FrancophonIA/ELRC3.0 huggingface dataset:
English: Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Croatian: Metadon (terapija održavanja metadonom [30 do 130 mg na dan])/ sofosbuvir (400 mg jedanput na dan)d
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
Croatian: Farmakokinetika ledipasvira, sofosbuvira i GS-331007 ispitana je u ispitivanjima ledipasvira/sofosbuvira faze 2/3 u bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu liječenih ledipasvirom/sofosbuvirom (n = 94) u trajanju od 8, 12 ili 24 tjedna te uspoređenih s bolesnicima bez oštećenja bubrega.
English: Co-administration with rosuvastatin (see section 4.5).
Croatian: Istovremena primjena s rosuvastatinom (vidjeti dio 4.5).
English: The E237G substitution showed a 1.3-fold reduction in susceptibility to sofosbuvir in the genotype 1a replicon assay.
Croatian: U testu replikona genotipa 1a, supstitucija E237G pokazala je smanjenje osjetljivosti na sofosbuvir za 1,3 puta.
English: At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose.
Croatian: Pri dozi bez vidljivog učinka, AUC izloženost ledipasviru bila je približno 7 puta veća u mužjaka i 3 puta veća u ženki od izloženosti ljudi pri preporučenoj kliničkoj dozi.
English: Impact of DAA therapy on drugs metabolized by the liver
Croatian: Utjecaj terapije direktno djelujućim antiviroticima na lijekove koji se metaboliziraju putem jetre
English: - 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).
Croatian: simptomima nalik gripi, mjehurićima u ustima, na očima i/ili na genitalijama
English: Dosed 1 hr After Dialysis
Croatian: Doza 1 h poslije dijalize
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Croatian: Lijekovi koji su umjereni induktori P-gp-a u crijevima (npr. okskarbazepin) mogu smanjiti koncentracije ledipasvira i sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: Contains lactose and sunset yellow FCF aluminium lake (E110).
Croatian: Sadrži laktozu i boju sunset yellow FCF aluminium lake (E110).
English: Such co-administration is not recommended.
Croatian: Ne preporučuje se njihova istovremena primjena.
English: LDV/SOF+RBV 24 weeks (n = 307)a,b
Croatian: LDV/SOF+RBV 24 tjedna (n = 307)a,b
English: Change in MELD score: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin, 57% (70/123) and 19% (23/123) had an improvement or no change in MELD score from baseline to post-treatment week 12, respectively; of the 32 patients whose MELD score was ≥ 15 at baseline, 59% (19/32) had a MELD score < 15 at post-treatment Week 12.
Croatian: Promjena MELD rezultata: Među onima koji su postigli SVR12 u 12 tjedana liječenja kombinacijom ledipasvir/sofosbuvir + ribavirin, njih 57 % (70/123) imalo je poboljšanje, a u 19 % (23/123) nije bilo promjene u MELD rezultatu od početka do 12. tjedna nakon liječenja; od 32 bolesnika čiji je MELD rezultat bio ≥ 15 na početku, 59 % (19/32) imalo je u 12. tjednu nakon liječenja MELD rezultat < 15.
English: Adult and adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC Patients without cirrhosis
Croatian: Odrasli i adolescenti u dobi od 12 ili više godina s CHC-om uzrokovanim genotipom 1, 4, 5 ili 6
English: Presence of baseline NS5A resistance-associated substitutionsc No
Croatian: Prisutnost početnih supstitucija u NS5A povezanih s rezistencijom c
English: Genotype 1a
Croatian: Genotip 1a
English: Dose modification of ribavirin in adults taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Croatian: Ako se Harvoni primjenjuje u kombinaciji s ribavirinom, a bolesnik ima ozbiljnu nuspojavu potencijalno povezanu s ribavirinom, dozu ribavirina potrebno je prilagoditi ili prekinuti njegovu primjenu, ako je to primjereno, sve dok se nuspojava ne povuče ili se ne smanji težina nuspojave.
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Croatian: Udio bolesnika u kojih je liječenje trajno prekinuto zbog štetnih događaja iznosio je 0 %, < 1 % odnosno 1 % kod bolesnika koji su primali ledipasvir/sofosbuvir tijekom 8, 12 odnosno 24 tjedna; te < 1 %, 0 %, odnosno 2 % kod bolesnika koji su primali kombiniranu terapiju ledipasvirom/sofosbuvirom
English: Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Croatian: Harvoni sadrži azo boju sunset yellow FCF aluminium lake (E110), koja može uzrokovati alergijske reakcije.
