FrancophonIA/ELRC3.0 huggingface dataset:
English: If there is a need to combine PREZISTA/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Slovenian: Če je potrebna sočasna uporaba zdravila PREZISTA/ritonavir in karbamazepina, je treba bolnike spremljati zaradi možnosti pojava neželenih učinkov povezanih s karbamazepinom.
English: If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.
Slovenian: Če imate kronično okužbo s hepatitisom B ali C vam bo zdravnik pogosteje opravljal krvne preiskave, ker pri vas obstaja zvečano tveganje za nastanek težav z jetri.
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking PREZISTA.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte strojev in ne vozite avtomobila, če ste po jemanju zdravila PREZISTA omotični.
English: PREZISTA is also available as an oral suspension for use in patients who are unable to swallow PREZISTA tablets (please refer to the Summary of Product Characteristics for PREZISTA oral suspension).
Slovenian: Zdravilo PREZISTA je na voljo tudi v obliki peroralne suspenzije in se uporablja pri bolnikih, ki tablet zdravila PREZISTA ne morejo pogoltniti (glejte tudi Povzetek glavnih značilnosti zdravila PREZISTA peroralna suspenzija).
English: Co-administration with CYP3Ametabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Slovenian: Sočasna uporaba s kortikosteroidi, ki se presnavljajo s CYP3A ni priporočljiva, razen če morebitna korist zdravljenja odtehta tveganje, bolnike pa je treba spremljati glede sistemskih kortikosteroidnih učinkov.
English: The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Slovenian: Absolutna peroralna biološka uporabnost enkratnega 600 mg odmerka samega darunavirja je bila približno 37% in se je zvečala na približno 82% v prisotnosti ritonavirja v odmerku 100 mg dvakrat na dan.
English: PREZISTA is not a cure for HIV infection.
Slovenian: Zdravilo PREZISTA ne ozdravi okužbe z virusom HIV.
English: Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients receive rifabutin at doses other than 300 mg/day.
Slovenian: Na osnovi podatkov pridobljenih s farmakokinetičnim modeliranjem, je 75% zmanjšanje odmerka priporočljivo tudi, če bolniki prejemajo rifabutin v odmerkih različnih od 300 mg/dan.
English: White to off-white opaque suspension
Slovenian: peroralna suspenzija bela do umazano bela neprozorna suspenzija
English: PREZISTA/ritonavir should not be used in children below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Slovenian: Zdravil PREZISTA/ritonavir se ne sme uporabljati pri otrocih, mlajših od 3 let, zaradi zadržkov glede varnosti (glejte poglavji 4.4 in 5.3).
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Avanafil Sildenafil Tadalafil Vardenafil
Slovenian: ZAVIRALCI FOSFODIESTRAZE TIPA (PDE-5) Za zdravljenje motenj erekcije: avanafil sildenafil tadalafil vardenafil
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Slovenian: Učinek visoke sistemske izpostavljenosti flutikazonu na plazemske koncentracije ritonavirja ni znan.
English: Limited efficacy data are available in paediatric patients below 15 kg and no recommendation on a posology can be made.
Slovenian: Podatki o učinkovitosti pri pediatričnih bolnikih s telesno maso manjšo od 15 kg so omejeni, zato pri njih ne moremo podati priporočil za odmerjanje.
English: PREZISTA tablets Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Slovenian: PREZISTA tablete Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
English: The rashes observed in clinical studies were mild to moderate in severity and did not result in discontinuation of therapy (see section 4.4).
Slovenian: Izpuščaji, ki so se pojavljali v kliničnih preskušanjih so bili blagi do zmerni in niso vodili v prekinitev zdravljenja (glejte poglavje4.4).
English: In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Slovenian: Večinoma se zdravilo PREZISTA lahko uporablja skupaj z drugimi zdravili proti HIV, ki spadajo v druge skupine [npr. NRTI (nukleozidni zaviralci reverzne transkriptaze), NNRTI (nenukleozidni zaviralci reverzne transkriptaze), CCR5 antagonisti in FI (zaviralci fuzije)].
English: PREZISTA oral suspension contains sodium methyl parahydroxybenzoate.
Slovenian: Zdravilo PREZISTA peroralna suspenzija vsebuje natrijev metilparahidroksibenzoat.
English: How to take PREZISTA
Slovenian: Kako jemati zdravilo PREZISTA
English: 200 ml bottle
Slovenian: 200 ml steklenica
English: PREZISTA might increase the risk of bleeding.
Slovenian: Zdravilo PREZISTA lahko zveča tveganje za krvavitve.
