FrancophonIA/ELRC3.0 huggingface dataset:
English: Proton pump inhibitors can be used without dose modification.
Slovenian: Zaviralci protonske črpalke se lahko uporabljajo sočasno brez prilagoditve odmerka.
English: In HCV-negative patients with severe renal impairment, no clinically relevant change in telaprevir exposure was observed (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic, ki niso bili okuženi s HCV, niso opazili klinično pomembnih sprememb v izpostavljenosti telaprevirju (glejte poglavje 5.2).
English: If you are breast-feeding, you must stop breast-feeding before starting to take INCIVO.
Slovenian: Če dojite, morate prenehati z dojenjem, preden začnete jemati zdravilo INCIVO.
English: High density polyethylene (HDPE) bottle containing 42 film-coated tablets and fitted with polypropylene (PP) child resistant closure and induction seal liner.
Slovenian: Plastenka iz polietilena velike gostote (HDPE), z 42 filmsko obloženimi tabletami in z za otroke varno polipropilensko (PP) zaporko z indukcijsko tesnilno folijo.
English: Increase in thyroid stimulating hormone (TSH) may occur during INCIVO combination treatment, which may indicate worsening or recurrence of pre-existing or previous hypothyroidism, or new-onset hypothyroidism (see section 4.8).
Slovenian: Med kombiniranim zdravljenjem z zdravilom INCIVO lahko pride do zvišanja koncentracije tirotropina (TSH), kar lahko kaže na poslabšanje ali ponovitev obstoječega ali predhodnega hipotiroidizma ali pojav hipotiroidizma (glejte poglavje 4.8).
English: Administration of INCIVO may increase systemic exposure to medicinal products that are substrates of CYP3A or P-gp, which could increase or prolong their therapeutic effect and adverse reactions.
Slovenian: Uporaba zdravila INCIVO lahko zveča sistemsko izpostavljenost učinkovinam, ki se presnavljajo s CYP3A ali P-gp, kar lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke.
English: In general, exposure levels in relation to human values were low in animal pharmacology and toxicology studies.
Slovenian: Na splošno so bile izpostavljenosti v farmakoloških in toksikoloških študijah na živalih majhne glede na izpostavljenosti pri ljudeh.
English: Concomitant administration with Class Ia or III antiarrhythmics, except for intravenous lidocaine (see section 4.5).
Slovenian: Sočasna uporaba s katerimkoli antiaritmikom Ia ali III, razen intravensko danega lidokaina (glejte poglavje 4.5).
English: The median time for telaprevir-resistant variants to become undetectable by population sequencing was longer for variants NS3-36 (6 months), NS3-155 (9 months) and NS3-36M+NS3-155K (12 months) predominantly observed in patients with genotype 1a than for variants NS3-54 (2 months) and NS3-156 (3 months) predominantly observed in patients with genotype 1b.
Slovenian: Mediani čas, da za telaprevir odporne variante niso bile več zaznavne s populacijskim sekvenciranjem je bil daljši za variante NS3-36 (6 mesecev), NS3-155 (9 mesecev) in NS3-36M+NS3-155K (12 mesecev), ki so jih predvsem opazili pri bolnikih z genotipom 1a, kot za variante NS3-54 (2 meseca) in NS3-156 (3 mesece), ki so jih predvsem opazili pri bolnikih z
English: In the analysis of an additional study, Study C211, the safety profile of combination therapy with INCIVO 1,125 mg twice daily was similar to the safety profile for patients receiving combination therapy with INCIVO 750 mg every 8 hours.
Slovenian: Pri analizi dodatne študije (študija C211) je bil varnostni profil kombiniranega zdravljenja z zdravilom INCIVO v odmerku 1.125 mg dvakrat na dan podoben varnostnemu profilu pri bolnikih, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO v odmerku 750 mg na 8 ur.
English: Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia.
Slovenian: Zmanjšanje odmerka ribavirina je najprimernejši način obvladovanja med zdravljenjem nastale anemije.
English: Telaprevir inhibits organic anion transporter polypeptides (OATPs) OATP1B1 and OATP2B1.
