FrancophonIA/ELRC3.0 huggingface dataset:
English: Some people may feel dizzy, weak or tired after being given Jinarc.
Croatian: Neke osobe mogu osjećati omaglicu, slabost ili umor nakon primanja Jinarca.
English: Patients have to be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration.
Croatian: Bolesnike treba uputiti da piju vodu ili druge tekućine na bazi vode na prvi znak žeđi kako bi se izbjeglo jako žeđanje i dehidracija.
English: Similar changes with other medicinal products have been associated with the potential to cause irreversible and potentially life-threatening liver injury.
Croatian: Slične promjene uz primjenu drugih lijekova bile su povezane s mogućnošću izazivanja ireverzibilnog i potencijalno životno ugrožavajućeg oštećenja jetre.
English: • high levels of sodium, uric acid and blood sugar
Croatian: • visoke razine natrija, mokraćne kiseline i šećera u krvi
English: The key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent [reproduced over at least 2 weeks] 25 %
Croatian: Ključni sekundarni kompozitni ishod (progresija ADPBB-a) bilo je vrijeme do pojave više događaja kliničke progresije: 1) pogoršanja funkcije bubrega (definirano kao trajno [ponavljano tijekom najmanje 2 tjedna]
English: Genotyping for PKD1 and PKD2 genes was conducted in a majority of patients entering the openlabel extension study (TEMPO 4:4) but the results are not yet known.
Croatian: Genotipizacija gena za PKD1 i PKD2 bila je provedena u većine bolesnika uključenih u otvoreni nastavak ispitivanja (TEMPO 4:4), no rezultati još nisu poznati.
English: • ALT or AST > 3-times ULN with persistent symptoms of hepatic injury noted above.
Croatian: • ALT ili AST > 3 puta GGN s trajnim simptomima oštećenja jetre koji su gore navedeni.
English: Pre-specified secondary endpoints were tested sequentially.
Croatian: Uzastopno su ispitani i unaprijed određeni sekundarni ishodi.
English: Taken with Jinarc these may increase the risk of low blood pressure when you stand up from sitting or lying down.
Croatian: Ako se uzimaju s Jinarcom mogu povećati rizik od niskog krvnog tlaka kada ustajete iz sjedećeg ili ležećeg položaja.
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01.
Croatian: Farmakoterapijska skupina: Diuretici, antagonisti vazopresina, ATK oznaka: C03XA01.
English: Jinarc causes water loss because it increases your urine production.
Croatian: Jinarc uzrokuje gubitak vode jer povećava stvaranje mokraće.
English: • if you have been told you have high levels of a chemical called uric acid in your blood (which may have caused attacks of gout).
Croatian: • ako Vam je rečeno da imate visoke razine kemijskog spoja koji se naziva mokraćna kiselina u krvi (što može izazvati napade gihta).
English: Since hypersensitivity is a contraindication (see section 4.3) treatment must never be restarted after an anaphylactic reaction or other serious allergic reactions.
Croatian: Budući da je preosjetljivost kontraindikacija (vidjeti dio 4.3), liječenje se nakon anafilaktičke reakcije ili druge ozbiljne alergijske reakcije nikada ne smije ponovno započinjati.
English: TEMPO 4:4 is an open-label extension study that included 871 subjects that completed TEMPO 3:4 from 106 centres across 13 countries.
Croatian: TEMPO 4:4 je otvoreni nastavak ispitivanja u koji je bilo uključeno 871 ispitanika koji su završili ispitivanje TEMPO 3:4 iz 106 centara u 13 zemalja.
English: No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Croatian: Nisu uočene klinički značajne promjene u klirensu za doze u rasponu od 5 do 60 mg.
English: According to these split dose regimens the total daily doses are 60, 90, or 120 mg.
Croatian: Ovisno o režimu s podijeljenim dozama, ukupne dnevne doze su 60, 90 ili 120 mg.
English: Jinarc can only be prescribed by doctors who are specialised in the treatment of ADPKD.
Croatian: Jinarc mogu propisati samo liječnici specijalizirani za liječenje ADPBB-a.
English: • decreased appetite
Croatian: • smanjen apetit
English: ‘Tolvaptan (n = 961) and placebo (n = 484) groups were well matched in terms of gender with an average age of 39 years.
Croatian: Skupina koja je primala tolvaptan (n = 961) i skupina koja je primala placebo (n = 484) bile su dobro usklađene s obzirom na spol s prosječnom dobi od 39 godina.
English: Uncommon: may affect up to 1 in 100 people • increase of bilirubin (a substance that can cause yellowing of skin or eyes) in the blood
Croatian: Manje često: mogu se javiti u do 1 na 100 osoba • porast bilirubina (tvar koja može uzrokovati žutu boju kože ili očiju) u krvi.
