natgillin/translations-raw huggingface dataset:
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).
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).
Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir
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
Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Kombinacijo zdravil darunavir/ritonavir se lahko uporablja med nosečnostjo le, če možna korist pretehta morebitno tveganje.
Medicinal products that may be affected by darunavir boosted with ritonavir Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Zdravila na katera lahko vpliva darunavir, okrepljen z ritonavirjem Darunavir in ritonavir sta zaviralca CYP3A, CYP2D6 in P-gp.
Reproductive system and breast disorders uncommon erectile dysfunction, gynaecomastia
Motnje reprodukcije in dojk občasni erektilna disfunkcija, ginekomastija
(CYP2D6 inhibition)
(zaviranje CYP2D6)
The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4.2, 4.3 and 4.4).
Učinkov hude okvare jeter na farmakokinetiko darunavirja še niso preučevali (glejte poglavja 4.2, 4.3 in 4.4).
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).
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).
Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Število virološko neuspešnih bolnikov in genotipi pred in po zdravljenju; razvoj mutacij b ob zaključku preskušanja, n/N
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).
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).
Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment.
Pred začetkom zdravljenja z zdraviloma darunavir/ritonavir je treba opraviti ustrezne laboratorijske teste in spremljati bolnika med zdravljenjem.
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).
Podatkov, pri tej populaciji je malo, zato je pri uporabi darunavirja v tej skupini potrebna previdnost (glejte poglavji 4.4 in 5.2).
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Priporočljiva je uporaba drugih zaviralcev agregacije trombocitov, na katere ne vpliva zaviranje ali indukcija CYP (npr. prasugrel).
Tablet dimension: 19.5 x 10 mm.
Velikost tablet: 19 x 10 mm.
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.
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.
with darunavir/cobicistat 800/150 mg
s kombinacijo darunavir/kobicistat 800/150 mg
LABEL for bottle
SAMOLEPILNA ETIKETA za plastenko
Monitor for fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary.
Morda bo potrebno zmanjšanje odmerka fesoterodina ali solifenacina.
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.
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.
The recommended dose regimens are as follows:
Priporočeno je odmerjanje:
Boosted darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Okrepljen darunavir lahko zviša plazemske koncentracije antimikotikov in posakonazol, izavukonazol, itrakonazol ali flukonazol lahko zvišajo koncentracije darunavirja.
What Darunavir Krka looks like and contents of the pack Darunavir Krka 400 mg film-coated tablets (tablets):
Izgled zdravila Darunavir Krka in vsebina pakiranja Darunavir Krka 400 mg filmsko obložene tablete (tablete):
This dose must not exceed the recommended adult dose, which is 800 milligram Darunavir Krka together with 100 milligram ritonavir once a day.
Ta odmerek ne sme preseči priporočenega odmerka za odrasle, ki je 800 mg zdravila Darunavir Krka skupaj s 100 mg ritonavirja enkrat na dan.
See the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.
Glejte Povzetek glavnih značilnosti zdravila Darunavir Krka 600 mg tablete.
In a study conducted in rats, the number of corpora lutea and implantations were decreased in the presence of maternal toxicity.
V študiji na podganah, se je v prisotnosti toksičnosti za samico zmanjšalo število rumenih telesc in vgnezditev.
Based on the different elimination pathways of the other NRTIs zidovudine, emtricitabine, stavudine, lamivudine, that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and boosted darunavir.
Zaradi različnih poti izločanja ostalih NRTI (zidovudin, emtricitabin, stavudin, lamivudin), ki se izločajo predvsem skozi ledvice, in abakavirja, ki se ne presnavlja preko CYP450, ni pričakovati medsebojnih delovanj med temi zdravili in okrepljenim darunavirjem.
If concomitant use of boosted darunavir 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.
Če je indicirana sočasna uporaba okrepljenega darunavirja s sildenafilom, vardenafilom ali tadalafilom, je priporočljivo uporabiti sildenafil v enkratnem odmerku največ 25 mg v 48 urah, vardenafil v enkratnem odmerku največ 2,5 mg v 72 urah ali tadalafil v enkratnem odmerku največ 10 mg v 72 urah.
At week 48, the virologic response, defined as the percentage of patients with confirmed plasma viral load < 50 HIV-1 RNA copies/ml, was evaluated in 16 paediatric patients 15 kg to < 20 kg and 5 paediatric patients 10 kg to < 15 kg receiving darunavir /ritonavir in combination with other antiretroviral agents (see section 4.2 for dosage recommendations per body weight).
