FrancophonIA/ELRC3.0 huggingface dataset:
English: For specific dosage instructions for dasabuvir and ribavirin, including dose modification, refer to the respective Summaries of Product Characteristics.
Croatian: Za specifične upute za doziranje dasabuvira i ribavirina, uključujući prilagođavanje doze, pročitajte odgovarajuće Sažetke opisa svojstava lijeka.
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Croatian: Ove povišene razine ALT-a značajno su češće primijećene u podskupini ispitanica koje su koristile lijekove koji sadrže etinilestradiol, poput kombiniranih oralnih kontraceptiva ili kontracepcijskih vaginalnih prstenova (6 od 25 ispitanica) (vidjeti dio 4.3).
English: Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1'.
Croatian: Ružičaste, duguljaste, bikonveksne, filmom obložene tablete dimenzija 18,8 mm x 10,0 mm, s otisnutom oznakom 'AV1' na jednoj strani.
English: 5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Croatian: U obje skupine 5 od 6 ispitanika s kompenziranom cirozom postiglo je SVR12.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Croatian: Donja granica kvantifikacije (engl. lower limit of quantification, LLOQ) testa iznosila je 25 IU/ml.
English: See section 5.1 for additional information.
Croatian: Za dodatne informacije vidjeti dio 5.1.
English: Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Croatian: Bolesnici s teškim oštećenjem jetre (Child-Pugh C) (vidjeti dio 5.2).
English: 7 of 7 subjects with genotype 1b infection and 51 of 56 subjects with genotype 1a infection achieved SVR12.
Croatian: Svih 7 ispitanika s infekcijom genotipa 1 b i 51 od 56 ispitanika s infekcijom genotipa 1a postiglo je SVR12.
English: If ribavirin is co-administered with Viekirax, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Croatian: Ako se ribavirin primjenjuje istodobno s lijekom Viekirax, vrijede kontraindikacije koje se odnose na primjenu ribavirina tijekom trudnoće (vidjeti i Sažetak opisa svojstava lijeka za ribavirin).
English: Coadministration of Viekirax with other antivirals has not been studied and therefore cannot be recommended.
Croatian: Istodobna primjena lijeka Viekirax s drugim antiviroticima nije ispitivana te se stoga ne može preporučiti.
English: Ombitasvir and its major inactive human metabolites (M29, M36) were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Croatian: Ombitasvir Ombitasvir i njegovi glavni neaktivni metaboliti u ljudi (M29, M36) nisu bili genotoksični u nizu in vitro ili in vivo testova, uključujući test mutagenosti na bakterijama, test kromosomskih aberacija na limfocitima iz ljudske periferne krvi te in vivo mikronukleusni test na miševima.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol.
Croatian: Troje bolesnika je prestalo uzimati Viekirax i dasabuvir na jedan do sedam dana, od kojih je jedan uzimao etinilestradiol.
English: Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Croatian: AFP* < 20 ng/ml, broj trombocita ≥ 90 x 109/l i albumin ≥ 35 g/l prije početka liječenja
English: Expected: ↓ esomeprazole, lansoprazole
Croatian: Očekuje se: ↓ esomeprazol, lanzoprazol
English: The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Croatian: Djelotvornost i sigurnost lijeka Viekirax u kombinaciji s dasabuvirom (s ribavirinom ili bez njega) ocijenjene su u sedam kliničkih ispitivanja faze 3, uključujući dva ispitivanja u kojima su sudjelovali isključivo ispitanici s cirozom (Child-Pugh stadij A), s više od 2360 ispitanika s kroničnom infekcijom hepatitisom C genotipa 1, kao što je sažeto prikazano u Tablici 6.
English: Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation comedications.
Croatian: Istodobna primjena lijeka Viekirax s rilpivirinom jedanput na dan može se razmotriti samo kod bolesnika bez poznatog produljenja QT-intervala i koji istodobno ne uzimaju druge lijekove koji uzrokuju produljenje QTintervala.
