FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of dasabuvir with other antivirals has not been studied and, therefore, cannot be recommended.
Croatian: Istodobna primjena dasabuvira s drugim antiviroticima nije ispitivana te se stoga ne može preporučiti.
English: Taking into account the protein binding and in vitro activity of M1 against HCV genotype 1, its contribution to efficacy is expected to be similar to that of dasabuvir.
Croatian: Uzimajući u obzir vezanje na proteine i in vitro aktivnost M1 protiv genotipa 1 HCV-a, očekivan je doprinos djelotvornosti sličan onome dasabuvira.
English: The blood to plasma concentration ratios in human ranged from 0.5 to 0.7 indicating that dasabuvir was preferentially distributed in the plasma compartment of whole blood.
Croatian: U ljudi su se omjeri između koncentracije u krvi i koncentracije u plazmi kretali u rasponu od 0,5 do 0,7, što upućuje na to da se dasabuvir preferencijalno raspodjeljuje u plazmatski dio pune krvi.
English: Exviera tablets are packed into foil blisters containing 2 tablets.
Croatian: Exviera tablete zapakirane su u blistere od aluminijske folije koji sadrže 2 tablete.
English: This will give the medicines the best chance to clear the hepatitis C virus infection.
Croatian: Tada postoji najveća vjerojatnost da će lijekovi izliječiti infekciju virusom hepatitisa C.
English: Contraceptive medicines that contains ethinyloestradiol cannot be used in combination with Exviera.
Croatian: Kontraceptivi koji sadrže etinilestradiol ne smiju se uzimati u kombinaciji s lijekom Exviera.
English: • Read the “Contraception” section of the package leaflet for ribavirin very carefully.
Croatian: • Vrlo pažljivo pročitajte dio „Kontracepcija“ u uputi o lijeku ribavirina.
English: Dasabuvir must not be administered as monotherapy.
Croatian: Dasabuvir se ne smije uzimati kao monoterapija.
English: AbbVie Spain, S.L.U.
Croatian: AbbVie Španjolska, S.L.U.
English: For patients with cirrhosis:
Croatian: Za bolesnike s cirozom:
English: Part 2 was a Phase 3 cohort consisting of 233 subjects.
Croatian: Drugi dio bilo je kohortno ispitivanje faze 3, koje je obuhvatilo 233 ispitanika.
English: R-warfarin
Croatian: R-varfarin
English: You should not breastfeed during treatment with Exviera.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Exviera.
English: Your doctor may also give you an antiviral medicine called ribavirin.
Croatian: Liječnik će Vam možda dati i antivirusni lijek koji se zove ribavirin.
English: In addition, M1 is a substrate of the hepatic uptake transporters OATP family and OCT1 and thus, the hepatocyte concentration and thereby contribution to efficacy, may be larger than dasabuvir.
Croatian: Dodatno, M1 je supstrat jetrenim prijenosnicima skupine OATP i OCT1i na taj način koncentracija hepatocita i njihov doprinos efikasnosti može biti veći nego dasabuvira.
English: PVC/PE/PCTFE aluminium foil blister packs.
Croatian: Blister pakiranja od PVC/PE/PCTFE aluminijske folije.
English: In case a dose of dasabuvir is missed, the prescribed dose can be taken within 6 hours.
Croatian: U slučaju da bolesnik propusti uzeti dozu dasabuvira, propisana doza može se uzeti unutar narednih 6 sati.
English: The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 kcal versus approximately 1000 kcal).
Croatian: Povećanje izloženosti bilo je neovisno o vrsti obroka (npr. obrok s visokim udjelom masnoća naspram obroka s umjerenim udjelom masnoća) ili njegovoj kalorijskoj vrijednosti (približno 600 kcal naspram približno 1000 kcal).
English: If you forget to take Exviera
Croatian: Ako ste zaboravili uzeti lijek Exviera
English: The film-coated tablets are for oral use.
Croatian: Filmom obložene tablete namijenjene su za peroralnu primjenu.
