FrancophonIA/ELRC3.0 huggingface dataset:
English: If ALT and AST levels remain below 3-times the upper limit of normal (ULN), Jinarc therapy may be cautiously re-started, with frequent monitoring at the same or lower doses, as transaminase levels appear to stabilise during continued therapy in some patients.
Croatian: Ako razine ALT-a i AST-a ostanu ispod vrijednosti 3 puta gornje granice normale (GGN), terapija Jinarcom može se oprezno nastaviti istim ili nižim dozama uz učestaliji nadzor, budući da se pokazalo da su se razine transaminaza u nekih bolesnika stabilizirale tijekom kontinuirane terapije.
English: • treatments containing ketoconazole for fungal infections, macrolide antibiotics like clarithromycin, or diltiazem as a treatment for high blood pressure and chest pain.
Croatian: • lijekove koji sadrže ketokonazol za gljivične infekcije, makrolidne antibiotike kao što je klaritromicin ili diltiazem kao terapiju za visok krvni tlak i bol u prsištu.
English: In-vitro studies indicate that tolvaptan is a substrate and competitive inhibitor of P-glycoprotein (P-gp).
Croatian: In vitro ispitivanja pokazuju da je tolvaptan supstrat i kompetitivni inhibitor P-glikoproteina (P-gp).
English: The result of the key secondary composite endpoint is primarily attributed to effects on worsening kidney function and medically significant kidney pain.
Croatian: Rezultati ključnog sekundarnog kompozitnog ishoda uglavnom su se mogli pripisati učincima pogoršanja funkcije bubrega i medicinski značajnoj bubrežnoj boli.
English: Additionally, patients have to drink 1-2 glasses of fluid before bedtime regardless of perceived thirst and replenish fluids overnight with each episode of nocturia.
Croatian: Osim toga, bolesnici trebaju popiti 1-2 čaše tekućine prije spavanja bez obzira na osjećaj žeđi, a za svaku epizodu nikturije tijekom noći popiti još tekućine.
English: Jinarc may increase the effect of these medicines.
Croatian: Jinarc može pojačati učinak tih lijekova.
English: Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition, have an increased risk of developing acute retention.
Croatian: Bolesnici s djelomičnom opstrukcijom protoka urina, naprimjer bolesnici s hipertrofijom prostate ili poremećajem mikcije, imaju povećan rizik od razvoja akutne retencije.
English: (CKD-Epidemiology formula) and historical TKV, available in 318 (23 %) of subjects, averaged 2,026 mL.
Croatian: (epidemiološka formula za KBB), a prosječna vrijednost prethodnih TKV-a, dostupnih za 318 (23 %) ispitanika, iznosila je 2026 ml.
English: Tolvaptan is not recommended in the paediatric age group.
Croatian: Tolvaptan se ne preporučuje u pedijatrijskoj dobnoj skupini.
English: • weight loss
Croatian: • gubitak težine.
English: Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements (see section 4.4).
Croatian: Liječenje tolvaptanom mora se započeti i pratiti pod nadzorom liječnika stručnog u zbrinjavanju ADPBB-a koji je u potpunosti upoznat s rizicima terapije tolvaptanom, uključujući hepatotoksičnost i potrebu za nadzorom (vidjeti dio 4.4).
English: Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60
Croatian: Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co.
English: Jinarc must not be used during pregnancy (see section 4.3).
Croatian: Jinarc se ne smije primjenjivati tijekom trudnoće (vidjeti dio 4.3).
English: The morning dose of Jinarc is to be taken at least 30 minutes before the morning meal.
Croatian: Jutarnju dozu Jinarca treba uzeti najmanje 30 minuta prije jutarnjeg obroka.
English: Diabetic patients with an elevated glucose concentration (e.g. in excess of 300 mg/dl) may present with pseudohyponatraemia.
Croatian: U dijabetičara s povišenom koncentracijom glukoze (npr. ako je veća od 300 mg/dl) može biti prisutna pseudohiponatrijemija.
English: The period of onset of hepatocellular injury (by ALT elevations > 3 × ULN) was within 3 to 14 months after initiating treatment and these increases were reversible, with ALT returning to < 3 × ULN within 1 to 4 months.
