FrancophonIA/ELRC3.0 huggingface dataset:
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Slovenian: HCV genotip in virusna obremenitev na začetku zdravljenja sta znana prognostične dejavnika, ki vplivata na pogostnost odziva.
English: The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Slovenian: Relativna koristnost kombinirane terapije z zdravilom Viraferon in ribavirinom je še posebej pomembna za podskupino bolnikov, ki jih je najtežje zdraviti (genotip 1 in velika virusna obremenitev) (Preglednica 3).
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Slovenian: Pri izdelavi zdravil iz človeške krvi ali plazme upoštevamo določene ukrepe za preprečevanje prenosa okužb na bolnike.
English: Viraferon is used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Slovenian: Viraferon se uporablja za zdravljenje odraslih bolnikov kroničnega hepatitisa B ali C, ki sta virusni okužbi jeter.
English: if you have had a severe nervous or mental disorder.
Slovenian: - če ste imeli kdaj v preteklosti hudo bolezen živčevja ali duševno bolezen.
English: Other side effects not listed above may also occur in some patients.
Slovenian: Pri nekaterih bolnikih se lahko pojavijo tudi drugi neželeni učinki, ki niso navedeni zgoraj.
English: Toxicity was demonstrated in monkeys given 100 x 106 IU/kg/day for 3 months.
Slovenian: Raziskave pa so pokazale toksičnost interferona pri opicah, ki so prejemale 100 x 106 i.e./kg na dan 3 mesece.
English: Enuresis, micturition disorder, urinary incontinence
Slovenian: enureza, motnje uriniranja, urinska inkontinenca
English: if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
Slovenian: če ste prejeli presadek organa, bodisi ledvice ali jeter, bi lahko zdravljenje z interferonom povečalo tveganje za njegovo zavrnitev.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Slovenian: Če pride do te reakcije, naj si potem temeljito sperejo usta.
English: Psychiatric and central nervous system (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
Slovenian: Psihiatrične motnje in centralni živčni sistem (CŽS): Med terapijo z zdravilom Viraferon so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6-mesečnem obdobju spremljanja.
English: For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
Slovenian: Za odmerke, ki ustrezajo polnim obratom, se mora lestvica poravnati s pravilno oznako odmerka, za tiste odmerke, ki ustrezajo klikom med polnimi obrati, pa se mora poravnati med dvema ustreznima oznakama odmerka za polni obrat.
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Slovenian: Če sumite na sindrom VKH, morate bolniku ukiniti protivirusno zdravljenje in se posvetovati glede uvedbe kortikosteroidne terapije (glejte poglavje 4.8).
English: Overall, in both studies, patients who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin.
Slovenian: Na splošno so v obeh študijah opazili, da je bila pri bolnikih, ki so prejemali zdravilo Viraferon z ribavirinom, manjša verjetnost za odziv kot pri tistih, ki so prejemali pegiliran interferon alfa-2b z ribavirinom.
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Slovenian: Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih učinkov in mora po potrebi uvesti ustrezno terapijo.
English: In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Slovenian: V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte poglavje 4.4).
English: All Genotypes
Slovenian: Vsi genotipi
English: Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in combination with ribavirin (from two studies) are shown in Table 3.
Slovenian: Pogostnosti ohranjenega virološkega odziva za terapevtske skupine, zdravljene eno leto z zdravilom Viraferon v monoterapiji ali v kombinaciji z ribavirinom (iz dveh raziskav) so podane v preglednici 3.
English: After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Slovenian: Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v 24 urah, če jo shranjujete v hladilniku (2°C - 8°C).
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10); rarely (≥1/10,000, <1/1,000); very rarely (<1/10,000); not known.
Slovenian: V okviru razvrstitve po organskih sistemih so neželeni učinki dodatno navedeni po pogostnosti v naslednje kategorije: zelo pogosti (≥1/10), pogosti (≥1/100, <1/10), redki (≥1/10.000, <1/1.000), zelo redki (<1/10.000) oziroma pogostnost ni znana.
