natgillin/translations-raw huggingface dataset:
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. 
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.
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). 
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.
Co-administration of tolvaptan and fluconazole, a moderate CYP3A inhibitor, produced a 200 % and 80 % increase in tolvaptan AUC and Cmax, respectively. 
Istovremena primjena tolvaptana i flukonazola, umjerenog inhibitora CYP3A, dovela je do povećanja AUC-a tolvaptana za 200 % i povećanja Cmax tolvaptana za 80 %.
Jinarc is contraindicated during breast-feeding (see section 4.3). 
Jinarc je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
How to take Jinarc 
Kako čuvati Jinarc
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). 
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).
Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Ireland 
Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co.
The active substance is tolvaptan. 
Djelatna tvar je tolvaptan.
Nocturia, Pollakiuria, Polyuria 
Nikturija, Polakisurija, Poliurija
These may increase the effect of Jinarc. 
Oni mogu pojačati učinak Jinarca.
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). 
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).
• A Patient Alert Card 
• Karticu s upozorenjima za bolesnika
Dose titration 
Titracija doze
• 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) 
• 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,
• dark urine 
• tamna mokraća
Abdominal pain, Abdominal distension, Constipation, Dyspepsia, 
Bol u abdomenu, Distenzija abdomena, Konstipacija, Dispepsija, Gastroezofagealna refluksna bolest
These may increase the effects of Jinarc. 
Oni mogu pojačati učinke Jinarca.
For subjects randomized, the baseline, average estimated glomerular filtration rate (eGFR) was 41 mL/min/1.73 m 
U randomiziranih je ispitanika početni prosječni eGFR iznosio 41 ml/min/1,73 m
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: 
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:
• if you suffer from too high or too low blood sodium. 
• ako imate previsoku ili prenisku razinu natrija u krvi.
Headache, Dizziness 
Glavobolja, Omaglica
Tolvaptan has not been extensively studied in ADPKD in combination with diuretics. 
Primjena tolvaptana u kombinaciji s diureticima u ADPBB-u nije opsežno ispitana.
Jinarc contains lactose as an excipient. 
Jinarc sadrži laktozu kao pomoćnu tvar.
Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister) 
Jinarc 15 mg tablete EU/1/15/1000/001-002 (blister)
• Patient information pack 
• Informativni paket za bolesnika
The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below. 
Incidencija nuspojava povezanih s terapijom tolvaptanom prikazana je u tablici niže.
Jinarc 30 mg tablets EU/1/15/1000/003-004 (blister) 
Jinarc 30 mg tablete EU/1/15/1000/003-004 (blister)
Further reductions have to be considered if patients cannot tolerate the reduced tolvaptan doses. 
Ako bolesnik ne može podnijeti smanjenu dozu tolvaptana treba razmotriti daljnja smanjenja.
Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister 
Jinarc 30 mg tablete 7 ili 28 tableta u blisteru (PVC/aluminijska folija)
Age Clearance of tolvaptan is not significantly affected by age. 
Dob Dob ne utječe značajno na klirens tolvaptana.
Very common: may affect more than 1 in 10 people 
Vrlo često: mogu se javiti u više od 1 na 10 osoba • žeđ (koja zahtijeva povećani unos vode)
Dose adjustment is not required in patients with renal impairment. 
U bolesnika s oštećenjem bubrega nije potrebna prilagodba doze.
Therefore, please inform your doctor immediately if you have signs that could indicate potential liver problems such as: 
Stoga, ukoliko imate znakove koji mogu upućivati na oštećenje jetre odmah se javite svome liječniku:
Jinarc 15 mg tablets: blisters with 7 or 28 tablets 
Jinarc 15 mg tablete: blisteri sa 7 ili 28 tableta
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. 
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.
Polydipsia 
Polidipsija
• Patient/Carer educational material 
• Edukacijski materijal za bolesnika/njegovatelja
Jinarc 30 mg tablets: blisters with 7 or 28 tablets 
Jinarc 30 mg tablete: blisteri sa 7 ili 28 tableta
• Breast-feeding (see section 4.6) 
• Dojenje (vidjeti dio 4.6).
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 
a), 75 % imalo je eGFR manji od 60 i veći od 30 ml/min/1,73 m
See leaflet for further information. 
Za daljnje informacije pročitajte uputu o lijeku.
15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side. 
Tableta od 15 mg: plava, trokutasta, s utisnutim „OTSUKA“ i „15“ na jednoj strani.
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. 
