natgillin/translations-raw huggingface dataset:
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 mL/min, n = 20) (see sections 4.2 and 4.4).
Iako darunavir nije ispitivan kod bolesnika s oštećenjem bubrega, analiza populacijske farmakokinetike pokazala je da kod bolesnika inficiranih HIV-om s umjerenim oštećenjem bubrega nije bilo značajnog utjecaja na farmakokinetiku darunavira (CrCl između 30-60 ml/min, n = 20) (vidjeti dijelove 4.2 i 4.4).
NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone
NARKOTIČKI ANALGETICI / LIJEČENJE OVISNOSTI O OPIOIDNIM LIJEKOVIMA
Ranitidine
Ranitidin
HMG CO-A REDUCTASE INHIBITORS Atorvastatin
INHIBITORI HMG-CoA REDUKTAZE Atorvastatin
Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Do istih razina doza, nije bilo teratogenosti s liječenjem samo darunavirom kod štakora i kunića, a niti kod miševa uz liječenje kombinacijom s ritonavirom.
A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with REZOLSTA has not been established.
Nije ustanovljena sigurna i učinkovita doza sildenafila za liječenje pulmonalne arterijske hipertenzije s istodobnom primjenom lijeka REZOLSTA.
Virologic failures selected for resistance testing were defined as: never suppressed: HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/mL at week 8, confirmed at the following visit; rebound: HIV-1 RNA < 50 copies/mL followed by confirmed HIV-1 RNA to ≥ 400 copies/mL or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/mL at last visit Virologic failures based on TLOVR non-VF censored algorithm (HIV-1 RNA > 50 copies/mL) IAS-USA lists
Virološki neuspjesi odabrani za ispitivanje rezistencije bili su definirani kao: nikada nije došlo do supresije: HIV-1 RNK < 1 log10 smanjenje u odnosu na početnu vrijednost i ≥ 50 kopija/ml u 8. tjednu, potvrđeno pri slijedećoj posjeti; povratak: HIV-1 RNK < 50 kopija/ml nakon čega je potvrđena HIV-1 RNK ≥ 400 kopija/ml ili potvrđen porast > 1 log10 HIV-1 RNK u odnosu na nadir; prekidi s HIV-1 RNK ≥ 400 kopija/ml na zadnjoj posjeti
Concomitant use of a HMG CoA reductase inhibitor and REZOLSTA may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy.
Istodobna primjena inhibitora HMG CoA reduktaze i lijeka REZOLSTA može povećati koncentracije lijeka za snižavanje lipida u plazmi, što može dovesti do štetnih događaja poput miopatije.
Co-administration of darunavir/cobicistat and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Istodobna primjena darunavira/kobicistata i lijekova koji se primarno metaboliziraju putem CYP3A može rezultirati povećanom sistematskom izloženošću takvim lijekovima, što može povećati ili produžiti njihov terapijski učinak i nuspojave.
* These adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
* ove nuspojave nisu bile prijavljene tijekom iskustva iz kliničkog ispitivanja s darunavirom/kobicistatom ali su zabilježene pri liječenju s darunavirom/ritonavirom te se također mogu očekivati s darunavirom/kobicistatom.
Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with REZOLSTA.
Nužan je oprez, a praćenje terapijskih koncentracija se preporučuje za ove antiaritmike ako je dostupno kada se primjenjuje istodobno s lijekom REZOLSTA.
The table below shows the 48-week efficacy data of the darunavir/cobicistat arm of the TMC114FD2HTX3001 trial:
U sljedećoj su tablici prikazani podaci o djelotvornosti nakon 48 tjedana u skupini koja je primala darunavir/kobicistat u ispitivanju TMC114FD2HTX3001:
As limited information is available on the use of REZOLSTA in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
S obzirom da su dostupni ograničeni podaci o primjeni lijeka REZOLSTA kod bolesnika u dobi od 65 godina i više, nužan je oprez, zbog povećane učestalosti smanjene funkcije jetre, te konkomitantnih bolesti ili druge terapije (vidjeti dijelove 4.2 i 5.2).
CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
If switching from ritonavir as a pharmacoenhancer to cobicistat, caution is required during the first two weeks of treatment with REZOLSTA, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer.
