FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, co-administration of REZOLSTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Croatian: Stoga je istodobna primjena lijeka REZOLSTA i sildenafila kada se primjenjuje za liječenje plućne arterijske hipertenzije kontraindicirana (vidjeti dio 4.3).
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/mL.
Croatian: Bolesnici inficirani s HIVom-1 koji su bili podobni za uključenje u ovo ispitivanje na probiru su imali genotip koji nije pokazivao RAM na darunavir i HIV-1 RNK ≥ 1000 kopija/ml u plazmi.
English: In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatment-naïve subjects was similar to that seen with darunavir/ritonavir 600/100 mg twice daily in treatment-experienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
Croatian: U analizi nakon 96 tjedana liječenja, sigurnosni profil darunavira/ritonavira od 800/100 mg jedanput na dan u prethodno neliječenih ispitanika bio je sličan profilu darunavira/ritonavira od 600/100 mg dva puta na dan u prethodno liječenih ispitanika, osim mučnine koja je češće opažena u prethodno neliječenih ispitanika.
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone,
Croatian: - Kortikosteroide koji uključuju betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
English: The combination of colchicine and REZOLSTA is contraindicated in patients with renal or hepatic impairment (see section 4.3).
Croatian: Kombinacija kolhicina i lijeka REZOLSTA je kontraindicirana u bolesnika s oštećenjem bubrega ili jetre (vidjeti dio 4.3).
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n = 12, age  65 years) (see section 4.4).
Croatian: Analiza populacijskih farmakokinetičkih podataka kod HIV-om inficiranih bolesnika (n = 12, dob ≥ 65 godina) pokazala je da farmakokinetika darunavira nije bitno različita u rasponu dobi (18 do 75 godina) (vidjeti dio 4.4).
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Croatian: Odabrani virusi nisu mogli rasti u prisutnosti darunavira u koncentracijama iznad 400 nM. Virusi odabrani u tim uvjetima, koji su pokazivali smanjenu osjetljivost na darunavir, (raspon: 23-50 puta) imali su 2 do 4 supstitucije aminokiselina u genu proteaze.
English: REZOLSTA contains the active substances darunavir and cobicistat.
Croatian: REZOLSTA sadrži djelatne tvari darunavir i kobicistat.
English: Co-administration of REZOLSTA and bosentan is not recommended.
Croatian: Istodobna primjena lijeka REZOLSTA i bosentana se ne preporučuje.
English: In the REZOLSTA arm of Phase III trial TMC114FD2HTX3001, mean eGFRCG change from baseline was -11.1 mL/min at week 48 and mean eGFRcystatin C change from baseline was +2.9 mL/min/1.73 m² at week 48.
Croatian: U skupini liječenoj lijekom REZOLSTA u ispitivanju faze III TMC114FD2HTX3001 srednja vrijednost promjene eGFRCG u odnosu na početnu vrijednost iznosila je -11,1 ml/min u 48. tjednu, dok je srednja vrijednost promjene eGFRcistatin C u odnosu na početnu vrijednost iznosila +2,9 ml/min/1,73 m² u 48. tjednu.
English: Cobicistat is a mechanism based inhibitor of CYP3A, and a weak CYP2D6 inhibitor.
Croatian: Kobicistat je inhibitor CYP3A temeljeno na mehanizmu i slabi inhibitor CYP2D6.
English: The pooled data of a single-arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals and one arm of a trial in which REZOLSTA 800/150 mg once daily and other antiretrovirals were administered, showed that 1.9% of patients discontinued treatment due to rash.
Croatian: Objedinjeni podaci iz ispitivanja s jednom skupinom u kojem je darunavir od 800 mg jedanput na dan ispitivan u kombinaciji s kobicistatom od 150 mg jedanput na dan i drugim antiretrovirusnim lijekovima te iz jedne skupine u ispitivanju u kojem su se primjenjivali REZOLSTA u dozi od 800/150 mg jedanput na dan i drugi antiretrovirusni lijekovi pokazali su da je 1,9% bolesnika prekinulo liječenje zbog osipa.
English: Medicinal products that may be affected by darunavir/cobicistat
Croatian: Lijekovi na koje može utjecati darunavir/kobicistat
English: No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Croatian: Nisu zapažene značajne razlike u farmakokinetici kobicistata između ispitanika s teškim oštećenjem funkcije bubrega i zdravih ispitanika, što je dosljedno s niskim bubrežnim klirensom kobicistata.