English: HIV coinfected patients without suppressive antiretroviral therapy should not be treated with dasabuvir.
Croatian: Bolesnici s istodobnom infekcijm HIV-om bez primjene supresivne antiretrovirusne terapije ne smiju se liječiti dasabuvirom.
English: Thirty-nine of the 50 subjects who received ribavirin required interruption of ribavirin, and 11 of these subjects were also treated with erythropoietin.
Croatian: 50 ispitanika koji su primali ribavirin, u njih 39 bilo je potrebno prekinuti liječenje ribavirinom, a 11 od njih bilo je liječeno i eritropoetinom.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant.
Croatian: U svih životinjskih vrsta izloženih ribavirinu primijećeni su značajni teratogeni i/ili embriocidni učinci; stoga je primjena ribavirina kontraindicirana u trudnica i muškaraca čije su partnerice trudne.
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Croatian: Iako je zbog osnovne uznapredovale jetrene bolesti teško ustanoviti uzročnu povezanost, mogući rizik se ne može isključiti.
English: All 3 (100%) subjects with GT 4 infection who were post liver transplant achieved SVR12
Croatian: Sva 3 (100%) ispitanika s infekcijom genotipom 4 kojima je transplantirana jetra postigla su SVR12.
English: ** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis.
Croatian: ** Kada se težina jetrene bolesti procjenjuje neinvazivnim metodama, točnost se poboljšava kombinacijom krvnih biomarkera ili kombinacijom mjerenja tvrdoće jetre i krvnih pretraga koje treba provesti prije 8-tjednog liječenja u svih bolesnika s umjerenom fibrozom.
English: A side-by-side tabulation is provided to simplify presentation; direct comparisons should not be made across trials that differ in trial designs.
Croatian: 4. Podaci su navedeni usporedno u tablici radi jednostavnijega prikaza; ne smiju se izravno uspoređivati podaci iz različito dizajniranih ispitivanja.
English: - Confusion - Notice swelling of your stomach area
Croatian: - primijećeno oticanje u području trbuha
English: Routine monitoring of liver enzymes is not necessary in patients that do not have cirrhosis (for cirrhotics, see above).
Croatian: Rutinsko praćenje jetrenih enzima nije potrebno u bolesnika koji nemaju cirozu (za bolesnike s cirozom, vidjeti prethodno navedeno).
English: Expected: ↓ S-mephenytoin
Croatian: Očekuje se: ↓ S-mefenitoin
English: The frequency of indirect bilirubin elevations was lower among subjects who did not receive ribavirin.
Croatian: Učestalost povišenja razina indirektnog bilirubina bila je manja u ispitanika koji nisu primali ribavirin.
English: Pregnancy and concomitant use with ribavirin
Croatian: Trudnoća i istodobna primjena s ribavirinom
English: 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: Medicinal products transported by BCRP
Croatian: Lijekovi koji se prenose putem BCRP-a
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravne ili neizravan štetne učinke u pogledu reproduktivne toksičnosti (vidjeti dio 5.3).
English: See sections 4.8 and 5.1 for additional information.
Croatian: Za dodatne informacije vidjeti dijelove 4.8 i 5.1.
English: While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is recommended.
Croatian: Iako nije potrebno prilagođavati dozu digoksina, preporučuje se odgovarajući nadzor razina digoksina u serumu.
English: Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately 60%) of drug related radioactivity in plasma.
Croatian: Nakon primjene doze od 400 mg 14C-dasabuvira u ljudi, neizmijenjeni dasabuvir bio je glavna komponenta (približno 60%) radioaktivnosti povezane s lijekom u plazmi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue treatment with dasabuvir, taking into account the importance of the therapy to the mother.
Croatian: Budući da lijek može uzrokovati nuspojave u dojenčadi, mora se donijeti odluka hoće li se prekinuti dojenje ili obustaviti liječenje dasabuvirom, uzimajući u obzir važnost terapije za majku.
English: It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera.
