FrancophonIA/ELRC3.0 huggingface dataset:
English: NA No dose adjustment required for diazepam; increase dose if clinically indicated.
Croatian: NP Nije potrebno prilagođavati dozu za diazepam; primijeniti veću dozu ako je to klinički indicirano.
English: Exviera contains lactose
Croatian: Exviera sadrži laktozu
English: • Treatment should be discontinued in patients who develop evidence of hepatic decompensation.
Croatian: • U bolesnika kod kojih se razviju znakovi dekompenzacije jetre liječenje je potrebno prekinuti.
English: ↔ abacavir
Croatian: ↔ abakavir
English: In genotype 1a, substitutions C316Y, M414T, Y448H, A553T, G554S, S556G/R, and Y561H in HCV NS5B reduced susceptibility to dasabuvir.
Croatian: Kod genotipa 1a, supstitucije C316Y, M414T, Y448H, A553T, G554S, S556G/R i Y561H u proteinu NS5B HCV-a smanjile su osjetljivost na dasabuvir.
English: See Table 2 for guidance regarding potential drug interactions and dosing recommendations for dasabuvir administered with ombitasvir/paritaprevir/ritonavir.
Croatian: Tablici 2 navode se smjernice o mogućim interakcijama lijekova i preporuke za doziranje dasabuvira primijenjenog s ombitasvirom/paritaprevirom/ritonavirom.
English: A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with ombitasvir/paritaprevir/ritonavir.
Croatian: Preporučuje se privremeno prekinuti s primjenom pitavastatina / fluvastatina tijekom liječenja ombitasvirom/paritaprevirom/ritonavirom.
English: The persistence of dasabuvir, ombitasvir and paritaprevir resistance-associated amino acid substitutions in NS5B, NS5A and NS3, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Croatian: Postojanost aminokiselinskih supstitucija u NS5B, NS5A i NS3, odnosno povezanih s rezistencijom na dasabuvir, ombitasvir i paritaprevir, ocijenjena je u ispitanika s infekcijom genotipom 1a u kliničkim ispitivanjima faze 2b.
English: Treated subjects (N = 233) had a median age of 49 years (range: 26 to 69); 10% were Black; 12% had compensated cirrhosis; 66% were treatment-naïve; 32% had failed prior treatment with pegIFN/RBV; 2% had failed prior treatment with sofosbuvir.
Croatian: Medijan dobi liječenih ispitanika (N = 233) iznosio je 49 godina (raspon: 26 do 69); 10% bili su crnci; 12% imalo je kompenziranu cirozu; 66% prethodno nije bilo liječeno; 32% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 2% nije ostvarilo odgovor na prethodno liječenje sofosbuvirom.
English: Table 6.
Croatian: Tablici 6.
English: Treatment-emergent amino acid substitutions in the pooled analysis of dasabuvir and ombitasvir/paritaprevir/ritonavir, with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Croatian: Tablica 5. Aminokiselinske supstitucije nastale tijekom liječenja primijećene u analizi objedinjenih podataka za režime liječenja dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom, s ribavirinom ili bez njega, u kliničkim ispitivanjima faze 2b i faze 3 (N=2510)
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of dasabuvir in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Croatian: Kliničko ispitivanje u ispitanika na zamjenskoj terapiji kod liječenja ovisnosti o opioidima U fazi 2 multicentričnog, otvorenog ispitivanja s jednom skupinom od 38 neliječenih ispitanika ili liječenih kombinacijom pegIFN/RBV, bez ciroze, s infekcijom HCV-om genotipa 1 koji uzimaju stalnu dozu metadona (N=19) ili buprenorfina s ili bez naloksona (N=19), ispitanici su tijekom 12 tjedana primali dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom.
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Preporučena doza atazanavira je 300 mg bez primjene ritonavira u kombinaciji s dasabuvirom ombitasvir/paritaprevir/rito
English: TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 24-week arm
Croatian: Stope relapsa u odnosu na početne laboratorijske vrijednosti u ispitanika s infekcijom genotipom 1a i kompenziranom cirozom nakon 12 i 24 tjedna liječenja dasabuvir i ombitasvir/paritaprevir/ritonavir s RBV-om
English: Since dasabuvir is a BCRP substrate, distribution to the milk may change if this transporter is inhibited or induced by co-administration of other medicinal products.
Croatian: supstrat, distribucija u mlijeko se može mijenjati ukoliko je prijenosnik inhibiran ili induciran istodobnom primjenom drugih lijekova.
