FrancophonIA/ELRC3.0 huggingface dataset:
English: Beginning the day after dasabuvir and ombitasvir/paritaprevir/ ritonavir are initiated; reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations.
Croatian: Počevši dan nakon uvođenja dasabuvira i ombitasvira/paritaprevira/r itonavira, ponovno uvedite takrolimus u sniženoj dozi na temelju koncentracija takrolimusa u krvi.
English: Not studied.
Croatian: Nije ispitivano.
English: Patients receiving ribavirin should also refer to the Summary of Product Characteristics of ribavirin.
Croatian: Bolesnici koji primaju ribavirin moraju pročitati i sažetak opisa svojstava lijeka za ribavirin.
English: During clinical trials with dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Croatian: Tijekom kliničkih ispitivanja dasabuvira s ombitasvirom/paritaprevirom/ritonavirom, s ribavirinom ili bez njega, prolazna povišenja razine ALT-a više od 5 puta gornje granice normale (GGN) primjećeno je kod oko 1% ispitanika (kod 35 od ukupno 3039 ispitanika).
English: Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Croatian: Može biti potrebno kliničko praćenje i prilagodba doze Smefenitoina.
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and one subject with HCV genotype 1b infection experienced relapse.
Croatian: Niti jedan ispitanik s infekcijom HCV-om genotipa 1b nije doživio virološki neuspjeh tijekom liječenja, a jedan je ispitanik s infekcijom HCV-om genotipa 1b doživio relaps.
English: In another open-label phase 3b study evaluating 12 weeks of ombitasvir/paritaprevir/ritonavir with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing ontreatment virologic failure or relapse.
Croatian: U drugom otvorenom ispitivanju faze 3b u kojem se ocjenjivala primjena ombitasvira/paritaprevira/ritonavira s dasabuvirom ili bez njega te bez ribavirina tijekom 12 tjedana u prethodno neliječenih ispitanika s infekcijom genotipom 1a i genotipom 4, koji nisu imali cirozu, ali su imali kroničnu bubrežnu bolest stadija 4 ili 5 (Ruby II), stopa SVR12 iznosila je 94,4% (17/18), a nijedan ispitanik nije doživio virološki neuspjeh tijekom liječenja niti relaps.
English: Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily
Croatian: Efavirenz/ emtricitabin e/tenofovir disoproksil fumarat
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is, therefore, not recommended.
Croatian: Dodavanje inhibitora proteaze HIV-a (atazanavir, darunavir) se ne preporučuje jer se izloženost rilpivirinu može još povećati.
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Croatian: Vidjeti dio 4.2 za preporuke o određivanju doza lijeka kod bolesnika s istodobnim infekcijama virusom HCV-a i virusom HIV-1.
English: Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Croatian: Pakiranje od 56 tableta (višestruko pakiranje koje sadrži 4 unutarnja pakiranja svako s 14 tableta).
English: Impact of ribavirin dose adjustment on probability of SVR In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Croatian: U kliničkim ispitivanjima faze 3, u 91,5% ispitanika nije bilo potrebno prilagođavati dozu ribavirina tijekom terapije.
English: Mechanism: CYP3A4 induction by apalutamide, enzalutamide or mitotane.
Croatian: Mehanizam: CYP3A4 indukcija apalutamido m, enzalutamid om ili mitotanom.
English: Table 14.
Croatian: Tablica 14.
English: CYP3A by atazanavir and CYP3A inhibition by the additional dose of ritonavir.
Croatian: CYP3A koju uzrokuje atazanavir i inhibicije CYP3A koju uzrokuje dodatna doza ritonavira.
English: Dasabuvir is recommended in combination with paritaprevir/ombitasvir/ritonavir, and ritonavir may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Croatian: Dasabuvir se preporuča u kombinaciji s paritaprevirom/ombitasvirom/ritonavirom, a ritonavir može izazvati rezistentnost na inhibitore proteaze (PI) kod bolesnika s istodobnom infekcijom HIV-om ako istodobno ne uzimaju antiretrovirusne lijekove.
English: ↑ keto conazole
Croatian: ↑ ketokonazol
English: Two patients discontinued dasabuvir and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinyloestradiol.
Croatian: Dva su bolesnika prestala uzimati dasabuvir u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom zbog povišenih razina ALT-a uključujući jednog na etinilestradiolu.
English: NA No dose adjustment is necessary for duloxetine.
