FrancophonIA/ELRC3.0 huggingface dataset:
English: EDURANT at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Croatian: EDURANT u preporučenoj dozi od 25 mg jedanput dnevno nije povezan s klinički značajnim učinkom na QTc.
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P450 (CYP) 3A system.
Croatian: In vitro ispitivanja pokazuju da se rilpivirin primarno oksidativno metabolizira putem sustava citokroma P450 (CYP) 3A.
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Croatian: Prilagodba doze se ne predlaže, ali se savjetuje oprez u bolesnika s umjerenim oštećenjem jetre.
English: In patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution.
Croatian: U bolesnika s teškim oštećenjem bubrega ili u završnoj fazi bolesti bubrega, rilpivirin treba primjenjivati s oprezom.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms.
Croatian: U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme započinjanja CART-a može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke patogene i prouzročiti ozbiljna klinička stanja ili pogoršanje simptoma.
English: The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Croatian: Djelotvornost i sigurnost primjene rilpivirina u djece mlađe od 12 godina još nisu utvrđene.
English: The combination of rilpivirine and dabigatran etexilate should be used with caution.
Croatian: Kombinaciju rilpivirina i dabigatran eteksilata treba primjenjivati s oprezom.
English: Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Croatian: Tablica 6: Virološki ishodi u adolescentnih ispitanika u ispitivanju TMC278-C213 - analiza tjedna 48 i tjedna 240; ITT-TLOVR* Tjedan 48 N=36
English: Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).
Croatian: Odabrani klinički laboratorijski poremećaji (3. ili 4. stupnja) koji su nastali tijekom liječenja i smatrani su nuspojavama, prijavljeni u bolesnika liječenih EDURANTOM bili su povišena amilaza gušterače (3,8%), povišen AST (2,3%), povišen ALT (1,6%), povišen LDL kolesterol (natašte, 1,5%), sniženi leukociti (1,2%), povišena lipaza (0,9%), povišen bilirubin (0,7%), povišeni trigliceridi (natašte, 0,6%), snižen hemoglobin (0,1%), snižen broj trombocita (0,1%), i povišen ukupan kolesterol (natašte,
English: In patients with severe renal impairment or end-stage renal disease, EDURANT should be used with caution, as plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Croatian: EDURANT treba primjenjivati s oprezom u bolesnika s teškim oštećenjem funkcije bubrega ili u završnoj fazi bubrežne bolesti, jer koncentracije u plazmi mogu biti povišene zbog promijenjene apsorpcije, distribucije i/ili metabolizma lijeka uslijed poremećaja funkcije bubrega.
English: In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem bubrega ili u završnoj fazi bolesti bubrega, kombinacija rilpivirina s jakim inhibitorom CYP3A (npr. inhibitor proteaze HIV-a pojačan ritonavirom) smije se primijeniti samo ako korist nadilazi rizik (vidjeti dio 5.2).
English: The incidence of virologic failure was higher in the rilpivirine arm than the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
Croatian: U 96. tjednu incidencija virološkog neuspjeha bila je viša u skupini liječenoj rilpivirinom nego u skupini liječenoj efavirenzom; međutim većina viroloških neuspjeha pojavila se tijekom prvih 48 tjedana liječenja.
English: EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh score C).
Croatian: EDURANT nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: * Intent-to-treat time to loss of virologic response.
Croatian: * Vrijeme do gubitka virološkog odgovora u populaciji s namjerom liječenja.
English: If you are taking any of the above, ask your doctor about alternatives.
Croatian: Ako uzimate bilo koji od gore navedenih lijekova, upitajte liječnika za savjet.
English: This interaction study has been performed with a dose higher than the recommended dose for rilpivirine.
Croatian: Ovo ispitivanje interakcije provedeno je s dozom rilpivirina višom od preporučene.
English: OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Croatian: OSTALI LIJEKOVI ANTIEPILEPTICI Karbamazepin Okskarbazepin Fenobarbital Fenitoin
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Croatian: U ispitivanju u kojem se 8 bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) uspoređivalo s 8 odgovarajućih kontrolnih ispitanika te 8 bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B) s 8 odgovarajućih kontrolnih ispitanika, izloženost višestrukim dozama rilpivirina bila je 47% viša u bolesnika s blagim oštećenjem jetre i 5% viša u bolesnika s umjerenim oštećenjem jetre.
English: Concomitant use of EDURANT with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine.
Croatian: Istovremena primjena EDURANTA s azolskim antimikoticima može prouzročiti povećanje koncentracije rilpivirina u plazmi.
