FrancophonIA/ELRC3.0 huggingface dataset:
English: If the abnormality is reversed, ribavirin may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Slovenian: Če nepravilnost izgine, se lahko ribavirin znova začne uporabljati v odmerku 600 mg na dan, katerega se nato po presoji lečečega zdravnika poveča na 800 mg na dan.
English: The effects on growth were less in those children treated for 24 weeks than those treated for 48 weeks.
Slovenian: Učinki na rast so bili pri otrocih, zdravljenih 24 tednov, manjši kot pri otrocih, zdravljenih 48 tednov.
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: 2 tablets in the morning and 2 tablets in the evening or 1 (400 mg) tablet in the morning and 1 (400 mg) tablet in the evening See adult dose
Slovenian: 2 tableti zjutraj in 2 tableti zvečer ali 1 (400 mg) tableta zjutraj in 1 (400 mg) tableta zvečer
English: Previously untreated patients:
Slovenian: Predhodno nezdravljeni bolniki:
English: • Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.).
Slovenian: • Psihiatrični učinki in učinki na osrednje živčevje (na primer depresija, samomorilne misli, poskus samomora in agresivno vedenje itd.).
English: Dose reduction of ribavirin depends on the initial ribavirin posology which depends on the medicinal product that is used in combination with ribavirin.
Slovenian: Zmanjšanje odmerka ribavirina je odvisno od začetnega odmerjanja ribavirina, ki pa je odvisno od zdravila, uporabljenega v kombinaciji z ribavirinom.
English: Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Slovenian: Prehajanje ribavirina v neplazemske prostore so najobsežneje proučevali na eritrocitih in ugotovili, da poteka predvsem preko ekvilibracijskega nukleozidnega prenašalca tipa es.
English: Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Slovenian: Zdravljenje mora uvesti in spremljati le zdravnik z izkušnjami pri zdravljenju bolnikov s kroničnim hepatitisom C.
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Slovenian: Poročali so o primerih mitohondrijske toksičnosti, še posebej v obliki laktacidoze in pankreatitisa, od katerih so bili nekateri smrtni (glejte poglavje 4.4).
English: Growth rate decrease (height and/or weight decrease for age)
Slovenian: zmanjšana hitrost rasti (zmanjšana telesna višina oziroma telesna masa glede na starost)
English: Mitochondrial toxicity
Slovenian: Mitohondrijska toksičnost:
English: Seventy percent (68/97) of all enrolled subjects completed this study of which 75 % (42/56) were sustained responders.
Slovenian: 70 % (68/97) vseh v študijo vključenih preiskovancev je študijo dokončalo in od tega jih je 75 % (42/56) doseglo trajni virološki odziv.
English: Skin laceration
Slovenian: laceracije kože
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 skozi ledvice.
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Slovenian: Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem*
English: In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Slovenian: Poleg tega v 26-tedenski študiji kancerogenosti z uporabo heterozigotnega mišjega modela p53 (+/-) ribavirin ni povzročil nastanka tumorjev pri največjem odmerku, ki so ga živali še prenašale, 300 mg/kg (faktor plazemske izpostavljenosti približno 2,5-večji od izpostavljenosti pri človeku).
English: 1 tablet in the morning and 2 tablets in the evening
Slovenian: 1 tableta zjutraj in 2 tableti zvečer
English: However, as in younger patients, renal function must be determined prior to administration of ribavirin (see section 5.2).
Slovenian: Vendar je treba, enako kot pri mlajših bolnikih, pred začetkom uporabe ribavirina preveriti delovanje ledvic (glejte poglavje 5.2).
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Slovenian: To je lahko še posebej pomembno pri bolnikih, pri katerih je znano, da so imeli v preteklosti že anemijo zaradi jemanja zidovudina.
English: Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Slovenian: Bolnike z okvarjenim delovanjem ledvic je treba bolj skrbno spremljati zaradi morebitnega razvoja anemije.
