FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving REZOLSTA.
Slovenian: Zaradi možnosti za prenos okužbe s HIV in možnosti za neželene učinke pri dojenčkih, je treba materam naročiti, naj v nobenem primeru ne dojijo, če jemljejo zdravilo REZOLSTA.
English: Ethinylestradiol (0.02 mg once daily)
Slovenian: etinilestradiol (0,02 mg enkrat na dan)
English: - Take your other HIV medicines used in combination with REZOLSTA as recommended by your doctor.
Slovenian: - Druga zdravila proti virusu HIV, ki jih uporabljate sočasno z zdravilom REZOLSTA, jemljite tako, kot vam je naročil zdravnik.
English: It is not known whether darunavir or cobicistat are excreted in human milk.
Slovenian: Ni znano, ali se darunavir oziroma kobicistat izločata v materino mleko.
English: *study was done with tenofovir disoproxil fumarate
Slovenian: *študijo so izvedli z dizoproksiltenofovirat fumaratom
English: (most often the lips or the eyes) - severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
Slovenian: (najpogosteje ustnic ali oči) - hud izpuščaj z mehurji in luščenjem kože, zlasti okrog ust, nosu, oči in spolovil
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately so you can be given the necessary treatment.
Slovenian: Če opazite kakršnekoli simptome okužbe ali druge simptome, na primer mišično oslabelost, oslabelost, ki se najprej pojavi v dlaneh in stopalih in nato širi proti trupu, palpitacije, tremor ali hiperaktivnost, nemudoma obvestite zdravnika, da boste prejeli potrebno zdravljenje.
English: The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject.
Slovenian: Odmerek digoksina je treba pazljivo titrirati do želenega kliničnega učinka in pri tem spremljati celoten klinični status bolnika.
English: REZOLSTA is used to treat adults 18 years or older who are infected by HIV (see How to take REZOLSTA).
Slovenian: Zdravilo REZOLSTA uporabljamo za zdravljenje odraslih, ki so stari 18 let ali več in so okuženi z virusom HIV (glejte poglavje Kako jemati zdravilo REZOLSTA).
English: Postpartum (6-12 weeks) N=6
Slovenian: Obdobje po porodu (6-12 tednov) (n=6)
English: Treatment with REZOLSTA during pregnancy results in low darunavir exposure.
Slovenian: Zdravljenje z zdravilom REZOLSTA med nosečnostjo povzroča zmanjšanje izpostavljenost darunavirju.
English: Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side.
Slovenian: Rožnata ovalna tableta velikosti 23 mm x 11,5 mm, z vtisnjeno oznako “800” na eni in “TG” na drugi strani.
English: Do not use this medicine after 6 weeks of first opening the bottle.
Slovenian: Zdravila ne uporabljajte več kot 6 tednov po prvem odprtju plastenke.
English: Second trimester of pregnancy N=7
Slovenian: Drugo trimesečje nosečnosti (n=7)
English: If you have renal and/or hepatic impairment see section ‘Do not combine REZOLSTA with any of the following medicines'.
Slovenian: Če imate bolezen ledvic ali jeter, glejte poglavje "Zdravila REZOLSTA ne smete kombinirati z nobenim od naslednjih zdravil".
English: Norethindrone drospirenone AUC ↑ 58% drospirenone Cmax ↑ 15% drospirenone Cmin ND
Slovenian: noretisteron drospirenon AUC ↑ 58% drospirenon Cmax ↑ 15% drospirenon Cmin ND
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking REZOLSTA.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte strojev in ne vozite avtomobila, če ste po jemanju zdravila REZOLSTA omotični.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with REZOLSTA and patients should be monitored during treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom REZOLSTA je treba opraviti ustrezne laboratorijske teste in spremljati bolnika med zdravljenjem.
English: For the treatment of pulmonary arterial hypertension Sildenafil Tadalafil
Slovenian: za zdravljenje pljučne arterijske hipertenzije sildenafil tadalafil
English: - Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
Slovenian: - Nemudoma povejte zdravniku, če opazite kakršnekoli simptome okužbe (npr. zvečane bezgavke ali zvišano telesno temperaturo).
