FrancophonIA/ELRC3.0 huggingface dataset:
English: Following multiple once daily dosing of 300 mg, tolvaptan exposure was only increased 6.4-fold when compared to a 30 mg dose.
Slovenian: Po večkratnem odmerjanju 300 mg tolvaptan enkrat na dan se je izpostavljenost tolvaptanu povečala le za 6,4-krat v primerjavi z odmerkom 30 mg.
English: Very common Common
Slovenian: Zelo pogosti
English: While there does not appear to be a synergistic or additive effect of concomitant use of tolvaptan with loop and thiazide diuretics, each class of agent has the potential to lead to severe dehydration, which constitutes a risk factor for renal dysfunction.
Slovenian: Čeprav ne kaže, da bi prihajalo do sinergijskih ali aditivnih učinkov sočasne uporabe tolvaptana z diuretiki ledvične zanke in tiazidnimi diuretiki, lahko vsak razred učinkovin povzroči hudo dehidracijo, kar predstavlja dejavnik tveganja za ledvično disfunkcijo.
English: • liver function abnormal
Slovenian: • nenormalna jetrna funkcija
English: • if you have been told that you have raised levels of liver enzymes in your blood which do not allow treatment with tolvaptan
Slovenian: • če so vam povedali, da imate zvišane ravni jetrnih encimov v krvi, ki ne dopuščajo zdravljenja s tolvaptanom.
English: • diuretics (used to increase your urine production).
Slovenian: • diuretiki (uporabljajo se za povečanje nastajanja urina).
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Slovenian: Končni razpolovni čas izločanja je približno 8 ur in koncentracije v stanju dinamičnega ravnovesja tolvaptan so dosežene po prvem odmerku.
English: * reported during post-marketing surveillance of tolvaptan approved for other indications observed in post-marketing with tolvaptan in ADPKD.
Slovenian: * poročano med spremljanjem po začetku trženja tolvaptana, odobrenega za druge indikacije opaženo v obdobju trženja s tolvaptanom pri bolnikih z ADPKD.
English: Therapy must be interrupted if the ability to drink or the accessibility to water is limited (see section 4.4).
Slovenian: Zdravljenje je treba prekiniti, če je zmožnost pitja ali dostop do vode omejen (glejte poglavje 4.4).
English: In patients treated with tolvaptan the reduction in eGFR was significantly less than in patients treated with placebo (p < 0.0001).
Slovenian: Pri bolnikih, zdravljenih s tolvaptanom, so se vrednosti eGFR zmanjšale bistveno manj kot pri bolnikih, ki so prejemali placebo (p < 0,0001).
English: Effects on free water clearance and urine volume are evident across all CKD stages with smaller absolute effects observed at later stages, consistent with the declining number of fully functioning nephrons.
Slovenian: Učinki na očistek proste vode in volumen urina so vidni v vseh stopnjah kronične ledvične bolezni, pri čemer so v kasnejših stopnjah absolutni učinki manjši, kar je v skladu z upadom števila povsem delujočih nefronov.
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Jinarc, kot bi smeli Če ste vzeli več tablet, kot je predpisan odmerek, spijte veliko količino vode in takoj pojdite k svojemu zdravniku ali v lokalno bolnišnico.
English: DO NOT take a double dose to make up for forgotten individual doses.
Slovenian: NE vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Slovenian: Tolvaptan je zvišal ravni lovastatina v plazmi za 1,3- do 1,5-krat.
English: Tolvaptan is a weak CYP3A4 substrate and does not appear to have any inhibitory activity.
Slovenian: Tolvaptan je šibak substrat CYP3A4 in ne kaže, da bi imel kakšno zaviralno aktivnost.
English: Co-administration of tolvaptan with rifampicin reduces Cmax and AUC for tolvaptan by about 85 %.
Slovenian: Sočasna uporaba tolvaptana z rifampicinom zmanjša Cmax in AUC tolvaptana za približno 85 %.
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.
Slovenian: Po enojnih peroralnih odmerkih so se vrednosti Cmax povečale manj, kot bi bilo sorazmerno z odmerkom, od 30 do 240 mg, nato pa so plato dosegle pri odmerkih od 240 do 480 mg; AUC se povečuje linearno.
English: This condition must be excluded prior and during treatment with tolvaptan.
Slovenian: To je treba izključiti pred zdravljenjem s tolvaptanom in po njem.
