FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience from controlled clinical trials with concomitant use of Samsca and other treatments for hyponatremia such as hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Croatian: Nema iskustva iz kontroliranih kliničkih ispitivanja s istovremenom primjenom Samsce i drugih načina liječenja hiponatremije kao što su hipertonična otopina natrijeva klorida, peroralne formulacije natrija, te lijekova koji povećavaju koncentraciju serumskog natrija.
English: Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition, have an increased risk of developing acute retention.
Croatian: Bolesnici s djelomičnom opstrukcijom protoka urina, na primjer bolesnici s hipertrofijom prostate ili poteškoćama s mokrenjem, imaju povećani rizik da razviju akutnu retenciju.
English: In the setting of hyponatremia, the treatment duration is determined by the underlying disease and its treatment.
Croatian: U slučaju hiponatremije, trajanje liječenja je određeno postojećom bolesti i terapijom iste.
English: • Hypovolemic hyponatremia
Croatian: • Hipovolemična hiponatremija
English: Antagonist means that it prevents vasopressin having its effect on water retention.
Croatian: Antagonist znači da sprječava učinak vazopresina na zadržavanje vode u tijelu.
English: 10 tablets 30 tablets 10 × 1 tablet 30 × 1 tablet
Croatian: 10 tablete 30 tablete 10 × 1 tableta 30 × 1 tableta
English: Other medicines and Samsca
Croatian: Drugi lijekovi i Samsca
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.
Croatian: U bolesnika koji uzimaju tolvaptan mora se nadzirati volumski status jer liječenje tolvaptanom može imati za posljedicu tešku dehidraciju, koja predstavlja rizični čimbenik za disfunkciju bubrega.
English: Liver function tests must be promptly performed in patients taking tolvaptan who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
Croatian: Odmah se moraju izvršiti pretrage funkcije jetre u bolesnika koji uzimaju tolvaptan a imaju simptome koji mogu ukazivati na oštećenje jetre, uključujući umor, anoreksiju, nelagodu u gornjem desnom dijelu trbuha, tamni urin ili žuticu.
English: Too rapid correction of serum sodium
Croatian: Prebrzi ispravak serumskog natrija
English: Co-administration of a 60 mg dose with a high-fat meal increases peak concentrations 1.4 fold with no change in AUC and no change in urine output.
Croatian: Davanje doze od 60 mg istovremeno s visokomasnim obrokom povećava vršne koncentracije 1,4 puta, s time da nema promjene ni u AUC-u niti u količini izlučenog urina.
English: Tolvaptan plasma concentrations have been decreased by up to 87 % (AUC) after the administration of CYP3A4 inducers.
Croatian: Koncentracije tolvaptana u plazmi smanjile su se za do 87 % unutar krivulje vrijeme-koncentracija (AUC) nakon davanja induktora CYP3A4.
English: 50 mL/min) impaired renal function were not significantly different to tolvaptan concentrations in patients with normal renal function (Ccr 80 to 150 mL/min).
Croatian: oštećenom funkcijom bubrega nisu bile znatno različite od koncentracija tolvaptana kod bolesnika s normalnom funkcijom bubrega (Ccr 80 do 150 ml/min).
English: After oral administration, tolvaptan is rapidly absorbed with peak plasma concentrations occurring about 2 hours after dosing.
Croatian: Nakon peroralne primjene, tolvaptan se brzo apsorbira s vršnim koncentracijama u plazmi oko 2 sata nakon davanja doze.
English: AndersonBrecon (UK) Ltd. Units 2-7,
Croatian: AndersonBrecon (UK) Ltd.
English: Too rapid correction of hyponatremia (increase ≥ 12 mmol/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death.
Croatian: Prebrzi ispravak hiponatremije (povećanje ≥ 12 mmol/l/24 sata) može dovesti do osmotske demijelinizacije koja dovodi do dizartije, mutizma, disfagije, letargije, promjena raspoloženja,
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,
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: Patients with very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium.
Croatian: Kod bolesnika s vrlo niskim početnim serumskim koncentracijama natrija možda postoji veća opasnost od prebrzog ispravka serumskog natrija.
English: Therefore after initiation of treatment, patients have to be closely monitored for serum sodium and volume status (see above).
Croatian: Prema tome, nakon početka liječenja, kod bolesnika moraju se pažljivo motriti serumski natrij i volumski status (vidjeti gore).
