FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Atazanavir (300 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
English: • tenofovir disoproxil
Croatian: • tenofovirdizoproksil
English: Table 5: Virologic outcomes of randomised treatment of studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 48 (primary) and week 96
Croatian: Tablica 5: Virološki ishodi randomiziranog liječenja u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 48. tjednu (primarno) i 96. tjednu Rilpivirin + emtricitabin/tenofovirdizoproksil
English: Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Darunavir (300 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
English: lactic acidosis3
Croatian: laktacidoza3
English: Maraviroc (300 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Maravirok (300 mg dvaput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
English: Ethinylestradiol/Norethindrone/ Tenofovir disoproxil
Croatian: Etinilestradiol/noretindron/ tenofovirdizoproksil
English: Didanosine (400 mg once daily)/ Rilpivirine1
Croatian: Didanozin (400 mg jedanput na dan)/ rilpivirin1
English: Eviplera must not be used in combination with products containing St. John's wort as coadministration may cause significant decreases in rilpivirine plasma concentrations.
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s lijekovima koji sadrže gospinu travu, jer njihova istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi.
English: Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Croatian: Istovremena primjena lijeka Eviplera s azolnim antimikoticima može prouzročiti povećanje koncentracije rilpivirina u plazmi (inhibicija enzima CYP3A).
English: The combination of Eviplera and H2-receptor antagonists should be used with particular caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Croatian: H2-receptora treba primjenjivati s osobitim oprezom, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Lopinavir (400 mg dvaput na dan)/ ritonavir (100 mg dvaput na dan)/tenofovirdizoproksil (245 mg jedanput na dan)
English: (may affect up to 1 in 100 people)
Croatian: (mogu se javiti u manje od 1 na 100 osoba)
English: PROTON PUMP INHIBITORS Omeprazole/Emtricitabine
Croatian: INHIBITORI PROTONSKE PUMPE
English: Steady-state administration of rilpivirine hydrochloride 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively,
Croatian: U stanju dinamičke ravnoteže, primjena rilpivirinklorida od 75 mg jedanput na dan rezultirala je srednjom vrijednosti Cmax približno 2,6 puta većom, a primjena doze od 300 mg jedanput na dan srednjom vrijednosti Cmax približno 6,7 puta većom od srednje vrijednosti Cmax u stanju dinamičke ravnoteže primijećene uz preporučenu dozu rilpivirinklorida od 25 mg jedanput na dan.
English: AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
Croatian: Etinilestradiol: AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
English: A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Eviplera should be used.
Croatian: H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon uzimanja lijeka Eviplera.
English: Sildenafil/Tenofovir disoproxil
Croatian: Sildenafil/tenofovirdizoproksil
English: AUC: ↓ 14% Cmax: ↓ 15% Cmin: ↓ 7%
Croatian: Simeprevir: AUC ↓ 14% Cmax: ↓ 15% Cmin: ↓ 7%
English: • carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines to treat epilepsy and prevent seizures) • rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
Croatian: • karbamazepin, okskarbazepin, fenobarbital i fenitoin (lijekovi za liječenje epilepsije i sprječavanje napadaja)
English: Rifabutin/Tenofovir disoproxil
Croatian: Rifabutin/ tenofovirdizoproksil
English: Rifabutin (300 mg once daily)/ Rilpivirine (50 mg once daily)
Croatian: Rifabutin (300 mg jedanput na dan)/rilpivirin (50 mg jedanput na dan)
English: Eviplera must not be used in combination with these anticonvulsants as co-administration may cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s ovim antiepilepticima, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
English: • Pain in the abdomen (tummy) caused by inflammation of the pancreas
Croatian: • bolovi u trbuhu prouzročeni upalom gušterače
English: Women of childbearing potential / contraception in males and females The use of Eviplera must be accompanied by the use of effective contraception.
Croatian: Uz primjenu lijeka Eviplera mora se koristiti učinkovita kontracepcija.
English: Famotidine/Tenofovir disoproxil
Croatian: Famotidin/ tenofovirdizoproksil
English: Concomitant use of Eviplera with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Croatian: Istovremena primjena lijeka Eviplera s IP pojačanim ritonavirom uzrokuje povećanje koncentracije rilpivirina u plazmi (inhibicija enzima CYP3A).