Po 48 tednih so potrdili virološki odziv (določen kot odstotek bolnikov s potrjeno plazemsko koncentracijo HIV-1 RNK < 50 kopij/ml) pri 16 pediatričnih bolnikih s telesno maso 15 kg do < 20 kg in pri 5 pediatričnih bolnikih s telesno maso 10 kg do < 15 kg pri režimu zdravljenja z zdraviloma darunavir/ritonavir v kombinaciji drugimi protiretrovirusnimi zdravili (za priporočila za odmerjanje glede na telesno maso glejte poglavje 4.2).
Darunavir Krka is not a cure for HIV infection.
Zdravilo Darunavir Krka ne ozdravi okužbe z virusom HIV.
Darunavir boosted with cobicistat is more sensitive to CYP3A induction than ritonavir-boosted darunavir: co-administration of darunavir/cobicistat with medicinal products that are strong inducers of CYP3A (e.g. St John's wort, rifampicin, carbamazepine, phenobarbital, and phenytoin) is contraindicated (see section 4.3).
Darunavir, okrepljen s kobicistatom, je bolj občutljiv za indukcijo s CYP3A od darunavirja, okrepljenega z ritonavirjem: sočasna uporaba učinkovin darunavir/kobicistat z zdravili, ki so močni induktorji CYP3A (npr. šentjanževka, rifampicin, karbamazipin, fenobarbital in fenitoin), je kontraindicirana (glejte poglavje 4.3).
There was no effect on mating or fertility with darunavir treatment in rats (see section 5.3).
Pri dajanju darunavirja podganam ni bilo učinkov na parjenje ali plodnost (glejte poglavje 5.3).
Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the coadministered medicinal product.
Darunavir, okrepljen z ritonavirjem ali s kobicistatom, zavira izločanje učinkovin, pri katerih je očistek v veliki meri odvisen od CYP3A, kar povzroči zvečano izpostavljenost sočasno uporabljenim zdravilom.
Greater effects may be expected when fluticasone is inhaled.
Kadar se flutikazon inhalira, lahko pričakujemo večje učinke.
The exposure to total darunavir and ritonavir after intake of darunavir/ritonavir 600/100 mg twice daily and darunavir/ritonavir 800/100 mg once daily as part of an antiretroviral regimen was generally lower during pregnancy compared with postpartum.
Izpostavljenost celokupnemu darunavirju in ritonavirju po vnosu kombinacije zdravil darunavir/ritonavir v odmerku 600/100 mg dvakrat na dan ali 800/100 mg enkrat na dan kot delu protiretrovirusnega zdravljenja, je bila na splošno manjša med nosečnostjo kot po porodu.
Even if you feel better, do not stop taking Darunavir Krka and ritonavir without talking to your doctor.
Tudi če se počutite bolje, ne smete prenehati z jemanjem zdravila Darunavir Krka in ritonavirja, ne da bi se posvetovali s svojim zdravnikom.
HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir Atazanavir
Zaviralci proteaz HIV - brez sočasne uporabe majhnega odmerka ritonavirja atazanavir
Coadministration with boosted darunavir may cause a large increase in the concentration of these medicines.
Sočasna uporaba z okrepljenim darunavirjem lahko povzroči veliko zvišanje koncentracij teh zdravil.
Some side effects are typical for anti-HIV medicines in the same family as Darunavir Krka.
Nekateri neželeni učinki so značilni za skupino zdravil proti okužbi s HIV, v katero sodi tudi zdravilo Darunavir Krka.
β-BLOCKERS Carvedilol Metoprolol Timolol
ANTAGONISTI ADRENERGIČNIH RECEPTORJEV BETA karvedilol metoprolol timolol
During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with low dose ritonavir, a high frequency of liver reactions was seen with rifampicin.
Ko so manjšo izpostavljenost poskušali nadomestiti s zvečanjem odmerka drugih zaviralcev proteaz v kombinaciji z ritonavirjem, so poročali o večji pogostnosti jetrnih neželenih učinkov, povezanih z rifampicinom.
In addition, patients on a stable dose of these antidepressants who start treatment with darunavir with low dose ritonavir should be monitored for antidepressant response.
Pri bolnikih na stabilnem odmerku teh antidepresivov, ki začenjajo zdravljenje z darunavirjem skupaj z majhnim odmerkom ritonavirja, je treba spremljati učinek zdravljenja z antidepresivom.
The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
- Močni induktorji CYP3A: rifampicin in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
Kadar testiranje genotipa HIV ni mogoče, se pri pediatričnih bolnikih, ki še niso prejemali zaviralcev proteaz HIV, priporoča odmerjanje zdravil darunavir/ritonavir enkrat na dan in pri bolnikih, ki so že prejemali zaviralce proteaz HIV, odmerjanje dvakrat na dan.
Metabolism and nutrition disorders common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Presnovne in prehranske motnje pogosti anoreksija, sladkorna bolezen, hiperholesterolemija, hipertrigliceridemija, hiperlipidemija
Darunavir co-administered with low dose ritonavir and etravirine 200 mg twice daily can be used without dose adjustments.
