FrancophonIA/ELRC3.0 huggingface dataset:
English: - Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min
Croatian: - apsolutni broj neutrofila ≥ 1500/mm - odgovarajuće kontrolirana funkcija tiroidne žlijezde (TSH) - izračunati klirens kreatinina ≥ 50 ml/min
English: 3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine.
Croatian: 3) liječen efavirenzom ili atazanavirom/ritonavirom u kombinaciji s tenofovir dizoproksil fumaratom i emtricitabinom ili lamivudinom.
English: No adjustment of methadone dose is required when initiating co-administration of telaprevir.
Croatian: Nije potrebna prilagodba doze metadona kad se istodobno počinje primjenjivati telaprevir.
English: The efficacy and safety of INCIVO in patients with genotype 1 chronic hepatitis C were evaluated in four Phase 3 studies: 3 in treatment-naïve patients and 1 in previously treated patients (relapsers, partial responders, and null responders).
Croatian: Djelotvornost i sigurnost primjene INCIVA u bolesnika s kroničnim hepatitisom C uzrokovanim genotipom 1 procjenjivala se u fazi III četiri ispitivanja: 3 u bolesnika koji prethodno nisu bili liječeni i jednom u prethodno liječenih bolesnika (s relapsom, djelomičnim odgovorom ili izostankom odgovora).
English: Liver transplant patients without cirrhosis
Croatian: Bolesnici s transplantiranom jetrom bez ciroze
English: Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment.
Croatian: Dostupni podaci sugeriraju da peginterferon alfa, a možda i ribavirin, mogu doprinijeti učestalosti i težini osipa koji je povezan s kombiniranim liječenjem INCIVOM.
English: The mean telaprevir Cmax and AUC were 10% and 21% greater, respectively, compared to healthy subjects (see section 4.2).
Croatian: Prosječna vrijednost Cmax bila je 10% veća, a vrijednost AUC 21% veća od onih u zdravih ispitanika (vidjeti
English: Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon-based therapies (e.g., hepatic decompensation, serious bacterial infections).
Croatian: Primjena u bolesnika s uznapredovalom bolešću jetre Hipoalbuminemija i nizak broj trombocita identificirani su kao prediktori za teške komplikacije jetrene bolesti kao i liječenja koja se temelje na interferonu (npr., dekompenzacija jetre, ozbiljne bakterijske infekcije).
English: No relevant effect of gender was identified.
Croatian: Značajan utjecaj spola nije
English: Doses may need to be increased when combined with telaprevir.
Croatian: Može biti potrebno povisiti dozu kad se primijenjuju istodobno s telaprevirom.
English: At the initiation and discontinuation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly adjusted (see sections 4.4 and 4.5, Immunosuppressants).
Croatian: Na početku i prilikom prekida liječenja INCIVOM, doze istodobno primjenjenog takrolimusa ili ciklosporina A, moraju se znatno prilagoditi (vidjeti djelove 4.4 i 4.5, Imunosupresivi).
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).
Croatian: Od 255 bolesnika koji prethodno nisu bili liječeni i prethodno liječenih bolesnika iz faze III ispitivanja 108, 111 i C216, u kojih su se varijante rezistentne na telaprevir pojavile tijekom liječenja, 152 (60%) bolesnika više nije imalo rezistentne varijante otkrivene pomoću populacijske analize nukleotidnih sljedova (medijan praćenja od 10 mjeseci).
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%.
Croatian: Stopa SVR12 odgovora za T12(b.i.d.)/PR skupinu, bila je 74% (274/369) u usporedbi sa 73% (270/371) u T12(q8h)/PR skupini s 95%-tnim intervalom pouzdanosti razlike: -4,9%, 12,0%.
English: TSH levels should be determined before and during the course of INCIVO combination treatment and treated as clinically appropriate, including potential adjustment of thyroid replacement therapy in patients with pre-existing hypothyroidism (see section 4.4,
Croatian: Vrijednosti TSH treba odrediti prije i tijekom kombiniranog liječenja s INCIVOM te liječiti ih klinički primjerenim načinom, uključujući moguću prilagodbu nadomjesnog liječenja tireoidnim hormonom u bolesnika s postojećom hipotireozom (vidjeti dio 4.4,
English: INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
Croatian: INCIVO se može primijeniti u bolesnika s kroničnom infekcijom hepatitisa C koji nikad prije nisu bili liječeni ili u bolesnika s kroničnom infekcijom hepatitisa C koji su prethodno bili liječeni interferonom.