English: • medicines which increase the level of sodium in your blood or which contain large amounts of salt, like tablets that dissolve in water and indigestion remedies.
Croatian: • lijekove koji povećavaju razinu natrija u Vašoj krvi ili koji sadrže velike količine soli kao što su tablete koje se otapaju u vodi ili pripravci za probavne tegobe.
English: The different strengths of Jinarc tablets have different shapes and embossing:
Croatian: Tablete Jinarca različite jačine imaju različit oblik i reljef:
English: Data for patients in CKD stage 3 are more limited than for patients in stage 1 or 2 (see section 5.1).
Croatian: Podaci za bolesnike s KBB-om u 3. stadiju su više ograničeni nego za bolesnike u 1. i 2. stadiju (vidjeti dio 5.1).
English: • if you are pregnant (see “Pregnancy and breast-feeding)
Croatian: • ako ste trudni (vidjeti „Trudnoća i dojenje“).
English: Effects on free water clearance and urine volume are evident across all CKD stages with smaller absolute effects observed at later stages, consistent with the declining number of fully functioning nephrons.
Croatian: Učinci na klirens slobodne vode i volumen urina vidljivi su u svim stadijima KBB-a, s manjim apsolutnim učincima u kasnijim stadijima, u skladu sa smanjenjem broja potpuno funkcionalnih nefrona.
English: What Jinarc is and what it is used for What you need to know before you take Jinarc How to take Jinarc
Croatian: Što je Jinarc i za što se koristi Što morate znati prije nego počnete uzimati Jinarc Kako uzimati Jinarc
English: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Croatian: Iako taj porast nije imao kliničku važnost, upućuje na činjenicu da tolvaptan može povećati izloženost supstratima CYP3A4.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Data related to smoking or alcohol history in ADPKD trials are too limited to determine possible interactions of smoking or alcohol with efficacy and safety of ADPKD treatment with tolvaptan.
Croatian: Podaci o prethodnom pušenju ili konzumiranju alkohola u ispitivanjima ADPBB-a su previše ograničeni za određivanje mogućih interakcija pušenja ili alkohola s djelotvornošću i sigurnošću liječenja ADPBB-a tolvaptanom.
English: In-vitro studies indicate that tolvaptan or its oxobutyric metabolite may have the potential to inhibit OATP1B1, OATP1B3, OAT3, BCRP and OCT1 transporters.
Croatian: In vitro ispitivanja pokazuju da tolvaptan ili njegov oksobutiratni metabolit imaju potencijal za inhibiciju prijenosnika OATP1B1, OATP1B3, OAT3, BCRP i OCT1.
English: In patients with severe hepatic impairment the benefits and risks of treatment with Jinarc must be evaluated carefully.
Croatian: U bolesnika s teškim oštećenjem jetre potrebno je pažljivo procijeniti koristi i rizike liječenja Jinarcom.
English: During treatment with Jinarc, your doctor will arrange monthly blood tests to check for changes in your liver function.
Croatian: Tijekom liječenja Jinarcom Vaš će Vas liječnik uputiti na pretrage krvi svaki mjesec kako bi se provjerile promjene u radu
English: The aim of dose titration is to block activity of vasopressin at the renal V2 receptor as completely and constantly as possible, while maintaining acceptable fluid balance (see section 4.4).
Croatian: Cilj titracije doze je spriječiti djelovanje vazopresina na V2 receptore u bubregu što je potpunije i neprekidnije moguće, uz istovremeno održavanje prihvatljive ravnoteže tekućine (vidjeti dio 4.4).
English: Appropriate replacement of water and/or electrolytes must continue until aquaresis abates.
Croatian: Odgovarajuća nadoknada vode i/ili elektrolita mora se nastaviti do smanjenja izlučivanja vode.
English: Therefore, diabetic patients treated with tolvaptan must be managed cautiously.
Croatian: Zato se zbrinjavanje dijabetičara liječenih tolvaptanom mora provoditi s oprezom.
English: Patients taking moderate or strong CYP3A inhibitors must be managed cautiously, in particular if the inhibitors are taken more frequently than once a day.
Croatian: Bolesnike koji uzimaju umjerene ili jake inhibitore CYP3A mora se zbrinjavati s oprezom, posebice ako inhibitore uzimaju češće od jednom na dan.
English: • Signs or symptoms of liver toxicity and severe dehydration
Croatian: • znakovi ili simptomi hepatotoksičnosti ili teške dehidracije
English: • if you have diabetes.
Croatian: • ako imate šećernu bolest.