English: Based on theoretical considerations REZOLSTA may increase the exposure to glecaprevir and pibrentasvir.
Croatian: Temeljeno na teorijskim postavkama REZOLSTA može povećati izloženost glekapreviru i pibrentasviru.
English: The evidence of efficacy of darunavir/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing darunavir/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Croatian: Dokaz djelotvornosti darunavira/ritonavira 800/100 mg jedanput na dan temelji se na analizi podataka dobivenih nakon 192 tjedna randomiziranog, kontroliranog, otvorenog ispitivanja faze III pod nazivom ARTEMIS, provedenog u bolesnika inficiranih HIV-1 prethodno neliječenih s ART-om, u kojem se uspoređivao darunavir/ritonavir 800/100 mg jedanput na dan i kombinacija lopinavir/ritonavir 800/200 mg po danu (primijenjena dva puta na dan ili jedanput na dan).
English: REZOLSTA should not be initiated in patients with creatinine clearance less than 70 mL/min when co-administered with one or more agent requiring dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipivoxil) (see sections 4.2, 4.8 and 5.2).
Croatian: REZOLSTA se ne smije započeti primjenjivati u bolesnika s klirensom kreatinina manjim od 70 ml/min ako se istodobno primjenjuje s jednim ili s više lijekova koji zahtijevaju prilagodbu doze temeljenu na klirensu kreatinina (npr. emtricitabin, lamivudin, tenofovirdizoproksil (u obliku fumarata, fosfata ili sukcinata) ili adefovirdipivoksil) (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with REZOLSTA is not recommended.
Croatian: Ne preporučuje se istodobna primjena tadalafila za liječenje plućne arterijske hipertenzije i lijeka REZOLSTA.
English: ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Croatian: ANTIKOAGULANSI /INHIBITORI AGREGACIJE TROMBOCITA
English: Co-administration of domperidone with REZOLSTA is contraindicated.
Croatian: Istodobna primjena domperidona s lijekom REZOLSTA je kontraindicirana.
English: REZOLSTA should not be used concurrently with products containing ritonavir or regimens containing ritonavir or cobicistat.
Croatian: REZOLSTA se ne smije uzimati istovremeno s lijekovima koji sadrže ritonavir ili režimima koji uključuju ritonavir ili kobicistat.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with HIV PIs.
Croatian: Prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartrozu kod bolesnika s hemofilijom tipa
English: Imputations according to the Snapshot algorithm.
Croatian: Pripisane vrijednosti izračunate prema algoritmu za globalnu snimku distribuiranog sustava (engl. snapshot algorithm).
English: Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Croatian: Temeljeno na teorijskim postavkama REZOLSTA može povećati izloženost grazopreviru.
English: The combination of lurasidone, pimozide, quetiapine or sertindole and REZOLSTA is contraindicated (see section 4.3).
Croatian: Kombinacija lurasidona, pimozida, kvetiapina ili sertindola i lijeka REZOLSTA je kontraindicirana (vidjeti dio 4.3).
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir
Croatian: LIJEKOVI KOJI DJELUJU NA HIV Inhibitori prijenosa lanca integraze Dolutegravir
English: HIV Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine
Croatian: Nukleo(z/t)idni inhibitori reverzne transkriptaze (NRTI) Didanozin
English: Refer to the table above for information on ARTEMIS and ODIN.
Croatian: Za podatke iz ARTEMIS i ODIN ispitivanja pogledajte tablice iznad.
English: Uncommon side effects (may affect up to 1 in 100 people) - symptoms of infection or of autoimmune disorders (immune reconstitution inflammatory syndrome) - osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) - enlargement of breasts - abnormal blood test results such as some tests for your pancreas, high level of sugar, abnormal levels of ‘lipids' (fats).
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - simptomi infekcije ili autoimunih poremećaja (upalni sindrom imunološke rekonstitucije) - osteonekroza (odumiranje tkiva kostiju uzrokovano gubitkom opskrbe krvlju u kostima) - povećanje dojki - odstupanja u rezultatima laboratorijskih krvnih testova poput testova za gušteraču, povišena razina šećera u krvi, odstupanja u razinama 'lipida' (masnoća).