English: Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food.
Croatian: Alternativno, može se uzimati 750 mg (dvije tablete od 375 mg) peroralno svakih 8 sati uz obrok.
English: Table 6 shows SVR rates by IL28B genotype and the stage of liver fibrosis at baseline.
Croatian: Tablica 6 pokazuje stope SVR uz IL28B genotipe i stadij fibroze jetre na početku ispitivanja.
English: If you are taking any of the above, ask your doctor about switching to another medicine.
Croatian: Ako uzimate neki od gore navedenih lijekova, upitajte liječnika možete li ga zamijeniti nekim drugim
English: There are no clinical data on the use of INCIVO in patients on haemodialysis.
Croatian: Nema kliničkih podataka o primjeni INCIVA u bolesnika na hemodijalizi.
English: The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Croatian: Incidencija nuspojava barem umjerenog intenziteta (≥ 2. stupnja) bila je viša u skupini koja je primala INCIVO nego u skupini koja je primala placebo.
English: Prior non-responders includes prior partial responders and prior null responders.
Croatian: Bez prethodnog odgovora uključuju one koji su prethodno djelomično odgovorili i one koji prethodno nisu uopće odgovorili.
English: filiāle Latvijā Mūkusalas iela 101
Croatian: Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā Mūkusalas iela 101
English: Because of the potential for adverse reactions in breastfed infants, due to the combined treatment of INCIVO with peginterferon alfa and ribavirin, breast-feeding must be discontinued prior to initiation of therapy.
Croatian: Zbog mogućih nuspojava u dojenčadi kao posljedica kombiniranog liječenja INCIVOM, peginterferonom alfa i ribavirinom, dojenje se mora prekinuti prije početka liječenja.
English: Co-administration of oral midazolam or triazolam with telaprevir is contraindicated.
Croatian: Istodobna primjena peroralnog midazolama ili triazolama s telaprevirom je kontraindicirana.
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
Croatian: Ispitivanje u trajanju od 3 godine temeljeno na praćenju bolesnika koji su postigli trajni virološki odgovor uz terapijski režim s INCIVOM pokazalo je da je > 99% (122/123) bolesnika održalo svoj status trajnog virološkog odgovora tijekom dostupnog razdoblja praćenja (medijan trajanja: 22 mjeseca).
English: Close monitoring of immunosuppressant blood levels, renal function and immunosuppressant related side effects are recommended when co-administered with telaprevir.
Croatian: Preporučuje se pomno praćenje razina imunosupresiva u krvi, funkcije bubrega i nuspojava povezanih s imunosupresivima kad se primjenjuju istodobno s telaprevirom.
English: AUC 1.31 (1.15-1.49) Cmax 1.27 (1.09-1.47) Cmin 1.36 (1.21-1.53) induction of CYP3A by phenytoin, and inhibition of CYP3A by telaprevir
Croatian: AUC 1,31 (1,15-1,49) Cmax 1,27 (1,09-1,47) Cmin 1,36 (1,21-1,53) Indukcija CYP3A fenitoinom i inhibicija CYP3A telaprevirom
English: No dose adjustment of INCIVO is required in stable liver transplant patients (see sections 4.8 and 5.1).
Croatian: Kod stabilnih bolesnika s transplantiranom jetrom, prilagodba doze INCIVA nije potrebna (vidjeti djelove 4.8 i 5.1).
English: In the event that co-administration of such medicinal products with INCIVO is judged strictly necessary, clinical monitoring including ECG assessments is recommended.
Croatian: U slučaju procjene da je istodobna primjena takvih lijekova s INCIVOM neophodna, preporučuje se klinički nadzor, uključujući praćenje EKG-a.
English: The clinical implications of this finding are currently unknown.
Croatian: Klinička implikacija ovog rezultata trenutno nije
English: Excipient: 2.3 mg of sodium per film-coated tablet.
Croatian: Pomoćna tvar: 2,3 mg natrija u jednoj filmom obloženoj tableti.
English: If you belong to this age group, please discuss the use of INCIVO with your doctor.
Croatian: Ako ste u toj dobnoj skupini, molimo Vas posavjetujete se s liječnikom o primjeni INCIVA.