Croatian: NP Nije potrebno prilagođavati dozu duloksetina.
English: No dose adjustment of dasabuvir is required in patients with mild hepatic impairment (Child-Pugh A).
Croatian: Nije potrebno prilagođavati dozu dasabuvira u bolesnika s blagim oštećenjem funkcije jetre (ChildPugh stadij A).
English: No clinically relevant changes in dasabuvir, paritaprevir, and ombitasvir exposures (based on comparison with historical data) were observed during the coadministration.
Croatian: Tijekom istodobne primjene nisu primijećene klinički značajne promjene izloženosti dasabuviru, paritapreviru ni ombitasviru (na temelju usporedbe s podacima iz prethodnih ispitivanja).
English: Exviera 250 mg film-coated tablets
Croatian: Exviera 250 mg filmom obložene tablete
English: Clinical Comments
Croatian: Klinička napomena
English: The following section describes the specific transporters and metabolizing enzymes that are affected by dasabuvir when combined with ombitasvir/paritaprevir/ritonavir.
Croatian: U nastavku ovog dijela opisuju se specifični prijenosnici i metabolizirajući enzimi na koje djeluje dasabuvir kada se kombinira s ombitasvirom/paritaprevirom/ritonavirom.
English: The SVR12 rates in HCV/HIV-1 co-infected subjects were thus consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Croatian: Dakle, stopa SVR12 kod ispitanika koji imaju istodobnu infekciju HCV-om i virusom HIV-1 bila je ista kao i stopa SVR12 zabilježena u fazi 3 ovog ispitivanja kod ispitanika koji imaju monoinfekciju HCV-om.
English: The most abundant plasma metabolite was M1, which represented 21% of drug-related radioactivity (AUC) in circulation following single dose; it's formed via oxidative metabolism predominantly by CYP2C8.
Croatian: cirkulirajuće radioaktivnosti povezane s lijekom nakon primjene jednokratne doze; M1 se formira oksidativnim metabolizmom uglavnom putem CYP2C8.
English: The M1 metabolite of dasabuvir had EC50 values of 39 and 8 nM against genotype 1a-H77 and 1bCon1 strains in HCV replicon cell culture assays, respectively, and the activity of the M1 metabolite was attenuated 3- to 4-fold in the presence of 40% human plasma.
Croatian: U testovima replikona HCV-a u staničnoj kulturi, EC50 metabolita M1 desavubira protiv sojeva genotipa 1a-H77 iznosio je 39 nM, a protiv sojeva genotipa 1b-Con1 8 nM, dok je aktivnost metabolita M1 protiv replikona bilo 3 do 4 puta slabije u prisutnosti 40% ljudske plazme.
English: NA ombitasvir/paritaprevir/ ritonavir).
Croatian: ombitasvir/paritaprevir/ritonavir.
English: Ribavirin dose modification did not impact SVR rates.
Croatian: Prilagodba doze ribavirina nije utjecala na stope trajnog virološkog odgovora (SVR).
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2D6 /CYP1A2 substrate duloxetine.
Croatian: Dasabuvir primijenjen s ombitasvirom/paritaprevirom/ritonavirom nije nije utjecao na izloženost duloksetinu, supstratu za CYP2D6/CYP1A2.
English: In genotype 1b, substitutions C316N, C316Y, M414T, Y448H, and S556G in HCV NS5B reduced susceptibility to dasabuvir.
Croatian: Kod genotipa 1b, supstitucije C316N, C316Y, M414T, Y448H i S556G u NS5B HCV-a smanjile su osjetljivost na dasabuvir.
English: Co-administration of dasabuvir and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products.
Croatian: Istodobna primjena dasabuvira i ombitasvira/paritaprevira/r itonavira s rilpivirinom jedanput na dan smije se uzeti u obzir jedino u bolesnika bez poznatog produljenja QT intervala te bez produljenja QT intervala zbog istodobno primijenjenih lijekova.
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Croatian: Nijedan ispitanik s HCV infekcijom genotipa 1b nije doživio virološki neuspjeh tijekom liječenja dok se relaps dogodio kod 2 ispitanika s HCV infekcijom genotipa 1b.