English: Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
Croatian: Harvoni s ribavirinomA tijekom 24 tjedna (vidjeti dijelove 4.4 i
English: therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Croatian: Ni jedan bolesnik nije bio prethodno liječen terapijom protiv HCV-a i ni jedan nije imao cirozu; 26 % (13/50) bolesnika prethodno nije bilo liječeno antiretrovirusnim lijekovima protiv HIV-a, a 74 % (37/50) bolesnika istovremeno je primalo antiretrovirusnu terapiju protiv HIV-a.
English: Sunset yellow FCF aluminium lake (E110)
Croatian: talk boja sunset yellow FCF aluminium lake (E110)
English: Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Croatian: Od 8 bolesnika koji nisu imali NS5A RAV u vrijeme virološkog neuspjeha, 7 bolesnika primalo je liječenje tijekom 8 tjedana (n = 3 ledipasvirom/sofosbuvirom; n = 4 ledipasvirom/sofosbuvirom +ribavirinom), a 1 je bolesnik primao ledipasvir/sofosbuvir tijekom 12 tjedana.
English: The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT).
Croatian: Medijan dobi bio je 56 godina (raspon: od 23 do 77); 74 % bolesnika bili su muškarci; 97 % bili su bijelci; 63 % imalo je infekciju HCV-om genotipa 1a; 94 % imalo je ne-CC IL28B alele (CT ili TT).
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
Croatian: Nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom prethodno liječenih bolesnika s kompenziranom cirozom (SIRIUS, n = 77), 8/8 bolesnika s početnim NS5A RAV-ovima koji nose smanjenu osjetljivost na ledipasvir za > 100 puta postiglo je SVR12.
English: The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Croatian: Skupinu NS5A RAV-ova koji su nosili povećanje > 100 puta i koji su bili opaženi u bolesnika činile su sljedeće supstitucije u genotipu 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) ili u genotipu 1b (Y93H).
English: No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili emtricitabina/ rilpivirina/ tenofovirdizoproksilfumarata.
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring dialysis.
Croatian: Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) koji zahtijeva dijalizu.
English: The clinical studies enrolled patients with or without cirrhosis, who were treatment-naïve or with prior treatment failure after therapy with PEG-IFN + ribavirin +/- an HCV protease inhibitor.
Croatian: Klinička ispitivanja uključila su bolesnike s cirozom ili bez nje, koji prethodno nisu bili liječeni ili u kojih je prethodno liječenje PEG-IFN + ribavirinom +/- inhibitorom proteaze HCV-a bilo neuspješno.
English: Severe RI (eGFR <30 mL/min/1.73 m2)
Croatian: Teško oštećenje bubrega (eGFR < 30 ml/min/ 1,73 m2)
English: Dosed 1 hr Before Dialysis
Croatian: Doza 1 h prije dijalize
English: For the same treatment arm, patients with baseline NS5A RAVs conferring a fold-change of > 100, relapse occurred in 4/13 (31%), as compared to 3/95 (3%) in those without any baseline RAVs or RAVs conferring a fold-change of ≤ 100.
Croatian: NS5A RAV-ovima koji su nosili promjenu > 100 puta, relaps je nastupio u 4/13 (31 %) u usporedbi s 3/95 (3 %) u onih bez ikakvih početnih RAV ili RAV koji nose promjenu ≤ 100 puta.
English: Use with HMG-CoA reductase inhibitors
Croatian: INHIBITORI HMG-CoA REDUKTAZE
English: For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
Croatian: + darunavir/ritonavir, molimo vidjeti niže.
English: Nervous system disorders: Very common headache
Croatian: Poremećaji živčanog sustava:
English: Changes in MELD and CPT score from baseline to post-treatment Week 12 were analyzed for all patients with decompensated cirrhosis (pre- or post-transplant) who achieved SVR12 and for whom data were available (n = 123) to assess the effect of SVR12 on hepatic function.
Croatian: Kako bi se procijenio učinak SVR12 na funkciju jetre, za sve bolesnike s dekompenziranom cirozom (prije ili poslije transplantacije) koji su postigli SVR12 i za koje su bili dostupni podaci (n = 123), analizirane su promjene u rezultatu MELD i CPT od početnih vrijednosti do 12. tjedna nakon liječenja.
English: Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Croatian: Liječnik će Vam možda trebati dati drugi lijek ili prilagoditi dozu lijeka koji uzimate.