English: Tacrolimus whole blood concentrations should be monitored upon initiation and throughout coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir and the dose and/or dosing frequency should be adjusted as needed.
Croatian: Potrebno je pratiti koncentracije takrolimusa u punoj krvi nakon započinjanja i tijekom cijelog razdoblja istodobne primjene s dasabuvirom i ombitasvirom/paritaprevir om/ritonavirom te po potrebi prilagođavati dozu i/ili učestalost doziranja.
English: Lopinavir/ritonavir 800/200 mg once daily (administered in the evening) was also administered with dasabuvir with ombitasvir/paritaprevir/ritonavir.
Croatian: Doza lopinavira/ritonavira od 800/200 mg jedanput na dan (primijenjena navečer) primjenjivala se i s dasabuvirom s ombitasvirom/paritaprevirom/ritonavirom.
English: The highest dasabuvir dose tested produced exposures equal to 16 to 24-fold (rat) or 6-fold (rabbit) the exposures in humans at the maximum recommended clinical dose.
Croatian: Najveća ispitivana doza dasabuvira dovela je do izloženosti 16 do 24 puta veće (štakor) odnosno 6 puta veće
English: See leaflet for further information.
Croatian: Za dodatne informacije pročitajte uputu o lijeku.
English: RUBY-I; treatment-naïve or pegIFN + RBV experienced with or without cirrhosis who have severe renal impairment or end stage renal disease (ESRD)
Croatian: RUBY-I; ispitanici s cirozom ili bez nje, prethodno neliječeni ili prethodno liječeni pegIFN i RBV koji imaju teško oštećenje funkcije bubrega ili završni stadij bubrežne bolesti
English: Monitor ciclosporin levels and adjust dose and/or dosing frequency as needed.
Croatian: . Pratiti razine ciklosporina te po potrebi prilagoditi dozu i/ili učestalost primjene.
English: Dasabuvir with ombitasvir/paritaprevir/ritonavir is expected to increase the exposure to rosuvastatin more than 3-fold.
Croatian: Očekuje se da primjena dasabuvira s ombitasvirom/paritaprevirom/ritonavirom povećava izloženost rosuvastatinu više nego trostruko.
English: If tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir are used concomitantly, tacrolimus should not be administered on the day dasabuvir and ombitasvir/paritaprevir/ ritonavir are initiated.
Croatian: Ako se takrolimus primjenjuje istodobno s dasabuvirom i ombitasvirom/paritaprevir om/ritonavirom, takrolimus se ne smije primijeniti na dan kada se uvode dasabuvir i ombitasvir/paritaprevir/rito navir.
English: Package leaflet: Information for the patient Exviera 250 mg film-coated tablets dasabuvir This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Exviera 250 mg filmom obložene tablete dasabuvir
English: Subjects with renal transplant and no cirrhosis were dosed for 12 weeks (with RBV for GT1a [n=9], without RBV for GT1b [n=3]).
Croatian: Ispitanici s bubrežnim transplantatom bez ciroze primali su terapiju tijekom 12 tjedana (bolesnici s genotipom 1a u kombinaciji s RBV-om [n=9], a oni s genotipom 1b bez RBV-a [n=3]).
English: Sirolimus dose and/or dosing frequency should be adjusted as needed.
Croatian: Po potrebi treba prilagoditi dozu i/ili učestalost doziranja sirolimusa.
English: HIV/HCV co-infected patients
Croatian: Ispitanici s istodobnom infekcijom HCV-om i HIV-om
English: Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis.
Croatian: Medijan dobi liječenih ispitanika (N=68) iznosio je 58 godina (raspon: 32-77 godina); 83,8% bili su muškarci; 58,8% bili su crnci; 73,5% ispitanika bilo je inficirano HCV-om genotipa 1a; 75,0% imalo je kroničnu bubrežnu bolest stadija 5, a 69,1% ispitanika bilo je na hemodijalizi.
English: The majority of adverse reactions presented in Table 3 were of grade 1 severity in dasabuvir- and ombitasvir/paritaprevir/ritonavir-containing regimens.
Croatian: Većina nuspojava navedenih u Tablici 3 bila je 1. stupnja težine u režimima liječenja koji su sadržavali dasabuvir i ombitasvir/paritaprevir/ritonavir.