English: Steady state digoxin concentrations have been increased (1.3-fold increase in maximum observed plasma concentration [Cmax] and 1.2-fold increase in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when co administered with multiple once daily 60 mg doses of tolvaptan.
Croatian: Koncentracije digoksina u stanju dinamičke ravnoteže su se povećale (1,3 puta povećanje maksimalne koncentracije u plazmi [Cmax] i 1,2-puta povećanje površine ispod krivulje vrijeme-koncentracija tijekom intervala doziranja [AUCτ]) kada se davao istodobno sa više doza od 60 mg tolvaptana jednom dnevno.
English: Therefore, diabetic patients treated with tolvaptan should be managed cautiously.
Croatian: Prema tome, bolesnike s dijabetesom koji primaju tolvaptan treba pažljivo pratiti.
English: Patients who received other treatment for hyponatremia or medicinal products which increase serum sodium concentration (see section 4.5) prior to initiation of treatment with Samsca must be managed very cautiously.
Croatian: S bolesnicima koji su primili drugi način liječenja za hiponatremiju ili lijekove koji povećavaju koncentracije serumskog natrija (vidjeti dio 4.5) prije početka liječenja sa Samscom mora se postupati vrlo oprezno.
English: Patients with known hypersensitivity reactions to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) may be at risk for hypersensitivity reaction to tolvaptan (see section 4.3 Contraindications).
Croatian: U bolesnika s poznatim reakcijama preosjetljivosti na benzazepin ili derivate benzazepina (npr. benazepril, konivaptan, fenoldopam mesilat ili mirtazapin) može postojati rizik od reakcije preosjetljivosti na tolvaptan (vidjeti dio 4.3 Kontraindikacije).
English: Tolvaptan plasma concentrations have been increased by up to 5.4-fold area under time-concentration curve (AUC) after the administration of strong CYP3A4 inhibitors.
Croatian: Koncentracije tolvaptana u plazmi povećale su se za do 5,4 puta unutar krivulje vrijeme-koncentracija (AUC) nakon davanja jakih inhibitora CYP3A4.
English: Rapid correction of hyponatremia, sometimes leading to neurological symptoms observed in clinical trials investigating other indications from post-authorisation safety study in hyponatremia secondary to SIADH observed in post-marketing with tolvaptan in ADPKD.
Croatian: Operativni i medicinski postupci ubrzana korekcija hiponatremije, koja ponekad dovodi do neuroloških simptoma opaženo u kliničkim ispitivanjima primjene u drugim indikacijama iz ispitivanja sigurnosti primjene kod hiponatremije zbog SIADH-a provedenog nakon stavljanja lijeka u promet opaženo pri primjeni tolvaptana u liječenju ADPBB-a u razdoblju nakon stavljanja lijeka u promet.
English: In case serum sodium increases ≥ 12 mmol/L within 24 hours or ≥ 18 mmol/L within 48 hours, tolvaptan treatment is to be interrupted or discontinued followed by administration of hypotonic fluid.
Croatian: U slučaju povećanja serumskog natrija ≥ 12 mmol/l unutar 24 sata ili ≥ 18 mmol/l unutar 48 sati, liječenje tolvaptanom treba privremeno prekinuti ili potpuno zaustaviti nakon čega treba dati hipotoničnu otopinu.
English: Dysgeusia
Croatian: disgeuzija
English: Caution should be exercised in coadministering CYP3A4 inhibitors (e.g. ketoconazole, macrolide antibiotics, diltiazem) with tolvaptan (see section 4.4).
Croatian: Treba biti oprezan kada se daju istovremeno inhibitori CYP3A4 (npr. ketoconazol, makrolidni antibiotici, diltiazem) i tolvaptan (vidjeti dio 4.4).
English: Rapid correction of hyponatremia
Croatian: Prebrza korekcija hiponatremije
English: • if you had an allergic reaction in the past to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste prije imali alergijsku reakciju na benzazepin, tolvaptan ili druge derivate benzazepina (npr. benazepril, konivaptan, fenoldopam-mesilat ili mirtazepin) ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).
Croatian: Drugi sastojci su laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza, hidroksipropilceluloza, magnezijev stearat, indigo carmine aluminium lake (E 132)
English: The no observed adverse effects level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the total daily dose of 60 mg/day on a mg/m2 basis.