English: Dose titration has to be performed cautiously to ensure that high doses are not poorly tolerated through overly rapid up-titration.
Croatian: Titraciju doze treba provesti uz oprez kako bi se osiguralo da zbog pretjerano brze titracije ne bi došlo do slabog podnošenja visokih doza.
English: Measurements of urine osmolality are recommended to monitor the adequacy of vasopressin inhibition.
Croatian: Preporučuje se mjerenje osmolalnosti urina kako bi se nadziralo je li inhibicija vazopresina odgovarajuća.
English: • diuretics (used to increase your urine production).
Croatian: • diuretike (primjenjuju se za povećanje stvaranja mokraće).
English: Final study report should be submitted by:
Croatian: Završno izvješće o ispitivanju treba podnijeti do:
English: You should always take the highest tolerable dose combination prescribed by your doctor.
Croatian: Morate uvijek uzimati najvišu propisanu kombinaciju doza koju možete podnijeti.
English: Studies in rats have shown excretion of tolvaptan in milk.
Croatian: Ispitivanja u štakora pokazuju da se tolvaptan izlučuje u mlijeko.
English: Following multiple once daily dosing of 300 mg, tolvaptan exposure was only increased 6.4-fold when compared to a 30 mg dose.
Croatian: Nakon višekratne primjene doze od 300 mg jednom dnevno, izloženost tolvaptanu povećala se samo 6,4 puta u usporedbi s dozom od 30 mg.
English: * reported during post-marketing surveillance of tolvaptan approved for other indications observed in post-marketing with tolvaptan in ADPKD.
Croatian: * Zabilježeno tijekom praćenja nakon stavljanja u promet tolvaptana odobrenog u drugim indikacijama Opaženo kod primjene tolvaptana u ADPBB-u nakon stavljanja u promet.
English: Effects on serum uric acid are attributable to the reversible renal hemodynamic changes that occur in response to tolvaptan effects on urine osmolality and may be clinically relevant.
Croatian: Učinci na serumsku razinu mokraćne kiseline pripisuju se reverzibilnim hemodinamskim promjenama u bubregu koje nastaju kao odgovor na učinke tolvaptana na osmolalnost urina i mogu biti klinički značajni.
English: In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended.
Croatian: U bolesnika u kojih se sumnja na predoziranje tolvaptanom, preporučuje se procjena vitalnih znakova, koncentracije elektrolita, EKG-a i statusa tekućina.
English: Tolvaptan metabolites have little to no contribution to the pharmacological effect of tolvaptan; all metabolites have no or weak antagonist activity for human V2 receptors when compared with tolvaptan.
Croatian: Metaboliti tolvaptana ne doprinose ili malo doprinose farmakološkom učinku tolvaptana; svi metaboliti ili nemaju ili imaju slabu antagonističku aktivnost prema ljudskim V2 receptorima u usporedbi s tolvaptanom.
English: No mortality was observed in rats or dogs following single oral doses of 2,000 mg/kg (maximum feasible dose).
Croatian: U štakora i pasa nije uočena smrtnost nakon jednokratnih oralnih doza od 2000 mg/kg (maksimalna moguća doza).
English: Testing must continue at increased time frequency until symptoms/signs/laboratory abnormalities stabilise or resolve, at which point Jinarc may be reinitiated.
Croatian: Pretrage se moraju nastaviti provoditi učestalije sve dok se simptomi/znakovi/laboratorijske abnormalnosti ne stabiliziraju ili povuku, nakon čega se Jinarc može ponovno uvesti.
English: A single oral dose of 2,000 mg/kg was lethal in mice and symptoms of toxicity in affected mice included decreased locomotor activity, staggering gait, tremor and hypothermia.
Croatian: Jednokratna oralna doza od 2000 mg/kg bila je letalna u miševa, a simptomi toksičnosti uključivali su smanjenu lokomotornu aktivnost, teturav hod, tremor i hipotermiju.
English: Tolvaptan affinity for the human V2 receptor is 1.8 times that of native AVP.
Croatian: Afinitet tolvaptana za ljudski V2 receptor je 1,8 puta veći nego afinitet prirodnog AVP-a.
English: The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR < 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Croatian: Rizik od oštećenja jetre u bolesnika s jako smanjenom bubrežnom funkcijom (tj. eGFR < 20) može biti povećan; ove bolesnike treba pažljivo nadzirati zbog pojave hepatotoksičnosti.
English: The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia.
Croatian: Znakovi i simptomi akutnog predoziranja mogu se predvidjeti kao pretjeran farmakološki učinak: porast serumske koncentracije natrija, poliurija, žeđ i dehidracija/hipovolemija.
