FrancophonIA/ELRC3.0 huggingface dataset:
English: If co-administered, no dose adjustment is required.
Slovenian: Pri sočasni uporabi prilagajanje odmerkov ni potrebno.
English: RNA levels ≥ 800,000 IU/ml; 10.8% had bridging fibrosis; none had cirrhosis; 38.9% had HCV genotype 1a; 58.3% had HCV genotype 1b; 2.8% had HCV genotype 1d; 21.6% had IL28B genotype CC; 54.1% had IL28B genotype CT; 24.3% had IL28B genotype TT; 28.4% (n = 21) were HCV treatment- naïve; 71.6% (n = 53) were treatment-experienced [14.9% (n = 11) were prior relapsers; 40.5% (n = 30) were prior non-responders; 16.2% (n = 12) could not be classified]; median time since liver transplantation was 2.5 years (range: 0.6 to 9.5 years); 67.6% (n = 50) received tacrolimus; 32.4% (n = 24) received cyclosporine A.
Slovenian: Vključenih je bilo 74 bolnikov, mediana starost je bila 56 let (razpon: 43-68 let); 91,9% je bilo moških; 24,3% je imelo indeks telesne mase ≥ 30 kg/m2; 1,4% je bilo črncev; 95,9% je imelo začetne koncentracije HCV RNK ≥ 800.000 i.e./ml; 10,8% je imelo mostno fibrozo; nihče ni imel ciroze; 38,9% je imelo HCV genotip 1a; 58,3% je imelo HCV genotip 1b; 2,8% je imelo HCV genotip 1d; 21,6% je imelo IL28B genotip CC; 54,1% je imelo IL28B genotip CT; 24,3% je imelo IL28B genotip TT; 28,4% (n = 21) še ni prejemalo zdravil proti HCV; 71,6% (n = 53) se je že zdravilo proti HCV [pri 14,9% (n = 11) se je bolezen po predhodnjem zdravljenju ponovila; pri 40,5% (n = 30) ni bilo odziva na predhodnje zdravljenje; pri 16,2% (n = 12) odziva niso mogli opredeliti]; mediani čas od presaditve jeter je bil 2,5 let (razpon: 0,6-9,5 let); 67,6% (n = 50) je prejemalo takrolimus; 32,4%
English: There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see section 5.1).
Slovenian: O ponovnem zdravljenju bolnikov, pri katerih je bilo zdravljenje z zaviralcem proteaze HCV NS3-4A neuspešno (glejte poglavje 5.1), ni kliničnih podatkov.
English: If your doctor stops INCIVO, it should not be restarted.
Slovenian: Če zdravnik prekine vaše zdravljenje z zdravilom INCIVO, ga ne smete ponovno začeti jemati.
English: BOTTLE LABEL (1-bottle pack)
Slovenian: NALEPKA NA PLASTENKI (1 plastenka)
English: Use in patients with advanced liver disease
Slovenian: Bolniki s presajenimi jetri
English: On-treatment virologic failure was defined as meeting a virologic stopping rule or having viral breakthrough.
Slovenian: Virološki neuspeh med zdravljenjem je bil določen s kriterijem za prekinitev zdravljenja ali za virusni preboj.
English: No or minimal fibrosis or portal fibrosis
Slovenian: Ni fibroze ali minimalna fibroza oziroma portalna fibroza
English: If the missed dose is noticed more than 6 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
Slovenian: Če se je na izpuščeni odmerek spomnil več kot 6 ur po času, ko bi ga moral vzeti, naj izpuščeni odmerek preskoči in nadaljuje z običajnim režimom jemanja zdravila.
English: )/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks Patients with planned total treatment duration of 24 weeks.
Slovenian: )/PR: INCIVO 1.125 mg dvakrat na dan 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov; T12(q8h)/PR: INCIVO 750 mg na 8 ur 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov Bolniki z načrtovanim celokupnim trajanjem zdravljenja 24 tednov.
English: For moderate rash that progresses, permanent discontinuation of INCIVO should be considered.
Slovenian: Če zmeren izpuščaj napreduje, je treba presoditi o prekinitvi zdravljenja z zdravilom INCIVO.