English: As liver function may change during treatment with dasabuvir administered with ombitasvir/paritaprevir/ritonavir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da prilikom liječenja dasabuvirom, s ombitasvirom/paritaprevirom/ritonavirom, može doći do promjene funkcije jetre, preporučuje se odgovarajući nadzor internacionalnog normaliziranog omjera
English: ↓ dasabuvir ombitasvir paritaprevir norethindrone (progestin only pill) 0.35 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Croatian: ↔ ombitasvir paritaprevir noretindron (pilula koja sadrži samo progestin) 0,35 mg jedanput na dan dasabuvir ombitasvir/ paritaprevir /ritonavir noretindron
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser HCV genotype 1b
Croatian: Djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV Relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV HCV genotipa 1b
English: How to store Exviera
Croatian: Kako čuvati lijek Exviera
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Croatian: njih 9/12 (75%) postiglo je SVR12, no nijedan ispitanik nije doživio virološki neuspjeh.
English: Medicinal products metabolised by CYP2C19
Croatian: Lijekovi koji se metaboliziraju putem CYP2C19
English: 5 mg single dose
Croatian: 5 mg pojedinačna doza
English: NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
Croatian: NP Nije potrebno prilagođavati dozu za karisoprodol; primijeniti veću dozu ako je to klinički indicirano.
English: Phase 3 global multicentre trials conducted with dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Croatian: Tablica 6. Globalna, multicentrična ispitivanja faze 3 provedena s dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom, u kombinaciji s ribavirinom (RBV) ili bez njega
English: Co-administration of dasabuvir + ombitasvir/paritaprevir/ ritonavir with everolimus is not recommended because of a significant increase in everolimus exposures which cannot be properly dose adjusted with available dose strengths.
Croatian: Istodobna primjena dasabuvira + ombitasvir/paritaprevir/rito navir s everolimusom se ne preporučuje zbog značajnog porasta izloženosti everolimusu,
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 or 24 weeks with or without ribavirin (investigator chosen dose) for GT1 and GT4 infection
Croatian: dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 12 ili 24 tjedna, u kombinaciji s ribavirinom ili bez njega (doza prema izboru ispitivača), za infekciju genotipom 1 ili 4
English: In subjects with mild, moderate and severe hepatic impairment, dasabuvir AUC values were 17% higher, 16% lower and 325% higher, respectively.
Croatian: U ispitanika s blagim oštećenjem funkcije jetre, srednje vrijednosti AUC-a bile su povišene za 17%, u onih s umjerenim oštećenjem funkcije bubrega 16% niže dok su u onih s teškim oštećenjem funkcije jetre bile povišene za 325%.
English: HIV-1 Co-infection
Croatian: Istodobna infekcija HIV-om tipa 1
English: Co-administration of dasabuvir and ombitasvir/paritaprevir/ritonavir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Croatian: sirolimusom ili everolimusom povećava koncentracije imunosupresivnog lijeka zbog inhibicije izoenzima CYP3A ritonavirom (vidjeti dio 4.5).
English: S-warfarin dasabuvir ombitasvir paritaprevir
Croatian: S-varfarin dasabuvir ombitasvir paritaprevir
English: Prior relapse
Croatian: Relaps Ostalo
English: Тел.
Croatian: navir.
English: multicentre, open-label
Croatian: multicentrično, otvoreno ispitivanje
English: Mitotane
Croatian: Mitotan
English: No increase in incidence of ALT elevations was observed with other types of systemic oestrogens commonly used for hormone replacement therapy (e.g., oestradiol and conjugated oestrogens).
Croatian: U ispitanica koje su primale druge vrste sistemskih lijekova koji sadrže estrogene i uobičajeno se koriste u hormonskom nadomijesnom liječenju (npr. estradiol i konjugirani estrogeni), povećanje incidencije povišenja razine ALT-a nije zabilježeno.
English: randomised, global multicentre, double-blind, regimen-controlled
Croatian: randomizirano, globalno, multicentrično, dvostruko slijepo ispitivanje kontrolirano terapijskim režimom
English: Peginteferon+ribavirin-experienced, without cirrhosis SAPPHIRE II
Croatian: Ispitanici prethodno liječeni s kombinacijom peginterferon+ribavirin, bez ciroze SAPPHIRE II
English: Tel: +421 2 5050 0777
Croatian: AbbVie s.r.o. Tel: +421 2 5050 0777
English: Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Croatian: Medijan dobi liječenih ispitanika (N = 22) iznosio je 54 godine (raspon: 34 do 68); 41% bili su crnci, 14% imalo je kompenziranu cirozu; 86% prethodno nije primalo liječenje za infekciju HCV-om; 14% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 68% imalo je infekciju HCV-om genotipa 1a.