English: In the description of Phase 3 study outcomes for Studies 108, 111, and C216, SVR, considered virologic cure, was defined based on the HCV RNA assessment in the study week 72 visit window, using the last measurement in the window.
Croatian: Prema opisu ishoda faze III ispitivanja za Ispitivanja 108, 111 i C216, SVR koji se virološki smatrao izlječenjem definiran je na temelju procjene HCV RNK na posjetu u 72. tjednu ispitivanja, s time da se koristilo posljednje mjerenje u tom vremenskom prozoru.
English: warfarin, dabigatran to prevent blood clots (anticoagulants)
Croatian: varfarin, dabigatran za sprječavanje nastanka krvnih ugrušaka (antikoagulansi)
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).
Croatian: Ove smjernice možda neće jednako vrijediti ako se prije početka terapije INCIVOM provelo uvodno liječenje peginterferonom alfa i ribavirinom (vidjeti dio 5.1).
English: Prior Non-responders N = 69 % (n/N)
Croatian: Bez prethodnog odgovora N = 69 % (n/N)
English: Administration of activated charcoal may also be used to aid in the removal of
Croatian: Može se primijeniti i aktivni ugljen kako bi se pridonijelo uklanjanju neapsorbirane djelatne tvari.
English: All of these reactions resolved with treatment
Croatian: Sve navedene reakcije povukle su se po prestanku liječenja.
English: An increase in dose from 750 mg every 8 hours to 1,875 mg every 8 hours in a multiple-dose study resulted in a less than proportional increase (i.e., about 40%) in telaprevir exposure.
Croatian: Povećanje doze sa 750 mg svakih 8 sati na 1875 mg svakih 8 sati u ispitivanju višekratnih doza rezultiralo je povećanjem izloženosti telapreviru manjem od proporcionalnog (npr. oko 40%).
English: domperidone to treat vomiting and nausea (antiemetics)
Croatian: domperidon za liječenje povraćanja i mučnine (antiemetici)
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.
Croatian: Ne postoje klinički podaci o ponovnom liječenju bolesnika u kojih terapija inhibitorom proteaze HCV NS3-4A kao što je telaprevir, nije bila uspješna, a ne postoje ni podaci o ponovnom liječenju telaprevirom.
English: Renal and urinary disorders uncommon blood creatinine increased b, pre-renal azotemia with or without acute renal failure
Croatian: Poremećaji bubrega i manje često povišen kreatinin u krvi b , prerenalna azotemija sa ili bez akutnog zatajenja bubrega
English: Table 13: SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Croatian: Tablica 13: Stope SVR-a prema odgovoru u 4. tjednu (smanjenje < 1 log10 ili ≥ 1 log10) u skupini T12(DS)/PR48: Ispitivanje C216
English: The dose of INCIVO must not be reduced, and INCIVO must not be restarted if discontinued.
Croatian: Doza INCIVA se ne smije smanjiti, a nakon prestanka uzimanja INCIVO ne smije se početi ponovno primjenjivati.
English: Results of a study conducted in healthy volunteers demonstrated a modest effect of telaprevir at a dose of 1,875 mg every 8 hours on the QTcF interval with a placebo-adjusted maximum mean increase of 8.0 msec (90% CI: 5.1-10.9) (see section 5.1).
Croatian: Rezultati ispitivanja provedenih u zdravih ispitanika pokazali su umjereni učinak telaprevira u dozi od 1875 mg svakih 8 sati na QTcF interval uz placebo prilagođeno maksimalno prosječno produljenje za 8,0 ms (90% CI: 5,1-10,9) (vidjeti dio 5.1).
English: Patients taking INCIVO may develop a skin rash.
Croatian: Bolesnici koji uzimaju INCIVO mogu dobiti kožni osip.
English: There are no clinical data on the use of INCIVO in HCV patients with moderate or severe renal impairment (CrCl ≤ 50 ml/min) (see section 4.4).
Croatian: Ne postoje klinički podaci o primjeni INCIVA u bolesnika s HCV-om i umjerenim do teškim oštećenjem funkcije bubrega (CrCl ≤ 50 ml/min) (vidjeti dio 4.4).
English: It is not known whether telaprevir, the active ingredient in INCIVO, is found in human breast milk.
Croatian: Nije poznato je li telaprevir, djelatna tvar u INCIVU, prisutan u majčinom mlijeku.
