FrancophonIA/ELRC3.0 huggingface dataset:
English: The dosage of other medicines might need to be changed since either their own or Darunavir Krka'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 Darunavir Krka.
English: Therefore, darunavir 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 darunavir 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: Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
Slovenian: Zdravim prostovoljcem so dajali enkratne odmerke do 3.200 mg peroralne raztopine samega darunavirja in do 1.600 mg darunavirja v tabletah v kombinaciji z ritonavirjem brez kakršnihkoli škodljivih simptomatičnih učinkov.
English: UROLOGICAL DRUGS Fesoterodine Solifenacin
Slovenian: ZDRAVILA ZA BOLEZNI SEČIL fesoterodin solifenacin
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Slovenian: Končna razpolovna doba izločanja darunavirja (v kombinaciji z ritonavirjem) je bila približno 15 ur.
English: Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Slovenian: Ne-nukleozidni zaviralci reverzne transkriptaze (NNRTI) efavirenz
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Slovenian: Vsi so pokazali najmanj 10-krat manjšo aktivnost od aktivnosti darunavirja proti divjemu tipu virusa HIV.
English: darunavir /ritonavir 10 kg to < 15 kg N=5
Slovenian: Izidi po 48. tednu darunavir/ritonavir 10 kg do < 15 kg n = 5
English: sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Slovenian: ** vsota aktivnih frakcij rifabutina (učinkovina + 25-O-deacetil presnovek)
English: BOX
Slovenian: ŠKATLA
English: Boosted darunavir may increase the exposure to grazoprevir.
Slovenian: Okrepljen darunavir lahko zveča izpostavljenost grazoprevirju.
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Slovenian: Med kliničnim preskušanjem zdravila (n = 2.613 bolnikov, ki so se že zdravili s protiretrovirusnimi zdravili in ki so se začeli zdraviti z zdraviloma darunavir/ritonavir 600/100 mg dvakrat na dan) se je pri 51,3 % preiskovancev pojavil najmanj en neželen učinek.
English: HERBAL PRODUCTS St John's wort (Hypericum perforatum)
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA šentjanževka (Hypericum perforatum)
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: - klaritromicin(antibiotik) - ciklosporin, everolimus, takrolimus, sirolimus (za zaviranje aktivnosti imunskega sistema), ker se lahko zvečajo terapevtski ali neželeni učinki teh zdravil.
English: The combination of boosted darunavir 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: Kombinacija darunavirja in učinkovin artemeter/lumefantrin se lahko uporablja brez prilagajanja odmerkov, vendar je zaradi zvečane izpostavljenosti lumefantrinu pri tej kombinaciji potrebna previdnost.
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 infections may arise.
Slovenian: Pri bolnikih, okuženih s HIV, ki imajo ob uvedbi CART hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Slovenian: Selekcionirani virusi niso mogli rasti pri koncentracijah darunavirja nad 400 nM. Virusi, selekcionirani v teh pogojih, z zmanjšano občutljivostjo za darunavir (razpon: 23- do 50-krat), so imeli do 4 substitucije aminokislin v genu za proteazo.
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 sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.8).
English: Medicinal products that may be affected by darunavir boosted with ritonavir
Slovenian: Zdravila, na katera lahko vpliva darunavir, okrepljen z ritonavirjem
English: CYP3A inducers that are contraindicated include rifampicin, St John's wort and lopinavir.
Slovenian: Kontraindicirani induktorji CYP3A vključujejo npr. rifampicin, šentjanževko in lopinavir.
English: 6/l (see section 4.2 and 4.4).
Slovenian: 6/l (glejte poglavji 4.2 in
English: Methadone individual dose ranging from 55 mg to 150 mg once daily
Slovenian: OPIODI / ZDRAVLJENJE ODVISNOSTI OD OPIOIDOV metadon individualni odmerki od 55 mg do 150 mg enkrat na dan
English: Darunavir contains a sulphonamide moiety.
Slovenian: Darunavir vsebuje sulfonamidno skupino.
English: Cardiac disorders uncommon myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia rare acute myocardial infarction, sinus bradycardia, palpitations
Slovenian: Srčne bolezni občasni miokardni infarkt, angina pektoris, podaljšan QT interval v elektrokardiogramu, tahikardija redki akutni miokardni infarkt, sinusna bradikardija, palpitacije
English: Tablets of lower strengths are available to construct the appropriate dosing regimen.
Slovenian: Za ustrezno odmerjanje so na voljo manjše jakosti tablet.