English: Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions
Croatian: Harvoni sadrži boju sunset yellow FCF aluminium lake (E110), koja može izazvati alergijske reakcije
English: Your doctor may give you a different medicine or adjust the dose of the medicine you are taking.
Croatian: Liječnik Vam može dati drugi lijek ili prilagoditi dozu lijeka koji uzimate.
English: Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition
Croatian: Tablica 11: Demografske i početne značajke u ispitivanju ION-1 Raspodjela bolesnika
English: SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
Croatian: Midazolam (2,5 mg jedna doza)/ ledipasvir (90 mg jedna doza)
English: • The active substances are ledipasvir and sofosbuvir.
Croatian: • Djelatne tvari su ledipasvir i sofosbuvir.
English: f One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
Croatian: f. Za jednog bolesnika u kojeg je virusno opterećenje postiglo < LLOQ na kraju liječenja nedostajali su početni podaci za
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol).
Croatian: • karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja);
English: Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition
Croatian: Tablica 8: Demografske i početne značajke u ispitivanju ION-3 Raspodjela bolesnika
English: No dose adjustment required.
Croatian: Nije potrebna prilagodba doze.
English: Ledipasvir AUC is dose proportional over the dose range of 3 to 100 mg. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Croatian: AUC sofosbuvira i GS-331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 400 mg.
English: Genotype 1b 0.004 Genotype 2a
Croatian: Genotip 1a Genotip 1b Genotip 2a Genotip 2b
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR.
Croatian: Nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom (bez ribavirina) prethodno liječenih bolesnika (skupina 1 u ispitivanju ION-2), 4/4 bolesnika s početnim NS5A RAV-ovima koji nose promjenu u osjetljivosti na ledipasvir ≤ 100 puta postiglo je SVR.
English: 24 weeks (n = 111)
Croatian: 24 tjedna (n = 111)
English: No dose adjustment of Harvoni or raltegravir is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili raltegravira.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
Croatian: Nisu utvrđene nikakve klinički važne razlike u farmakokinetici sofosbuvira ili GS-331007 zbog spola.
English: Change in CPT score and class: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir with ribavirin, 60% (74/123) and 34% (42/123) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 32 patients who had CPT C cirrhosis at baseline, 53% (17/32) had CPT B cirrhosis at post-treatment Week 12; of the 88 patients who had CPT B cirrhosis at baseline, 25% (22/88) had CPT A cirrhosis at post-treatment Week 12.
Croatian: Promjena CPT rezultata i stadija: Među onima koji su postigli SVR12 u 12 tjedana liječenja kombinacijom ledipasvir/sofosbuvir + ribavirin, poboljšanje CPT rezultata imalo je 60 % (74/123), a 34 % (42/123) nije imalo nikakvu promjenu CPT rezultata od početka do 12. tjedna nakon liječenja; od 32 bolesnika koji su na početku imali cirozu CPT stadija C, 53 % (17/32) imalo je u 12. tjednu nakon liječenja cirozu CPT stadija B; od 88 bolesnika koji su na početku imali cirozu CPT stadija B, 25 % (22/88) imalo je u 12. tjednu nakon liječenja cirozu CPT stadija A.
English: Genotype 4d 0.60 Genotype 5a
Croatian: Genotip 3a Genotip 4a Genotip 4d Genotip 5a
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Croatian: Raltegravir (400 mg dvaput na dan)/ sofosbuvir (400 mg jedanput na dan)d
English: Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1
Croatian: Ispitivanje 4063 bilo je otvoreno kliničko ispitivanje s tri skupine ispitanika u kojem se procijenilo liječenje ledipasvirom/sofosbuvirom u trajanju od 8, 12 i 24 tjedna u ukupno 95 bolesnika s CHC-om uzrokovanim genotipom 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) ili 6 (2 %) i s ESRD-om koji je zahtijevao dijalizu: 45 prethodno neliječenih bolesnika zaraženih HCV-om genotipa 1 bez ciroze primalo je ledipasvir/sofosbuvir tijekom 8 tjedana; 31 prethodno liječen bolesnik zaražen HCV-om genotipa 1 i prethodno neliječeni ili već liječeni bolesnici zaraženi HCV-om genotipa 2, 5 i 6 bez ciroze primali su ledipasvir/sofosbuvir tijekom 12 tjedana; a 19 bolesnika zaraženih HCV-om genotipa 1, 2 i 4 s kompenziranom cirozom primalo je ledipasvir/sofosbuvir tijekom 24 tjedna.
English: Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC including those with cirrhosis (randomised 1:1:1:1).
