FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of TKV increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80 % per year vs 5.51 % per year, respectively (ratio of geometric mean 0.974; 95 % CI 0.969 to 0.980; p < 0.0001).
Croatian: Stopa porasta UVB-a tijekom 3 godine bila je značajno manja u ispitanika liječenih tolvaptanom nego u ispitanika koji su primali placebo: 2,80 % godišnje naspram 5,51 % godišnje (omjer geometrijske srednje vrijednosti 0,974; 95 % CI od 0,969 do 0,980; p < 0,0001).
English: EU/1/15/1000/003 7 tablets EU/1/15/1000/004 28 tablets
Croatian: EU/1/15/1000/003 7 tableta EU/1/15/1000/004 28 tableta
English: Dose adjustment for patients taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors, tolvaptan doses have to be reduced as follows:
Croatian: Prilagodba doze za bolesnike koji uzimaju umjerene inhibitore CYP3A U bolesnika koji uzimaju umjerene inhibitore CYP3A, doze tolvaptana trebaju se smanjiti kako slijedi:
English: • ALT or AST > 3-times ULN and (BT > 2-times ULN or International Normalized Ratio
Croatian: • ALT ili AST > 3 puta GGN i (ukupni bilirubin > 2 puta GGN ili međunarodni omjer normalizacije [INR] > 1,5)
English: To mitigate the risk of significant and/or irreversible liver injury, blood testing for hepatic transaminases and bilirubin is required prior to initiation of Jinarc, continuing monthly for 18 months and at regular 3-monthly intervals thereafter.
Croatian: Kako bi se smanjio rizik od značajnog i/ili ireverzibilnog oštećenja jetre, prije uvođenja Jinarca nužno je učiniti krvne pretrage jetrenih transaminaza i bilirubina te ih nastaviti provoditi svaki mjesec tijekom 18 mjeseci, a nakon toga redovito u 3-mjesečnim intervalima.
English: The trial utilized a randomized withdrawal design, to enrich for patients that were able to tolerate tolvaptan for a 5-week, single-blind pre-randomization period consisting of a 2-week titration period and 3-week run-in period.
Croatian: U ispitivanju je korišten pristup randomiziranog ustezanja od lijeka kako bi se zadržao što veći broj bolesnika koji su mogli podnositi tolvaptan tijekom petotjednog, jednostruko slijepog predrandomizacijskog razdoblja koje se sastojalo od dvotjednog razdoblja titracije i trotjednog uvodnog razdoblja.
English: • dehydration
Croatian: • dehidracija
English: Concurrent monitoring for symptoms that may indicate liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, dark urine or jaundice) is recommended.
Croatian: Preporučuje se istovremeno pratiti pojavu simptoma koji mogu ukazivati na oštećenje jetre (kao što su umor, anoreksija, mučnina, nelagoda u gornjem desnom dijelu abdomena, povraćanje, vrućica, osip, svrbež, taman urin ili žutica).
English: If a patient shows abnormal ALT, AST or BT levels prior to initiation of treatment which fulfil the criteria for permanent discontinuation (see below) the use of tolvaptan is contraindicated (see section 4.3).
Croatian: Ako bolesnik već prije započinjanja liječenja ima abnormalne razine ALT-a, AST-a ili ukupnog bilirubina koje zadovoljavaju uvjete za trajno ukidanje (vidjeti niže) primjena tolvaptana je kontraindicirana (vidjeti dio 4.3).
English: Subgroup analysis of the primary and secondary endpoints by CKD stage found similar, consistent treatment effects relative to placebo for subjects in stages 2, 3a, 3b and 4 at baseline.
Croatian: Analizom primarnih i sekundarnih mjera ishoda po podskupinama prema stadiju KBB-a, u ispitanika koji su na početku ispitivanja imali stadij 2, 3a, 3b i 4 pronađeni su slični, dosljedni učinci liječenja u usporedbi s placebom.
English: Tolvaptan is contraindicated in anuric patients (see section 4.3).
Croatian: Tolvaptan je kontraindiciran kod bolesnika s anurijom (vidjeti dio 4.3).