English: Investigations Common increased blood creatinine
Slovenian: Preiskave pogosti zvišana vrednost kreatinina v krvi
English: Clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.
Slovenian: Priporočljivo je klinično spremljanje, saj je pri nekaterih bolnikih treba prilagoditi vzdrževalni odmerek.
English: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas
Slovenian: INTERAKCIJE Z DRUGIMI ZDRAVILI IN PRIPOROČILA ZA ODMERJANJE Zdravila po terapevtskih področjih
English: 30 tablets in a plastic bottle.
Slovenian: V plastenki je 30 tablet.
English: The clinical relevance of this increase is unknown, therefore, darunavir/ritonavir should be used with caution.
Slovenian: Klinični pomen tega povišanja ni znan, zato je potrebna previdnost pri uporabi darunavirja/ritonavirja.
English: Darunavir Results from a mass balance study with
Slovenian: Darunavir Izsledki preskušanja masnega ravnovesja z uporabo s
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Slovenian: Študije pri kuncih ex vivo in pri psih in vivo kažejo, da ima kobicistat majhen potencial za podaljšanje intervala QT in da lahko nekoliko podaljša interval PR ter zmanjša delovanje levega prekata pri povprečnih koncentracijah, ki so najmanj 10-krat višje od izpostavljenosti pri človeku pri uporabi priporočenega dnevnega odmerka 150 mg.
English: The type of food does not affect exposure to REZOLSTA.
Slovenian: Vrsta hrane ne vpliva na izpostavljenost zdravilu REZOLSTA.
English: When didanosine is co-administered with REZOLSTA, didanosine should be administered on an empty stomach 1 hour before or 2 hours after REZOLSTA (which is administered with food).
Slovenian: Pri sočasni uporabi z zdravilom REZOLSTA je treba didanozin jemati na prazen želodec 1 uro pred odmerjanjem zdravila REZOLSTA ali 2 uri po njem (pri čemer je treba zdravilo REZOLSTA jemati s hrano).
English: REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older.
Slovenian: Zdravilo REZOLSTA je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih (starih 18 let ali več), okuženih z virusom humane imunske pomanjkljivosti-1 (HIV-1).
English: Co-administration of REZOLSTA and rilpivirine can be used without dose adjustments, as the expected increase in rilpivirine concentrations is not considered clinically relevant.
Slovenian: Zdravilo REZOLSTA in rilpivirin je mogoče uporabljati brez prilagajanja odmerkov, saj pričakovano zvišanje koncentracije rilpivirina ne velja za klinično pomembno.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Slovenian: ZAVIRALCI FOSFODIESTRAZE TIPA 5 (PDE-5) za zdravljenje erektilne disfunkcije sildenafil tadalafil vardenafil
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Vse simptome vnetja je treba ovrednotiti in če je treba, uvesti primerno zdravljenje.
English: ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Slovenian: Bolniki, ki še niso jemali protiretrovirusnih zdravil Priporočeni režim odmerjanja je ena filmsko obložena tableta zdravila REZOLSTA enkrat na dan skupaj s hrano.
English: If concomitant use of REZOLSTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Slovenian: Če je indicirana sočasna uporaba zdravila REZOLSTA s sildenafilom, vardenafilom ali tadalafilom, je priporočljivo naslednje odmerjanje: sildenafil v enkratnem odmerku, ki ne presega 25 mg v 48 urah, vardenafil v enkratnem odmerku, ki ne presega 2,5 mg v 72 urah, in tadalafil v enkratnem odmerku, ki ne presega 10 mg v 72 urah.
English: Infrequently a rash may become severe or potentially life-threatening.
Slovenian: Redko lahko izpuščaj postane hud ali življenju nevaren.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na plastičnem vsebniku poleg oznake Uporabno do/EXP.
English: ANTIMALARIALS Artemether/Lumefantrine
Slovenian: ANTIMALARIKI artemeter/ lumefantrin
English: Do not combine REZOLSTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Slovenian: Zdravila REZOLSTA ne smete kombinirati z nobenim od naslednjih zdravil Če jemljete katero od naštetih zdravil, prosite zdravnika, naj vam predpiše drugo zdravilo.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with REZOLSTA should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Slovenian: Seznam primerov medsebojnega delovanja med posameznimi učinkovinami v spodnji preglednici ni popoln, zato je treba za vsako zdravilo, ki se jemlje sočasno z zdravilom REZOLSTA, pregledati podatke o poti presnove, interakcijah, morebitnih tveganjih in posebnih ukrepih ob sočasni uporabi.
