FrancophonIA/ELRC3.0 huggingface dataset:
English: b. Includes subjects who discontinued due to adverse event, loss to follow-up or subject withdrawal, and subjects with reinfection
Croatian: Uključuje ispitanike koji su prekinuli liječenje zbog štetnog događaja, ispitanike koji su izgubljeni iz praćenja ili koji su se povukli iz ispitivanja te ispitanike kod kojih je došlo do reinfekcije.
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Croatian: Ova kombinacija predstavlja povećani rizik od hiperbilirubinemije (uključujući okularni ikterus), posebice kada je ribivarin sastavni dio terapijskog režima za hepatitis C.
English: CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) ciclosporin, sirolimus, tacrolimus, amlodipine, rilpivirine and alprazolam.
Croatian: CYP3A supstrati koji su ocijenjeni u ispitivanjima interakcija lijekova za koje je možda potrebna prilagodba doze i/ili kliničko praćenje uključuju (vidjeti Tablicu 2) ciklosporin, sirolimus, takrolimus, amlodipin, rilpivirin i alprazolam.
English: On-treatment virologic failure Post-treatment relapse Other
Croatian: Virološki neuspjeh tijekom liječenja Relaps nakon liječenja
English: AMINOSALICYLATE Sulfasalazine
Croatian: AMINOSALICILATI sulfasalazin
English: Paritaprevir was approximately 97-98.6% bound to human plasma proteins.
Croatian: Približno 97 do 98,6% paritaprevira vezalo se za proteine u ljudskoj plazmi.
English: Your doctor will test your blood before, during and after your treatment with Viekirax.
Croatian: Liječnik će napraviti krvne pretrage prije, tijekom i nakon liječenja lijekom Viekirax kako bi:
English: How long to take Viekirax for
Croatian: Koliko dugo uzimati lijek Viekirax
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Viekirax.
Croatian: Ako se bilo što od gore navedenoga odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete lijek Viekirax.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinyloestradiol.
Croatian: Troje bolesnika je prestalo uzimati Viekirax i dasabuvir na jedan do sedam dana, od kojih je jedan uzimao etinilestradiol.
English: See Table 2 for guidance regarding potential interactions with other medicinal products and dosing recommendations.
Croatian: Za smjernice u vezi potencijalnih interakcija s drugim lijekovima i preporuke za doziranje vidjeti Tablicu 2.
English: The combination of atazanavir and Viekirax + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen (see sections 4.4 and 4.8).
Croatian: Kombinacija atazanavira i lijeka Viekirax + dasabuvir povećava razine bilirubina, pogotovo u slučaju kada se ribavirin koristi za liječenje hepatitisa C (vidjeti dijelove 4.4 i 4.8).
English: ↑ astemizole/terfenadine
Croatian: ↑ astemizol/terfenadin
English: ANTI-DIURETIC HORMONE Conivaptan
Croatian: ANTIDIURETSKI HORMON konivaptan
English: Viekirax tablets are taken with other antiviral medicines such as dasabuvir and ribavirin.
Croatian: Viekirax tablete se uzimaju s drugim antivirusnim lijekovima poput dasabuvira i ribavirina.
English: Y93H, Y93N or M28V in combination with Q30R reduced the activity of ombitasvir by more than 42,802-fold.
Croatian: Supstitucija Y93H, Y93N ili M28V je u kombinaciji sa supstitucijom Q30R smanjila aktivnost ombitasvira više od 42 802 puta.
English: Expected ↑ alfuzosin
Croatian: Očekuje se: ↑ alfuzosin
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2D6/CYP1A2 substrate, duloxetine.
Croatian: Viekirax primijenjen s dasabuvirom ili bez njega nije utjecao na izloženost supstratu za CYP2D6/CYP1A2, duloksetinu.
English: Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
Croatian: Istodobna primjena režima utemeljenih na efavirenzu (induktor enzima) s kombinacijom paritaprevir/ritonavir + dasabuvir dovela je do povišenja razine ALT-a, što je uzrokovalo rani prekid ispitivanja.
English: Medicines you must not take with Viekirax Medicine or active substance
Croatian: Lijekovi koje ne smijete uzimati s lijekom Viekirax Lijek ili djelatna tvar
English: Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4).
Croatian: Istodobna primjena sirolimusa s lijekom Viekirax i dasabuvirom se ne preporučuje, osim ako koristi ne nadmašuju rizike (vidjeti dio 4.4).