Croatian: Vrlo je važno da pročitate i upute o lijeku za druge antivirusne lijekove koje uzimate s lijekom
English: At steady-state the exposures ratio of M1 to dasabuvir is approximately 0.6.
Croatian: Pri ravnotežnim koncentracijama omjer izloženosti M1 u odnosu na dasabuvir je otprilike 0,6.
English: Dasabuvir was greater than 99.5%, and M1 major metabolite of dasabuvir was 94.5% bound to human plasma proteins over a concentration range of 0.05 to 5 µg/mL.
Croatian: Više od 99,5% dasabuvira i 94,5% M1 glavnog metabolita dasabuvira vezalo se za proteine u ljudskoj plazmi pri rasponu koncentracija od 0,05 do 5 µg/ml.
English: The dasabuvir exposures obtained with the 400 mg formulation and the 250 mg tablet are similar.
Croatian: Izloženost dasabuviru postignuta s 400 mg ili 250 mg je slična.
English: c. Substitutions were observed in combination with other emergent substitutions at NS3 position R155 or D168.
Croatian: Supstitucije su primijećene u kombinaciji s drugim supstitucijama nastalima tijekom liječenja u NS3 na položajima R155 ili D168.
English: Treatment of patients with HIV co-infection
Croatian: Liječenja bolesnika s istodobnom infekcijom HIV-om
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, obratite se svom liječniku prije nego uzmete ovaj lijek.
English: Patients treated with vitamin K antagonists
Croatian: Bolesnici koji se liječe antagonistima vitamina
English: Outcome for subjects without SVR12
Croatian: Ishodi za ispitanike bez SVR12
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
Croatian: ALT >5-20 × GGN* (3. stupanj) >20 × GGN (4. stupanj) Hemoglobin <100-80 g/l (2. stupanj) <80-65 g/l (3. stupanj) <65 g/l (4. stupanj) Ukupni bilirubin >3-10 × GGN (3. stupanj) >10 × GGN (4. stupanj) *GGN: gornja granica normale
English: TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Croatian: UKUPNO +Ostale vrste neuspjeha liječenja kombinacijom pegIFN/RBV uključuje manji precizno dokumentirani izostanak odgovora, relaps/proboj ili druge oblike neuspjeha liječenja kombinacijom pegIFN/RBV.
English: The marketing authorisation holder (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: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Use with statins
Croatian: Primjena sa statinima
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 29% to 39% higher dasabuvir exposures than non-Asian subjects.
Croatian: Na temelju analize farmakokinetike populacije iz faze 3 kliničkih ispitivanja, Azijati su imali 29% do 39% višu izloženost dasabuviru od onih koji nisu Azijati.
English: Exposures of cyclobenzaprine, a CYP1A2 substrate, were decreased.
Croatian: Izloženost ciklobenzaprinu, supstratu za CYP1A2, bila je smanjena.
English: Female patients: Women of childbearing potential should not receive ribavirin unless they are using an effective form of contraception during treatment with ribavirin and for 4 months after treatment.
Croatian: Bolesnice ženskoga spola: Žene reproduktivne dobi ne smiju primati ribavirin ako ne koriste učinkovit oblik kontracepcije tijekom liječenja ribavirinom i još 4 mjeseca po njegovu završetku.
English: Genotype 1a N=67b % (n)
Croatian: Genotip 1a N=67b % (n)
English: Your doctor will test your blood before, during and after your treatment with Exviera.
Croatian: Liječnik će napraviti krvne pretrage prije, tijekom i nakon liječenja lijekom Exviera kako bi:
English: These medicines can affect the way Exviera and ombitasvir/paritaprevir/ritonavir work and Exviera and ombitasvir/paritaprevir/ritonavir can affect the way these other medicines work.
Croatian: Ti lijekovi mogu utjecati na način na koji Exviera i ombitasvir/paritaprevir/ritonavir djeluju, a Exviera i ombitasvir/paritaprevir/ritonavir mogu utjecati na način na koji ti drugi lijekovi djeluju.
