FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not have sex with a pregnant woman unless you use a condom.
Slovenian: Ne smete imeti spolnih odnosov z nosečo žensko brez uporabe kondoma.
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 kakršnakoli možnost za zanositev:
English: Anorexia, increased appetite, decreased appetite
Slovenian: anoreksija, povečan apetit, zmanjšan apetit
English: The patient was observed for two days in the emergency room, during which time no adverse reaction from the overdose was noted.
Slovenian: Bolnika so opazovali dva dni na urgentnem oddelku in v tem času niso ugotovili nobene neželene reakcije zaradi prevelikega odmerka.
English: Reduce ribavirin dose* if:
Slovenian: Odmerek ribavirina zmanjšajte*, če:
English: Suicide attempts, panic attack, hallucination
Slovenian: poskus samomora, napad panike, halucinacije
English: No histopathological effects on bone were observed.
Slovenian: Pri tem niso opažali nikakršnih histopatoloških učinkov na kosti.
English: Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Slovenian: Uporaba nukleozidnih analogov, samih ali v kombinaciji z drugimi nukleozidi, je povzročila laktacidozo.
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: • have another liver problem in addition to hepatitis C infection.
Slovenian: • imate poleg okužbe s hepatitisom C še kakšno drugo težavo z jetri,
English: Haemodialysis (ESRD)
Slovenian: Hemodializa (ESRD)
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: This will lessen the possibility for ribavirin to be left in the woman's body.
Slovenian: Tako boste zmanjšali možnost za prehajanje ribavirina v telo ženske.
English: Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo v kombinaciji z drugimi zdravili neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Slovenian: Ob koncu obdobja okrevanja so bile spremembe na tibialni in femoralni kosti minimalne, čeprav so bile na splošno statistično pomembne v primerjavi s kontrolno skupino samcev pri vseh velikostih odmerka ter pri samicah, ki so prejemale dva največja odmerka v primerjavi s kontrolno skupino.
English: Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Slovenian: Glejte navodilo za uporabo (peg)interferona alfa za podrobnejše informacije o teh varnostnih vprašanjih.
English: Paediatric patients (children 3 years of age and older and adolescents)
Slovenian: Pediatrični bolniki (otroci, stari 3 leta ali več, in mladostniki)
English: These include:
Slovenian: Med njimi so:
English: Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Slovenian: Anemija se pojavi kmalu po začetku prejemanja zdravila, vendar je hitro reverzibilna po koncu zdravljenja.
English: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Slovenian: V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so podatki za 210 od 412 preiskovancev (51 %).
English: The majority of adverse reactions reported in the study were mild or moderate in severity.
Slovenian: Neželeni učinki, o katerih so poročali v tej študiji, so bili po jakosti večinoma blagi ali zmerni.
English: Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Slovenian: Populacijska farmakokinetična analiza je bila opravljena z uporabo redko vzorčenih serumskih koncentracij iz štirih kontroliranih kliničnih preskušanj.
English: Potential to exacerbate immunosuppression
Slovenian: Možnost za poslabšanje imunosupresije
English: Do not chew the film-coated tablets.
Slovenian: Filmsko obloženih tablet ne smete žvečiti.
English: Genotype 1
Slovenian: Genotip 1
English: The other ingredients are
Slovenian: - Druge sestavine so:
English: Do not take Ribavirin Teva Pharma B.V. if any of the following apply to you or the child you are caring for.
Slovenian: Ne jemljite zdravila Ribavirin Teva Pharma B.V., če se katero od navedenega nanaša na vas ali otroka, za katerega skrbite.
English: Discontinue ribavirin if:
Slovenian: Ribavirin prenehajte uporabljati, če:
English: Transient rashes do not necessitate interruption of treatment.
Slovenian: Pri prehodnem izpuščaju ni potrebna prekinitev zdravljenja.
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 112 film-coated tablets 140 film-coated tablets 168 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 112 filmsko obloženih tablet 140 filmsko obloženih tablet 168 filmsko obloženih tablet
English: Routine monthly pregnancy tests must be performed during this time.
Slovenian: V tem času morate vsak mesec redno opravljati teste nosečnosti.
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Slovenian: Laboratorijske preiskave je treba opraviti v 2. in 4. tednu zdravljenja, kasneje pa periodično glede na klinično stanje bolnika.
