FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Ti bolniki so prejemali darunavir 800 mg enkrat na dan v kombinaciji s kobicistatom 150 mg enkrat na dan skupaj z optimiziranim osnovnim režimom (OBROptimised Background Regimen) zdravljenja z dvema aktivnima NRTI po izboru raziskovalca.
English: Medicinal products that may be affected by darunavir/cobicistat
Slovenian: Zdravila, na katera lahko vpliva darunavir/kobicistat
English: Tell your doctor if you take: - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Slovenian: Zdravniku povejte, če jemljete: - amlodipin, karvedilol, diltiazem, dizopiramid, felodipin, flekainid, lidokain, metoprolol, meksiletin, nikardipin, nifedipin, propafenon, timolol, verapamil (za bolezni srca), ker se lahko zvečajo terapevtski ali neželeni učinki teh zdravil;
English: 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).
Slovenian: Čeprav darunavirja niso proučevali pri bolnikih z okvaro ledvic, je populacijska analiza farmakokinetike pokazala, da farmakokinetika darunavirja ni pomembno spremenjena pri bolnikih z zmerno okvaro ledvic, okuženih s HIV (očistek kreatinina med 30-60 ml/min, n = 20) (glejte poglavji 4.2 in 4.4).
English: When administered with food, the relative exposure of darunavir is 1.7-fold higher as compared to intake without food.
Slovenian: Pri odmerjanju skupaj s hrano je relativna izpostavljenost darunavirju 1,7-krat večja kot pri odmerjanju brez hrane, zato je treba tablete zdravila REZOLSTA jemati skupaj s hrano.
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Slovenian: Drugih učinkov na parjenje ali plodnost pri zdravljenju z darunavirjem v odmerkih do 1.000 mg/kg/dan in pri stopnjah izpostavljenosti pod vrednostmi (0,5-kratni AUC) pri klinično priporočenem odmerku za človeka ni bilo.
English: ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
Slovenian: ANTIMIKOTIKI klotrimazol flukonazol itrakonazol izavukonazol posakonazol
English: REZOLSTA must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting.
Slovenian: Zdravila REZOLSTA se ne sme uporabljati skupaj z drugimi protivirusnimi zdravili, ki vsebujejo ojačevalec, ali protivirusnimi zdravili, ki potrebujejo okrepitev z ojačevalcem.
English: Based on the different elimination pathways of the other NRTIs (i.e. emtricitabine, lamivudine, stavudine and zidovudine) that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP, no interactions are expected for these medicinal compounds and REZOLSTA.
Slovenian: Glede na drugačno pot izločanja drugih NRTI (kot so emtricitabin, lamivudin, stavudin in zidovudin), ki se izločajo predvsem skozi ledvice, in glede na to, da presnova abakavirja ne poteka z encimi CYP, ni pričakovati interakcij med navedenimi učinkovinami in zdravilom REZOLSTA.
English: There are no data regarding the use of darunavir or cobicistat in patients with severe hepatic impairment.
Slovenian: Ni podatkov o uporabi darunavirja oziroma kobicistata pri bolnikih s hudo okvaro jeter.
English: 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
Slovenian: Virološki neuspeh zdravljenja (izbran za testiranje odpornosti) je bil opredeljen kot: brez supresije: zmanjšanje koncentracije HIV-1 RNA za < 1 log10 od izhodišča in ≥ 50 kopij/ml po 8 tednih zdravljenja, potrjeno pri naslednjem obisku; povratni učinek: koncentracija HIV-1 RNA < 50 kopij/ml s kasnejšim potrjenim zvišanjem koncentracije HIV-1 RNA na ≥ 400 kopij/ml ali s potrjenim zvišanjem koncentracije HIV-1 RNA za > 1 log10 od najnižje vrednosti; prekinitve s koncentracijo HIV-1 RNA ≥ 400 kopij/ml pri zadnjem obisku virološki neuspeh zdravljenja po algoritmu TLOVR, pri čemer so cenzurirani podatki bolnikov, pri katerih ni prišlo do virološkega neuspeha (koncentracija HIV-1 RNA > 50 kopij/ml) (TLOVR = čas do izgube virološkega odziva, angl. time-to-loss of virologic response)
English: 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.