Potreban je oprez tijekom prva dva tjedna liječenja lijekom REZOLSTA u slučaju prijelaza s ritonavira kao farmakokinetičkog pojačivača na kobicistat, naročito ako su doze bilo kojeg od istodobno primijenjenih lijekova titrirane ili prilagođene tijekom primjene ritonavira kao farmakokinetičkog pojačivača.
The effect of cobicistat on serum creatinine was investigated in a Phase I trial in subjects with normal renal function (eGFR ≥ 80 mL/min, n = 12) and mild to moderate renal impairment (eGFR:50-79 mL/min, n = 18).
Učinak kobicistata na kreatinin u serumu ispitivan je u ispitivanju faze I u ispitanika s normalnom funkcijom bubrega (eGFR ≥ 80 ml/min, n = 12), te kod blagog do umjerenog oštećenja bubrega (eGFR:50-79 ml/min, n = 18).
What REZOLSTA looks like and contents of the pack Film-coated, pink, oval shaped tablet, mentioning TG on one side, 800 on the other side.
Ružičasta filmom obložena tableta, ovalnog oblika, s navedenim TG na jednoj strani, 800 na drugoj strani.
Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Povišena kreatin fosfokinaza (CPK), mialgija, miozitis i rijetko rabdomioliza bili su prijavljeni uz primjenu inhibitora proteaze HIV-a, osobito u kombinaciji s NRTI.
Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Istodobnom primjenom lijeka REZOLSTA i kortikosteroida koji se metaboliziraju putem CYP3A (npr flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju.
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Preporučuje se uzimanje drugih inhibitora agregacije trombocita na koje ne utječe CYP inhibicija ili indukcija (npr. prasugrel) (vidjeti dio 4.3).
Number of subjects with virologic failure and genotype data that develop mutations c at endpoint, n/N
Broj ispitanika s virološkim neuspjehom i spareni genotip koji su razvili mutacije c na ishodu, n/N
ART-experienced patients
ART-om prethodno liječeni bolesnici
HIV-1 RNA < 50 copies/mL All patients
HIV-1 RNK < 50 kopija/ml Svi bolesnici
No human data on the effect of darunavir or cobicistat on fertility are available.
Nema dostupnih podataka o učinku darunavira ili kobicistata na plodnost u ljudi.
The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
U sljedećoj tablici prikazani su podaci analiza djelotvornosti primjene nakon 48 i 96 tjedana ispitivanja ARTEMIS:
When REZOLSTA is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Kada se REZOLSTA istodobno primjenjuje s lijekovima koji sadrže drospirenon preporučuje se kliničko praćenje radi rizika od nastanka hiperkalemije.
Elbasvir/grazoprevir to treat hepatitis C infection
biljni pripravak koji se koristi kod depresije elbasvir/grazoprevir liječenje infekcije hepatitisom C
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.
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.
Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Preporučuje se kliničko praćenje kada se lijek REZOLSTA istodobno primjenjuje s perfenazinom, risperidonom ili tioridazinom.
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.
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.
Nizatidine
Nizatidin
C-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
C kobicistata 86% i 8,2% doze izolirano je u fecesu, odnosno mokraći.
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%).
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%).
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.
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.
Darunavir and cobicistat are metabolised by CYP3A.
Darunavir i kobicistat se metaboliziraju putem enzima CYP3A.
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).
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).
Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Stoga se ne može isključiti istiskivanje s proteina lijekova koji imaju visoki afinitet vezanja na α1-kiseli glikoprotein (vidjeti dio 4.5).
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.
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.
Co-administration of REZOLSTA and these anticoagulants is not recommended.
Ne preporučuje se istodobna primjena lijeka REZOLSTA i ovih antikoagulansa.
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).
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).
With ritonavir-boosted darunavir, a small decrease in methadone plasma concentrations was observed.
Kod darunavira pojačanog ritonavirom, zapaženo je malo smanjenje koncentracije metadona u plazmi.
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
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
Co-administration of REZOLSTA with rifabutin and rifapentine is not recommended.
Istodobna primjena lijeka REZOLSTA s rifabutinom i rifapentinom se ne preporučuje.
Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Darunavir se ekstenzivno metabolira putem jetrenog CYP sustava, gotovo isključivo izoenzimom CYP3A4.
Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with REZOLSTA.
Preporučeno je kliničko praćenje terapijskih učinaka i nuspojava kada se ovi lijekovi primjenjuju istodobno s lijekom REZOLSTA.
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).
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).
Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
Ozbiljne nuspojave bile su dijabetes melitus, preosjetljivost (na lijek), upalni sindrom imunološke rekonstitucije, osip, Stevens-Johnsonov sindrom i povraćanje.
Concomitant administration of REZOLSTA with dabigatran or ticagrelor is contraindicated.
Istodobna primjena lijeka REZOLSTA s dabigatranom ili tikagrelorom je kontraindicirana.
REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
REZOLSTA može biti primijenjena istodobno s inhibitorima protonske pumpe bez prilagodbe doze.
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.
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.
Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Ispitivanja interakcija s darunavirom/kobicistatom, darunavirom/ritonavirom i s kobicistatom provedena su samo u odraslih.
Famotidine
Famotidin
Caution should be exercised when clarithromycin is combined with REZOLSTA.
Nužan je oprez kada se klaritromicin kombinira s lijekom REZOLSTA.
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.
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.
Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistat.
If you take more REZOLSTA than you should Contact your doctor, pharmacist or nurse immediately.
Ako uzmete više lijeka REZOLSTA nego što ste trebali Odmah kontaktirajte svog liječnika, ljekarnika ili medicinsku sestru.
In the darunavir/cobicistat fixed-dose combination treament arm, 363 HIV-1 infected, adult, treatment-naïve patients were treated.
U skupini koja je primala kombinaciju fiksnih doza darunavira/kobicistata bila su liječena 363 prethodno neliječena odrasla bolesnika s infekcijom virusom HIV-1.
Tenofovir disoproxil *
Tenofovirdizoproksil*
No special precautions or dose adjustments are required in patients with renal impairment.
Nisu potrebne posebne mjere opreza ili prilagodbe doze kod bolesnika s oštećenjem bubrega.
HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Ne-nukleo(z/t)idni inhibitori reverzne transkriptaze (NNRTI) Efavirenz
Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Istodobna primjena amiodarona, bepridila, dronedarona, ivabradina, kinidina ili ranolazina i lijeka REZOLSTA je kontraindicirana (vidjeti dio 4.3).
Thyroid follicular cell adenomas were noted in male rats.
Folikularni stanični adenomi štitnjače zabilježeni su kod muških štakora.
The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Najčešće ozbiljne nuspojave su akutno zatajenje bubrega, infarkt miokarda, upalni sindrom imunološke rekonstitucije, trombocitopenija, osteonekroza, proljev, hepatitis i pireksija.
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].
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].
Your doctor should do blood tests before you start REZOLSTA.
Prije započinjanja lijeka REZOLSTA liječnik Vam treba napraviti krvne pretrage.
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.
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.
How to store REZOLSTA
Kako uzimati lijek REZOLSTA
It is not recommended to co-administer REZOLSTA with glecaprevir/pibrentasvir.
Ne preporučuje se istodobna primjena lijeka REZOLSTA s glekaprevirom/pibrentasvirom.
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).
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).
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).
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).
REZOLSTA 800 mg/150 mg film-coated tablets
REZOLSTA 800 mg/150 mg filmom obložene tablete
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.
Istodobna primjena kobicistata s lijekovima koji su supstrati ovih transportera može rezultirati povišenim koncentracijama u plazmi istodobno primijenjenih lijekova.
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.
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.
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).
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).
Concomitant use of everolimus or irinotecan and REZOLSTA is not recommended.
Istodobna primjena everolimusa ili irinotekana i lijeka REZOLSTA se ne preporučuje.
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.
Nakon započinjanja terapije, ona se ne smije prekidati bez uputa dobivenih od Vašeg liječnika.
No dosage adjustment of REZOLSTA is necessary for patients with mild to moderate hepatic impairment.
Nije potrebna prilagodba doze lijeka REZOLSTA za bolesnike s blagim do umjerenim oštećenjem funkcije jetre.
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).
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).
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu zaraženi HIV-om-1, a koji imaju umjereno oštećenje funkcije jetre (Child-Pugh stadij B).