FrancophonIA/ELRC3.0 huggingface dataset:
English: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti protiretrovirusnih zdravil, ki se morajo sočasno jemati pri zdravljenju HCV, za seznanitev s toksičnostmi, specifičnimi za posamezno zdravilo, njihovim zdravljenjem ter možnostjo prekrivanja le-teh z zdravilom Pegasys, če ga uporabljamo skupaj z ribavirinom ali brez.
English: For persistent ALT values ≥10 x ULN discontinue treatment.
Slovenian: Pri dolgotrajno zvišanih vrednostih ALT ≥ 10-krat ULN - prekinitev zdravljenja.
English: Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
Slovenian: Preglednica 24: Deleži serokonverzije HBeAg (%) glede na znižanje HBV-DNA od izhodišča do 12. tedna zdravljenja z zdravilom Pegasys pri pediatričnih bolnikih
English: Lift the pre-filled pen straight up (90° angle).
Slovenian: Dvignite peresnik navpično (kot 90°).
English: ● Take the long needle and place it firmly on to the tip of the syringe (2).
Slovenian: ● Vzemite dolgo iglo in jo trdno namestite na vrh injekcijske brizge (2).
English: Chronic Hepatitis C: Pegasys is used in combination with other medicines, for the treatment of chronic hepatitis C (CHC).
Slovenian: Kronični hepatitis C: zdravilo Pegasys uporabljamo v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C.
English: Allow the refrigerated pre-filled pen to adjust to room temperature for about 20 minutes.
Slovenian: Potem ko ste vzeli napolnjeni injekcijski peresnik iz hladilnika, ga 20 minut pustite na sobni temperaturi.
English: Place used pre-filled pen and cap in a puncture-proof disposable container that is available through your pharmacy or healthcare provider.
Slovenian: Uporabljeni napolnjeni injekcijski peresnik in pokrovček dajte v zabojnik za ostre predmete, ki ga lahko dobite v lekarni ali pri zdravstvenem delavcu.
English: Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC <750 cells/mm3), and thrombocytopenia (13% experienced a platelet count <50,000 cells/mm3) (see section 4.4).
Slovenian: Hematološke laboratorijske nenormalnosti, ki so jih opazili v prvih 20 tednih preskušanja, so vključevale anemijo (26 % bolnikov je imelo hemoglobin < 10 g/dl), nevtropenijo (30 % je imelo ANC < 750 celic/mm3) in trombocitopenijo (13 % je imelo število trombocitov < 50.000 celic/mm3) (glejte poglavje 4.4).
English: The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).
Slovenian: Pogostnost in resnost najpogostejših neželenih učinkov, ki so jih opazili pri zdravilu Pegasys, je bila podobna učinkom, ki so jih opazili pri interferonu alfa-2a (glejte preglednico 9).
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.
Slovenian: Za specifično aktivnost glede genotipa virusa hepatitisa C (HCV) glejte poglavji 4.2 in 5.1.
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Slovenian: Priporočljivo je, da v primeru ponovnega pojava ali pojava novih psihiatričnih motenj in jemanja psihoaktivnih substanc, ukrepamo zgodaj.
English: Avoid your navel and areas that could be irritated by a belt or waistband.
Slovenian: Izogibajte se popka in mestom, kjer bi lahko prišlo do draženja zaradi pasu.
English: Platelet <25,000 cells/mm3: discontinue treatment.
Slovenian: Trombociti < 25.000 celic/mm3: prekinitev zdravljenja.
English: In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/97) and 59% (58/99), respectively.
Slovenian: Pri bolnikih, ki so v študiji WV16241 prejemali le zdravilo Pegasys, je 12 mesecev po koncu zdravljenja delež HBV DNA odziva znašal 42 % (41/97), normalizacija ALT pa 59 % (58/99).
English: In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close haematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicinal products should be stopped (see section 4.4).
Slovenian: V posameznih primerih, kjer je korist sočasnega zdravljenja z ribavirinom in azatioprinom večja kot možno tveganje, je med sočasnim zdravljenjem z azatioprinom priporočljivo skrbno spremljanje hematoloških parametrov, da se lahko ugotovijo znaki mielotoksičnosti.
English: Infections: Lung infection, skin infections
Slovenian: Okužbe: okužba pljuč, okužbe kože.