English: Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Slovenian: Sočasno okužene bolnike, ki prejemajo tako antiretrovirusno zdravljenje (ARV) kot zdravljenje hepatitisa, je treba skrbno spremljati in jim v teku zdravljenja določati oceno po Child-Pughu.
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Slovenian: Njegovo genotoksično delovanje so beležili tudi v testu na celicah mišjega limfoma, in pri odmerkih 20-200 mg/kg v testu na mišjih mikronukleusih.
English: *AUC12 (ng.hr/mL) for Ribavirin; AUC0-24 (IU.hr/mL) for interferon alfa-2b
Slovenian: *AUC12 (ng.h/ml) za ribavirin; AUC0-24 (i.e. x h/ml) za interferon alfa-2b
English: Long-term efficacy data
Slovenian: Dolgoročni podatki o učinkovitosti zdravila
English: > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b), or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
Slovenian: > 5 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni z interferonom alfa-2b) ali > 4 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b)
English: suicide, stroke (cerebrovascular events).
Slovenian: - samomor, - možganska kap (možganskožilni dogodki).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropskega agencije za zdravila http://www.ema.europa.eu/.
English: Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Slovenian: Vsakega bolnika, pri katerem se med zdravljenjem pojavijo pomembne motnje delovanja jeter, je treba skrbno spremljati.
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Slovenian: Tmax (hr) Cmax (ng/ml) AUC* Navidezni očistek l/hr/kg ni bil določen
English: You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Slovenian: Test nosečnosti mora biti pri vas negativen pred zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
English: For children or adolescents who cannot swallow a film-coated tablet, an oral solution of ribavirin is available.
Slovenian: Za otroke in mladostnike, ki ne morejo pogoltniti filmsko obloženih tablet je na voljo peroralna raztopina zdravila z ribavirinom.
English: Histological response
Slovenian: Histološki odziv na zdravljenje
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, kot so virusno breme, HCV genotip in histološka stopnja bolezni.
English: Older people (≥ 65 years of age)
Slovenian: Starejši bolniki (≥ 65 let starosti)
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 faza podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku je 0,05; 3,73 in 79 ur).
English: Women of childbearing potential/contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah.
English: These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
Slovenian: Ti odmerki povzročijo pri živalih sistemsko izpostavljenost, ki je bistveno manjša kot pri človeku pri uporabi terapevtskih odmerkov.
English: There is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Slovenian: Ni dokazov o medsebojnem delovanju ribavirina z nenukleozidnimi zaviralci reverzne transkriptaze ali zaviralci proteaz.
English: If it gets worse, your doctor will decide whether or not your Ribavirin Teva Pharma B.V. treatment needs to be changed.
Slovenian: Če se poslabša, se bo vaš zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Ribavirin Teva ali ne.
English: In 3- and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/kg and above.
Slovenian: V 3- in 6-mesečni študiji na miših za proučevanje učinkov ribavirina na testise in spermo so se anomalije sperme, pojavile pri odmerku 15 mg/kg in več.
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 oziroma s predhodnimi ali obstoječimi motnjami srčnega ritma morate skrbno nadzorovati.
English: Table 3 provides guidelines for discontinuation based on the patient's indirect bilirubin concentration.
Slovenian: Preglednica 3 prikazuje smernice za prenehanje zdravljenja glede na bolnikovo koncentracijo indirektnega bilirubina.
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Slovenian: Zaradi pomanjkanja podatkov v teh dveh multičentričnih študijah pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je potrebno pred uporabo kombinacije ribavirina in interferona alfa-2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem (glejte poglavja 4.1, 4.4 in 4.8).
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Slovenian: sarkoidoza*, revmatoidni artritis (nov pojav ali poslabšanje obstoječega)
English: Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Slovenian: Pri bolnikih, ki se zdravijo z interferonom alfa-2b in ribavirinom po predhodni ponovitvi bolezni po terapiji z interferonom, ali pri tistih, ki se zdravijo krajši čas, bo varnostni profil verjetno boljši od spodaj opisanega.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Slovenian: Študija 1 (RIBAVIC; P01017) je bila randomizirana, multicentrična študija, v katero so vključili 412 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi tudi z virusom HIV.
