FrancophonIA/ELRC3.0 huggingface dataset:
English: Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:
Slovenian: Tako bolnice kot bolniki morajo biti posebno previdni pri spolnih odnosih, če obstaja kakršna koli možnost za zanositev:
English: PVC/Aclar
Slovenian: PVC/Aclar - aluminij
English: • Men:
Slovenian: • Moški:
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Slovenian: V tej podskupini je bila stopnja stalnega virološkega odziva 56 % (463/823).
English: If it gets worse, your doctor will decide whether or not your Ribavirin Mylan treatment needs to be changed.
Slovenian: Če se poslabša, se bo zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Ribavirin Mylan ali ne.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Slovenian: Kadarkoli je mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
English: Study 22
Slovenian: Študija 2
English: ≥ 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Slovenian: ≥ 2 g/dl zmanjšanje vrednosti hemoglobina med katerimkoli 4-tedenskim obdobjem med zdravljenjem (stalno zmanjšanje odmerka)
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: This should be discussed with your doctor (see section “Do not take Ribavirin Mylan”).
Slovenian: Pogovorite se o tem z zdravnikom (glejte poglavje “Ne uporabljajte zdravila Ribavirin Mylan”).
English: Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Slovenian: Anemija se pojavi kmalu po začetku jemanja zdravila, vendar je hitro reverzibilna po koncu zdravljenja.
English: Dose modifications were required in 30% of patients, most commonly for anaemia and neutropenia.
Slovenian: Prilagoditev odmerka je bila potrebna pri 30 % bolnikov, najpogosteje zaradi anemije in nevtropenije.
English: Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Slovenian: Takoj se posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč, če kažejo neobičajne simptome obnašanja, se počutijo depresivno ali če želijo škodovati sebi ali drugim.
English: METAVIR Fibrosis Score F2
Slovenian: METAVIR Ocena fibroze F2
English: Gwent, NP22 3AA United Kingom
Slovenian: Gwent, NP22 3AA Velika Britanija
English: Routine monthly pregnancy tests must be performed during this time.
Slovenian: V tem času morate vsak mesec rutinsko opravljati nosečnostni test.
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Slovenian: sarkoidoza*, revmatoidni artritis (novi ali poslabšanje)
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5 year observational follow-up study.
Slovenian: Podatkov je sicer malo, a med 5-letno opazovalno spremljevalno študijo ni bilo dokazov o dolgoročnih učinkih na spolno dozorevanje.
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Slovenian: To pa ne izključuje pojava jetrnih dogodkov pri bolnikih s cirozo, vključno s hepatokarcinomom.
English: In this subgroup, there was a 92% (89/97) sustained virological response rate.
Slovenian: V tej podskupini bolnikov je bila stopnja stalnega virološkega odziva 92 % (89/97).
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Slovenian: • Zvišanje vrednosti hormonov povezanih s ščitnico (TSH) pri otrocih in mladostnikih.
English: Elderly (≥ 65 years of age)
Slovenian: Starejši (≥ 65 let)
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Slovenian: Omejena količina predhodnih podatkov kaže, da je lahko zdravljenje, ki traja 48 tednov, povezano z večjo stopnjo stalnega virološkega odziva (11/11) in z manjšim tveganjem za relaps (0/11 v primerjavi s 7/96 po 24 tednih zdravljenja).
English: • had a previous heart condition or have heart disease.
Slovenian: • imeli resno bolezen srca v preteklosti ali imate težave s srcem,
English: Renal failure, renal insufficiency*
Slovenian: ledvična odpoved, ledvična insuficienca*
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Slovenian: Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1,5 ure), čemur sledita hitra faza porazdelitve in faze podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku so 0,05, 3,73 in 79 ur).
English: You or your female partner must use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Slovenian: Vi in vaša partnerka morate uporabljati učinkovito kontracepcijsko zaščito v času jemanja ribavirina in še 7 mesecev po zaključku zdravljenja.
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Slovenian: Izrazit varnostni problem pri ribavirinu je hemolitična anemija, ki se pojavi v prvih tednih zdravljenja.
English: Hepatotoxicity (including fatalities)*
Slovenian: hHepatotoksičnost (vključno s smrtnimi primeri)*
English: Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Slovenian: Ni nujno, da se bodo pri vas pojavili vsi ti neželeni učinki, če pa se pojavijo, boste zaradi njih morda potrebovali zdravniško pomoč.
