FrancophonIA/ELRC3.0 huggingface dataset:
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 mg/100 mg odmerku darunavirja z ritonavirjem posledica matične učinkovine.
English: How to store Darunavir Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Darunavir Mylan Vsebina pakiranja in dodatne informacije
English: - in certain patients who have used antiretroviral medicines before (your doctor will determine this).
Slovenian: - Pri nekaterih bolnikih, ki so že prejemali protiretrovirusna zdravila (to bo določil zdravnik).
English: Other strengths of Darunavir Mylan are available.
Slovenian: Na voljo so druge jakosti zdravila Darunavir Mylan.
English: Co-administration 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).
Slovenian: Sočasna uporaba učinkovin darunavir/kobicistat s šibkimi do zmernimi induktorji CYP3A (npr. efavirenz, etravirin, nevirapin, boceprevir, flutikazon in bosentan) ni priporočljiva (glejte spodnjo preglednico interakcij).
English: The dosage of other medicines might need to be changed since either their own or darunavir'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 darunavirja.
English: Based on theoretical considerations darunavir is expected to increase alfuzosin plasma concentrations.
Slovenian: Na podlagi teoretičnih podatkov se pričakuje, da darunavir poveča koncentracije alfuzosina v plazmi.
English: - The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day.
Slovenian: - Predpisani odmerek darunavirja in ritonavirja mora otrok zaužiti dvakrat na dan ali enkrat na dan.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Slovenian: Čeprav darunavirja niso proučevali pri bolnikih z okvaro ledvic, pa je populacijska analiza farmakokinetike pokazala, da farmakokinetika darunavirja ni pomembno spremenjena pri bolnikih z zmerno okvaro ledvic, okuženih s HIV (očistek kreatinina med 30-60 ml/min, n=20) (glejte poglavji 4.2 in 4.4).
English: Always take with ritonavir and food.
Slovenian: Zdravilo vedno jemljite z ritonavirjem in hrano.
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Slovenian: Preglednica prikazuje podatke analize učinkovitosti po 48 in 96 tednih preskušanja ARTEMIS:
English: Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women (18 in each arm) during the second and third trimesters, and postpartum.
Slovenian: Darunavir/ritonavir (600 mg/100 mg dvakrat na dan ali 800 mg/100 mg enkrat na dan) v kombinaciji z osnovno shemo so ocenjevali v kliničnem preskušanju pri 36 nosečnicah (18 v vsaki skupini) med drugim in tretjim trimesečjem nosečnosti ter v obdobju po porodu.
English: Therapy should be initiated by a health care provider experienced in the management of HIV infection.
Slovenian: Terapijo sme uvesti samo zdravnik z izkušnjami z zdravljenjem okužbe s HIV.
English: angioedema, pruritus, urticaria 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: 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 darunavirjem/ritonavirjem je treba opraviti ustrezne laboratorijske teste in spremljati bolnika med zdravljenjem.
English: 800 milligram
Slovenian: 800 miligramov
English: These can be seen in the results of blood and/or urine tests.
Slovenian: To pokažejo rezultati testov krvi/urina, ki vam jih bo razložil zdravnik.
English: The combination of 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 artemeterja/lumefantrina se lahko uporablja brez prilagajanja odmerkov, vendar je zaradi zvečane izpostavljenosti lumefantrinu pri tej kombinaciji potrebna previdnost.
English: Voriconazole should not be combined with boosted darunavir unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Slovenian: Vorikonazola se ne sme sočasno uporabljati z okrepljenim darunavirjem, razen če ocena razmerja med koristmi in tveganjem in upravičuje uporabo vorikonazola.
English: If there is a need to combine darunavir/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Slovenian: Če je potrebna sočasna uporaba darunavirja/ritonavirja in karbamazepina, je treba bolnike spremljati zaradi možnosti pojava neželenih učinkov, povezanih s karbamazepinom.
English: Darunavir cannot work properly without food.
Slovenian: Brez hrane darunavir ne more pravilno delovati.
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to PIs in virologic failures at endpoint in the ARTEMIS, ODIN and TITAN trials.
Slovenian: Spodnja preglednica prikazuje razvoj mutacij zaviralcev proteaze HIV-1 in zmanjšanje občutljivosti za PI pri bolnikih z virološko odpovedjo v preskušanjih ARTEMIS, ODIN in TITAN.
English: Limited data are available in patients with HIV-1 clades other than B (see section 5.1).
Slovenian: Podatkov o zdravljenju bolnikov z drugimi podtipi virusa HIV-1 (razen pod-tipa B) je malo (glejte poglavje 5.1).