English: Paediatric Use: Children are particularly prone to develop depression when being treated with Viraferon and ribavirin.
Slovenian: Uporaba pri otrocih: Otrocih so še bolj nagnjeni k depresiji kadar so zdravljeni z zdarvilom Viraferon in ribavirinom.
English: Do not use Viraferon after the expiry date which is stated on the package.
Slovenian: Zdravila Viraferon ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Slovenian: Pridobiva se iz klona E. coli, v katerega je vgrajen plasmidni hibrid izdelan z genetskim inženiringom, ki vsebuje gen za interferon alfa-2b iz človeških levkocitov.
English: Милко Бичев" № 7, ет.3
Slovenian: Милко Бичев" № 7, ет.3 BG-София 1504
English: Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Slovenian: Kronični hepatitis B: Zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki imajo znake replikacije virusa hepatitisa B (prisotnost HBV-DNA in HBeAg), povečano vrednost alanin-aminotransferaze (ALT) in histološko dokazano aktivno vnetje in/ali fibrozo jeter.
English: Viraferon has been classified as recombinant interferon alfa-2b.
Slovenian: Viraferon je opredeljen kot rekombinantni interferon alfa2b.
English: During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary.
Slovenian: Med sočasno terapijo s ksantinskimi snovmi morate spremljati serumsko koncentracijo teofilina in po potrebi prilagoditi odmerek zdravila.
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Slovenian: Dodatek terapije z alfa interferoni, in sicer v monoterapiji ali v kombinaciji z ribavirinom, lahko poveča tveganje pri tej podskupini bolnikov.
English: Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Slovenian: Viraferon je sterilna, stabilna formulacija visokoprečiščenega interferona alfa-2b, ki ga izdelujemo s tehnikami rekombinantne DNA.
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Slovenian: Bolniki, ki so nagnjeni k nastanku avtoimunskih bolezni, so lahko bolj ogroženi zaradi tega.
English: • swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
Slovenian: • otekanje dlani, stopal, gležnjev, obraza, ustnic, ust ali žrela, ki lahko povzroči težave s požiranjem ali dihanjem, koprivnica, izguba zavesti.
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCVRNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Slovenian: V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCVRNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV-RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
English: While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Slovenian: Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so ga opažali tudi pri tistih z malignimi boleznimi, zdravljenimi z interferonom alfa.
English: The aetiology has not been defined.
Slovenian: Etiologija teh motenj ni bila ugotovljena.
English: Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the injection needle (Diagram I).
Slovenian: Potrkajte po rezervoarju s prstom, da bodo morebitni zračni mehurčki splavali na vrh rezervoarja, tik pod injekcijsko iglo (slika I).
English: High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus monkeys.
Slovenian: Tudi za velike odmerke drugih oblik interferonov alfa in beta je znano, da povzročijo od odmerka odvisne učinke v smislu izgube ovulacije ali splava pri opicah rhesus.
English: Relapse patients (adults): Viraferon is given in combination with ribavirin.
Slovenian: Bolniki z relapsom bolezni (odrasli): Viraferon se uporablja v kombinaciji z ribavirinom.
English: The appropriate dose can then be withdrawn with a sterile injection syringe and injected.
Slovenian: Potem lahko posesate ustrezni odmerek v sterilno injekcijsko brizgo in ga injicirate.
English: Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Slovenian: Vsi bolniki, ki tožijo o spremembah ostrine vida ali vidnega polja ali ki imajo druge oftalmološke simptome med zdravljenjem z zdravilom Viraferon, morajo biti takoj poslani na celoten oftalmološki pregled.
English: In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
Slovenian: V kliničnih raziskavah, opravljenih pri širokem razponu indikacij in širokem razponu odmerkov (od 6 mio i.e./m2 na teden pri dlakastocelični levkemiji do največ 100 mio i.e./m2 na teden pri melanomu), so bili najpogosteje opaženi neželeni učinki zvišana telesna temperatura, utrujenost, glavobol in mialgija.