Slovenian: Telaprevir zavira organska anionska polipeptidna prenašalca (OATP- organic anion transporter polypeptides) OATP1B1 in OATP2B1.
English: Detectable HCV RNA below the lower limit of assay quantification should not be used as a substitute for “undetectable” (target not detected), for making decisions on treatment duration, as this may lead to an insufficient duration of therapy and higher relapse rates.
Slovenian: Zaznavnih koncentracij HCV RNK, nižjih od spodnje meje kvantifikacije, se, pri odločanju o trajanju zdravljenja ne sme zamenjevati z nezaznavnimi koncentracijami (nezaznaven analit), ker to lahko vodi v prekratek čas zdravljenja in večje stopnje relapsa.
English: Consult with a specialist in dermatology.
Slovenian: Posvetujte se z dermatologom.
English: Table 10: SVR rates by extent of liver fibrosis at baseline: Study 111
Slovenian: Preglednica 10: stopnje SVR po obsegu jetrne fibroze na začetku študije: študija 111
English: Patients received INCIVO at a dosage of 750 mg every 8 hours.
Slovenian: Bolniki so prejemali zdravilo INCIVO v odmerku 750 mg vsakih 8 ur.
English: Use of INCIVO should be avoided in patients with congenital QT prolongation, or a family history of congenital QT prolongation or sudden death.
Slovenian: Uporabi zdravila INCIVO pri bolnikih s kongenitalnim podaljšanjem intervala QT oziroma s kongenitalnim podaljšanjem intervala QT ali primeri nenadne smrti v družinski anamnezi se je treba izogibati.
English: In the case of missing data within the week 72 window, the last HCV RNA data point from week 12 of follow-up onwards was used.
Slovenian: Če v 72. tednu ni bilo podatkov, je bil uporabljen zadnji podatek o koncentraciji HCV RNK po 12. tednu.
English: Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration.
Slovenian: V 4. in 12. tednu bo zdravnik preveril koncentracijo virusa v krvi, da bo lahko določil čas trajanja vašega zdravljenja.
English: Chemistry evaluations (electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, TSH) are recommended as frequently as the haematology evaluations or as clinically indicated (see section 4.8).
Slovenian: Tudi biokemične preiskave (elektroliti, določanje kreatinina v serumu, sečna kislina, jetrni encimi, bilirubin in TSH) je priporočeno opravljati tako pogosto kot hematološke preiskave ali pa glede na bolnikovo klinično stanje (glejte poglavje 4.8).
English: If trazodone is used with telaprevir, the combination should be used with caution and a lower dose of trazodone should be considered.
Slovenian: Če torej uporabljate trazodon skupaj s telaprevirjem, je treba to kombinacijo uporabljati previdno in po potrebi bolniku predpisati manjši odmerek trazodona.
English: Clinical drug-drug interaction studies with substrates of CYP2B6, CYP2C8, CYP2D6, CYP2C19 and UGT1A1, UGT2B7 and UGT1A3 indicate no clinically relevant impact of the suppression observed in vitro.
Slovenian: Klinične študije medsebojnih delovanj s substrati CYP2B6, CYP2C8, CYP2D6, CYP2C19 ter UGT1A1, UGT2B7 in UGT1A3 pa niso pokazale klinično pomembnega učinka in vitro opažene supresije.
English: Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir (> 25-fold increase in telaprevir IC50).
Slovenian: Variante V36A/M, T54A/S, R155K/T in A156S so pokazale nižje stopnje rezistence na telaprevir in vitro (3-kratno do 25-kratno zvečanje IC50 za telaprevir), varianti A156V/T in V36M+R155K sta imeli višjo stopnjo rezistence in vitro za telaprevir (> 25-kratno zvečanje IC50 za telaprevir).
English: warfarin, dabigatran to prevent blood clots (anticoagulants)
Slovenian: varfarin, dabigatran za preprečevanje nastanka krvnih strdkov (antikoagulanti)
English: Therefore, you and your partner must use two other birth control methods during the time you are taking INCIVO and for 2 months after stopping this medicine.