English: Serious adverse reactions are diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash and vomiting.
Slovenian: Resni neželeni učinki so diabetes melitus, preobčutljivost (za učinkovino), sindrom obnove imunskega odgovora, izpuščaj in bruhanje.
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg)
Slovenian: Pediatrični bolniki, ki imajo izkušnje z ART (stari 3 do 17 let in s telesno maso najmanj 40 kg)
English: Studies have been performed at lower than recommended doses of darunavir or with a different dosing regimen (see section 4.2 Posology).
Slovenian: Izvedene so bile študije z odmerki darunavirja, manjšimi od priporočenih ali z drugačnim režimom odmerjanja (glejte poglavje 4.2 Odmerjanje).
English: There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
Slovenian: Pri uporabi te kombinacije obstaja zvečana verjetnost za pojav s sildenafilom povezanih neželenih učinkov (vključno z motnjami vida, hipotenzijo, podaljšanim časom erekcije in sinkopo).
English: If you notice after 12 hours, then skip the intake and take the next doses as usual.
Slovenian: Če to opazite po 12 urah, potem preskočite ta odmerek in vzemite naslednje odmerke kot običajno.
English: Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Slovenian: Zdravila, ki vplivajo na izpostavljenost zdraviloma darunavir/ritonavir Darunavir in ritonavir se presnavljata z encimom CYP3A.
English: 150 mg twice daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: 150 mg dvakrat na dan darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: HIV-1 RNA < 50 copies/ml
Slovenian: HIV-1 RNK < 50 kopij/ml
English: 20 mg once daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: 20 mg enkrat na dan darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs.
Slovenian: Pri miših, podganah in psih so bila toksikološka preskušanja pri izpostavljenosti, ki je dosegala raven klinične izpostavljenosti, opravljena samo z darunavirjem, pri podganah in psih pa v kombinaciji z ritonavirjem.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Slovenian: Učinek visoke sistemske izpostavljenosti flutikazonuna plazemske koncentracije ritonavirja ni znan.
English: C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Slovenian: C označenega darunavirja z ritonavirjem so v seču izmerili približno 79,5 % danega odmerka darunavirja
English: If you notice after 6 hours, then skip the intake and take the next doses as usual.
Slovenian: Če to opazite po 6 urah, potem preskočite ta odmerek in vzemite naslednje odmerke kot običajno.
English: Psychiatric disorders common insomnia uncommon depression, disorientation, anxiety, sleep disorder, abnormal dreams, nightmare, decreased libido rare confusional state, altered mood, restlessness
Slovenian: Psihiatrične motnje pogosti nespečnost občasni depresija, dezorientacija, tesnoba, motnje spanja, nenavadne sanje, nočne more, zmanjšan libido redki stanje zmedenosti, spremenjeno razpoloženje, nemir
English: In a multiple dose study with darunavir co-administered with 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 (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Slovenian: Preskušanje večkratnega odmerjanja darunavirja z ritonavirjem (600/100 mg dvakrat na dan), 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 ChildPughovi lestvici, n = 8) jetrno okvaro primerljive s tistimi pri zdravih posameznikih.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Slovenian: Bolniki, sočasno okuženi z virusom hepatitisa B in/ali virusom hepatitisa C Med 1.968 bolniki, ki so že bili zdravljeni s protiretrovirusnimi zdravili in so prejemali darunavir skupaj z ritonavirjem (600/100 mg dvakrat na dan), jih je bilo 236 okuženih tudi s hepatitisom B ali C. Pri bolnikih s sočasno okužbo je povišanje koncentracij jetrnih transaminaz bolj verjetno (pred zdravljenjem in kot posledica zdravljenja), kot pri bolnikih, ki nimajo kroničnega virusnega hepatitisa (glejte poglavje 4.4).
English: Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Slovenian: Začetni genotip ali fenotip in virološki izid Začetni genotip in FC darunavirja (stopnja spremembe občutljivosti glede na referenco) sta dejavnika, ki nakazujeta virološki izid.
English: Darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole, or fluconazole may increase darunavir concentrations.
Slovenian: Darunavir lahko zviša plazemske koncentracije antimikotikov in posakonazol, itrakonazol ali flukonazol lahko zvišajo koncentracije darunavirja.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Slovenian: Zdravljenje s kombinacijo zdravil darunavir/kobicistat 800/150 mg med nosečnostjo zmanjša izpostavljenost darunavirju (glejte poglavji 4.4 in 5.2).