English: Tablet core
Croatian: Jezgra tablete:
English: Use in diabetic patients
Croatian: Primjena u bolesnika s dijabetesom
English: NA ↔ ombitasvir /paritaprevir and dasabuvir (based on the cross-study comparison)
Croatian: ↔ ombitasvir/paritaprevir i dasabuvir (na temelju usporedbe podataka iz različitih ispitivanja)
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse
Croatian: AbbVie Deutschland GmbH & Co.
English: Wort (hypericum perforatum)
Croatian: Gospina trava (Hypericum perforatum)
English: The overall safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects.
Croatian: Ukupan sigurnosni profil u ispitanika s istodobnom infekcijom HCV-om i HIV-om tipa 1 bio je sličan onome u ispitanika s infekcijom samo HCV-om.
English: Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Croatian: Peg-IFN + RBV, n (%)
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Croatian: Istodobna primjena dasabuvira s ombitasvirom/paritaprevirom/ritonavirom uključuje tri direktno djelujuća antivirotika protiv HCV-a u različitim fazama životnog ciklusa virusa, s različitim mehanizmima djelovanja i profilima rezistencije koji se ne preklapaju.
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing dasabuvir, ombitasvir and paritaprevir with or without ribavirin (for 8, 12 or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Croatian: Od 2510 ispitanika s infekcijom HCV-om genotipa 1 koji su u kliničkim ispitivanjima faze 2b i 3 liječeni režimima koji su sadržavali dasabuvir, paritaprevir i ombitasvir, u kombinaciji s ribavirinom ili bez njega (tijekom 8, 12 ili 24 tjedna), ukupno je njih 74 (3%) doživjelo virološki neuspjeh
English: Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 14.
Croatian: Stope relapsa u ispitanika s infekcijom genotipom 1a i cirozom u odnosu na početne laboratorijske vrijednosti prikazane su u Tablici 14.
English: NA No dose adjustment is necessary for escitalopram.
Croatian: NP Nije potrebno prilagođavati dozu escitaloprama.
English: Ethinyloestradiol containing oral contraceptives are contraindicated (see section 4.3).
Croatian: Primjena oralnih kontraceptiva koji sadrže etinilestradiol je kontraindicirana (vidjeti dio 4.3)
English: Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 250 mg dasabuvira (u obliku natrijeva hidrata).
English: Darunavir combined with ombitasvir/paritaprevir/ ritonavir + dasabuvir is not recommended in patients with extensive PI resistance.
Croatian: Kombinacija darunavira s ombitasvirom/paritaprevir om/ritonavirom i dasabuvirom se ne preporučuje kod bolesnika s opsežnom rezistencijom na PI.
English: Dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin were assessed in 68 subjects with genotype 1 infection with or without cirrhosis who have severe renal impairment or ESRD (see Section 5.1).
Croatian: Dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega ocijenjeni su u 68 ispitanika s infekcijom genotipom 1, s cirozom ili bez nje, koji imaju teško oštećenje funkcije bubrega ili završni stadij bubrežne bolesti (vidjeti dio 5.1).
English: Serum bilirubin elevations
Croatian: Povišene razine bilirubina u serumu
English: Recommended co-administered medicinal product(s) and treatment duration for dasabuvir by patient population
Croatian: Preporučeni lijek(ovi) za istodobnu primjenu s dasabuvirom te trajanje liječenja prema skupinama bolesnika
English: It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk.
Croatian: Nije poznato izlučuje li se djelatna tvar lijeka Exviera (dasabuvir) u majčino mlijeko.
English: e. Observed in combination in 6% (4/67) of the subjects.
Croatian: Primijećeno u kombinaciji u ispitanika s infekcijom genotipom 1b. e. Primijećeno u kombinaciji u 6% (4/67) ispitanika.
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih pitanja o tim lijekovima, obratite se svom liječniku ili ljekarniku.
English: In all eight trials, the dasabuvir dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily.
Croatian: U svih je osam ispitivanja doza dasabuvira iznosila 250 mg dvaput na dan, a doza lijeka ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg jedanput na dan.
English: Other pegIFN/RBV failures
Croatian: Ostale vrste neuspjeha liječenja kombinacijom pegIFN/RBV
English: Mechanism: CYP3A4/CY P2C8 induction by rifampicin.
Croatian: Mehanizam: CYP3A4/C YP2C8 indukcija rifampicino m.
English: NA No dose adjustment is necessary for zolpidem.
Croatian: NP Nije potrebno prilagođavati dozu zolpidema.