English: The CKD stage 3 can be subdivided further to stage 3a 30 %, (eGFR 45 mL/min/1.73 m to less than 60 mL/min/1.73 m 2) and stage 3b 45 %, (eGFR between 30-45 mL/min/1.73 m
Croatian: Stadij 3 KBB-a može se dalje podijeliti na stadij 3a 30 %, (eGFR od 45 ml/min/1,73 m do manje od 60 ml/min/1,73 m 2) i stadij 3b
English: This difference was maintained in the pre-specified MMRM analysis (3.15 mL/min/1.73 m2, 95 %CI 1.462 to 4.836, p = 0.0003) and with sensitivity analyses where baseline eGFR data were carried forward (2.64 mL/min/1.73 m2, 95 %CI 0.672 to 4.603, p = 0.0086).
Croatian: Ta se razlika održala u prethodno određenoj MMRM analizi (3,15 ml/min/1,73 m2, 95 %CI 1,462 do 4,836, p = 0,0003) i kod analiza osjetljivosti u kojima su početni podaci o eGFR-u bili preneseni dalje (2,64 ml/min/1,73 m2, 95 %CI
English: Furthermore, tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
Croatian: Nadalje, tolvaptan je bio povezan s idiosinkratskim povišenjima razine alanin i aspartat aminotransferaza (ALT-a i AST-a) u krvi, a u rjeđim slučajevima i istovremenim povišenjem ukupnog bilirubina.
English: In this trial a total of 1,445 adult patients (age 18-50 years) with evidence of rapidly-progressing, early ADPKD (meeting modified Ravine criteria, total kidney volume (TKV) ≥ 750 mL, estimated creatinine clearance ≥ 60 mL/min) were randomized 2:1 to treatment with tolvaptan or placebo.
Croatian: U ovom ispitivanju ukupno je randomizirano 1445 odraslih bolesnika (u dobi 18-50 godina) s dokazanom brzo progresivnom, ranom ADPBB (koja je zadovoljila modificirane Ravineove kriterije [engl. modified Ravine criteria], ukupni volumen bubrega [UVB] ≥ 750 ml, procijenjen klirens kreatinina ≥ 60 ml/min) u omjeru 2:1 za liječenje tolvaptanom ili primanje placeba.
English: Tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
Croatian: Tolvaptan je povezan s idiosinkratskim povišenjima razine alanin i aspartat aminotransferaza (ALT i AST) u krvi, a u rijetkim slučajevima i istovremenim povišenjem ukupnog bilirubina.
English: Co-administration of tolvaptan and fluconazole, a moderate CYP3A inhibitor, produced a 200 % and 80 % increase in tolvaptan AUC and Cmax, respectively.
Croatian: Istovremena primjena tolvaptana i flukonazola, umjerenog inhibitora CYP3A, dovela je do povećanja AUC-a tolvaptana za 200 % i povećanja Cmax tolvaptana za 80 %.
English: Jinarc is contraindicated during breast-feeding (see section 4.3).
Croatian: Jinarc je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: How to take Jinarc
Croatian: Kako čuvati Jinarc
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Croatian: Herikerbergweg 292
English: The renal function events were 61.4 % less likely for tolvaptan compared with placebo (hazard ratio, 0.39; 95 % CI, 0.26 to 0.57; nominal p < 0.0001), while renal pain events were 35.8 % less likely in tolvaptan-treated patients (hazard ratio, 0.64; 95 % CI, 0.47 to 0.89; nominal p = 0.007).
Croatian: Događaji povezani s funkcijom bubrega bili su 61,4 % manje vjerojatni pri primjeni tolvaptana u usporedbi s placebom (omjer hazarda 0,39; 95 % CI od 0,26 do 0,57; nominalna p vrijednost < 0,0001), a događaji povezani s bubrežnom boli bili su 35,8 % manje vjerojatni u bolesnika liječenih tolvaptanom (omjer hazarda 0,64; 95 % CI od 0,47 do 0,89; nominalna p vrijednost = 0,007).
English: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Ireland
Croatian: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co.
English: The active substance is tolvaptan.
Croatian: Djelatna tvar je tolvaptan.