Slovenian: Zato morate vi in vaš partner med in še dva meseca po koncu zdravljenja z zdravilom INCIVO uporabljati dve drugi kontracepcijski metodi.
English: To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants).
Slovenian: Za nadzorovanje anemije so ob uvedbi zdravila INCIVO uporabljali manjši odmerek ribavirina (600 mg/dan); med celotnim zdravljenjem so pri 36,5% bolnikov odmerek ribavirina še dodatno zmanjšali; 41,9% bolnikov je prejelo ESA; 21,6% bolnikov je prejelo transfuzijo krvi (glejte poglavji 4.4 in 4.5 Imunosupresivi).
English: Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the
Slovenian: Jemanje zdravila INCIVO brez hrane ali neupoštevanje intervala odmerjanja lahko povzroči znižanje plazemskih koncentracij telaprevirja in zmanjšanje terapevtskega učinka zdravila INCIVO.
English: Based on in vitro studies, telaprevir may potentially increase plasma concentrations of medicinal products in which excretion is dependent upon multidrug and toxin extrusion (MATE)-1 and MATE2-K (see table 2).
Slovenian: In vitro študije kažejo, da telaprevir lahko zveča plazemske koncentracije učinkovin, katerih izločanje je odvisno od prenašalcev za ekstruzijo več učinkovin in toksinov MATE-1 (MATE - multidrug and toxin extrusion protein) in MATE2-K (glejte preglednico 2).
English: A total of 215 of 1,169 patients treated with a T12/PR regimen in a Phase 3 clinical trial had on-treatment virologic failure (n = 125) or relapse (n = 90).
Slovenian: Pri skupaj 215 od 1.169 bolnikov, zdravljenih s shemo T12/PR v kliničnem preskušanju faze III, so med zdravljenjem ugotovili virološki neuspeh (n = 125) ali ponovitev bolezni (n = 90).
English: Rare side effects (affects less than 1 in 1,000 people): - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Slovenian: Redki neželeni učinki (pojavijo se pri manj kot 1 od 1.000 bolnikov) - razširjen hud izpuščaj z luščenjem kože, ki ga lahko spremljajo zvišana telesna temperatura, gripi podobni simptomi ter pojav mehurjev v ustih, na očeh in/ali na genitalijah (Stevens-Johnsonov sindrom).
English: Other enzymes are also involved in the metabolism (see section 5.2).
Slovenian: Pri presnovi sodelujejo tudi drugi encimi (glejte poglavje 5.2).
English: For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below).
Slovenian: Če zmerni izpuščaj napreduje v hudega (≥ 50% telesne površine), je treba ukiniti zdravilo INCIVO (glejte spodaj).
English: The total duration of treatment of peginterferon alfa and ribavirin varies from 24 to 48 weeks depending on treatment response and whether you have been treated before.
Slovenian: Celotno zdravljenje s peginterferonom alfa in ribavirinom traja od 24 do 48 tednov, kar je odvisno od odziva na zdravljenje in ali ste se že prej zdravili.
English: Table 5 shows the response rates for the T12(b.i.d.
Slovenian: V preglednici 5 so prikazane stopnje odziva za skupini T12(b.i.d.
English: In a fertility and early embryonic development study in rats, an increase in non-viable conceptuses was observed.
Slovenian: V študiji plodnosti in zgodnjega razvoja zarodka pri podganah so opazili povečano število mrtvih zarodkov.
English: Following completion of INCIVO therapy contraceptive recommendations should be followed as in the Summary of Product Characteristics for ribavirin, and as described below.
Slovenian: Po zaključku zdravljenja z zdravilom INCIVO je treba upoštevati navodila v Povzetku glavnih značilnosti zdravila ribavirin in kot je opisano v nadaljevanju.
English: When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended.
Slovenian: Kadar se zdravilo uporablja pri bolniku z napredovalo boleznijo jeter je priporočeno skrbno spremljanje in zgodnja obravnava neželenih učinkov.