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • izrazit umor
English: A pooled analysis of subjects with genotype 1 HCV infection, who were treated with dasabuvir, ombitasvir and paritaprevir with or without ribavirin in Phase 2b and 3 clinical trials, was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in these recommended regimens.
Croatian: Učinak supstitucija/polimorfizama HCV-a prisutnih na početku ispitivanja na odgovor na liječenje Analiza objedinjenih podataka prikupljenih u kliničkim ispitivanjima faze 2b i 3 u ispitanika s infekcijom HCV-om genotipa 1 liječenih dasabuvirom, ombitasvirom i paritaprevirom, u kombinaciji s ribivarinom ili bez njega, provedena je kako bi se istražila povezanost između supstitucija/polimorfizama NS3/4A, NS5A ili NS5B prisutnih na početku ispitivanja i ishoda liječenja tim preporučenim režimima.
English: The impact of prior dasabuvir, ombitasvir, or paritaprevir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Croatian: ombitasvirom ili paritaprevirom na djelotvornost drugih inhibitora NS5A, inhibitora NS3/4A proteaze ili inhibitora NS5B.
English: When starting coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir, give one fifth of the total daily dose of ciclosporin once daily with ombitasvir/ paritaprevir /ritonavir.
Croatian: Kada se započinje istodobna primjena s dasabuvirom i ombitasvirom/paritaprevir om/ritonavirom, primijeniti jednu petinu ukupne dnevne doze ciklosporina jedanput na dan s ombitasvirom/ pariteprivirom/ritonavirom
English: They are always taken with other antiviral medicines such as ombitasvir/paritaprevir/ritonavir.
Croatian: Uvijek se uzimaju s drugim antivirusnim lijekovima kao što je ombitasvir/paritaprevir/ritonavir.
English: The mean EC50 of dasabuvir against replicons containing NS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Croatian: U testu replikona HCV-a u staničnoj kulturi, srednja vrijednost EC50 dasabuvira protiv replikona koji sadrže NS5B iz palete izolata genotipa 1a odnosno 1b prikupljenih u prethodno neliječenih ispitanika iznosila je 0,77 nM (raspon: 0,4 do 2,1 nM; n=11) odnosno 0,46 nM (raspon: 0,2 do 2 nM; n=10).
English: The long-term clinical impact of the emergence or persistence of virus containing dasabuvir and ombitasvir/paritaprevir/ritonavirresistance-associated substitutions on future treatment is unknown.
Croatian: Nije poznat dugoročan klinički utjecaj pojave ili postojanosti virusa koji sadrži supstitucije povezane s rezistencijom na dasabuvir i ombitasvir/paritaprevir/ritonavir.
English: To be noted, atazanavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of the ombitasvir/paritaprevir/ritonavir fixed dose combination.
Croatian: Potrebno je uzeti u obzir da se atanazavir mora primjenjivati bez ritonavira jer se doza od 100 mg ritonavira jednom dnevno unosi kao dio fiksne kombinacije ombitasvir/paritaprevir/ritonavir.
English: They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritonavir.
Croatian: Uvijek se uzimaju s drugim antivirusnim lijekom koji sadrži ombitasvir/paritaprevir/ritonavir.
English: Mechanism: possible enzyme induction by efavirenz.
Croatian: moguće je da efavirenz inducira enzime.
English: BIGUANIDE ORAL ANTIHYPERGLYCEMICS Metformin
Croatian: BIGVANIDNI ORALNI ANTIHIPERGLIKEMICI
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Croatian: Varijante nastale tijekom liječenja i njihova prevalencija u tim populacijama s virološkim neuspjehom prikazane su u Tablici 5. Među 67 ispitanika s infekcijom genotipom 1a, varijante NS3 primijećene su u 50 ispitanika, varijante NS5A u 46 ispitanika, varijante NS5B u 37 ispitanika, a varijante nastale tijekom liječenja na ciljnim mjestima svih triju lijekova primijećene su u 30 ispitanika.
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2C9 substrate warfarin.
Croatian: Dasabuvir primijenjen s ombitasvirom/paritaprevirom/ritonavirom nije utjecao na izloženost varfarinu, supstratu za CYP2C9.
English: In the genotype 1a replicon, the activity of dasabuvir was reduced 21- to 32-fold by the M414T, S556G or Y561H substitutions; 152- to 261-fold by the A553T, G554S or S556R substitutions; and 1472- and 975-fold by the C316Y and Y448H substitutions, respectively.