English: Animal studies do not indicate harmful effects on fertility (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na štetne učinke na plodnost (vidjeti dio 5.3).
English: No human data on the effect of dasabuvir on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju dasabuvira na plodnost u ljudi.
English: • Less than 6 hours until your next dose - do not take the missed dose, take your next dose as usual with food.
Croatian: • manje od 6 sati do sljedeće doze - nemojte uzeti propuštenu dozu, a sljedeću dozu uzmite s hranom prema uobičajenom rasporedu.
English: *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: See also Section 4.8 for discussion of safety information for RUBY-I.
Croatian: Za informacije o sigurnosti za RUBY-I pogledajte i dio 4.8.
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (Table 2).
Croatian: Supstrati za CYP2C19 koji su ispitivani u ispitivanjima interakcije lijekova uključuju omeprazol i escitalopram (Tablica 2).
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Croatian: U ispitivanju nakon transplantacije jetre, doza ribavirina određivala se pojedinačno, a većina ispitanika primala je 600 do 800 mg na dan (vidjeti dio 5.1).
English: AUC (ng*hr/ml) (CV%)
Croatian: AUC (ng*h/ml) (CV%)
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would results in <10% change in dasabuvir exposures.
Croatian: Na temelju analize farmakokinetike populacije iz faze 3 kliničkih ispitivanja, povećanje ili smanjenje dobi za 10 godina s 54 godine života (medijan dobi u fazi 3 ispitivanja) rezultiraju u <10% promjene u izloženosti dasabuviru.
English: • There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
Croatian: • Postoji rizik od urođenih mana djeteta kada se ribavirin primjenjuje kod bolesnica koje zatrudne.
English: Exviera should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Croatian: Lijek Exviera se ne smije uzimati u trudnoći niti ga smiju uzimati žene u reproduktivnoj dobi bez da koriste učinkovitu metodu kontracepcije.
English: Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists*
Croatian: Namjena lijeka alprazolam, diazepam za liječenje tjeskobe, paničnih napadaja i tegoba sa spavanjem ciklosporin, everolimus, sirolimus, takrolimus za potiskivanje imunosnog sustava ciklobenzaprin, karisoprodol za liječenje mišićnih grčeva dabigatran za razrjeđivanje krvi deferasiroks pomaže u smanjenju razine željeza u krvi digoksin, amlodipin za liječenje srčanih tegoba ili visokog krvnog tlaka furosemid koristi se kod prekomjernog nakupljanja tekućine u tijelu hidrokodon za liječenje boli imatinib za liječenje nekih vrsta raka krvi levotiroksin za liječenje tegoba štitne žlijezde darunavir/ritonavir, atazanavir/ritonavir, rilpivirin za liječenje HIV infekcije omeprazol, lanzoprazol, esomeprazol za liječenje želučanog vrijeda i drugih želučanih tegoba rosuvastatin, pravastatin, fluvastatin, pitavastatin za snižavanje razine kolesterola u krvi s-metfenitoin za liječenje epilepsije teriflunomid za liječenje multiple skleroze sulfasalazin za liječenje upalne bolesti crijeva ili reumatoidnog artritisa varfarin i drugi slični lijekovi koji se nazivaju antagonisti vitamina K*
English: (administere d in the evening)
Croatian: (primijenjen navečer)
English: ANTIARRYTHMICS Digoxin
Croatian: ANTIARITMICI Digoksin
English: Age, median (range) years Male gender, n (%)
Croatian: Medijan dobi (raspon) u godinama Muški spol, n (%)
English: The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4).
Croatian: Makismalna dnevna doza rosuvastatina smije biti 5 mg (vidjeti dio 4.4).
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Croatian: 12 tjedana Liječenje u trajanju od 8 tjedana može se razmotriti u prethodno neliječenih bolesnika s infekcijom genotipom 1b i minimalnom do umjerenom fibrozom** (vidjeti dio 5.1, ispitivanje GARNET)
English: Dasabuvir had no effects on embryo-foetal viability or on fertility in rodents and were not teratogenic in two species.
