FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Croatian: Darunavir pokazuje antivirusnu aktivnost in vitro protiv širokog panela HIV-1 skupine M (A, B, C, D, E, F, G) i skupine O primarno izolata s EC50 vrijednostima u rasponu od < 0,1 do 4,3 nM.
English: If there is a need to combine darunavir/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Croatian: U slučaju potrebe za kombinacijom darunavira/ritonavira i karbamazepina, bolesnike se mora pratiti zbog potencijalnih nuspojava povezanih s karbamazepinom.
English: Increased plasma concentrations of lovastatin or simvastatin may cause myopathy, including rhabdomyolysis.
Croatian: Povišene koncentracije lovastatina ili simvastatina u plazmi mogu uzrokovati miopatiju, uključujući rabdomiolizu.
English: Tablet dimension: 19.5 x 10 mm.
Croatian: Dimenzija tablete: 19,5 x 10 mm.
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.
Croatian: Cdarunavir na zdravim dobrovoljcima pokazalo je da većinu radioaktivnosti u plazmi nakon jednostruke doze od 400/100 mg darunavira s ritonavirom treba pripisati osnovnoj djelatnoj tvari.
English: Darunavir Krka works by reducing the amount of HIV in your body.
Croatian: Darunavir Krka djeluje tako da smanjuje količinu virusa HIV-a u Vašem tijelu.
English: Buspirone
Croatian: Buspiron
English: Some side effects are typical for anti-HIV medicines in the same family as Darunavir Krka.
Croatian: Neke su nuspojave tipične za lijekove protiv HIV-a koji spadaju u istu skupinu kao i Darunavir Krka.
English: Tell your doctor if you have diabetes.
Croatian: - Upozorite liječnika ako imate šećernu bolest.
English: Your doctor will advise you how to deal with your symptoms or whether Darunavir Krka must be stopped.
Croatian: Liječnik će Vam savjetovati što učiniti vezano uz pojavu simptoma i morate li prestati s uzimanjem lijeka Darunavir Krka.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Croatian: Sistemski učinci kortikosteroida uključujući Cushingov sindrom i adrenalnu supresiju bili su prijavljeni u bolesnika koji su primali ritonavir i inhalirali ili intranazalno primijenili flutikazon.
English: Perphenazine,risperidone, thioridazine (to treat psychiatric conditions).
Croatian: perfenazin, risperidon, tioridazin (za liječenje psihijatrijskih stanja).
English: Clonazepam
Croatian: Klonazepam
English: Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile.
Croatian: Teško oštećenje funkcije jetre može rezultirati povećanom izloženosti darunaviru i pogoršati njegov sigurnosni profil.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Croatian: Na temelju normalne aproksimacije razlike u % odgovora Podtipovi A1, D, F1, G, K, CRF02_AG, CRF12_BF i CRF06_CPX Razlika srednjih vrijednosti
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Croatian: Ako bolesnik već uzima gospinu travu, potrebno je prestati s uzimanjem gospine trave i ako je moguće provjeriti razine virusa.
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.
Croatian: Kliničko ispitivanje u kojem je korišten koktel lijekova koji se metaboliziraju putem citokroma CYP2C9, CYP2C19 i CYP2D6 pokazala su povišenje aktivnosti CYP2C9 i CYP2C19 i inhibiciju aktivnosti CYP2D6 uz prisustvo darunavira/ritonavira, što može biti pripisano prisustvu niske doze ritonavira.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
Croatian: Liječenje darunavirom/kobicistatom od 800/150 mg tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dio 5.2), što može biti povezano s povećanim rizikom neuspjeha liječenja i povećanim rizikom prijenosa HIV-a na dijete.
English: At present the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically relevant.
Croatian: Za sada se čini da učinak raltegravira na koncentracije darunavira u plazmi nije klinički značajan.
English: Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)
Croatian: Doza za odrasle koji prije nisu uzimali antiretrovirusne lijekove (to će odrediti Vaš liječnik)
English: The Darunavir Krka 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 od 400 miligrama ili 800 miligrama nije namijenjena za primjenu u djece mlađe od 3 godine ili tjelesne težine manje od 40 kilograma.
English: The table below shows the efficacy data of the 48 week analysis from the TITAN trial.
Croatian: Tablica ispod prikazuje analizirane podatke djelotvornosti nakon 48. tjedna ispitivanja TITAN.
English: sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Croatian: zbroj aktivnih komponenti rifabutina (osnovni lijek + 25-Odesacetil metabolit)
English: It is important to talk to your doctor if you develop a rash.