English: Male: impotence, prostatitis, erectile dysfunction.
Slovenian: moški: impotenca, prostatitis, motnje erekcije.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: The use of Ribavirin Mylan is contraindicated during pregnancy.
Slovenian: Uporaba zdravila Ribavirin Mylan je kontraindicirana v času nosečnosti.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Slovenian: Opomba:Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsule, je na voljo peroralna raztopina z učinkovino ribavirin, ki se lahko po potrebi uporabi.
English: Ribavirin (Ribavirin Mylan) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Slovenian: Ribavirin (Ribavirin Mylan) je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
English: If you are a woman who is breast-feeding, you must not take this medicine.
Slovenian: Če ste doječa mati, ne smete jemati tega zdravila.
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Slovenian: Te raziskave kažejo, da je kancerogenost ribavirina za človeka malo verjetna.
English: If necessary, an interdisciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Slovenian: Če je potrebno, uporabite interdisciplinarni pristop, skupaj z vključitvijo specialista s področja duševnega zdravja ali odvisnosti za oceno stanja, zdravljenje in spremljanje takega bolnika.
English: b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Slovenian: b: n = število preizkušancev, ki so se odzvali na zdravljenje, in število preizkušancev z danim genotipom virusa ter določena dolžina zdravljenja.
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Ribavirin Mylan and for seven months after treatment.
Slovenian: Čeprav podatki o približno 300 prospektivno spremljanih nosečnostih z izpostavljenostjo očeta ribavirinu niso pokazali ne povečanega tveganja za pojav malformacij v primerjavi s splošno populacijo, ne specifičnega vzorca malformacij, morate moškim bolnikom ali njihovim partnerkam v rodni dobi svetovati, naj med zdravljenjem z zdravilom Ribavirin Mylan in še sedem mesecev po koncu zdravljenja uporabljajo učinkovito kontracepcijo.
English: It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Slovenian: Ni znano, ali ima ribavirin iz sperme potencialne teratogene ali genotoksične učinke na človeški zarodek ali plod.
English: All patients in selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Slovenian: Pri vseh bolnikih zbranih v študijah kroničnega hepatitisa C so opravili jetrno biopsijo pred vključitvijo v študijo, toda v nekaterih primerih (tj. pri bolnikih z genotipoma 2 in 3), je lahko zdravljenje možno brez histološke potrditve.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Slovenian: Moškim z nosečo partnerko naročite, naj uporabljajo kondom, da se čim bolj zmanjša prehajanje ribavirina v partnerko.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin Mylan therapy:
Slovenian: Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo terapije z zdravilom Ribavirin Mylan:
English: The overall sustained response rate after a 24-week treatment duration was 50%.
Slovenian: Skupna stopnja stalnega virološkega odziva po 24-tedenskem zdravljenju je bila 50 %.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevton.
English: In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg = 1,000 mg and > 75 kg = 1,200 mg.
Slovenian: V teh primerih kjer ni na voljo specifičnih priporočil glede odmerjanja, je treba uporabiti naslednji odmerej: Telesna masa bolnika < 75 kg = 1000 mg in > 75 kg = 1200 mg.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje ki je naveden v Prilogi V*.
English: No response at Treatment Week
Slovenian: Ni odziva v tednu zdravljenja
English: Dose modification for paediatric patients
Slovenian: Prilagajanje odmerjanja pri pediatričnih bolnikih
English: The study results are summarized in Table 14.
Slovenian: Povzetek izsledkov študije je podan v Preglednici 14.
English: Dose modification for adults
Slovenian: Prilagajanje odmerjanja pri odraslih
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2)
Slovenian: Zdravilo, namenjeno izključno za uporabo na točno določenih specializiranih področjih (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Slovenian: Za navedene časovne točke (4. teden zdravljenja in 12. teden zdravljenja) so pokazali, da napovedujejo trajni virološki odziv (Preglednica 10).
English: • have another liver problem in addition to hepatitis C infection.
