FrancophonIA/ELRC3.0 huggingface dataset:
English: No human data on the effect of darunavir or cobicistat on fertility are available.
Croatian: Nema dostupnih podataka o učinku darunavira ili kobicistata na plodnost u ljudi.
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Croatian: U sljedećoj tablici prikazani su podaci analiza djelotvornosti primjene nakon 48 i 96 tjedana ispitivanja ARTEMIS:
English: When REZOLSTA is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Croatian: Kada se REZOLSTA istodobno primjenjuje s lijekovima koji sadrže drospirenon preporučuje se kliničko praćenje radi rizika od nastanka hiperkalemije.
English: Elbasvir/grazoprevir to treat hepatitis C infection
Croatian: biljni pripravak koji se koristi kod depresije elbasvir/grazoprevir liječenje infekcije hepatitisom C
English: Separate trials of darunavir/ritonavir and cobicistat suggest no dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, REZOLSTA should be used with caution in these patients.
Croatian: Različita ispitivanja darunavira/ritonavira i kobicistata ukazuju na to da se prilagodba doze ne preporučuje u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetre, međutim, REZOLSTA se u tih bolesnika mora primjenjivati s oprezom.
English: Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Croatian: Preporučuje se kliničko praćenje kada se lijek REZOLSTA istodobno primjenjuje s perfenazinom, risperidonom ili tioridazinom.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Limited information is available on the use of REZOLSTA in patients co-infected with hepatitis B and/or C virus.
Croatian: Bolesnici istodobno inficirani virusom hepatitisa B i/ili hepatitisa C Informacije o primjeni lijeka REZOLSTA u bolesnika koji su istodobno inficirani virusom hepatitisa B i/ili hepatitisa C su ograničene.
English: Nizatidine
Croatian: Nizatidin
English: C-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
Croatian: C kobicistata 86% i 8,2% doze izolirano je u fecesu, odnosno mokraći.
English: The most frequent adverse reactions reported in the pooled data of the Phase 3 study GS-US-216-130 and the REZOLSTA arm of Phase 3 study TMC114FD2HTX3001 were diarrhoea (23%), nausea (17%), rash (13%), and headache (10%).
Croatian: Prema objedinjenim podacima iz kliničkog ispitivanja faze III GS-US-216-130 i skupine liječene lijekom REZOLSTA u ispitivanju faze III TMC114FD2HTX3001, najčešće prijavljene nuspojave bile su proljev (23%), mučnina (17%), osip (13%) i glavobolja (10%).
English: In women receiving REZOLSTA during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Croatian: U žena koje uzimaju lijek REZOLSTA tijekom drugog tromjesečja trudnoće, srednje intra-individualne vrijednosti Cmax, AUC24h i Cmin za ukupni darunavir bile su 49%, 56% odnosno 92% niže, u usporedbi s postpartalnim razdobljem; tijekom trećeg tromjesečja trudnoće, vrijednosti Cmax, AUC24h i Cmin za ukupni darunavir bile su 37%, 50% i 89% niže, u usporedbi s postpartalnim razdobljem.
English: Darunavir and cobicistat are metabolised by CYP3A.
Croatian: Darunavir i kobicistat se metaboliziraju putem enzima CYP3A.
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat (e.g. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St John's wort) (see section 4.3 and interaction table below).
Croatian: Očekuje se da bi lijekovi koji induciraju aktivnost CYP3A povećavali klirens darunavira i kobicistata, rezultirajući sniženim koncentracijama darunavira i kobicistata u plazmi (npr. efavirenz, karbamazepin, fenitoin, fenobarbital, rifampicin, rifapentin, rifabutin, gospina trava) (vidjeti dio 4.3 i tablicu interakcija ispod).
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Croatian: Stoga se ne može isključiti istiskivanje s proteina lijekova koji imaju visoki afinitet vezanja na α1-kiseli glikoprotein (vidjeti dio 4.5).
English: In a multiple dose trial with darunavir/ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n = 8) and moderate (Child-Pugh Class B, n = 8) hepatic impairment were comparable with those in healthy subjects.