English: HIV-RNA
Slovenian: HIV-RNK
English: - Tell your doctor if you have had problems with your kidneys.
Slovenian: - Povejte zdravniku, če ste že imeli težave z ledvicami.
English: Midazolam (oral) Triazolam
Slovenian: midazolam (peroralna oblika) triazolam
English: Your doctor will advise you how to deal with your symptoms or whether REZOLSTA must be stopped.
Slovenian: Zdravnik vam bo povedal, kako glede na vaše simptome ravnati in ali je treba prekiniti zdravljenje z zdravilom REZOLSTA.
English: Darunavir, cobicistat, or the combination of both have not been studied in patients receiving dialysis, and therefore no recommendation can be made for these patients (see section 5.2).
Slovenian: Uporabe darunavirja, kobicistata ali kombinacije obeh niso proučevali pri bolnikih, ki se zdravijo z dializo, zato za uporabo pri teh bolnikih ni mogoče dati priporočil (glejte poglavje 5.2).
English: All of these serious ADRs occurred in one (0.1%) subject except for rash in 4 (0.6%) subjects.
Slovenian: Vsi resni neželeni učinki so se pojavili pri enem preiskovancu (0,1%), z izjemo izpuščaja, ki se je pojavil pri 4 preiskovancih (0,6%).
English: A
Slovenian: d
English: What REZOLSTA is and what it is used for What you need to know before you take REZOLSTA How to take REZOLSTA
Slovenian: Kaj je zdravilo REZOLSTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo REZOLSTA Kako jemati zdravilo REZOLSTA Možni neželeni učinki
English: - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Slovenian: - ciklosporin, everolimus, takrolimus, sirolimus (za zaviranje aktivnosti imunskega sistema), ker se lahko zvečajo terapevtski ali neželeni učinki teh zdravil.
English: Rare drug reaction with eosinophilia and systemic symptoms*
Slovenian: urtikarija redki reakcija na zdravilo z eozinofilijo in sistemskimi simptomi*
English: Paroxetine Sertraline
Slovenian: paroksetin sertralin
English: White, high density polyethylene (HDPE) bottle containing 30 tablets, fitted with polypropylene (PP) child resistant closure with induction seal.
Slovenian: Bela plastenka iz polietilena velike gostote (HDPE), ki vsebuje 30 tablet in je opremljena z za otroke varno polipropilensko (PP) zaporko in indukcijsko zataljenim zaprtjem.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: Med jemanjem tega zdravila lahko še vedno prenesete okužbo z virusom HIV na druge, čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
English: REZOLSTA might increase the risk of bleeding.
Slovenian: Zdravilo REZOLSTA lahko zveča tveganje za krvavitve.
English: In a pre- and postnatal development assessment in rats, darunavir with and without ritonavir, caused a transient reduction in body weight gain of the offspring pre-weaning and there was a slight delay in the opening of eyes and ears.
Slovenian: Pri pred in postnatalnem ovrednotenju razvoja pri podganah je darunavir z ali brez ritonavirja povzročil prehodno zmanjšanje telesne mase mladičev pred odstavitvijo od dojenja, prisotna je bila tudi majhna zakasnitev pri odpiranju oči in ušes.
English: REZOLSTA should not be used in combination with another antiretroviral that requires pharmacoenhancement since dosing recommendations for such combination have not been established.
Slovenian: Zdravila REZOLSTA se ne sme uporabljati v kombinaciji z drugimi protiretrovirusnimi zdravili, pri katerih je potrebna okrepitev s farmakokinetičnim ojačevalcem, saj priporočila za odmerjanje v okviru take kombinacije niso dognana.
English: EXP Do not use after 6 weeks of first opening the bottle.
Slovenian: EXP Zdravila ne uporabljajte več kot 6 tednov po prvem odprtju plastenke.
English: Third trimester of pregnancy N=6
Slovenian: Tretje trimesečje nosečnosti (n=6)
English: Plasma concentrations of these medicinal products may be increased when co-administered with REZOLSTA, resulting in reduced serum cortisol concentrations.