English: PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Slovenian: PREZISTA 400 mg in 800 mg tablete se lahko uporabljajo za zagotavljanje ustreznega odmerjanja za zdravljenje okužbe s HIV-1 pri odraslih in pediatričnih bolnikih, starih 3 leta in več in s telesno maso najmanj 40 kg:
English: PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Slovenian: PREZISTA je protiretrovirusno zdravilo, ki se uporablja za zdravljenje okužbe z virusom imunske pomanjkljivosti pri človeku (HIV).
English: PREZISTA/ritonavir should not be used in children with a body weight of less than 15 kg as the dose for this population has not been established in a sufficient number of patients (see section 5.1).
Slovenian: Zdravila PREZISTA/ritonavir se ne sme uporabljati pri otrocih s telesno maso, manjšo od 15 kg, ker odmerjanja pri tej populaciji ni bilo mogoče določiti pri zadostnem številu bolnikov (glejte poglavje 5.1).
English: PREZISTA oral suspension is available in packs of one bottle.
Slovenian: Zdravilo PREZISTA peroralna suspenzija je na voljo v pakiranju z enim vsebnikom.
English: The table below shows the efficacy data of the 48-week and 96-week analyses from the pooled POWER 1 and POWER 2 trials.
Slovenian: Spodnja preglednica kaže podatke analize o učinkovitosti po 48-tedenih in 96-tednih iz zbranih izsledkov preskušanj POWER 1 in POWER 2.
English: PREZISTA/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Slovenian: Kombinacijo zdravil PREZISTA/ritonavir se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje (glejte poglavja 4.4, 4.6 in 5.2).
English: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml n=11 for AUC12h
Slovenian: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml n=11 za AUC12h
English: Contains sodium methyl parahydroxybenzoate (E219).
Slovenian: Vsebuje natrijev metilparahidroksibenzoat (E219).
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Slovenian: Stopnje izpostavljenosti izpuščaju (vse vzročnosti) so bile 10,9; 4,2 in 3,8 na 100 bolnikov let (PYR-patient years) oziroma 2,4; 1,1 in 2,3 na 100 bolnikov let pri izpuščaju, povezanem z zdravilom.
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of PREZISTA/ritonavir.
Slovenian: Na podlagi ugotovitev bo v prisotnosti zdravila PREZISTA/ritonavir morda potrebno odmerke karbamazepina zmanjšati za 25% do 50%.
English: - The child must swallow the tablets with a drink such as water or milk.
Slovenian: - Otrok mora tablete pogoltniti s pijačo, kot je voda ali mleko.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Slovenian: Podatki o sočasni uporabi parenteralnega midazolama in drugih zaviralcev proteaz kažejo na možnost 3-4 kratnega zvečanja plazemskih koncentracij midazolam.
English: HIV RNA < 50 copies/ml
Slovenian: HIV RNK < 50 kopij/ml
English: PREZISTA in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Slovenian: V kombinaciji z ritonavirjem, zdravilo PREZISTA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 g intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 82-89%).
Slovenian: Flutikazon: v klinični študiji, v kateri so pri zdravih prostovoljcih 7 dni sočasno uporabljali 100 mg ritonavirja v kapsulah dvakrat na dan s 50 µg flutikazonpropionata (štirikrat na dan intranazalno), so se plazemske koncentracije flutikazona pomembno zvečale, medtem, ko so se intrinzične koncentracije kortizola zmanjšale za približno 86% (90% interval zaupanja 82%-89%).
English: Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat).
Slovenian: Zato je sočasna uporaba zdravil, pri katerih so zvišane plazemske koncentracije povezane z resnimi in/ali življenje ogrožujočimi dogodki, kontraindicirana (velja za darunavir okrepljen z ritonavirjem ali s kobicistatom).
English: The dosage of other medicines might need to be changed since either their own or PREZISTA's therapeutic effect or side effects may be influenced when combined.
Slovenian: Lahko bo potrebna tudi sprememba odmerjanja drugih zdravil, zaradi vpliva kombinacije na terapevtske ali neželene učinke le-teh ali zdravila PREZISTA.
English: The dose of cobicistat to be used with PREZISTA in children less than 18 years of age has not been established.
Slovenian: Odmerka kobicistata za uporabo z zdravilom PREZISTA pri otrocih, mlajših od 18 let niso določili.
English: PREZISTA 100 mg/ml oral suspension darunavir
Slovenian: PREZISTA 100 mg/ml peroralna suspenzija darunavir
English: - Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
Slovenian: - Nemudoma povejte svojemu zdravniku, če opazite kakršne koli simptome okužbe (npr. zvečane bezgavke ali zvišano telesno temperaturo).
English: See leaflet for further information.
Slovenian: Za podrobnejše podatke glejte navodilo za uporabo.