Slovenian: Sočasna uporaba zdravila REZOLSTA in kortikosteroidov, ki se presnavljajo s pomočjo encimov CYP3A (npr flutikazonpropionata in drugih inhaliranih ali nazalnih kortikosteroidov) lahko poveča tveganje za razvoj sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvičnih žlez.
English: Limited information is available in this population.
Slovenian: O uporabi pri tej skupini bolnikov je na voljo le malo podatkov.
English: As REZOLSTA contains darunavir and cobicistat, interactions that have been identified with darunavir (in combination with cobicistat or with low dose ritonavir) or with cobicistat determine the interactions that may occur with REZOLSTA.
Slovenian: Ker zdravilo REZOLSTA vsebuje darunavir in kobicistat, je mogoče na podlagi interakcij, ki so jih opažali z darunavirjem (v kombinaciji s kobicistatom ali z majhnimi odmerki ritonavirja) ali s kobicistatom, predvidevati interakcije, do katerih lahko pride pri uporabi zdravila REZOLSTA.
English: Tenofovir disoproxil *
Slovenian: dizoproksiltenofovirat*
English: REZOLSTA might increase sugar levels in the blood.
Slovenian: Zdravilo REZOLSTA lahko zveča koncentracijo sladkorja v krvi.
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).
Slovenian: Zdravniku povejte, če jemljete: - bosentan (za zdravljenje bolezni srca) - deksametazon (oblika za injiciranje)(kortikosteroid) - efavirenz, etravirin, nevirapin (za zdravljenje okužbe z virusom HIV) - rifapentin, rifabutin (za zdravljenje bakterijskih okužb)
English: Some clinical trials suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Slovenian: Po podatkih nekaterih kliničnih študij bi lahko raltegravir povzročil zmerno znižanje koncentracije darunavirja v plazmi.
English: The plastic bottle comes with a child resistant cap and must be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Slovenian: Plastenka ima za otroke varno zaporko, ki jo odprete takole: Potisnite plastično navojno zaporko navzdol in jo pri tem obračajte v nasprotni smeri urinega kazalca.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročali so tudi o avtoimunskih boleznih (kot je Gravesova bolezen in avtoimunski hepatitis), vendar je čas do njihovega pojava bolj raznolik in se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Slovenian: Podtipi A1, D, F1, G, K, CRF02_AG, CRF12_BF in CRF06_CPX razlika povprečnih vrednosti
English: (MATE1 inhibition)
Slovenian: (zaviranje prenašalca MATE1)
English: REZOLSTA can be co-administered with H2-receptor antagonists without dose adjustments.
Slovenian: Zdravilo REZOLSTA je mogoče uporabljati sočasno z antagonisti histaminskih receptorjev H2 brez prilagajanja odmerkov.
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.
Slovenian: V preskušanju večkratnih odmerkov darunavirja/ritonavirja (600/100 mg dvakrat na dan) se je pokazalo, da so bile celokupne plazemske koncentracije darunavirja pri posameznikih z blago (razred A po Child-Pughovi lestvici, n = 8) in srednje hudo (razred B po Child-Pughovi lestvici, n = 8) jetrno okvaro primerljive s tistimi pri zdravih posameznikih.
English: Increased monitoring for rifabutin associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Slovenian: Bolnika je treba spremljati glede pojava neželenih učinkov rifabutina, med drugim nevtropenije in uveitisa, ker je mogoče pričakovati zvečano izpostavljenost rifabutinu.
English: HIV-1 infected patients who were eligible for this trial had a plasma HIV-1 RNA ≥ 1,000 copies/mL.
