FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Na temelju različitih puteva eliminacije drugih NRTIova, zidovudina, emtricitabina, stavudina, lamivudina, koji se primarno izlučuju putem bubrega, te abakavira čiji metabolizam nije posredovan CYP450, ne očekuju se interakcije ovih lijekova i darunavira primijenjenog istodobno s niskom dozom ritonavira.
English: Medicinal products that may be affected by darunavir boosted with ritonavir
Croatian: Lijekovi na koje može utjecati darunavir pojačan s ritonavirom
English: Tell your doctor if you notice any musculoskeletal problems.
Croatian: - Upozorite liječnika ako primijetite bilo kakve tegobe s mišićima ili kostima.
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).
Croatian: Učinak teškog oštećenja funkcije jetre na farmakokinetiku darunavira nije ispitivan (vidjeti dijelove 4.2, 4.3 i 4.4).
English: 20 mg once daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Croatian: 20 mg jedanput na dan darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
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).
Croatian: Iako darunavir nije ispitivan u bolesnika s oštećenjem funkcije bubrega, analiza populacijskih farmakokinetičkih podataka pokazala je da u bolesnika inficiranih HIVom s umjerenim oštećenjem funkcije bubrega nije bilo značajnog utjecaja na farmakokinetiku darunavira (CrCl između 30-60 ml/min, n=20) (vidjeti dijelove 4.2 i
English: HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir Atazanavir
Croatian: Inhibitori Proteaze (IP) HIV-a - bez istodobne primjene dodatne niske doze ritonavira Atazanavir
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Croatian: Tijekom kliničkog dijela programa razvoja darunavira/ritonavira (n=3063), teške kožne reakcije, koje mogu biti praćene vrućicom i/ili povišenjima transaminaza, bile su prijavljene u 0,4% bolesnika.
English: Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Croatian: Broj ispitanika s virološkim neuspjehom i odgovarajući fenotip na početku/na kraju liječenja koji pokazuju gubitak osjetljivosti na IP na ishodu u usporedbi s onim na početku liječenja, n/N Inhibitori proteaze (IP) darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: 150 mg twice daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Croatian: 150 mg dvaput na dan darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: POWER 1 and POWER 2 are randomised, controlled trials comparing darunavir co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Croatian: U randomiziranim, kontroliranim ispitivanjima POWER 1 i POWER 2 uspoređivao se darunavir primijenjen istodobno s ritonavirom (600/100 mg dvaput na dan) s kontrolnom skupinom koja je primala režim IP prema izboru ispitivača u bolesnika inficiranih s HIV-1 koji su pokazali neuspjeh u više od 1 režima s IP.
English: Serious adverse reactions are diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash and vomiting.
Croatian: Ozbiljne nuspojave bile su dijabetes melitus, preosjetljivost (na lijek), upalni sindrom imunološke rekonstitucije, osip i povraćanje.
English: If this is noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Croatian: Ako se primijeti da je doza propuštena više od 6 sati nakon uobičajenog vremena uzimanja lijeka, propuštena doza se ne smije uzeti, a bolesnik mora ponovno nastaviti s uobičajenim rasporedom doziranja.
English: Darunavir was rapidly absorbed following oral administration.
Croatian: Darunavir se apsorbirao brzo nakon peroralne primjene.
English: KRKA-POLSKA Sp. z o.o.
Croatian: Sp. z o.o.
English: If a once daily dose of darunavir and/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 ritonavir with food as soon as possible.
Croatian: U slučaju kad je doza darunavira i/ili ritonavira koja se uzima jedanput na dan propuštena unutar 12 sati od uobičajenog vremena uzimanja, bolesnike se mora uputiti da propisanu dozu darunavira i ritonavira uzmu s hranom što je prije moguće.
English: Number of mutations from the list of mutations associated with a diminished response to darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V)
Croatian: Broj mutacija s popisa mutacija povezanih sa smanjenim odgovorom na darunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L ili M, T74P, L76V, I84V ili L89V)
English: If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Croatian: Ako je primijećeno da je doza propuštena više od 12 sati nakon uobičajenog vremena uzimanja lijeka, propuštena doza se ne smije uzeti, a bolesnik mora ponovno nastaviti s uobičajenim rasporedom doziranja.
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).
Croatian: Stoga se darunavir ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dijelove 4.3, 4.4 i 5.2).
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).
Croatian: Očekuje se da će lijekovi koji induciraju aktivnost CYP3A povisiti klirens darunavira i ritonavira i tako dovesti do smanjenih koncentracija ovih tvari u plazmi, te posljedično darunavira i na taj način dovesti do gubitka terapijskog učinka i mogućeg razvoja rezistencije (vidjeti dijelove 4.3 i 4.4).