Darunavir se skupaj z majhnim odmerkom ritonavirja in z 200 mg etravirina dvakrat na dan lahko uporablja brez prilagajanja odmerkov.
It belongs to a group of medicines called protease inhibitors.
Sodi v skupino zaviralcev proteaz.
The clinical trial data from ART-experienced patients (TITAN trial and the pooled analysis of the POWER 1, 2 and 3 and DUET 1 and 2 trials) showed that virologic response to darunavir coadministered with low dose ritonavir was decreased when 3 or more darunavir RAMs (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) were present at baseline or when these mutations developed during treatment.
Podatki iz kliničnih preskušanj pri bolnikih z izkušnjami z ART (preskušanje TITAN in združeni podatki preskušanj POWER 1, 2, 3 in DUET 1 in 2) so pokazali, da je bil virološki odziv na darunavir z majhnim odmerkom ritonavirja zmanjšan, če so bile ob začetku zdravljenja prisotne ali so se med zdravljenjem razvile ≥ 3 mutacije, povezane z odpornostjo proti darunavirju (DRV-RAM) (V11I, V32I, L33F, I47V, I50V, I54L ali M, T74P, L76V, I84V in L89V).
DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
DRESS (Drug Rash with Eosinophilia and Systemic Symptoms - kožni izpuščaj z eozinofilijo in sistemskimi simptomi) in StevensJohnsonov sindrom sta se pojavila redko (< 0,1 %).
The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
Učinki sočasne uporabe zdravil so lahko podcenjeni in potrebno je klinično spremljanje varnosti zdravila.
What Darunavir Krka looks like and contents of the pack Film-coated tablets (tablets) are orangish brown, oval, biconvex, engraved with a mark S2 on one side.
Izgled zdravila Darunavir Krka in vsebina pakiranja Filmsko obložene tablete (tablete) so oranžasto rjave, ovalne, izbočene, z vtisnjeno oznako S2 na eni strani.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is described in the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.
- pri vseh drugih bolnikih z izkušnjami z ART ali pri bolnikih, pri katerih ni rezultatov testiranja genotipa, je priporočeno odmerjanje opisano v Povzetku glavnih značilnosti zdravila Darunavir Krka 600 mg tablete.
Medicinal products that affect darunavir exposure (cobicistat as pharmacoenhancer)
Zdravila, ki vplivajo na izpostavljenost darunavirju (farmakokinetični ojačevalec je kobicistat)
Titanium dioxide (E171) Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
polivinilalkohol makrogol titanov dioksid (E171) smukec (E553b) rumeni železov oksid (E172) rdeči železov oksid (E172)
Darunavir co-administered with low dose ritonavir must 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).
Zdravilo darunavir skupaj z majhnim odmerkom ritonavirja ne smete uporabljati sočasno z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih je zvečana sistemska izpostavljenost povezana z resnimi in/ali življenjsko nevarnimi neželenimi učinki (majhna terapevtska širina) (glejte poglavje 4.3).
Lurasidone Pimozide Sertindole
perfenazin risperidon tioridazin lurazidon pimozid sertindol
Co-administration with boosted darunavir may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Sočasna uporaba z okrepljenim darunavirjem lahko pomembno zveča izpostavljenost dabigatranu ali tikagrelorju.
Medicinal products that affect darunavir exposure (ritonavir as pharmacoenhancer)
Zdravila, ki vplivajo na izpostavljenost darunavirju (farmakokinetični ojačevalec je ritonavir)
common angioedema, pruritus, urticaria rare drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Redki reakcija na zdravilo z eozinofilijo in sistemskimi simptomi*, Stevens-Johnsonov sindrom*
Darunavir should not be used in paediatric patients below 3 years of age or less than 15 kg body weight (see sections 4.4 and 5.3).
Darunavir se pri pediatričnih bolnikih, mlajših od 3 let ali s telesno maso, manjšo od 15 kg, ne sme uporabljati (glejte poglavji 4.4 in 5.3).
The following patient populations were evaluated (see section 5.1): 80 ART-experienced HIV-1 infected paediatric patients aged from 6 to 17 years and weighing at least 20 kg who received darunavir tablets with low dose ritonavir twice daily in combination with other antiretroviral agents.
Ocenili so naslednje populacije bolnikov (glejte poglavje 5.1): - 80 sHIV-1 okuženih pediatričnih bolnikov, starih 6 do17 let in s telesno maso najmanj 20 kg, z izkušnjami z ART, ki so prejemali tablete darunavirja skupaj z majhnim odmerkom ritonavirja dvakrat na dan in drugimi protiretrovirusnimi zdravili.
