FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir Krkad.d.has only been used in limited numbers of patients 65 years or older.
Croatian: Darunavir Krka d.d. je primjenjivan samo u ograničenog broja bolesnika u dobi od 65 godina ili starijih.
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.
Croatian: Prema tome, kobicistat koji se koristi kao farmakokinetički pojačivač darunavira ne smije se početi davati bolesnicima s klirensom kreatinina manjim od 70 ml/min, ako bilo koji od istodobno primijenjenih lijekova zahtjeva prilagodbu doze temeljenu na klirensu kreatinina: npr. emtricitabin, lamivudin, tenofovir dizoproksil (u obliku fumarata, fosfata ili sukcinata) ili adefovir dipovoksil.
English: Darunavir Krkad.d.cannot work properly without food.
Croatian: Darunavir Krka d.d. ne može pravilno djelovati bez hrane.
English: Baseline genotype or phenotype and virologic outcome Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Croatian: Početni genotip ili fenotip i virološki ishod Početni genotip i PV darunavira (promjena u osjetljivosti u odnosu na referentnu vrijednost) pokazali su se predikcijskim faktorima virološkog ishoda.
English: What Darunavir Krka d.d.contains -The active substance is darunavir.
Croatian: Što Darunavir Krka d.d. sadrži - Djelatna tvar je darunavir.
English: The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1-acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Croatian: Povišena izloženost darunaviru u bolesnika inficiranih s HIV-1 u usporedbi sa zdravim ispitanicima može se objasniti višim koncentracijama α1-kiselog glikoproteina (AAG, od engl. α1-acid glycoprotein) u bolesnika inficiranih s HIV-1, što može rezultirati višim vezivanjem darunavira na AAG u plazmi i stoga višim koncentracijama u plazmi.
English: • For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least
Croatian: - Za liječenje HIV-1 infekcije u pedijatrijskih bolesnika u dobi od 3 godine i težine najmanje 15 kg.
English: Virogic failures were defined as: never suppressed: confirmed HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/ml at the week-8; rebound: HIV-1 RNA < 50 copies/ml followed by confirmed HIV-1 RNA to ≥ 400 copies/ml or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/ml at last visit IAS-USA lists In GS-US216-130 baseline phenotype was not available
Croatian: Virološki neuspjeh definiran je kao: nikad suprimiran: potvrđena HIV-1 RNK < 1 log10 smanjenje u odnosu na početnu vrijednost i ≥ 50 kopija/ml u 8.tjednu; povratak: HIV-1 RNK < 50 kopija/ml nakon čega slijedi potvrđena HIV-1 RNK do ≥ 400 kopija/ml ili potvrđeni > 1 log10 HIV-1 RNK porast u odnosu na najnižu točku (od engl.nadir); prekid liječenja sa HIV-1 RNK ≥ 400 kopija/ml pri zadnjoj posjeti IAS-USA liste U GS-US216-130 fenotip na početku nije bio dostupan
English: Co-administration with strong CYP3A4 inhibitors is not recommended and caution is warranted, these interactions are described in the interaction table below (e.g. indinavir, azole antifungals like clotrimazole).
Croatian: inhibitorima se ne preporučuje i savjetuje se oprez, ove interakcije opisane su u tablici interakcija ispod (npr. indinavir, antifungalni azoli poput klotrimazola).
English: Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Croatian: Na temelju normalne aproksimacije razlike u % odgovora Bolesnik koji nije završio ispitivanje zabilježen je kao neuspjeh: bolesnicima koji su prijevremeno prekinuli ispitivanje pripisana je promjena jednaka 0
English: Refer to section 4.4 if creatinine clearance is used for dose adjustment of tenofovir disoproxil.
Croatian: Pogledajte dio 4.4 ako se klirens kreatinina koristi za prilagodbu doze tenofovir dizoproksila.
English: twice daily the child must take one dose in the morning, and one dose in the evening.
Croatian: Ako je Darunavir Krka d.d. propisan dvaput na dan dijete mora uzeti jednu dozu ujutro, a jednu dozu navečer.
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Croatian: KORTIKOSTEROIDI Kortikosteroidi prvenstveno metabolizirani putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon)
English: if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6), if you have severe liver problems.