Slovenian: • imate poleg okužbe z virusom hepatitisa C še druge težave z jetri,
English: Preclinical data - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Slovenian: Plodnost Predklinični podatki - Plodnost: v študijah na živalih je ribavirin povzročil reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
English: Elderly patients (≥ 65 years of age)
Slovenian: Starejši bolniki ( 65 let starosti)
English: This was true for all HCV genotypes, particularly Genotype 1, in which the relapse rate was reduced by 30% compared with interferon alfa2b monotherapy.
Slovenian: To je veljalo za vse HCV genotipe, a še posebej za genotip 1, kjer se je delež ponovitev zmanjšal za 30 % v primerjavi z monoterapijo z interferonom alfa-2b.
English: Homicidal ideation*, mania*, mental status change
Slovenian: samomorilne misli*, manija*, spremembe duševnega stanja
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Slovenian: Za pediatrične bolnike (otroke in mladostnike) s telesno maso manj kot 47 kg je na voljo peroralna raztopina.
English: Ribavirin capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Slovenian: Zdravilo Ribavirin Mylan naj bolnik jemlje peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
English: Duration of treatment in children and adolescents
Slovenian: Trajanje zdravljenja pri otrocih in mladostnikih
English: Mitochondrial toxicity
Slovenian: Toksičnost za mitohondrije
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Slovenian: Čeprav bi lahko pri večini teh bolnikov zmanjšali odmerek, je pri tej skupini bolnikov potrebno skrbno spremljanje hematoloških parametrov (glejte poglavje 4.2, “Laboratorijske preiskave” v nadaljevanju in poglavje 4.8).
English: Very rarely reported side effects (may affect up to 1 in 10,000 people): suicide, stroke (cerebrovascular events).
Slovenian: Zelo redko poročani neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): samomor, možganska kap (možganskožilni dogodki).
English: − This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV-co-infection), as well as prognostic factors of response (HCV genotype and viral load).
Slovenian: To tveganje je treba pretehtati glede na značilnosti bolezni pri otroku, na primer glede na znake napredovanja bolezni (predvsem fibrozo), druge sočasne bolezni, ki bi lahko negativno vplivale na napredovanje bolezni (npr. sočasno okužbo s HIV), pa tudi prognostične dejavnike odziva na zdravljenje (genotip HCV in virusno breme).
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Slovenian: Zaradi možnosti tveganja neželenih učinkov pri dojenih otrocih, morajo matere pred začetkom zdravljenja z dojenjem prekiniti.
English: This will lessen the possibility for ribavirin to be left in the woman's body.
Slovenian: Tako boste zmanjšali potencialno nevarnost za prehajanje ribavirina v telo ženske.
English: Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Slovenian: Čeprav ribavirin nima neposrednih srčnožilnih učinkov, lahko anemija zaradi ribavirina povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
English: 2 capsules in the morning and 2 capsules in the evening See adult dose
Slovenian: 2 kapsuli zjutraj in 2 kapsuli zvečer Glejte odmerjanje za odrasle
English: Duration of treatment - Retreatment
Slovenian: Trajanje ponovnega zdravljenja:
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection = 125 IU/ml.
Slovenian: a: Odziv na zdravljenje je bil opredeljen kot nemerljiva vrednost HCV-RNA v 24. tednu po zdravljenju, spodnja meja detekcije = 125 i.e./ml.
English: Children and adolescents must not take combination therapy with Ribavirin Mylan and alpha interferon when there is existence or history of serious nervous or mental problems, such as severe depression, thoughts of suicide or attempted suicide.
Slovenian: Otrok in mladostnikov ni dovoljeno zdraviti s kombinacijo zdravila Ribavirin Mylan in alfa interferona, če so imeli v preteklosti resne živčne ali duševne težave, na primer hudo depresijo, samomorilne misli ali poskus samomora.
English: What Ribavirin Mylan is and what it is used for What you need to know before you take Ribavirin Mylan How to take Ribavirin Mylan Possible side effects
Slovenian: Kaj je zdravilo Ribavirin Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ribavirin Mylan Kako uporabljati zdravilo Ribavirin Mylan Možni neželeni učinki
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Slovenian: Poleg tega so pri pediatričnih bolnikih pogosteje poročali o samomorilnih mislih ali poskusih samomora kot pri odraslih bolnikih (2,4 % v primerjavi z 1 %) med zdravljenjem in v 6-mesečnem obdobju spremljanja bolnikov po zdravljenju.
English: − It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced height in some patients.