Croatian: U ispitivanjima primjene višestrukih doza s darunavirom/ritonavirom (600/100 mg) dva puta na dan, pokazalo se da su ukupne koncentracije darunavira u plazmi kod ispitanika s blagim (Child-Pugh stadij A, n = 8) i umjerenim (Child-Pugh stadij B, n = 8) oštećenjem jetre usporedive s onima kod zdravih ispitanika.
English: Co-administration of REZOLSTA and these anticoagulants is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka REZOLSTA i ovih antikoagulansa.
English: Tell your doctor if you take: - Bosentan (to treat heart disease) - Dexamethasone (injectable) (corticosteroid) - Efavirenz, etravirine, nevirapine (to treat HIV infection) - Rifapentine, rifabutin (to treat bacterial infections).
Croatian: Upozorite svog liječnika ako uzimate: - bosentan (za liječenje bolesti srca) - deksametazon (u obliku injekcije) (kortikosteroid) - efavirenz, etravirin, nevirapin (za liječenje HIV infekcije) - rifapentin, rifabutin (za liječenje bakterijskih infekcija).
English: With ritonavir-boosted darunavir, a small decrease in methadone plasma concentrations was observed.
Croatian: Kod darunavira pojačanog ritonavirom, zapaženo je malo smanjenje koncentracije metadona u plazmi.
English: Number of subjects with virologic failure and phenotype data that show a loss of susceptibility to PIs at endpoint compared to baseline d, n/N
Croatian: Broj ispitanika s virološkim neuspjehom i odgovarajući fenotip koji pokazuju gubitak osjetljivosti na IP na ishodu u usporedbi s onim na početku d, n/N
English: Co-administration of REZOLSTA with rifabutin and rifapentine is not recommended.
Croatian: Istodobna primjena lijeka REZOLSTA s rifabutinom i rifapentinom se ne preporučuje.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Croatian: Darunavir se ekstenzivno metabolira putem jetrenog CYP sustava, gotovo isključivo izoenzimom CYP3A4.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with REZOLSTA.
Croatian: Preporučeno je kliničko praćenje terapijskih učinaka i nuspojava kada se ovi lijekovi primjenjuju istodobno s lijekom REZOLSTA.
English: When also taking into account the clinical trial data of DRV/COBI/emtricitabine/tenofovir alafenamide, StevensJohnson syndrome occurred rarely (in 1 out of 2,551 subjects) consistent with the DRV/rtv clinical trial program (see Severe skin reactions in Section 4.4).
Croatian: Kad se u obzir uzmu i podaci iz kliničkog ispitivanja darunavira/kobicistata/emtricitabina/tenofoviralafenamida, Stevens-Johnsonov sindrom zabilježen je rijetko (u 1 od 2551 ispitanika), što odgovara podacima iz programa kliničkih ispitivanja darunavira/ritonavira (vidjeti odlomak „Teške kožne reakcije“ u dijelu 4.4).
English: Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
Croatian: Ozbiljne nuspojave bile su dijabetes melitus, preosjetljivost (na lijek), upalni sindrom imunološke rekonstitucije, osip, Stevens-Johnsonov sindrom i povraćanje.
English: Concomitant administration of REZOLSTA with dabigatran or ticagrelor is contraindicated.
Croatian: Istodobna primjena lijeka REZOLSTA s dabigatranom ili tikagrelorom je kontraindicirana.
English: REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
Croatian: REZOLSTA može biti primijenjena istodobno s inhibitorima protonske pumpe bez prilagodbe doze.
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/mL.
Croatian: ODIN je randomizirano, otvoreno ispitivanje faze III koje je usporedilo darunavir/ritonavir 800/100 mg jedanput na dan naspram darunavira/ritonavira 600/100 mg dva puta na dan u ART-iskusnih bolesnika inficiranih s HIV-1, a na probiru pri uključivanju u ispitivanje testiranje genotipa u tih bolesnika nije pokazalo darunavir RAM (tj. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) dok je probir HIV-1 RNK bio > 1000 kopija/ml.
English: Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Croatian: Ispitivanja interakcija s darunavirom/kobicistatom, darunavirom/ritonavirom i s kobicistatom provedena su samo u odraslih.
English: Famotidine
Croatian: Famotidin
English: Caution should be exercised when clarithromycin is combined with REZOLSTA.