Croatian: Razina pri kojoj nisu opažene nuspojave (engl. no observed adverse effects level, NOAEL) na reproduktivnu funkciju ženki (100 mg/kg/dan) bila je otprilike 8 puta viša od ukupne dnevne doze od 60 mg/dan na temelju mg/m2.
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, including a high proportion of patients with tumours (especially Small Cell Lung Cancer), patients with low baseline serum sodium as well as patients with concomitant use of diuretics and/or sodium chloride solution the incidence of rapid correction of hyponatremia was found to be higher than in clinical trials.
Croatian: U ispitivanju sigurnosti primjene tolvaptana kod hiponatremije zbog SIADH-a provedenom nakon stavljanja lijeka u promet, koje je uključivalo velik udio bolesnika s tumorima (osobito rakom pluća malih stanica), bolesnike s niskom početnom razinom natrija, kao i bolesnike koji su istodobno primali diuretike i/ili otopinu natrijevog klorida, pronašlo se da je incidencija prebrze korekcije hiponatremije bila viša nego u kliničkim ispitivanjima.
English: In healthy adult subjects, oral administration of 7.5 to 120 mg doses of tolvaptan produced a increase in urine excretion rate within 2 hours of dosing.
Croatian: U zdravih odraslih ispitanika, peroralno davanje doza tolvaptana od 7,5 do 120 mg dovelo je do znatnog povećanja brzine izlučivanja urina u roku od 2 sata nakon doziranja.
English: Generalised rash
Croatian: generalizirani osip
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to benzazepine or benzazepine derivatives (see section 4.4)
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na benzazepin ili derivate benzazepina (vidjeti dio 4.4)
English: Concomitant use of Samsca with other treatments for hyponatremia or other medicinal products that increase serum sodium concentration may result in a higher risk for developing rapid correction of serum sodium (see section 4.4) and is therefore not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations where rapid correction may represent a risk for osmotic demyelination (see section 4.4).
Croatian: Istodobna primjena Samsce s drugim načinima liječenja hiponatremije ili drugim lijekovima koji povećavaju koncentraciju serumskog natrija može povećati opasnost od razvoja prebrze korekcije serumskog natrija (vidjeti dio 4.4) pa se stoga ne preporučuje za vrijeme početnog liječenja ili za druge bolesnike s vrlo niskim početnim koncentracijama serumskog natrija gdje prebrza korekcija može predstavljati opasnost od osmotske demijelinizacije (vidjeti dio 4.4).
English: In 2 pivotal, double-blind, placebo-controlled, clinical trials, a total of 424 patients with euvolemic or hypervolemic hyponatremia (serum sodium < 135 mEq/L) due to a variety of underlying causes (heart failure [HF], liver cirrhosis, SIADH and others) were treated for 30 days with tolvaptan (n = 216) or placebo (n = 208) at an initial dose of 15 mg/day.
Croatian: U 2 pivotalna, dvostruko slijepa klinička ispitivanja kontrolirana placebom, ukupan broj od 424 bolesnika s euvolemičnom ili hipervolemijskom hiponatremijom (serumski natrij < 135 mEq/l) iz raznih razloga (zatajenje srca, ciroza jetre, SIADH i drugi) liječen je 30 dana sa tolvaptanom (n = 216)
English: In a population pharmacokinetic analysis in patients with hepatic oedema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.
Croatian: U populacijskoj farmakokinetičkoj analizi kod bolesnika s edemom jetre, AUC tolvaptana kod bolesnika s teškim (Child-Pugh stadij C) te blagim ili umjerenim (Child-Pugh stadij A i B) oštećenjem jetre bio je 3,1 odnosno 2,3 puta veći nego kod zdravih ispitanika.
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake (E 132)
Croatian: 6.1 Popis pomoćnih tvari kukuruzni škrob hidroksipropilceluloza laktoza hidrat magnezijev stearat celuloza, mikrokristalična indigo carmine aluminium lake (E 132)
English: Samsca is contraindicated during pregnancy (see section 4.3).
Croatian: Samsca je kontraindicirana za vrijeme trudnoće (vidjeti dio 4.3).
English: In an analysis on population pharmacokinetics for patients with heart failure, tolvaptan concentrations of patients with mildly (creatinine clearance [Ccr] 50 to 80 mL/min) or moderately (Ccr 20 to
Croatian: U populacijskoj farmakokinetičkoj analizi kod bolesnika sa zatajenjem srca, koncentracije tolvaptana kod bolesnika s blago (klirens kreatinina [Ccr] 50 do 80 ml/min) ili umjereno (Ccr 20 do 50 ml/min)
English: Urinary output must be secured.