English: Within each frequency grouping, ADRs are presented in order of decreasing frequency.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema učestalosti.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja liječenja kombiniranom antiretrovirusnom terapijom (CART) može se pojaviti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
English: By baseline CD4 count (× 10
Croatian: Prema početnom broju CD4 (× 10
English: (inhibition of CYP3A enzymes)
Croatian: (inhibicija enzima CYP3A)
English: Of those patients who were responders at week 96, 74% of patients receiving rilpivirine remained with undetectable viral load (< 50 HIV-1 RNA copies/ml) at week 240 compared to 81% of patients receiving efavirenz.
Croatian: Od onih bolesnika koji su imali odgovor u 96. tjednu, 74% bolesnika koji su primili rilpivirin i dalje je imalo nemjerljivo virusno opterećenje (< 50 HIV-1 RNK kopija/ml) u 240. tjednu u usporedbi s 81% bolesnika koji su primili efavirenz.
English: How to store EDURANT
Croatian: Kako čuvati EDURANT
English: In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment.
Croatian: U analizi objedinjenih podataka o rezistenciji iz 96. tjedna, tijekom drugih 48 tjedana uočene su niže stope virološkog neuspjeha u odnosu na prvih 48 tjedana liječenja.
English: EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Croatian: EDURANT je, u kombinaciji s drugim antiretrovirusnim lijekovima, indiciran za liječenje bolesnika u dobi od 12 godina i starijih zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i imaju virusno opterećenje ≤ 100 000 HIV-1 RNA kopija/ml.
English: EDURANT should be used with caution in patients with moderate hepatic impairment.
Croatian: EDURANT treba primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre.
English: In the week 240 resistance analysis of the TMC278-C213 trial, rilpivirine resistance-associated mutations (RAMs) were observed in 46.7% (7/15) of subjects with virologic failure and post-baseline genotypic data.
Croatian: U analizi podataka o rezistenciji iz 240. tjedna ispitivanja TMC278-C213, mutacije povezane s rezistencijom (RAM-ovi) na rilpivirin uočene su u 46,7% (7/15) ispitanika s virološkim neuspjehom i genotipskim podacima u razdoblju nakon početka ispitivanja.
English: 6 cells/l in the rilpivirine arm and +219 × 10
Croatian: 6 stanica/l u skupini koja je primala rilpivirin i +219 × 10
English: Immune system disorders uncommon immune reactivation syndrome
Croatian: Poremećaji imunološkog sustava manje često sindrom imunološke reaktivacije
English: Table 4 below shows the results of the week 48 and the week 96 efficacy analysis for patients treated with rilpivirine and patients treated with efavirenz from the pooled data from the ECHO and THRIVE trials.
Croatian: Tablica 4 pokazuje rezultate analize djelotvornosti u 48. i 96. tjednu u bolesnika liječenih rilpivirinom i bolesnika liječenih efavirenzom na temelju objedinjenih podataka iz ispitivanja ECHO i THRIVE.
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Croatian: Više je bolesnika koji su imali virološki neuspjeh uz rilpivirin razvilo rezistenciju povezanu s lamivudinom/emtricitabinom nego onih koji su imali virološki neuspjeh uz efavirenz (vidjeti dio 5.1).
English: EDURANT must be taken with a meal (see section 5.2).
Croatian: EDURANT se mora uzimati uz obrok (vidjeti dio 5.2).
English: After single dose oral administration of
Croatian: Nakon peroralne primjene jedne doze
English: AZOLE ANTIFUNGAL AGENTS Ketoconazole*
Croatian: AZOLNI ANTIMIKOTICI Ketokonazol*
English: The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
Croatian: Ovojnica filmom obložene tablete sadrži laktozu hidrat, hipromelozu 2910 6 mPa.s, titanijev dioksid (E171), makrogol 3000 i triacetin.
English: In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
Croatian: U bolesnika s početnim virusnim opterećenjem < 100 000 kopija/ml, 9 od 27 bolesnika s virološkim neuspjehom na rilpivirin, tijekom liječenja pojavila se rezistencija na rilpivirin (genotipska analiza), uz sljedeću učestalost fenotipske križne rezistencije: etravirin 4/9, efavirenz 3/9 i nevirapin 1/9.
English: No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nisu opaženi klinički važni učinci na plodnost (vidjeti dio 5.3).
English: Hepatitis B and/or hepatitis C virus co-infection
Croatian: Istovremena infekcija virusom hepatitisa B i/ili C
English: Take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Croatian: H2-receptora najmanje 12 sati prije ili najmanje 4 sata poslije EDURANTA (pogledajte dio 2 “Drugi lijekovi i EDURANT”).
