FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of tolvaptan in combination with other options may increase the risk of overly rapid correction of serum sodium (see sections 4.4 and 4.5).
Slovenian: Uporaba tolvaptana v kombinaciji z drugimi možnostmi lahko poveča tveganje prehitrega popravka natrija v serumu (glejte poglavji 4.4 in 4.5).
English: Samsca is not recommended in the paediatric age group.
Slovenian: Uporaba zdravila Samsca se v pediatrični populaciji ne priporoča.
English: Tolvaptan is a selective vasopressin V2-receptor antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2-receptor of the distal portions of the nephron.
Slovenian: Tolvaptan je selektivni antagonist receptorja V2 vazopresina, ki specifično blokira vezavo arginin vazopresina (AVP) na receptorje V2 distalnega dela nefrona.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tolvaptan in breast milk (for details see 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki za živali so pokazali, da se tolvaptan izloča v mleko (za podrobnosti glejte poglavje 5.3).
English: If sodium correction exceeds 6 mmol/L during the first 6 hours of administration or 8 mmol/L during the first 6-12 hours, respectively, the possibility that serum sodium correction may be overly rapid should be considered.
Slovenian: Če popravek natrija preseže 6 mmol/l v prvih 6 urah dajanja ali 8 mmol/l v prvih 6-12 urah, je treba razmisliti o možnosti prehitrega popravka natrija v serumu.
English: Therefore, diabetic patients treated with tolvaptan should be managed cautiously.
Slovenian: Zato je treba bolnike s sladkorno boleznijo, ki se zdravijo s tolvaptanom, skrbno obravnavati.
English: Other side effects Very common (may affect more than 1 in 10 people)
Slovenian: Drugi neželeni učinki: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: For patients with an appropriate increase in serum sodium, the underlying disease and serum sodium levels must be monitored at regular intervals to evaluate further need of tolvaptan treatment.
Slovenian: Pri bolnikih z ustreznim zvišanjem ravni natrija v serumu je treba v rednih intervalih nadzirati osnovno bolezen in ravni natrija v serumu, da se oceni dodatna potreba po zdravljenju s tolvaptanom.
English: EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) was a long-term outcome, double-blind, controlled clinical trial in patients hospitalised with worsening HF and signs and symptoms of volume overload.
Slovenian: EVEREST (Učinkovitost antagonizma vazopresina v študiji izida srčne odpovedi z zdravilom Tolvaptan - Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) je bilo dvojno slepo, nadzirano klinično preskušanje za pridobitev dolgoročnih rezultatov pri hospitaliziranih bolnikih s popuščanjem srca, ki se je slabšalo, in znaki ter simptomi volumske preobremenitve.
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.
Slovenian: Prehiter popravek hiponatriemije (povečanje ≥ 12 mmol/l/24 ur) lahko povzroči osmotsko demielinizacijo, ki povzroči disartrijo, mutizem, disfagijo, letargijo, afektivne spremembe, spastično kvadriparezo, epileptične napade, komo ali smrt.
English: Polydipsia, Dehydration, Hyperkalemia, Hyperglycemia, Hypoglycemia1, Hypernatremia1, Hyperuricemia1, Decreased appetite
Slovenian: Presnovne in prehranske motnje polidipsija, dehidracija, hiperkaliemija, hiperglikemija, hipoglikemija1, hipernatriemija1, hiperurikemija1, zmanjšan apetit
English: Co-administration with vasopressin analogues
Slovenian: Sočasno dajanje z analogi vazopresinov
English: Tolvaptan has not been studied in patients with severe renal failure.
Slovenian: Tolvaptana niso preučevali pri bolnikih s hudo ledvično odpovedjo.
English: Samsca is unlikely to adversely affect your ability to drive or to operate machinery.
Slovenian: Ni verjetno, da bi zdravilo Samsca vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
English: What Samsca is and what it is used for
Slovenian: Kaj je zdravilo Samsca in za kaj ga uporabljamo
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 ni očitnega učinka sinergije ali aditivnega učinka sočasne uporabe tolvaptana in diuretikov ledvične zanke ter tiazidnih diuretikov, lahko vsaka skupina učinkovin povzroči hudo dehidracijo, kar predstavlja dejavnik tveganja za ledvično disfunkcijo.
English: In addition to its renal aquaretic effect, tolvaptan is capable of blocking vascular vasopressin V2receptors involved in the release of coagulation factors (e.g., von Willebrand factor) from endothelial cells.