English: It may harm them,
Slovenian: Novih,
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Slovenian: Nespremenjenega darunavirja v blatu je bilo približno 41,2% danega odmerka, v seču pa 7,7%.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Kljub temu, da so ocenili, da je vzrokov več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, večjim indeksom telesne mase), so poročali o primerih osteonekroze, še posebej pri bolnikih z napredovalo boleznijo HIV in/ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji (CART - Combination Antiretroviral Therapy).
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Slovenian: V študiji z eno samo skupino preiskovancev, v kateri so preskušali 800 mg darunavirja enkrat na dan v kombinaciji s 150 mg kobicistata enkrat na dan in z drugimi protiretrovirusnimi zdravili, je 2,2% bolnikov prekinilo zdravljenje zaradi izpuščaja.
English: Total number of virologic failures a, n
Slovenian: Celokupno št. viroloških odpovedi a, n (%)
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes, PREZISTA with low dose ritonavir should not be used in paediatric patients below 3 years of age.
Slovenian: Ker stopnja razvoja hematoencefalne bariere in jetrnih encimov pri ljudeh ni zanesljivo določena, zdravila PREZISTA skupaj z majhnim odmerkom ritonavirja ne smete uporabljati pri pediatričnih bolnikih, mlajših od 3 leti.
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Slovenian: V kliničnem preskušanju faze III (GS-US-216-130) s kombinacijo darunavir/kobicistat (N=313 bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili) je imelo 66,5% preiskovancev vsaj en neželen učinek.
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: Number of mutations from the list of mutations associated with a diminished response to PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V) fold change in EC50 “Patients with no/non-naïve use of ENF” are patients who did not use ENF or who used ENF but not for the first time “Patients with naïve use of ENF” are patients who used ENF for the first time
Slovenian: Število mutacij s seznama mutacij, ki so povezane z zmanjšanim odzivom na zdravilo PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L ali M, T74P, L76V, I84V ali L89V) spremembe EC50 “bolniki, ki še niso/niso prvič jemali ENF” so bolniki, ki še niso jemali ENF ali pa so ga uporabljali, vendar ne prvič “bolniki, ki so prvič jemali ENF” so bolniki, ki so v preskušanju prvič uporabili ENF
English: Your doctor will determine whether PREZISTA tablets or oral suspension is right for the child.
Slovenian: Vaš zdravnik bo določil ali so za otroka bolj primerne PREZISTA tablete ali peroralna suspenzija.
English: No pharmacokinetic data are available in patients with severe hepatic impairment.
Slovenian: Ni podatkov o farmakokinetiki zdravila PREZISTA pri bolnikih z okvaro jeter.
English: A clinical study utilising a cocktail of medicinal products that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of darunavir/ritonavir, which may be attributed to the presence of low dose ritonavir.
Slovenian: Klinična študija v kateri so uporabljali mešanico zdravilnih učinkovin, ki se presnavljajo s citokromi CYP2C9, CYP2C19 in CYP2D6 je v prisotnosti učinkovin darunavir/ritonavir pokazala zvečanje aktivnosti CYP2C9 in CYP2C19 ter zmanjšanje aktivnosti CYP2D6, kar lahko pripišemo prisotnosti majhnega odmerka ritonavirja.
English: In GS-US216-130 baseline phenotype was not available
Slovenian: v študiji GS-US-216-130 ni bilo na voljo podatkov o izhodiščnem stanju fenotipa
English: PREZISTA should not be used in children - below 3 years of age, because of safety concerns (see sections 4.4 and 5.3), or, - less than 15 kg body weight, as the dose for this population has not been established in a sufficient number of patients (see section 5.1).
Slovenian: Zdravila PREZISTA se ne sme uporabljati pri otrocih, ki - so mlajši od 3 let, zaradi zadržkov glede varnosti (glejte poglavji 4.4 in 5.3) ali - pri bolnikih s telesno maso manjšo od 15 kg, ker odmerjanja pri tej populaciji ni bilo mogoče določiti pri zadostnem številu bolnikov (glejte poglavje 5.1).
English: In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Slovenian: Pri bolnikih, ki jemljejo zdravilo PREZISTA skupaj z raltegravirjem (pri okužbi s HIV), se izpuščaji lahko pojavijo pogosteje (večinoma blagi do zmerni) kot pri bolnikih, ki teh dveh zdravil ne jemljejo skupaj.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Slovenian: Populacijska analiza farmakokinetike pri bolnikih okuženih s HIV, je pokazala, da farmakokinetika darunavirja ni bistveno drugačna v razponu starosti, ki so ga proučevali pri bolnikih, okuženih s HIV (od 18 do 75 let) (n=12, starost  65) (glejte poglavje 4.4).
English: Manufacturer Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Slovenian: Izdelovalec Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italija
English: C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Slovenian: C pri zdravih prostovoljcih, je pokazalo, da je bila večina radioaktivnosti, izmerjene v plazmi po enkratnem 400/100 mg odmerku darunavirja z ritonavirjem posledica matične učinkovine.