English: In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone.
Slovenian: V s placebom nadzorovanih preskušanjih faze II in III so v fazi zdravljena z zdravilom INCIVO/placebo pri 2,5% bolnikov, ki so prejemali kombinacijo z zdravilom INCIVO, in pri 0,7% bolnikov, ki so prejemali samo peginterferon alfa in ribavirin, poročali o transfuzijah.
English: Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate < 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5).
Slovenian: Zdravilo INCIVO je treba uporabljati previdno pri bolnikih: - ki imajo v pretekli anamnezi pridobljeno podaljšanje intervala QT; - ki imajo klinično pomembno bradikardijo (perzistentna srčna frekvenca < 50 utripov na minuto); - ki imajo v pretekli anamnezi srčno popuščanje z zmanjšanjem iztisne frakcije levega ventrikla;
English: The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12.
Slovenian: Primarni cilj študije je bilo s SVR12 oceniti protiretrovirusno učinkovitost zdravil INCIVO, peginterferona alfa-2a in ribavirina pri bolnikih, sočasno okuženih s HCV/HIV-1.
English: Ribavirin dose reductions were used for management of anaemia.
Slovenian: Pri zdravljenju anemije so zmanjšali odmerek ribavirina.
English: dexamethasone if taken by mouth or through to treat asthma or to treat inflammatory and autoimmune conditions (corticosteroids)
Slovenian: budezonid, flutikazon, ki ga vdihnete skozi usta ali nos, deksametazon, ki ga zaužijete skozi usta za zdravljenje astme ali za zdravljenje vnetnih ali avtoimunskih bolezni (kortikosteroidi)
English: Clinical monitoring is recommended.
Slovenian: Priporočljivo je tudi klinično spremljanje bolnika.
English: Table 11 shows the response rates for the recommended simultaneous start (T12/PR48) and the Pbo/PR48 arms.
Slovenian: V preglednici 11 so prikazane stopnje odziva za krak s priporočenim sočasnim začetkom zdravljenja (T12/PR48) in krak
English: Treatment-naive patients or prior relapsers who were non-cirrhotic and achieved extended rapid virologic response (eRVR) received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 12 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 24 weeks).
Slovenian: Nezdravljeni bolniki ali bolniki brez ciroze, pri katerih se je bolezen ponovila in so dosegli hiter virološki odziv (eRVR- extended rapid virologic response), so prejeli 12-tedensko zdravljenje z zdravilom INCIVO, skupaj s peginterferonom alfa-2a in ribavirinom, sledilo mu je 12-tedensko zdravljenje s peginterferonom alfa-2a in ribavirinom (skupno trajanje zdravljenja 24 tednov).
English: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment.
Slovenian: Pri kombiniranem zdravljenju z zdravilom INCIVO so poročali o hudih, lahko življenju nevarnih in smrtnih kožnih reakcijah.
English: At week 12, INCIVO dosing ended and patients continued on peginterferon alfa-2a and ribavirin treatment.
Slovenian: Po 12 tednih so zaključili z jemanjem zdravila INCIVO in nadaljevali z zdravljenjem s peginterferonom alfa-2a in ribavirinom.
English: Purpose of the medicine flecainide, propafenone to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Slovenian: za zdravljenje določenih srčnih bolezni, na primer motenj srčnega ritma (antiaritmiki)
English: Since INCIVO treatment always needs to be used together with peginterferon alfa and ribavirin, please also check the package leaflets for the dosage instructions of these medicines.
Slovenian: Ker je treba zdravilo INCIVO vedno uporabljati skupaj s peginterferonom alfa in ribavirinom preberite tudi navodila za odmerjanje teh dveh zdravil.
English: Female patients of childbearing age and their male partners A hormonal contraceptive (‘the pill') may not be reliable during the treatment with INCIVO.
Slovenian: Hormonska kontracepcija (na primer tabletka) med zdravljenjem z zdravilom INCVIVO ni zanesljiva.
English: C - telaprevir and VRT-127394 towards total radioactivity recovered in faeces was 31.8% and 18.7%, respectively.