Slovenian: Poleg ledvičnega diuretičnega učinka lahko tolvaptan zavira receptorje V2 vaskularne vazopresine pri sproščanju koagulacijskih faktorjev (npr. von Willebrandovega faktorja) iz endotelijskih celic.
English: What Samsca is and what it is used for What you need to know before you take Samsca How to take Samsca
Slovenian: Kaj je zdravilo Samsca in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Samsca Kako jemati zdravilo Samsca
English: Blood urine present1, Alanine aminotransferase increased (see section 4.4)1, Aspartate aminotransferase increased (see section 4.4)1, Blood creatinine
Slovenian: Preiskave prisotnost krvi v urinu1, zvišana raven alanin aminotransferaz (glejte poglavje 4.4)1, zvišana raven aspartat aminotransferaz (glejte poglavje 4.4)1, zvišanje vrednosti kreatinina v krvi zvišana raven bilirubina (glejte poglavje 4.4)1
English: At 7 days after discontinuing treatment, sodium values decreased to levels of placebo treated patients.
Slovenian: 7. dan po prekinitvi zdravljenja so se ravni natrija znižale na ravni bolnikov, ki so prejemali placebo.
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01
Slovenian: Farmakoterapevtska skupina: diuretiki, antagonisti vazopresina, oznaka ATC C03XA01 Mehanizem delovanja
English: If you take more Samsca than you should
Slovenian: Če ste vzeli večji odmerek zdravila Samsca, kot bi smeli
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 blage ali zmerne okvare delovanja jeter (razreda A in B po Child-Pughu) na farmakokinetiko tolvaptana je bil raziskan pri 87 bolnikih z boleznijo jeter različnih izvorov.
English: These patients should be monitored more frequently regarding their serum sodium and administration of hypotonic fluid is recommended.
Slovenian: Pri teh bolnikih je treba pogosteje nadzirati natrij v serumu, priporoča pa se tudi dajanje hipotonične tekočine.
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.
Slovenian: Sočasna uporaba odmerka 60 mg z obrokom z visoko vsebnostjo maščob 1,4-krat poveča največje koncentracije, brez spremembe v AUC in izločanju urina.
English: In patients at higher risk of demyelination syndromes, for example those with hypoxia, alcoholism or malnutrition, the appropriate rate of sodium correction may be lower than that in patients without risk factors; these patients should be very carefully managed.
Slovenian: Pri bolnikih, pri katerih je tveganje za demielinizacijski sindrome, na primer pri bolnikih s hipoksijo, alkoholizmom, slabo prehranjenostjo, je lahko stopnja popravka natrija nižja kot pri bolnikih brez dejavnikov tveganja; te bolnike je treba skrbno uravnavati.
English: The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium.
Slovenian: Odmerek se lahko zviša do največ 60 mg enkrat dnevno, odvisno od prenašanja bolnika, da se doseže zaželena raven natrija v serumu.
English: Other medicines and Samsca
Slovenian: Druga zdravila in zdravilo Samsca
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Slovenian: Po enkratnih peroralnih odmerkih ≥ 300 mg so se najvišje koncentracije v plazmi približale platoju, mogoče zaradi nasičenosti absorpcije.
English: This condition should be excluded prior and during treatment with tolvaptan.
Slovenian: To je treba izključiti pred zdravljenjem s tolvaptanom in po njem.
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, dry mouth and dehydration (see section 4.8).
Slovenian: Tolvaptan lahko povzroči neželene učinke, povezane z izgubo vode, kot so žeja, suha usta in dehidracija (glejte poglavje 4.8).
English: This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatremia).
Slovenian: Zaradi te bolezni lahko pride do neustreznega nastajanja hormona vazopresina, kar povzroči preveliko znižanje ravni natrija v krvi (hiponatriemija).
English: If you forget to take Samsca
Slovenian: Če ste pozabili vzeti zdravilo Samsca
English: • if you suffer from a kidney disease called autosomal dominant polycystic kidney disease
Slovenian: • če imate bolezen ledvic, imenovano avtosomna dominantna policistična bolezen ledvic • če imate sladkorno bolezen.
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 prevelik odmerek tolvaptana se priporoča ocena življenjskih znakov, koncentracije elektrolitov, EKG in tekočinskega statusa.
English: Lactose and galactose intolerance
Slovenian: Neprenašanje laktoze in galaktoze
English: If you stop taking Samsca this may lead to reoccurrence of your low sodium.
Slovenian: Če prenehate jemati zdravilo Samsca, lahko to povzroči ponovno znižanje ravni natrija.
English: Patients receiving digoxin should therefore be evaluated for excessive digoxin effects when treated with tolvaptan.