English: Driving and using machines Do not drive or use machinery if you become drowsy, tired, or confused from this medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če postanete zaradi tega zdravila zaspani, utrujeni ali zmedeni, ne vozite in ne upravljajte strojev.
English: Chronic hepatitis B:
Slovenian: Kronični hepatitis B:
English: Pull off the cap of the pen and disinfect the rubber membrane (see Diagram C) with one cleansing swab.
Slovenian: Snemite pokrovček peresnika in dezinficirajte gumijasto opno (slika C) z enim čistilnim tamponom.
English: If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
Slovenian: Če si sami injicirate zdravilo Viraferon ali ga dajete otroku v kombinaciji z ribavirinom, injicirajte priporočeni odmerek takoj, ko se spomnite, in nadaljujte z zdravljenjem kot običajno.
English: In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
Slovenian: V Preglednici 1 je podana pogostnost z zdravljenjem povezanih neželenih učinkov, o katerih so poročali predhodno nezdravljeni bolniki v kliničnih preskušanjih, v katerih so se zdravili eno leto.
English: Dosages that are to be administered 3 times a week are best given every other day.
Slovenian: Pri odmerjanju zdravila 3-krat na teden je najbolje, da ga jemljete vsak drugi dan.
English: Slowly inject the diluent, aiming the stream of liquid at the glass wall of the vial in order to avoid production of air bubbles.
Slovenian: Počasi injicirajte topilo v vialo, curek tekočine pa usmerite proti stekleni steni viale, da preprečite nastajanje zračnih mehurčkov.
English: Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).
Slovenian: Viraferon je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitivne izvide za serumsko HCV-RNA ali anti-HCV (glejte poglavje 4.4).
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Slovenian: Rekombinantni interferon alfa-2b tudi zavira replikacijo virusov in vitro in in vivo.
English: The vial and injection materials intended for single use must be discarded.
Slovenian: Vialo in pripomočke za injiciranje, ki so namenjeni za enkratno uporabo, morate zavreči.
English: These are all very serious side effects.
Slovenian: Vsi ti neželeni učinki so zelo resni.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Slovenian: Če opazite kakšne mehurčke, potegnite bat nekoliko nazaj in nežno potrkajte po brizgi, pri čemer naj bo igla usmerjena navzgor, dokler ne bodo mehurčki izginili.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
Slovenian: Pri nekaterih bolnikih so ugotavljali močnejšo otopelost in komo, vključno s primeri encefalopatije, običajno pri starostnikih, zdravljenih z večjimi odmerki.
English: Do not use Viraferon if you notice changes in the appearance of Viraferon.
Slovenian: Ne uporabljajte zdravila Viraferon, če opazite spremembe videza zdravila Viraferon.
English: If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Slovenian: Če rentgenogram pokaže pljučne infiltrate ali znake motenosti pljučne funkcije, morate bolnika skrbno nadzorovati in po potrebi ukiniti interferon alfa.
English: Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in Schering-Plough monitored clinical trials.
Slovenian: Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri bolnikih, ki so prejeli zdravilo Viraferon v kliničnih raziskavah, ki so potekale pod nadzorom družbe Schering-Plough.
English: Any patient developing liver function abnormalities during treatment with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Slovenian: Vse bolnike, pri katerih se med zdravljenjem z zdravilom Viraferon pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo.
English: Gently push the injection needle onto the pen as shown in Diagram E. (Notice that the rear portion of the injection needle will pierce through the rubber membrane that you disinfected previously).
Slovenian: Nežno potisnite injekcijsko iglo na peresnik, kot je prikazano na sliki E. (Opomba: Zadnji del injekcijske igle bo predrl skozi gumijasto opno, ki ste jo prej dezinficirali).
English: Children and adolescents: if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Slovenian: Otroci in mladostniki: - če ste kdaj imeli resno živčno ali duševno bolezen, npr. hudo depresijoali samomorilne misli.
English: If you are injecting Viraferon yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Slovenian: Če si zdravilo Viraferon injicirate sami, pazite, da bo predpisani odmerek jasno napisan na pakiranju zdravila, ki ga jemljete.
