FrancophonIA/ELRC3.0 huggingface dataset:
English: The dosage of other medicines might need to be changed since either their own or Darunavir Krka's therapeutic effect or side effects may be influenced when combined.
Croatian: Postoji mogućnost da će biti potrebno promijeniti doziranje drugih lijekova, s obzirom na mogućnost promjene terapijskog učinka ili nuspojava tih lijekova ili lijeka Darunavir Krka kada se primjenjuju u kombinaciji.
English: Darunavir Krka might increase sugar levels in the blood.
Croatian: Darunavir Krka može povisiti razine šećera u krvi.
English: Therefore, darunavir tablets should be taken with ritonavir and with food.
Croatian: Stoga se darunavir tablete moraju uzimati s ritonavirom te uz hranu.
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Croatian: Oni mogu uključiti žutu boju kože ili bjeloočnica, tamnu mokraću (boje čaja), blijede stolice (pokreti crijeva), mučninu, povraćanje, gubitak apetita ili bol, probadanje ili bol i nelagodu na desnoj strani u predjelu ispod rebara.
English: Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Croatian: Ritonavir inhibira transportere P-glikoprotein, OATP1B1 i OATP1B3 te istodobna primjena sa supstratima ovih transportera može rezultirati povećanjem koncentracije ovih lijekova u plazmi (npr. dabigatran eteksilat, digoksin, statini i bosentan; vidjeti tablicu interakcija ispod).
English: Caution should be used in pregnant women 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: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom i oportunističkom infekcijom u povijesti bolesti, ubrzo nakon početka liječenja protiv HIV-a mogu se pojaviti znakovi i simptomi upale zbog prijašnjih infekcija.
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.
Croatian: U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme započinjanja kombinirane antiretrovirusne terapije (KART) može se pojaviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: It is not recommended to alter the dose of ritonavir.
Croatian: Ne preporučuje se mijenjati dozu ritonavira.
English: The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Croatian: Preporuke za darunavir pojačan s ritonavirom vezano uz supstrate CYP3A4, CYP2D6, P glikoproteina, OATP1B1 i OATP1B3 primjenjive su također za darunavir pojačan s kobicistatom (vidjeti kontraindikacije i preporuke navedene u dijelu iznad).
English: Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Croatian: Karcinogeni potencijal darunavira procjenjivao se tijekom 104 tjedna, peroralnom primjenom darunavira u miševa i štakora.
English: Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Croatian: Darunavir i ritonavir su inhibitori CYP3A, CYP2D6 i P-gp-a.
English: Some clinical studies suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Croatian: Neka klinička ispitivanja pokazuju da raltegravir može uzrokovati umjereno smanjenje koncentracija darunavira u plazmi.
English: Dose adjustment for buprenorphine may not be necessary when coadministered with darunavir/ritonavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Croatian: Prilagodba doze buprenorfina možda neće biti potrebna kada se primjenjuje istodobno s darunavirom/ritonavirom, ali se preporučuje pažljivo kliničko praćenje znakova opijatne toksičnosti.
English: Darunavir in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Croatian: Darunavir u kombinaciji s ritonavirom ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Darunavir Krka 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 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: 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 infections may arise.
Croatian: U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme početka liječenja kombiniranom antiretrovirusnom terapijom (KART) može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
English: The child must take Darunavir Krka always together with ritonavir.
Croatian: - Dijete uvijek mora uzimati lijek Darunavir Krka zajedno s ritonavirom.
English: Pharmacokinetics of total darunavir (mean ± SD)
Croatian: Farmakokinetika ukupnog darunavira (srednja vrijednost ± SD)
English: Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are co-administered with darunavir and low dose ritonavir.
Croatian: Preporučuju se alternativne ili dodatne kontracepcijske mjere kada se kontraceptivi na bazi estrogena primjenjuju istodobno s darunavirom i niskom dozom ritonavira.
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.
Croatian: Kombinacija darunavira i artemetera/lumefantrina može se primijeniti bez prilagodbe doze, međutim, zbog povećane izloženosti lumefantrinu, tu se kombinaciju mora primjenjivati s oprezom.