English: Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Slovenian: Pri zdravljenju z zdravilom Pegasys se je pojavilo zmanjšanje hematoloških vrednosti (levkopenija, nevtropenija, limfopenija, trombocitopenija in hemoglobin), ki se je v večini primerov popravilo s spremembo odmerka in se po 4 do 8 tednih po prekinitvi zdravljenja vrnilo na raven pred začetkom zdravljenja (glejte poglavji 4.2 in 4.4).
English: Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours.
Slovenian: Absorpcija Po enkratni subkutani injekciji 180 mikrogramov zdravila Pegasys pri zdravih prostovoljcih so serumske koncentracije peginterferona alfa-2a lahko merili v 3 do 6 urah.
English: Available in packs of 1 pre-filled syringe.
Slovenian: Na voljo je pakiranje z 1 napolnjeno injekcijsko brizgo.
English: There is no further accumulation after 8 weeks of once weekly dosing.
Slovenian: Po 8 tednih zdravljenja enkrat na teden do kumulacije ne prihaja več.
English: 500 to < 750 cells/mm3: Immediate 1 level adjustment.
Slovenian: 500 do < 750 celic/mm3: takojšnje zmanjšanje odmerka 1. stopnje.
English: Treatment difference [95%CI]
Slovenian: Razlika med zdravljenjema [95% interval zaupanja]
English: Tap the syringe gently to bring the bubbles to the top.
Slovenian: Nežno potrkajte po injekcijski brizgi, da se mehurčki pomaknejo proti vrhu.
English: The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Slovenian: Odmerek ribavirina, ki se uporablja v kombinaciji z zdravilom Pegasys, je naveden v preglednici 1.
English: cells/mm3
Slovenian: mm3
English: Take your next injection on the regularly scheduled day.
Slovenian: Naslednjo injekcijo si injicirajte kot predvideno.
English: Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Slovenian: Preglednica 11: Značilnosti posameznih bioloških označevalcev v 12. tednu zdravljenja pri HBeAg pozitivnih in HBeAg negativnih bolnikih s kroničnim hepatitisom B glede na genotip
English: Muscle and bone disorders: Serious muscle damage and pain Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Slovenian: Pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
English: * For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
Slovenian: kopij/ml za HBeAg-negativne /anti-HBe-pozitivne bolnike: HBV DNA < 2 x 104 kopij/ml
English: ● if you have had an organ transplant (liver or kidney) or have one planned in the near future.
Slovenian: • če ste kdaj imeli ali imate načrtovano transplantacijo organa (jeter ali ledvic),
English: Therapy should initially be re-instituted at 90 micrograms Pegasys and the neutrophil count monitored.
Slovenian: Zdravljenje ponovno vpeljemo z odmerkom 90 mikrogramov zdravila Pegasys, število nevtrofilcev pa moramo spremljati.
English: Table 16: Relapse of virological response at the end of treatment for rapid virological response population
Slovenian: Preglednica 16: Ponovitev bolezni ob koncu zdravljenja za bolnike s hitrim virološkim odzivom
English: Pegasys injection is normally taken at bedtime.
Slovenian: Zdravilo Pegasys ponavadi injiciramo v času.
English: With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Slovenian: Ko je brizga obrnjena navzgor, preverite, če je vrh igle potopljen v raztopino zdravila Pegasys.
English: Subcutaneous administration of Pegasys should be limited to the abdomen and thigh, as the extent of absorption based on AUC was about 20% to 30% higher upon injection in the abdomen and thigh.
Slovenian: Podkožno dajanje zdravila Pegasys moramo omejiti na predel trebuha in stegen, kjer je bil obseg absorpcije na podlagi AUC 20 do 30 % višji.
English: • Severe hepatic dysfunction or decompensated cirrhosis of the liver
Slovenian: • avtoimunski hepatitis, • huda motnja jetrnega delovanja ali dekompenzirana ciroza jeter,
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Slovenian: Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so se pojavili značilni teratogeni in/ali embriocidni učinki.
English: Both studies compared Pegasys plus placebo vs Pegasys plus lamivudine vs lamivudine alone.
Slovenian: Obe študiji sta primerjali kombinacijo zdravila Pegasys in placeba, zdravila Pegasys in lamivudina ter lamivudin.