Immune system disorders uncommon immune reconstitution inflammatory syndrome, (drug) hypersensitivity
Bolezni imunskega sistema občasni vnetni sindrom obnove imunskega odgovora, preobčutljivost (za zdravilo)
Eye disorders uncommon conjunctival hyperaemia, dry eye rare visual disturbance
Očesne bolezni občasni konjunktivalna hiperemija, suho oko redki motnje vida
Coadministration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
Sočasna uporaba učinkovin darunavir/kobicistat s šibkimi do zmernimi induktorji CYP3A (npr. efavirenz, etravirin, nevirapin, boceprevir, flutikazon in bosentan) ni priporočljiva (glejte spodnjo preglednico medsebojnih delovanj z drugimi zdravili).
Endocrine disorders uncommon hypothyroidism, increased blood thyroid stimulating hormone
Bolezni endokrinega sistema občasni hipotiroidizem, povišana koncentracija tirotropina v krvi
ANTIMALARIALS Artemether/Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether AUC ↓ 16% artemether Cmin ↔ artemether Cmax ↓ 18% dihydroartemisinin AUC ↓ 18% dihydroartemisinin Cmin ↔ dihydroartemisinin Cmax ↓ 18% lumefantrine AUC ↑ 175% lumefantrine Cmin ↑ 126% lumefantrine Cmax ↑ 65% darunavir AUC ↔ darunavir Cmin ↓ 13% darunavir Cmax ↔
ANTIMALARIKI artemeter/lumefantrin 80/480 mg, 6 odmerkov ob uri 0, 8, 24, 36, 48 in artemeter AUC ↓ 16 % artemeter Cmin ↔ artemeter Cmax ↓ 18 % dihidroartemisinin AUC ↓ 18 % dihidroartemisinin Cmin ↔ dihidroartemisinin Cmax ↓ 18 % lumefantrin AUC ↑ 175 % lumefantrin Cmin ↑ 126 % lumefantrin Cmax ↑ 65 % darunavir AUC ↔ darunavir Cmin ↓ 13 % darunavir Cmax ↔
Pregnant or breast feeding mothers should not take darunavir with cobicistat.
Noseče ali doječe matere ne smejo jemati zdravila darunavir skupaj s kobicistatom.
Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine,metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Povejte svojemu zdravniku, če jemljete: - amlodipin, diltiazem, dizopiramid, karvedilol,felodipin, flekainid,lidokain, metoprolol, meksiletin, nifedipin, nikardipin, propafenon, timolol, verapamil (za bolezni srca), ker se lahko zvečajo terapevtski ali neželeni učinki teh zdravil.
Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Pri uporabi 150 mg kobicistata z 800 mg darunavirja enkrat na dan je zvečanje farmakokinetičnih parametrov darunavirja primerljivo kot pri uporabi ritonavirja (glejte poglavje 5.2).
Co-administration of darunavir with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Sočasna uporaba darunavirja z majhnim odmerkom ritonavirja in učinkovin, pri katerih je očistek v veliki meri odvisen od CYP3A in pri katerih so zvišane plazemske koncentracije povezane z resnimi in/ali življenjsko nevarnimi dogodki.
Based on the different elimination pathways of the other NRTIs zidovudine, emtricitabine, stavudine, lamivudine, that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and darunavir coadministered with low dose ritonavir.
Zaradi različnih poti izločanja ostalih NRTI (zidovudin, emtricitabin, stavudin, lamivudin), ki se izločajo predvsem skozi ledvice, in abakavirja, ki se ne presnavlja preko CYP450, ni pričakovati medsebojnih delovanj med temi zdravili in darunavirjem skupaj z majhnim odmerkom ritonavirja.
The pharmacokinetic properties of darunavir, co-administered with cobicistat or ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients.
Farmakokinetične lastnosti darunavirja pri sočasni uporabi s kobicistatom ali z ritonavirjem so ovrednotili pri zdravih odraslih prostovoljcih in pri bolnikih, okuženih s HIV-1.
Limited data is available in patients with HIV-1 clades other than B.
O zdravljenju bolnikov z drugimi podtipi HIV-1 (razen podtipa B) je na voljo malo podatkov.
The pharmacokinetic properties of darunavir, co-administered with ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients.
Farmakokinetične lastnosti darunavirja pri sočasni uporabi z ritonavirjem so ovrednotili pri zdravih odraslih prostovoljcih in pri bolnikih, okuženih s HIV-1.
ANTIMYCOBACTERIALS Rifampicin
UČINKOVINE Z DELOVANJEM PROTI MIKOBAKTERIJAM rifampicin rifapentin
Concomitant use of other PDE-5 inhibitors for the treatment of erectile dysfunction with boosted darunavir should be done with caution.
Pri sočasni uporabi zaviralcev PDE5 (za zdravljenje motenj erekcije) z okrepljenim darunavirjem je primerljiva.