FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on theoretical considerations co-administration of REZOLSTA with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Slovenian: Glede na teoretična izhodišča sočasna uporaba zdravila REZOLSTA z dabigatranom ali tikagrelorjem lahko zveča njihove koncentracije, kar lahko poveča tveganje za krvavitve.
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).
Slovenian: Varnost in učinkovitost zdravila REZOLSTA pri pediatričnih bolnikih, starih od 3 do 17 let, nista bili dokazani (glejte poglavji 4.4 in 5.3).
English: Each tablet contains 800 mg of darunavir (as ethanolate) and 150 mg cobicistat.
Slovenian: Ena tableta vsebuje 800 mg darunavirja (v obliki etanolata) in 150 mg kobicistata.
English: REZOLSTA contains the active substances darunavir and cobicistat.
Slovenian: Zdravilo REZOLSTA vsebuje učinkovini darunavir in kobicistat.
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate) and 150 mg cobicistat.
Slovenian: Ena filmsko obložena tableta vsebuje 800 mg darunavirja (v obliki etanolata) in 150 mg kobicistata.
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).
Slovenian: vorikonazol se lahko uporablja samo po zdravnikovi presoji - rifabutin (proti bakterijskim okužbam) - tadalafil, sildenafil, vardenafil (za erektilno disfunkcijo ali zvišan krvni tlak v pljučnem krvnem obtoku) - amitriptilin, dezipramin, imipramin, nortriptilin, paroksetin, sertralin, trazodon (za zdravljenje depresije in tesnobe) - maravirok (za zdravljenje okužbe s HIV) - kolhicin (za zdravljenje protina in družinske mediteranske mrzlice).
English: What REZOLSTA contains - The active substances are darunavir and cobicistat.
Slovenian: Kaj vsebuje zdravilo REZOLSTA - Učinkovini sta darunavir in kobicistat.
English: 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.
Slovenian: CYP3A, lahko zveča sistemsko izpostavljenost tem zdravilom, to pa lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke.
English: ANTIMYCOBACTERIALS Rifampicin
Slovenian: UČINKOVINE Z DELOVANJEM PROTI MIKOBAKTERIJAM rifampicin
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).
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - simptomi okužbe ali avtoimunskih motenj (vnetni sindrom imunske obnove) - osteonekroza (odmiranje kostnega tkiva zaradi motene prekrvavitve kosti) - zvečanje dojk - nenormalni izvidi krvnih preiskav, kot so testi delovanja trebušne slinavke, zvišana koncentracija sladkorja, nenormalne koncentracije ‘lipidov' (maščob).
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with REZOLSTA has not been established.
Slovenian: Pri sočasni uporabi z zdravilom REZOLSTA še niso določili varnega in učinkovitega odmerka sildenafila za zdravljenje pljučne arterijske hipertenzije.
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.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - alergijske reakcije, kot je srbenje - zmanjšan apetit - nenormalne sanje - bruhanje, bolečina ali napetost v trebuhu, prebavne motnje (dispepsija), nabiranje plinov v črevesju - bolečina v mišicah - utrujenost - nenormalne izvidi krvnih preiskav, kot so testi delovanja jeter ali ledvic.
English: lopinavir/ ritonavir 800/200 mg per day N = 346
Slovenian: lopinavir/ ritonavir 800/200 mg na dan n = 346
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282
Slovenian: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
English: Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART, and in ART-experienced patients with no darunavir RAMs receiving REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART.
Slovenian: Nizko stopnjo pojavljanja odpornih virusov HIV-1 so opažali pri bolnikih, ki predhodno niso prejemali protiretrovirusnih zdravil in so prvič prejemali zdravilo REZOLSTA oziroma darunavir/ritonavir 800/100 mg enkrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili, in pri bolnikih, ki so že prej prejemali protiretrovirusna zdravila in še niso izkazovali mutacij za odpornost na darunavir ter so prejemali zdravilo REZOLSTA oziroma darunavir/ritonavir 800/100 mg enkrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila REZOLSTA in kombinacije zdravil elbasvir/grazoprevir je kontraindicirana (glejte poglavje 4.3).