English: Uncommon: may affect up to 1 in 100 people • increase of bilirubin (a substance that can cause yellowing of skin or eyes) in the blood
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov • zvišanje ravni bilirubina (snovi, ki povzroča porumenelost kože ali oči) v krvi
English: • medicines which increase the level of sodium in your blood or which contain large amounts of salt, like tablets that dissolve in water and indigestion remedies.
Slovenian: • zdravila, ki zvišujejo raven natrija v krvi ali zdravila, ki vsebujejo velike količine soli, kot so tablete, ki se razpustijo v vodi, in zdravil za prebavne motnje (dispepsijo).
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).
Slovenian: Ta izguba vode lahko povzroči neželene učinke, kot so suha usta in žeja ali bolj resne neželene učinke, kot so težave z ledvicami (glejte poglavje 4).
English: If you stop taking Jinarc your kidney cysts may grow as fast as they did before you started treatment with Jinarc.
Slovenian: Če prenehate jemati zdravilo Jinarc, bodo morda vaše ledvične ciste rastle tako hitro, kot pred zdravljenjem z zdravilom Jinarc.
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.
Slovenian: Trenutno ni na voljo dolgoročnih podatkov, ki bi potrdili, ali dolgotrajno zdravljenje z zdravilom Jinarc še naprej upočasnjuje stopnjo upada ledvične funkcije in vpliva na klinične rezultate ADPKD, vključno z zakasnitvijo nastopa končne stopnje ledvične bolezni.
English: Swallow the tablets without chewing, with a glass of water.
Slovenian: Tablete zaužijte brez žvečenja s kozarcem vode.
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.
Slovenian: Obdobje nastopa poškodovanja jetrnih celic (zvišanje ALT > 3 × ULN) je bilo v 3 do 14 mesecih po uvedbi zdravljenja, pri čemer so bila ta zvišanja reverzibila, vrednosti ALT pa so se na < 3 × ULN vrnile v 1 do 4 mesecih.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tolvaptan in one or more subsets of the paediatric population in polycystic kidney disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s tolvaptanom za eno ali več podskupin pediatrične populacije s policistično boleznijo ledvic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Therefore, diabetic patients treated with tolvaptan must be managed cautiously.
Slovenian: Zato je treba bolnike s sladkorno boleznijo, ki se zdravijo s tolvaptanom, skrbno obravnavati.
English: The result of the key secondary composite endpoint is primarily attributed to effects on worsening kidney function and medically significant kidney pain.
Slovenian: Rezultat ključnega sestavljenega sekundarnega opazovanega dogodka je mogoče v prvi vrsti pripisati učinkom slabšanja delovanja ledvic in medicinsko znatni bolečini ledvic.
English: These data also showed significant benefit from tolvaptan vs. placebo (p < 0.0001).
Slovenian: Ti podatki so pokazali tudi pomembne koristi tolvaptana v primerjavi s placebom (p < 0,0001).
English: Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD).
Slovenian: Zdravilo Jinarc je zdravilo, ki se uporablja za zdravljenje bolezni, imenovane "avtosomna dominantna policistična bolezen ledvic" (ADPKD, autosomal dominant polycystic kidney disease).
English: No mortality was observed in rats or dogs following single oral doses of 2,000 mg/kg (maximum feasible dose).
Slovenian: Smrtnosti pri podganah ali psih po enojnih peroralnih odmerkih 2.000 mg/kg (največji možen odmerek) ni bilo.
English: In-vitro studies indicate that tolvaptan or its oxobutyric metabolite may have the potential to inhibit OATP1B1, OATP1B3, OAT3, BCRP and OCT1 transporters.
Slovenian: Študije in vitro kažejo, da lahko tolvaptan ali njegov oksobutirni presnovek zavirata OATP1B1, OATP1B3, OAT3, BCRP in OCT1 prenašalce.
English: The safety and efficacy of Jinarc in CKD stage 5 have not been adequately explored and therefore tolvaptan treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
Slovenian: Varnosti in učinkovitosti zdravila Jinarc pri 5. stopnji kronične ledvične bolezni nista bili ustrezno raziskani, zato je treba zdravljenje s tolvaptanom prekiniti, če ledvična insuficienca napreduje do 5. stopnje kronične ledvične bolezni.
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.
Slovenian: V perinatalnih in postnatalnih študijah na podganah so opazili zapoznelo osifikacijo in zmanjšano telesno maso mladičev pri visokih odmerkih 1.000 mg/kg/dan.
English: Decreased uric acid clearance by the kidney is a known effect of tolvaptan.