Slovenian: Z virusom HIV-1 okuženi bolniki, ki so bili primerni za to študijo, so imeli koncentracijo HIV-1 RNA v plazmi ≥ 1000 kopij/ml.
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with REZOLSTA.
Slovenian: Priporočeni odmerek emtricitabina/tenofoviralafenami da v kombinaciji z zdravilom REZOLSTA je 200 mg/10 mg enkrat na dan.
English: HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Slovenian: Ne-nukleozidni oziroma ne-nukleotidni zaviralci reverzne transkriptaze virusa HIV (NNRTI) efavirenz
English: * 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.
Slovenian: * V kliničnih preskušanjih darunavirja/kobicistata o teh neželenih učinkih niso poročali, vendar so jih opazili pri zdravljenju s kombinacijo darunavir/ritonavir in so pričakovani tudi pri uporabi kombinacije darunavir/kobicistat.
English: People taking REZOLSTA may develop a skin rash.
Slovenian: Pri ljudeh, ki jemljejo zdravilo REZOLSTA se lahko pojavi izpuščaj na koži.
English: Combinations with optimised background regimens (OBRs) other than ≥ 2 NRTIs have not been studied in this population.
Slovenian: Pri tej populaciji so preučevali samo kombinacije z optimiziranimi osnovnimi režimi (OBRoptimized background regimens) z ≥ 2 NRTI.
English: It is given with cobicistat, which increases the amount of darunavir in your blood.
Slovenian: Uporablja se skupaj s kobicistatom, ki zveča koncentracijo darunavirja v krvi.
English: Some side effects are typical for HIV medicines in the same family as REZOLSTA.
Slovenian: Nekateri neželeni učinki so značilni za skupino zdravil proti okužbi s HIV, v katero sodi tudi zdravilo REZOLSTA.
English: When REZOLSTA is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Slovenian: Pri sočasni uporabi zdravila REZOLSTA z zdravili, ki vsebujejo drospirenon je priporočljivo klinično spremljanje bolnika zaradi možne hiperkaliemije.
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).
Slovenian: Povejte zdravniku, če jemljete: - alfentanil (močno, kratkodelujoče zdravilo za injiciranje, ki se uporablja pri kirurških posegih) - digoksin (za določene srčne bolezni) - klaritromicin (antibiotik) - klotrimazol, flukonazol, itrakonazol, izavukonazol, posakonazol (proti glivičnim okužbam);
English: Co-administration with the following medicinal products due to the potential for loss of therapeutic effect (see section 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St John's wort, (Hypericum perforatum).
Slovenian: Sočasna uporaba z naslednjimi zdravili zaradi možnosti zmanjšanja terapevtskega učinka (glejte poglavje 4.5): - karbamazepin, fenobarbital, fenitoin - rifampicin - lopinavir/ritonavir - šentjanževka (Hypericum perforatum)
English: Darunavir and cobicistat are metabolised by CYP3A.
Slovenian: Darunavir in kobicistat se presnavljata z encimom CYP3A.
English: The overall safety profile of REZOLSTA is based on available clinical trial data from darunavir boosted with either cobicistat or ritonavir, from cobicistat and from post-marketing data from darunavir/ritonavir.
Slovenian: Celoten profil varnostnih lastnosti zdravila REZOLSTA temelji na razpoložljivih podatkih iz kliničnih študij z uporabo darunavirja, okrepljenega bodisi s kobicistatom ali z ritonavirjem, oziroma z uporabo kobicistata in iz podatkov o uporabi darunavirja/ritonavirja po prihodu zdravil na trg.
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone,
Slovenian: - kortikosteroide, vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom.
English: In these pharmacokinetic trials, the exposure of darunavir 800 mg boosted with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. Darunavir as a component of REZOLSTA is bioequivalent to darunavir 800 mg once daily in combination with cobicistat 150 mg once daily co-administered as single medicinal products (see section 5.2).