English: Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject Viraferon”).
Slovenian: Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (nanaša se na "Kako si sami injicirate zdravilo Viraferon").
English: The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Slovenian: Neželeni učinki, ki so navedeni v Preglednici 2, so povzeti iz pediatričnih kliničnih preskušanj.
English: Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T. Then return the pen to the refrigerator.
Slovenian: Pokrovček peresnika postavite nazaj na peresnik, pri čemer naj bo trikotnik spet nasproti kazalnika odmerkov, kot je prikazano na sliki T. Vrnite peresnik v hladilnik.
English: In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
Slovenian: V kliničnih preskušanjih pri skupini bolnikov s hepatitisom C so bolnike eno leto zdravili z zdravilom Viraferon samostojno ali v kombinaciji z ribavirinom.
English: Pack of 1, 6 or 12.
Slovenian: Pakiranje po 1, 6 ali 12.
English: Increase in serum ALT/AST (SGPT/SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Slovenian: Povečanje serumske vrednosti ALT/AST (SGPT/SGOT) so opažali kot motnjo pri nekaterih bolnikih brez hepatitisa in tudi pri nekaterih bolnikih s kroničnim hepatitisom B, in je sovpadalo z očistkom virusne DNAp.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b.
Slovenian: = milijonov mednarodnih enot; TIW = trikrat na teden a: vrednost p na podlagi Cochran-Mantel Haenszelovega testa hi-kvadrat b: vrednost p na podlagi testa hi-kvadrat c: preiskovanci s telesno maso < 75 kg so prejemali odmerek 100 µg/teden pegiliranega interferona alfa-2b in preiskovanci s telesno maso ≥ 75 kg so prejemali 150 µg/teden pegiliranega interferona alfa-2b.
English: Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
Slovenian: Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom Viraferon.
English: Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Slovenian: Tudi bolniki in njihove partnerke morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SPC za ribavirin).
English: The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Slovenian: Uporaba interferona alfa-2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje 4.3).
English: It is recommended that those patients who have pre-existing cardiac abnormalities and/or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Slovenian: Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCVRNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Viraferon 3 MIU/m
Slovenian: 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 Viraferon prejemali v odmerku 3 mio i.e./m2
English: Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Slovenian: Pred uvedbo terapije z zdravilom Viraferon za zdravljenje kroničnega hepatitisa C določite serumsko koncentracijo tirotropnega hormona (TSH).
English: This leaflet was last approved on
Slovenian: Navodilo je bilo odobreno
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Slovenian: Bolniki, primerni za vključitev v te raziskave, so imeli kronični hepatitis C, ki je bil potrjen s pozitivnim izvidom testa polimerazne verižne reakcije za HCV-RNA (PCR) (> 100 kopij/ml), izvidom jetrne biopsije, ki je histološko potrdil diagnozo kroničnega hepatitisa brez drugega vzroka za kronični hepatitis, ter nenormalno serumsko vrednostjo ALT.
English: Pack sizes of 1, 2 or 8
Slovenian: Velikosti pakiranj: 1, 2 ali 8 kompletov.
English: What Viraferon looks like and contents of the pack
Slovenian: Izgled zdravila Viraferon in vsebina pakiranja
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Slovenian: To je granulomatozna vnetna bolezen, ki vpliva na oči, ušesa, možganske ovojnice in kožo.
English: The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
Slovenian: Odmerjanje pa je individualno in zdravnik bo lahko vaš odmerek prilagodil vašim potrebam:
English: Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Slovenian: Zelo redko opisani neželeni učinki (pri manj kot 1 na vsakih 10.000 bolnikov): nizek krvni tlak, zabuhel obraz, sladkorna bolezen, krči v nogah, bolečine v hrbtu, težave z ledvicami, poškodbe živcev, krvavitev iz dlesni, aplastična anemija.
English: The pen is now ready to set the dose.
Slovenian: Peresnik je zdaj pripravljen za nastavitev odmerka.