English: Ribavirin plus interferon
Slovenian: Ribavirin + interferon
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Slovenian: Za pediatrične bolnike (otroke in mladostnike), ki tehtajo manj kot 47 kg je na voljo peroralna raztopina.
English: > 4 mg/dL (adults)
Slovenian: > 4 mg/dl (odrasli)
English: Do not take more than the recommended dosage and take the medicine for as long as prescribed.
Slovenian: Ne prekoračite predpisanega odmerka in zdravilo jemljite tako dolgo, kot vam je predpisal zdravnik.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Slovenian: Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno zdravljenje, vendar lahko zahtevajo prekinitev zdravljenja.
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Slovenian: HCV genotip in začetna vrednost virusne obremenitve sta prognostična dejavnika, za katera je znano, da vplivata na odziv.
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Slovenian: S standardnimi preiskavami krvi vam bodo preverjali kri, ledvice in delovanje jeter.
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 uvedbo zdravljenja z zdravilom Ribavirin Teva:
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 bo ribavirin iz sperme povzročil svoje potencialne teratogene ali genotoksične učinke na človeški zarodek ali plod.
English: Nucleoside analogues
Slovenian: Nukleozidni analogi
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Slovenian: V študijo je bilo vključenih 118 bolnikov; od tega je bilo 57 % moških, 80 % kavkazijcev, 78 % bolnikov z genotipom 1 in 64 % otrok, starih ≤12 let.
English: Sustained response was assessed by the response rate six months after the cessation of treatment.
Slovenian: Trajni virološki odziv so ocenjevali na podlagi odziva šest mesecev po prenehanju zdravljenja.
English: Previously treated adult patients:
Slovenian: Predhodno zdravljeni odrasli bolniki:
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Slovenian: Zmanjšanje števila celic CD4+ je bilo reverzibilno in se je popravilo po zmanjšanju odmerka ali po prekinitvi terapije.
English: It is not known whether ribavirin is excreted in human milk.
Slovenian: Ni znano, ali se ribavirin pri ljudeh izloča v materino mleko.
English: Adults:
Slovenian: Odrasli:
English: Of these, sixty-three were sustained responders.
Slovenian: Triinšestdeset od teh bolnikov je imelo trajen odziv.
English: Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Slovenian: Konvencionalne študije kancerogenosti pri glodavcih z majhnimi izpostavljenostmi v primerjavi z izpostavljenostjo pri človeku v terapevtskih pogojih (faktor 0,1 pri podganah in 1 pri miših) niso pokazale nobene tumorogenosti ribavirina.
English: Haemoglobin Adult: ≥ 12 g/dL (females); ≥ 13 g/dL (males) Children and adolescents: ≥ 11 g/dL (females); ≥ 12 g/dL (males)
Slovenian: Odrasli ≥12 g/dl (ženske); ≥13 g/dl (moški) Otroci in mladostniki ≥11 g/dl (ženske); ≥12 g/dl (moški)
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Slovenian: Poleg tega so bile pri 98 % bolnikov (51/52), ki so imeli normalne vrednosti ALT v 24. tednu spremljanja, ob njihovem zadnjem obisku ohranjene normalne vrednosti ALT.
English: Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Slovenian: Kaže, da so učinki teh sospremenljivk na očistek ribavirina omejenega kliničnega pomena zaradi precejšnje rezidualne variabilnosti, ki je ta model ni upošteval.
English: There are no data in children or adolescents with a history of cardiac disease.
Slovenian: Ni podatkov o otrocih in mladostnikih s srčno boleznijo v anamnezi.
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Slovenian: Te študije kažejo, da je kancerogenost ribavirina za človeka malo verjetna.
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Slovenian: Zato je priporočljivo pred uvedbo ribavirina pri vseh bolnikih ovrednotiti delovanje ledvic.
English: The decision to treat should be made on a case by case basis (see section 4.4).
Slovenian: Odločitev za zdravljenje mora biti sprejeta za vsak primer posebej (glejte poglavje 4.4).
English: Bipolar disorder*
Slovenian: bipolarna motnja*
English: Ribavirin must be used in combination with other medicinal products (see section 5.1).
Slovenian: Ribavirin je treba uporabljati v kombinaciji z drugimi zdravili (glejte poglavje 5.1).
English: Take your prescribed dose by mouth with water and during your meal.