Croatian: Nužan je oprez kada se klaritromicin kombinira s lijekom REZOLSTA.
English: In some patients with advanced HIV infection and a history of unusual infections due to a weakened immune system (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 neuobičajenim infekcijama radi oslabljenog imunološkog sustava (oportunistička infekcija) u povijesti bolesti, ubrzo nakon početka liječenja HIV-a mogu se pojaviti znakovi i simptomi upale zbog prijašnjih infekcija.
English: Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistat.
English: If you take more REZOLSTA than you should Contact your doctor, pharmacist or nurse immediately.
Croatian: Ako uzmete više lijeka REZOLSTA nego što ste trebali Odmah kontaktirajte svog liječnika, ljekarnika ili medicinsku sestru.
English: In the darunavir/cobicistat fixed-dose combination treament arm, 363 HIV-1 infected, adult, treatment-naïve patients were treated.
Croatian: U skupini koja je primala kombinaciju fiksnih doza darunavira/kobicistata bila su liječena 363 prethodno neliječena odrasla bolesnika s infekcijom virusom HIV-1.
English: Tenofovir disoproxil *
Croatian: Tenofovirdizoproksil*
English: No special precautions or dose adjustments are required in patients with renal impairment.
Croatian: Nisu potrebne posebne mjere opreza ili prilagodbe doze kod bolesnika s oštećenjem bubrega.
English: HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Croatian: Ne-nukleo(z/t)idni inhibitori reverzne transkriptaze (NNRTI) Efavirenz
English: Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Croatian: Istodobna primjena amiodarona, bepridila, dronedarona, ivabradina, kinidina ili ranolazina i lijeka REZOLSTA je kontraindicirana (vidjeti dio 4.3).
English: Thyroid follicular cell adenomas were noted in male rats.
Croatian: Folikularni stanični adenomi štitnjače zabilježeni su kod muških štakora.
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Croatian: Najčešće ozbiljne nuspojave su akutno zatajenje bubrega, infarkt miokarda, upalni sindrom imunološke rekonstitucije, trombocitopenija, osteonekroza, proljev, hepatitis i pireksija.
English: Rare side effects (may affect up to 1 in 1,000 people) - a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung].
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - reakcija koja se naziva DRESS [teški osip, koji može biti praćen vrućicom, umorom, oticanjem lica ili limfnih čvorova, povišenjem eozinofila (vrsta bijelih krvnih stanica), učincima na jetru, bubrege ili pluća].
English: Your doctor should do blood tests before you start REZOLSTA.
Croatian: Prije započinjanja lijeka REZOLSTA liječnik Vam treba napraviti krvne pretrage.
English: These patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily with an investigator selected optimised background regimen (OBR) consisting of 2 active NRTIs.
Croatian: Ti bolesnici su primili darunavir od 800 mg jedanput na dan u kombinaciji s kobicistatom od 150 mg jedanput na dan i optimizirani osnovni režim (OOR) liječenja po odabiru ispitivača koji se sastojao od 2 aktivna NRTIja.
English: A
Croatian: d
English: How to store REZOLSTA
Croatian: Kako uzimati lijek REZOLSTA
English: It is not recommended to co-administer REZOLSTA with glecaprevir/pibrentasvir.
Croatian: Ne preporučuje se istodobna primjena lijeka REZOLSTA s glekaprevirom/pibrentasvirom.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Croatian: Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu zaraženi s HIV-1, a koji imaju teško oštećenje funkcije bubrega (procijenjeni klirens kreatinina ispod 30 ml/min).
English: Therefore, REZOLSTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Croatian: Stoga se REZOLSTA ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dijelove 4.3, 4.4 i 5.2).
English: REZOLSTA 800 mg/150 mg film-coated tablets
Croatian: REZOLSTA 800 mg/150 mg filmom obložene tablete
English: Co-administration of cobicistat with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products.
Croatian: Istodobna primjena kobicistata s lijekovima koji su supstrati ovih transportera može rezultirati povišenim koncentracijama u plazmi istodobno primijenjenih lijekova.