English: Eviplera must not be used in combination with rifampicin as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s rifampicinom, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
English: AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
Croatian: Ketokonazol: AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
English: Renal impairment
Croatian: Virološki neuspjehc
English: Rifabutin (300 mg once daily)/ Rilpivirine (25 mg once daily)
Croatian: Rifabutin (300 mg jedanput na dan)/rilpivirin (25 mg jedanput na dan)
English: In treatment-naïve HIV-1 infected patients
Croatian: U virološki suprimiranih bolesnika zaraženih virusom HIV-1
English: Eviplera [outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Eviplera [samo vanjsko pakiranje]
English: Atorvastatin/Tenofovir disoproxil
Croatian: Atorvastatin/tenofovirdizoproksil
English: Interaction not studied with Eviplera.
Croatian: Nisu ispitane interakcije s lijekom Eviplera.
English: Atazanavir/Ritonavir/Rilpivirine Interaction not studied.
Croatian: Atazanavir/ritonavir/rilpivirin
English: • Joint stiffness
Croatian: • ukočenost zglobova
English: Rilpivirine + Emtricitabine/ Tenofovir disoproxil n = 550
Croatian: Efavirenz + emtricitabin/tenofovirdizoproksil n = 550
English: Rilpivirine + Emtricitabine/Tenofovir disoproxil n = 550
Croatian: Efavirenz + emtricitabin/ tenofovirdizoproksil n = 550
English: Eviplera must not be used in combination with rifapentine as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s rifapentinom, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
English: GS-3310074:
Croatian: GS-3310074: AUC: ↔ Cmax: ↔
English: Common:
Croatian: Očekivano:
English: Very common: headache1, 2, 3, dizziness1, 2, 3 Common:
Croatian: glavobolja1, 2, 3, omaglica1, 2, 3
English: AUC: ↔ Cmax: ↔ Cmin: ↔
Croatian: Emtricitabin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Triacetin
Croatian: Didanozin
English: Metformin/Tenofovir disoproxil
Croatian: Metformin/ tenofovirdizoproksil
English: AUC: ↔ Cmin: ↔ Cmax: ↓ 9%
Croatian: Rilpivirin: AUC: ↔ Cmin: ↔ Cmax: ↓ 9%
English: Omeprazole/Tenofovir disoproxil
Croatian: Omeprazol/ tenofovirdizoproksil
English: H2-antagonists can only be taken once a day if you take Eviplera.
Croatian: Ako uzimate Evipleru, H2-antagoniste smijete uzimati samo jedanput na dan.
English: IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/ Emtricitabine
Croatian: Takrolimus/tenofovirdizoproksil/emtricitabin Takrolimus: AUC: ↔
English: Cardiovascular
Croatian: Kardiovaskularni učinci
English: AUC: ↔ Cmin: ↔ Cmax: ↔
Croatian: Noretindron: AUC: ↔ Cmin: ↔ Cmax: ↔
English: Methadone/Tenofovir disoproxil
Croatian: Metadon/tenofovirdizoproksil
English: Severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia (see section 4.4).
Croatian: konjunktivitisom, angioedemom, povećanom funkcijom jetre prema nalazima pretraga i/ili eozinofilijom (vidjeti dio 4.4).
English: pain1, fatigue2
Croatian: bol1, umor2
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261).
Croatian: Eviplera ili svim njegovim djelatnim tvarima u randomiziranim kontroliranim kliničkim ispitivanjima (n = 1261).
English: Voxilaprevir
Croatian: IMUNOSUPRESIVI
English: Didanosine/Tenofovir disoproxil
Croatian: Didanozin/ tenofovirdizoproksil
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Croatian: U cilju optimalnog liječenja infekcije HIV-om u bolesnika koji su istovremeno zaraženih HBV-om, liječnici se trebaju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
English: • Stomach pain
Croatian: • bolovi u trbuhu
English: Digoxin/Tenofovir disoproxil
Croatian: Digoksin/tenofovirdizoproksil
English: AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
Croatian: R(-) metadon: AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
English: rabeprazole
Croatian: GLUKOKORTIKOIDI
English: • any signs of inflammation or infection
Croatian: • bilo kakav znak upale ili infekcije • tegobe s kostima
English: Recommendation concerning co-administration with Eviplera
Croatian: Preporuke za istovremenu primjenu s lijekom Eviplera
English: Rilpivirine: AUC: ↔
Croatian: Rifampicin: AUC: ↔ Cmax: ↔
English: Hypromellose
Croatian: ANTIARITMICI
English: Contents of the pack and other information What Eviplera contains
Croatian: Što Eviplera sadrži
English: Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance (CrCl) 50-80 mL/min).