Croatian: Važno je da razgovarate s liječnikom ako se pojavi osip.
English: The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Croatian: Vrsta hrane ne utječe na izloženost darunaviru (vidjeti dijelove 4.4, 4.5 i 5.2).
English: 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.
Croatian: Međutim, kada testiranje genotipa HIV-a nije moguće provesti, preporučeni režim doziranja darunavira/ritonavira je jedanput na dan u pedijatrijskih bolesnika koji prethodno nisu uzimali inhibitore proteaze HIV-a i dvaput na dan, preporučeni režim doziranja u bolesnika koji su prethodno uzimali inhibitore proteaze HIV-a.
English: Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Croatian: Pri istim razinama doza, nije bilo teratogenosti s liječenjem darunavirom u štakora i kunića, a niti u miševa uz liječenje kombinacijom s ritonavirom.
English: Endocrine disorders uncommon hypothyroidism, increased blood thyroid stimulating hormone
Croatian: Endokrini poremećaji manje često hipotireoza, povišen tiroidni stimulirajući hormon u krvi
English: Both arms used an Optimised Background Regimen (OBR) consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs).
Croatian: Obje skupine bolesnika su primale optimizirani osnovni režim (OOR) liječenja koji se sastojao od najmanje 2 antiretrovirusna lijeka (NRTI sa ili bez NNRTI).
English: Flurazepam Midazolam (parenteral) Zoldipem
Croatian: Midazolam (parenteralni) Zoldipem
English: Sedative/hypnotics are extensively metabolised by CYP3A.
Croatian: Sedativi/hipnotici se opsežno metaboliziraju putem CYP3A.
English: Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Croatian: Darunavir/ritonavir se smije uzimati tijekom trudnoće samo ako potencijalna korist opravdava potencijalni rizik (vidjeti dijelove 4.4, 4.6 i 5.2).
English: Tell your doctor if you have haemophilia.
Croatian: - Upozorite liječnika ako imate hemofiliju.
English: ≥ 15 kg to < 30 kg
Croatian: ≥ 15 kg do < 30 kg
English: CALCIUM CHANNEL BLOCKERS
Croatian: BLOKATORI KALCIJEVIH KANALA
English: For ART-experienced paediatric patients HIV genotypic testing is recommended.
Croatian: Za pedijatrijske bolesnike koji su prethodno liječeni ART-om, preporučuje se testiranje genotipa HIV-a.
English: The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1acid 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: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Croatian: Trenutno nema prikladnih podataka pomoću kojih bi se odlučilo je li istodobna primjena tenofovir dizoproksila i kobicistata povezana s povećanim rizikom za bubrežne nuspojave u usporedbi s režimima koji uključuju tenofovir dizoproksil bez kobicistata.
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Croatian: U tablici ispod prikazani su analizirani podaci djelotvornosti nakon 48 i 96 tjedana iz ispitivanja ARTEMIS:
English: Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat).
Croatian: Stoga je istodobno liječenje s takvim lijekovima čije su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima kontraindicirano (odnosi se na darunavir pojačan bilo ritonavirom ili bilo kobicistatom).
English: Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Croatian: Darunavir Krka od 600 mg tablete mogu se primjenjivati da bi se osigurali prikladni režimi doziranja (vidjeti dio 4.2): - Za liječenje HIV-1 infekcije u odraslih bolesnika prethodno liječenih antiretrovirusnom terapijom (ART), uključujući bolesnike koji su prethodno bili liječeni u znatnoj mjeri.
English: Investigations common increased blood creatinine
Croatian: Pretrage često povišen kreatinin u krvi
English: This guidance is based on the half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 24 hours.
Croatian: Ova smjernica temeljena je na poluvijeku darunavira u prisutnosti ritonavira te preporučenom intervalu doziranja od približno 24 sata.
English: As darunavir and ritonavir are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Croatian: S obzirom da darunavir i ritonavir imaju visok afinitet vezanja na proteine plazme, nije vjerojatno da bi se značajno uklonili hemodijalizom ili peritonealnom dijalizom.
English: The weight-based dose regimen for darunavir and ritonavir is provided in the tables above.
Croatian: Režim doziranja za darunavir i ritonavir na temelju tjelesne težine naveden je u tablicama iznad.
English: When administered without food, the relative bioavailability of darunavir in the presence of low dose ritonavir is 30% lower as compared to intake with food.
Croatian: Kada se uzima bez hrane, relativna bioraspoloživost darunavira u prisutnosti niske doze ritonavira je 30% niža u usporedbi s uzimanjem s hranom.