English: H2-RECEPTOR ANTAGONISTS Ranitidine
Croatian: ANTAGONISTI H2 RECEPTORA Ranitidin
English: Monitor for fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary.
Croatian: Potrebno pratiti kako bi se uočile nuspojave fesoterodina ili solifenacina, može biti potrebno smanjenje doze fesoterodina ili solifenacina.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Croatian: Darunavir se ekstenzivno metabolira u jetrenom CYP sustavu, gotovo isključivo izoenzimom CYP3A4.
English: Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and cobicistat and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).
Croatian: Istodobno liječenje s bilo kojim od slijedećih lijekova, radi očekivanog smanjenja koncentracija darunavira, ritonavira i kobicistata u plazmi i potencijalnog gubitka terapijskog učinka (vidjeti dijelove 4.4 i 4.5).
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.
Croatian: Kombinacija pojačanog darunavira i artemetera/lumefantrina može se primijeniti bez prilagodbe doze, međutim, zbog povećane izloženosti lumefantrinu, tu se kombinaciju mora primjenjivati s oprezom.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/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/ritonavirom.
English: In a multiple dose study with darunavir co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Croatian: U ispitivanjima primjene višestrukih doza darunavira primijenjenog istodobno s ritonavirom (600/100 mg) dvaput na dan, pokazalo se da su ukupne koncentracije darunavira u plazmi u ispitanika s blagim (Child-Pugh stadij A, n=8) i umjerenim (Child-Pugh stadij B, n=8) oštećenjem funkcije jetre usporediva s onom u zdravih ispitanika.
English: For use in these patients, more suitable formulations containing darunavir should be checked for their availability.
Croatian: Za primjenu u tih bolesnika mora se provjeriti dostupnost prikladnijih oblika koji sadrže darunavir.
English: If parenteral midazolam is coadministered with darunavir with low dose ritonavir, it should be done in an intensive care unit (ICU) or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Croatian: Ako se parenteralni midazolam istodobno primjenjuje s pojačanim darunavirom, primjena bi morala biti u jedinici intenzivnog liječenja ili sličnom odjelu gdje je osigurano pomno kliničko praćenje, te primjereno medicinsko zbrinjavanje u slučaju respiratorne depresije i/ili produljene sedacije.
English: Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Croatian: Broj ispitanika s virološkim neuspjehom i spareni genotip na početku/na kraju liječenja, koji su razvili mutacije b na ishodu ispitivanja, n/N
English: In patients taking Darunavir Krka 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 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: Advice on missed doses
Croatian: Preporuka u slučaju propuštenih doza
English: Darunavir co-administered with low dose ritonavir must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
Croatian: Darunavir primijenjen istodobno s niskom dozom ritonavira se ne smije kombinirati s lijekovima čiji klirens u velikoj mjeri ovisi o CYP3A i čija je povišena sistemska izloženost povezana s ozbiljnim i/ili po život opasnim događajima (uski terapijski indeks) (vidjeti dio 4.3).
English: During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing darunavir/ritonavir + raltegravir compared to those containing darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
Croatian: Tijekom kliničkog razvojnog programa raltegravira, u prethodno liječenih bolesnika, opažen je osip, koji je, bez obzira na uzročno-posljedičnu povezanost, češće opažen s režimima primjene koji sadrže darunavir/ritonavir + raltegravir u usporedbi na režime koji su sadržavali samo darunavir/ritonavir bez raltegravira ili raltegravir bez darunavira/ritonavira.
English: OPIOID ANTAGONIST Naloxegol
Croatian: ANTAGONISTI OPIOIDA Naloksegol
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.
Croatian: Najčešće ozbiljne nuspojave su akutno zatajenje bubrega, infarkt miokarda, upalni sindrom imunološke rekonstitucije, trombocitopenija, osteonekroza, proljev, hepatitis i pireksija.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Croatian: Liječenje darunavirom/kobicistatom 800/150 mg tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dijelove 4.4 i 5.2).
English: There was no effect on mating or fertility with darunavir treatment in rats (see section 5.3).