Croatian: Nemojte uzimati Darunavir Krka d.d. - ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako imate teške jetrene tegobe.
English: When administration of atorvastatin and boosted darunavir is desired, it is recommended to start with an atorvastatin dose of 10 mg once daily.
Croatian: Kada se želi primijeniti atorvastatin i pojačan darunavir, preporučuje se početi s dozom atorvastatina od 10 mg jedanput na dan.
English: 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2).
Croatian: Darunavir Krka d.d. od 400 mg i 800 mg tablete mogu se primjenjivati da bi se osigurali prikladni režimi doziranja za liječenje HIV-1 infekcije u odraslih i pedijatrijskih bolesnika od 3 godine starosti i tjelesne težine barem 40 kg koji: - nisu prethodno liječeni antiretrovirusnom terapijom (ART) (vidjeti dio 4.2).
English: tablets and how much ritonavir (capsules, tablets or solution) the child must take.
Croatian: Liječnik će odrediti koliko tableta lijeka Darunavir Krka d.d. i koliko ritonavira (kapsula, tableta ili otopine) dijete mora uzimati.
English: In contrast to these data with darunavir /ritonavir, darunavir/cobicistat may increase these antidepressant plasma concentrations (CYP2D6 and/or CYP3A inhibition).
Croatian: Suprotno u odnosu na ove podatke s darunavirom/ritonavirom, darunavir/kobicistat može povisiti koncentracije tih antidepresiva u plazmi (CYP2D6 i/ili CYP3A inhibicija).
English: Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with darunavir/cobicistat once daily in combination with other ART, and in ARTexperienced patients with no darunavir RAMs receiving darunavir/cobicistat in combination with other ART.
Croatian: Niske stope razvijanja rezistentnog HIV-1 virusa bile su uočene u bolesnika koji prethodno nisu liječeni ART-om i koji su liječeni prvi put s darunavirom/kobicistatom jedanput na dan u kombinaciji s drugim ART-om, i u bolesnika koji su prethodno liječeni ART-om bez mutacija povezanih s rezistencijom (RAM) na darunavir koji primaju darunavir/kobicistat u kombinaciji s drugim ART-om.
English: Darunavir/ritonavir 10 kg to < 15 kg N=5
Croatian: Ishodi u 48 tjednu darunavir/ritonavir 10 kg do < 15 kg N=5
English: Outcomes darunavir/ritonavir
Croatian: darunavir/ritonavi
English: Patients should be instructed to take darunavir with cobicistat or low dose ritonavir within 30 minutes after completion of a meal.
Croatian: Bolesnike se mora uputiti da uzimaju darunavir s kobicistatom ili niskom dozom ritonavira unutar 30 minuta nakon završetka obroka.
English: Other medicines and Darunavir Krka d.d.
Croatian: Drugi lijekovi i Darunavir Krka d.d.
English: One ritonavir a 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: For use in these patients, more suitable formulations containing darunavir should be checked for their availability.
Croatian: Za primjenu u tih bolesnika potrebno je provjeriti dostupnost prikladnijih oblika koji sadrže darunavir.
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Croatian: Atorvastatin 10 mg jedanput na dan atorvastatin AUC ↑ 3-4 puta atorvastatin Cmin ↑ ≈5.5-10 puta atorvastatin Cmax ↑ ≈2 puta darunavir/ritonavir atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin NO
English: 400 or 800 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Croatian: Tableta lijeka Darunavir Krka d.d. od 400 miligrama ili 800 miligrama nije namijenjena za primjenu u djece mlađe od 3 godine ili tjelesne težine manje od 40 kilograma.
English: 600 mg tablets can be used to construct the twice daily 600 mg regimen.
Croatian: Darunavir Krka d.d. od 600 mg tablete mogu se primijeniti za dostizanje režima doziranja od 600 mg dvaput na dan.
English: Even when you feel better, do not stop taking Darunavir Krka d.d.. Talk to your doctor first.
Croatian: Čak i ako se osjećate bolje, nemojte prestati uzimati lijek Darunavir Krka d.d. Najprije razgovarajte sa svojim liječnikom.