Croatian: Razdoblje unutar kojeg je nastalo hepatocelularno oštećenje (prema porastu ALT-a > 3 × GGN) bilo je unutar 3 do 14 mjeseci od početka liječenja, i ti su porasti bili reverzibilni, a ALT je pala < 3 × GGN unutar 1 do 4 mjeseca.
English: Longer term data are not currently available to show whether long-term therapy with Jinarc continues to slow the rate of renal function decline and affect clinical outcomes of ADPKD, including delay in the onset of end-stage renal disease.
Croatian: Trenutačno nisu dostupni dugoročniji podaci koji bi mogli pokazati usporava li dugotrajna terapija Jinarcom i dalje brzinu slabljenja funkcije bubrega i utječe li na kliničke ishode ADPKD, uključujući odgađanje početka završne faze bolesti bubrega.
English: Therapy must be interrupted if the ability to drink or the accessibility to water is limited (see section 4.4).
Croatian: Liječenje se mora prekinuti ako je sposobnost unosa vode ili dostupnost vode ograničena (vidjeti dio 4.4).
English: • if you are breastfeeding (see “Pregnancy and breast-feeding).
Croatian: • ako dojite (vidjeti „Trudnoća i dojenje“).
English: The primary end point for TKV did not distinguish a difference in change (−1.7 %) over the 5 year treatment between early- and delayed-treated subjects at the pre-specified threshold of statistical significance (p = 0.3580).
Croatian: Primarni ishod za UVB nije pokazao razliku u promjeni (−1,7 %) tijekom 5 godina liječenja između rano i kasno liječenih ispitanika pri prethodno određenoj graničnoj vrijednosti statističke značajnosti (p = 0,3580).
English: Statins commonly used in the tolvaptan phase 3 pivotal trial (e.g., rosuvastatin and pitavastatin) are OATP1B1 or OATP1B3 substrates, however no difference in AE profile was observed during the phase 3 pivotal trial for tolvaptan in ADPKD.
Croatian: Statini koji su se obično primjenjivali u fazi 3 pivotalnog ispitivanja tolvaptana (npr. rosuvastatin i pitavastatin) su supstrati za OATP1B1 ili OATP1B3, međutim nije uočena razlika u profilu nuspojava tijekom faze 3 pivotalnog ispitivanja tolvaptana u ADPBB-u.
English: The inclusion criteria identified patients who at baseline had evidence of early disease progression.
Croatian: Kriteriji uključenja odredili su bolesnike u kojih je na početku dokazana rana progresija bolesti.
English: This water loss may result in side effects such as dry mouth and thirst or even more severe side effects like kidney problems (see section 4).
Croatian: Gubitak vode može prouzročiti nuspojave kao što su suha usta i žeđ ili čak i ozbiljnije nuspojave kao što su tegobe s bubrezima (vidjeti dio 4).
English: Swallow the tablets without chewing, with a glass of water.
Croatian: Progutajte tablete bez žvakanja s čašom vode.
English: The effect of mildly or moderately impaired hepatic function (Child-Pugh classes A and B) on the pharmacokinetics of tolvaptan was investigated in 87 patients with liver disease of various origins.
Croatian: Učinak blagog ili umjerenog oštećenja funkcije jetre (Child-Pugh stadij A i B) na farmakokinetiku tolvaptana ispitivan je u 87 bolesnika s bolešću jetre različitog porijekla.
English: Women of childbearing potential must use adequate contraceptive measures during Jinarc use.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom primjene Jinarca.
English: If you stop taking Jinarc
Croatian: Ako prestanete uzimati Jinarc
English: Dehydration, Hypernatraemia, Decreased appetite, Hyperuricaemia, Hyperglycaemia, Gout
Croatian: Dehidracija, Hipernatrijemija, Smanjen apetit, Hiperuricemija, Hiperglikemija, Giht
English: The physician educational material should contain:
Croatian: Edukacijski materijal za liječnika mora sadržavati:
English: Tolvaptan is extensively metabolised in the liver almost exclusively by CYP3A.