English: In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
Slovenian: V ključnem preskušanju klinične učinkovitosti so bolnikom naročili, naj za doseganje kar največje plazemske koncentracije ribavirina zdravilo jemljejo sočasno s hrano.
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Slovenian: Farmakokinetika ribavirina in interferona alfa-2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
English: Table 10.
Slovenian: Preglednica 10.
English: Lower respiratory tract infection
Slovenian: okužba spodnjih dihal
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 and for seven months after treatment.
Slovenian: Četudi 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 uporabljajo učinkovito kontracepcijo med zdravljenjem z zdravilom Ribavirin Teva Phama B.V.
English: Conflicting findings are reported in literature on co-administration between abacavir and ribavirin.
Slovenian: V literaturi so poročali o nasprotujočih izsledkih pri sočasni uporabi abakavirja in ribavirina.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Slovenian: Zdravljenje je trajalo 48 tednov, bolnike pa so spremljali 6 mesecev, razen tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800.000 i.e./ml (Amplicor) - te so zdravili 24 tednov in jih spremljali 6 mesecev.
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, ribavirin dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Slovenian: Zaradi bistvenega zvišanja koncentracije ribavirina v plazmi pri bolnikih z zmerno in hudo okvaro ledvic je pri odraslih bolnikih z očistkom kreatinina < 50 ml/minuto odmerek ribavirina priporočljivo prilagoditi.
English: The selection of ribavirin formulation is based on individual characteristics of the patient.
Slovenian: Farmacevtsko obliko ribavirina je treba izbrati glede na individualne lastnosti posameznega bolnika.
English: Ribavirin (800 mg/day)
Slovenian: ribavirin (800 mg/dan)
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: Decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children.
Slovenian: Znižanje srednjega percentila telesne višine po 1 letu po začetku spremljanja je bilo najbolj izrazito pri otrocih pred puberteto.
English: Anti-thyroid antibody positive
Slovenian: pozitivna protitelesa anti-TSH
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Slovenian: Podatki o končni višini v odrasli dobi so bili na voljo za 14 od teh otrok in so pokazali, da je bilo pri dvanajstih 10 do 12 let po koncu zdravljenja zmanjšanje percentila telesne višine še vedno > 15 percentilov.
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 ribavirin teratogen in genotoksičen (glejte poglavji 4.4 in 5.3).
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected with HIV.
Slovenian: Študija 2 (P02080) je bila randomizirana, enocentrična študija, v katero so vključili 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi tudi z virusom HIV.
English: If the child is weighing less than 47 kg or unable to swallow tablets an oral solution of ribavirin should be used.
Slovenian: Če otrok tehta manj kot 47 kg ali ne more požirati tablet, je treba uporabiti peroralno raztopino ribavirina.
English: It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Slovenian: Možno je, da je bila povečana biološka uporabnost v tej študiji posledica zakasnjenega prehajanja ribavirina ali spremenjenega pH.
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Slovenian: nenormalno obnašanje, depresivno razpoloženje, emocijske motnje, strah, nočne more
English: Transfer into seminal fluid
Slovenian: Prehajanje v semensko tekočino
English: Haemoglobin concentrations should be monitored closely during treatment and corrective action taken as necessary (see section 4.2).
Slovenian: Koncentracijo hemoglobina je treba med zdravljenjem skrbno spremljati in po potrebi ustrezno ukrepati (glejte poglavje 4.2).
English: However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Slovenian: Specifičnih farmakokinetičnih raziskav pri starostnikih niso opravljali, vendar v populacijski farmakokinetični študiji starost ni bila ključni dejavnik kinetike ribavirina - odločilni dejavnik je delovanje ledvic.
English: Plasma concentrations achieved in rat pups were below human plasma concentrations at the therapeutic dose.
Slovenian: Plazemske koncentracije, dosežene pri podganjih mladičih, so bile pod plazemskimi koncentracijami pri ljudeh po prejemu terapevtskega odmerka.