English: Cobicistat as a pharmacokinetic enhancer of darunavir should, therefore, not be initiated in patients with creatine clearance less than 70 ml/min if any co-administered agent requires dose adjustment based on creatinine clearance: e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipovoxil.
Slovenian: Kobicistata kot farmakokinetičnega ojačevalca darunavirja se ne sme uvesti bolnikom z očistkom kreatinina manj kot 70 ml/min, če je treba za eno ali več sočasno danih učinkovin odmerek prilagajati na osnovi očistka kreatinina (npr. emtricitabin, lamivudin, dizoproksiltenofovirat (v obliki fumarata, fosfata ali sukcinata) ali adefovirdipivoksilat).
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 μg 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 8289%).
Slovenian: Flutikazon: v kliničnem preskušanju, v katerem 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: 600 milligram
Slovenian: 600 miligramov
English: Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack Do not store above 25°C.
Slovenian: Darunavir Mylan 800 mg filmsko obložene tablete Pretisni omot (PVC/PE/PVDC-Al) Ne shranjujte pri temperaturi nad 25 °C.
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Slovenian: V obeh krakih preskušanja so uporabljali osnovno shemo zdravljenja, ki je bila sestavljena iz 300 mg tenofovirdizoproksil fumarata enkrat na dan in 200 mg emtricitabina enkrat na dan.
English: Rifabutin 150 mg once every other day rifabutin AUC** ↑ 55% rifabutin Cmin
Slovenian: 150 mg enkrat vsak drugi dan rifabutin AUC** ↑ 55 % rifabutin Cmin
English: Polyvinyl alcohol, partially hydrolysed Titanium dioxide (E171) Macrogol
Slovenian: Filmska obloga tablete polivinilalkohol, delno hidroliziran titanov dioksid (E171) makrogol smukec
English: The recommended dose of darunavir with low dose ritonavir should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Slovenian: Priporočeni odmerek darunavirja skupaj z majhnim odmerkom ritonavirja ne sme preseči priporočenega odmerka za odrasle (600 mg/100 mg dvakrat na dan ali 800 mg/100 mg enkrat na dan).
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: Boosted darunavir may increase the exposure to grazoprevir.
Slovenian: Okrepljeni darunavir lahko zveča izpostavljenost grazoprevirju.
English: In the setting of lack or loss of virological response, resistance testing should be performed.
Slovenian: V primeru premajhnega virološkega odziva ali neodziva je treba izvesti testiranje odpornosti na darunavir.
English: Darunavir might increase sugar levels in the blood.
Slovenian: Darunavir lahko zveča koncentracijo sladkorja v krvi.
English: Uncommon side effects (may affect up to 1 in 100 people) - chest pain, changes in electrocardiogram, rapid heart beating - decreased or abnormal skin sensitivity, pins and needles, attention disturbance, loss of memory,
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - bolečine v prsih, spremembe elektrokardiograma, hitro bitje srca - zmanjšana ali nenavadna občutljivost kože, zbadanje, motnje pozornosti, izguba spomina,
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Slovenian: Odmerek simeprevirja v tej interakcijski študiji je bil 50 mg ob sočasni uporabi s kombinacijo darunavir/ritonavir, v primerjavi s skupino, ki je uporabila samo 150 mg simeprevirja.
English: Instructions for adults - Take two 400 milligram tablets at the same time, once a day, every day.
Slovenian: Navodila za odrasle - Enkat na dan, vsak dan vzemite dve 400-miligramski tableti istočasno.
English: Voriconazole should not be combined with darunavir coadministered with low dose ritonavir unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Slovenian: Vorikonazola se ne sme sočasno uporabljati z darunavirjem z majhnim odmerkom ritonavirja, razen če ocena razmerja med koristmi in tveganjem opravičuje uporabo vorikonazola.
English: (CYP3A and OATP1B inhibition).
Slovenian: (zaviranje CYP3A in OATP1B)
English: In an interaction study #, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with darunavir and low dose ritonavir.
Slovenian: V študiji medsebojnih delovanj# je bila sistemska izpostavljenost sildenafilu po zaužitju enkratnega odmerka 100 mg samega sildenafila in enkratnega odmerka 25 mg sildenafila skupaj z darunavirjem in majhnim odmerkom ritonavirja primerljiva.
English: Cobicistat has not been studied in patients receiving dialysis, and, therefore, no recommendation can be made for the use of darunavir/cobicistat in these patients.
Slovenian: Pri bolnikih, ki se zdravijo z dializo, kobicistata niso preučevali, zato priporočil za uporabo darunavirja/kobicistata pri teh bolnikih ni mogoče podati.
English: Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines.