Croatian: Nužno je osigurati izmokravanje izlučenog urina.
English: • raised levels of creatinine in the blood.
Croatian: • povišena razina jetrenih enzima u krvi • povišene razine kreatinina u krvi.
English: Co-administration with other treatments for hyponatremia and medicinal products that increase serum sodium concentration
Croatian: Istodobna primjena s drugim načinima liječenja hiponatremije i lijekovima koji povećavaju koncentraciju serumskog natrija
English: • Hypernatremia
Croatian: • Hipernatremija
English: No information is available in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetre (Child-Pugh stadij C).
English: It is unknown whether tolvaptan is excreted in human milk.
Croatian: Nije poznato izlučuje li se tolvaptan u majčino mlijeko.
English: Samsca causes water loss because it increases your urine production.
Croatian: Pijte dovoljno vode Samsca uzrokuje gubitak vode jer povećava stvaranje urina.
English: Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration.
Croatian: Lijekovi s visokim sadržajem natrija kao što su šumeći pripravci protiv boli i određeni oblici liječenja dispepsije koji sadrže natrij, također mogu povećati koncentraciju serumskog natrija.
English: In these patients dosing has to be managed cautiously and electrolytes and volume status must be monitored (see section 4.4).
Croatian: Kod tih se bolesnika doziranje mora pažljivo provoditi, te nadzirati elektrolite i volumski status (vidjeti dio 4.4).
English: • Pregnancy (see section 4.6)
Croatian: • Trudnoća (vidjeti dio 4.6) • Dojenje (vidjeti dio 4.6)
English: How to take Samsca
Croatian: Kako uzimati Samscu
English: Co-administration with vasopressin analogues
Croatian: Istovremeno davanje s vazopresinskim analozima
English: In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported (see section 4.8).
Croatian: Tijekom iskustva s primjenom tovaptana u liječenju ADPBB-a u razdoblju nakon stavljanja lijeka u promet zabilježeno je akutno zatajenje jetre koje je zahtijevalo transplantaciju jetre (vidjeti dio 4.8).
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Croatian: Nije potrebno prilagođavati dozu kod bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A i B).
English: During titration, patients must be monitored for serum sodium and volume status (see section 4.4).
Croatian: Za vrijeme titracije, bolesnicima se mora nadzirati serumski natrij i volumski status (vidjeti dio 4.4).
English: Caution has to be exercised in co-administering CYP3A4 inducers (e.g. rifampicin, barbiturates) with tolvaptan.
Croatian: Treba biti oprezan kada se induktor CYP3A4 (npr: rifampicin, barbiturat) daje istovremeno s tolvaptanom.
English: How to store Samsca
Croatian: Kako čuvati Samscu
English: Teratogenicity was noted in rabbits given 1,000 mg/kg/day (up to 15 times the exposure in humans at the 60 mg dose, based on AUC).
Croatian: Teratogenost je primijećena kod kunića koji su primili 1000 mg/kg/dan (do 15 puta veća izloženost nego u ljudi pri primjeni doze od 60 mg, na temelju AUC).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Samscu Lijek čuvajte izvan pogleda i dohvata djece.
English: For patients at risk of overly rapid correction of sodium e.g. patients with oncological conditions, very low baseline serum sodium, taking diuretics, or taking sodium supplementation a dose of 7.5 mg should be considered (see section 4.4).
Croatian: U bolesnika u kojih postoji rizik od prebrze korekcije natrija, npr. u bolesnika s onkološkim bolestima, vrlo niskom početnom razinom natrija, onih koji uzimaju diuretike ili nadomjeske natrija, potrebno je razmotriti primjenu doze od 7,5 mg (vidjeti dio 4.4).
English: In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of tolvaptan.
Croatian: Anafilaksija (uključujući anafilaktički šok i generalizirani osip) je, prema iskustvima nakon stavljanja lijeka na tržište, vrlo rijetko zabilježena nakon primjene tolvaptana.
English: Constipation, Diarrhoea1, Dry mouth
Croatian: Poremećaji probavnog sustava mučnina konstipacija, proljev1, suha usta
English: Therefore, more precautionary limits apply during the early treatment phase.
Croatian: Stoga se kao mjera opreza tijekom rane faze liječenja primjenjuju veća ograničenja.