English: Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Slovenian: Dajanje darunavirja pri miših in podganah ni povzročilo statistično pomembnega zvečanja pojavnosti nobenih drugih benignih ali malignih novotvorb.
English: Patients received a weight-based twice daily treatment regimen, patients weighing 10 kg to < 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Slovenian: Bolniki s telesno maso 10 kg do < 15 kg so prejeli darunavir/ritonavir 25/3 mg/kg dvakrat na dan, bolniki s telesno maso15 kg do < 20 kg pa darunavir/ritonavir 375/50 mg dvakrat na dan.
English: When used in combination with darunavir co-administered with low dose ritonavir, dose adjustment of indinavir from 800 mg twice daily to 600 mg twice daily may be warranted in case of intolerance.
Slovenian: Pri uporabi v kombinaciji z darunavirjem z majhnim odmerkom ritonavirja bo v primeru intolerance morda treba zmanjšati odmerek indinavirja z 800 mg dvakrat na dan na 600 mg dvakrat na dan.
English: When the recommendation is the same for darunavir when co-administered with a low dose ritonavir or cobicistat, the term “boosted darunavir” is used.
Slovenian: Če so priporočila za uporabo darunavirja ob uporabi majhnega odmerka ritonavirja in kobicistata enaka, uporabljamo izraz "okrepljen darunavir".
English: In case a dose of darunavir and/or ritonavir is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible.
Slovenian: Če je bil odmerek darunavirja in/ali ritonavirja izpuščen in je bilo to opaženo v 6 urah od časa, ko je po navadi zaužit, je treba bolniku svetovati, naj čim prej vzame predpisani odmerek darunavirja in ritonavirja s hrano.
English: Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).
Slovenian: - Povejte svojemu zdravniku, če ste alergični na sulfonamide (zdravila za zdravljenje določenih okužb).
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Slovenian: 150 mg dvakrat na dan maravirok AUC ↑ 305 % maravirok Cmin ND maravirok Cmax ↑ 129 % koncentracije darunavirja in ritonavirja so bile primerljive s podatki iz starejših preskušanj
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Slovenian: ANTAGONISTI ENDOTELINSKIH RECEPTORJEV bosentan
English: Adverse reactions observed with darunavir/ritonavir in clinical trials and post-marketing
Slovenian: Neželeni učinki kombinacije darunavir/ritonavir opaženi v kliničnih študijah in v obdobju trženja zdravila
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Slovenian: ODIN je randomizirano, odprto preskušanje faze III, v katerem so primerjali režim darunavir/ritonavir 800/100 mg enkrat na dan z režimom darunavir/ritonavir 600/100 mg dvakrat na dan pri s HIV-1 okuženih bolnikih z izkušnjami z ART, pri katerih ob vključitvi v preskušanje testi genotipa niso pokazali nobene mutacije, povezane z odpornostjo proti darunavirju (npr.: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), in so imeli plazemsko koncentracijo HIV-1 RNK > 1.000 kopij/ml.
English: Co-administration is contraindicated (see section 4.3)
Slovenian: Sočasna uporaba je kontraindicirana (glejte poglavje 4.3).
English: The Darunavir Krka 400 and 800 milligram tablets are used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and who have not used antiretroviral medicines before.
Slovenian: Tablete zdravila Darunavir Krka po 400 in 800 mg uporabljamo za zdravljenje odraslih in otrok (starih 3 leta ali več in s telesno maso najmanj 40 kg), ki so okuženi z virusom HIV in - še niso prejemali nobenega drugega protiretrovirusnegazdravila.
English: based on published data with darunavir/ritonavir
Slovenian: na osnovi objavljenih podatkov s kombinacijo darunavir/ritonavir
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of these compounds and consequently that of darunavir, leading to loss of therapeutic effect and possible development of resistance (see sections 4.3 and 4.4).
Slovenian: Zdravila, ki inducirajo delovanje CYP3A pričakovano zvečajo očistek darunavirja in ritonavirja ter znižajo plazemske koncentracije teh učinkovin in darunavirja, kar vodi v izgubo terapevtskega učinka in razvoja odpornosti (glejte poglavji 4.3 in 4.4).
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir
Slovenian: atorvastatin 10 mg enkrat na dan atorvastatin AUC ↑ 3- do 4-krat atorvastatin Cmin ↑ ≈5,5- do 10-krat atorvastatin Cmax ↑ ≈2-krat darunavir/ritonavir
English: Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Kombinacijo zdravil darunavir/ritonavir se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
English: Medicinal products that may be affected by darunavir boosted with ritonavir Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Slovenian: Zdravila na katera lahko vpliva darunavir, okrepljen z ritonavirjem Darunavir in ritonavir sta zaviralca CYP3A, CYP2D6 in P-gp.