Croatian: Liječenje darunavirom nije imalo učinak na parenje i plodnost u štakora (vidjeti dio 5.3).
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of Pgp)
Croatian: Digoksin 0,4 mg jednokratna doza digoksin AUC ↑ 61% digoksin Cmin ND digoksin Cmax ↑ 29% (↑ digoxin zbog vjerojatne inhibicije P-gp)
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: Na temelju različitih puteva eliminacije 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: darunavir /ritonavir 10 kg to < 15 kg N=5
Croatian: Ishodi u 48 tjednu darunavir/ritonavir 10 kg do < 15 kg N=5
English: Concomitant use of other PDE-5 inhibitors for the treatment of erectile dysfunction with boosted darunavir should be done with caution.
Croatian: Mora se s oprezom istodobno primjenjivati druge inhibitore PDE-5 za liječenje erektilne disfunkcije s pojačanim darunavirom.
English: an up to five-fold increase was seen in a limited subset of subjects
Croatian: ¶ akod limitirane podskupine ispitanika primijećeno je povišenje do pet puta
English: Dose adjustment for buprenorphine may not be necessary when coadministered with boosted darunavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Croatian: Prilagodba doze buprenorfina možda neće biti potrebna kada se primjenjuje istodobno s pojačanim darunavirom, ali se preporučuje pažljivo kliničko praćenje znakova opijatne toksičnosti.
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.
Croatian: U slučaju kad se doza darunavira i/ili ritonavira propusti unutar 6 sati od uobičajenog vremena uzimanja, bolesnike se mora uputiti da propisanu dozu darunavira i ritonavira uzmu s hranom što je prije moguće.
English: When administered without food, the relative bioavailability of darunavir in the presence of cobicistat or low dose ritonavir is lower as compared to intake with food.
Croatian: Kada se uzima bez hrane, relativna bioraspoloživost darunavira u prisutnosti kobicistata ili niske doze ritonavira je niža u usporedbi s uzimanjem s hranom.
English: See the Summary of Product Characteristics for Darunavir Krka 600 mg tablets (see section 4.5).
Croatian: Vidjeti sažetak opisa svojstava lijeka za Darunavir Krka 600 mg tablete (vidjeti dio 4.5).
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Croatian: Tijekom razvojnog kliničkog programa (n=2613 prethodno liječenih ispitanika u kojih je započela terapija s darunavirom/ritonavirom od 600/100 mg dvaput na dan), 51,3% ispitanika doživjelo je najmanje jednu nuspojavu.
English: TREATMENT FOR PREMATURE EJACULATION Dapoxetine
Croatian: TERAPIJA PRIJEVREMENE EJAKULACIJE Dapoksetin
English: Based on theoretical considerations boosted darunavir may increase the exposure to glecaprevir and pibrentasvir.
Croatian: Temeljeno na teorijskim postavkama pojačani darunavir može povećati izloženost glekapreviru i pibrentasviru.
English: ANTI-DIABETICS Metformin
Croatian: ANTIDIJABETICI Metformin
English: In addition, patients on a stable dose of these antidepressants who start treatment with darunavir with low dose ritonavir should be monitored for antidepressant response.
Croatian: Dodatno, bolesnike na stabilnoj dozi tih antidepresiva koji započnu liječenje s darunavirom s niskom dozom ritonavira mora se pratiti na odgovor na antidepresive.
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 600 mg tablets.
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 600 mg tablete.
English: Even if you feel better, do not stop taking Darunavir Krka or ritonavir without talking to your doctor.
Croatian: Čak i ako se osjećate bolje, nemojte prekidati uzimanje lijeka Darunavir Krka ili ritonavira bez da se posavjetujete sa svojim liječnikom.
English: Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure.
Croatian: Liječenje darunavirom/kobicistatom od 800/150 mg primijenjenog jedanput na dan tijekom trudnoće rezultira niskom izloženošću darunaviru.
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Croatian: U obzir je potrebno uzeti alternativne kortikosteroide koji su manje ovisni o metabolizmu putem CYP3A npr. beklometazon za intranazalnu primjenu ili za inhaliranje, naročito za dugotrajnu primjenu.