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Slovenian: Ribavirin se je izkazal za aktivnega v transformacijskem testu na celicah Balb/3T3 in vitro.
English: 3 x 200 mg tabletsa
Slovenian: 3 x 200 mg tabletaa
English: In subjects with creatinine clearance between 30 and 50 mL/min, AUCtf was twofold greater compared with control subjects.
Slovenian: Pri osebah z očistkom kreatinina med 30 in 50 ml/min je bila AUCtf dvakrat večja kot pri kontrolnih preiskovancih.
English: At the end of 5 years, 85 % (80/94) of all enrolled subjects and 86 % (54/63) of sustained responders completed the study.
Slovenian: Na koncu 5-letnega obdobja je študijo dokončalo 85 % (80/94) vseh vključenih preiskovancev in 86 % (54/63) tistih s trajnim odzivom.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Slovenian: Pomembni neželeni učinki, ki so se pojavili med zdravljenjem pri tej populaciji bolnikov, so bili živčnost (8 %), agresija (3 %), jeza (2 %), depresija/depresivno razpoloženje (4 %) ter hipotireoza (3 %), 5 preiskovancev pa je prejelo zdravljenje z levotiroksinom zaradi hipotireoze oziroma zvišane vrednosti TSH.
English: Patients with low CD4 counts:
Slovenian: Bolniki z majhnim številom celic CD4:
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Slovenian: • ženska v rodni dobi (glejte poglavje “Nosečnost in dojenje ”),
English: Peripheral ischaemia*
Slovenian: periferna ishemija*
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Slovenian: Možnost interakcij prek encimov citokroma P450 je torej minimalna.
English: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
Slovenian: Izsledki študij in vitro z uporabo pripravkov človeških in podganjih jetrnih mikrosomov niso pokazali presnove ribavirina prek encimov citokroma P450.
English: Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Slovenian: Dvajset otrok (21 %) od skupaj 97 otrok je imelo zmanjšanje telesne višine za > 15 percentilov, 10 od teh 20 otrok pa je imelo zmanjšanje telesne višine za > 30 percentilov od začetka zdravljenja do konca dolgoročnega spremljanja bolnikov (do 5 let).
English: There is no evidence from toxicity studies that ribavirin induces liver enzymes.
Slovenian: Študije toksičnosti niso pokazale znakov, da ribavirin inducira jetrne encime.
English: It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Slovenian: Možno je, da je bila zmanjšana biološka uporabnost v tej študiji posledica zakasnjenega prehajanja ribavirina ali spremenjenega pH.
English: 4 x 200 mg tabletsb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Slovenian: 4 x 200 mg tabletab Glejte priporočila za odmerjanje pri odraslih bolnikih a 1 zjutraj, 2 zvečer b 2 zjutraj, 2 zvečer
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serije
English: Ribavirin may be used in combination with interferon alfa-2b (see section 4.4).
Slovenian: Ribavirin se lahko uporablja v kombinaciji z interferonom alfa-2b (glejte poglavje 4.4).
English: Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Slovenian: Izjemno skrbno moramo paziti, da preprečimo zanositev bolnice med zdravljenjem (glejte poglavje 5.3).
English: Ulcerative colitis*
Slovenian: ulcerozni kolitis*
English: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Slovenian: cerebrovaskularne krvavitve*, cerebrovaskularna ishemija*, encefalopatija*, polinevropatija*
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving ribavirin in combination with peginterferon alfa-2b.
Slovenian: V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b.
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Slovenian: V petletno dolgoročno opazovalno študijo za spremljanje bolnikov so vključili 97 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v dveh prej omenjenih multicentričnih preskušanjih.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Slovenian: Če bolezen napreduje do jetrne dekompenzacije, je treba pri teh bolnikih nemudoma ukiniti zdravljenje hepatitisa in ponovno oceniti učinkovitost antiretrovirusnega zdravljenja.
English: Acute hypersensitivity
Slovenian: Akutna preobčutljivost