English: Reproductive system and breast disorders uncommon erectile dysfunction, gynaecomastia
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija, ginekomastija
English: (CYP2D6 inhibition)
Slovenian: (zaviranje CYP2D6)
English: The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4.2, 4.3 and 4.4).
Slovenian: Učinkov hude okvare jeter na farmakokinetiko darunavirja še niso preučevali (glejte poglavja 4.2, 4.3 in 4.4).
English: Treatment with darunavir/cobicistat 800/150 mg once daily during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Slovenian: Pokazalo se je, da zdravljenje s kombinacijo darunavir/kobicistat 800/150 mg enkrat na dan, v drugem in tretjem trimesečju nosečnosti povzroča zmanjšanje izpostavljenosti darunavirju z znižanjem vrednosti Cmin za približno 90% (glejte poglavje 5.2).
English: Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Slovenian: Število virološko neuspešnih bolnikov in genotipi pred in po zdravljenju; razvoj mutacij b ob zaključku preskušanja, n/N
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: Dokazi o učinkovitosti zdravil darunavir/ritonavir 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 kombinaciji 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: Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment.
Slovenian: Pred začetkom zdravljenja z zdraviloma darunavir/ritonavir je treba opraviti ustrezne laboratorijske teste in spremljati bolnika med zdravljenjem.
English: Limited information is available in this population, and therefore, darunavir should be used with caution in this age group (see sections 4.4 and 5.2).
Slovenian: Podatkov, pri tej populaciji je malo, zato je pri uporabi darunavirja v tej skupini potrebna previdnost (glejte poglavji 4.4 in 5.2).
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Slovenian: Priporočljiva je uporaba drugih zaviralcev agregacije trombocitov, na katere ne vpliva zaviranje ali indukcija CYP (npr. prasugrel).
English: Tablet dimension: 19.5 x 10 mm.
Slovenian: Velikost tablet: 19 x 10 mm.
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of darunavir/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Slovenian: Pediatrični bolniki, ki imajo izkušnje z ART, stari 3 leta do < 6 let Farmakokinetiko, varnost, prenosljivost in učinkovitost zdravil darunavir/ritonavir dvakrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili pri 21 s HIV-1 okuženih pediatričnih bolnikih, ki že imajo izkušnje z ART, starih 3 do < 6 let in s telesno maso 10 kg do < 20 kg, so ocenili v odprtem preskušanju faze II, ARIEL.
English: with darunavir/cobicistat 800/150 mg
Slovenian: s kombinacijo darunavir/kobicistat 800/150 mg
English: LABEL for bottle
Slovenian: SAMOLEPILNA ETIKETA za plastenko
English: Monitor for fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary.
Slovenian: Morda bo potrebno zmanjšanje odmerka fesoterodina ali solifenacina.
English: If parenteral midazolam is coadministered with darunavir with low dose ritonavir, it should be done in an intensive care unit (ICU) 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 darunavir skupaj z majhnim odmerkom ritonavirja uporabljati sočasno s parenteralno obliko midazolama, ju je treba odmerjati na oddelku intenzivne terapije ali v podobni enoti, kar zagotavlja skrbno spremljanje bolnika in ustrezno zdravljenje v primeru depresije dihanja in/ali dolgotrajne sedacije.
English: The recommended dose regimens are as follows:
Slovenian: Priporočeno je odmerjanje:
English: Boosted darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Slovenian: Okrepljen darunavir lahko zviša plazemske koncentracije antimikotikov in posakonazol, izavukonazol, itrakonazol ali flukonazol lahko zvišajo koncentracije darunavirja.
English: What Darunavir Krka looks like and contents of the pack Darunavir Krka 400 mg film-coated tablets (tablets):
Slovenian: Izgled zdravila Darunavir Krka in vsebina pakiranja Darunavir Krka 400 mg filmsko obložene tablete (tablete):
English: This dose must not exceed the recommended adult dose, which is 800 milligram Darunavir Krka together with 100 milligram ritonavir once a day.
Slovenian: Ta odmerek ne sme preseči priporočenega odmerka za odrasle, ki je 800 mg zdravila Darunavir Krka skupaj s 100 mg ritonavirja enkrat na dan.