Slovenian: V teh farmakokinetičnih študijah se je s kobicistatom 150 mg okrepljena izpostavljenost darunavirju 800 mg ujemala z izpostavljenostjo, ki so jo opažali po ojačanju z ritonavirjem 100 mg. Darunavir je kot sestavina zdravila REZOLSTA biološko enakovreden darunavirju 800 mg enkrat na dan v kombinaciji s kobicistatom 150 mg enkrat na dan pri sočasnem odmerjanju vsakega zdravila posebej (glejte poglavje 5.2).
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).
Slovenian: Zato se zdravila REZOLSTA pri bolnikih s hudo okvaro jeter (razred C po Child-Pughovi lestvici) ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
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 pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri bolnikih, okuženih s HIV, s hudo imunsko pomanjkljivostjo ob uvedbi kombinirane protiretrovirusne terapije (CART - Combination Antiretroviral Therapy) se lahko pojavi vnetna reakcija na asimptomatske ali prikrite oportunistične okužbe in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Slovenian: Kobicistat se presnavlja z oksidacijo s CYP3A (kar je glavna pot) in s CYP2D6 (kar je manj pomembna pot), ni pa podvržen glukuronidaciji.
English: Atorvastatin (10 mg once daily): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Slovenian: ZAVIRALCI REDUKTAZE HMG-COA atorvastatin fluvastatin pitavastatin pravastatin rosuvastatin atorvastatin (10 mg enkrat na dan): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
English: 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).
Slovenian: Vpliv kobicistata na koncentracijo kreatinina v serumu so proučevali v študiji faze I pri osebah z normalno ledvično funkcijo (z ocenjeno hitrostjo glomerulne filtracije (eGFR) ≥ 80 ml/min, n = 12) in pri bolnikih z blago do zmerno okvaro ledvic (eGFR:50-79 ml/min, n = 18).
English: During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Slovenian: V kliničnem preskušanju darunavirja/ritonavirja (n = 3.063) so se pri 0,4% bolnikov pojavile hude kožne reakcije, ki jih je lahko spremljala zvišana telesna temperatura in/ali povišane koncentracije transaminaz.
English: Dose adjustment for buprenorphine may not be necessary when co-administered with REZOLSTA but a careful clinical monitoring for signs of opiate toxicity is recommended.
Slovenian: Pri sočasni uporabi zdravila REZOLSTA prilagajanje odmerkov buprenorfina ni vedno potrebno, priporočljivo pa je skrbno klinično spremljanje bolnika glede znakov toksičnega delovanja opiatov.
English: Refer to the table above for information on ARTEMIS and ODIN.
Slovenian: Za podatke iz študij ARTEMIS in ODIN glejte zgornjo preglednico.
English: Your doctor will explain these to you - allergic reactions such as nettle rash (urticaria), severe swelling of the skin and other tissues
Slovenian: - alergijske reakcije, kot so koprivnica (urtikarija), huda oteklost kože in drugih tkiv
English: Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
Slovenian: Resni neželeni učinki so bili sladkorna bolezen, preobčutljivost (na zdravilo), vnetni sindrom imunske obnove, izpuščaj, Stevens-Johnsononov sindrom in bruhanje.
English: Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila REZOLSTA z amjodaronom, bepridilom, dronedaronom, ivabradinom, kinidinom ali ranolazinom je kontraindicirana (glejte poglavje 4.3).
English: Since darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substances.
Slovenian: Ker sta darunavir in kobicistat v velikem odstotku vezana na beljakovine, je malo verjetno, da bi lahko s hemodializo odstranili pomembno količino obeh učinkovin.
English: Concomitant use of salmeterol and REZOLSTA is not recommended.
Slovenian: Sočasna uporaba salmeterola in zdravila REZOLSTA ni priporočljiva.