English: Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine, when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - elbasvir/grazoprevir - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Croatian: Istodobna primjena sa sljedećim lijekovima zbog potencijalnih ozbiljnih i/ili po život opasnih nuspojava (vidjeti dio 4.5): - alfuzozin - amiodaron, bepridil, dronedaron, ivabradin, kinidin, ranolazin - astemizol, terfenadin - kolhicin, kada se koristi u bolesnika s oštećenjem bubrega i/ili jetre (vidjeti dio 4.5) - rifampicin - ergot derivati (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - cisaprid - dapoksetin - domperidon - naloksegol - lurasidon, pimozid, kvetiapin, sertindol (vidjeti dio 4.5) - elbasvir/grazoprevir - triazolam, peroralno primijenjen midazolam (mjere opreza za parenteralno primijenjen midazolam, vidjeti dio 4.5) - sildenafil - kada se primjenjuje za liječenje plućne arterijske hipertenzije, avanafil - simvastatin, lovastatin i lomitapid (vidjeti dio 4.5) - dabigatran, tikagrelor.
English: - Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Colchicine (to treat gout or familial Mediterranean fever).
Croatian: Vorikonazol se smije uzimati samo nakon medicinske procjene. - rifabutin (protiv bakterijskih infekcija) - tadalafil, sildenafil, vardenafil (za erektilnu disfunkciju ili povišeni krvni tlak u plućnom krvotoku) - amitriptilin, desipramin, imipramin, nortriptilin, paroksetin, sertralin, trazodon (za liječenje depresije i tjeskobe) - maravirok (za liječenje HIV infekcije) - kolhicin (za liječenje gihta ili obiteljske mediteranske vrućice).
English: The resistance profile of REZOLSTA is driven by darunavir.
Croatian: Darunavir je uzrok profila rezistencije lijeka REZOLSTA.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/mL, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Croatian: Nakon 48 tjedana, pokazalo se da virološki odgovor definiran kao postotak bolesnika s razinom u plazmi HIV-1 RNK < 50 kopija/ml nije inferioran uz liječenje uz darunavir/ritonavir od 800/100 mg jedanput na dan (pri prethodno definiranoj granici neinferiornosti od 12%) u usporedbi s darunavirom/ritonavirom od 600/100 mg dva puta na dan u ITT i OP populacijama.
English: Caution should be used with co-administration of REZOLSTA and parenteral midazolam.
Croatian: Nužan oprez kod istodobne primjene lijeka REZOLSTA parenteralno primijenjenim midazolamom.
English: Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Croatian: Kobicistat je inhibitor citokroma P450 podskupine CYP3A temeljeno na mehanizmu.
English: There are no data regarding the use of darunavir or cobicistat in patients with severe hepatic impairment.
Croatian: Ne postoje podaci vezani uz primjenu darunavira ili kobicistata u bolesnika s teškim oštećenjem jetre.
English: REZOLSTA should not be used concurrently with products or regimens containing ritonavir or cobicistat.
Croatian: REZOLSTA se ne smije uzimati istodobno s lijekovima ili režimima koji uključuju ritonavir ili kobicistat.
English: REZOLSTA should not be used in treatment-experienced patients with one or more DRV-RAMs or HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
Croatian: REZOLSTA se ne smije primjenjivati u prethodno liječenih bolesnika koji imaju jednu ili više DRV-RAM ili HIV-1 RNK ≥ 100 000 kopija/ml ili broj CD4+ stanica < 100 stanica x 10
English: With baseline CD4+ cell count ≥ 200 median CD4+ cell count change from baseline (x 10
Croatian: S početnim brojem CD4+ stanica < 200 S početnim brojem CD4+ stanica ≥ 200 Medijan promjene broja CD4+ stanica u odnosu na početni (x 10
English: Common side effects (may affect up to 1 in 10 people) - allergic reactions such as itching - decreased appetite - abnormal dreams - vomiting, pain or swelling of the belly, indigestion, flatulence - muscle pain - tiredness - abnormal blood test results such as some tests for your liver or kidney.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - alergijske reakcije poput svrbeža - smanjen apetit - nenormalni snovi - povraćanje, bol ili oticanje trbuha, probavne tegobe, vjetrovi - bolovi u mišićima - umor - odstupanja u rezultatima laboratorijskih testova poput testova za jetru ili bubrege.
English: REZOLSTA should not be used in paediatric patients below 3 years of age (see sections 4.2 and 5.3).
Croatian: REZOLSTA se ne smije primjenjivati u pedijatrijskih bolesnika mlađih od 3 godine (vidjeti dijelove 4.2 i 5.3).