English: Your doctor will explain these to you - weakness.
Slovenian: Te spremembe vam bo pojasnil zdravnik.
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).
Slovenian: Zdravila REZOLSTA se ne sme uvesti bolnikom z očistkom kreatinina pod 70 ml/min, kadar se sočasno uporablja z učinkovinami (na primer emtricitabin, lamivudin, dizoproksiltenofovirat (v obliki fumarata, fosfata ali sukcinata) ali adefovirdipivoksilat), pri katerih je potrebno prilagajanje odmerkov na osnovi očistka kreatinina (glejte poglavja 4.2, 4.8 in 5.2).
English: Concomitant use of everolimus and REZOLSTA is not recommended.
Slovenian: Sočasna uporaba everolimusa in zdravila REZOLSTA ni priporočljiva.
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.
Slovenian: Z virusom HIV-1 okuženi bolniki, ki so bili primerni za to študijo, so imeli v izbirnem (screening) postopku genotip brez mutacij, ki bi bile povezane z odpornostjo na darunavir, in koncentracijo HIV-1 RNA v plazmi ≥ 1000 kopij/ml.
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.
Slovenian: Dokaz učinkovitosti zdravila REZOLSTA enkrat na dan temelji na analizi podatkov po 48 tednih zdravljenja v študiji GS-US-216-130 pri bolnikih brez predhodnega protiretrovirusnega zdravljenja in pri bolnikih s predhodnim protiretrovirusnim zdravljenjem, podatkov iz študije TMC114FD2HTX3001 pri bolnikih brez predhodnega protiretrovirusnega zdravljenja ter podatkov dveh študij faze III ARTEMIS in ODIN, v katerih so bolniki brez predhodnega protiretrovirusnega zdravljenja oziroma bolniki s predhodnim protiretrovirusnim zdravljenjem prejemali darunavir/ritonavir 800/100 mg enkrat na dan.
English: Based on theoretical considerations REZOLSTA may increase the exposure to glecaprevir and pibrentasvir.
Slovenian: Glede na teoretična izhodišča je mogoče pričakovati, da lahko zdravilo PREZISTA zveča izpostavljenost glekaprevirju in pibrentasvirju.
English: Clinical monitoring is recommended when co-administering REZOLSTA with beta-blockers and a lower dose of the beta-blocker should be considered.
Slovenian: Pri sočasni uporabi zdravila REZOLSTA z antagonisti adrenergičnih receptorjev beta je priporočljivo klinično spremljanje bolnika, treba pa je razmisliti tudi o znižanju odmerka antagonista adrenergičnih receptorjev beta.
English: (inhibition of CYP3A)
Slovenian: (indukcija CYP3A)
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Slovenian: Vpliva hude okvare jeter na farmakokinetiko kobicistata niso preučevali.
English: Darunavir and cobicistat are metabolised by the hepatic system.
Slovenian: Darunavir in kobicistat se presnavljata z encimskim sistemom v jetrih.
English: REZOLSTA and raltegravir can be used without dose adjustments.
Slovenian: REZOLSTA in raltegravir je mogoče uporabljati brez prilagajanja odmerkov.
English: Caution should be used with co-administration of REZOLSTA and parenteral midazolam.
Slovenian: Pri sočasni uporabi zdravila REZOLSTA in parenteralne oblike midazolama je potrebna previdnost.
English: Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Slovenian: Kobicistat Pri farmakokinetičnih lastnostih kobicistata niso ugotovili klinično pomembnih razlik med spoloma.
English: Based on theoretical considerations, REZOLSTA is expected to increase the exposure of lomitapide when coadministered.
Slovenian: Glede na teoretična izhodišča, je mogoče pričakovati, da zdravilo REZOLSTA, kadar je sočasno uporabljeno z lomitapidom zviša izpostavljenost lomitapidu.
English: (CYP3A, CYP2D6 and/or P-gp inhibition)
Slovenian: (zaviranje CYP3A, CYP2D6 in/ali P-gp))
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).