English: Your doctor will determine whether Darunavir Krka tablets is right for the child.
Croatian: Liječnik će odrediti jesu li za Vaše dijete prikladne tablete lijeka Darunavir Krka.
English: HERBAL PRODUCTS St John's wort (Hypericum perforatum)
Croatian: BILJNI PRIPRAVCI Gospina trava (Hypericum perforatum)
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Croatian: Smatra se da su opaženi hepatocelularni tumori i tumori štitnjače u glodavaca od ograničenog značaja za ljude.
English: Concomitant use with strong CYP3A inducers is contraindicated, since these may reduce the exposure to cobicistat and darunavir leading to loss of therapeutic effect.
Croatian: Istodobna primjena snažnih induktora CYP3A je kontraindicirana, budući da to može sniziti izloženost kobicistatu i darunaviru i dovesti do gubitka terapijskog učinka.
English: Data on comparison with a 150 mg once daily reference dose is lacking.
Croatian: Nedostaju podaci usporedbe s referentnom dozom od 150 mg jedanput na dan.
English: An OBR consisting of at least 2 NRTIs with or without enfuvirtide (ENF) was used in both trials.
Croatian: U oba ispitivanja primijenjen je OOR koji se sastojao od najmanje 2 NRTI sa ili bez enfuvirtida (ENF).
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Croatian: Tijekom kliničkog ispitivanja faze III GS-US-216-130 s darunavirom/kobicistatom (N=313 ispitanika koji prethodno nisu liječeni i ispitanici koji su prethodno liječeni), u 66,5% ispitanika javila se barem jedna nuspojava.
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 tenofovirdizoproksila.
English: Darunavir Krka is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Croatian: Darunavir Krka je antiretrovirusni lijek koji se koristi za liječenje infekcije uzrokovane virusom humane imunodeficijencije (HIV).
English: ≥ 30 kg to < 40 kg
Croatian: ≥ 30 kg do < 40 kg
English: Take your other HIV medicines used in combination with Darunavir Krka and ritonavir as recommended by your doctor.
Croatian: - Ostale lijekove protiv HIV-a koje primjenjujete istodobno s lijekom Darunavir Krka i ritonavirom, uzimajte prema preporuci Vašeg liječnika.
English: 400/100 mg twice daily
Croatian: 400/100 mg dvaput na dan
English: Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir (see sections 4.3, 4.4 and
Croatian: Stoga, darunavir može imati različite kontraindikacije i preporuke za istodobno primijenjene lijekove, ovisno o tome je li djelatna tvar pojačana ritonavirom (vidjeti dijelove 4.3, 4.4 i 4.5).
English: Thyroid follicular cell adenomas were noted in male rats.
Croatian: Folikularni stanični adenom štitnjače zabilježen je u muških štakora.
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
Croatian: Rosuvastatin 10 mg jedanput na dan rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
English: Darunavir is primarily metabolised by CYP3A.
Croatian: Darunavir se primarno metabolizira putem CYP3A.
English: Avanafil to treat erectile dysfunction
Croatian: Za liječenje erektilne disfunkcije Avanafil
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Darunavir/ritonavir should not be used in children below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Croatian: Darunavir/ritonavir se ne smije primjenjivati u djece uzrasta ispod 3 godine zbog sigurnosnih razloga (vidjeti dijelove 4.4 i 5.3).
English: In addition, patients on a stable dose of these antidepressants who start treatment with boosted darunavir should be monitored for antidepressant response.
Croatian: Dodatno, bolesnike na stabilnoj dozi tih antidepresiva koji započnu liječenje s pojačanim darunavirom mora se pratiti na odgovor na antidepresive.
English: Fentanyl Oxycodone Tramadol
Croatian: Fentanil Oksikodon Tramadol
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: sažetak opisa svojstava lijeka, dio 4.2).
English: MedDRA system organ class Frequency category
Croatian: Klasifikacija organskih sustava prema MedDRA-i Kategorija učestalosti
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 180 film-coated tablets
Croatian: 30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 180 filmom obloženih tableta
English: Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Croatian: - ciklosporin, everolimus, takrolimus, sirolimus (za prigušivanje imunološkog sustava), s obzirom na mogućnost pojačanog terapijskog učinka ili nuspojava tih lijekova.
English: Titanium dioxide (E171)
Croatian: poli(vinilni alkohol) makrogol titanijev dioksid (E171)
English: When the recommendation is the same for darunavir when co-administered with a low dose ritonavir or cobicistat, the term “boosted darunavir” is used.