Croatian: U bolesnika s blagim oštećenjem bubrega (klirens kreatinina (CrCl) 50 - 80 ml/min) ograničeni podaci kliničkih ispitivanja podupiru doziranje lijeka Eviplera jedanput na dan.
English: Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms/0.5 ml Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms/0.5 ml Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms/0.5 ml Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms/0.5 ml
Croatian: A konjugirano na 16,7 do 33,3 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe C konjugirano na 7,1 do 12,5 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe W135 konjugirano na 3,3 do 8,3 mikrograma na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae 5 mikrograma oligosaharida meningokokne grupe
English: 5 vials + 5 vials
Croatian: Y konjugirano na 5,6 do 10,0 mikrograma proteina na 0,5 ml CRM197 bakterije Corynebacterium diphtheriae
English: The effects of treatment were greatest in the first year.
Croatian: Terapija je najviše djelovala tijekom prve godine.
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Jinarc nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food.
Croatian: Jutarnju dozu lijeka treba uzimati najmanje 30 minuta prije doručka, dok se večernja doza može uzimati uz obrok ili bez njega.
English: Jinarc is available as tablets (15, 30, 45, 60 and 90 mg).
Croatian: Dostupan je u obliku tableta (15, 30, 45, 60 i 90 mg).
English: Doses may need to be reduced in patients taking certain other medicines.
Croatian: Doze treba smanjiti ako bolesnik uzima određene druge lijekove.
English: Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects.
Croatian: Bolesnici trebaju započeti s dozom od 45 mg ujutro i 15 mg uvečer (45+15 mg), a dozu zatim treba povećati na 60+30 mg ili 90+30 mg, ovisno o količini koju bolesnik može podnijeti.
English: Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.
Croatian: Bolesnici trebaju piti puno vode ili drugih tekućina (osim soka od grejpa) tijekom liječenja.
English: Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015.
Croatian: Jinarc je dobio odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 27. svibnja 2015.
English: Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter.
Croatian: Krvne nalaze s ciljem provjere funkcije jetre bolesnika treba provesti prije početka terapije lijekom Jinarc, te ih zatim ponoviti svaki mjesec tijekom 18 mjeseci i svaka tri mjeseca nakon toga.
English: Vasopressin controls the amount of water and sodium that the kidneys remove.
Croatian: Vazopresin kontrolira količinu vode i natrija koju bubrezi izlučuju.
English: What measures are being taken to ensure the safe and effective use of Jinarc?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jinarc?
English: Other information about Jinarc
Croatian: Ostale informacije o lijeku Jinarc
English: The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity.
Croatian: Tvrtka će također provesti istraživanje kako bi utvrdila sigurnost lijeka, kao i rizik od otrovanja jetre.
English: The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day).
Croatian: Najčešće nuspojave lijeka Jinarc (koje se mogu javiti u više od 2 na 10 osoba) jesu žeđ, poliurija (povećana proizvodnja mokraće), nokturija (potreba za mokrenjem tijekom noći) i polakiurija (povećana potreba za mokrenjem tijekom dana).
English: Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems).
Croatian: Jinarc može povisiti koncentracije određenih jetrenih enzima u krvi (što je znak mogućih problema s jetrom).
English: In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%.
Croatian: U bolesnika koji su uzimali placebo lijek ukupna veličina bubrega povećala se za 19 %, dok se u onih koji su uzimali Jinarc povećala za 10 %.
English: Side effects reported with Jinarc are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Jinarc pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Croatian: Tvrtka koja stavlja u promet lijek Jinarc dostavit će bolesnicima i liječnicima za koje se očekuje da će upotrebljavati lijek informacije o riziku od toksičnosti za jetru i važnosti sprječavanja trudnoće tijekom terapije.
English: The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment.
Croatian: U prvom ispitivanju obuhvaćeno je 1445 bolesnika s normalnom ili umjereno smanjenom bubrežnom funkcijom i mjerena je promjena veličine bubrega nakon 3 godine liječenja.
English: Why is Jinarc authorised in the EU?
Croatian: Zašto je lijek Jinarc odobren u EU-u?
English: What is Jinarc and what is it used for?
Croatian: Što je Jinarc i za što se primjenjuje?
English: Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment.
Croatian: Tijekom terapije bolesnike treba nadzirati kako bi se uočili simptomi ozljede jetre (kao što su gubitak apetita, mučnina i povraćanje, svrbež, umor i bol na gornjoj desnoj strani trbuha).