English: For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Croatian: Za preporuke o doziranju antivirusnih lijekova za HIV vidjeti dio 4.4 (Liječenje bolesnika s istodobnom infekcijom virusom HIV-a) i dio 4.5.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Croatian: COBAS TaqMan HCV testom (verzija 2.0), namijenjenim za uporabu sa sustavom High Pure System.
English: In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
Croatian: U više od 500 analiziranih uzoraka genotipa 1a prikupljenih na početku ispitivanja, najčešće primijećene varijante povezane s rezistencijom bile su M28V (7,4%) u NS5A te S556G (2,9%) u
English: In subjects receiving Viekirax and dasabuvir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Croatian: U ispitanika koji su primali lijekove Viekirax i dasabuvir bez ribavirina, nuspojave najčešće povezane s ribavirinom (npr. mučnina, nesanica, anemija) bile su manje učestale te nijedan ispitanik (0/588) nije trajno obustavio liječenje zbog nuspojava.
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: When starting coadministration with Viekirax, administer 0.5 mg tacrolimus once every week.
Croatian: Kada se započinje istodobna primjena s lijekom Viekirax, primijeniti 0,5 mg takrolimusa jedanput na tjedan.
English: • enzalutamide
Croatian: • enzalutamid
English: Psychiatric disorders Very common
Croatian: Psihijatrijski poremećaji vrlo često nesanica
English: Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Croatian: Viekirax i dasabuvir + ribavirin 12 ili 24 tjedna N = 380 n (%)
English: d. Observed in combination in genotype 1b-infected subjects.
Croatian: d. Primijećeno u kombinaciji u ispitanika s infekcijom genotipom 1b.
English: The safety and efficacy of Viekirax in children below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Viekirax u djece mlađe od 18 godina nisu ustanovljene.
English: Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral agents 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 antivirotika s izravnim djelovanjem 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: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinylestradiol.
Croatian: Dvoje bolesnika je prestalo uzimati Viekirax i dasabuvir zbog povišenja razina ALT-a, od kojih je jedan uzimao etinilestradiol.
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: Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s etiniliestradiolom može povećati rizik od porasta razine ALTa (vidjeti dijelove 4.3 i 4.4.).
English: INFORMATION IN BRAILLE viekirax
Croatian: 16. PODACI NA BRAILLEOVOM PISMU viekirax
English: Ombitasvir, paritaprevir and ritonavir should be administered with food.
Croatian: Ombitasvir, paritaprevir i ritonavir potrebno je primjenjivati s hranom.
English: Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 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: Asthenia 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: Potent inhibitors of P-gp, BCRP, OATP1B1 and/or OATP1B3 have the potential to increase the exposure to paritaprevir.
Croatian: Snažni inhibitori P-gp-a, BCRP-a, OATP1B1 i/ili OATP1B3 mogu povećati izloženost paritapreviru.
English: • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Croatian: • Postoji i rizik od prirođenih mana djeteta kada se ribavirin primjenjuje kod bolesnika muškog spola čije partnerice zatrudne.
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.
Croatian: Sažetak sigurnosnog profila temelji se na objedinjenim podacima iz kliničkih ispitivanja faze 2 i 3, u kojima je sudjelovalo više od 2600 ispitanika liječenih lijekovima Viekirax i dasabuvir u kombinaciji s ribavirinom ili bez njega.
English: ↑ pravastatin 1.37
Croatian: ↑ furosemid 1,42
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine.
Croatian: Ispitanici su bili na ustaljenoj antiretrovirusnoj terapiji (engl. antiretroviral therapy, ART) za infekciju HIV-om tipa 1 koja je uključivala atazanavir ili raltegravir pojačan ritonavirom istovremeno primijenjene s okosnicom liječenja tenofovirom s emtricitabinom ili lamivudinom.
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
Croatian: Interakcije između lijekova ocijenjene su za režim liječenja lijekom Viekirax i dasabuvirom, ali ne i za režim liječenja lijekom Viekirax bez dasabuvira, s karbamazepinom, furosemidom, zolpidemom, darunavirom dvaput na dan, darunavirom (primjena navečer), atazanavirom (primjena navečer), rilpivirinom, abakavirom/lamivudinom, dolutegravirom, metforminom, sulfametoksazolom/trimetoprimom, ciklobenzaprinom, karisoprodolom, hidrokodonom/paracetamolom ili diazepamom.