Slovenian: Učinkovitost darunavirja 800 mg enkrat na dan s sočasnim odmerjanjem 100 mg ritonavirja enkrat na dan pri bolnikih, ki predhodno še niso prejemali protiretrovirusnih zdravil Dokazi o učinkovitosti darunavirja/ritonavirja 800/100 mg enkrat na dan temeljijo na analizi podatkov po 192 tednih zdravljenja v randomiziranem, nadzorovanem, odprtem kliničnem preskušanju faze III (ARTEMIS), pri bolnikih okuženih s HIV-1, ki še niso prejemali protiretrovirusnega zdravljenja, v katerem so primerjali darunavir/ritonavir 800/100 mg enkrat na dan in lopinavir/ritonavir 800/200 mg na dan (ki so ga dajali z režimom dvakrat na dan ali enkrat na dan).
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking REZOLSTA.
Slovenian: Pri bolnikih, ki jemljejo zdravilo REZOLSTA, je priporočljivo skrbno spremljanje bolnika in prilagajanje odmerka metformina.
English: No special precautions or dose adjustments are required in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic posebna opozorila ali prilagoditve odmerka niso potrebni.
English: darunvir/ritonavir 600/100 mg twice daily + OBR N = 296
Slovenian: darunvir/ritonavir 600/100 mg dvakrat na dan + OBR n = 296
English: REZOLSTA should not be used in paediatric patients below 3 years of age (see sections 4.2 and 5.3).
Slovenian: Pri pediatričnih bolnikih, ki so mlajši od 3 let, se zdravila REZOLSTA ne sme uporabljati (glejte poglavji 4.2 in 5.3).
English: Co-administration of REZOLSTA and bosentan is not recommended.
Slovenian: Sočasna uporaba zdravila REZOLSTA in bosentana ni priporočljiva.
English: Darunavir given with low dose ritonavir may be considered as an alternative.
Slovenian: Kot alternativno zdravljenje se lahko uporabi darunavir, skupaj z majhnim odmerkom ritonavirja.
English: REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
Slovenian: Zdravilo REZOLSTA je mogoče uporabljati sočasno z zaviralci protonske črpalke brez prilagajanja odmerkov.
English: (CYP3A inhibition, UGT/SULT induction)
Slovenian: (zaviranje CYP3A, indukcija UDP-glukuronoziltransferaze (UGT)/sulfotransferaze (SULT))
English: HIV-1 RNA < 50 copies/mL With Baseline
Slovenian: HIV-1 RNA < 50 kopij/ml Z začetno konc.
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Slovenian: Znaki in simptomi hudih kožnih reakcij lahko med drugimi vključujejo hud izpuščaj ali izpuščaj in zvišanje telesne temperature, slabo počutje, utrujenost, bolečine v mišicah ali sklepih, mehurjaste izpuščaje, razjede v ustih, konjunktivitis, hepatitis in/ali eozinofilijo.
English: Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Slovenian: Glede na teoretična izhodišča je mogoče pričakovati, da zdravilo REZOLSTA zveča izpostavljenost grazoprevirju.
English: Co-administration of domperidone with REZOLSTA is contraindicated.
Slovenian: Sočasna uporaba domperidona in zdravila REZOLSTA je kontraindicirana
English: Cobicistat is not expected to induce CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, or P-gp (MDR1).
Slovenian: Prav tako ni pričakovati, da bi kobicistat induciral CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1 ali P-gp (protein, povezan z odpornostjo na več zdravil, z angleško oznako MDR1).
English: Imputations according to the Snapshot algorithm.
Slovenian: Pripisane vrednosti, izračunane z uporabo algoritma TLOVR.
English: Interactions with medicinal products
Slovenian: Preglednica medsebojnega delovanja z drugimi zdravili
English: Co-administration of REZOLSTA and etravirine is not recommended.
Slovenian: Sočasna uporaba zdravila REZOLSTA in etravirina ni priporočljiva.
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.
Slovenian: Pri ženskah, ki so prejemale zdravilo REZOLSTA v tretjem trimesečju nosečnosti pa so bile celokupne vrednosti darunavirja Cmax, AUC24h in Cmin nižje za 37%, 50% oziroma 89% kot v obdobju po porodu.