Croatian: Tolvaptan se opsežno metabolizira u jetri i to gotovo isključivo putem CYP3A.
English: A secondary endpoint testing the persistence of positive effects on renal function indicated that the preservation of eGFR observed by the end of the TEMPO 3:4 pivotal trial (3.01 to 3.34 mL/min/1.73 m at follow-up visits 1 and 2) could be preserved during open-label treatment.
Croatian: Sekundarni ishod testiranja održanja pozitivnih učinaka na funkciju bubrega pokazao je da se očuvanje eGFR-a opaženo na kraju ključnog ispitivanja TEMPO 3:4 (3,01 do 3,34 ml/min/1,73 m na 1. i 2. kontrolnom pregledu) moglo očuvati tijekom otvorene faze liječenja.
English: Concomitant use of tolvaptan with medicinal products that increase serum sodium concentration may result in a higher risk for developing hypernatraemia (see section 4.4) and is therefore not recommended.
Croatian: Istovremena primjena tolvaptana s lijekovima koji povećavaju serumsku koncentraciju natrija može imati za posljedicu veći rizik za razvoj hipernatrijemije (vidjeti dio 4.4) i zato se ne preporučuje.
English: • increased need to urinate, to urinate at night, or to urinate more frequently
Croatian: • povećana potreba za mokrenjem, mokrenjem noću, učestalijim mokrenjem
English: Approximately 35 % of subjects were chronic kidney disease (CKD) stage 1, 48 % CKD stage 2, and 17 % CKD stage 3 (eGFRCKD-EPI).
Croatian: Približno 35 % ispitanika imalo je kroničnu bolest bubrega (KBB) 1. stadija, 48 % KBB 2. stadija i 17 % KBB 3. stadija (eGFRKBB-EPI).
English: (CKD stage 4), respectively.
Croatian: (stadij 4 KBB-a).
English: For split-dose regimens of 30, 60 and 120 mg/day in ADPKD patients, tolvaptan exposure (AUC) increases linearly.
Croatian: Kod primjene režima podijeljenih doza od 30, 60 i 120 mg/dan u bolesnika s ADPBB-om izloženost tolvaptanu (AUC) raste linearno.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetre (Child-Pugh stadij A i B).
English: In a peri- and post-natal study in rats, delayed ossification and reduced pup bodyweight were seen at the high dose of 1,000 mg/kg/day.
Croatian: U perinatalnim i postnatalnim ispitivanjima na štakorima, zamijećeno je kašnjenje okoštavanja i smanjena tjelesna težina mladunčadi pri visokoj dozi od 1000 mg/kg/dan.
English: The other ingredients are lactose monohydrate (see section 2), maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake.
Croatian: Drugi sastojci su laktoza hidrat (vidjeti dio 2), kukuruzni škrob, mikrokristalična celuloza, hidroksipropilceluloza, magnezijev stearat, indigo carmine aluminium lake.
English: Following single oral doses, Cmax values show less than dose proportional increases from 30 to 240 mg and then a plateau at doses from 240 to 480 mg, AUC increases linearly.
Croatian: Nakon jednokratnih oralnih doza, vrijednosti Cmax pokazuju porast manji od porasta proporcionalnog dozi pri dozama od 30 do 240 mg, a zatim plato pri dozama od 240 do 480 mg.
English: Studies in animals showed effects on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su utjecaj na plodnost (vidjeti dio 5.3).
English: Jinarc contains lactose
Croatian: Jinarc sadrži laktozu
English: In vitro studies indicated that tolvaptan has no inhibitory activity for CYP3A.
Croatian: In vitro ispitivanja pokazala su da tolvaptan nema inhibitorno djelovanje na CYP3A.
English: • the risk of hepatotoxicity associated with the use of Jinarc
Croatian: • rizik od hepatotoksičnosti povezan s primjenom Jinarca
English: Co-administration with medicinal products that increase serum sodium concentration There is no experience from controlled clinical trials with concomitant use of tolvaptan and hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Croatian: Istovremena primjena s lijekovima koji povećavaju serumsku koncentraciju natrija Iz kontroliranih kliničkih ispitivanja nema iskustava s istovremenom primjenom tolvaptana i hipertonične otopine natrijeva klorida, oralne formulacije natrija i lijekova koji povećavaju serumsku koncentraciju natrija.