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom HIV-infekcijom i oportunističkom infekcijom u povijesti bolesti, ubrzo nakon početka liječenja HIV-a mogu se pojaviti znakovi i simptomi upale prethodnih infekcija.
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Croatian: Bolesnici s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml koji su imali virološki neuspjeh pokazali su veću stopu rezistencije koja se pojavila uz liječenje na klasu nenukleozidnih inhibitora reverzne transkriptaze (NNRTI).
English: BR=background regimen N=number of subjects
Croatian: BR = prateće liječenje N = broj ispitanika
English: The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Croatian: Farmakokinetička izloženost rilpivirinu u bolesnika s istovremenom infekcijom bila je usporediva s onom u bolesnika bez istovremene infekcije.
English: The recommended dose of EDURANT is one 25 mg tablet taken once daily.
Croatian: Preporučena doza EDURANTA je jedna tableta od 25 mg koja se uzima jedanput dnevno.
English: PROTON PUMP INHIBITORS Omeprazole*
Croatian: INHIBITORI PROTONSKE PUMPE Omeprazol*
English: (induction of CYP3A enzymes)
Croatian: (indukcija enzima CYP3A)
English: Concomitant use of rilpivirine with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Croatian: Istovremena primjena rilpivirina s inhibitorima proteaze pojačanima ritonavirom uzrokuje povećanje koncentracije rilpivirina u plazmi, ali prilagodba doze nije potrebna.
English: If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal.
Croatian: Ako bolesnik povraća unutar 4 sata od uzimanja lijeka, treba uzeti drugu tabletu EDURANTA uz obrok.
English: ANTACIDS Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Croatian: Antacidi (npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat)
English: In the week 96 pooled resistance analysis of the Phase III trials (ECHO and THRIVE), 42 out of 86 subjects with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis).
Croatian: U analizi objedinjenih podataka o rezistenciji u 96. tjednu iz ispitivanja faze III (ECHO i THRIVE), kod 42 od 86 ispitanika s virološkim neuspjehom na rilpivirin, pojavila se rezistencija na rilpivirin (genotipska analiza).
English: If you notice after 12 hours, then skip that dose and take the next doses as usual.
Croatian: Ako to primijetite nakon što je prošlo više od 12 sati, tada preskočite tu dozu i uzmite sljedeću tabletu u uobičajeno vrijeme.
English: Hepatobiliary disorders very common increased transaminases common increased bilirubin
Croatian: Poremećaji jetre i žuči vrlo često povišene transaminaze često povišen bilirubin
English: No dose adjustment of EDURANT is required in older patients.
Croatian: Prilagodba doze EDURANTA u starijih osoba nije potrebna.
English: The most commonly observed resistance-associated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Croatian: Najčešće primijećene mutacije povezane s rezistencijom koje su se pojavile uključivale su L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C i M230I.
English: - The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Croatian: - Pomoćne tvari u jezgri filmom obložene tablete su laktoza hidrat, umrežena karmelozanatrij, povidon K30, polisorbat 20, silicirana mikrokristalična celuloza i magnezijev stearat.
English: In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz).
Croatian: U analizi djelotvornosti objedinjenih podataka iz ispitivanja faze III u odraslih bolesnika tijekom 96 tjedana, bolesnici liječeni rilpivirinom s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml imali su veći rizik od virološkog neuspjeha (18,2% uz rilpivirin u odnosu na 7,9% uz efavirenz) u usporedbi s bolesnicima koji su imali početno virusno opterećenje ≤ 100 000 HIV-1 RNK kopija/ml (5,7% uz rilpivirin u odnosu na 3,6% uz efavirenz).
English: 6 cells/l).
Croatian: 6 stanica/l).
English: 400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
Croatian: 400 mg jedanput dnevno ketokonazol AUC ↓ 24% ketokonazol Cmin ↓ 66% ketokonazol Cmax ↔
English: Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/ml
Croatian: Početne značajke bolesti Medijan početne HIV-1 RNK u plazmi (raspon) log10 kopija/ml
English: The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Croatian: Učinak rilpivirina u preporučenoj dozi od 25 mg jedanput dnevno na QTcF interval procijenjen je u randomiziranom križnom ispitivanju kontroliranom placebom i djelatnom tvari (moksifloksacin 400 mg jedanput dnevno) u 60 zdravih odraslih ispitanika, uz 13 mjerenja tijekom 24 sata u stanju dinamičke ravnoteže.
English: If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule.
Croatian: Ako je bolesnik propustio uzeti dozu EDURANTA unutar 12 sati od vremena kad je obično uzima, bolesnik mora što prije uzeti lijek uz obrok i nastaviti uzimati lijek prema uobičajenom rasporedu.