Croatian: Odrasli s cirozom ili bez nje koji prethodno nisu bili liječeni - ION-1 (ispitivanje 0102) - genotip 1 Ispitivanje ION-1 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u 865 bolesnika s CHC-om uzrokovanim genotipom 1, uključujući one s cirozom (randomizirani u omjeru 1:1:1:1), koji prethodno nisu bili liječeni.
English: Patients without cirrhosis 89% (25/28)
Croatian: Bolesnici s cirozom 73% (16/22)
English: No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Croatian: Nisu opaženi značajni učinci ledipasvira ili sofosbuvira na fetalni razvoj u štakora i kunića.
English: Rifapentine
Croatian: Rifapentin
English: Famotidine dosed simultaneously with Harvonid
Croatian: Famotidin primijenjen istovremeno s lijekom
English: Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.5).
English: 8 weeks (n = 215)
Croatian: 8 tjedana (n = 215)
English: No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili efavirenza/ emtricitabina/ tenofovirdizoproksilfumarata.
English: Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Croatian: Tablica 4: Smjernica za prilagodbu doze ribavirina u odraslih kod istovremene primjene s lijekom Harvoni
English: No dose adjustment of Harvoni or methadone is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili metadona.
English: Harvoni [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Harvoni [samo vanjsko pakiranje]
English: Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Croatian: Medijan dobi 670 liječenih bolesnika bio je 59 godina (raspon: od 21 do 81 godine); 77 % bolesnika bili su muškarci; 91 % bili su bijelci; srednja vrijednost indeksa tjelesne mase iznosila je 28 kg/m2 (raspon: od 18 do 49 kg/m2); 94 % imalo je infekciju HCV-om genotipa 1, a 6 % imalo je infekciju HCV-om genotipa 4; u 78 % bolesnika prethodna HCV terapija nije bila uspješna.
English: No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili ciklosporina na početku njihove istodobne primjene.
English: Age (years): median (range) Male gender
Croatian: Dob (godine): medijan (raspon) 56 (24-67) Muški spol
English: Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Croatian: Tablica 15: Stope relapsa u odabranim podskupinama u ispitivanju ION-2 LDV/SOF
English: Use with moderate P-gp inducers
Croatian: Primjena s umjerenim induktorima P-glikoproteina
English: EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Croatian: Y93C/F/H/N/S za infekciju HCV-om genotipa 1a i L31I/F/M/V, P32L, P58D, A92K i Y93C/H/N/S za infekciju
English: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Harvoni se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže sofosbuvir.
English: Cross-resistance
Croatian: Ukrižena rezistencija
English: - Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see section 4.4).
Croatian: U bolesnika za koje se smatra da imaju niski rizik od progresije kliničke bolesti i koji imaju daljnje mogućnosti ponovnog liječenja može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (vidjeti dio 4.4).
English: ↔ Emtricitabine ↑ Tenofovir
Croatian: ↑ Tenofovir
English: Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Croatian: Tablica 10: Stope relapsa prema početnim značajkama u ispitivanju ION-3, populacija s virološkim neuspjehom*
English: 24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Croatian: Ova 4 bolesnika bez ciroze s relapsom imala su početne polimorfizme NS5A povezane s rezistencijom.
English: Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Croatian: Harvoni je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
English: b Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: b. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Croatian: Očekuje se da će istovremena primjena lijeka Harvoni s tipranavirom (pojačanim ritonavirom) smanjiti koncentraciju ledipasvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Harvoni.
Croatian: Nakon što počnete uzimati lijek Harvoni, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: 12 weeks (n = 111)
Croatian: 12 tjedana (n = 111)
English: - Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.
Croatian: - U bolesnika koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (u bolesnika bez ciroze) ili 24 tjedna (u bolesnika s cirozom).
English: No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Croatian: Nisu utvrđene nikakve klinički važne razlike u farmakokinetici ledipasvira, sofosbuvira i GS-331007 zbog rase.
English: d 3/3 of these patients had cirrhosis.
Croatian: d. 3/3 bolesnika imalo je cirozu. e. 0/4 bolesnika imalo je cirozu.
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih pitanja o ovim lijekovima, obratite se svom liječniku ili ljekarniku.
English: c Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: c. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC.
Croatian: U ispitivanju ION-3 procjenjivalo se 8 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega te 12 tjedana liječenja ledipasvirom/sofosbuvirom bolesnika s CHC-om uzrokovanim genotipom 1, bez ciroze, koji prethodno nisu bili liječeni.