Slovenian: Plazemske koncentracije teh zdravil se lahko ob sočasnem dajanju zdravila REZOLSTA povečajo, kar povzroči zmanjšanje serumskih koncentracij kortizola.
English: REZOLSTA must therefore not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
Slovenian: Zato se zdravila REZOLSTA ne sme uporabljati skupaj učinkovinami, katerih očistek je močno odvisen od CYP3A in pri katerih je zvečana sistemska izpostavljenost povezana z resnimi in/ali življenjsko nevarnimi neželenimi učinki (imajo nizek terapevtski indeks) (glejte poglavje 4.3).
English: This protein binding is concentration dependent indicative for saturation of binding.
Slovenian: Ta vezava na protein je odvisna od koncentracije in kaže na nasičenje vezavnih mest.
English: REZOLSTA and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Slovenian: Zdravilo REZOLSTA in artemeter/lumefantrin je mogoče uporabljati brez prilagajanja odmerkov, vendar je zaradi zvečane izpostavljenosti lumefantrinu pri uporabi kombinacije obeh zdravil potrebna previdnost.
English: It is recommended that the lowest possible dose of digoxin should initially be given to patients on REZOLSTA.
Slovenian: Priporočljivo je, da bolniki, ki sočasno jemljejo zdravilo REZOLSTA, na začetku prejemajo najnižji možen odmerek digoksina.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: If REZOLSTA is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Slovenian: Če je treba zdravilo REZOLSTA uporabljati sočasno s parenteralno obliko midazolama, ju je treba odmerjati na oddelku intenzivne terapije ali v podobni enoti, tako da je poskrbljeno za skrbno spremljanje bolnika in ustrezno zdravljenje v primeru depresije dihanja in/ali dolgotrajne sedacije.
English: At present the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically relevant;
Slovenian: Zaenkrat ne kaže, da bi bil učinek raltegravirja na koncentracijo darunavirja v plazmi lahko klinično pomemben.
English: Cobicistat is 97 to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Slovenian: Kobicistat se v 97-98% veže na plazemske beljakovine, povprečno razmerje med koncentracijo zdravila v plazmi in krvi je bilo 2.
English: You must eat a meal or a snack within 30 minutes prior to taking your REZOLSTA.
Slovenian: V roku 30 minut pred jemanjem zdravila REZOLSTA morate pojesti obrok ali prigrizek.
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily)
Slovenian: KONTRACEPTIVI Z ESTROGENOM drospireron (3 mg enkrat na dan)
English: To ensure administration of the entire dose of both darunavir and cobicistat, the tablet should be swallowed whole.
Slovenian: Da bi zagotovili vnos celotnega odmerka tako darunavirja kot kobicistata, je treba pogoltniti celo tableto.
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effect of darunavir.
Slovenian: Kobicistat nima zaznavne aktivnosti proti virusu HIV-1 in ne deluje antagonistično na protivirusne učinke darunavirja.
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Slovenian: Zaenkrat ni na voljo zadostnih podatkov, da bi lahko ugotovili, ali je sočasna uporaba dizoproksiltenofovirata in kobicistata povezana z večjim tveganjem za ledvične neželene učinke kot režimi, ki vključujejo dizoproksiltenofovirat brez kobicistata.
English: In the Phase III single-arm trial (GS-US-216-130), a decrease in eGFRCG was noted at week 2, which remained stable through week 48.
Slovenian: V študiji faze III z eno samo skupino preiskovancev (GS-US-216-0130) so po 2 tednih zdravljenja opažali zmanjšanje vrednosti eGFRCG, ki pa je nato ostala stabilna do konca 48. tedna.
English: Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
Slovenian: Pri zdravih prostovoljcih so po peroralnem odmerjanju zdravila REZOLSTA opažali najvišjo koncentracijo kobicistata v plazmi po 2 do 5 urah po odmerjanju.
English: Patients should be instructed to take REZOLSTA within 30 minutes after completion of a meal (see sections 4.4, 4.5 and 5.2).