Slovenian: označenega telaprevirja k skupni količini radioaktivnosti, izmerjene v blatu, je znašal 31,8%, za VRT-127394 pa je znašal
English: You should contact your doctor immediately if you develop a rash or have a rash that gets worse.
Slovenian: Takoj se obrnite na svojega zdravnika tudi: - če se izpuščaj poslabša ALI
English: Steady-state exposure to telaprevir was 46% lower in subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9) compared to healthy subjects.
Slovenian: Izpostavljenost telaprevirju v stanju dinamičnega ravnovesja pri preiskovancih z blago okvaro jeter (razred A po Child-Pughu, ocena 5-6) je bila za 15% manjša kot pri zdravih preiskovancih, izpostavljenost telaprevirju v stanju dinamičnega ravnovesja pri preiskovancih z zmerno okvaro jeter (razred B po Child-Pughu, ocena 7-9) pa je bila za 46% manjša kot pri zdravih preiskovancih.
English: During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia,
Slovenian: V fazi zdravljenja z zdravilom INCIVO oz. placebom so najpogosteje poročali o naslednjih neželenih učinkih jakosti najmanj 3.stopnje, ki je prejemala zdravilo INCIVO (pogostnost ≥ 1,0%): anemija, izpuščaj, trombocitopenija, limfopenija, pruritus innavzea.
English: versus 750 mg every 8 hours (q8h) were 1.08 (1.02; 1.13) for AUC24,ss, 0.878 (0.827; 0.930) for Ctrough,ss, and 1.18 (1.12;1.24) for Cmax,ss.
Slovenian: Na osnovi populacijskega farmakokinetičnega modela izpostavljenosti telaprevirju v stanju dinamičnega ravnovesja je bila geometrična sredina razmerja najmanjših kvadratov (90% IZ) 1.125 mg dvakrat na dan v primerjavi s 750 mg na osem ur 1,08 (1,02; 1,13) za AUC24,ss, 0,878 (0,827; 0,930) za Cskozi,ss, in 1,18 (1,12;1,24) for Cmax,ss.
English: Each bottle contains one pouch or two pouches to keep the tablets dry (desiccant).
Slovenian: Vsaka plastenka vsebuje eno ali dve vrečki s sušilnim sredstvom.
English: 73.8% (59/80) of patients in the pooled peginterferon alfa-2a group met the criteria (undetectable HCV RNA (target not detected) at week 4 through week 20) for the shortened 24 week peginterferon/ribavirin treatment duration versus 61.7% (50/81) of patients in the pooled
Slovenian: V združeni skupini, ki je prejemala peginterferon alfa-2a je 73,8% (59/80) bolnikov v primerjavi z 61,7% (50/81) v združeni skupini, ki je prejemala peginterferon alfa-2b, doseglo kriterije za skrajšanje zdravljenja s peginterferonom/ribavirinom na 24 tednov (nezaznavna koncentracija HCV RNK (nezaznaven analit) med tedni 4 do 20).
English: Table 17: Treatment outcome in genotype 1 HCV-infected liver transplant recipients (Study HPC3006)
Slovenian: Preglednica 17: Izid zdravljenja pri z HCV genotipa 1 okuženih bolnikov s presajenimi jetri
English: Ελλάδα
Slovenian: Hud izpuščaj
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be
Slovenian: Preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin, ki ju morate
English: Tell your doctor if you have had or are going to have a liver or other organ transplant as INCIVO might not be right for you in this situation.
Slovenian: Povejte zdravniku, če so vam ali vam bodo presadili jetra, ker v tem primeru zdravilo INCIVO
English: Consider consultation with a specialist in dermatology.
Slovenian: Presodite ali je potreben posvet z dermatologom.
English: Note that the virologic stopping rules taken into account in this treatment outcome analysis are actual stopping rules, i.e., those derived from disposition and exposure data, as opposed to mathematical stopping rules, i.e., derived from the
Slovenian: Opomba: v analizi zdravljenja so upoštevani dejanski kriteriji za prekinitev zdravljenja (kriteriji na osnovi bolezni in podatkov o izpostavljenosti) in ne kriterijev določenih na osnovi podatkov o koncentraciji HCV RNK.