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Croatian: U ispitivanju s jednom skupinom u kojem je darunavir od 800 mg jedanput na dan ispitivan u kombinaciji s kobicistatom od 150 mg jedanput na dan i drugim antretrovirusnim lijekovima 2,2% bolesnika prekinulo je liječenje radi osipa.
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.
Croatian: Tijekom kliničkog razvojnog programa darunavira/ritonavira (n=3063), hepatitis je prijavljen u 0,5% bolesnika koji su primali kombiniranu antiretrovirusnu terapiju s darunavirom/ritonavirom.
English: Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines.
Croatian: Darunavir u kombinaciji s kobicistatom ili ritonavirom ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Darunavir is metabolised by the hepatic system.
Croatian: Darunavir se metabolizira putem jetrenog sustava.
English: How to store Darunavir Krka Contents of the pack and other information
Croatian: Kako Darunavir Krka izgleda i sadržaj pakiranja
English: This should be taken into consideration if darunavir with cobicistat is administered to patients in whom the estimated creatinine clearance is used to adjust doses of co-administered medicinal products (see section 4.2 and cobicistat SmPC).
Croatian: To se mora uzeti u obzir ako se darunavir s kobicistatom primjenjuje bolesnicima u kojih se procijenjeni klirens kreatinina koristi za prilagodbu istodobno primijenjenih lijekova (vidjeti dijelove 4.2 i sažetak opisa svojstava lijeka za kobicistat).
English: At week 48, the virologic response, defined as the percentage of patients with confirmed plasma viral load < 50 HIV-1 RNA copies/ml, was evaluated in 16 paediatric patients 15 kg to < 20 kg and 5 paediatric patients 10 kg to < 15 kg receiving darunavir /ritonavir in combination with other antiretroviral agents (see section 4.2 for dosage recommendations per body weight).
Croatian: U tjednu 48, virološki odgovor, definiran kao postotak bolesnika s potvrđenim virusnim opterećenjem u plazmi < 50 HIV-1 RNK kopija/ml, procijenjen je u 16 pedijatrijskih bolesnika u skupini 15 kg do < 20 kg i 5 pedijatrijskih bolesnika u skupini 10 kg do < 15 kg koji su primali darunavir/ritonavir u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 4.2 za preporuke o doziranju prema tjelesnoj težini).
English: Psychiatric disorders common insomnia uncommon depression, disorientation, anxiety, sleep disorder, abnormal dreams, nightmare, decreased libido rare confusional state, altered mood, restlessness
Croatian: Psihijatrijski poremećaji često nesanica manje često depresija, dezorijentiranost, anksioznost, poremećaj spavanja, nenormalni snovi, noćne more, smanjen libido rijetko stanje konfuzije, promijenjeno raspoloženje, nemir
English: Coadministration with darunavir/ritonavir may cause a large increase in the concentration of these medicines.
Croatian: Istodobna primjena s darunavirom/ritonavirom može izazvati velik porast koncentracije tih lijekova.
English: 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: The concomitant use with boosted darunavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Croatian: Istodobna primjena s pojačanim darunavirom može zahtijevati snižavanje doze alfentanila i zahtijeva praćenje rizika na produljenu ili odgođenu respiratornu depresiju.
English: Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Croatian: Lijekovi koji utječu na izloženost darunaviru/ritonaviru Darunavir i ritonavir se metaboliziraju putem CYP3A.
English: Co-administration with boosted darunavir may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Croatian: Istodobna primjena s pojačanim darunavirom može dovesti do značajnog povećanja izloženosti dabigatranu ili tikagreloru.
English: Since darunavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Croatian: S obzirom na to da darunavir ima visoki afinitet vezanja na proteine, nije vjerojatno da bi dijaliza bila korisna pri značajnijem uklanjanju djelatne tvari.
English: Coadministration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
Croatian: Ne preporučuje se istodobna primjena darunavira/kobicistata sa slabim do umjerenim induktorima CYP3A (npr. efavirenz, etravirin, nevirapin, boceprevir, flutikazon i bosentan) (vidjeti tablicu interakcija ispod).