English: Nocturia, Pollakiuria, Polyuria
Croatian: Nikturija, Polakisurija, Poliurija
English: These may increase the effect of Jinarc.
Croatian: Oni mogu pojačati učinak Jinarca.
English: Teratogenicity was noted in rabbits given 1,000 mg/kg/day (7.5 times the exposure from the 120 mg/day human dose on an AUC basis).
Croatian: Zamijećena je teratogenost u zečeva pri davanju 1000 mg/kg/dan (7,5 puta veća izloženost nego izloženost pri dozi primijenjenoj u ljudi od 120 mg/dan na AUC osnovi).
English: • A Patient Alert Card
Croatian: • Karticu s upozorenjima za bolesnika
English: Dose titration
Croatian: Titracija doze
English: • if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine)
Croatian: • ako ste alergični na tolvaptan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)ili ako ste alergični na benzazepin ili derivate benzazepina (npr. benazepril, konivaptan,
English: • dark urine
Croatian: • tamna mokraća
English: Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Croatian: Bol u abdomenu, Distenzija abdomena, Konstipacija, Dispepsija, Gastroezofagealna refluksna bolest
English: These may increase the effects of Jinarc.
Croatian: Oni mogu pojačati učinke Jinarca.
English: For subjects randomized, the baseline, average estimated glomerular filtration rate (eGFR) was 41 mL/min/1.73 m
Croatian: U randomiziranih je ispitanika početni prosječni eGFR iznosio 41 ml/min/1,73 m
English: Dose adjustment for patients taking strong CYP3A inhibitors In patients taking strong CYP3A inhibitors (see section 4.5), tolvaptan doses have to be reduced as follows:
Croatian: Prilagodba doze za bolesnike koji uzimaju jake inhibitore CYP3A U bolesnika koji uzimaju jake inhibitore CYP3A (vidjeti dio 4.5), doze tolvaptana trebaju se smanjiti kako slijedi:
English: • if you suffer from too high or too low blood sodium.
Croatian: • ako imate previsoku ili prenisku razinu natrija u krvi.
English: Headache, Dizziness
Croatian: Glavobolja, Omaglica
English: Tolvaptan has not been extensively studied in ADPKD in combination with diuretics.
Croatian: Primjena tolvaptana u kombinaciji s diureticima u ADPBB-u nije opsežno ispitana.
English: Jinarc contains lactose as an excipient.
Croatian: Jinarc sadrži laktozu kao pomoćnu tvar.
English: Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister)
Croatian: Jinarc 15 mg tablete EU/1/15/1000/001-002 (blister)
English: • Patient information pack
Croatian: • Informativni paket za bolesnika
English: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below.
Croatian: Incidencija nuspojava povezanih s terapijom tolvaptanom prikazana je u tablici niže.
English: Jinarc 30 mg tablets EU/1/15/1000/003-004 (blister)
Croatian: Jinarc 30 mg tablete EU/1/15/1000/003-004 (blister)
English: Further reductions have to be considered if patients cannot tolerate the reduced tolvaptan doses.
Croatian: Ako bolesnik ne može podnijeti smanjenu dozu tolvaptana treba razmotriti daljnja smanjenja.
English: Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Croatian: Jinarc 30 mg tablete 7 ili 28 tableta u blisteru (PVC/aluminijska folija)
English: Age Clearance of tolvaptan is not significantly affected by age.
Croatian: Dob Dob ne utječe značajno na klirens tolvaptana.
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba • žeđ (koja zahtijeva povećani unos vode)
English: Dose adjustment is not required in patients with renal impairment.
Croatian: U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze.
English: Therefore, please inform your doctor immediately if you have signs that could indicate potential liver problems such as:
Croatian: Stoga, ukoliko imate znakove koji mogu upućivati na oštećenje jetre odmah se javite svome liječniku:
English: Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Croatian: Jinarc 15 mg tablete: blisteri sa 7 ili 28 tableta
English: In a population pharmacokinetic analysis for patients with ADPKD, tolvaptan concentrations were increased, compared to healthy subjects, as renal function decreased below eGFR of 60 mL/min/1.73 m2. An eGFRCKD-EPI decrease from 72.2 to 9.79 (mL/min/1.73 m2) was associated with a 32 % reduction in total body clearance.