Slovenian: Zmanjšan očistek sečne kisline ledvic je znan učinek tolvaptana.
English: • desmopressin (used to increase blood clotting factors or to control urine output or bedwetting).
Slovenian: • dezmopresin (uporablja se za povečanje faktorja strjevanja krvi ali za nadzor izločanja urina ali močenja postelje).
English: In this case your doctor may prescribe you Jinarc tablets with 30 mg or 15 mg tolvaptan which have to be taken once a day in the morning.
Slovenian: V tem primeru vam lahko zdravnik predpiše zdravilo Jinarc tablete s 30 mg ali 15 mg tolvaptana, ki jih jemljete enkrat na daj zjutraj.
English: Jinarc can only be prescribed by doctors who are specialised in the treatment of ADPKD.
Slovenian: Zdravilo Jinarc vam lahko predpiše le zdravnik, ki se je specializiral za zdravljenje ADPKD.
English: If an anaphylactic reaction or other serious allergic reactions occur, administration of tolvaptan must be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali druga resna alergijska reakcija, je treba dajanje tolvaptana takoj prekiniti in uvesti ustrezno zdravljenje.
English: A single oral dose of 2,000 mg/kg was lethal in mice and symptoms of toxicity in affected mice included decreased locomotor activity, staggering gait, tremor and hypothermia.
Slovenian: Enojni peroralni odmerek 2.000 mg/kg je bil smrten pri miših, simptomi toksičnosti pri prizadetih miših pa so vključevali zmanjšano lokomotorno aktivnost, nestabilno gibanje, tremor in hipotermijo.
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).
Slovenian: Zato morajo imeti bolniki dostop do vode (ali drugih vodnih tekočin) in biti sposobni spiti ustrezne količine teh tekočin (glejte poglavje 4.2).
English: Increasing age has no effect on tolvaptan plasma concentrations.
Slovenian: Starost ne vpliva na koncentracije tolvaptana v plazmi.
English: In healthy subjects, tolvaptan, a CYP3A substrate, had no effect on the plasma concentrations of some other CYP3A substrates (e.g. warfarin or amiodarone).
Slovenian: Pri zdravih prostovoljcih ni imel tolvaptan, substrat CYP3A, nobenega učinka na koncentracije nekaterih drugih substratov CYP3A v plazmi (npr. varfarina ali amiodarona).
English: • Pregnancy (see section 4.6)
Slovenian: • nosečnost (glejte poglavje 4.6).
English: Effects on serum uric acid are attributable to the reversible renal hemodynamic changes that occur in response to tolvaptan effects on urine osmolality and may be clinically relevant.
Slovenian: Učinke na sečno kislino v serumu so pripisali reverzibilnim ledvičnim hemodinamičnim spremembam, ki so se pojavile kot odgovor na vpliv tolvaptana na osmolalnost urina, in so morda klinično pomembne.
English: In-vitro studies indicate that tolvaptan is a substrate and competitive inhibitor of P-glycoprotein (P-gp).
Slovenian: Študije in vitro kažejo, da je tolvaptan substrat in kompetitivni zaviralec P-glikoproteina (P-gp).
English: • ALT or AST > 3-times ULN with persistent symptoms of hepatic injury noted above.
Slovenian: • ravni ALT ali AST > 3-krat ULN z vztrajanjem simptomov poškodbe jeter, opisanih zgoraj
English: The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR < 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Slovenian: Tveganje za poškodovanje jeter pri bolnikih z močno zmanjšanim delovanjem ledvic (tj. ocenjena stopnja glomerularne filtracije [eGFR] < 20) je lahko povečano; te bolnike je treba skrbno spremljati zaradi jetrne toksičnosti.
English: For split-dose regimens of 30, 60 and 120 mg/day in ADPKD patients, tolvaptan exposure (AUC) increases linearly.
Slovenian: Pri režimih z razdeljenim odmerjanjem 30, 60 in 120 mg/dan pri bolnikih z ADPKD se je izpostavljenost tolvaptanu (AUC) povečevala linearno.
English: • experience swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Slovenian: • se pojavi oteklost obraza, ustnic ali jezika, srbenje, generalizirani izpuščaj, hudo sopenje ali kratka sapa (simptomi alergijske reakcije).
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.
Slovenian: Učinek blago ali zmerno okvarjenega delovanja jeter (razred A ali B po Child-Pughu) na farmakokinetiko tolvaptana je bil raziskan pri 87 bolnikih z boleznijo jeter različnih izvorov.