English: without talking to your doctor first Anti-HIV medicine may make you feel better.
Croatian: Uz lijekove protiv HIV-a možete se početi osjećati bolje.
English: Clinical monitoring is recommended when co-administering boosted darunavir with these sedatives/hypnotics and a lower dose of the sedatives/hypnotics should be considered.
Croatian: Preporučuje se kliničko praćenje kada se istodobno primjenjuje darunavir s tim sedativima/hipnoticima i u obzir treba uzeti nižu dozu sedativa/hipnotika.
English: The maraviroc dose should be 150 mg twice daily when co-administered with darunavir with low dose ritonavir.
Croatian: Doza maraviroka mora biti 150 mg dvaput na dan kada se primjenjuje istodobno s darunavirom s niskom dozom ritonavira.
English: In patients taking Darunavir Krka d.d.and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Croatian: U bolesnika koji uzimaju Darunavir Krka d.d. i raltegravir (za HIV infekciju) u kombinaciji, osipi (obično blagi ili umjereni) mogu se javiti češće nego u bolesnika koji uzimaju samo jedan od ovih lijekova.
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.
Croatian: Ovi bolesnici su primali darunavir 800 mg jedanput na dan u kombinaciji s kobicistatom od 150 mg jedanput na dan s osnovnim liječenjem koje je uključilo 2 aktivna NRTI-ja po izboru ispitivača.
English: and cobicistat or ritonavir as recommended by your doctor.
Croatian: Krka d.d. i ritonavirom, uzimajte prema preporuci Vašeg liječnika.
English: Darunavir with low dose ritonavir may increase the exposure to grazoprevir.
Croatian: Darunavir s niskom dozom ritonavira može povećati izloženost grazopreviru.
English: Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
Croatian: perfenazin, risperidon, tioridazin (za liječenje psihijatrijskih stanja).
English: CALCIUM CHANNEL BLOCKERS
Croatian: BLOKATORI KALCIJEVIH KANALA Amlodipin
English: Your doctor will advise you how to deal with your symptoms or whether Darunavir Krka d.d.
Croatian: Liječnik će Vam savjetovati što učiniti vezano uz pojavu simptoma i morate li prestati s uzimanjem lijeka Darunavir Krka d.d.
English: Caution should be used in pregnantwomen with concomitant medications which may further decrease darunavir exposure (see sections 4.5 and 5.2).
Croatian: U trudnica je potreban oprez s konkomitantnom terapijom koja može dodatno sniziti izloženost darunaviru (vidjeti dijelove 4.5 i 5.2).
English: Efavirenz in combination with darunavir may result in sub-optimal darunavir Cmin.
Croatian: Efavirenz u kombinaciji s darunavirom može rezultirati suboptimalnom vrijednošću Cmin darunavira.
English: Take Darunavir Krkad.d.with food.
Croatian: - Lijek Darunavir Krka d.d. uzimajte s hranom.
English: 100 milligram ritonavir oral solution: 80 milligram per millilitre
Croatian: 100 miligrama oralna otopina ritonavira: 80 miligrama po mililitru
English: can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Croatian: NRTI (nukleozidni inhibitori reverzne transkriptaze), NNRTI (ne-nukleozidni inhibitori reverzne transkriptaze), antagonisti receptora CCR5 i IF (inhibitori fuzije)].
English: is and what it is used for What you need to know before you take Darunavir Krka d.d.
Croatian: Što je Darunavir Krka d.d. i za što se koristi Što morate znati prije nego počnete uzimati Darunavir Krka d.d. Kako uzimati Darunavir Krka d.d.
English: Perphenazine, risperidone, thioridazine (to treat psychiatric conditions)
Croatian: - perfenazin, risperidon, tioridazin (za liječenje psihijatrijskih stanja)
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔* * Using cross-study comparisons to historical pharmacokinetic data
Croatian: LIJEKOVI KOJI DJELUJU NA HIV Inhibitori prijenosa lanca integraze Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔* * Koristeći unakrižnu usporedbu ispitivanja s prethodnim farmakokinetičkim podacima
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.