English: Most ADRs occurred in the first 48 weeks of treatment.
Croatian: Većina nuspojava pojavila se tijekom prvih 48 tjedana liječenja.
English: If you vomit less than 4 hours after taking EDURANT, take another tablet with a meal.
Croatian: Ako povraćate a prošlo je manje od 4 sata od uzimanja EDURANTA, uzmite drugu tabletu uz obrok.
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Croatian: Ispitanici u kojih se postigao virološki odgovor (dva uzastopna virusna opterećenja < 50 kopija/ml) i održao se do 48./96. tjedna.
English: There was no teratogenicity with rilpivirine in rats and rabbits.
Croatian: Rilpivirin nije bio teratogen u štakora i kunića.
English: Rilpivirine-treated Resistance
Croatian: Liječeni rilpivirinom Rezistencija
English: Considering all of the available in vitro and in vivo data in treatment-naïve subjects, the following resistance-associated mutations, when present at baseline, may affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, and M230L.
Croatian: Razmatrajući sve dostupne podatke in vitro i in vivo za ispitanike koji prethodno nisu bili liječeni, na djelovanje rilpivirina mogu utjecati sljedeće mutacije povezane s rezistencijom kad su prisutne na početku: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I i M230L.
English: 6 cells/l)
Croatian: 6 stanica/l)
English: Table 6 summarizes the week 48 and week 240 virologic outcome results for trial TMC278-C213.
Croatian: Tablica 6 sažeto prikazuje rezultate viroloških ishoda u 48. i 240. tjednu ispitivanja TMC278-C213.
English: The pharmacokinetics, safety, tolerability and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase II trial in antiretroviral treatment-naïve HIV-1 infected adolescent subjects weighing at least 32 kg.
Croatian: Farmakokinetika, sigurnost, podnošljivost i djelotvornost rilpivirina u dozi od 25 mg jedanput dnevno, u kombinaciji s osnovnim režimom po izboru ispitivača koji je sadržavao dva NRTI, bili su procijenjeni u ispitivanju TMC278-C213, otvorenom ispitivanju faze II s jednom skupinom ispitanika, u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnom terapijom, tjelesne težine od najmanje 32 kg.
English: Nervous system disorders very common headache dizziness common somnolence
Croatian: Poremećaji živčanog sustava vrlo često glavobolja omaglica često somnolencija
English: It is not known whether rilpivirine is excreted in human milk.
Croatian: Nije poznato izlučuje li se rilpivirin u majčino mlijeko u ljudi.
English: EDURANT 25 mg film-coated tablets rilpivirine
Croatian: EDURANT 25 mg filmom obložene tablete rilpivirin
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast-feed if they are receiving rilpivirine.
Croatian: Zbog mogućnosti prijenosa HIV-a te zbog mogućnosti nuspojava u dojene novorođenčadi, majkama treba savjetovati da ne doje ako primaju rilpivirin.
English: Resistance outcome by background NRTI regimen used (pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis) tenofovir/ emtricitabine zidovudine/ lamivudine abacavir/ lamivudine
Croatian: Tablica 5: Ishod rezistencije prema osnovnom NRTI režimu (analiza objedinjenih podataka iz ispitivanja ECHO i THRIVE u 96. tjednu) tenofovir/ emtricitabin zidovudin/ lamivudin abakavir/ lamivudin svi*
English: In ECHO, randomisation was stratified by screening viral load.
Croatian: U ispitivanju ECHO, randomizacija je bila stratificirana prema virusnom opterećenju na probiru.
English: Medicinal products that are affected by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Croatian: Rilpivirin u dozi od 25 mg jedanput dnevno najvjerojatnije neće imati klinički važan učinak na izloženost lijekovima koje metaboliziraju enzimi CYP-a.
English: Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
Croatian: Rilpivirin se primarno metabolizira putem citokroma P450 (CYP)3A.
English: Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48 and week 240.
Croatian: Ispitanici u kojih se postigao virološki odgovor (dva uzastopna virusna opterećenja < 50 kopija/ml) i održao se do 48./240. tjedna.
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Croatian: Rilpivirin je diarilpirimidinski nenukleozidni inhibitor reverzne transkriptaze (NNRTI) virusa HIV-1.
English: What EDURANT looks like and contents of the pack White to off-white, film-coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.
Croatian: Bijela do gotovo bijela, filmom obložena, okrugla, bikonveksna tableta s “TMC” utisnutim na jednoj strani i “25” na drugoj strani.
English: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily.
Croatian: Za bolesnike koji istodobno uzimaju rifabutin, doza EDURANTA mora se povisiti na 50 mg (dvije tablete od 25 mg), i uzeti jedanput dnevno.