English: • if you are pregnant (see “Pregnancy and breast-feeding)
Slovenian: • če ste noseči (glejte poglavje "Nosečnost in dojenje").
English: Patients have to be maintained on the highest tolerable tolvaptan dose.
Slovenian: Pri bolnikih je treba vzdrževati najvišji odmerek tolvaptana, ki ga prenašajo.
English: Periodic monitoring of plasma osmolality or serum sodium (to calculate plasma osmolarity) and/or body weight should be considered to monitor the risk of dehydration secondary to the aquaretic effects of tolvaptan in case of patient's insufficient water intake.
Slovenian: Razmisliti je treba o periodičnem merjenju osmolalnosti plazme ali natrija v serumu (za izračun osmolarnosti plazme) in/ali telesne mase za spremljanje tveganja dehidracije zaradi diuretičnega učinka tolvaptana v primeru nezadostnega vnosa vode pri bolniku.
English: Concomitant use of medicinal products that are potent CYP3A inducers (e.g., rifampicin) will decrease tolvaptan exposure and efficacy.
Slovenian: Sočasna uporaba zdravil, ki so močni induktorji CYP3A (npr. rifampicina), bo zmanjšala izpostavljenost tolvaptanu in njegovo učinkovitost.
English: While these concomitant elevations were reversible with prompt discontinuation of tolvaptan, they represent a potential for significant liver injury.
Slovenian: Čeprav so bila sočasna zvišanja reverzibilna pri hitri ukinitvi tolvaptana, predstavljajo možnost za močno poškodbo jeter.
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.
Slovenian: Diuretična ali nediuretična antihipertenzivna zdravila Krvnega tlaka med stanjem v preskušanjih z ADPKD niso rutinsko merili, zato tveganja ortostatske/posturalne hipotenzije zaradi farmakodinamičnih interakcij s tolvaptanom ni mogoče izključiti.
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.
Slovenian: Ključni sekundarni opazovani dogodek je bil primerjava učinkovitosti zdravljenja s tolvaptanom v primerjavi s placebom pri zmanjševanju odklona letnega upada eGFR v vseh izmerjenih časovnih točkah v preskušanju.
English: • full or bloated or uncomfortable feeling in the stomach
Slovenian: • polnost, napihnjenost ali nelagoden občutek v želodcu
English: Effect of tolvaptan on glomerular filtration rate (GFR)
Slovenian: Učinek tolvaptana na stopnjo glomerularne filtracije (GFR, glomerular filtration rate)
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).
Slovenian: Ob nastopu simptomov ali znakov, ki so enaki kot pri poškodbi jeter, ali če se med zdravljenjem zaznajo klinično pomembne nenormalne ravni ALT ali AST, je treba dajanje zdravila Jinarc takoj prekiniti in teste čim prej ponoviti, vključno z ALT, AST, skupnim bilirubinom in alkalno fosfatazo (AF) (idealno v 48-72 urah).
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.
Slovenian: Poleg ledvičnega akvaretičnega učinka lahko tolvaptan zavre žilne vazopresinske receptorje V2, ki sodelujejo pri sproščanju koagulacijskih dejavnikov (npr. von Willebrandov faktor) iz endotelijskih celic.
English: By blocking the effect of vasopressin, Jinarc slows the development of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production.
Slovenian: Z zaviranjem učinka vazopresina zdravilo Jinarc upočasni razvoj cist v ledvicah pri bolnikih z ADPKD, zmanjša simptome bolezni in poveča nastajanje urina.
English: In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended.
Slovenian: Pri bolnikih s sumom na preveliki odmerek tolvaptana se priporoča ocena življenjskih znakov, koncentracije elektrolitov, EKG in tekočinskega statusa.
English: Other medicines and Jinarc
Slovenian: Druga zdravila in zdravilo Jinarc
English: In case of abnormal baseline levels below the limits for permanent discontinuation treatment can only be initiated if the potential benefits of treatment outweigh the potential risks and liver function testing must continue at increased time frequency.
Slovenian: V primeru nenormalnih izhodiščnih ravni pod omejitvami za stalno prekinitev je dovoljeno zdravljenje uvesti le, če so možne koristi zdravljenja večje od možnih tveganj ter še pogosteje nadaljevati s preverjanjem delovanja jeter.
English: • the importance of pregnancy prevention, before and during treatment with Jinarc
Slovenian: • pomen preprečevanja nosečnosti pred zdravljenjem z zdravilom Jinarc in med njim
English: It is not recommended to administer Jinarc with vasopressin analogues.