English: Other medicinal products associated with severe cutaneous reactions should be used with caution during administration of INCIVO combination treatment to avoid potential confusion as to which medicinal product could be contributing to a severe cutaneous reaction.
Slovenian: Da bi se izognili morebitnim dvomom o tem katero zdravilo je povzročilo hudo kožno reakcijo je med kombiniranim zdravljenjem z zdravilom INCIVO pri uporabi drugih zdravil, povezanih s hudimi kožnimi reakcijami potrebna previdnost.
English: Among patients treated with telaprevir, on-treatment virologic failure was more frequent in patients with genotype 1a than with genotype 1b and more frequent in prior null responders than in other populations (treatment-naïve, prior relapsers, prior partial responders; see section 5.1, Clinical Experience, Efficacy in Previously Treated Adults).
Slovenian: Tudi pri bolnikih, ki se prej niso odzvali na zdravljenje, je bila pogostejša kot pri drugih populacijah (pri še nezdravljenih bolnikih, pri bolnikih, ki so imeli predhodno ponovitev bolezni ali pri tistih, ki so se prej le delno odzvali na zdravljenje; glejte poglavje 5.1, Klinične izkušnje in Učinkovitost pri predhodno
English: In vitro studies Activity of telaprevir against HCV
Slovenian: Klinične študije za proučevanje intervala QT
English: These guidelines may not perform similarly when a lead-in treatment with peginterferon alfa and ribavirin has been used prior to starting INCIVO therapy (see section 5.1).
Slovenian: Te smernice morda ne bodo enako učinkovite če se pred uvedbo zdravljenja z zdravilom INCIVO bolnik zdravi s peginterferonom alfa in ribavirinom (glejte
English: 5.8% of patients discontinued INCIVO alone due to rash events and 2.6% of patients discontinued INCIVO combination treatment for rash events compared to none of those receiving peginterferon
Slovenian: Zdravljenje z zdravilom INCIVO v monoterapiji je bilo zaradi pojava izpuščaja ukinjeno pri 5,8% bolnikov, kombinirano zdravljenje z zdravilom INCIVO je bilo zaradi pojava izpuščaja ukinjeno pri 2,6% bolnikov, v primerjavi z bolniki, ki so prejemali samo peginterferon alfa in ribavirin, pri katerih ni bilo nobene ukinitve zdravljenja zaradi pojava izpuščaja.
English: Refer to section 4.3 for HMG-CoA reductase inhibitors that are contraindicated with INCIVO.
Slovenian: Zaviralci reduktaze HMG-CoA, ki so kontraindicirani pri uporabi zdravila INCIVO, so navedeni v poglavju 4.3.
English: Examples are: blood count levels, thyroid (a gland in your neck that controls your metabolism) levels, liver and kidney
Slovenian: Primeri so: število nekaterih krvnih celic, koncentracije ščitničnih (žleza v vratu, ki uravnava presnovo) hormonov, preiskave delovanja
English: Not applicable.
Slovenian: Podatki niso na voljo.
English: The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA < 25 IU/ml).
Slovenian: Število bolnikov z odzivom ob zaključku zdravljenja (HCV RNA < 25 IU/ml) predstavlja imenovalec pri izračunu stopnje relapsa.
English: - Patients with detectable HCV RNA at either weeks 4 or 12 receive an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
Slovenian: - Bolniki z zaznavno koncentracijo HCV RNK v 4. ali v 12. tednu naj prejemajo samo peginterferon alfa in ribavirin še dodatnih 36 tednov, do skupnega trajanja zdravljenja 48 tednov.
English: Telaprevir exposure was similar regardless of whether the total daily dose of 2,250 mg was administered as 750 mg every 8 hours (q8h) or 1,125 mg twice daily (b.i.d.).
Slovenian: Ne glede na to, ali je bil dnevni odmerek 2.250 mg zaužit kot 750 mg na osem ur ali kot 1.125 mg dvakrat na dan, je bila celokupna izpostavljenost telaprevirju podobna.