English: reactivation of herpes simplex and herpes zoster has been observed in clinical trials with darunavir co-administered with low dose ritonavir.
Croatian: Nadalje, u kliničkim ispitivanjima s darunavirom primijećena je reaktivacija herpesa simpleksa i herpesa zostera uz istodobno liječenje niskom dozom ritonavira.
English: Concomitant use of everolimus and REZOLSTA is not recommended.
Croatian: Istodobna primjena everolimusa i lijeka REZOLSTA se ne preporučuje.
English: Consult the Summary of Product Characteristics for darunavir for further details.
Croatian: Za više detalja pogledajte sažetak opisa svojstava lijeka za darunavir.
English: - In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: - Nakon što počnete uzimati lijekove za liječenje HIV infekcije osim oportunističkih infekcija također se mogu javiti i autoimuni poremećaji (stanje u kojem imunosni sustav napada zdravo tjelesno tkivo).
English: lopinavir/ ritonavir 800/200 mg per day N = 346
Croatian: lopinavir/ ritonavir 800/200 mg na dan N = 346
English: Tablet film-coat
Croatian: Film ovojnica tablete
English: Hepatic impairment REZOLSTA has not been investigated in patients with hepatic impairment.
Croatian: Oštećenje bubrega REZOLSTA nije bila ispitivana u bolesnika s oštećenjem bubrega.
English: REZOLSTA should not be used in paediatric patients below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Croatian: REZOLSTA se ne smije primjenjivati u pedijatrijskih bolesnika mlađih od 3 godine zbog sigurnosnih razloga (vidjeti dijelove 4.4 i 5.3).
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate) and 150 mg cobicistat.
Croatian: Jedna filmom obložena tableta sadrži 800 mg darunavira (u obliku darunaviretanolata) i 150 mg kobicistata.
English: Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka REZOLSTA s elbasvirom/grazoprevirom je kontraindicirana (vidjeti dio 4.3).
English: Based on theoretical considerations REZOLSTA is expected to increase the plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.
Croatian: Temeljeno na teorijskim postavkama očekuje se da će REZOLSTA povećati koncentracije fluvastatina, pitavastatina, pravastatina, lovastatina i simvastatina u plazmi. (inhibicija CYP3A i/ili transporta)
English: Efficacy of darunavir/cobicistat fixed-dose combination 800/150 mg once daily in ART-naïve patients TMC114FD2HTX3001 is a randomized, active-controlled, double blind, Phase III trial to evalate the efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus darunavir/cobicistat fixed-dose combination + emtricitabine/tenofovir disoproxil fumarate.
Croatian: TMC114FD2HTX3001 je randomizirano, aktivnim komparatorom kontrolirano, dvostruko slijepo ispitivanje faze III provedeno radi ocjene djelotvornosti i sigurnosti darunavira/kobicistata/emtricitabina/tenofoviralafenamida u odnosu na kombinaciju fiksnih doza darunavira/kobicistata + emtricitabin/tenofovirdizoproksilfumarat.
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282
Croatian: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
English: The evidence of efficacy of REZOLSTA once daily is based on the analysis of 48 week data from trial GS-US-216-130 in ART-naïve and ART-experienced patients, trial TMC114FD2HTX3001 in ART-naïve patients, and two Phase III trials ARTEMIS and ODIN conducted with darunavir/ritonavir 800/100 mg q.d.
Croatian: Dokaz djelotvornosti lijeka REZOLSTA jedanput na dan temelji se na analizi podataka iz ispitivanja u trajanju 48 tjedana GS-US-216-130 u bolesnika koji prethodno nisu liječeni ART-om i bolesnika koji su liječeni ART-om, ispitivanja TMC114FD2HTX3001 u bolesnika koji prethodno nisu liječeni ART-om i dva ispitivanja faze III ARTEMIS i ODIN koja su provedena s darunavirom/ritonavirom od 800/100 mg jedanput na dan u bolesnika koji prethodno nisu liječeni ART-om odnosno bolesnika koji su liječeni ART-om.
English: Efficacy of darunavir 800 mg once daily co-administered with 100 mg ritonavir once daily in ART-naïve patients
Croatian: Djelotvornost darunavira od 800 mg jedanput na dan primijenjenog istodobno sa 100 mg ritonavira jedanput na dan u ART-naivnih bolesnika
English: The effects of other medicines might be influenced if you take REZOLSTA.