English: Tablet film-coat polyvinyl alcohol macrogol talc titanium dioxide (E171) iron oxide yellow (E172)
Slovenian: polivinilalkohol, makrogol, smukec, titanov dioksid (E171), rumeni železov oksid (E172)
English: After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 l/h with an inter-individual variability of 27.2%.
Slovenian: Po peroralni uporabi je bila ocenjena vrednost navideznega skupnega očistka (Cl/F) 32,4 l/h z 27,2% stopnjo variabilnosti med posamezniki.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin, including pregnancy testing requirements (see section 4.6).
Slovenian: Preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin, vključno z zahtevami glede testiranja nosečnosti (glejte poglavje 4.6).
English: Concomitant use may lead to adverse events such as nausea, dizziness, hypotension and syncope.
Slovenian: Sočasna uporaba lahko vodi do pojava neželenih učinkov, kot sonavzea, omotica, hipotenzija in sinkopa.
English: Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients.
Slovenian: Študija 111 je bila randomizirana, odprta študija faze III, ki je bila opravljena pri še nezdravljenih bolnikih.
English: Fifty-five out of 60 patients received ribavirin at a fixed dose of 800 mg/day and the remaining 5 patients received a weight-based ribavirin dose.
Slovenian: Izmed 60 bolnikov jih je 55 prejemalo fiksni odmerek 800 mg ribavirina/dan, 5 bolnikov pa je prejemalo odmerke ribavirina na osnovi telesne mase.
English: Rarely patients may have other symptoms with the rash that may be a sign of a severe skin reaction.
Slovenian: Redko se skupaj z izpuščajem pojavijo tudi drugi simptomi, ki lahko kažejo na hudo kožno reakcijo.
English: Due to the combined treatment with peginterferon alfa and ribavirin, female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment.
Slovenian: Zaradi kombiniranega zdravljenja s peginterferonom alfa in ribavirinom, morajo bolnice v rodni dobi in njihovi partnerji ter bolniki in njihove partnerice med zdravljenjem z zdravilom INCIVO uporabljati 2 učinkoviti kontracepcijski metodi.
English: HIV-ANTIVIRAL AGENTS: HIV-PROTEASE INHIBITORS (PIs) atazanavir/ritonavir*
Slovenian: ZDRAVILA PROTI OKUŽBI Z VIRUSOM HIV: ZAVIRALCI PROTEAZE HIV (PI) atazanavir/ritonavir*
English: Efficacy in adults with HCV/HIV-1 co-infection
Slovenian: Učinkovitost pri odraslih bolnikih s sočasno okužbo s HCV/ HIV-1
English: Since INCIVO must be used in combination with ribavirin and ribavirin can be very damaging to an unborn baby, both female and male patients must take special precautions in order to prevent pregnancy.
Slovenian: Zdravilo INCIVO je treba uporabljati v kombinaciji z ribavirinom in ribavirin lahko škoduje nerojenemu otroku, zato morajo bolnice in bolniki upoštevati posebne ukrepe za preprečevanje nosečnosti.
English: Do not eat the desiccant.
Slovenian: Sušilnega sredstva ne smete pojesti.
English: Yellow caplet-shaped tablets of approximately 20 mm in length, marked with ‘T375' on one side.
Slovenian: Rumene, ovalne tablete, dolge približno 20 mm z oznako ‘T375' na eni strani.
English: Via C. Janssen IT-04100 Borgo San Michele Latina, Italy
Slovenian: Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina, Italija
English: The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Slovenian: Na začetku je treba bolniku predpisati najmanjši odmerek digoksina, potem pa spremljati njegovo serumsko koncentracijo in na podlagi nje titrirati odmerek digoksina, da bi dosegli želeni klinični učinek.
English: Of a combined 255 treatment-naïve and previously treated patients from Phase 3 studies 108, 111, and C216 in whom telaprevir-resistant variants had emerged during treatment, 152 (60%) patients no longer had resistant variants detected by population sequencing (median follow-up of 10 months).