English: Side effects with unknown frequency: a rash may become severe or potentially life-threatening: - rash with blisters and peeling skin over much of the body - red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever.
Slovenian: Neželeni učinki z neznano pogostnostjo: izpuščaj, ki lahko hud ali življenjsko nevaren - izpuščaj z mehurčki in luščenjem kože po večjem delu telesa
English: In the table below it is specified when recommendations for REZOLSTA differ from those for darunavir boosted with low dose ritonavir.
Slovenian: Če se priporočila za zdravilo REZOLSTA razlikujejo od priporočil za uporabo darunavirja, okrepljenega z majhnim odmerkom ritonavirja, je to navedeno v spodnji preglednici.
English: Refer to the Summary of Product Characteristics for PREZISTA for further information.
Slovenian: Za dodatne informacije glejte Povzetek glavnih značilnosti zdravila za zdravilo PREZISTA.
English: Metabolism and nutrition disorders Common anorexia, hypercholesterolaemia, hypertriglyceridaemia
Slovenian: Presnovne in prehranske motnje pogost anoreksija, hiperholesterolemija, hipertrigliceridemija občasni sladkorna bolezen, dislipidemija, hiperglikemija, hiperlipidemija
English: The combination of avanafil and REZOLSTA is contraindicated (see section 4.3).
Slovenian: Kombinacija avanafila in zdravila REZOLSTA je kontraindicirana (glejte poglavje 4.3).
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).
Slovenian: Zato se zdravljenja z zdravilom REZOLSTA ne sme uvesti med nosečnostjo, pri ženskah, ki med zdravljenjem z zdravilom REZOLSTA zanosijo, pa je treba razmisliti o prehodu na drug režim zdravljenja (glejte poglavji 4.2 in 4.6).
English: Darunavir exposure was shown to be comparable in a bioavailability trial between REZOLSTA and darunavir/ritonavir 800/100 mg q.d.
Slovenian: Primerljivost izpostavljenosti darunavirju so dokazali v študiji biološke uporabnosti, v kateri so primerjali zdravilo REZOLSTA in darunavir/ritonavir 800/100 mg enkrat na dan pri zdravih osebah v stanju dinamičnega ravnovesja in v stanju sitosti.
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).
Slovenian: Zato se zdravljenja z zdravilom REZOLSTA ne sme uvesti med nosečnostjo, pri ženskah, ki med zdravljenjem z zdravilom REZOLSTA zanosijo, je treba preiti na drug režim zdravljenja (glejte poglavji 4.4 in 4.6).
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).
Slovenian: Pri sočasni uporabi zdravil, ki inducirajo aktivnost encima CYP3A, (na primer efavirenz, karbamazepin, fenitoin, fenobarbital, rifampicin, rifapentin, rifabutin in šentjanževka) je mogoče pričakovati zvečan očistek darunavirja in kobicistata, kar zniža njuni koncentraciji v plazmi (glejte poglavje 4.3 in spodnjo preglednico interakcij).
English: Colloidal silicon dioxide Silicified microcrystalline cellulose Crospovidone
Slovenian: Jedro tablete hipromeloza koloidni silicijev dioksid silicizirana mikrokristalna celuloza krospovidon magnezijev stearat
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.
Slovenian: Če bolniki, ki imajo normalno ledvično in jetrno funkcijo, potrebujejo zdravilo REZOLSTA, je priporočljivo znižanje odmerka kolhicina ali prekinitev zdravljenja z njim.
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Slovenian: Pri uporabi darunavirja/ritonavirja so poročali o z zdravilom povezanim hepatitisom (akutni hepatitis, citolitični hepatitis).
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
Slovenian: Bolniki, ki so že jemali protiretrovirusna zdravila Bolniki, ki so se že zdravili s protiretrovirusnimi zdravili in nimajo z rezistenco na darunavir povezanih mutacij (DRV-RAM - Resistance-Associated Mutations)*, in imajo < 100.000 kopij/ml HIV-1 RNK v plazmi ter število celic CD4+ ≥ 100 celic x 10
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.