Ipak, u dvostruko slijepom, placebom kontroliranom ispitivanju, slučajevi porasta mokraćne kiseline i/ili gihta nisu bili ozbiljni i nisu uzrokovali prekid terapije.
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) 
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)
The dose combinations are: 45 mg + 15 mg 
Kombinacije doza su: 45 mg + 15 mg 60 mg + 30 mg 90 mg + 30 mg
Wed. Thu. 
Osip, Svrbež
Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate). 
Svaka tableta od 90 mg sadrži približno 24 mg laktoze (u obliku hidrata).
Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate). 
Svaka tableta od 45 mg sadrži približno 12 mg laktoze (u obliku hidrata).
Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate). 
Svaka tableta od 60 mg sadrži približno 16 mg laktoze (u obliku hidrata).
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. 
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
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 
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
30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side. 
Tableta od 30 mg: plava, okrugla, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side. 
Jinarc 30 mg tablete Plava, okrugla (promjer: 8 mm), blago konveksna, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
Renal and urinary disorders 
Opstrukcija protoka urina
• Hypernatraemia 
• Hipernatrijemija.
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) 
+ Jinarc 45 mg tablete EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister u kartonskom ovitku)
Jinarc may cause your liver to not work properly. 
Jinarc može uzrokovati poremećaj u radu jetre.
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 
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
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 
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.
Otsuka Pharmaceutical Italy S.r.l. 
United Kingdom Otsuka Pharmaceuticals (UK) Ltd.
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. 
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.
Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets 
Jinarc 15 mg tablete Jinarc 30 mg tablete Jinarc 45 mg tablete Jinarc 60 mg tablete Jinarc 90 mg tablete tolvaptan
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) 
+ Jinarc 90 mg tablete EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister u kartonskom ovitku)
Jinarc 30 mg tablets 
Jinarc 30 mg tablete
Anaphylactic shock, 
Anafilaktički šok, Generalizirani osip
• pain in the abdomen 
• bol u trbuhu
Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side. 
Plava, trokutasta (dulja os: 6,58 mm, kraća os: 6,20 mm), blago konveksna, s utisnutim „OTSUKA“ i „15“ na jednoj strani.
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 
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.
Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan 
Jinarc 15 mg tablete Jinarc 45 mg tablete tolvaptan
Jinarc 30 mg tablets tolvaptan 
Jinarc 30 mg tablete tolvaptan
• The Patient information leaflet 
• Uputu o lijeku s informacijama za bolesnika
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 
Na početku je bolesnicima prosječna procijenjena brzina glomerularne filtracije (eGFR) bila 82 ml/min/1,73 m
Jinarc 15 mg tablets tolvaptan 
Jinarc 15 mg tablete tolvaptan
Each 60 mg tablet contains 60 mg tolvaptan. 
Svaka tableta od 60 mg sadrži 60 mg tolvaptana.
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. 
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.
Each 45 mg tablet contains 45 mg tolvaptan. 
Svaka tableta od 45 mg sadrži 45 mg tolvaptana.
Effect of other medicinal products on the pharmacokinetics of tolvaptan 
Učinak drugih lijekova na farmakokinetiku tolvaptana Inhibitori CYP3A
1,692 mL (height adjusted 972 mL/m). 
(KBB-EPI), a njih 79 % imalo je hipertenziju i srednju vrijednost UVB-a od 1692 ml (972 ml/m prilagođenoj prema visini).
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 
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.
United Kingdom Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0)203 747 5300 
Tel: +44 (0)203 747 5300
30 but greater than 15 mL/min/1.73 m 
45 %, (eGFR između 30 i 45 ml/min/1,73 m
Jinarc 15 mg tablets 
Jinarc 15 mg tablete
Tolvaptan daily split-dose Reduced split-dose 90+30 mg 
Smanjena podijeljena doza 90+30 mg
• Patterns of medicinal product utilisation, especially with regards to off label use and use in patients over 50 years old 
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
Jinarc 30 mg tablets + Jinarc 60 mg tablets 
Jinarc 30 mg tablete + Jinarc 60 mg tablete
Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets 
+ Jinarc 45 mg tablete Jinarc 30 mg tablete + Jinarc 60 mg tablete Jinarc 30 mg tablete
In addition, increased use of allopurinol and other medicinal products used to manage gout were observed in the double-blind, placebo-controlled trial. 
Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju, uočen je i porast primjene alopurinola i drugih lijekova za liječenje gihta.
• gout 
• giht
Each 15 mg tablet contains 15 mg tolvaptan. 
Svaka tableta od 15 mg sadrži 15 mg tolvaptana.
Each 90 mg tablet contains 90 mg tolvaptan. 