English: Diuretics or non-diuretic anti-hypertensive medicinal product(s) Standing blood pressure was not routinely measured in ADPKD trials, therefore a risk of orthostatic/postural hypotension due to a pharmacodynamic interaction with tolvaptan cannot be excluded.
Croatian: Diuretici i antihipertenziv(i) bez diuretskog djelovanja Krvni tlak u stojećem stavu nije rutinski mjeren u ispitivanjima ADPBB-a i zato se ne može isključiti rizik od ortostatske/posturalne hipotenzije zbog farmakodinamičke interakcije s tolvaptanom.
English: In addition to its renal aquaretic effect, tolvaptan is capable of blocking vascular vasopressin V2 receptors involved in the release of coagulation factors (e.g., von Willebrand factor) from endothelial cells.
Croatian: Osim svog učinka na izlučivanje vode u bubrezima, tolvaptan može blokirati i vaskularne vazopresinske V2 receptore koji sudjeluju u otpuštanju faktora koagulacije (npr. von Willebrandov faktor) iz endotelnih stanica.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane slijedom prema padajućoj ozbiljnosti.
English: What you need to know before you take Jinarc
Croatian: Što morate znati prije nego počnete uzimati Jinarc
English: If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake.
Croatian: Ako dehidracija postane očita, poduzmite odgovarajuće mjere koje mogu uključivati potrebu prekidanja ili smanjenja doze tolvaptana i povećanje unosa tekućine.
English: Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration.
Croatian: Lijekovi s visokim sadržajem natrija kao što su analgetici u obliku šumećih pripravaka i neki lijekovi za dispepsiju koji sadrže natrij također mogu povećati serumsku koncentraciju natrija.
English: In patients treated with tolvaptan the reduction in eGFR was significantly less than in patients treated with placebo (p < 0.0001).
Croatian: Smanjenje eGFR-a bilo je značajno manje u bolesnika liječenih tolvaptanom nego u bolesnika koji su primali placebo (p < 0,0001).
English: At the onset of symptoms or signs consistent with hepatic injury or if clinically significant abnormal ALT or AST increases are detected during treatment, Jinarc administration must be immediately interrupted and repeat tests including ALT, AST, BT and alkaline phosphatase (AP) must be obtained as soon as possible (ideally within 48-72 hours).
Croatian: Ako nastupe simptomi ili znakovi koji ukazuju na oštećenje jetre ili ako se uoči klinički značajan abnormalan porast ALT-a ili AST-a tijekom liječenja, primjena Jinarca mora se odmah prekinuti i što prije (najbolje unutar 48-72 sata) se moraju ponoviti pretrage uključujući ALT, AST, ukupni bilirubin i alkalnu fosfatazu (AP).
English: The initial dose is 60 mg tolvaptan per day as a split-dose regimen of 45 mg + 15 mg (45 mg taken upon waking and prior the morning meal and 15 mg taken 8 hours later).
Croatian: Početna doza je 60 mg tolvaptana na dan u režimu s dvije podijeljene doze od 45 mg + 15 mg (45 mg uzima se nakon buđenja i prije jutarnjeg obroka, a 15 mg uzima se 8 sati kasnije).
English: Do not take Jinarc:
Croatian: Nemojte uzimati Jinarc:
English: Concomitant use of medicinal products that are potent CYP3A inducers (e.g., rifampicin) will decrease tolvaptan exposure and efficacy.
Croatian: Istovremena primjena lijekova koji su jaki induktori CYP3A (npr. rifampicin) smanjit će izloženost tolvaptanu i njegovu djelotvornost.
English: Co-administration of tolvaptan and ketoconazole resulted in a 440 % increase in area under time-concentration curve (AUC) and 248 % increase in maximum observed plasma concentration (Cmax) for tolvaptan.
Croatian: Istovremena primjena tolvaptana i ketokonazola imala je za posljedicu povećanje površine ispod krivulje vrijeme-koncentracija (AUC) za 440 % i povećanje najveće koncentracije tolvaptana u plazmi (Cmax) za 248 %.