English: It is unknown whether peginterferon alfa-2a/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se peginterferon alfa-2a/presnovki izločajo v materino mleko.
English: In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
Slovenian: V študiji WV16240 sta bila primarna cilja raziskave HBeAg serokonverzija in število HBV DNA pod 105 kopij/ml.
English: There are no data on the effects of peginterferon alfa-2a on fertility in women.
Slovenian: Podatkov o vplivu peginterferona alfa-2a na plodnost žensk ni.
English: Cardiovascular system
Slovenian: Srčnožilni sistem
English: A clinical trial evaluated 50 CHC patients with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment, or with end stage renal disease (ESRD) requiring chronic hemodialysis (HD).
Slovenian: V kliničnem preskušanju so ovrednotili 50 bolnikov s CHC, ki so imeli zmerno (kreatininski očistek 30 do 50 ml/min), hudo (kreatininski očistek manj kot 30 ml/min) ledvično okvaro ali končno ledvično odpoved, pri kateri je potrebna kronična hemodializa.
English: Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
Slovenian: Med bolniki iz študije WV16240, ki so prejemali le zdravilo Pegasys in so bili vključeni v dolgotrajno študijo sledenja, je delež trajne HBeAg serokonverzije 12 mesecev po zaključku zdravljenja znašal 48 % (73/153).
English: The solution for injection is for single use only.
Slovenian: Raztopina za injiciranje je za enkratno uporabo.
English: Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24-week treatment duration (see section 5.1).
Slovenian: 16tedensko zdravljenje je lahko povezano z manjšo možnostjo odziva in tveganje za ponovitev bolezni je večje kot pri 24-tedenskem zdravljenju (glejte poglavje 5.1).
English: It is important to consider the treatment with Pegasys +/- ribavirin induced a growth inhibition during treatment, the reversibility of which is uncertain.
Slovenian: Pomembno je upoštevati, da zdravljenje z zdravilom Pegasys z ribavirinom ali brez povzroči zastoj rasti med zdravljenjem, za katerega ne moremo zagotovo reči, da je reverzibilen.
English: Educational problem
Slovenian: Socialne okoliščine težave z učenjem
English: Dispose of the syringe and needle safely in a closed container.
Slovenian: V zaprt vsebnik varno spravite injekcijsko brizgo in iglo.
English: HBV-DNA was measured by the COBAS AMPLICOR HBV
Slovenian: HBV DNA so merili s testom COBAS AMPLICORTM HBV MONITOR
English: Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Slovenian: Zdravilo Pegasys uporabljamo za zdravljenje kroničnega hepatitisa B ali kroničnega hepatitisa C pri odraslih.
English: Other medicines and Pegasys
Slovenian: Druga zdravila in zdravilo Pegasys
English: Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see section 4.2).
Slovenian: Glede na izpostavljenost, farmakodinamični odziv in prenašanje pri starejših bolnikih ni potreben manjši odmerek zdravila Pegasys (glejte poglavje
English: Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Slovenian: Študije na živalih z interferonom alfa-2a so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Slovenian: Sočasna uporaba ribavirina in zidovudina ni priporočljiva zaradi povečanega tveganja za nastanek anemije (glejte poglavje 4.5).
English: Study YV25718 was conducted in previously untreated paediatric patients aged 3 to 17 years (51% < 12 years old) with HBeAg positive CHB and ALT > ULN but < 10 x ULN in two blood samples taken ≥ 14 days apart during the 6 months before the first dose of study drug.
Slovenian: Študijo YV25718 so izvedli pri predhodno nezdravljenih pediatričnih bolnikih, starih od 3 do 17 let (51 % < 12 let) s CHB, ki so bili HBeAg pozitivni in so imeli ALT > ULN, a < 10 x ULN v dveh vzorcih krvi, odvzetih ≥ 14-dnevnim presledkom v 6-mesečnem obdobju pred prejemom prvega odmerka študijskega zdravila.
English: Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Slovenian: Podatki farmakokinetičnih podštudij v ključnih preskušanjih faze III dokazujejo, da med lamivudinom in zdravilom Pegasys pri bolnikih s HBV ali zdravilom Pegasys in ribavirinom pri bolnikih s HCV ne prihaja do farmakokinetičnih interakcij.