Slovenian: Od skupaj 255 še nezdravljenih oziroma predhodno zdravljenih bolnikov iz študij tretje faze 108, 111 in C216, v katerih so se med zdravljenjem pojavile za telaprevir rezistentne variante, jih 152 (60%) več ni imelo rezistentnih variant, ugotovljenih s sekvencioniranjem populacije (mediana dolžina spremljanja 10 mesecev).
English: Rat offspring exposed to telaprevir in utero showed normal body weight at birth.
Slovenian: Mladiči podgan, ki so bili telaprevirju izpostavljeni v maternici, so imeli normalno porodno maso.
English: Marketing Authorisation Holder Janssen Cilag International NV Turnhoutseweg 30
Slovenian: Imetnik dovoljenja za promet z zdravilom Janssen Cilag International NV Turnhoutseweg 30
English: Haemoglobin should be monitored at regular intervals prior to and during INCIVO combination treatment (see section 4.4, Laboratory tests).
Slovenian: Koncentracije hemoglobina je treba spremljati v rednih časovnih razmikih pred in med kombiniranim zdravljenjem z zdravilom INCIVO (glejte poglavje 4.4, Laboratorijske preiskave).
English: )/PR group was 74% (274/369) compared to 73% (270/371) in the T12(q8h)/PR group with 95% confidence interval of the difference: -4.9%, 12.0%.
Slovenian: Stopnja SVR12 je bila za skupino T12(q8h)/PR 74% (274/369), v primerjavi s 73% (270/371) v skupini T12(q8h)/PR, pri čemer je 95% interval zaupanja za razliko -4,9%, 12,0%.
English: In an HCV subtype 1b replicon assay, the telaprevir IC50 value against wild-type HCV was 0.354 µM similar to a subtype 1a infectious virus assay IC50 of 0.28 µM.
Slovenian: Pri testu podtipa 1b replikona HCV je IC50 za telaprevir v primerjavi z divjim tipom virusa HCV znašala 0,354 µM, podobno kot pri določanju IC50 za podtip 1a infekcioznega virusa, ki je znašala
English: parenterally administered midazolam*
Slovenian: parenteralno uporabljen midazolam*
English: There are no clinical data on re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy, such as telaprevir, nor are there data on repeated courses of telaprevir treatment.
Slovenian: Ni kliničnih podatkov o ponovnem zdravljenju bolnikov, pri katerih je bilo zdravljenje na osnovi zaviralca proteaze HCV NS3-4A, na primer telaprevirja, neuspešno, niti ni podatkov o večkratnih ciklusih zdravljenja s
English: Concomitant administration of INCIVO and drugs transported by these transporters such as fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan and repaglinide should be undertaken with caution (see table 2).
Slovenian: Pri sočasni uporabi zdravila INCIVO in učinkovin, ki jih ti prenašalci prenašajo, npr. fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan in repaglinid, je potrebna previdnost (glejte preglednico 2).
English: Most laboratory values return to levels observed with peginterferon alfa and ribavirin by week 24, except platelet counts, which remain at levels lower than observed with peginterferon alfa and ribavirin until week 48 (see section 4.4).
Slovenian: Večina laboratorijskih izvidov se je povrnila na vrednosti, opažene pri jemanju peginterferona alfa in ribavirina v 24. tednu, razen števila trombocitov, ki je ostalo nižje kot je bilo pri jemanju peginterferona alfa in ribavirina do 48. tedna (glejte poglavje 4.4).
English: Purpose of the medicine alfuzosin to treat symptoms of an enlarged prostate (alpha-1-adrenoreceptor antagonists)
Slovenian: alfuzosin za zdravljenje simptomov povečane prostate (antagonisti adrenergičnih receptorjev alfa 1)
English: The clinical relevance of this is uncertain as administration of telaprevir with a single dose of buprenorphine, a partial UGT1A3 substrate, to healthy adult subjects did not result in increases in buprenorphine exposures.
Slovenian: Klinični pomen teh ugotovitev ni znan, saj sočasno dajanje telaprevirja in enega odmerka buprenorfina (delni substrat UGT1A3) zdravim prostovoljcem ni povzročilo povečanja izpostavljenosti buprenorfinu.