English: The bioequivalence between REZOLSTA and darunavir/cobicistat 800/150 mg co-administered as single agents was established under fed and fasted conditions in healthy subjects.
Croatian: Bioekvivalencija između lijeka REZOLSTA i darunavira/kobicistata od 800/150 mg primijenjenih istodobno kao pojedinačnih komponenti bila je ustanovljena u zdravih ispitanika u stanju sitosti i natašte.
English: Co-administration of REZOLSTA and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals such as clotrimazole).
Croatian: Istodobna primjena lijeka REZOLSTA i drugih lijekova koji inhibiraju CYP3A može smanjiti klirens darunavira i kobicistata i može rezultirati povišenim koncentracijama darunavira i kobicistata u plazmi (npr. antifungalni azoli poput klotrimazola).
English: Concomitant use of everolimus or irinotecan and REZOLSTA is not recommended.
Croatian: Istodobna primjena everolimusa ili irinotekana i lijeka REZOLSTA se ne preporučuje.
English: Do not stop taking REZOLSTA without talking to your doctor first After therapy has started, it must not be stopped without instruction of the doctor.
Croatian: Nakon započinjanja terapije, ona se ne smije prekidati bez uputa dobivenih od Vašeg liječnika.
English: No dosage adjustment of REZOLSTA is necessary for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze lijeka REZOLSTA za bolesnike s blagim do umjerenim oštećenjem funkcije jetre.
English: Tell your doctor if you take: - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures) - Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Clotrimazole, fluconazole, itraconazole, isavuconazole, posaconazole (against fungal infections).
Croatian: Upozorite liječnika ako uzimate: - alfentanil (u obliku injekcije, jaki i kratkodjelujući lijek za liječenje boli koji se koristi pri kirurškim postupcima) - digoksin (za liječenje određenih srčanih poremećaja) - klaritromicin (antibiotik) - klotrimazol, flukonazol, itrakonazol, izavukonazol, posakonazol (protiv gljivičnih infekcija).
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Croatian: Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu zaraženi HIV-om-1, a koji imaju umjereno oštećenje funkcije jetre (Child-Pugh stadij B).
English: It is not known whether darunavir or cobicistat are excreted in human milk.
Croatian: Nije poznato izlučuju li se darunavir ili kobicistat u majčino mlijeko u ljudi.
English: For patients with renal impairment the Summary of Product Characteristics for clarithromycin should be consulted for the recommended dose.
Croatian: Za bolesnike s oštećenjem bubrega za preporučenu dozu klaritromicina mora se pogledati sažetak opisa svojstava lijeka za klaritromicin.
English: - Tell your doctor if you have had problems with your kidneys.
Croatian: - Upozorite liječnika ako ste prije imali tegobe s bubrezima.
English: Clinical monitoring is recommended when co-administering REZOLSTA with these analgesics.
Croatian: Preporučeno je kliničko praćenje kada se REZOLSTA istodobno primjenjuje s tim analgeticima.
English: There are no pharmacokinetic data regarding the use of REZOLSTA in patients with hepatic impairment.
Croatian: Ne postoje farmakokinetički podaci o primjeni lijeka REZOLSTA u bolesnika s oštećenjem jetre.
English: You must eat a meal or a snack within 30 minutes prior to taking your REZOLSTA.
Croatian: Unutar 30 minuta prije uzimanja lijeka REZOLSTA morate pojesti obrok ili nešto prigristi.
English: This recommendation is different from ritonavir-boosted darunavir.
Croatian: Ova preporuka se razlikuje u odnosu na ritonavirom pojačan darunavir.
English: Based on theoretical considerations REZOLSTA may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Croatian: Temeljeno na teorijskim postavkama REZOLSTA može povećati koncentracije buprenorfina i/ili norbuprenorfina u plazmi.
English: The resistance profile of REZOLSTA is supported by two Phase III trials conducted with darunavir/ritonavir in treatment-naïve (ARTEMIS) and treatment-experienced (ODIN) patients and the analysis of 48 week data from trial GS-US-216-130 in treatment-naïve and treatment-experienced patients.