English: The risk of growth inhibition 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 (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Slovenian: Tveganje za zastoj rasti je treba pretehtati glede na značilnosti bolezni pri otroku, na primer glede na znake napredovanja bolezni (opazna fibroza), druge sočasne bolezni, ki bi lahko negativno vplivale na napredovanje bolezni (npr. sočasna okužba z virusom HIV) in prognostični dejavniki odziva na zdravljenje (za okužbo s HBV večinoma genotip HBV in vrednosti ALT; za okužbo s HCV večinoma genotip HCV in vrednosti HCV-RNA) (glejte poglavje 5.1).
English: Dispose of the full container as instructed by your healthcare provider or pharmacist.
Slovenian: Ko je napolnjen, ga zavrzite v skladu z navodilom, ki vam ga je dal zdravstveni delavec ali farmacevt.
English: ● Do not try to use the pre-filled pen again
Slovenian: • Ne poskušajte ponovno uporabiti napolnjenega injekcijskega peresnika.
English: Table 18: Relapse of virological response after the end of treatment in genotype 2 or 3 patients with a rapid viral response
Slovenian: Preglednica 18: Ponovitev bolezni po končanem zdravljenju bolnikov z genotipom 2 ali 3 in hitrim virološkim odzivom
English: HBeAg Seroconversion
Slovenian: HBeAg serokonverzija
English: In study WV16241, the primary efficacy endpoints were ALT normalisation and HBVDNA below 2 x 104 copies/ml.
Slovenian: V študiji WV16241 sta bila primarna cilja raziskave normalizacija ALT in število HBV DNA pod 2 x 104 kopij/ml.
English: * 95% CI for difference: 11% to 33% p-value (stratified Cochran-Mantel-Haenszel test) = 0.001 ** 95% CI for difference: 3% to 16% p-value (stratified Cochran-Mantel-Haenszel test) = 0.003
Slovenian: *95 % CI za razliko: 11 % do 33 % p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = 0,001 **95 % CI za razliko: 3 % do 16 % p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = 0,003
English: If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible.
Slovenian: Če ste pozabili vzeti odmerek 1 ali 2 dni po predvidenem času, si priporočeni odmerek injicirajte takoj, ko je mogoče.
English: Exploratory analyses based on limited data show paediatric patients with greater decline in HBV-DNA at week 12 of therapy were more likely to achieve HBeAg seroconversion at 24 weeks of follow-up (Table 24).
Slovenian: Eksploratorne analize, ki temeljijo na omejenih podatkih, kažejo, da so pediatrični bolniki z večjim znižanjem HBV-DNA v 12. tednu zdravljenja bolj verjetno dosegli serokonverzijo HBeAg po
English: Patients receiving azathioprin in combination with ribavirin and peginterferon are at increased risk of developing severe blood disorders.
Slovenian: Pri bolnikih, ki prejemajo azatioprin v kombinaciji z ribavirinom in peginterferonom, obstaja povečano tveganje za nastanek hudih krvnih bolezni.
English: • HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by medicinal products such as atazanavir and indinavir
Slovenian: • bolniki, ki so sočasno okuženi s HIV in HCV, imajo cirozo in število točk po Child-Pughovi klasifikaciji ≥ 6, razen v primeru indirektne hiperbilirubinemije, ki so jo povzročila zdravila, kot sta atazanavir in indinavir, • kombinacija s telbivudinom (glejte poglavje 4.5),
English: ● With one hand, pinch a fold of loose skin.
Slovenian: ● Z eno roko stisnite kožo v gubo.
English: Skin disorders: Toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa)
Slovenian: Bolezni kože: toksična epidermalna nekroliza/Stevens-Johnsonov sindrom/multiformni eritem (spekter kožnih izpuščajev z različno stopnjo resnosti, vključno s smrtjo, ki je lahko povezan z mehurji v ustih, nosu, očeh in drugih mukoznih membranah ter ločitvijo pokožnice od podlage na prizadetih mestih), angioedem (otekanje kože in sluznic).