English: HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for discontinuation of INCIVO, section 4.2).
Slovenian: Koncentracije HCV RNK je treba spremljati v 4. in 12. tednu zdravljenja ter glede na klinične indikacije (glejte tudi navodila za prekinitev zdravljenja z zdravilom INCIVO v poglavju 4.2).
English: Patients were randomised in a 2:2:1 ratio to one of three treatment groups: simultaneous start (T12/PR48): INCIVO from day 1 through week 12; delayed start (T12(DS)/PR48): INCIVO from week 5 through week 16; Pbo/PR48: placebo through week 16.
Slovenian: Bolnike so v razmerju 2:2:1 randomizirali v eno od treh terapevtskih skupin: sočasni začetek (T12/PR48): jemanje zdravila INCIVO od 1. dne do 12. tedna; odloženi začetek (T12(DS)/PR48): jemanje zdravila INCIVO od 5. tedna do 16. tedna; Pbo/PR48: jemanje placeba do 16. tedna.
English: escitalopram, trazodone to treat mood disorders (antidepressants)
Slovenian: escitalopram, trazodon za zdravljenje motenj razpoloženja (antidepresivi)
English: Clinical comment
Slovenian: Klinična opomba
English: HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration.
Slovenian: Koncentracije HCV RNK je treba določati v 4. in 12. tednu, da bi ugotovili potrebno trajanje zdravljenja.
English: A 3-year follow-up study of patients who achieved SVR with an INCIVO-based regimen showed that > 99% (122/123) of patients maintained their SVR status through the available follow-up period
Slovenian: 3-letna študija za spremljanje bolnikov, ki so dosegli trajni virološki odziv s shemo zdravljenja na osnovi zdravila INCIVO, je pokazala, da je > 99% (122/123) bolnikov ohranjalo trajni virološki odziv skozi ves čas razpoložljivega obdobja spremljanja (mediana vrednost trajanja 22 mesecev).
English: In the case of a serious skin reaction, discontinuation of other medicinal products known to be associated with serious skin reactions should be considered.
Slovenian: Pri pojavu hude kožne reakcije je treba razmisliti o prekinitvi zdravljenja z zdrugimi zdravili, povezanimi s hudimi kožnimi reakcijami.
English: The dose of INCIVO must not be reduced, and INCIVO must not be restarted if discontinued.
Slovenian: Odmerka zdravila INCIVO ne smete zmanjšati in ga, po ukinitvi, ne smete ponovno uvesti.
English: Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when telaprevir is co-administered with alfentanil or fentanyl, including oral, buccal, nasal and extended-release transdermal or transmucosal preparations of fentanyl, especially at initiation of treatment.
Slovenian: Priporočamo skrbno spremljanje terapevtskega in neželenih učinkov (vključno z depresijo dihanja) pri sočasni uporabi telaprevirja in alfentanila ali fentanila, vključno s peroralnimi, bukalnimi, intranazalnimi oblikami, transdermalnimi oblikami s podaljšanim sporoščanjem ali transmukozalnimi oblikami fentanila, še posebej ob uvedbi zdravljenja.
English: All patients started with a dose of 600 mg/day of ribavirin and 180 µg/week of peginterferon alfa-2a.
Slovenian: Vsi bolniki so pričeli z odmerkom 600 mg ribavirina/dan in 180 µg peginterferona alfa-2a/teden.
English: At week 12, INCIVO dosing ended and patients continued on standard therapy only.
Slovenian: V 12. tednu so ti bolniki prenehali z jemanjem zdravila INCIVO in so nadaljevali z običajnim zdravljenjem.
English: clarithromycin, erythromycin, telithromycin, troleandomycin to treat bacterial infections (antibacterials)
Slovenian: klaritromicin, eritromicin, telitromicin, troleandomicin za zdravljenje okužb (antibiotiki)
English: It is not known whether telaprevir, the active ingredient in INCIVO, is found in human breast milk.
Slovenian: Ni znano, ali se telaprevir, učinkovina v zdravilu INCIVO, nahaja v materinem mleku.