English: However, when driving vehicles or using machines it has to be taken into account that occasionally dizziness, asthenia or fatigue may occur.
Croatian: Ipak, ako se upravlja vozilima ili radi sa strojevima treba uzeti u obzir da se povremeno može javiti omaglica, astenija ili umor.
English: Jinarc may reduce the effect of desmopressin.
Croatian: Jinarc može smanjiti učinak dezmopresina.
English: The safety and efficacy of Jinarc in CKD stage 5 have not been adequately explored and therefore tolvaptan treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
Croatian: Sigurnost i djelotvornost Jinarca u 5. stadiju KBB-a nisu odgovarajuće istražene te je stoga liječenje tolvaptanom potrebno prekinuti ako renalna insuficijencija dosegne 5. stadij KBB-a.
English: If you stop taking Jinarc your kidney cysts may grow as fast as they did before you started treatment with Jinarc.
Croatian: Ako prestanete uzimati Jinarc ciste u Vašim bubrezima mogu rasti istom brzinom kao prije nego što ste započeli liječenje Jinarcom.
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces, where unchanged tolvaptan accounted for 32 % of radioactivity.
Croatian: Pokusima s radioaktivno obilježenim tolvaptanom otkriveno je 40 % radioaktivnosti u urinu, 59 % u fecesu, dok je nepromijenjeni tolvaptan činio 32 % radioaktivnosti.
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Croatian: Tolvaptan je povećao plazmatske razine lovastatina za 1,3 do 1,5 puta.
English: Increasing age has no effect on tolvaptan plasma concentrations.
Croatian: Porast dobi nema utjecaja na koncentraciju tolvaptana u plazmi.
English: The pharmacodynamically predictable and most commonly reported adverse reactions are thirst, polyuria, nocturia, and pollakiuria occurring in approximately 55 %, 38 %, 29 % and 23 % of patients, respectively.
Croatian: Farmakodinamički predvidive i najčešće prijavljene nuspojave bile su žeđ, poliurija, nikturija i polakisurija u otprilike 55 %, 38 %, 29 % odnosno 23 % bolesnika.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tolvaptan in one or more subsets of the paediatric population in polycystic kidney disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka tolvaptan u jednoj ili više podskupina pedijatrijske populacije u policističnoj bolesti bubrega (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: While these criteria were useful in enriching the study population with patients who were rapidly progressing, subgroup analyses based on stratification criteria (age, TKV, GFR, Albuminuria, Hypertension) indicated the presence of such risk factors at younger ages predicts more rapid disease progression.
Croatian: Dok su ti kriteriji pomogli u uključivanju bolesnika s brzo progresivnom bolešću u ispitivanu populaciju, analize podskupina temeljene na kriterijima stratifikacije (dob, UVB, GFR, albuminurija, hipertenzija) upućivale su na zaključak da prisutnost tih rizičnih čimbenika u mlađoj dobi prognozira bržu progresiju bolesti.
English: While these concomitant elevations were reversible with prompt discontinuation of tolvaptan, they represent a potential for significant liver injury.
Croatian: Iako su ti istovremeni porasti bili reverzibilni uz brzo ukidanje tolvaptana, oni predstavljaju moguće značajno oštećenja jetre.
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Croatian: Čini se da nakon jednokratnih oralnih doza od ≥ 300 mg, vršna plazmatska koncentracija dosiže plato, moguće zbog saturacije apsorpcije.
English: • ALT or AST > 8-times ULN
Croatian: • ALT ili AST > 8 puta GGN
English: In healthy subjects, tolvaptan, a CYP3A substrate, had no effect on the plasma concentrations of some other CYP3A substrates (e.g. warfarin or amiodarone).
Croatian: U zdravih ispitanika, tolvaptan, supstrat CYP3A, nije imao učinak na plazmatske koncentracije nekih drugih supstrata CYP3A (npr. varfarina ili amiodarona).
English: Fatigue, Thirst
Croatian: Umor, Žeđ
English: The morning dose is to be taken at least 30 minutes before the morning meal.
Croatian: Jutarnju dozu treba uzeti najmanje 30 minuta prije jutarnjeg obroka.
English: Do not use this medicine after the expiry date which is stated on the carton, wallet card and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, kartonskom ovitku i blisteru iza „Rok valjanosti“ (EXP).
English: Effect of tolvaptan on glomerular filtration rate (GFR)
Croatian: Učinak tolvaptana na brzinu glomerularne filtracije (GFR)
English: Talk to your doctor before taking Jinarc
Croatian: Obratite se svom liječniku prije nego uzmete Jinarc:
English: The healthcare professional training material shall contain the following key elements
Croatian: Materijal za obuku zdravstvenih djelatnika sadržavat će sljedeće ključne elemente
English: In contrast, there was no effect of tolvaptan on either progression of hypertension or albuminuria.