Croatian: Kada se primijeni u kombinaciji s darunavirom istodobno primijenjenim s niskom dozom ritonavira u kombinaciji s indinavirom, može biti potrebna prilagodba doze indinavira s 800 mg dvaput na dan na 600 mg dvaput na dan u slučaju nepodnošljivosti.
English: Imputations according to the TLOVR algorithm b
Croatian: Pripisane vrijednosti izračunate prema TLOVR algoritmu b
English: The concomitant use with darunavir and low dose ritonavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Croatian: Istodobna primjena s darunavirom i niskom dozom ritonavira može zahtijevati snižavanje doze alfentanila i zahtijeva praćenje rizika na produljenu ili odgođenu respiratornu depresiju.
English: Clinical monitoring is recommended when co-administering darunavir with low dose ritonavir with these antidepressants and a dose adjustment of the antidepressant may be needed.
Croatian: Preporučuje se kliničko praćanje kada se ti antidepresivi primjenjuju istodobno s pojačanim darunavirom, a može biti potrebna prilagodba doze antidepresiva.
English: Viruses isolated from patients on darunavir/ritonavir 600/100 mg twice daily experiencing virologic failure by rebound that were susceptible to tipranavir at baseline remained susceptible to tipranavir after treatment in the vast majority of cases.
Croatian: Izolirani virusi u bolesnika na darunaviru/ritonaviru od 600/100 mg dvaput na dan u kojih je došlo virološkog neuspjeha zbog ponovnog porasta virusa u krvi, bili su osjetljivi na tipranavir na početku liječenja u velikoj većini su slučajeva ostali osjetljivi na tipranavir i nakon liječenja.
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 boosted darunavir.
Croatian: Lamivudin Stavudin Zidovudin drugih NRTI-ova, zidovudina, emtricitabina, stavudina, lamivudina, koji se primarno izlučuju putem bubrega, te abakavira čiji metabolizam nije posredovan CYP450, ne očekuju se interakcije ovih lijekova i pojačanog darunavira.
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 a i podaci o fenotipu koji pokazuju rezistenciju na IP na ishodu ispitivanjac, n/N HIV IP darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: 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 d.d.
Croatian: - U svih ostalih bolesnika prethodno liječenih ART-om ili u slučaju nemogućnosti genotipizacije HIV-1, preporučeni režim doziranja opisan je u sažetku opisa svojstava lijeka za Darunavir Krka d.d. 600 mg tablete.
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.
Croatian: Pedijatrijski bolesnici prethodno liječeni ART-om u dobi od 3 do 6 godina Farmakokinetika, sigurnost, podnošljivost i djelotovornost darunavira/ritonavira dvaput na dan u kombinaciji s drugim antiretrovirusnim lijekovima, procijenjene su u otvorenom ispitivanju ARIEL faze II, u 21 pedijatrijskog bolesnika prethodno liječenih ART-om inficiranih s HIV-1, u dobi od 3 do < 6 godina i težine 10 kg do < 20 kg.
English: Instructions for children 3 years of age and above, weighing more than 40 kilograms Take 800 milligram Darunavir Krka d.d.
Croatian: Upute za djecu od 3 godine i više, težine najmanje 40 kilograma - Uzmite 800 miligrama lijeka Darunavir Krka d.d. (2 tablete koja sadrže
English: The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a Phase I study in healthy subjects that were administered darunavir 800 mg with either cobicistat at 150 mg or ritonavir at 100 mg once daily.
Croatian: Učinak farmakokinetičkog pojačivača kobicistata na darunavir bio je procijenjen u ispitivanju faze I u zdravih dobrovoljaca kojima je darunavir od 800 mg bio primijenjen bilo s kobicistatom od 150 mg ili ritonavirom od 100 mg jedanput na dan.
English: Lopinavir/ ritonavir 800/200 mg per day N=346
Croatian: lopinavir/ ritonavir 800/200 mg na dan N=346
English: Take your other HIV medicines used in combination with Darunavir Krkad.d.and ritonavir as recommended by your doctor.
Croatian: - Ostale lijekove protiv HIV-a koje primjenjujete istodobno s lijekom Darunavir Krka d.d. i kobicistatom ili ritonavirom uzimajte prema preporuci Vašeg liječnika.
