovenian: Pri odločanju, ali je pred začetkom zdravljenja potrebna jetrna biopsija, upoštevajte tekoče terapevtske smernice.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso nevedeni v tem navodilu.
English: Blisters - No special storage conditions.
Slovenian: Pretisni omoti - Za shranjevanje niso potrebna posebna navodila.
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (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, ki je pri nekaterih bolnikih povzročil manjšo telesno višino (glejte poglavje 4.4).
English: The mechanism by which ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Slovenian: Mehanizem delovanja, prek katerega ribavirin v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b deluje proti HCV, ni znan.
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Slovenian: Pri bolnikih s pozitivnim izvidom na HIV in sočasno okužbo s HCV, ki prejemajo zaviralec nukleozidne reverzne transkriptaze (NRTI - »nucleoside reverse transcriptase inhibitor«) v povezavi z zdravljenjem (posebno ddI in d4T) z interferonom alfa-2b in ribavirinom, je potrebna previdnost.
English: p value b
Slovenian: Vredno st p b
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 12).
Slovenian: Stalen virološki odziv (SVR) pa je bil opredeljen kot nezaznavna vrednost HCV-RNA 24 tednov po zdravljenju (Preglednica 12).
English: Adult patients: Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed (see section 5.1).
Slovenian: Odrasli bolniki: Zdravilo Ribavirin Mylan je indicirano v kombinaciji z interferonom alfa-2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki so se predhodno odzvali (z normalizacijo vrednosti ALT na koncu zdravljenja) na monoterapijo z interferonom alfa, a se je bolezen kasneje ponovila (glejte poglavje 5.1).
English: The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa2b or peginterferon alfa-2b.
Slovenian: Neželeni učinki, navedeni v tem poglavju, izvirajo v prvi vrsti iz kliničnih preskušanj in/ali spontano poročanih neželenih učinkov, ko je bil ribavirin uporabljen v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b.
English: Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and in height percentiles were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (< 3
Slovenian: Hujšanje in zastoj rasti sta bila zelo pogosta med zdravljenjem (ob koncu zdravljenja je znašalo povprečno zmanjšanje telesne mase 15 percentilov, višine pa 8 percentilov glede na osnovno vrednost ) in tudi njihova hitrost rasti je bila zmanjšana (pri 70 % bolnikov se je upočasnila za do 3 percentile).
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two peginterferon alfa-2b/ ribavirin regimens [peginterferon alfa-2b 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 shemama peginterferona alfa -2b in ribavirin a [peginterferon alfa-2b v odmerku 1,5 µg/kg in 1 µg/kg subkutano enkrat na teden, oboje v kombinaciji z ribavirinom 800 do 1.400 mg peroralno na dan (v dveh deljenih odmerkih)] in zdravljenja s peginterferonom alfa-2a 180 µg enkrat na teden subkutano z ribavirinom 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 s tem zdravilom.
English: - The use of Ribavirin and interferon alfa-2b or peginterferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Slovenian: Uporaba ribavirina in interferona alfa-2b ali peginterferona alfa-2b pri otrocih in mladostnikih , ki imajo ali so kdaj imeli hude psihiatrične motnje v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje
English: Ribavirin Mylan is indicated for the treatment of chronic hepatitis C (CHC) and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (3 years of age and older) and adolescents).
Slovenian: Zdravilo Ribavirin Mylan je indicirano za zdravljenje kroničnega hepatitisa C (CHC) in ga morate uporabljati izključno v kombinaciji z interferonom alfa-2b (odrasli, otrocih, stari 3 leta in več, in mladostniki).
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare Nervous system disorders
Slovenian: nenormalno obnašanje, depresivno razpoloženje, emocijske motnje, strah, nočne more
English: Table 11 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients Study 11
Slovenian: Preglednica 11 Stalni virološki odziv glede na genotip po jemanju ribavirina v kombinaciji s peginterferonom alfa-2b pri bolnikih, sočasno okuženih s HCV in HIV Študija 1
English: Usual daily Ribavirin Mylan dose
Slovenian: Običajni dnevni odmerek zdravila Ribavirin Mylan
English: Pancytopenia: Ribavirin Mylan can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Slovenian: Pancitopenija: Zdravilo Ribavirin Mylan lahko v kombinaciji s peginterferonom povzroči zmanjšanje števila krvnih ploščic (trombocitov) in rdečih ter belih krvnih celic.
English: Note 2: In adult patients and children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce the interferon alfa-2b dose by one-half dose.
Slovenian: Opomba 2: Pri odraslih bolnikih in otrocih ter mladostnikih, ki se zdravijo z zdravilom Ribavirin Mylan v kombinaciji z interferonom alfa-2b, se odmerek interferona alfa-2b zmanjša na polovico odmerka.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Slovenian: hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, motnje koncentracije, somnolenca, motnje pozornosti, slabo spanje
English: Paediatric patients (children 3 years of age and older and adolescents): Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Slovenian: Pediatrični bolniki (otroci stari 3 leta ali več in mladostniki):Zdravilo Ribavirin Mylan je indicirano za uporabo v kombinirani terapiji z interferonom alfa-2b za zdravljenje otrok in mladostnikov, starih 3 leta in več, ki imajo predhodno nezdravljen kronični hepatitis C vseh tipov, z izjemo genotipa 1, brez jetrne dekompenzacije in pozitiven izvid na serumsko RNA-HCV.