English: (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
Croatian: KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
English: Clinical monitoring is recommended when co-administering darunavir with β-blockers.
Croatian: Preporučeno je kliničko praćenje kada se darunavir istodobno primjenjuje s β-blokatorima.
English: Medicinal products that may be affected by darunavir boosted with ritonavir Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Croatian: Lijekovi na koje može utjecati darunavir pojačan s ritonavirom Darunavir i ritonavir su inhibitori CYP3A, CYP2D6 i P-gp-a.
English: Even if you feel better, do not stop taking Darunavir Krka and ritonavir without talking to your doctor.
Croatian: Čak i ako se osjećate bolje, nemojte prestati uzimati lijek Darunavir Krka i ritonavir bez prethodnog razgovora s liječnikom.
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Croatian: Stoga se ne može isključiti istiskivanje proteina lijekovima koji imaju visoki afinitet vezanja na α1-kiseli glikoprotein (vidjeti dio 4.5).
English: Last Observation Carried Forward imputation
Croatian: Prenijeta pripisana vrijednost zadnjeg opažanja
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jirovecii (formerly known as Pneumocystis carinii).
Croatian: Relevantni primjeri su citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i pneumonija koju uzrokuje
English: Therefore, darunavir tablets should be taken with cobicistat or ritonavir and with food.
Croatian: Stoga se darunavir tablete moraju uzimati s kobicistatom ili ritonavirom te uz hranu.
English: What Darunavir Krka looks like and contents of the pack Darunavir Krka 400 mg film-coated tablets (tablets):
Croatian: Kako Darunavir Krka izgleda i sadržaj pakiranja Darunavir Krka 400 mg filmom obložene tablete (tablete):
English: If antidepressants are co-administered with boosted darunavir, the recommended approach is a dose titration of the antidepressant based on a clinical assessment of antidepressant response.
Croatian: Ako se antidepresivi primjenjuju uz pojačan darunavir, preporučeni pristup je titracija doze antidepresiva temeljeno na kliničkoj procjeni odgovora na antidepresiv.
English: Not studied with darunavir/ritonavir.
Croatian: Nije ispitano s darunavirom/ritonavirom.
English: Pregnant or breast feeding mothers should not take darunavir with cobicistat.
Croatian: Trudnice ili dojilje ne smiju uzimati darunavir s kobicistatom.
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.
Croatian: U svih ostalih bolesnika prethodno liječenih ART-om ili u slučaju nemogućnosti genotipizacije HIV-1, preporučeni režim doziranja je 600 mg dvaput na dan uz 100 mg ritonavira dvaput na dan, uzeto s hranom.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Croatian: Preporučuje se uzimanje drugog antitrombocitnog lijeka na kojeg ne utječe CYP inhibicija ili indukcija (npr. prasugrela).
English: Nevirapine 200 mg twice daily nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition)
Croatian: Nevirapin 200 mg dvaput na dan nevirapin AUC ↑ 27% nevirapin Cmin ↑ 47% nevirapin Cmax ↑ 18% darunavir: koncentracije su bile konzistentne s već postojećim podacima (↑ nevirapin zbog CYP3A inhibicije)
English: This dose must not exceed the recommended adult dose, which is 800 milligram Darunavir Krka together with 100 milligram ritonavir once a day.
Croatian: Ova doza ne smije prekoračiti preporučenu dozu za odrasle, što je 800 miligrama lijeka Darunavir Krka zajedno sa 100 miligrama ritonavira jedanput na dan.
English: Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Croatian: Stoga se darunavir mora primjenjivati samo u kombinaciji s farmakokinetičkim pojačivačem (vidjeti dijelove 4.4 i 5.2).
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Croatian: Kortikosteroidi prvenstveno metabolizirani putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon)
English: Do not combine Darunavir Krka with products that contain St John's wort (Hypericum perforatum).
Croatian: Nemojte kombinirati Darunavir Krka s pripravcima koji sadrže gospinu travu (Hypericum perforatum).
English: Darunavir is not recommended for use in paediatric patients below 3 years of age or less than 15 kg body weight (see sections 4.2 and 5.3).
Croatian: Darunavir se ne preporučuje u pedijatrijskih bolesnika mlađih od 3 godine starosti ili manje od 15 kg tjelesne težine (vidjeti dijelove 4.2 i 5.3).
English: Titanium dioxide (E171) Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
Croatian: poli(vinilni alkohol) makrogol titanijev dioksid (E171) talk (E553b) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
Croatian: Stoga, učinci na istodobno primijenjene lijekove mogu biti podcijenjeni pa može biti indicirano kliničko praćenje sigurnosti.