Svaka tableta od 90 mg sadrži 90 mg tolvaptana.
Each Jinarc 30 mg tablet contains 30 mg tolvaptan. 
Svaka tableta Jinarca od 30 mg sadrži 30 mg tolvaptana.
Each tablet contains 15 mg tolvaptan. 
Svaka tableta sadrži 15 mg tolvaptana.
Each tablet contains 30 mg tolvaptan. 
Svaka tableta sadrži 30 mg tolvaptana.
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 
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
Each Jinarc 15 mg tablet contains 15 mg tolvaptan. 
Svaka tableta Jinarca od 15 mg sadrži 15 mg tolvaptana.
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 
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
Each 30 mg tablet contains 30 mg tolvaptan. 
Svaka tableta od 30 mg sadrži 30 mg tolvaptana.
• shortness of breath 
• nedostatak zraka
Each Jinarc 60 mg tablet contains 60 mg tolvaptan. 
Svaka tableta Jinarca od 60 mg sadrži 60 mg tolvaptana.
Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan 
Jinarc 30 mg tablete Jinarc 90 mg tablete tolvaptan
Each Jinarc 90 mg tablet contains 90 mg tolvaptan. 
Svaka tableta Jinarca od 90 mg sadrži 90 mg tolvaptana.
Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan 
Jinarc 30 mg tablete Jinarc 60 mg tablete tolvaptan
7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging 
7 × 30 mg tableta i 7 × 90 mg tableta u kartonskom pakiranju 14 × 30 mg tableta i 14 × 90 mg tableta u kartonskom pakiranju 28 × 30 mg tableta i 28 × 90 mg tableta u kartonskom pakiranju
7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging 
7 × 30 mg tableta i 7 × 60 mg tableta u kartonskom pakiranju 14 × 30 mg tableta i 14 × 60 mg tableta u kartonskom pakiranju 28 × 30 mg tableta i 28 × 60 mg tableta u kartonskom pakiranju
EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg) 
EU/1/15/1000/005 14 tableta (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tableta (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tableta (28 × 15 mg + 28 × 45 mg)
Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister 
7 ili 28 tableta u blisteru (PVC/aluminijska folija)
Each Jinarc 45 mg tablet contains 45 mg tolvaptan. 
Svaka tableta Jinarca od 45 mg sadrži 45 mg tolvaptana.
EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg) 
EU/1/15/1000/014 14 tableta (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tableta (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tableta (28 × 15 mg + 28 × 45 mg)
Mon. Tue. 
• umor.
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 
14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta
30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side. 
Tableta od 30 mg: plava, okrugla (promjer: 8 mm), blago konveksna, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
• fatigue 
• svrbež
EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg) 
EU/1/15/1000/008 14 tableta (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tableta (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tableta (28 × 30 mg + 28 × 60 mg)
reduction in reciprocal serum creatinine during treatment [from end of titration to last on medicinal product visit]) 
smanjenje recipročne vrijednosti serumskog kreatinina za 25 % tijekom liječenja [od završetka titracije do posljednjeg posjeta za vrijeme liječenja]) 2) medicinski značajna bubrežna bol (definirana kao traženje bolovanja, primjena analgetika posljednje linije, narkotika te antinociceptivnih, radioloških ili kirurških intervencija) 3) pogoršanje hipertenzije
Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 
14 tableta u 1 blisteru (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta
Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets. 
+ Jinarc 15 mg tablete: blisteri s kartonskim ovitkom ili bez njega sa 14 (7 jačih tableta + 7 slabijih tableta),
Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets. 
+ Jinarc 30 mg tablete: blisteri s kartonskim ovitkom ili bez njega sa 14 (7 jačih tableta + 7 slabijih tableta),
EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg) 
EU/1/15/1000/020 14 tableta (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tableta (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tableta (28 × 30 mg + 28 × 90 mg)
EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg) 
EU/1/15/1000/011 14 tableta (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tableta (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tableta (28 × 30 mg + 28 × 90 mg)
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 
14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 
14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta
EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg) 
EU/1/15/1000/017 14 tableta (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tableta (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tableta (28 × 30 mg + 28 × 60 mg)
Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate). 
Pomoćna(e) tvar(i) s poznatim učinkom Svaka tableta od 15 mg sadrži približno 35 mg laktoze (u obliku hidrata).
Decreased uric acid clearance by the kidney is a known effect of tolvaptan. 
Poznat učinak tolvaptana je smanjeni klirens mokraćne kiseline putem bubrega.
• nausea 
• umor
Asthenia 
Doziranje