English: In the darunavir/cobicistat fixed-dose combination treament arm, 363 HIV-1 infected, adult, treatment-naïve patients were treated.
Slovenian: V študijski skupini s fiksno kombinacijo darunavir/kobicistat so zdravili 363 odraslih, ki so bili okuženi z virusom HIV-1 in predhodno še niso bili zdravljeni.
English: Pack size of one bottle.
Slovenian: Velikosti pakiranja: ena plastenka.
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Slovenian: Najpogostejši resni neželeni učinki so akutna ledvična odpoved, miokardni infarkt, vnetni sindrom imunske obnove, trombocitopenija, osteonekroza, diareja, hepatitis in zvišana telesna temperatura.
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.
Slovenian: V študijski skupini z zdravilom REZOLSTA v študiji faze III z oznako TMC114FD2HTX3001 je bila povprečna sprememba vrednosti eGFRCG od izhodišča po 48 tednih -11,1 ml/min in povprečna sprememba vrednosti eGFRcystatin C od izhodišča po 48 tednih +2,9 ml/min/1,73 m².
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Slovenian: Zaviranje presnove preko CYP3A s kobicistatom zveča sistemsko izpostavljenost substratom CYP3A, kot je darunavir, ki ima sicer zaradi presnove, odvisne od CYP3A, omejeno biološko uporabnost in krajši razpolovni čas.
English: The table below shows the 48-week efficacy data of the darunavir/cobicistat arm of the TMC114FD2HTX3001 trial:
Slovenian: V spodnji preglednici so prikazani rezultati analize učinkovitosti po 48 tednih zdravljenja v študijski skupini s kombinacijo darunavir/kobicistat v študiji TMC114FD2HTX3001:
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Slovenian: Ni pričakovati, da bi kobicistat zaviral CYP1A2, CYP2B6, CYP2C8, CYP2C9 ali CYP2C19.
English: Co-administration of REZOLSTA with rifabutin and rifapentine is not recommended.
Slovenian: Sočasna uporaba zdravila REZOLSTA z rifabutinom oziroma rifapentinom ni priporočljiva.
English: In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used.
Slovenian: Pri vseh ostalih bolnikih, ki so že jemali protiretrovirusna zdravila, in bolnikih, pri katerih izvid genotipskega testiranja HIV-1 ni na voljo, uporaba zdravila REZOLSTA ni primerna.
English: Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Slovenian: Ozdravljenju bolnikov z drugimi podtipi virusa HIV-1 (razen podtipa B) je malo podatkov (glejte poglavje 5.1).
English: HIV-1 RNA < 50 copies/mL All patients
Slovenian: HIV-1 RNK < 50 kopij/ml vsi bolniki z začetno
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Slovenian: V nasprotju z ritonavirjem kobicistat ni induktor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in UGT1A1.
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.
Slovenian: Združeni podatki iz študije z eno samo skupino preiskovancev, v kateri so preskušali darunavir 800 mg enkrat na dan v kombinaciji s kobicistatom 150 mg enkrat na dan in druga protiretrovirusna zdravila, ter podatki ene študijske skupine v študiji, v kateri so bolnikom odmerjali zdravilo REZOLSTA v odmerku 800/150 mg enkrat na dan in druga protiretrovirusna zdravila, kažejo, da je 1,9% bolnikov prekinilo zdravljenje zaradi izpuščaja.
English: REZOLSTA cannot work properly without food.
Slovenian: Zdravilo REZOLSTA brez hrane ne učinkuje, kot bi moralo.
English: The most frequent adverse reactions reported during the darunavir/ritonavir clinical development program and as spontaneous reports are diarrhoea, nausea, rash, headache, and vomiting.
Slovenian: V okviru programa kliničnih študij z darunavirjem/ritonavirjem in spontanih poročilih so najpogosteje poročali o diareji, navzei, izpuščaju, glavobolu in bruhanju.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot je Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv in se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.8).