English: No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 4.2).
Croatian: Nije potrebno prilagođavati dozu dasabuvira u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, ili u bolesnika sa završnim stadijem bubrežne bolesti koji su na dijalizi (vidjeti dio 4.2).
English: Lower ribavirin dose at initiation may be appropriate.
Croatian: Na početku liječenja mogla bi biti primjerena manja doza ribavirina.
English: HIV ANTIVIRALS: INTEGRASE STRAND TRANSFER INHIBITOR Dolutegravir
Croatian: ANTIVIROTICI ZA LIJEČENJE HIV-a: INIHIBITOR PRIJENOSA LANCA INTEGRAZE Dolutegravi r
English: In subjects with liver transplant, no cirrhosis and GT1 infection, patients were dosed with dasabuvir and ombitasvir/paritaprevir/ritonavir for 12-24 weeks, with and without RBV.
Croatian: Ispitanici s jetrenim transplantatom i infekcijom genotipom 1 bez ciroze primali su dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 12 - 24 tjedna, u kombinaciji s RBV-om ili bez njega.
English: Some patients have reported feeling very tired when taking Exviera with other medicines for their hepatitis C infection.
Croatian: Neki bolesnici koji su za liječenje infekcije hepatitisa C uzimali lijek Exviera u kombinaciji s drugim lijekovima osjećali su se jako umorno tijekom liječenja.
English: Medicinal products metabolised by CYP2C9
Croatian: Lijekovi koji se metaboliziraju putem CYP2C9
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Croatian: Ishod liječenja dasabuvir i ombitasvir/paritaprevir/ritonavir s RBV-om tijekom 12 tjedana n/N % 95% CI
English: For patients that require ribavirin, refer to the ribavirin Summary of Product Characteristics for information regarding use in patients with renal impairment.
Croatian: U bolesnika u kojih je potrebna primjena ribavirina, za informacije o primjeni kod bolesnika s oštećenjem funkcije bubrega vidjeti sažetak opisa svojstava lijeka za ribavirin.
English: Geometric mean Cmax, AUC of multiple doses of dasabuvir 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Croatian: Geometrijske srednje vrijednosti Cmax i AUC-a nakon višekratnih doza dasabuvira 250 mg dvaput na dan i ombitasvirom/paritaprevirom/ritonavirom 25 mg/150 mg/100 mg jedanput na dan primijenjenih s hranom u zdravih dobrovoljaca
English: Exviera 250 mg film-coated tablets dasabuvir
Croatian: Exviera 250 mg filmom obložene tablete dasabuvir
English: 5 mg once daily
Croatian: 5 mg jedanput na dan
English: Primary SVR12 Assessment for Part 2, Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Croatian: Tablica 17. Primarna ocjena SVR12 u 2. dijelu ispitivanja TURQUOISE-I kod ispitanika s istodobnom infekcijom HCV-om genotipa 1 i virusom HIV-1
English: Rilpivirine was also administered with food in the evening and 4 hours after dinner with dasabuvir + ombitasvir/paritaprevir/ritonavir in the study.
Croatian: U ispitivanju rilpivirin se uzimao i s hranom navečer te 4 sata nakon večere, s dasabuvirom +
English: Following a 400 mg 14C-dasabuvir dose, approximately 94% of the radioactivity was recovered in faeces with limited radioactivity (approximately 2%) in urine.
Croatian: približno 94% radioaktivnosti pronađeno je u fecesu, a ograničena količina radioaktivnosti (približno
English: L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Croatian: varijante A1567T u genotipu 1a te R155Q i D168H u genotipu 1b; NS5A varijante Y93C/H u genotipu 1a te L31F/V ili Y93H u kombinaciji s L28M, L31F/V ili P58S u genotipu 1b; NS5B varijante Y448H u genotipu 1a te M414T i Y448H u genotipu 1b.
English: No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu dasabuvira u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, ili u bolesnika sa završnim stadijem bubrežne bolesti koji su na dijalizi (vidjeti dio 5.2).