Croatian: Profil rezistencije lijeka REZOLSTA podupiru dva ispitivanja faze III koja su provedena s darunavirom/ritonavirom u bolesnika koji prethodno nisu bili liječeni (ARTEMIS) i u bolesnika koji su prethodno liječeni (ODIN) i analiza podataka nakon 48 tjedana iz ispitivanja GS-US-216-130 za bolesnike koji prethodno nisu bili liječeni i bolesnike koji su prethodno liječeni.
English: One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products, but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Croatian: Jedna filmom obložena tableta lijeka REZOLSTA jedanput na dan uzeta s hranom može se primijeniti u bolesnika koji su prethodno bili izloženi antiretrovirusnim lijekovima, ali bez mutacija povezanih s rezistencijom na darunavir (engl. darunavir resistance associated mutations, DRV-RAM)*, a koji u plazmi imaju HIV-1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
English: Investigations Common increased blood creatinine
Croatian: Pretrage često povišen kreatinin u krvi
English: There were insufficient pharmacokinetic data in the clinical trials to determine the effect of hepatitis B and/or C virus infection on the pharmacokinetics of darunavir and cobicistat (refer to sections 4.4 and
Croatian: Istodobna infekcija virusom hepatitisa B i/ili hepatitisa C Nije bilo dovoljno podataka o farmakokinetici u kliničkim ispitivanjima za utvrđivanje učinka infekcije virusom hepatitisa B i/ili C na farmakokinetiku darunavira i kobicistata (pogledajte dijelove 4.4 i 4.8).
English: Skin and subcutaneous tissue disorders Very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip (uključujući makularni, makulopapularni, papularni, eritematozni, pruritički osip, generalizirani osip i alergijski dermatitis)
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Croatian: Potrebno je uzeti u obzir zamjenske kortikosteroide koji manje ovise o metabolizmu putem CYP3A, npr. beklometazon za intranazalnu ili inhalacijsku primjenu, osobito za dugoročnu primjenu.
English: Triazolam or oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety Sildenafil to treat a heart and lung disorder called pulmonary arterial hypertension.
Croatian: lovastatin, simvastatin i lomitapid snižavanje razina kolesterola triazolam ili oralni (koji se uzima kroz usta) midazolam pomaže Vam pri spavanju i/ili smanjuje tjeskobu sildenafil liječenje poremećaja srca i pluća koje se zove plućna arterijska hipertenzija.
English: REZOLSTA should not be initiated in patients with creatinine clearance less than 70 mL/min, if any co-administered medicinal product (e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate), or adefovir dipivoxil) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Croatian: REZOLSTA se ne smije započinjati u bolesnika s klirensom kreatinina manjim od 70 ml/min, ako bilo koji od istovremeno primijenjenih lijekova (npr. emtricitabin, lamivudin, tenofovirdizoproksil (u obliku fumarata, fosfata ili sukcinata) ili adefovirdipivoksil) zahtijeva prilagodbu doze na osnovi klirensa kreatinina (vidjeti dijelove 4.4, 4.8 i 5.2).
English: REZOLSTA can be used with these NRTIs without dose adjustment.
Croatian: REZOLSTA se može primijeniti s ovim NRTI lijekovima bez prilagodbe doze.
English: The safety and efficacy of REZOLSTA in paediatric patients aged 3 to 17 years have not been established (see sections 4.4 and 5.3).
Croatian: Sigurnost i djelotvornost lijeka REZOLSTA u pedijatrijskih bolesnika u dobi od 3 do 17 godina nisu ustanovljene (vidjeti dijelove 4.4 i 5.3).
English: Genotypic testing should guide the use of REZOLSTA (see sections 4.2, 4.4 and 5.1).
Croatian: Primjena lijeka REZOLSTA mora se voditi genotipskim pretragama (vidjeti dijelove 4.2, 4.4 i 5.1).
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with REZOLSTA is required.
Croatian: Ako je potrebno liječenje lijekom REZOLSTA preporučuje se smanjiti dozu kolhicina ili prekinuti liječenje kolhicinom u bolesnika s normalnom funkcijom bubrega ili jetre.
English: Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breast-feeding.
Croatian: Ako ste trudni, planirate trudnoću ili dojite odmah se obratite svom liječniku.
English: Outcomes at Week 48
Croatian: Ishodi u Tjednu 48