English: Based upon the safety profile of PREZISTA/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for PREZISTA/ritonavir.
Slovenian: Glede na varnostni profil kombinacije zdravil PREZISTA/ritonavir, zvečanje izpostavljenosti darunavirju v prisotnosti ritonavirja ne zahteva zmanjšanja odmerka zdravil PREZISTA/ritonavir.
English: PREZISTA might increase sugar levels in the blood.
Slovenian: Zdravilo PREZISTA, lahko zviša koncentracijo sladkorja v krvi.
English: common angioedema, pruritus, urticaria rare drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Slovenian: pogosti angioedem, srbenje, urtikarija redki reakcija na zdravilo z eozinofilijo in sistemskimi simptomi*, Stevens-Johnsonov sindrom*
English: The safety and efficacy of PREZISTA have not been established in patients with severe underlying liver disorders and PREZISTA is therefore contraindicated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s sočasno hudo okvaro jeter niso dokazali varnosti in učinkovitosti zdravila PREZISTA, zato je zdravilo PREZISTA pri bolnikih s hudo okvaro jeter kontraindicirano.
English: If you take PREZISTA two times a day and if you notice within 6 hours, you must take the oral suspension immediately.
Slovenian: Če jemljete zdravilo PREZISTA dvakrat na dan in to opazite v 6 urah, morate vzeti peroralno suspenzijo takoj.
English: PREZISTA 800 milligram tablets are intended for once daily use only.
Slovenian: 800-miligramske tablete zdravila PREZISTA so namenjene samo za uporabo enkrat na dan.
English: Some side effects are typical for anti-HIV medicines in the same family as PREZISTA.
Slovenian: Nekateri neželeni učinki so značilni za zdravila proti okužbi s HIV iz iste skupine zdravil kot je zdravilo PREZISTA.
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Slovenian: - kortikosteroide, vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom.
English: Other strengths of PREZISTA are available.
Slovenian: Na voljo so druge jakosti zdravila PREZISTA.
English: The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1-acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Slovenian: Zvečana izpostavljenost darunavirju pri bolnikih, okuženih s HIV-1 v primerjavi z zdravimi preiskovanci lahko razložimo z višjimi koncentracijami α1-kislega glikoproteina (AAG) pri bolnikih okuženih s HIV-1, kar je povzročilo večjo vezavo darunavirja na plazemski AAG in zato večje plazemske koncentracije.
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Slovenian: Tudi AUC vsote aktivnih frakcij rifabutina (učinkovina + 25-O-deacetil presnovek) je bila povečana 1,6-krat, Cmax pa je ostal primerljiv.
English: PREZISTA 75 mg, 150 mg and 600 mg film-coated tablets 3 years
Slovenian: PREZISTA 75 mg, 150 mg in 600 mg filmsko obložene tablete 3 leta
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
Slovenian: rosuvastatin 10 mg enkrat na dan rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
English: • antiretroviral therapy (ART)-naïve (see section 4.2).
Slovenian: • ki nimajo izkušenj s protiretrovirusnim zdravljenjem (ART - antiretroviral treatment) (glejte poglavje 4.2).
English: Shake the bottle vigorously prior to each dose.
Slovenian: Steklenico pred vsakim odmerjanjem močno pretresite.
English: Investigations common increased blood creatinine * 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: Preiskave pogosti zvišana vrednost kreatinina v krvi * 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: Pregnant or breast-feeding mothers should not take PREZISTA with cobicistat.
Slovenian: Noseče ali doječe matere ne smejo jemati zdravila PREZISTA skupaj s kobicistatom.
English: PREZISTA/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Kombinacijo zdravil PREZISTA/ritonavir se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
English: Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat (see sections 4.3, 4.4 and 4.5).
Slovenian: Darunavir ima zato lahko različne kontraindikacije in priporočila za sočasno uporabo z drugimi zdravili, odvisno od tega ali je okrepljen z ritonavirjem ali s kobicistatom (glejte poglavja 4.3, 4.4 in 4.5)
English: No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, PREZISTA should be used with caution in these patients.
Slovenian: Pri bolnikih z blago (razred A po Child-Pughovi lestvici) ali zmerno (razred B po Child-Pughovi lestvici) okvaro jeter ni potrebno prilagajati odmerka, vseeno pa je potrebna previdnost pri uporabi zdravila PREZISTA pri teh bolnikih.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with PREZISTA/ritonavir.
Slovenian: V kliničnem preskušanju zdravil darunavir/ritonavir (n=3.063) se je hepatitis pojavil pri 0,5% bolnikov, ki so prejemali kombinirano protiretrovitusno zdravljenje PREZISTA/ritonavir.