Croatian: U replikonu genotipa 1a, supstitucije M414T, S556G i Y561H smanjile su aktivnost dasabuvira 21 do 32 puta, supstitucije A553T, G554S i S556R 152 do 261 puta, supstitucija C316Y 1472 puta, a supstitucija Y448H 975 puta.
English: The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Croatian: Učinak na Cmax i AUC antivirusnih lijekova izravnog učinka i lopinavira bila je slična kao i kad se doza od 400/100 mg lopinavira/ritonavira primjenila dvaput dnevno s dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom.
English: How to take Exviera
Croatian: Kako uzimati lijek Exviera
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipack containing 56 (4 packs of 14) film-coated tablets - including blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija višestrukog pakiranja koje sadrži 56 (4 pakiranja s 14) filmom obloženih tableta
English: If dose adjustments of concomitant medicinal products are made due to treatment with dasabuvir and ombitasvir/paritaprevir/ritonavir, doses should be re-adjusted after administration of dasabuvir and ombitasvir/paritaprevir/ritonavir is completed.
Croatian: Ako se zbog liječenja dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom prilagode doze istodobno primijenjenih lijekova, te se doze moraju ponovno prilagoditi nakon što liječenje dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom završi.
English: Talk to your doctor or pharmacist before taking Exviera if you: - have liver disease other than hepatitis C; - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što uzmete lijek Exviera ako: - osim hepatitisa C imate druge bolesti jetre;
English: Alprazolam 0.5 mg single dose
Croatian: Alprazolam 0,5 mg pojedinačna doza
English: 200 mg once daily followed by 200 mg twice daily
Croatian: Klinička napomena jedanput na dan te potom 200 mg dvaput na dan
English: Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Croatian: Dasabuvir se ne smije koristiti u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh stadij B ili C) (vidjeti dio 5.2).
English: Ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide atazanavir pharmacokinetic enhancement.
Croatian: Doza ritonavira u ombitasvir/paritaprevir/rito navir će djelovati kao farmakokinetički pojačivač atazanaviru.
English: To be noted, darunavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of the ombitasvir/paritaprevir/ritonavir fixed dose combination.
Croatian: Potrebno je uzeti u obzir da se darunavir mora primjenjivati bez ritonavira jer se doza od 100 mg ritonavira jednom dnevno unosi kao fiksne kombinacije ombitasvir/paritaprevir/ritonavir.
English: paritaprevir used together with dasabuvir + ombitasvir/paritaprevir/ ritonavir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Croatian: Klinička napomena sirolimus posljedica je inhibicije CYP3A4 ritonavirom paritaprevir dasabuvirom + ombitasvir/paritaprevir/rito navir, sirolimus treba davati u dozi od 0,2 mg dvaput tjedno (svaka 3 ili 4 dana, ista dva dana svakog tjedna).
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
Croatian: TURQUOISE-I: ispitanici s istodobnom infekcijom HCV-om genotipa 1 ili 4 i virusom HIV-1, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV, bez ciroze ili s kompenziranom cirozom
English: Mechanism: CYP3A4 induction by carbamazepi ne.
Croatian: Mehanizam: indukcija CYP3A4 karbamazep inom.
English: ↔ nor ethindrone
Croatian: ↔ etinilestradiol
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Croatian: U ispitanika koji su primali dasabuvir i ombitasvir/paritaprevir/ritonavir s ribavirinom, primijećena su prolazna povišenja razina bilirubina u serumu (najčešće indirektnog bilirubina), što je bilo povezano s inhibicijom prijenosnika bilirubina OATP1B1/1B3 koju uzrokuje paritaprevir te hemolizom induciranom primjenom ribavirina.
English: Skin and subcutaneous tissue disorders Very common Pruritus Common
Croatian: Poremećaji kože i potkožnog tkiva vrlo često pruritus često pruritus rijetko angioedem angioedem
English: • St. John's Wort (Hypericum perforatum)
Croatian: • gospina trava (Hypericum perforatum)
English: In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Croatian: (AFP < 20 ng/ml, broj trombicita ≥ 90 x 109/l i albumin ≥ 35 g/l), stope relapsa bile su slične kod ispitanika iz skupine koja je liječena 12 tjedana kao i kod ispitanika iz skupine koja je liječena 24