Croatian: Suprotno tome, tolvaptan nije imao učinka na progresiju hipertenzije ni albuminurije.
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Croatian: Učestalost nuspojava zabilježenih nakon stavljanja lijeka u promet ne može se odrediti jer su izvedene iz spontanih prijava.
English: Pre-treatment sodium abnormalities (hyponatraemia or hypernatraemia) must be corrected prior to initiation with tolvaptan therapy.
Croatian: Prethodno postojeće abnormalnosti razina natrija (hiponatrijemija ili hipernatrijemija) moraju se korigirati prije početka terapije tolvaptanom.
English: • flu-like syndrome (joint and muscle pain with fever)
Croatian: • sindrom nalik gripi (bolovi u zglobovima i mišićima s vrućicom).
English: In case of abnormal baseline levels below the limits for permanent discontinuation treatment can only be initiated if the potential benefits of treatment outweigh the potential risks and liver function testing must continue at increased time frequency.
Croatian: U slučaju da su te početne abnormalne vrijednosti ispod granica za trajno ukidanje, liječenje se može započeti samo ako moguća korist liječenja nadmašuje moguće rizike, a provjere funkcije jetre moraju se nastaviti provoditi učestalije.
English: Therefore, the effect of vasopressin analogues such as desmopressin may be attenuated in patients using such analogues to prevent or control bleeding when co-administered with tolvaptan.
Croatian: Stoga učinak vazopresinskih analoga kao što je dezmopresin može biti oslabljeno u bolesnika koji ih koriste za prevenciju ili kontrolu krvarenja kada se primjenjuju istovremeno s tolvaptanom.
English: Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD).
Croatian: Jinarc je lijek za liječenje bolesti koja se zove „autosomno dominantna policistična bolest bubrega“ (ADPBB).
English: • if you have been told that you have raised levels of liver enzymes in your blood which do not allow treatment with tolvaptan
Croatian: • ako Vam je rečeno da imate povišene razine jetrenih enzima u krvi zbog kojih se ne smijete liječiti tolvaptanom.
English: Periodic monitoring of plasma osmolality or serum sodium (to calculate plasma osmolarity) and/or body weight should be considered to monitor the risk of dehydration secondary to the aquaretic effects of tolvaptan in case of patient's insufficient water intake.
Croatian: Potrebno je razmotriti povremeni nadzor osmolalnosti plazme ili serumskog natrija (za izračunavanje osmolarnosti plazme) i/ili tjelesne težine kako bi se nadzirao rizik od dehidracije nastale zbog učinka tolvaptana na izlučivanje vode u slučaju nedovoljnog unosa vode od strane bolesnika.
English: Current clinical practice suggests that Jinarc therapy is to be interrupted upon confirmation of sustained or increasing transaminase levels and permanently discontinued if significant increases and/or clinical symptoms of hepatic injury persist.
Croatian: Sadašnja klinička praksa nalaže da se terapija Jinarcom mora prekinuti nakon potvrde da je razina transaminaza i dalje povišena ili raste, a trajno ukinuti ako se nastavi značajan rast i/ili ako su klinički simptomi oštećenja jetre i dalje prisutni.
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Croatian: Terminalni poluvijek eliminacije je otprilike 8 sati, a koncentracije tolvaptana u stanju dinamičke ravnoteže postižu se nakon prve doze.
English: If an anaphylactic reaction or other serious allergic reactions occur, administration of tolvaptan must be discontinued immediately and appropriate therapy initiated.
Croatian: Ako dođe do anafilaktičke reakcije ili druge ozbiljne alergijske reakcije, primjena tolvaptana mora se odmah prekinuti i uvesti odgovarajuća terapija.
English: Tolvaptan is a weak CYP3A4 substrate and does not appear to have any inhibitory activity.
Croatian: Tolvaptan je slab supstrat CYP3A4 i čini se da nema nikakvo inhibitorno djelovanje.
English: In females, abnormal oestrus cycles were seen in both studies.
Croatian: U ženki su u oba ispitivanja uočeni poremećeni estrusni ciklusi.
English: Jinarc has minor influence on the ability to drive or use machines.
Croatian: Jinarc malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Volume depletion
Croatian: • Deplecija volumena.
English: Tolvaptan must not be taken with grapefruit juice (see section 4.5).
Croatian: Tolvaptan se ne smije uzimati sa sokom od grejpa (vidjeti dio 4.5).