Croatian: U analizi populacijske farmakokinetike za bolesnike s ADPBB-om, koncentracije tolvaptana su se povećale, u usporedbi sa zdravim ispitanicima, sa smanjenjem funkcije bubrega ispod eGFR-a od 60 ml/min/1,73 m2.
English: Polydipsia
Croatian: Polidipsija
English: • Patient/Carer educational material
Croatian: • Edukacijski materijal za bolesnika/njegovatelja
English: Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Croatian: Jinarc 30 mg tablete: blisteri sa 7 ili 28 tableta
English: • Breast-feeding (see section 4.6)
Croatian: • Dojenje (vidjeti dio 4.6).
English: Approximately 5 %, 75 % and 20 % had an eGFR 60 mL/min/1.73 m or greater (CKD stage 2), or less than 60 and greater than 30 mL/min/1.73 m
Croatian: a), 75 % imalo je eGFR manji od 60 i veći od 30 ml/min/1,73 m
English: See leaflet for further information.
Croatian: Za daljnje informacije pročitajte uputu o lijeku.
English: 15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Croatian: Tableta od 15 mg: plava, trokutasta, s utisnutim „OTSUKA“ i „15“ na jednoj strani.
English: However, events of increased uric acid and/or gout were not serious and did not cause discontinuation of therapy in the double-blind, placebo-controlled trial.
Croatian: Ipak, u dvostruko slijepom, placebom kontroliranom ispitivanju, slučajevi porasta mokraćne kiseline i/ili gihta nisu bili ozbiljni i nisu uzrokovali prekid terapije.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister in wallet card)
Croatian: Jinarc 30 mg tablete + Jinarc 60 mg tablete EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister u kartonskom ovitku)
English: The dose combinations are: 45 mg + 15 mg
Croatian: Kombinacije doza su: 45 mg + 15 mg 60 mg + 30 mg 90 mg + 30 mg
English: Wed. Thu.
Croatian: Osip, Svrbež
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Croatian: Svaka tableta od 90 mg sadrži približno 24 mg laktoze (u obliku hidrata).
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Croatian: Svaka tableta od 45 mg sadrži približno 12 mg laktoze (u obliku hidrata).
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Croatian: Svaka tableta od 60 mg sadrži približno 16 mg laktoze (u obliku hidrata).
English: A total of 1,370 patients (age 18-65) with chronic kidney disease (CKD) with an eGFR between 25 and 65 mL/min/1.73 m if younger than age 56; or eGFR between 25 and 44 mL/min/1.73 m 2, plus eGFR decline >2.0 mL/min/1.73 m2/year if between age 56-65 were randomized to either tolvaptan (n = 683) or placebo (n = 687) and were treated for a period of 12 months.
Croatian: Ukupno 1370 bolesnika (u dobi od 18-65 godina) s kroničnom bolešću bubrega (KBB) i eGFR-om između 25 i 65 ml/min/1,73 m ako su bili mlađi od 56 godina; ili eGFR-om između 25 i
English: 7 × 15 mg tablets and 7 × 45 mg tablets 14 × 15 mg tablets and 14 × 45 mg tablets 28 × 15 mg tablets and 28 × 45 mg tablets
Croatian: 7 × 15 mg tableta i 7 × 45 mg tableta 14 × 15 mg tableta i 14 × 45 mg tableta 28 × 15 mg tableta i 28 × 45 mg tableta
English: 30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Croatian: Tableta od 30 mg: plava, okrugla, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
English: Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Croatian: Jinarc 30 mg tablete Plava, okrugla (promjer: 8 mm), blago konveksna, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
English: Renal and urinary disorders
Croatian: Opstrukcija protoka urina
English: • Hypernatraemia
Croatian: • Hipernatrijemija.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister in wallet card)
Croatian: + Jinarc 45 mg tablete EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister u kartonskom ovitku)
English: Jinarc may cause your liver to not work properly.
Croatian: Jinarc može uzrokovati poremećaj u radu jetre.