Slovenian: Po podatkih ločenih študij z darunavirjem/ritonavirjem oziroma s kobicistatom odmerka zdravila REZOLSTA pri bolnikih z blago (razred A po Child-Pughovi lestvici) oziroma zmerno okvaro jeter (razred B po Child-Pughovi lestvici) ni treba prilagajati.
English: REZOLSTA and antacids can be used concomitantly without dose adjustment.
Slovenian: Zdravilo REZOLSTA in antacide je mogoče uporabljati sočasno brez prilagajanja odmerkov.
English: Based on theoretical considerations REZOLSTA may increase plasma concentrations of these analgesics.
Slovenian: Glede na teoretična izhodišča lahko zdravilo REZOLSTA zvišuje plazemske koncentracije navedenih analgetikov.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with REZOLSTA.
Slovenian: Pri sočasni uporabi varfarina in zdravila REZOLSTA je priporočljivo spremljanje internacionalnega normaliziranega razmerja (INR).
English: Uncommon immune reconstitution inflammatory syndrome
Slovenian: občasni vnetni sindrom imunske obnove
English: The safety and efficacy of REZOLSTA, darunavir, or cobicistat have not been established in patients with severe underlying liver disorders.
Slovenian: Pri bolnikih s sočasno hudo okvaro jeter niso dokazali varnosti in učinkovitosti zdravila REZOLSTA, darunavirja in kobicistata, zato je zdravilo REZOLSTA pri bolnikih s hudo okvaro jeter kontraindicirano.
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.
Slovenian: Zlasti pri dolgotrajni uporabi je treba premisliti o uporabi drugih kortikosteroidov, ki so manj odvisni od presnove s pomočjo encimov CYP3a, npr. beklometazona za intranazalno uporabo ali inhaliranje.
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.
Slovenian: Pri bolnikih s hemofilijo tipa A in B, zdravljenih z zaviralci proteaz virusa HIV, so poročali o zvečanih krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozo.
English: (CYP3A inhibition and/or transport)
Slovenian: (zaviranje CYP3A in/ali transporta učinkovin)
English: Co-administration of REZOLSTA with dapoxetine is contraindicated.
Slovenian: Sočasna uporaba zdravila REZOLSTA in dapoksetina je kontraindicirana.
English: The combination of rifampicin and REZOLSTA is contraindicated (see section 4.3).
Slovenian: Uporaba kombinacije rifampicina in zdravila REZOLSTA je kontraindicirana (glejte poglavje 4.3).
English: Co-administration of REZOLSTA and nevirapine is not recommended.
Slovenian: Sočasna uporaba zdravila REZOLSTA in nevirapina ni priporočljiva.
English: The antiretroviral effect of REZOLSTA is due to the darunavir component.
Slovenian: Sestavina, ki je v zdravilu REZOLSTA odgovorna za protiretrovirusno delovanje, je darunavir.
English: Polyvinyl alcohol- partially hydrolysed Macrogol 3350
Slovenian: Filmska obloga tablete polivinilalkohol - delno hidroliziran makrogol 3350 titanov dioksid smukec rdeči železov oksid črni železov oksid
English: Renal impairment REZOLSTA has not been investigated in patients with renal impairment.
Slovenian: Okvara ledvic Uporabe zdravila REZOLSTA niso proučevali pri bolnikih z okvaro ledvic.
English: Refer to the Summary of Product Characteristics of other antiretroviral medicinal products for dosing information.
Slovenian: Za podatke o odmerjanju drugih protiretrovirusnih zdravil glejte Povzetek glavnih značilnosti zdravila posameznega zdravila.
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + emtricitabine/tenofovir disoproxil fumarate N = 363
Slovenian: Izidi po 48 tednih predhodno nezdravljeni darunavir/kobicistat 800/150 mg enkrat na dan + emtricitabin/dizoproksiltenofovirijev fumarat N = 363
English: REZOLSTA should be used with caution in patients with a known sulphonamide allergy.
Slovenian: Pri bolnikih z znano preobčutljivostjo na sulfonamide je pri uporabi zdravila REZOLSTA potrebna previdnost.