English: Marketing Authorisation Holder Janssen Cilag International NV Turnhoutseweg 30
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Janssen Cilag International NV Turnhoutseweg 30
English: alfentanil, fentanyl to treat pain (analgesics) or used during surgery to induce sleep digoxin, intravenous lidocaine to treat certain heart disorders such as abnormal heart beat (antiarrhythmics)
Croatian: alfentanil, fentanil za liječenje boli (analgetici) ili se primjenjuju tijekom operativnih zahvata za izazivanje sna digoksin, lidokain primjenjen u venu za liječenje određenih srčanih poremećaja, kao što su poremećeni otkucaji srca (antiaritmici)
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „Rok valjanosti“.
English: Caution is warranted and clinical monitoring is recommended for itraconazole, posaconazole, and voriconazole.
Croatian: Nalaže se oprez i preporučuje kliničko praćenje itrakonazola, posakonazola i vorikonazola.
English: SVR rates were higher (absolute difference of at least 28%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA (< 800,000, ≥ 800,000 IU/ml), and extent of liver fibrosis.
Croatian: Stope SVR bile su više (apsolutna razlika od najmanje 28%) u skupini T12/PR nego u skupini Pbo/PR48 u svim podskupinama bolesnika podijeljenih prema spolu, dobi, rasi, etničkoj pripadnosti, indeksu tjelesne mase, podtipu HCV genotipa, početnoj koncentraciji HCV RNK (< 800 000, ≥ 800 000 IU/ml) i opsegu fibroze jetre.
English: Patients taking INCIVO frequently get an itchy skin rash.
Croatian: Bolesnici koji uzimaju INCIVO često dobiju kožni osip popraćen svrbežom.
English: Antiretroviral therapy regimens included efavirenz, atazanavir/ritonavir, raltegravir, etravirine, or darunavir/ritonavir in combination with tenofovir or abacavir and either lamivudine or emtricitabine.
Croatian: Režim antiretrovirusnog liječenja uključio je efavirenz, atazanavir/ritonavir, raltegravir, etravirin ili darunavir/ritonavir u kombinaciji s tenofovirom ili abakavirom te lamivudinom ili emtricitabinom.
English: Effect on unbound telaprevir concentrations is unknown (see sections 4.2 and 4.4).
Croatian: Učinak na koncentracije nevezanog telaprevira nije poznat (vidjeti dio 4.2
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin, including pregnancy testing requirements (see section 4.6).
Croatian: Vidjeti Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin, uključujući potrebno testiranje na trudnoću (vidjeti dio 4.6).
English: INCIVO must be taken with peginterferon alfa and ribavirin to prevent treatment failure.
Croatian: INCIVO se mora uzimati s peginterferonom alfa i ribavirinom kako bi se spriječio neuspjeh liječenja.
English: Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry.
Croatian: U svakoj bočici nalazi se jedna ili dvije vrećice (sredstvo za sušenje) kako bi se tablete očuvale suhima.
English: Signs might be yellowing of the skin or eyes (jaundice), swelling of the stomach (ascites) or legs due to fluid, and bleeding from swollen veins (varices) in the gullet (oesophagus).
Croatian: Znakovi mogu biti žuta boja kože i bjeloočnica (žutica), oticanje trbuha (ascites) ili nogu zbog nakupljanja tekućine te krvarenje iz oteknutih vena (varikoziteti) u jednjaku (ezofagusu).
English: Transporters In vitro studies demonstrated that telaprevir is an inhibitor of OATP1B1 and OATP2B1.
Croatian: In vitro ispitivanja su pokazala da je telaprevir inhibitor OATP1B1 i OATP2B1.
English: In the Pbo/PR arm, 2 (9%) patients had baseline bridging fibrosis and no patients had baseline cirrhosis.
Croatian: U skupini Pbo/PR, 2 (9%) bolesnika na početku ispitivanja je imalo premoštavajuću fibrozu, a nijedan bolesnik na početku nije imao cirozu.
English: If the HCV RNA concentration is > 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
Croatian: Ako je koncentracija HCV RNK > 1000 IU/ml, potrebno je prekinuti primjenu INCIVA, peginterferona alfa i ribavirina.
English: to decrease blood pressure (calcium channel blockers) to treat HIV infections (CCR5 antagonist)
Croatian: za liječenje HIV infekcija (CCR5 antagonist)
English: ↑ triazolam inhibition of CYP3A
Croatian: ↑ kolhicin inhibicija CYP3A
English: Co-administration with carbamazepine is contraindicated.