English: 7 × 15 mg tablets and 7 × 45 mg tablets in card packaging 14 × 15 mg tablets and 14 × 45 mg tablets in card packaging 28 × 15 mg tablets and 28 × 45 mg tablets in card packaging
Croatian: 7 × 15 mg tableta i 7 × 45 mg tableta u kartonskom pakiranju 14 × 15 mg tableta i 14 × 45 mg tableta u kartonskom pakiranju 28 × 15 mg tableta i 28 × 45 mg tableta u kartonskom pakiranju
English: 90 mg tablet: blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallow-convex, debossed with “OTSUKA” and “90” on one side
Croatian: Tableta od 90 mg: plava, peterokutna (dulja os 9,7 mm, kraća os 9,5 mm), blago konveksna, s utisnutim „OTSUKA“ i „90“ na jednoj strani.
English: Otsuka Pharmaceutical Italy S.r.l.
Croatian: United Kingdom Otsuka Pharmaceuticals (UK) Ltd.
English: 35 % reduction in the LS means of change in eGFR of -2.34 mL/min/1.73 m in tolvaptan group relative to a -3.61 mL/min/1.73 m in placebo group observed over the course of one year.
Croatian: Terapijska razlika u promjeni eGFR-a opažena u ovom ispitivanju iznosi 1,27 ml/min/1,73 m2, što predstavlja 35 %-tno smanjenje srednje vrijednosti promjene eGFR-a dobivene metodom najmanjih kvadrata (engl. least square, LS) za -2,34 ml/min/1,73 m u skupini liječenoj tolvaptanom u odnosu na -3,61 ml/min/1,73 m u skupini koja je primala placebo, a koje je opaženo u razdoblju od jedne godine.
English: Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Croatian: Jinarc 15 mg tablete Jinarc 30 mg tablete Jinarc 45 mg tablete Jinarc 60 mg tablete Jinarc 90 mg tablete tolvaptan
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister in wallet card)
Croatian: + Jinarc 90 mg tablete EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister u kartonskom ovitku)
English: Jinarc 30 mg tablets
Croatian: Jinarc 30 mg tablete
English: Anaphylactic shock,
Croatian: Anafilaktički šok, Generalizirani osip
English: • pain in the abdomen
Croatian: • bol u trbuhu
English: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Croatian: Plava, trokutasta (dulja os: 6,58 mm, kraća os: 6,20 mm), blago konveksna, s utisnutim „OTSUKA“ i „15“ na jednoj strani.
English: 45 mg tablet: blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side
Croatian: Tableta od 45 mg: plava, četvrtasta (stranica 6,8 mm, dulja os 8,2 mm), blago konveksna, s utisnutim „OTSUKA“ i „45“ na jednoj strani.
English: Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Croatian: Jinarc 15 mg tablete Jinarc 45 mg tablete tolvaptan
English: Jinarc 30 mg tablets tolvaptan
Croatian: Jinarc 30 mg tablete tolvaptan
English: • The Patient information leaflet
Croatian: • Uputu o lijeku s informacijama za bolesnika
English: At baseline, patients had average estimated glomerular filtration rate (eGFR) of 82 mL/min/1.73 m2 (CKD-EPI) with 79 % having hypertension and a mean TKV of
Croatian: Na početku je bolesnicima prosječna procijenjena brzina glomerularne filtracije (eGFR) bila 82 ml/min/1,73 m
English: Jinarc 15 mg tablets tolvaptan
Croatian: Jinarc 15 mg tablete tolvaptan
English: Each 60 mg tablet contains 60 mg tolvaptan.
Croatian: Svaka tableta od 60 mg sadrži 60 mg tolvaptana.
English: 15 mg tablet: blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Croatian: Tableta od 15 mg: plava, trokutasta (dulja os: 6,58 mm, kraća os: 6,20 mm), blago konveksna, s utisnutim „OTSUKA“ i „15“ na jednoj strani.
English: Each 45 mg tablet contains 45 mg tolvaptan.
Croatian: Svaka tableta od 45 mg sadrži 45 mg tolvaptana.
English: Effect of other medicinal products on the pharmacokinetics of tolvaptan
Croatian: Učinak drugih lijekova na farmakokinetiku tolvaptana Inhibitori CYP3A
English: 1,692 mL (height adjusted 972 mL/m).