English: Combination therapy with other medicines in chronic hepatitis C In the case of combination therapy with Pegasys, please follow the dosing regimen recommended by your doctor and refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Slovenian: Kombinirano zdravljenje z drugimi zdravili pri kroničnem hepatitisu C Pri kombiniranem zdravljenju z zdravilom Pegasys, prosimo, upoštevajte odmerjanje, ki vam ga je predpisal zdravnik, in glejte tudi navodila za uporabo zdravil, ki jih jemljete v kombinaciji z zdravilom Pegasys.
English: If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible.
Slovenian: Če ste pozabili vzeti odmerek 3 do 5 dni po predvidenem času, si priporočeni odmerek injicirajte takoj, ko je mogoče.
English: Other published on-treatment biomarkers that are predictive of the final outcome of Pegasys treatment may be considered.
Slovenian: Med zdravljenjem se lahko uporabijo tudi drugi biološki označevalci, objavljeni v literarutri, ki napovedujejo končni izid zdravljenja z zdravilom Pegasys.
English: Chronic hepatitis C
Slovenian: Kronični hepatitis C
English: SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Slovenian: povzroči višji delež trajnega virološkega odziva kot odmerek 800 mg na dan, kadar je zdravljenje skrajšano na 16 tednov.
English: If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
Slovenian: Če ste pozabili vzeti odmerek 6 dni po predvidenem času, počakajte in vzemite odmerek naslednji predvideni dan za odmerjanje.
English: Do not:
Slovenian: Ne:
English: Absolute Neutrophil Count
Slovenian: Absolutno število nevtrofilcev
English: If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure.
Slovenian: Če prejemate HAART, lahko sočasno jemanje zdravila Pegasys in ribavirina poveča tveganje za nastanek laktacidoze ali odpovedi jeter.
English: INFORMATION IN BRAILLE pegasys 90 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI pegasys 90 mcg
English: Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
Slovenian: Pri zdravljenju z zdravilom Pegasys so laboratorijske preiskave pokazale klinično značilne bolezenske spremembe ščitnice, ki so zahtevale klinično intervencijo (glejte poglavje 4.4).
English: Table 20: Sustained virological response in HALT-C by previous treatment regimen in nonresponder population
Slovenian: Preglednica 20: Trajni virološki odziv v študiji HALT-C glede na prejšnjo shemo zdravljenja pri bolnikih, ki se na prejšnje zdravljenje niso odzvali Prejšnje zdravljenje
English: A similar negative predictive value has been observed in HIV-HCV co-infected patients treated with Pegasys monotherapy or in combination with ribavirin (100% (130/130) or 98% (83/85), respectively).
Slovenian: Podobno negativno napovedno vrednost so opazili pri bolnikih, sočasno okuženih s HIV in HCV, ki so prejemali samostojno zdravljenje z zdravilom Pegasys (100 % (130/130) ali kombinirano zdravljenje z ribavirinom (98 % (83/85)).
English: However, several independent studies have demonstrated the 135mcg dose to be safe, efficacious and well tolerated, in patients with ESRD (see section 4.2).
Slovenian: Vendar pa so številne neodvisne študije pokazale, da je odmerek 135 µg za bolnike s končno ledvično odpovedjo varen, učinkovit in dobro prenosljiv.
English: Baseline variables in co-infected cirrhotic patients that may be associated with hepatic decompensation include: increased serum bilirubin, decreased haemoglobin, increased alkaline phosphatase or decreased platelet count, and treatment with didanosine (ddI).
Slovenian: Osnovne spremenljivke pri sočasno okuženih bolnikih s cirozo, ki je lahko povezana z jetrno dekompenzacijo, vključujejo zvišan serumski bilirubin, znižan hemoglobin, zvišano alkalno fosfatazo ali zmanjšano število trombocitov in zdravljenje z didanozinom
English: If the Pegasys dose is reduced or withheld, therapy can be restored once the flare is subsiding (see section 4.4).
Slovenian: Če odmerek zdravila Pegasys zmanjšamo ali dajanje začasno prekinemo, lahko zdravljenje nadaljujemo, ko se nihanja umirijo (glejte poglavje 4.4).
English: ● Take the short needle and place it firmly on to the tip of the syringe (5).
Slovenian: ● Vzamite kratko iglo in jo trdno namestite na vrh brizge (5).
English: ● The active substance is peginterferon alfa-2a.
Slovenian: • Zdravilna učinkovina je peginterferon alfa-2a.