Slovenian: Predpisani odmerek zaužijte z vodo, med jedjo.
English: Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination.
Slovenian: Odmerjanje pri otrocih, starejših od 3 let, in mladostnikih je odvisno od posameznikove telesne mase in zdravil, uporabljenih v kombinaciji.
English: * Number (%) of patients a. Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Slovenian: * Število (%) bolnikov a. Opredeljeno kot vrednost serumske RNA-HCV pod mejo detekcije z uporabo raziskovalnega testa RT-PCR ob koncu zdravljenja in v obdobju spremljanja bolnikov.
English: The mechanism by which ribavirin in combination with other medicinal products exerts its effects against HCV is unknown.
Slovenian: Mehanizem delovanja, preko katerega ribavirin v kombinaciji z drugimi zdravili deluje proti HCV, ni znan.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Slovenian: Takšno delovanje lahko zveča tveganje za pojav laktacidoze, ki jo povzročajo analogi purinskih nukleozidov (npr. didanozin ali abakavir).
English: Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Slovenian: Raziskave genotoksičnosti so pokazale, da ima ribavirin nekaj genotoksičnega delovanja.
English: 3 MIU/m2 3 times a week (n = 54)
Slovenian: 3 mio i.e./m2 3-krat na teden (n = 54)
English: - If you have or develop severe kidney or liver problems, this treatment will be stopped.
Slovenian: - Če imate hude težave z ledvicami ali jetri oziroma če se tovrstne težave pojavijo, bo zdravljenje ustavljeno.
English: 15 mg/kg/day as 2 divided doses (n = 17)
Slovenian: 15 mg/kg/dan v obliki 2 deljenih odmerkov (n = 17)
English: You or your female partner must use an effective contraceptive during the time you are taking this medicine and for 7 months after stopping treatment.
Slovenian: Vi ali vaša partnerka morate uporabljati učinkovito kontracepcijo v času jemanja tega zdravila in še 7 mesecev po zaključku zdravljenja.
English: Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Slovenian: Ribavirin je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
English: Tell your doctor or pharmacist if you or the child you are caring for, are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with ribavirin may increase your risk of developing severe blood disorders.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če vi ali otrok, za katerega skrbite: - jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati: - azatioprin je zdravilo, ki zavira delovanje vašega imunskega sistema; njegova uporaba v kombinaciji z ribavirinom lahko poveča tveganje za nastanek hudih krvnih bolezni.
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 čimbolj zmanjša prehajanje ribavirina v partnerko.
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Slovenian: Dodatno zdravljenje s samimi alfa interferoni ali v kombinaciji z ribavirinom lahko namreč poveča tveganje pri tej podskupini bolnikov.
English: In general, the adverse reactions profile in children and adolescents was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition.
Slovenian: Na splošno je bil profil neželenih učinkov pri otrocih in mladostnikih podoben, kot so ga opazili pri odraslih, čeprav pri pediatričnih bolnikih obstaja tudi posebna skrb glede zastoja rasti.
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Slovenian: • Zvišanje hormonov povezanih s ščitnico (TSH) pri otrocih in mladostnikih.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults.
Slovenian: Populacija je vključevala predvsem otroke z blagim do zmernim hepatitisom C. V dveh multicentričnih študijah je bil delež trajnega virološkega odziva pri otrocih in mladostnikih podoben tistemu pri odraslih.
English: Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Slovenian: Bolnike, ki so med zdravljenjem utrujeni, zaspani ali zmedeni, morate torej opozoriti, da ne smejo voziti ali upravljati s stroji.
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Slovenian: Izrazit varnostni problem pri ribovirinu je hemolitična anemija, ki se pojavi v prvih tednih zdravljenja.
English: The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Slovenian: Razviti model očistka je pokazal, da so glavne sospremenljivke telesna masa, spol, starost in serumski kreatinin.
English: Teratogenic risk
Slovenian: Tveganje za teratogenost
English: The decision to treat should be made on a case by case.
Slovenian: Odločitev za zdravljenje mora biti sprejeta za vsakega bolnika posebej.
English: Combination therapy also decreased the relapse rate.
Slovenian: Kombinirana terapija je tudi zmanjšala odstotek ponovitev bolezni.