Croatian: Dasabuvir nije utjecao na vijabilnost embrija/fetusa niti na plodnost glodavaca i nije bio teratogen u dvije vrste.
English: For dosing recommendations with calcineurin inhibitors refer to section 4.5.
Croatian: Za preporuke o doziranju s inhibitorima kalcineurina vidjeti dio 4.5.
English: Treatment:
Croatian: Liječenje:
English: Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Croatian: U 17 ispitanika (27,0%) je zabilježeno prolazno povišenje ukupnog bilirubina >3 x GGN (većinom indirektnog); 15 od tih ispitanika je uzimalo atazanavir.
English: Treatment duration was fixed in each trial and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Croatian: Trajanje liječenja u svakom je ispitivanju bilo fiksno i nije se vodilo prema razinama HCV RNK u ispitanika (nije se primjenjivao algoritam liječenja prema odgovoru).
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Croatian: Klinički nadzor i prilagodba doze mogu biti potrebni za ostale supstrate za CYP1A2 (npr. ciprofloksacin, ciklobenzaprin, teofilin i kofein).
English: Patient population
Croatian: Populacija bolesnika
English: Q2 2023
Croatian: 2023.godine
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Croatian: Vezanje za proteine u plazmi nije značajno izmijenjeno u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Some patients may also take an antiviral medicine called ribavirin.
Croatian: Neki bolesnici možda će uzimati i antivirusni lijek koji se zove ribavirin.
English: If you are not sure, talk to your doctor or pharmacist before taking Exviera.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete lijek Exviera.
English: Extra precautions are needed if Exviera is taken together with ribavirin.
Croatian: Potreban je poseban oprez ukoliko se lijek Exviera uzima u kombinaciji s ribavirinom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dasabuvir and ombitasvir/paritaprevir/ritonavir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja dasabuvira i ombitasvira/paritaprevira/ritonavira u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog hepatitisa C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Medicinal Product/ Possible Mechanism of Interaction
Croatian: Lijek/mogu ći mehanizam interakcije
English: TURQUOISE III (open-label)
Croatian: TURQUOISE III (otvoreno ispitivanje)
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Croatian: Sveukupno 37 (97,4%) od 38 ispitanika postiglo je SRV12.
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Croatian: Među ispitanicima koji su primali preporučeni režim, njih je 97% postiglo ukupan SVR (181 bolesnik s kompenziranom cirozom postigla su 97% SVR-a), dok je u 0,5% ispitanika nastupio virološki proboj, a 1,2% ispitanika doživjelo je relaps nakon liječenja.
English: Medicines you must tell your doctor about before taking Exviera Medicine or active substance
Croatian: Lijekovi o kojima morate obavijestiti svog liječnika prije nego uzmete lijek Exviera Lijek ili djelatna tvar
English: PEARL II (open-label)
Croatian: PEARL II (otvoreno ispitivanje)
English: Clinical monitoring and lower doses of imatinib are recommended.
Croatian: Preporučuje se kliničko praćenje i smanjenje doze imatiniba.
English: • carbamazepine, phenytoin, phenobarbital
Croatian: • karbamazepin, fenitoin, fenobarbital
English: Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medicinal products modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje direktno djelujućim antivirotikom treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: The combination of atazanavir and ombitasvir/paritaprevir/ ritonavir + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen, see sections 4.4 and 4.8.
Croatian: Kombinacija atazanavir i ombitasvir/paritaprevir/rito navir + dasabuvir povećava razine bilirubina, pogotovo u slučaju kada je ribavirin dio režima liječenja hepatitisa C, vidjeti dijelove 4.4 i 4.8.
English: Available pharmacokinetic data in animals have shown excretion of dasabuvir and metabolites in milk (see section 5.3).
Croatian: Dostupni farmakokinetički podaci iz istraživanja na životinjama pokazali su da se dasabuvir i njegovi metaboliti izlučuju u mlijeko (vidjeti dio 5.3).