Slovenian: Uporaba zdravila Jinarc z analogi vazopresina se ne priporoča.
English: The results of the primary endpoint, the rate of change in TKV for subjects randomised to tolvaptan (normalised as percentage) to the rate of change for subjects on placebo, were highly statistically significant.
Slovenian: Rezultati primarnega opazovanega dogodka, stopnje spremembe TKV za osebe, randomizirane za tolvaptan (normalizirano v obliki odstotka), glede na stopnjo spremembe za osebe na placebu, so bili statistično izjemno značilni.
English: Volume status must be monitored in patients taking tolvaptan because treatment with tolvaptan may result in severe dehydration which constitutes a risk factor for renal dysfunction.
Slovenian: Pri bolnikih, ki jemljejo tolvaptan, je treba spremljati volemijo, saj lahko zdravljenje s tolvaptanom povzroči hudo dehidracijo, ki predstavlja dejavnik tveganja za ledvično disfunkcijo.
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.
Slovenian: Sočasna uporaba tolvaptana z zdravili, ki zvišujejo koncentracije natrija v serumu, lahko povzroči večje tveganje za razvoj hipernatriemije (glejte poglavje 4.4), zato ni priporočljiva.
English: Jinarc causes water loss because it increases your urine production.
Slovenian: Zdravilo Jinarc povzroča izgubo vode zaradi večjega nastajanja urina.
English: • flu-like syndrome (joint and muscle pain with fever)
Slovenian: • gripi podoben sindrom (bolečine sklepov in mišic z zvišano telesno temperaturo)
English: Women of childbearing potential must use adequate contraceptive measures during Jinarc use.
Slovenian: Ženske v rodni dobi morajo med uporabo zdravila Jinarc uporabljati ustrezno kontracepcijo.
English: • if you have a condition which increases the sodium in your blood
Slovenian: • če imate stanje, zaradi katerega se poviša raven natrija v vaši krvi.
English: Acute reductions in mean total kidney volume were also observed following 3 weeks of therapy in all CKD stages, ranging from -4.6 % for CKD stage 1 to -1.9 % for CKD stage 4.
Slovenian: Akutna zmanjšanja povprečnega skupnega ledvičnega volumna so opazili tudi po 3 tednih zdravljenja za vse stopnje kronične ledvične bolezni, v razponu od −4,6 % za 1. stopnjo kronične ledvične bolezni do −1,9 % za 4. stopnjo kronične ledvične bolezni.
English: • ALT or AST > 3-times ULN and (BT > 2-times ULN or International Normalized Ratio
Slovenian: • ravni ALT ali AST > 3-krat ULN in (skupin bilirubin > 2-krat ULN ali mednarodno normalizirano razmerje [INR, International Normalized Ratio] > 1,5)
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.
Slovenian: Če ostajajo ravni ALT in AST pod 3-kratnikom ULN, se lahko zdravljenje z zdravilom Jinarc previdno nadaljuje s pogostim spremljanjem z enakim ali nižjim odmerkom, saj kaže, da se ravni transaminaz med nadaljevanjem zdravljenja pri nekaterih bolnikih stabilizirajo.
English: Effect of other medicinal products on the pharmacokinetics of tolvaptan
Slovenian: Vpliv drugih zdravil na farmakokinetiko tolvaptana
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.
Slovenian: Vendar pa dogodki zvišane sečne kisline in/ali protina niso bili resni in v dvojno slepem, s placebom nadzorovanem preskušanju niso povzročili prekinitve zdravljenja.
English: Testing must continue at increased time frequency until symptoms/signs/laboratory abnormalities stabilise or resolve, at which point Jinarc may be reinitiated.
Slovenian: Testiranje se mora nadaljevati bolj pogosto, dokler se simptomi/znaki/nenormalni laboratorijski izvidi ne stabilizirajo ali izzvenijo; tedaj se lahko zdravljenje z zdravilom Jinarc nadaljuje.
English: The dose combinations are: 45 mg + 15 mg
Slovenian: Kombinacije odmerkov so: 45 mg + 15 mg
English: Pre-treatment sodium abnormalities (hyponatraemia or hypernatraemia) must be corrected prior to initiation with tolvaptan therapy.
Slovenian: Nenormalnosti natrija (hiponatriemija ali hipernatriemija) je treba pred uvedbo zdravljenja s tolvaptanom odpraviti.
English: Jinarc may increase the effect of these medicines.
Slovenian: Zdravilo Jinarc lahko poveča učinek teh zdravil.