Croatian: Kada je preporuka ista za darunavir istodobno primijenjen s niskom dozom ritonavira ili kobicistatom, korišten je termin „pojačan darunavir“.
English: Both arms used an optimised background regimen (OBR) of ≥ 2 NRTIs.
Croatian: U obje skupine primijenjen je optimizirani osnovni režim (OOR) od ≥ 2 NRTI.
English: This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Croatian: Ova smjernica temeljena je na 15 satnom poluvijeku darunavira u prisutnosti ritonavira te preporučenom intervalu doziranja od približno 12 sati.
English: As limited information is available on the use of darunavir in patients aged 65 and over, caution should be exercised in the administration of darunavir in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Croatian: S obzirom da su dostupni ograničeni podaci o primjeni darunavira u bolesnika u dobi od 65 godina i više, nužan je oprez kod primjene darunavira u starijih bolesnika zbog povećane učestalosti smanjene funkcije jetre te istodobne bolesti ili druge terapije (vidjeti dijelove 4.2 i 5.2).
English: No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, darunavir should be used with caution in these patients.
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre, međutim, darunavir se u tih bolesnika mora primjenjivati s oprezom.
English: The child must take Darunavir Krka with food.
Croatian: - Dijete mora uzimati lijek Darunavir Krka s hranom.
English: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml n=11 for AUC12h
Croatian: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml n=11 za AUC12h
English: Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Croatian: Kobicistat od 150 mg koji je primijenjen s 800 mg darunavira jedanput na dan, poboljšava farmakokinetičke parametre darunavira sličnu ritonaviru (vidjeti dio 5.2).
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Croatian: Ponovljena primjena darunavira štakorima uzrokovala je indukciju mikrosomalnih enzima jetre te povećanu eliminaciju hormona štitnjače, što je u štakora predispozicija za razvoj neoplazmi štitnjače, ali ne i u ljudi.
English: Eye disorders uncommon conjunctival hyperaemia, dry eye rare visual disturbance
Croatian: Poremećaj oka manje često konjunktivalna hiperemija, suho oko rijetko poremećaj vida
English: These can include, but are not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Croatian: Oni mogu uključivati, ali nisu ograničeni na, teški osip ili osip praćen vrućicom, općom malaksalošću, umorom, tupim bolovima u mišićima i zglobovima, stvaranjem mjehurića, oralnim lezijama, konjunktivitisom, hepatitisom i/ili eozinofilijom.
English: The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with ritonavir.
Croatian: Farmakokinetički parametri darunavira u stanju dinamičke ravnoteže bili su usporedivi kada je pojačan ritonavirom.
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the darunavir/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Croatian: Ti su rezultati potvrđeni analizom podataka u 96. tjednu liječenja u ispitivanju TITAN, sa 60,4% bolesnika u skupini liječenoj darunavirom/ritonavirom koji su imali HIV-1 RNK < 50 kopija/ml u 96. tjednu u usporedbi s 55,2% u skupini liječenoj lopinavirom/ritonavirom [razlika: 5,2%, 95% CI (-2,8;13,1)].
English: In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Croatian: Pri donošenju odluke o početku liječenja darunavirom primijenjenog istodobno s niskom dozom ritonavira, mora se pažljivo razmotriti dosadašnje liječenje pojedinog bolesnika i obrasce mutacija povezanih s različitim lijekovima.
English: Applicable to darunavir boosted with cobicistat, not when boosted with ritonavir: Darunavir boosted with cobicistat is more sensitive for CYP3A induction than darunavir boosted with ritonavir.
Croatian: Primjenjivo na darunavir pojačan s kobicistatom, ne kada je pojačan ritonavirom: - Darunavir pojačan s kobicistatom osjetljiviji je na CYP3A indukciju, nego darunavir pojačan s ritonavirom.
English: Treatment with darunavir/cobicistat 800/150 mg once daily during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Croatian: Liječenje darunavirom/kobicistatom 800/150 mg jedanput na dan tijekom drugog i trećeg tromjesečja rezultiralo je niskom izloženošću darunaviru, sa smanjenjem od otprilike 90% Cmin razina (vidjeti dio 5.2).
English: Pravastatin 40 mg single dose pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63%
Croatian: Pravastatin 40 mg jednokratna doza pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63%
English: The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting.
Croatian: Najčešće nuspojave prijavljene u kliničkim ispitivanjima i spontano prijavljene su proljev, mučnina, osip, glavobolja i povraćanje.