English: Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Croatian: paracetamol (primijenjen kao fiksna kombinacija hidrokodon/ paracetamol
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
Croatian: Simvastatin, lovastatin i atorvastatin su kontraindicirani (vidjeti dijelove 4.3 i 4.5).
English: Do not use the medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza 'Rok valjanosti'.
English: Viekirax without dasabuvir may increase the plasma concentrations of dabigatran etexilate.
Croatian: Viekirax bez dasabuvira može povećati koncentracije dabigatran eteksilata u plazmi.
English: Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
Croatian: Film ovojnica: poli(vinilni alkohol) (E1203) polietilenglikol 3350 talk (E553b) titanijev dioksid (E171) željezov oksid, crveni (E172)
English: SVR12, n/N (%) [95% CI] Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse
Croatian: SVR12, n/N (%) [95% CI] Ishod za ispitanike koji nisu postigli SVR12
English: Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Croatian: Rizik od dekompenzacije jetre i zatajenja jetre u bolesnika s cirozom
English: 4-24 mg/16 mg once daily
Croatian: 4-24 mg/1-6 mg jedanput na dan
English: No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Viekirax u starijih bolesnika (vidjeti dio 5.2).
English: Norethindrone (progestin only pill) 0.35 mg once daily
Croatian: ↓ dasabuvir noretindron (tableta koja sadrži samo progestin) 0,35 mg jedanput na dan noretindron
English: Follow the dosing recommendations in Table 1.
Croatian: Slijedite preporuke za doziranje iz Tablice
English: ↑ pimozide
Croatian: ↑ pimozid
English: • If you have severe liver problems other than hepatitis C.
Croatian: - imate neku drugu jetrenu bolest osim hepatitisa C;
English: Itraconazole Posaconazole
Croatian: itrakonazol posakonazol
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
English: Ethinylestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Croatian: Etinilestradiol je kontraindiciran u kombinaciji s lijekom Viekirax (vidjeti dijelove 4.3 i 4.4).
English: The activity of paritaprevir was reduced 96-fold by D168V, and 50- to 219-fold by each of the other D168 substitutions.
Croatian: D168V smanjila je aktivnost paritaprevira 96 puta, a svaka druga D168 supstitucija 50 do 219 puta.
English: − Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
Croatian: Film ovojnica tablete: poli(vinilni alkohol) (E1203), polietilenglikol 3350, talk (E553b), titanijev dioksid (E171) i crveni željezov oksid (E172).
English: One subject with HCV genotype 1a infection relapsed post-treatment.
Croatian: Jedan ispitanik s infekcijom HCV-om genotipa 1a je doživio relaps nakon liječenja.
English: During clinical trials with Viekirax and dasabuvir 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 lijeka Viekirax i dasabuvira s ribavirinom ili bez njega došlo je do prolaznog povišenja razina ALT-a više od 5 puta iznad gornje granice normale (GGN) kod oko 1% ispitanika (35 od 3039).
English: Clinical Comments recommended-(↑ paritaprevir).
Croatian: Kliničke napomene preporuča se (↑
English: Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility.
Croatian: Tablici 3 navode se nuspojave čija je uzročna povezanost s paritaprevirom/ombitasvirom/ritonavirom, u kombinaciji s dasabuvirom i/ili ribavirinom ocijenjena barem kao moguća.
English: • ranolazine
Croatian: • ranolazin
English: • If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se svome liječniku ili ljekarniku.
English: NA A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Viekirax with or without dasabuvir .
Croatian: NP Mora se razmotriti smanjenje doze hidrokodona za 50% i/ili kliničko praćenje kada se primjenujuje s lijekom Viekirax s dasabuvirom ili bez njega.
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 12 months post liver transplant
Croatian: CORAL-I: ispitanici prethodno neliječeni ili prethodno liječeni pegIFN i RBV kod kojih je prošlo barem 12 mjeseci od presađivanja jetre
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: Mechanism: OATP1B1 inhibition by paritaprevir.