English: Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Slovenian: Ribavirin ima dve presnovni poti: 1) reverzibilno fosforilacijsko pot ter; 2) razgradno pot, ki obsega deribozilacijo in amidno hidrolizo in tvori triazolski karboksikislinski presnovek.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Slovenian: Kot odrasli bolniki so imeli tudi otroci in mladostniki še druge psihiatrične neželene učinke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje 4.4).
English: A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.
Slovenian: Dominantni poskus letalnosti pri podganah je bil negativen, kar pomeni, da se morebitne mutacije pri podganah niso prenašale prek moških gamet.
English: The attempt to self-harm has also been reported in adults, children, and adolescents.
Slovenian: Pri odraslih, otrocih in mladostnikih so poročali tudi o poskusih samopoškodovanja.
English: The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Slovenian: Varnost in učinkovitost uporabe ribavirina skupaj z neposredno delujočimi protivirusnimi zdravili pri teh bolnikih nista dokazani.
English: Homicidal ideation*, mania*, mental status change
Slovenian: morilske misli*, manija*, spremembe duševnega stanja
English: Prior to initiation of treatment with ribavirin the physician must comprehensively inform both male and female patients of the teratogenic risk of ribavirin, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with ribavirin (see section 4.6).
Slovenian: Pred uvedbo zdravljenja z ribavirinom mora zdravnik bolnike in bolnice izčrpno seznaniti s teratogenim tveganjem ribavirina, potrebo po učinkoviti in stalni kontracepciji, možnostjo za neuspešnost kontracepcije ter možnimi posledicami nosečnosti, če se ta pojavi med zdravljenjem ali po zdravljenju z ribavirinom (glejte poglavje 4.6).
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Slovenian: Če vaša partnerka sicer trenutno ni noseča, a je v rodni dobi, mora opraviti test nosečnosti vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
English: The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Slovenian: Razmerje koncentracij ribavirina v polni krvi proti plazmi je približno 60 proti 1; prebitek ribavirina v polni krvi pa je v obliki ribavirinskih nukleotidov, sekvestriranih v eritrocitih.
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Slovenian: Vrednost HCV-RNA je treba med zdravljenjem meriti periodično (glejte poglavje 4.2).
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Slovenian: pljučni infiltrati*, pnevmonitis*, intersticijski pnevmonitis*
English: Dose modification for paediatric patients
Slovenian: Prilagoditev odmerka pri pediatričnih bolnikih
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 stanje obvladali z zmanjšanjem odmerka, je pri tej skupini bolnikov potrebno skrbno spremljanje hematoloških parametrov (glejte poglavje 4.2, »Laboratorijske preiskave« v nadaljevanju in poglavje 4.8).
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, povezana z ribavirinom, povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
English: Haemoglobin in patients with No Cardiac Disease
Slovenian: Hemoglobin pri bolnikih brez srčne bolezni
English: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Slovenian: Ni videti, da bi starost pomembno vplivala na farmakokinetiko ribavirina.
English: Nephrotic syndrome*
Slovenian: nefrotski sindrom*
English: Among those patients with elevated uric acid levels, very few patients treated with the combination developed clinical gout, none of which required treatment modification or discontinuation from the clinical trials.
Slovenian: Med bolniki s povečanimi vrednostmi sečne kisline se je le pri zelo majhnem številu bolnikov, zdravljenih s to kombinacijo, pojavil klinično opazen protin in pri nobenem ni bila potrebna prilagoditev zdravljenja ali izločitev iz kliničnega preskušanja.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Slovenian: Zaradi nevarnosti za pojav neželenih reakcij pri dojenih otrocih, moramo dojenje ukiniti pred pričetkom zdravljenja.
English: This appears to be due to reduction of apparent clearance in these patients.
Slovenian: Kot kaže, je to posledica zmanjšanja navideznega očistka ribavirina pri tovrstnih bolnikih.
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Slovenian: Ribavirin ne zavira encimov citokroma P450.
English: Dosing of ribavirin for children and adolescent patients is determined by the patient body weight.
Slovenian: Odmerek ribavirina za otroke in mladostnike se določi na podlagi bolnikove telesne mase.
English: Treatment with ribavirin in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Slovenian: Zdravljenje z ribavirinom v kombinaciji s peginterferonom alfa-2b je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
English: Table 2 Management of Adverse Reactions Laboratory values
Slovenian: Preglednica 2 Obvladovanje neželenih učinkov Laboratorijske vrednosti