English: Even though the clinical relevance of this finding is not known, to minimise the unnecessary risk of increasing the maximal exposure the morning dose should be taken under fasted conditions (see section 4.2).
Croatian: Iako klinički značaj ovog nalaza nije poznat, jutarnju dozu je potrebno uzeti natašte (vidjeti dio 4.2) kako bi se smanjio nepotreban rizik od povećanja maksimalne izloženosti.
English: This disease causes growth of fluid-filled cysts in the kidneys which put pressure on surrounding tissues and reduce kidney function, possibly leading to kidney failure.
Croatian: Ova bolest uzrokuje rast cista ispunjenih tekućinom u bubrezima što uzrokuje pritisak na okolna tkiva i smanjuje funkciju bubrega što može dovesti do zatajenja bubrega.
English: • desmopressin (used to increase blood clotting factors or to control urine output or bedwetting).
Croatian: • dezmopresin (primjenjuje se za povećanje faktora zgrušavanja krvi ili za kontrolu izlučivanja mokraće i mokrenja u krevet).
English: Jinarc is to be administered twice daily in split dose regimens of 45 mg + 15 mg, 60 mg + 30 mg or 90 mg + 30 mg.
Croatian: Jinarc treba primjenjivati dva puta dnevno u režimima s dvije podijeljene doze od 45 mg + 15 mg, 60 mg + 30 mg ili 90 mg + 30 mg.
English: The key secondary endpoint was a comparison of the efficacy of tolvaptan treatment vs. placebo in reducing the decline of annualized eGFR slope across all measured time points in the trial.
Croatian: Ključna sekundarna mjera ishoda bila je usporedba djelotvornosti liječenja tolvaptanom naspram placeba u smanjivanju opadanja eGFR-a na godišnjoj razini (engl. annualized eGFR slope) u svim vremenskim točkama mjerenja u ovom ispitivanju.
English: Idiosyncratic hepatic toxicity
Croatian: Idiosinkratska hepatotoksičnost
English: • experience swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Croatian: • osjetite oticanje lica, usana ili jezika, svrbež, osip po cijelom tijelu ili teško zviždanje u plućima ili nedostatak zraka (simptomi alergijske reakcije).
English: Uric acid increases
Croatian: Porast mokraćne kiseline
English: Co-administration of tolvaptan with a high-fat meal increased peak concentrations of tolvaptan up to 2-fold but left AUC unchanged.
Croatian: Istovremena primjena tolvaptana uz obrok s visokim udjelom masnoća povećala je vršnu koncentraciju tolvaptana i do dva puta, ali je AUC ostao nepromijenjen.
English: The no observed adverse effect level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the maximum human recommended dose of 120 mg/day on a mg/m basis.
Croatian: Razina pri kojoj nisu opažene nuspojave (NOAEL) na reproduktivnu funkciju ženki (100 mg/kg/dan) bila je otprilike 8 puta veća od najveće preporučene doze za ljude od 120 mg/dan na mg/m osnovi.
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake
Croatian: 6.1 Popis pomoćnih tvari kukuruzni škrob hidroksipropilceluloza laktoza hidrat magnezijev stearat mikrokristalična celuloza indigo carmine aluminium lake
English: A reversible reduction in GFR has been observed in ADPKD trials at the initiation of tolvaptan treatment.
Croatian: U ispitivanjima ADPBB-a uočeno je reverzibilno smanjenje GFR-a na početku liječenja tolvaptanom.
English: Taken with Jinarc these may increase the risk of side effects due to water loss.
Croatian: Ako se uzimaju s Jinarcom mogu povećati rizik od nuspojava zbog gubitka vode.
English: Therefore, patients must have access to water (or other aqueous fluids) and be able to drink sufficient amounts of these fluids (see section 4.2).
Croatian: Zbog toga bolesnici moraju imati pristup vodi (ili drugim tekućinama na bazi vode) i mogućnost unosa dovoljnih količina tih tekućina (vidjeti dio 4.2).