Croatian: (KBB-EPI), a njih 79 % imalo je hipertenziju i srednju vrijednost UVB-a od 1692 ml (972 ml/m prilagođenoj prema visini).
English: 60 mg tablet: blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side
Croatian: Tableta od 60 mg: plava, modificiranog pravokutnog oblika (dulja os 9,9 mm, kraća os 5,6 mm), blago konveksna, s utisnutim „OTSUKA“ i „60“ na jednoj strani.
English: United Kingdom Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0)203 747 5300
Croatian: Tel: +44 (0)203 747 5300
English: 30 but greater than 15 mL/min/1.73 m
Croatian: 45 %, (eGFR između 30 i 45 ml/min/1,73 m
English: Jinarc 15 mg tablets
Croatian: Jinarc 15 mg tablete
English: Tolvaptan daily split-dose Reduced split-dose 90+30 mg
Croatian: Smanjena podijeljena doza 90+30 mg
English: • Patterns of medicinal product utilisation, especially with regards to off label use and use in patients over 50 years old
Croatian: Dodatno, ispitivanje mora pružiti informacije o: ishodima trudnoća u bolesnica liječenih Jinarcom obrascima potrošnje lijeka, posebno s obzirom na primjenu izvan odobrenih indikacija te primjenu u bolesnika starijih od 50 godina nuspojavama povezanima s dugotrajnom primjenom Jinarca
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets
Croatian: Jinarc 30 mg tablete + Jinarc 60 mg tablete
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets
Croatian: + Jinarc 45 mg tablete Jinarc 30 mg tablete + Jinarc 60 mg tablete Jinarc 30 mg tablete
English: In addition, increased use of allopurinol and other medicinal products used to manage gout were observed in the double-blind, placebo-controlled trial.
Croatian: Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju, uočen je i porast primjene alopurinola i drugih lijekova za liječenje gihta.
English: • gout
Croatian: • giht
English: Each 15 mg tablet contains 15 mg tolvaptan.
Croatian: Svaka tableta od 15 mg sadrži 15 mg tolvaptana.
English: Each 90 mg tablet contains 90 mg tolvaptan.
Croatian: Svaka tableta od 90 mg sadrži 90 mg tolvaptana.
English: Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Croatian: Svaka tableta Jinarca od 30 mg sadrži 30 mg tolvaptana.
English: Each tablet contains 15 mg tolvaptan.
Croatian: Svaka tableta sadrži 15 mg tolvaptana.
English: Each tablet contains 30 mg tolvaptan.
Croatian: Svaka tableta sadrži 30 mg tolvaptana.
English: 7 × 30 mg tablets and 7 × 90 mg tablets 14 × 30 mg tablets and 14 × 90 mg tablets 28 × 30 mg tablets and 28 × 90 mg tablets
Croatian: 7 × 30 mg tableta i 7 × 90 mg tableta 14 × 30 mg tableta i 14 × 90 mg tableta 28 × 30 mg tableta i 28 × 90 mg tableta
English: Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Croatian: Svaka tableta Jinarca od 15 mg sadrži 15 mg tolvaptana.
English: 7 × 30 mg tablets and 7 × 60 mg tablets 14 × 30 mg tablets and 14 × 60 mg tablets 28 × 30 mg tablets and 28 × 60 mg tablets
Croatian: 7 × 30 mg tableta i 7 × 60 mg tableta 14 × 30 mg tableta i 14 × 60 mg tableta 28 × 30 mg tableta i 28 × 60 mg tableta
English: Each 30 mg tablet contains 30 mg tolvaptan.
Croatian: Svaka tableta od 30 mg sadrži 30 mg tolvaptana.
English: • shortness of breath
Croatian: • nedostatak zraka
English: Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Croatian: Svaka tableta Jinarca od 60 mg sadrži 60 mg tolvaptana.
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Croatian: Jinarc 30 mg tablete Jinarc 90 mg tablete tolvaptan
English: Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Croatian: Svaka tableta Jinarca od 90 mg sadrži 90 mg tolvaptana.
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Croatian: Jinarc 30 mg tablete Jinarc 60 mg tablete tolvaptan