Slovenian: V kombinaciji s kobicistatom ali ritonavirjem, darunavir nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: atorvastatin Cmax ↑ 319%
Slovenian: atorvastatin Cmax ↑ 319 % Ω atorvastatin Cmin ND
English: Other severe side effects were diabetes (common), and inflammation of the pancreas (uncommon).
Slovenian: Druga resna neželena učinka sta bila sladkorna bolezen (pogosto) in vnetje trebušne slinavke (občasno).
English: Based upon the safety profile of darunavir/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for darunavir/ritonavir.
Slovenian: Glede na varnostni profil kombinacije darunavir/ritonavir, zvečanje izpostavljenosti darunavirju v prisotnosti ritonavirja ne zahteva zmanjšanja odmerka darunavirja/ritonavir.
English: 100 milligram a ritonavir oral solution: 80 milligram per milliliter
Slovenian: 100 miligramov a peroralna raztopina ritonavirja: 80 miligramov na mililiter
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Slovenian: KORTIKOSTEROIDI kortikosteroidi, ki se presnavljajo predvsem s CYP3A (vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom in triamcinolonom)
English: NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone individual dose ranging from 55 mg to 150 mg once daily
Slovenian: OPIODI / ZDRAVLJENJE ODVISNOSTI OD OPIOIDOV metadon odmerki 55 mg-150 mg enkrat na dan
English: Darunavir Mylan 800 mg tablets is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Slovenian: Zdravilo Darunavir Mylan 800 miligramov se ne sme uporabljati pri otrocih, mlajših od 3 let, ali s telesno maso manj kot 40 kg.
English: Ritonavir may decrease plasma concentrations of voriconazole.
Slovenian: Ritonavir lahko zmanjša plazemske koncentracije vorikonazola.
English: If a once daily dose of darunavir and/or cobicistat or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and cobicistat or ritonavir with food as soon as possible.
Slovenian: Če je bil enkrat dnevni odmerek darunavirja/ in/ ali kobicistata ali ritonavirja izpuščen in je bilo to opaženo v 12 urah od časa, ko je ponavadi zaužit, je treba bolniku svetovati, naj čimprej vzame predpisani odmerek darunavirja in kobicistata ali ritonavirja s hrano.
English: - The child must swallow the tablets with a drink such as water or milk.
Slovenian: - Otrok mora tablete pogoltniti s pijačo, kot sta voda ali mleko.
English: Darunavir Mylan 400 mg film-coated tablets This medicinal product does not require any special storage conditions.
Slovenian: Darunavir Mylan 400 mg filmsko obložene tablete Za shranjevanje zdravila niso potrebna posebna navodila.
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: 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 okrepljenega darunavirja in učinkovin artemeter/lumefantrin se lahko uporablja brez prilagajanja odmerkov, vendar je zaradi zvečane izpostavljenosti lumefantrinu, pri tej kombinaciji potrebna previdnost.
English: Caution should be used in pregnant women with concomitant medications which may further decrease darunavir exposure (see sections 4.5 and 5.2).
Slovenian: Pri nosečnicah, ki sočasno jemljejo zdravila, katera lahko dodatno zmanjšajo izpostavljenost darunavirju, je potrebna previdnost (glejte poglavji 4.5 in 5.2).
English: Concomitant use of other PDE-5 inhibitors for the treatment of erectile dysfunction with boosted darunavir should be done with caution.
Slovenian: Pri sočasni uporabi zaviralcev PDE-5 (za zdravljenje motenj erekcije) z okrepljenim darunavirjem je potrebna previdnost.
English: Darunavir Mylan 800 mg tablets are intended for once daily use only.
Slovenian: 800-miligramske tablete zdravila Darunavir Mylan so namenjene za uporabo enkrat na dan.
English: ● In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Slovenian: • Pri vseh drugih bolnikih, predhodno zdravljenih z ART, pri katerih ni rezultatov testiranja genotipa, je priporočeno odmerjanje 600 mg darunavirja dvakrat na dan, skupaj s 100 mg ritonavirja dvakrat na dan, s hrano.
English: Darunavir binds primarily to plasma α1-acid glycoprotein.
Slovenian: Darunavir se veže predvsem na plazemski alfa1- kisli glikoprotein.
English: Serious adverse reactions are diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash and vomiting.
Slovenian: Resni neželeni učinki so diabetes melitus, preobčutljivost (na učinkovino), sindrom obnove imunskega odgovora, izpuščaj in bruhanje.
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: V primeru, da je bil odmerek darunavirja in/ali ritonavirja izpuščen in je bilo to opaženo v 6 urah od običajnega časa zaužitja odmerka, je treba bolniku svetovati, naj predpisani odmerek darunavirja in ritonavirja čimprej vzame skupaj s hrano.