English: Diarrhoea, Dry mouth
Croatian: Dijareja, Suha usta
English: • Pregnancy (see section 4.6)
Croatian: • Trudnoća (vidjeti dio 4.6).
English: This trial evaluated the effects of tolvaptan on safety, TKV and eGFR in subjects receiving active treatment for 5 years (early-treated), compared with subjects treated with placebo for 3 years, then switched to active treatment for 2 years (delayed-treated).
Croatian: U ovom su se ispitivanju ocjenjivali učinci tolvaptana na sigurnost, UVB i eGFR ispitanika koji su primali aktivnu terapiju tijekom 5 godina (rano liječeni), u usporedbi s ispitanicima koji su primali placebo tijekom 3 godine, a zatim bili prebačeni na aktivnu terapiju tijekom 2 godine (kasno liječeni).
English: Before bedtime you must drink 1 or 2 glasses of water even if you do not feel thirsty and you must also drink water after you urinating at night.
Croatian: Zato je važno da imate pristup vodi i da možete piti dovoljne količine kada osjećate žeđ. Prije spavanja morate popiti 1 ili 2 čaše vode čak i ako niste žedni te također morate popiti još vode nakon mokrenja noću.
English: The patient information pack should contain:
Croatian: Informativni paket za bolesnika mora sadržavati:
English: Dose reduction of tolvaptan is recommended for patients while taking moderate or strong CYP3A inhibitors (see section 4.2).
Croatian: Preporučuje se smanjenje doze tolvaptana u bolesnika za vrijeme uzimanja umjerenih ili jakih inhibitora CYP3A (vidjeti dio 4.2).
English: Patients must be managed carefully and liver enzymes must be monitored regularly (see section 4.4).
Croatian: Bolesnike se mora pažljivo kontrolirati te redovito nadzirati jetrene enzime (vidjeti dio 4.4).
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, polyuria, nocturia, and pollakiuria (see section 4.8).
Croatian: Tolvaptan može uzrokovati nuspojave povezane s gubitkom tekućine kao što su žeđ, poliurija, nikturija i polakisurija (vidjeti dio 4.8).
English: • digoxin (a medicine for the treatment of irregular heart beat and heart failure), dabigatran (used to thin the blood), rosuvastatin or pitavastatin (used to lower blood cholesterol) methotrexate (used to treat cancer, arthritis), ciprofloxacin (an antibiotic), sulfasalazine (for treatment of inflammatory bowel disease or rheumatoid arthritis) or metformin (for treatment of diabetes).
Croatian: • digoksin (lijek za liječenje nepravilnih otkucaja srca i zatajenja srca), dabigatran (za razrjeđivanje krvi), rosuvastatin ili pitavastatin (za smanjenje kolesterola u krvi), metotreksat (za liječenje raka, artritisa), ciprofloksacin (antibiotik), sulfasalazin (za liječenje upalne bolesti crijeva ili reumatoidnog artritisa) ili metformin (za liječenje šećerne bolesti).
English: If dehydration or renal dysfunction becomes evident, appropriate action must be taken which may include the need to interrupt or reduce doses of tolvaptan and/or diuretics and increased fluid intake.
Croatian: Ako dehidracija ili renalna disfunkcija postanu očite, moraju se poduzeti odgovarajuće mjere koje mogu uključivati potrebu za prekidom ili smanjenjem doza tolvaptana i/ili diuretika i pojačano uzimanje tekućine.
English: Patients receiving digoxin or other narrow therapeutic P-gp substrates (e.g., dabigatran) must therefore be managed cautiously and evaluated for excessive effects when treated with tolvaptan.
Croatian: Zato se bolesnike koji primaju digoksin ili drugi lijek s uskom terapijskom širinom koji je supstrat za P-gp (npr. dabigatran) mora zbrinjavati s oprezom te procijeniti s obzirom na moguće pretjerane učinke kada se liječe tolvaptanom.
English: Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) stages 1 to 4 with evidence of rapidly progressing disease.
Croatian: Jinarc se koristi za liječenje ADPBB-a u odraslih s kroničnom bolešću bubrega (KBB) 1. do 4. stadija s dokazanim brzim napredovanjem bolesti.