English: Duloxetine 60 mg single dose dasabu vir + ombitas vir/parit aprevir/ ritonavi r duloxetine
Croatian: Duloksetin 60 mg pojedinačna doza dasabuvir ombitasvir/ paritaprevir /ritonavir duloksetin
English: ↑ dabigatran etexilate dasabuvir + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Croatian: Dasabuvir + ombitasvir/paritaprevir/ ritonavir može povećati koncentracije dabigatraneteksilata u plazmi.
English: Methadone ↔ ombitasvir/paritaprevir and dasabuvir (based on the cross-study comparison)
Croatian: NP ↔ ombitasvir/paritaprevir i dasabuvir (na temelju usporedbe podataka iz različitih ispitivanja)
English: Concomitant use is contraindicated (see section 4.3).
Croatian: Istodobna primjena je kontraindicirana (vidjeti dio 4.3).
English: Mechanism: CYP3A4 inhibition by ritonavir.
Croatian: Mehanizam: inhibicija CYP3A4 ritonavirom.
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Croatian: Mehanizam: inhibicija UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
English: Tel: +39 06 928921
Croatian: AbbVie S.r.l. Tel: +39 06 928921
English: All treatment-emergent variants in NS5A remained detectable at posttreatment Week 48.
Croatian: Sve varijante u NS5A nastale tijekom liječenja bile su mjerljive u
English: 5 mg single dose and other vitamin K antagonists dasabu vir +
Croatian: 5 mg pojedinačna doza i drugi antagonisti vitamina
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Croatian: Većina ispitanika (86,8%) imalo je početnu razinu HCV RNA najmanje 800,000 IU/ml a većina (84.2%) je imala infekciju HCV-om genotipa 1a, 15,8% je imalo portalnu fibrozu (F2) a 5,3%
English: *Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
Croatian: 24 tjedna (vidjeti dio 5.1.) *Napomena: za bolesnike s infekcijom genotipom 1 nepoznatog podtipa ili mješovitom infekcijom genotipom 1
English: Pooled efficacy analysis
Croatian: Analiza objedinjenih podataka o djelotvornosti
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: Mechanism: CYP2C19 induction by ritonavir.
Croatian: Mehanizam: indukcija CYP2C19 ritonavirom.
English: 13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Croatian: Relaps u 2/15 bolesnika (potvrđena razina HCV RNK nakon liječenja od ≥ 15 IU/ml prije ili tijekom razdoblja određivanja SVR12, među ispitanicima koji su imali HCV RNK < 15 IU/ml na zadnjem mjerenju uz najmanje
English: In Part 1a, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 weeks.
Croatian: U dijelu 1a svi su ispitanici primali dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom tijekom 12 ili 24 tjedna.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Exviera.
Croatian: Nakon što počnete uzimati lijek Exviera, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijekove protiv šećerne bolesti.
English: 400 mg once daily
Croatian: 400 mg jedanput na dan
English: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir with or without ribavirin:
Croatian: Nuspojave koje se javljaju kada se lijekovi Exviera i ombitasvir/paritaprevir/ritonavir uzimaju s ribavirinom ili bez njega:
English: Treatment-naïve pegIFN + RBVexperienced
Croatian: Ispitanici prethodno liječeni s pegIFN + RBV
English: ↑ rilpivirine
Croatian: ↑ rilpivirin
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Croatian: Tablica 12. SVR12 za ispitanike s infekcijom genotipom 1b prethodno liječene kombinacijom peginterferon+ribavirin u ispitivanju PEARL II
English: Subjects with HCV GT4 received ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 Weeks.
Croatian: Ispitanici s infekcijom HCV-om genotipa 4 primali su ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom tijekom 12 ili 24 tjedna.
English: Trial
Croatian: Ispitivanje
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Croatian: skupina A: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV skupina B: placebo
English: If sirolimus is dasabuvir ombitasvir
Croatian: Ako se sirolimus primjenjuje zajedno s dasabuvir ombitasvir
English: Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir .
Croatian: Dasabuvir se uvijek mora uzimati zajedno s ombitasvirom/paritaprevirom/ritonavirom.
English: Mechanism: CYP3A inhibition by ritonavir.
Croatian: Mehanizam: inhibicija CYP3A uzrokovana ritonavirom.
English: The EC50 of dasabuvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 7.7 and 1.8 nM, respectively.
Croatian: U testovima replikona HCV-a u staničnoj kulturi, EC50 dasabuvira protiv sojeva genotipa 1a-H77 iznosio je 7,7 nM, a protiv sojeva genotipa 1b-Con1 1,8 nM.