English: NA Patients should be monitored for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Croatian: Preporučuje se nadzor bolesnika na kliničke učinke; može biti potrebno smanjenje doze furosemida ombitasvir
English: Not studied:
Croatian: Nije ispitivano:
English: Y56H alone could not be evaluated due to poor replication capacity, however, the combination of Y56H and D168A/V/Y reduced the activity of paritaprevir by 700- to 4118fold.
Croatian: Y56H kao jedina supstitucija nije se mogla ocijeniti zbog slabe sposobnosti replikacije, ali je kombinacija supstitucija Y56H i D168A/V/Y smanjila aktivnost paritaprevira od 700 do 4118 puta.
English: Cirrhosis was not a risk factor for elevated ALT (see section 4.4).
Croatian: Ciroza nije bila faktor rizika za povišenje razine ALT-a (vidjeti dio 4.4).
English: Atazanavir can be used in combination with Viekirax and dasabuvir, if administered at the same time.
Croatian: Atazanavir se smije koristiti u kombinaciji s lijekom Viekirax i dasabuvirom ukoliko se primjenjuje u isto vrijeme.
English: IMMUNOSUPPRESSANTS Ciclosporin
Croatian: IMUNOSUPRESIVI ciklosporin
English: HMG CoA REDUCTASE INHIBITOR Rosuvastatin
Croatian: INHIBITORI HMG-CoA REDUKTAZE rosuvastatin
English: Use of ethinyloestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see sections 4.4 and 4.5).
Croatian: Primjena lijekova koji sadrže etinilestradiol poput većine kombiniranih oralnih kontraceptiva ili kontracepcijskih vaginalnih prstenova (vidjeti dijelove 4.4 i 4.5).
English: Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Croatian: Viekirax tablete su ružičaste, duguljaste filmom obložene tablete, dimenzija 18,8 mm x 10,0 mm s oznakom „AV1“.
English: Ritonavir was greater than 99% bound to human plasma proteins.
Croatian: Više od 99% ritonavira vezalo se za proteine u ljudskoj plazmi.
English: While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is ombitasvir
Croatian: Iako nije potrebno prilagođavati dozu digoksina, preporučuje se odgovarajući nadzor razina digoksina u serumu.
English: 300/100 mg once daily (administered 12 hours apart)
Croatian: 300/100 mg jedanput na dan (primijenjen u razmaku od 12 sati)
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see sections 4.3 and 4.5).
Croatian: Simvastatin, lovastatin i atorvastatin su kontraindicirani (vidjeti dijelove 4.3 i 4.5).
English: The efficacy of Viekirax in patients previously exposed to Viekirax, or to medicinal products of the same classes as those of Viekirax (NS3/4A inhibitors or NS5A inhibitors), has not been demonstrated.
Croatian: Nije utvrđena djelotvornost lijeka Viekirax u bolesnika koji su prethodno dobivali Viekirax ili lijekove iz istog razreda kao Viekirax (inhibitori NS3/4A ili inhibitori NS5A).
English: Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.
Croatian: S obzirom na niske stope virološkog neuspjeha primijećene uz preporučene režime liječenja u ispitanika s infekcijom HCV-om genotipa 1a i 1b, čini se prisutnost varijanti na početku ispitivanja malo utječe na vjerojatnost postizanja trajnog virološkog odgovora (engl. sustained virological response, SVR).
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Croatian: Moraju se poduzeti iznimne mjere opreza kako bi se izbjegla trudnoća u bolesnica i partnerica bolesnika muškoga spola kada se Viekirax primjenjuje u kombinaciji s ribavirinom, za dodatne informacije vidjeti dio 4.6 i sažetak opisa svojstava lijeka za ribavirin.
English: 800 mg once daily (given at the same time)
Croatian: 800 mg jedanput na dan (primijenjen u isto vrijeme)
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Croatian: Medijan dobi liječenih ispitanika iznosio je 51 godinu (raspon: 26 do 64); 68,5% bili su muškarci; 5,3% bili su crnci.
English: Accumulation is minimal for ombitasvir and approximately 1.5- to 2-fold for ritonavir and paritaprevir.
Croatian: Kumulacija ombitasvira je minimalna, dok je kumulacija ritonavira i paritaprevira približno 1,5 do 2 puta veća.
English: Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Croatian: Ombitasvir, paritaprevir i ritonavir apsorbirali su se nakon peroralne primjene uz srednju vrijednost tmax od približno 4 do 5 sati.