English: The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF. Tolvaptan treatment had no statistically significant favourable or unfavourable effects on overall survival or the combined endpoint of CV mortality or HF hospitalisation, and did not provide convincing evidence for clinically relevant benefit.
Croatian: Primarni cilj ispitivanja bilo je usporediti učinke tolvaptana + SNJ sa placebom +SNJ na vrijeme do smrtnosti od bilo kojeg uzroka i na vrijeme do prve pojave kardiovaskularne (KV) smrtnosti ili hospitalizacije zbog zatajenja srca.
English: Samsca contains lactose
Croatian: Samsca sadrži laktozu.
English: No teratogenic effects were seen in rabbits at 300 mg/kg/day (up to 5 times the exposure in humans at the 60 mg dose, based on AUC).
Croatian: Kod kunića nije primijećen teratogeni učinak kod 300 mg/kg/dan (do 5 puta veća izloženost nego u ljudi pri primjeni doze od 60 mg, na temelju AUC).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTERI S JEDINIČNIM DOZAMA
English: In these clinical trials, clinically significant increases (greater than 3 × Upper Limit of Normal) in serum alanine aminotransferase (ALT), along with clinically significant increases (greater than 2 × Upper Limit of Normal) in serum total bilirubin were observed in 3 patients treated with tolvaptan.
Croatian: (više od 3 × od gornje granice normalnih vrijednosti (GGN)) povišenja vrijednosti alanin aminotransferaze (ALT) u serumu, kao i klinički značajan porast (veći od 2 × od gornje granice normalnih vrijednosti) serumskog bilirubina.
English: Anaphylactic shock,
Croatian: Poremećaji imunološkog sustava anafilaktički šok,
English: • sense of taste altered • kidney problems
Croatian: • promijenjen osjet okusa
English: Tolvaptan has not been studied in patients with severe renal failure.
Croatian: Tolvaptan nije ispitivan kod bolesnika s teškim zatajenjem bubrega.
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.
Croatian: Iako se čini da istovremena upotreba tolvaptana s diureticima Henleove petlje i tiazidnim diureticima nema sinergistički ili aditivni učinak, svaka od ovih klasa lijekova može dovesti do teške dehidracije,
English: • general feeling of being unwell
Croatian: • općenito loše osjećanje
English: Each tablet contains 7.5 mg tolvaptan.
Croatian: Svaka tableta sadrži 7,5 mg tolvaptana.
English: • patchy bleeding in the skin
Croatian: • krvarenja u obliku mrlja po koži
English: Clinical efficacy and safety
Croatian: Klinička djelotvornost i sigurnost Hiponatremija
English: Co-administration of Samsca with other treatments for hyponatremia, and medicinal products that increase serum sodium concentration, is not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena Samsce s drugim načinima liječenja hiponatremije i s lijekovima koji povećavaju koncentracije serumskog natrija za vrijeme početnog liječenja ili za druge bolesnike s vrlo niskim početnim koncentracijama serumskog natrija (vidjeti dio 4.5).
English: Block-7, City North Business Campus, Stamullen, Co.Meath, K32 YD60 Ireland
Croatian: Meath, K32 YD60
English: Samsca is contraindicated during breast-feeding (see section 4.3).
Croatian: Samsca je kontraindicirana za vrijeme dojenja (vidjeti dio 4.3).
English: Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely.
Croatian: Hitna potreba za akutnim podizanjem serumskog natrija Tolvaptan nije ispitivan u situacijama hitne potrebe akutnog podizanja serumskog natrija.
English: Liver injury induced by tolvaptan was observed in clinical trials investigating a different indication (autosomal dominant polycystic kidney disease [ADPKD]) with long-term use of tolvaptan at higher doses than for the approved indication (see section 4.8).
Croatian: Kod dugotrajne primjene tolvaptana u dozama višim od onih za odobrenu indikaciju, u kliničkim ispitivanjima druge indikacije (autosomno dominantna policistična bolest bubrega, ADPBB) zapažena su oštećenja jetre uzrokovana tolvaptanom (vidjeti dio 4.8).
English: • tiredness, general weakness
Croatian: • umor, opća slabost
English: The elevations gradually improved after discontinuation of tolvaptan.
Croatian: Nakon prekida davanja tolvaptana povišene vrijednosti su se postupno smanjivale.
English: Samsca contains lactose as an excipient.
Croatian: Samsca sadrži laktozu kao pomoćnu tvar.