Croatian: Mehanizam: OATP1B1 inhibicija paritaprevir om.
English: − Tablet core: copovidone, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
Croatian: Jezgra tablete: kopovidon, vitamin E polietilenglikolsukcinat, propilenglikolmonolaurat, sorbitanmonolaurat, koloidni bezvodni silicijev dioksid (E551), natrijev stearilfumarat.
English: Age, median (range) years Male gender, n (%) Prior HCV Treatment: naïve, n (%) Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Croatian: Peg-IFN + RBV, n (%) Početne razine albumina, medijan g/L < 35, n (%)
English: Note: Doses used for Viekirax and dasabuvir were: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Croatian: Napomena: Primijenjene doze lijeka Viekirax i dasabuvira su bile sljedeće: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg jedanput na dan i dasabuvir 400 mg dvaput na dan ili 250 mg dvaput na dan.
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: U ispitanika koji su prije početka ispitivanja imali povoljne vrijednosti za sva tri parametra (AFP < 20 ng/ml, broj trombocita ≥ 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 tjedna.
English: Alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone)
Croatian: Namjena lijeka alprazolam, diazepam za liječenje tjeskobe, paničnih napadaja i problema sa spavanjem ciklosporin, takrolimus za potiskivanje imunosnog sustava ciklobenzaprin, karisoprodol za liječenje mišićnih grčeva kolhicin za bolesnike kod kojih su testovi pokazali normalnu funkciju bubrega i jetre za liječenje napadaja gihta ili obiteljske mediteranske groznice digoksin, amlodipin, nifedipin, valsartan, diltiazem, verapamil, kandesartan, losartan za liječenje srčanih tegoba ili povišenog krvnog tlaka furosemid za izlučivanje prekomjerno nakupljene tekućine u tijelu hidrokodon za liječenje boli levotiroksin za tegobe sa štitnjačom rilpivirin, darunavir, atazanavir za liječenje HIV infekcije omeprazol, lanzoprazol, esomeprazol za liječenje želučanog vrijeda i drugih želučanih tegoba imatinib za liječenje određenih vrsta raka krvi fluvastatin, pitavastatin, pravastatin, rosuvastatin za snižavanje razine kolesterola u krvi dabigatran za razrjeđivanje krvi feksofenadin za liječenje peludne groznice s-mefenitoin za liječenje epilepsije sulfasalazin za liječenje upalnih bolesti crijeva repaglinid za snižavanje razina šećera u krvi eritromicin za liječenje bakterijskih infekcija steroidni ili kortikosteroidni lijekovi (poput flutikazona)
English: CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) cyclosporine, 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, takrolimus, amlodipin,
English: If statin treatment is required during the treatment period, a switch to a reduced dose of pravastatin/rosuvastatin is possible (see section 4.5, Table 2).
Croatian: Ako je liječenje statinima nužno tijekom razdoblja liječenja s Viakiraxom, moguće je prebacivanje na smanjenu dozu pravastatina/rosuvastatina (vidjeti dio 4.5, Tablica 2).
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
Croatian: Stope relapsa u odnosu na početne laboratorijske vrijednosti u ispitanika s infekcijom genotipom 1a i kompenziranom cirozom nakon 12 i 24 tjedna liječenja
English: Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Croatian: Ombitasvir i paritaprevir ne inhibiraju prijenosnik organskih aniona (OAT1) in vivo te se ne očekuje da će inhibirati prijenosnike organskih kationa (OCT1 i OCT2), prijenosnike organskih aniona (OAT3) niti proteine za izlučivanje više lijekova i toksina (MATE1 i MATE2K) pri klinički značajnim koncentracijama.
English: 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Croatian: 56 tableta (višestruko pakiranje sadrži 4 unutarnje kutije, od kojih svaka ima 14 tableta).
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Croatian: Tijekom ili nakon liječenja antiviroticima koji djeluju izravno zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), neki od njih sa smrtnim ishodom.