English: This dose must not exceed the recommended adult dose, which is 800 milligram Darunavir Krka d.d.
Croatian: Ova doza ne smije prekoračiti preporučenu dozu za odrasle, što je 800 miligrama lijeka Darunavir Krka d.d. zajedno sa 100 miligrama ritonavira jedanput na dan.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take Darunavir Krka d.d..
Croatian: Liječnik može procijeniti koliko je teška Vaša bolest jetre prije nego što odluči možete li uzimati lijek Darunavir Krka d.d. - Upozorite liječnika ako imate šećernu bolest.
English: is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.
Croatian: Darunavir Krka d.d. se koristi za liječenje odraslih i djece u dobi od 3 godine i starije, tjelesne težine najmanje 15 kilograma, koji su zaraženi HIV-om te su prethodno koristili druge antiretrovirusne lijekove.
English: Darunavir/ritonavir N=80
Croatian: Ishodi u 48. tjednu darunavir/ritonavir N=80
English: Monitoring of renal function may be indicated when darunavir coadministered with low dose ritonavir is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Croatian: Praćenje funkcije bubrega može biti indicirano kada se darunavir istodobno primijenjen s niskom dozom ritonavira daje u kombinaciji s tenofovir dizoproksilomom, posebno u bolesnika s podležećom sistemskom ili bubrežnom bolešću ili u bolesnika koji uzimaju nefrotoksične lijekove.
English: (CYP3A and OATP1B inhibition)
Croatian: (CYP3A i OATP1B inhibicija) kontraindicirana (vidjeti dio 4.3).
English: cannot work properly without ritonavir.
Croatian: Darunavir Krka d.d. ne može pravilno djelovati bez ritonavira.
English: once daily.
Croatian: Doziranje jedanput na dan
English: - The other ingredients are cellulose, microcrystalline; crospovidone, hydroxypropylcellulose; silica, colloidal anhydrous; silicified microcrystalline cellulose (cellulose, microcrystalline; silica, colloidal anhydrous) and magnesium stearate (E470b) in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172) in film coating.
Croatian: - Drugi sastojci su mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, koloidni bezvodni silicijev dioksid, silicificirana mikrokristalična celuloza (mikrokristalična celuloza, koloidni bezvodni silicijev dioksid) i magnezijev stearat (E470b) u jezgri tablete te poli(vinilni alkohol), makrogol, titanijev dioksid (E171), talk (E553b), žuti željezov oksid (E172) i crveni željezov oksid (E172) u film ovojnici tablete.
English: Sildenafil Tadalafil Vardenafil sildenafil alone and a single intake of 25 mg sildenafil co-administered with darunavir and low dose ritonavir.
Croatian: Tadalafil Vardenafil unosom jednokratne doze od 100 mg samo sildenafila i unosa jednokratne doze od 25 mg sildenafila istodobno primijenjenog s darunavirom i niskom dozom ritonavira.
English: 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 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.
Croatian: U nastavku je navedena populacija bolesnika koja je bila procijenjena (vidjeti dio 5.1): - 80 pedijatrijskih bolesnika u dobi od 6 do 17 godina i težine najmanje 20kg, prethodno liječenih ART-om, a inficirani su virusom HIV-1 te su primali darunavir tablete s niskom dozom ritonavira dvaput na dan u kombinaciji s drugim antiretrovirusnim lijekovima.
English: If you forget to take Darunavir Krka d.d.
Croatian: Ako ste zaboravili uzeti lijek Darunavir Krka d.d.
English: Darunavirgiven with low dose ritonavir may be considered as an alternative.
Croatian: Darunavir koji se daje s niskom dozom ritonavira može se uzeti u obzir kao zamjena.
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔
Croatian: 300 mg jedanput na dan atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11%
English: Concentrations of these medicinal products may be increased when coadministered with darunavir with low dose ritonavir resulting in the potential for increased adverse events usually associated with these agents.
Croatian: Koncentracije tih lijekova mogu se povećati kada se primjenjuju istodobno s darunavirom s niskom dozom ritonavira rezultirajući potencijalom za povećanje nuspojava obično povezanih s tim lijekovima.