English: Viekirax, when co-administered with dasabuvir, 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: Mehanizam djelovanja Viekirax primijenjen zajedno s dasabuvirom kombinira tri direktno djelujuća antivirotika koji imaju različite mehanizme djelovanja i profile rezistencije koji se međusobno ne preklapaju, što omogućuje ciljano djelovanje na HCV u nekoliko različitih stadija životnog ciklusa virusa.
English: Viekirax without ribavirin and without dasabuvir was also evaluated in genotype 1b infected subjects in Phase 2 studies M13-393 (PEARL-I) and M12-536.
Croatian: Liječenje lijekom Viekirax bez ribavirina i bez dasabuvira ispitivalo se u ispitanika s infekcijom genotipom 1b u ispitivanju faze II M13-393 (PEARL-I) i M12-536.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 55% higher, 100% higher and 15% higher ombitasvir, paritaprevir and ritonavir exposures than male subjects.
Croatian: Na temelju analize farmakokinetike populacije iz kliničkih ispitivanja faze 3, ženski ispitanici imaju otprilike oko 55% višu izloženost ombitasviru, 100% višu izloženost paritapreviru i 15% višu izloženost ritonaviru u odnosu na muške ispitanike.
English: In the genotype 1b replicon, the activity of ombitasvir was reduced by less than 10-fold by variants at amino acid positions 30 and 31.
Croatian: U replikonu genotipa 1b, varijante na aminokiselinskim položajima 30 i 31 smanjile su aktivnost ombitasvira manje od 10 puta.
English: In Part 2, SVR12 was achieved by 27/28 (96.4%) subjects with HCV GT4/HIV-1 coinfection (95% CI: 82.3%, 99.4%) with no virologic failures.
Croatian: U drugom je dijelu SVR12 postiglo 27/28 (96,4%) ispitanika s istodobnom infekcijom HCV-om genotipa 4 i HIV-om tipa 1 (95% CI: 82,3%; 99,4%), a nije zabilježen nijedan slučaj virološkog neuspjeha.
English: Cases of depression and more rarely of suicidal ideation and suicide attempt have been reported with Viekirax with or without dasabuvir treatment in combination with ribavirin in the majority of the cases.
Croatian: Prijavljeni su slučajevi depresije te rjeđe slučajevi suicidalnih misli i pokušaja samoubojstva kod primjene lijeka Viekirax, s dasabuvirom ili bez njega, u većini slučajeva u kombinaciji s ribavirinom.
English: Extra precautions are needed if Viekirax is taken together with ribavirin.
Croatian: Potreban je poseban oprez ukoliko se lijek Viekirax uzima u kombinaciji s ribavirinom.
English: Emtricitabine/ tenofovir
Croatian: / tenofovir
English: randomised, global multicentre, double-blind, regimen-controlled
Croatian: randomizirano, globalno, multicentrično, dvostruko slijepo, režimom kontrolirano ispitivanje
English: For a general comment on treatment of HIV co-infected patients, including a discussion on different antiretroviral regimens that may be used, please see section 4.4 (Treatment of HIV co-infected patients).
Croatian: Za opće upute o liječenju bolesnika s istodobnom infekcijom HIV-om, uključujući informacije o različitim kombinacijama liječenja, vidjeti dio 4.4 (Liječenje bolesnika s istodobnom infekcijom HIV-om).
English: Viekirax should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Croatian: Viekirax se ne smije primjenjivati kod trudnica niti kod žena reproduktivne dobi koje ne koriste pouzdan oblik kontracepcije.
English: • colchicine in patients with renal or hepatic impairment
Croatian: • kolhicin u bolesnika s oštećenjem funkcije bubrega ili jetre
English: In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
Croatian: U više od 200 analiziranih uzoraka genotipa 1b prikupljenih na početku ispitivanja, najčešće primijećene varijante povezane s rezistencijom bile su Y93H (7,5%) u NS5A te C316N (17,0%) i S556G (15%) u
English: Although ALT elevations associated with Viekirax and dasabuvir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur.
Croatian: Iako su povišene razine ALT-a povezane s lijekom Viekirax i dasabuvirom bile asimptomatične, bolesnike treba uputiti da prate rane znakove upozorenja na upalu jetre, poput umora, slabosti, gubitka apetita, mučnine i povraćanja, kao i znakove koji se javljaju kasnije, poput žutice i promjene boje fecesa te da se odmah posavjetuju s liječnikom ako se pojave takvi simptomi.
English: Lower ribavirin dose at initiation may be appropriate.
Croatian: Prilikom započinjanja liječenja može biti prikladna niža doza ribavirina.