Croatian: Ako uzimate lijek REZOLSTA to može utjecati na učinke drugih lijekova.
English: For further details, consult the maraviroc Summary of Product Characteristics.
Croatian: Za više detalja pogledajte sažetak opisa svojstava lijeka za maravirok.
English: Cobicistat does not select any HIV resistance mutations, due to its lack of antiviral activity.
Croatian: Radi nedostatka antivirusne aktivnosti, kobicistat ne utječe na odabir bilo koje mutacije za rezistenciju HIV-a.
English: Efficacy of darunavir 800 mg once daily co-administered with 100 mg ritonavir once daily in ART-experienced patients
Croatian: Djelotvornost darunavira od 800 mg jedanput na dan primijenjenog istodobno sa 100 mg ritonavira jedanput na dan u ART- iskusnih bolesnika
English: REZOLSTA and raltegravir can be used without dose adjustments.
Croatian: REZOLSTA i dolutegravir se mogu uzimati bez prilagodbe doza.
English: Adverse reactions with darunavir/cobicistat in adult patients
Croatian: Nuspojave s darunavirom/kobicistatom u odraslih bolesnika
English: Each tablet contains 800 mg of darunavir (as ethanolate) and 150 mg cobicistat.
Croatian: Jedna tableta sadrži 800 mg darunavira (u obliku darunaviretanolata) i 150 mg kobicistata.
English: Co-administration of REZOLSTA and etravirine is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka REZOLSTA i etravirina.
English: REZOLSTA 800 mg/150 mg tablets darunavir/cobicistat
Croatian: REZOLSTA 800 mg/150 mg tablete darunavir/kobicistat
English: Limited data is available in patients with HIV-1 clades other than B.
Croatian: Za bolesnike s drugim podtipovima HIV-1 osim podtipa B, dostupni su ograničeni podaci.
English: Co-administration is contraindicated (see section 4.3)
Croatian: Istodobna primjena je kontraindicirana (vidjeti dio 4.3)
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of renal tubular secretion of creatinine.
Croatian: Pokazalo se da kobicistat smanjuje procijenjeni klirens kreatinina radi inhibicije bubrežne tubularne sekrecije kreatinina.
English: Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen (see sections 4.4 and 4.6).
Croatian: Stoga se liječenje lijekom REZOLSTA ne smije započinjati tijekom trudnoće, a žene koje zatrudne tijekom liječenja lijekom REZOLSTA trebaju prijeći na zamjenski režim (vidjeti dijelove 4.4 i 4.6).
English: Caution should be exercised when combining one of these anti-neoplastic agents with REZOLSTA.
Croatian: Potreban je oprez kada se neki od tih antineoplastika kombinira s lijekom REZOLSTA.
English: REZOLSTA should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
Croatian: Bolesnici s jednom ili više mutacija povezanih s rezistencijom na darunavir (DRV-RAM) ili HIV-1 RNK ≥ 100 000 kopija/ml ili brojem CD4+ stanica < 100 stanica x 10
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation
Croatian: Pripisane vrijednosti izračunate prema TLOVR algoritmu Prenesena pripisana vrijednost zadnjeg opažanja (od engl.
English: Your doctor will explain these to you - weakness.
Croatian: Vam objasniti rezultate laboratorijskih testova. - slabost.
English: Darunavir and cobicistat are metabolised by the hepatic system.
Croatian: Darunavir i kobicistat se metaboliziraju putem jetre.
English: Prior data with ritonavir-boosted darunavir however showed a decrease in these anti-depressant plasma concentrations (unknown mechanism); the latter may be specific to ritonavir.
Croatian: Temeljeno na teorijskim postavkama očekuje se da će REZOLSTA povećati koncentracije tih antidepresiva u plazmi. (CYP2D6 i/ili CYP3A inhibicija) Međutim, prijašnji podaci s darunavirom pojačanim ritonavirom pokazali su smanjenje koncentracija tih antidepresiva u plazmi (nepoznat mehanizam); potonje bi moglo biti specifično za ritonavir.
English: Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen (see sections 4.2 and 4.6).
Croatian: Stoga se liječenje lijekom REZOLSTA ne smije započinjati tijekom trudnoće, a žene koje zatrudne tijekom liječenja lijekom REZOLSTA trebaju prijeći na zamjenski režim (vidjeti dijelove 4.2 i 4.6).