English: No adjustment of methadone dose is required when initiating co-administration of telaprevir.
Slovenian: Ob uvedbi zdravljenja s telaprevirjem ni potrebna prilagoditev odmerka metadona.
English: Other includes patients with detectable HCV RNA at their actual end of treatment but who did not have viral breakthrough, and patients with a missing HCV RNA assessment during planned follow-up.
Slovenian: Ostalo vključuje preiskovance z zaznavno HCV RNK ob načrtovanem koncu zdravljenja, ki pa niso imeli virusnega preboja, in bolnike, pri katerih manjka ocena HCV RNK pri načrtovanem spremljanju.
English: Treatment-naive patients and prior relapsers who did not achieve eRVR, prior partial responders, prior null responders, and all cirrhotic patients received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 36 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 48 weeks).
Slovenian: Nezdravljeni bolniki in bolniki brez ciroze, pri katerih se je bolezen ponovila in, ki niso dosegli eRVR, bolniki s predhodno delnim odzivom in bolniki, ki se na zdravljenje niso odzvali ter vsi bolniki s cirozo, so prejeli 12-tedensko zdravljenje z zdravilom INCIVO, skupaj s peginterferonom alfa-2a in ribavirinom, sledilo mu je 36-tedensko zdravljenje s peginterferonom alfa-2a in ribavirinom (skupno trajanje zdravljenja 48 tednov).
English: BOTTLE LABEL (4-bottle pack)
Slovenian: NALEPKA NA PLASTENKI (4 plastenke)
English: The control regimen (Pbo/PR) had a fixed treatment duration of 48 weeks, with telaprevir-matching placebo for the first 12 weeks and peginterferon alfa-2a and ribavirin for 48 weeks.
Slovenian: Za kontrolno shemo (Pbo/PR) je bilo določeno trajanje zdravljenja 48 tednov, enako za telaprevir kot za placebo v prvih 12. tednih, in z jemanjem peginterferona alfa-2a in ribavirina v
English: Please consult sections 4.4 and 5.1 regarding the selection of peginterferon alfa-2a or -2b.
Slovenian: Za navodila o izbiri peginterferona alfa-2a ali -2b glejte poglavji 4.4 in 5.1.
English: Pregnancy and breast-feeding If you are pregnant, you must not take INCIVO.
Slovenian: Če ste noseči, ne smete jemati zdravila INCIVO.
English: Table 1: Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment
Slovenian: Preglednica 1: smernice za ukinitev zdravljenja z zdravilom INCIVO, peginterferonom alfa in ribavirinom
English: Study HPC3006 was an open-label, Phase 3b study in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected patients who were first time liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A. No patients had cirrhosis of the liver graft.
Slovenian: HPC3006 je bila odprta študija faze IIIb pri še nezdravljenih in že zdravljenih kroničnih s HCV-1 okuženih bolnikih, ki so jim prvič presadili jetra in so prejemali stabilen odmerek imunosupresiva (takrolimus ali ciklosporin A).
English: In the C211 Phase 3 clinical trial, there was no difference in the type of emerging variants between patients receiving telaprevir 1,125 mg twice daily (b.i.d.)
Slovenian: V kliničnem preskušanju faze III (C211) ni bilo razlik v pojavu za telaprevir rezistentnih variant med bolniki, ki so prejemali 1.125 mg telaprevirja dvakrat na dan in bolniki, ki so prejemali 750 mg telaprevirja na 8 ur.
English: Study HPC3008 was an open-label, Phase 3b study conducted in patients with chronic genotype 1 HCV/HIV-1 co-infection who were treatment-naïve for hepatitis C or who did not achieve SVR with prior treatment with peginterferon alfa (2a or 2b) and ribavirin (including prior relapsers, prior partial responders and prior null responders).
Slovenian: Odprta študija, faze 3b pri bolnikih s kroničnim HCV genotipa 1, sočasno okuženih s HIV, ki še niso prejemali zdravil proti hepatitisu C ali s predhodnim zdravljenjem s peginterferonom alfa (2a ali 2b) in ribavirinom (vključno z bolniki s ponovitvijo bolezni, z delnim odzivom ali bolniki, ki se na predhodno zdravljenje niso odzvali).