Slovenian: Bolnikom je treba naročiti, naj vzamejo zdravilo REZOLSTA v roku 30 minut po obroku (glejte poglavja 4.4, 4.5 in 5.2).
English: Voriconazole should not be combined with REZOLSTA unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Slovenian: Vorikonazola se ne sme uporabljati v kombinaciji z zdravilom REZOLSTA, razen če ocena razmerja med koristmi in tveganji upravičuje sočasno uporabo obeh zdravil.
English: This recommendation is different from ritonavir-boosted darunavir.
Slovenian: To priporočilo se razlikuje od priporočila za darunavir, okrepljen z ritonavirjem.
English: If REZOLSTA is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of REZOLSTA with food as soon as possible.
Slovenian: V primeru, da je bil odmerek zdravila REZOLSTA izpuščen in je bilo to opaženo v 12 urah od časa, ko je ponavadi zaužit, je treba bolniku svetovati, naj čimprej vzame predpisani odmerek zdravila REZOLSTA s hrano.
English: There was no effect on mating or fertility in animals (see section 5.3).
Slovenian: Pri živalih nista vplivala na parjenje oziroma plodnost (glejte poglavje 5.3).
English: As darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Slovenian: Ker se darunavir in kobicistat v veliki meri vežeta na plazemske beljakovine, je malo verjetno, da bi ju lahko v večji meri odstranili s hemodializo ali peritonealno dializo (glejte poglavji 4.2 in 5.2).
English: This effect on serum creatinine, leading to a decrease in the estimated creatinine clearance, should be taken into consideration when REZOLSTA is administered to patients, in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
Slovenian: Navedeni učinek na koncentracijo kreatinina v serumu, zaradi katerega se zmanjša ocenjeni očistek kreatinina, je treba upoštevati, kadar zdravilo REZOLSTA prejemajo bolniki, pri katerih se na osnovi ocenjenega očistka kreatinina sprejema odločitve o kliničnem zdravljenju, vključno s prilagajanjem odmerkov sočasno uporabljanih zdravil.
English: Maximum plasma concentration of darunavir in the presence of cobicistat is generally achieved within 3 to 4.5 hours.
Slovenian: Darunavir je v prisotnosti kobicistata večinoma dosegel najvišjo koncentracijo v plazmi v 3 do 4,5 urah.
English: Paediatric population The pharmacokinetics of REZOLSTA in paediatric patients have not been investigated.
Slovenian: Pediatrična populacija Farmakokinetike zdravila REZOLSTA pri pediatričnih bolnikih niso proučevali.
English: TMC114FD2HTX3001 (darunavir/cobicistat arm)
Slovenian: TMC114FD2HTX3001 (študijska skupina z darunavirjem/kobicistatom)
English: Amitriptyline Desipramine Imipramine Nortriptyline Trazodone
Slovenian: amitriptilin desipramin imipramin nortriptilin trazodon
English: A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Slovenian: Pogost neželen učinek zdravila REZOLSTA je kožni izpuščaj (pogostejši je, če se zdravilo uporablja v kombinaciji z raltegravirjem), srbenje.
English: Elbasvir/grazoprevir to treat hepatitis C infection
Slovenian: zeliščno zdravilo za zdravljenje depresije elbasvir/grazoprevir zdravljenje okužbe z virusom hepatitisa C
English: Description of clinical studies of darunavir/ritonavir in adults
Slovenian: Opis kliničnih študij z darunavirjem/ritonavirjem pri odraslih
English: 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.
Slovenian: Pri prehodu s farmakokinetičnega ojačevalca ritonavirja na kobicistat je prva dva tedna zdravljenja z zdravilom REZOLSTA potrebna previdnost, zlasti če je bilo treba med uporabo ritonavirja kot farmakokinetičnega ojačevalca titrirati ali prilagoditi odmerke katerega od sočasno uporabljenih zdravil.
English: Severe hepatic impairment could result in an increase of darunavir and/or cobicistat exposure and a worsening of its safety profile.
Slovenian: Pri hudi okvari jeter se lahko izpostavljenost darunavirju in/ali kobicistatu zveča in poslabša njun varnostni profil.
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Slovenian: Kobicistat zavira prenašalce glikoproteina-p (P-gp), BCRP, MATE1, OATP1B1 in OATP1B3.