natgillin/translations-raw huggingface dataset:
Jinarc is contraindicated in patients with elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan (see sections 4.3 and 4.4).
Jinarc je kontraindiciran u bolesnika s povišenim jetrenim enzimima i/ili znakovima ili simptomima oštećenja jetre prije započinjanja liječenja koji zadovoljavaju uvjete za trajno ukidanje liječenja tolvaptanom (vidjeti dijelove 4.3 i 4.4).
No teratogenic effects were seen in rabbits at 300 mg/kg/day (about 1.25 to 2.65 times the exposure in humans at the 120 mg/day dose, based on AUC).
Nisu zamijećeni teratogeni učinci u zečeva pri dozi od 300 mg/kg/dan (otprilike 1,25 do 2,65 puta veća izloženost nego izloženost u ljudi pri dozi od 120 mg/dan na temelju AUC).
• Hepatotoxicity associated with the use of Jinarc.
hepatotoksičnosti povezan s primjenom Jinarca.
Alanine aminotransferase increased,
Povišena alanin aminotransferaza, Povišena aspartat aminotransferaza, Smanjenje tjelesne težine
In post-marketing experience, anaphylaxis (including anaphylactic shock and rash generalised) has been reported very rarely following administration of tolvaptan.
Anafilaksija (uključujući anafilaktički šok i generalizirani osip) je, prema iskustvima nakon stavljanja lijeka na tržište, vrlo rijetko zabilježena nakon primjene tolvaptana.
To mitigate the risk of significant or irreversible liver injury, blood testing for hepatic transaminases is required prior to initiation of Jinarc treatment, continuing monthly for 18 months and at regular 3-monthly intervals thereafter (see section 4.4).
Kako bi se smanjio rizik od značajnog ili ireverzibilnog oštećenja jetre, prije početka liječenja Jinarcom nužno je učiniti krvne pretrage jetrenih transaminaza te ih nastaviti provoditi svaki mjesec tijekom 18 mjeseci, a nakon toga redovito u 3-mjesečnim intervalima (vidjeti dio 4.4).
Tablet.
Tableta
It is unknown whether tolvaptan is excreted in human breast milk.
Nije poznato izlučuje li se tolvaptan u majčino mlijeko.
Therefore, serum creatinine, electrolytes and symptoms of electrolyte imbalances (e.g. dizziness, fainting, palpitations, confusion, weakness, gait instability, hyper-reflexia, seizures, coma) have to be assessed prior to and after starting tolvaptan to monitor for dehydration.
Stoga, prije i nakon započinjanja liječenja tolvaptanom moraju se procijeniti serumske razine kreatinina, elektrolita i simptomi neravnoteže elektrolita (npr. omaglica, nesvjestica, palpitacije, konfuzija, slabost, nestabilnost pri hodu, hiperrefleksija, napadaji, koma) kao znakovi dehidracije.
Single oral doses up to 480 mg (4 times the maximum recommended daily dose) and multiple doses up to 300 mg once daily for 5 days have been well tolerated in trials in healthy subjects.
Zdravi ispitanici u ispitivanjima dobro su podnosili jednokratne oralne doze do 480 mg (4 puta maksimalna preporučena dnevna doza) i višekratne doze do 300 mg jednom dnevno tijekom 5 dana.
Two (2/957, 0.2 %) of these tolvaptan treatedpatients, as well as a third patient from an extension open label trial, exhibited increases in hepatic enzymes (> 3 × ULN) with concomitant elevations in BT (> 2 × ULN).
Od tih bolesnika liječenih tolvaptanom u njih dvojice (2/957; 0,2 %), kao i u još jednog, trećeg, bolesnika iz produžetka otvorenog ispitivanja, došlo je do porasta jetrenih enzima (> 3 × GGN) uz istovremen porast ukupnog bilirubina (> 2 × GGN).
The primary focus of the clinical program for development of tolvaptan tablets for the treatment of ADPKD is a single pivotal, multinational, phase 3, randomised, placebo controlled trial in which the long-term safety and efficacy of oral split dose tolvaptan regimens (titrated between 60 mg/day and 120 mg/day) were compared with placebo in 1,445 adult subjects with ADPKD.
U središtu interesa kliničkog programa za razvoj tableta tolvaptana za liječenje ADPBB-a je pivotalno, multinacionalno, randomizirano, placebom kontrolirano ispitivanje faze 3 u kojem je uspoređivana dugoročna sigurnost i djelotvornost tolvaptana primijenjenog peroralno u režimu s podijeljenim dozama (titrirane između 60 mg/dan i 120 mg/dan) i placeba u 1445 odraslih ispitanika s ADPBB-om.
Transporter substrates
Supstrati prijenosnika
The phase 3, multi-centre, international, randomized-withdrawal, placebo-controlled, double-blind trial 156-13-210 compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo in patients able to tolerate tolvaptan during a five-week titration and run-in period on tolvaptan.
U multicentričnom, međunarodnom, placebom kontroliranom, dvostruko slijepom ispitivanju 156-13210 faze 3 s randomiziranim ustezanjem (engl. randomized-withdrawal) lijeka uspoređena je djelotvornost i sigurnost tolvaptana (u dozi od 45 do 120 mg na dan) i placeba u bolesnika koji su mogli podnijeti tolvaptan tijekom petotjedne titracije i uvodnog (engl. run-in) razdoblja terapije tolvaptanom.
Abnormal hepatic function
Abnormalna jetrena funkcija
The Patient/Carer educational material shall contain the following key messages:
Edukacijski materijal za bolesnika/njegovatelja sadržavat će sljedeće ključne poruke:
The primary endpoint of the trial was the change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline levels to post-treatment assessment.
Primarna mjera ishoda ovog kliničkog ispitivanja bila je promjena u procijenjenoj brzini glomerularne filtracije (eGFR) od početne razine prije liječenja do procijenjene vrijednosti nakon liječenja.
EU/1/15/1000/001 7 tablets EU/1/15/1000/002 28 tablets
EU/1/15/1000/001 7 tableta EU/1/15/1000/002 28 tableta
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).
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).
EU/1/15/1000/003 7 tablets EU/1/15/1000/004 28 tablets
EU/1/15/1000/003 7 tableta EU/1/15/1000/004 28 tableta
Dose adjustment for patients taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors, tolvaptan doses have to be reduced as follows:
Prilagodba doze za bolesnike koji uzimaju umjerene inhibitore CYP3A U bolesnika koji uzimaju umjerene inhibitore CYP3A, doze tolvaptana trebaju se smanjiti kako slijedi:
• ALT or AST > 3-times ULN and (BT > 2-times ULN or International Normalized Ratio
• ALT ili AST > 3 puta GGN i (ukupni bilirubin > 2 puta GGN ili međunarodni omjer normalizacije [INR] > 1,5)
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.
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.
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.
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.
• dehydration
• dehidracija
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.
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).
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).
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).
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.
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.
Tolvaptan is contraindicated in anuric patients (see section 4.3).
Tolvaptan je kontraindiciran kod bolesnika s anurijom (vidjeti dio 4.3).
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
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
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).
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
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).
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.
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).