Croatian: Istodobna primjena s karbamazepinom je kontraindicirana.
English: The contribution of unchanged
Croatian: Udjeli neizmijenjenog
English: Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Croatian: Na osnovu rezultata kliničkih ispitivanja interakcija lijekova (npr. escitalopram, zolpidem, etinilestradiol), indukcija metaboličkih enzima telaprevirom se ne može isključiti.
English: The Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (DAIDS, version 1.0, December 2004) was used in the pooled laboratory datasets.
Croatian: Za grupiranje objedinjenih podataka koristila se podjela AIDS tablice za stupnjevanje težine nuspojava u odraslih i pedijatrijskih bolesnika (DAIDS, verzija 1.0, prosinac 2004.).
English: It is not recommended to co-administer sildenafil or vardenafil and telaprevir.
Croatian: Ne preporučuje se istodobno primjenjivati sildenafil ili vardenafil i telaprevir.
English: The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl < 50 ml/min) or in patients on haemodialysis.
Croatian: Djelotvornost i sigurnost primjene u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (CrCl < 50 ml/min) ili u bolesnika na hemodijalizi nije utvrđena.
English: Ribavirin dose reductions were used for management of anaemia.
Croatian: Za liječenje anemije koristilo se smanjenje doze ribavirina.
English: Purpose of the medicine flecainide, propafenone to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Croatian: Svrha uzimanja lijeka flekainid, propafenon za liječenje određenih srčanih poremećaja, kao što su nepravilni otkucaji srca (antiaritmici)
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
Croatian: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
English: In a follow-up study of 98 treatment-naïve and prior treatment-failure patients who were treated with a INCIVO regimen in a Phase 2 or Phase 3study and did not achieve SVR, telaprevir-resistant variants were no longer detected in 85% (83/98) of patients (median follow-up of 27.5 months).
Croatian: U ispitivanju temeljenom na praćenju 98 bolesnika koji prethodno nisu bili liječeni i bolesnika u kojih je liječenje bilo neuspješno, a koji su u fazi II ili III ispitivanja bili liječeni INCIVOM i nisu postigli trajni virološki odgovor, varijante rezistentne na telaprevir više se nisu mogle otkriti kod 85% (83/98) bolesnika (medijan praćenja: 27,5 mjeseci).
English: See section 4.4 for recommendations for monitoring of rash and discontinuation of INCIVO, ribavirin, and peginterferon alfa.
Croatian: Vidjeti dio 4.4 za preporuke za praćenje osipa i prekid primjene INCIVA, ribavirina i peginterferona alfa.
English: Patients on an efavirenz-based regimen must receive INCIVO 1,125 mg every 8 hours.
Croatian: Bolesnici na režimu temeljenom na efavirenzu, moraju uzeti 1125 mg INCIVA, svakih 8 sati.
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).
Croatian: Ne postoje klinički podaci o ponovnom liječenju bolesnika u kojih terapija inhibitorom HCV NS3-4A proteaze nije bila uspješna (vidjeti dio 5.1).
English: INCIVO has not been studied in HCV-infected patients with moderate hepatic impairment (Child-Pugh B, score 7-9).
Croatian: INCIVO nije bio ispitivan u bolesnika zaraženih HCV-om s umjerenim oštećenjem funkcije jetre (Child-Pugh B, indeks 7-9).
English: The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Croatian: Da bi se dobio željeni klinički učinak, treba pratiti koncentracije digoksina u serumu i koristiti ih za titraciju doze digoksina.
English: The concomitant use of rifabutin and telaprevir is not recommended.
Croatian: Ne preporučuje se istodobna primjena rifabutina i telaprevira.
English: Plasma HCV RNA values were measured using the COBAS
Croatian: Vrijednosti HCV RNK u plazmi mjerene
English: (> 5.0 x ULN)
Croatian: (> 5,0 x GGN)
English: Exposure to telaprevir is higher during co-administration of peginterferon alfa and ribavirin than after administration of telaprevir alone.
Croatian: Izloženost telapreviru viša je tijekom istodobne primjene peginterferona alfa i ribavirina nego nakon primjene samog telaprevira.
English: INCIVO 375 mg film-coated tablets
Croatian: INCIVO 375 mg filmom obložene tablete