English: By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Croatian: Inhibirajući receptore vazopresina u bubrezima, Jinarc može usporiti formiranje cisti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jinarc have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Jinarc također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Jinarc are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Jinarc kontinuirano se prate.
English: The European Medicines Agency decided that Jinarc's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Jinarc nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: Jinarc must also not be used in pregnant and breastfeeding women.
Croatian: Lijek Jinarc ne smiju uzimati trudnice ni dojilje.
English: While the most common side effects are manageable, the Agency identified liver toxicity as the most important risk with Jinarc, which was addressed by putting in place several measures (see below).
Croatian: Iako se najčešće nuspojave mogu kontrolirati, Agencija je identificirala toksičnost za jetru kao najvažniji rizik lijeka Jinarc koji se može ukloniti provođenjem nekoliko mjera (vidjeti u nastavku).
English: What are the risks associated with Jinarc?
Croatian: Koji su rizici povezani s lijekom Jinarc?
English: Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.
Croatian: Jinarc se pokazao djelotvornim u usporavanju formiranja cisti u usporedbi s placebom (prividno liječenje) u dvama glavnim ispitivanjima u koja su uključene odrasle osobe s autosomatskom dominantnom policističnom bubrežnom bolešću koja je ubrzano napredovala.
English: An overview of Jinarc and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Jinarc i zašto je odobren u EU-u
English: For more information about using Jinarc, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Jinarc pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The second study included 1,370 patients with moderately to severely reduced kidney function.
Croatian: Drugo ispitivanje obuhvaćalo je 1370 bolesnika s umjereno do znatno smanjenom bubrežnom funkcijom.
English: Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.
Croatian: Jinarc mogu koristiti osobe s normalnom do znatno smanjenom bubrežnom funkcijom, kao i oni čija bolest brzo napreduje.
English: In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.
Croatian: U 262 bolesnika sa značajno smanjenom funkcijom bubrega, smanjenje funkcije bubrega bilo je 17 % manje kod bolesnika koji su uzimali Jinarc nakon jedne godine liječenja u usporedbi s bolesnicima koji su uzimali placebo.
English: The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin.
Croatian: Djelatna tvar lijeka Jinarc, tolvaptan, antagonist je vazopresin-2-receptora: inhibira receptore (ciljna mjesta) u bubrezima na koje se veže hormon vazopresin.
English: In autosomal dominant polycystic kidney disease, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts.
Croatian: Smatra se da u slučaju autosomatske dominantne bolesti policističnih bubrega stanice bubrega ne odgovaraju normalno na vazopresin, što rezultira formiranjem cisti ispunjenih tekućinom.
English: Jinarc contains the active substance tolvaptan.
Croatian: Jinarc sadrži djelatnu tvar tolvaptan.
English: How is Jinarc used?
Croatian: Kako se Jinarc koristi?
English: This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail.
Croatian: To je nasljedno stanje u kojem se na bubrezima razvijaju brojne tekućinom ispunjene ciste, što naposljetku utječe na funkciju bubrega i može uzrokovati zatajenje bubrega.
English: Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease.
Croatian: Jinarc je lijek koji se koristi za liječenje odraslih osoba s autosomatskom dominantnom bolešću policističnih bubrega.
English: Subsequent supportive results confirmed that increase in kidney size over 5 years was slower with Jinarc.
Croatian: Naknadnim je popratnim rezultatima potvrđeno da je povećanje veličine bubrega tijekom 5 godina bilo sporije u bolesnika koji su uzimali Jinarc.
English: Jinarc must not be started in certain patients with increased blood levels of liver enzymes or with signs or symptoms of liver injury.
Croatian: Terapija lijekom Jinarc ne smije se započeti u bolesnika s povišenim koncentracijama jetrenih enzima u krvi, odnosno sa znakovima ili simptomima ozljede jetre.
English: The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition.
Croatian: Agencija je zaključila da postoji nezadovoljena potreba za liječenjem autosomatske dominantne bolesti policističnih bubrega te je zaključila kako je Jinarc djelotvoran u usporavanju formiranja cisti i mogućeg smanjivanja funkcije bubrega u bolesnika s ovim poremećajem.
English: Kidney size increases with disease severity due to swelling caused by cyst formation.
Croatian: Veličina bubrega raste s obzirom na ozbiljnost bolesti zbog oticanja koje uzrokuje formiranje cista.