English: Metabolism and nutrition disorders common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Croatian: Poremećaji metabolizma i prehrane često anoreksija, dijabetes melitus, hiperkolesterolemija, hipertrigliceridemija, hiperlipidemija
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.
Croatian: Bolesnici su primili režim liječenja dvaput na dan ovisno o tjelesnoj težini, pri čemu su bolesnici tjelesne težine 10 kg do < 15 kg primili darunavir/ritonavir 25/3 mg/kg dvaput na dan, dok su bolesnici tjelesne težine 15 kg do < 20 kg primili darunavir/ritonavir 375/50 mg dvaput na dan.
English: Medicinal products that affect darunavir exposure (cobicistat as pharmacoenhancer)
Croatian: Lijekovi koji utječu na izloženost darunaviru (kobicistat kao farmakokinetički pojačivač)
English: Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Croatian: Ne-nukleo(z/t)idni inhibitori reverzne transkriptaze (NNRTI) Efavirenz
English: The maraviroc dose should be 150 mg twice daily when co-administered with boosted darunavir.
Croatian: Doza maraviroka mora biti 150 mg dvaput na dan kada se primjenjuje istodobno s pojačanim darunavirom.
English: Efavirenz in combination with darunavir /ritonavir 800/100 mg once daily may result in sub-optimal darunavir Cmin.
Croatian: Efavirenz u kombinaciji s darunavirom/ritonavirom od 800/100 mg jedanput na dan može rezultirati suboptimalnim vrijednostima darunavira Cmin.
English: 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 ↔
Croatian: ANTIMALARICI Artemeter/Lumefantrin 80/480 mg, 6 doza u 0., 8., 24., 36., 48. i 60. satu 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 ↔
English: 100 milligram ritonavir oral solution: 80 milligram per milliliter
Croatian: 100 miligrama oralna otopina ritonavira: 80 miligrama po mililitru
English: Cardiac disorders uncommon myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia rare acute myocardial infarction, sinus bradycardia, palpitations
Croatian: Srčani poremećaji manje često infarkt miokarda, angina pektoris, produljeni QT interval na elektrokardiogramu, tahikardija rijetko akutni infarkt miokarda, sinusna bradikardija, palpitacije
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted darunavir.
Croatian: Metabolizam alfentanila posredovan je putem CYP3A i kao takav može biti inhibiran pojačanim darunavirom.
English: Darunavir Krka is not a cure for HIV infection.
Croatian: Darunavir Krka neće izliječiti infekciju HIV-om.
English: Iron oxide, yellow (E172) - only for 400 mg film-coated tablets Iron oxide, red (E172)
Croatian: talk (E553b) željezov oksid, žuti (E172) - samo u 400 mg filmom obloženim tabletama željezov oksid, crveni (E172)
English: Tenofovir alafenamide ↔ Tenofovir ↑
Croatian: Emtricitabin/tenofoviralafenamid Tenofoviralafenamid ↔ Tenofovir ↑
English: Darunavir and cobicistat are metabolised by CYP3A, and co-administration with CYP3A inducers may therefore result in subtherapeutic plasma exposure to darunavir.
Croatian: Darunavir i kobicistat se metaboliziraju putem enzima CYP3A, stoga istodobna primjena s CYP3A induktorima može rezultirati supterapijskim izloženostima darunaviru u plazmi.
English: No special precautions or dose adjustments for darunavir/ritonavir are required in patients with renal impairment.
Croatian: Nisu potrebne posebne mjere opreza ili prilagodbe doze za darunavir/ritonavir u bolesnika s oštećenjem funkcije bubrega.
English: Postpartum (6-12 weeks)
Croatian: Postpartalno razdoblje (6-12 tjedana)
English: However, dizziness has been reported in some patients during treatment with regimens containing darunavir co-administered with low dose ritonavir and should be borne in mind when considering a patient's ability to drive or operate machinery (see section 4.8).
Croatian: Međutim, prijavljena je omaglica u nekih bolesnika tijekom liječenja režimima koji su sadržavali darunavir primijenjen istodobno s niskom dozom ritonavira, što se mora imati na umu kada se procjenjuje bolesnikova sposobnost vožnje ili upravljanja strojevima (vidjeti dio 4.8).
English: One ritonavira dose is between 15 and 30 kilograms 600 milligram
Croatian: Jedna doza darunavira je Jedna doza ritonavira a je između 15 i 30 kilograma 600 miligrama
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using darunavir/ritonavir, interruption or discontinuation of treatment should be considered promptly.
Croatian: Ako postoje dokazi o novoj ili pogoršanju disfunkcije jetre (uključujući klinički značajno povišenje enzima jetre i/ili simptomi poput umora, anoreksije, mučnine, žutice, tamne mokraće, osjetljivosti jetre, hepatomegalije) u bolesnika koji uzimaju darunavir/ritonavir mora se odmah razmotriti privremeni ili trajni prekid liječenja.