Slovenian: Pomembno je upoštevati, da kombinirana terapija povzroči zastoj rasti, ki je pri nekaterih bonikih povzročil manjšo telesno višino.
English: However, if a week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Slovenian: Če pa se je v 12. tednu pojavil odziv na zdravljenje, je bila razlika v stalnem virološkem odzivu (SVR) majhna, ne glede na predhodno zdravljenje ali bolnikov predhodni odziv na zdravljenje.
English: Contact your doctor immediately if you notice any of the following side effects occurring during combination treatment with an alpha interferon product:
Slovenian: Nemudoma se posvetujte z zdravnikom, če se pojavi kateri od naslednjih neželenih učinkov med zdravljenjem v kombinaciji z zdravilom, ki vsebuje alfa interferon:
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Slovenian: Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v anamnezi in/ali s predhodnimi ali obstoječimi motnjami srčnega ritma morate strogo nadzorovati.
English: Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2).
Slovenian: Za zmanjševanje odmerka pri pediatričnih bolnikih brez bolezni srca veljajo za vrednosti hemoglobina enake smernice kot za odrasle bolnike brez bolezni srca (Preglednica 2).
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy can induce a growth inhibition that may be irreversible in some patients.
Slovenian: Pri odločitvi glede odložitve zdravljenja do odrasle dobe je pomembno upoštevati, da kombinirano zdravljenje lahko povzroča zastoj rasti, ki je pri nekaterih bolnikih lahko ireverzibilen.
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Slovenian: Tako ribavirin kot njegovi triazolski karboksamidni in triazolski karboksikislinski presnovki se izločajo tudi prek ledvic.
English: B.
Slovenian: D.
English: Table 3 Management of Adverse Reactions Laboratory Values
Slovenian: Preglednica 3 Obvladovanje neželenih učinkov Laboratorijske vrednosti
English: Children and adolescents are particularly prone to develop depression when being treated with ribavirin and interferon alpha.
Slovenian: Otroci in mladostniki so še bolj nagnjeni k depresiji kadar so zdravljeni z ribavirinom in interferonom alfa.
English: This medicine does not affect your ability to drive or use machines; however, interferon alfa-2b may affect your ability to drive or use machines.
Slovenian: To zdravilo ne vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, medtem ko interferon alfa-2b lahko vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji.
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Slovenian: Za otroke in mladostnike, ki ne morejo pogoltniti trde kapsule je na voljo peroralna raztopina ribavirina.
English: The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Slovenian: Izbira terapevtske sheme mora temeljiti na pričakovani učinkovitosti in varnosti kombinirane terapije za vsakega posameznega bolnika (glejte poglavje 5.1).
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast feeding”)
Slovenian: • moški in je vaša partnerica v rodni dobi (glejte poglavje “Nosečnost in dojenje”),
English: The Ribavirin Mylan hard capsule is a white, opaque, hard capsule imprinted with green ink.
Slovenian: Trde kapsule zdravila Ribavirin Mylan so bele, neprozorne, trde kapsule z zelenim črnilom nastisnjeno oznako.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Slovenian: • ženska v rodni dobi (glejte poglavje “Nosečnost in dojenje”),
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Slovenian: Vmesna analiza je pokazala visoko stopnjo stalnega virološkega odziva v tej podskupini (n=49), ki je bila tudi prospektivno potrjena (n=48).
English: You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Slovenian: Vaš test nosečnosti mora biti negativen pred zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
English: Package leaflet: Information for the patient
Slovenian: Navodilo za uporabo: Informacije za uporabnika
English: This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
Slovenian: Ta koristen učinek se je ohranjal ne glede na standardne napovedne dejavnike odziva na interferon alfa-2b, npr. virusno breme, HCV genotip in histološka stopnja bolezni.
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Slovenian: Dolgoročnejši podatki, ki so na voljo za otroke, ki so se zdravili s kombinirano terapijo s pegiliranim interferonom/ ribavirinom kažejo znatno upočasnitev rasti.
English: Ribavirin Dose (mg/kg)
Slovenian: Odmerek ribavirina (mg/kg)
English: All Genotypes Genotype 1 Genotype 2 Genotype 3c Genotype 4
Slovenian: Vsi genotipi Genotip 1 Genotip 2 Genotip 3