English: There was 1 relapse in the 12week arm and 1 on-treatment virologic failure in the 24-week arm.
Croatian: Zabilježen je 1 relaps u skupini liječenoj 12 tjedana i 1 virološki neuspjeh tijekom liječenja u skupini koja je terapiju primala 24 tjedna.
English: − Tablet core: copovidone, tocofersolan, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.
Croatian: Jezgra tablete: kopovidon, tokofersolan, propilenglikolmonolaurat, sorbitanmonolaurat, koloidni bezvodni silicijev dioksid (E 551), natrijev stearilfumarat.
English: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinyloestradiol.
Croatian: Dvoje bolesnika je prestalo uzimati Viekirax i dasabuvir zbog povišenja razina ALT-a, od kojih je jedan uzimao etinilestradiol.
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Croatian: Ne očekuje se da će ostali supstrati za CYP2C9 (NSAIL-ovi (npr. ibuprofen), antidijabetici (npr. glimepirid, glipizid)) zahtijevati prilagodbu doze.
English: In mice, an increased incidence of open eye lid was present in foetuses of dams administered ombitasvir; however, the relationship to treatment with ombitasvir is uncertain.
Croatian: U miševa je uočena povećana incidencija malformacija vjeđa (otvorene vjeđe, engl. open eyelid) kod fetusa ženki koje su primile ombitasvir, međutim, povezanost s primjenom ombitasvira nije sigurna.
English: TURQUOISE II (open-label)
Croatian: TURQUOISE II (otvoreno ispitivanje)
English: Coadministration with ethinyloestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s etinilestradiolom može povećati rizik od porasta razine ALTa (vidjeti dijelove 4.3 i 4.4.).
English: Unchanged ombitasvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Croatian: Ombitasvir u nepromijenjenu obliku bio je najzastupljenija komponentna primijećena u mlijeku štakora u laktaciji, ali nije imao učinka na mladunčad koja je sisala.
English: NNRTIs other than rilpivirine (efavirenz, etravirine and nevirapine) are contraindicated (see section 4.3).
Croatian: Drugi nenukleozidni inhibitori reverzne transkriptaze (NNRTI), osim rilpivirina (efavirenz, etravirin i nevirapin) su kontraindicirani (vidjeti dio 4.3).
English: Viekirax and dasabuvir for 8 weeks n/N (%)
Croatian: Viekirax i dasabuvir tijekom 8 tjedana n/N (%)
English: If parenteral midazolam is co-administered with Viekirax with or without dasabuvir, close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised and dosage adjustment should be considered.
Croatian: Ukoliko se parenteralni midazolam primjenjuje istodobno s lijekom Viekirax s dasabuvirom ili bez njega, mora se provoditi pomno kliničko praćenje respiratorne depresije i/ili produljene sedacije te se mora razmotriti prilagodba doze.
English: • ergotamine, dihydroergotamine, ergonovine, methylergometrine
Croatian: • ergotamin, dihidroergotamin, ergonovin, metilergometrin
English: NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at posttreatment Week 48.
Croatian: NS3 varijante V36A/M i R155K te NS5B varijante M414T i S556G bile su mjerljive u 48. tjednu nakon liječenja, dok NS3 varijanta D168V i sve ostale varijante NS5B nisu bile primijećene u 48. tjednu nakon liječenja.
English: Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Croatian: Postojanost odgovora Ukupno je 660 ispitanika u kliničkim ispitivanjima faze 2 i 3 postiglo željene razine HCV RNK i u trenutku određivanja SVR12 i u trenutku određivanja SVR24.
English: Note: For laboratory abnormalities, refer to Table 4
Croatian: Napomena: za odstupanja u laboratorijskim vrijednostima vidjeti Tablicu 4
English: Paritaprevir/ritonavir had no effects on embryo-foetal viability or on fertility when evaluated in rats at exposures 2- to 8-fold higher than the exposure in humans at the recommended clinical dose.
Croatian: Paritaprevir/ritonavir nije utjecao na vijabilnost embrija/fetusa niti na plodnost u istraživanjima na štakorima pri izloženostima od 2 do 8 puta većima od izloženosti koja se postiže u ljudi pri preporučenoj kliničkoj dozi.
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑ = increase (more than 20%), ↓ = decrease (of more than 20%), ↔ = no change or change less than 20%).
Croatian: dasabuviru i istodobno primijenjenom lijeku (↑ = povećanje (za više od 20%), ↓ = smanjenje (za više od 20%), ↔ = nema promjene ili je promjena manja od 20%).