English: 3 years In-use shelf life after first opening HDPE bottle: 100 days
Slovenian: 3 leta Rok uporabnosti po prvem odprtju HDPE plastenke: 100 dni.
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 maso 15 kg do < 20 kg pa darunavir/ritonavir 375 mg/50 mg dvakrat na dan.
English: An OBR consisting of at least 2 NRTIs with or without enfuvirtide (ENF) was used in both trials.
Slovenian: V obeh preskušanjih so uporabljali shemo OBR, ki je vsebovala najmanj 2 NRTI, z ali brez enfuvirtida (ENF).
English: Some side effects are typical for anti-HIV medicines in the same family as darunavir.
Slovenian: Nekateri neželeni učinki so značilni za skupino zdravil proti okužbi s HIV, v katero sodi tudi darunavir.
English: What is Darunavir Mylan?
Slovenian: Kaj je zdravilo Darunavir Mylan?
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking Darunavir Mylan.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte strojev in ne vozite avtomobila, če ste po jemanju zdravila Darunavir Mylan omotični.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Slovenian: V kliničnem preskušanju darunavirja/ritonavirja (n=3.063) se je hepatitis pojavil pri 0,5 % bolnikov, ki so prejemali kombinirano protiretrovirusno zdravljenje z darunavirjem/ritonavirjem.
English: These patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily with an investigator selected background regimen consisting of 2 active NRTIs.
Slovenian: Ti bolniki so prejemali 800 mg darunavirja enkrat na dan skupaj s 150 mg kobicistata enkrat na dan skupaj z optimiziranim osnovnim režimom (OBR - Optimised Background Regimen) zdravljenja z dvema aktivnima NRTI po izboru raziskovalca.
English: 150 mg twice daily darunavir AUC ↔ #darunavir Cmin ↔ darunavir Cmax ↔
Slovenian: 20 mg enkrat na dan darunavir AUC ↔ #darunavir Cmin ↔ darunavir Cmax ↔
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: - The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: - Močni induktorji CYP3A: rifampicin in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
English: 375 milligram darunavir + 50 milligram ritonavir twice a day between 30 and 40 kilograms
Slovenian: 375 miligramov darunavirja + 50 miligramov ritonavirja dvakrat na dan med 30 in 40 kilogrami
English: Patients should be instructed to take Darunavir Mylan with low dose ritonavir within 30 minutes after completion of a meal.
Slovenian: Bolnike je treba poučiti, da najkasneje v 30 minutah po obroku vzamejo zdravilo Darunavir Mylan skupaj z majhnim odmerkom ritonavirja.
English: Ciclosporin Sirolimus Tacrolimus Everolimus
Slovenian: IMUNOSUPRESIVI ciklosporin sirolimus takrolimus everolimus
English: The evidence of efficacy of darunavir co-administered with ritonavir (600/100 mg twice daily) in ART-experienced patients is based on the 96 weeks analysis of the Phase III trial TITAN in ART-experienced lopinavir naïve patients, on the 48 week analysis of the Phase III trial ODIN in ART-experienced patients with no DRV-RAMs, and on the analyses of 96 weeks data from the Phase IIb trials POWER 1 and 2 in ART-experienced patients with high level of PI resistance.
Slovenian: Dokazi o učinkovitosti darunavirja z ritonavirjem (600 mg/100 mg dvakrat na dan) pri bolnikih, predhodno zdravljenih z ART, temeljijo na analizi podatkov po 96 tednih zdravljenja v kliničnem preskušanju faze III (preskušanje TITAN) pri bolnikih, predhodno zdravljenih z ART, ki še niso prejemali lopinavirja, na analizi podatkov po 48 tednih preskušanja faze III (ODIN) pri bolnikih, predhodno zdravljenih z ART, ki nimajo DRV-RAMov, ter na analizi podatkov po 96 tednih zdravljenja iz kliničnih preskušanj faze IIb (preskušanja POWER 1, in 2) pri bolnikih, predhodno zdravljenih z ART z visoko stopnjo odpornosti za PI.
English: - Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Slovenian: - Povejte svojemu zdravniku, če ste že kdaj imeli težave z jetri, vključno z okužbo s hepatitisom B ali C. Zdravnik bo lahko ovrednotil resnost vaše jetrne bolezni, preden se odloči, ali lahko jemljete darunavir.
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 pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri bolnikih, okuženih s HIV, s hudo imunsko pomanjkljivostjo ob uvedbi kombinirane protiretrovirusne terapije (CART - Combination Antiretroviral Therapy), se lahko pojavi vnetna reakcija na asimptomatske ali prikrite oportunistične okužbe in povzroči resna klinična stanja ali poslabšanje simptomov.