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔*
Croatian: LIJEKOVI KOJI DJELUJU NA HIV Inhibitori prijenosa lanca integraze Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔*
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of darunavir used in combination with cobicistat or low dose ritonavir treatment.
Croatian: Mora se razmotriti pojačano praćenje AST/ALT u bolesnika s podležećim kroničnim hepatitisom, cirozom ili u bolesnika koji su prije liječenja imali povišenja transaminaza, posebno tijekom prvih nekoliko mjeseci liječenja darunavirom koji se uzima u kombinaciji s kobicistatom ili niskom dozom ritonavira.
English: It is not recommended to alter the dose of cobicistat or ritonavir.
Croatian: Ne preporučuje se mijenjati dozu kobicistata ili ritonavira.
English: Adverse reactions observed with darunavir/cobicistat in adult patients
Croatian: Nuspojave zabilježene s darunavirom/kobicistatom u odraslih bolesnika
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when darunavir coadministered with low dose ritonavir is given in combination with efavirenz.
Croatian: Kliničko praćenje toksičnosti na središnji živčani sustav povezano s povećanom izloženosti efavirenzu može biti indicirano kada je darunavir istodobno primijenjen s niskom dozom ritonavira i dan u kombinaciji s efavirenzom.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Croatian: Prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartrozu u bolesnika s hemofilijom tipa
English: In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
Croatian: Pri odlučivanju o uvođenju liječenja darunavirom u bolesnika prethodno liječenih ART-om, u primjeni darunavira treba se rukovoditi rezultatima genotipizacije (vidjeti dijelove 4.2, 4.3, 4.4 i 5.1).
English: If antidepressants are co-administered with darunavir with low dose ritonavir, the recommended approach is a dose titration of the antidepressant based on a clinical assessment of antidepressant response.
Croatian: Ako se antidepresivi primjenjuju uz darunavir s niskom dozom ritonavira, preporučeni pristup je titracija doze antidepresiva temeljeno na kliničkoj procjeni odgovora na antidepresiv.
English: No treatment related mortalities were noted in juvenile rats dosed at 1,000 mg/kg darunavir (single dose) on day 26 of age or at 500 mg/kg (repeated dose) from day 23 to 50 of age, and the exposures and toxicity profile were comparable to those observed in adult rats.
Croatian: Nije bila zabilježena smrtnost uslijed liječenja mladih štakora pri dozi od 1000 mg/kg darunavira (jednokratna doza) na 26. dan starosti ili pri dozama od 500 mg/kg (ponovljene doze) od 23. do 50. dana starosti.
English: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Croatian: - kortikosteroidi uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Croatian: U 192 tjednoj analizi nije bilo novih sigurnosnih nalaza u prethodno neliječenih ispitanika, a u kojih je srednja vrijednost trajanja liječenja darunavirom/ritonavirom od 800/100 mg jednaput na dan bila 162,5 tjedana.
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by darunavir co-administered with low dose ritonavir.
Croatian: Metabolizam alfentanila posredovan je putem CYP3A, i kao takav može biti inhibiran darunavirom istodobno primijenjenim s niskom dozom ritonavira.
English: In addition, pharmacokinetic modeling and simulation of darunavir exposures in paediatric patients across the ages of 3 to < 18 years confirmed the darunavir exposures as observed in the clinical studies and allowed the identification of weight-based darunavir/ritonavir once daily dosing regimens for paediatric patients weighing at least 15 kg that are either ART-naïve or treatment-experienced paediatric patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Croatian: Dodatno, farmakokinetičko modeliranje i simulacija izloženosti darunaviru u pedijatrijskih bolesnika u rasponu dobi 3 do < 18 godina potvrdilo je izloženosti darunaviru kako je uočeno u kliničkim ispitivanjima, te je identificiralo režim doziranja za darunavir/ritonavir temeljen na težini jednaput na dan za pedijatrijske bolesnike težine najmanje 15 kg koji prethodno nisu liječeni ART-om ili za prethodno liječene pedijatrijske bolesnike koji nemaju DRV-RAM* a imaju plazmatsku HIV-1 RNK < 100 000 kopija/ml i broj CD4+ stanica ≥ 100 stanica x 10
English: Rilpivirine 150 mg once daily rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
Croatian: Rilpivirin 150 mg jedanput na dan rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79% darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Croatian: 150 mg dvaput na dan maravirok AUC ↑ 305% maravirok Cmin ND maravirok Cmax ↑ 129% koncentracije darunavira, ritonavira bile su sukladne s podacima u anamnezi.