English: However, co-administration of digoxin with Viekirax without dasabuvir may result in increased plasma concentrations (see Table 2).
Croatian: Međutim, istodobna primjena digoksina i lijeka Viekirax bez dasabuvira može dovesti do povećanja koncentracije u plazmi (vidjeti Tablicu 2).
English: Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing's syndrome and subsequent adrenal suppression have been reported with ritonavir-containing regimens.
Croatian: Istodobna primjena inhalacijskih glukokortikoida koji se metaboliziraju putem CYP3A može povećati sistemsku izloženost glukokortikoidima, a uz režime liječenja koji su sadržavali ritonavir prijavljeni su slučajevi Cushingova sindroma i naknadne supresije nadbubrežne žlijezde.
English: If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving Viekirax with or without dasabuvir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Croatian: Ako bolesnik već uzima lijek(ove) ili tijekom liječenja lijekom Viekirax, s dasabuvirom ili bez njega, počne uzimati neki drugi lijek za koji se očekuje moguća interakcija, potrebno je razmotriti prilagodbu doze istodobno primijenjenih lijekova ili odgovarajući klinički nadzor (Tablica 2).
English: In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%, 98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%).
Croatian: U dijelu 1a, SVR12 postiglo je 29/31 (93,5%) ispitanika u skupini liječenoj 12 tjedana (95% CI: 79,3%; 98,2%) te 29/32 (90,6%) ispitanika u skupini liječenoj 24 tjedna (95% CI: 75,8%; 96,8%).
English: Medicinal products that inhibit CYP3A4 and transport proteins Paritaprevir is eliminated via CYP3A4 mediated metabolism and biliary excretion (substrate of the hepatic transporters OATP1B1, P-gp and BCRP).
Croatian: Lijekovi koji inhibiraju CYP3A4 i prijenosne proteine Paritaprevir se eliminira putem metabolizma posredovanog CYP3A4 i bilijarnom ekskrecijom (supstrat za jetrene prijenosnike OATP1B1, P-gp i BCRP).
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2C9 substrate, warfarin.
Croatian: Viekirax primijenjen s dasabuvirom ili bez njega nije utjecao na izloženost supstratu za CYP2C9, varfarinu.
English: Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Croatian: *Podaci uključuju sve ispitanike s infekcijom genotipom 1 iz ispitivanja faze 2 i 3, uključujući ispitanike s cirozom.
English: Following dosing of ombitasvir/paritaprevir /ritonavir, mean plasma half-life of ritonavir was approximately 4 hours.
Croatian: Nakon primjene ombitasvira/ paritaprevira/ritonavira, srednja vrijednost poluvijeka ritonavira u plazmi iznosila je približno 4 sata.
English: Overall, 107 of 113 subjects without cirrhosis and 147 of 155 subjects with cirrhosis achieved SVR12 after 12-24 weeks of treatment.
Croatian: Sveukupno, 107 od 113 ispitanika bez ciroze i 147 od 155 ispitanika s cirozom postiglo je
English: 10 subjects (29.4%) had at least one post baseline haemoglobin value of less than 10 g/dL.
Croatian: U 10 ispitanika (29,4%) zabilježena je barem jedna vrijednost hemoglobina manja od 10 g/dl nakon početka ispitivanja.
English: ↓ carbamaze pine 10, 11epoxide ombitasvir
Croatian: karbamazepin 10, 11epoksid ombitasvir
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 Viekirax with or without dasabuvir.
Croatian: Utjecaj na Cmax i AUC antivirusnih lijekova direktnog učinka i lopinavira, bio je sličan onome zabilježenom pri primjeni lopinavira/ritonavira 400/100 mg dvaput na dan s lijekom Viekirax s dasabuvirom ili bez njega.
English: Examples of contraindicated enzyme inducers are provided in section 4.3.
Croatian: Primjeri kontraindiciranih induktora enzima navode se u dijelu 4.3.
English: Avoid concomitant use of tacrolimus or sirolimus with Viekirax and dasabuvir unless the benefits outweigh the risks.
Croatian: Potrebno je izbjegavati istodobnu primjenu takrolimusa ili sirolimusa s lijekom Viekirax i dasabuvirom, osim ako koristi ne nadmašuju rizike.
English: Elevations in ALT were generally not associated with bilirubin elevations.
Croatian: Povišenja razina ALT-a u načelu nisu bila povezana s povišenjem razina bilirubina.