English: OUTER CARTON (4-bottle pack)
Slovenian: ŠKATLA (4 plastenke)
English: T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
Slovenian: T12(DS)/PR % (n/N) zmanjšanje koncentracije HCV RNK za < 1 log10 v zmanjšanje koncentracije HCV RNK za ≥ 1 log10 v 4. tednu vključuje samo podatke o bolnikih, pri katerih je na razpolago podatek o koncentraciji HCV RNK 4. tednu
English: Co-administration of domperidone with INCIVO should be avoided (see section 4.4).
Slovenian: Sočasni uporabi domperidona z zdravilom INCIVO se je torej treba izogibati (glejte poglavje 4.4).
English: Table 13 shows the SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction in HCV RNA) for prior partial responders and for prior null responders in the T12(DS)/PR group.
Slovenian: Preglednica 13 kaže stopnje SVR glede na odziv v 4. tednu pri bolnikih v skupini T12(DS)/PR, ki so se na predhodno zdravljenje delno odzvali ali se niso odzvali (zmanjšanje koncentracije HCV RNK za < 1 log10 ali ≥ 1 log10)
English: No adjustment of the buprenorphine dose is required when co-administered with telaprevir.
Slovenian: Pri sočasni uporabi s telaprevirjem ni potrebno prilagajati odmerka buprenorfina.
English: In placebo-controlled Phase 2 and 3 trials, the overall incidence and severity of rash increased when INCIVO was co-administered with peginterferon alfa and ribavirin.
Slovenian: V s placebom nadzorovanih preskušanjih faze II in III sta se skupna pogostnost in jakost izpuščaja povečali, ko so bolniki jemali zdravilo INCIVO sočasno s peginterferonom alfa in ribavirinom.
English: Similar proportions of patients in both treatment groups had telaprevir-resistant variants at the time of failure.
Slovenian: V času virološkega neuspeha je bil delež za telaprevir rezistentnih variant pri obeh skupinah bolnikov podoben.
English: Haemoglobin values gradually improve after completion of INCIVO dosing.
Slovenian: Po prenehanju jemanja zdravila INCIVO se koncentracije hemoglobina postopoma zvečujejo.
English: OUTER CARTON (1-bottle pack)
Slovenian: ŠKATLA (1 plastenka)
English: Close monitoring of immunosuppressant blood levels, renal function and immunosuppressant related side effects are recommended when co-administered with telaprevir.
Slovenian: Pri sočasni uporabi imunosupresiva s telaprevirjem je priporočljivo skrbno spremljanje koncentracij imunosupresiva v krvi, delovanja ledvic ter neželenih učinkov imunosupresiva.
English: Among prior relapsers in the T12/PR24 treatment group who had undetectable HCV RNA (target not detected) at week 4 and 12 of treatment, the SVR rate was 100%
Slovenian: Med tistimi bolniki iz terapevtske skupine T12/PR24, ki se jim je bolezen ponovila in so imeli v 4. in 12. tednu zdravljenja nemerljive koncentracije HCV RNK (nezaznaven analit), je bila stopnja trajnega virološkega odziva 100% (24/24).
English: )/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Slovenian: )/PR: INCIVO 1.125 mg dvakrat na dan 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov T12(q8h)/PR: INCIVO 750 mg na 8 ur 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov
English: No clinical data are available regarding the treatment of pre- or peri-liver or other transplant patients with INCIVO in combination with peginterferon alfa and ribavirin.
Slovenian: Klinični podatki o zdravljenju bolnikov z zdravilom INCIVO v kombinaciji s peginterferonom alfa in ribavirinom pred ali ob presaditvi jeter ali drugih organov niso na voljo.
English: The appropriate dose of INCIVO in hepatitis C-infected patients with moderate hepatic impairment has not been determined.
Slovenian: Ustrezen odmerek zdravila INCIVO pri bolnikih s hepatitisom C in zmerno okvaro jeter ni bil določen, zato uporaba zdravila INCIVO pri teh bolnikih ni priporočena