Slovenian: Pri bolnikih, ki prejemajo digoksin, je treba oceniti izrazite učinke digoksina, če se zdravijo s tolvaptanom.
English: Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely.
Slovenian: Tolvaptana niso preučili v okoliščinah, kjer je treba nujno akutno zvišati natrij v serumu.
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: Dehidracija Pri bolnikih, ki uporabljajo tolvaptan, je treba nadzirati stanje volumna, ker lahko zdravljenje s tolvaptanom povzroči hudo dehidracijo, ki predstavlja dejavnik tveganja za ledvično disfunkcijo.
English: 10 tablets 30 tablets 10 × 1 tablet 30 × 1 tablet
Slovenian: 10 tablet 30 tablet 10 × 1 tableta 30 × 1 tableta
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.
Slovenian: Raven brez vidnega neželenega učinka (NOAEL, no observed adverse effect level) za učinke na razmnoževanje pri samicah (100 mg/kg/dan) je bila približno 8-krat večja od skupnega dnevnega odmerka 60 mg/dan na podlagi mg/m2.
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)
Slovenian: • preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na benzazepin ali derivate benzazepina (glejte poglavje 4.4)
English: Co-administration of grapefruit juice and tolvaptan resulted in a 1.8-fold increase in exposure to tolvaptan.
Slovenian: Sočasna uporaba soka grenivke in tolvaptana je povzročila 1,8-kratno povečanje izpostavljenosti tolvaptanu.
English: Following 3 days of treatment, the pooled analysis of the two trials revealed five-fold more tolvaptan than placebo patients achieved normalisation of serum sodium concentrations (49 % vs. 11 %).
Slovenian: Po 3 dneh zdravljenja je združena analiza dveh preskušanj razkrila, da je petkrat več bolnikov, ki so prejemali tolvaptan, doseglo normalizacijo koncentracij natrija v serumu v primerjavi z bolniki, ki so prejemali placebo (49 % v primerjavi z 11 %).
English: Elevated transaminases2
Slovenian: zvišana raven transaminaz2
English: For single doses 60 mg to 480 mg, a mean of about 7 litres was excreted during 0 to 12 hours, independent of dose.
Slovenian: Po enkratnih odmerkih od 60 mg do 480 mg je bilo v času 0 do 12 ur izločenih povprečno približno 7 litrov, neodvisno od odmerka.
English: The adverse reaction profile of tolvaptan in SIADH is based on a clinical trials database of 3,294 tolvaptan-treated patients and is consistent with the pharmacology of the active substance.
Slovenian: Profil neželenih učinkov tolvaptana pri SIADH temelji na podatkovni bazi kliničnih preskušanj 3.294 bolnikov, ki so prejemali tolvaptan, in ustreza farmakologiji učinkovine.
English: Samsca must not be taken with grapefruit juice (see section 4.5).
Slovenian: Zdravila Samsca se ne sme jemati s sokom grenivke (glejte poglavje 4.5).
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, koncentracije tolvaptana v stanju dinamičnega ravnovesja pa so dosežene po prvem odmerku.
English: Samsca causes water loss because it increases your urine production.
Slovenian: Zdravilo Samsca povzroči izgubo vode, saj zveča izločanje urina.
English: Tolvaptan is extensively metabolised by the liver.
Slovenian: Tolvaptan se izčrpno presnavlja v jetrih.
English: If fluid restricted patients are treated with tolvaptan, extra caution has to be exercised to ensure that patients do not become overly dehydrated.
Slovenian: Če se bolnikom, zdravljenim s tolvaptanom, omeji dostop do vode, je treba ravnati skrajno previdno, da se prepreči pretirana dehidracija bolnikov.
English: Too rapid correction of serum sodium
Slovenian: Prehiter popravek natrija v serumu
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 resne neželene učinke, kot so težave z ledvicami (glejte poglavje 4).
English: Tolvaptan must not be re-initiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to treatment with tolvaptan.
Slovenian: Uporabe tolvaptana pri bolnikih ni dovoljeno ponovno uvesti brez dokončne potrditve, da vzrok za opaženo poškodbo jeter ni povezan z zdravljenjem s tolvaptanom.
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.
Slovenian: Če se natrij v serumu poveča za ≥ 12 mmol/l v roku 24 ur ali ≥ 18 mmol/l v roku 48 ur, je treba zdravljenje s tolvaptanom ustaviti ali prekiniti in nato dati hipotonično tekočino.
English: In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4 % (42/958)] compared to those receiving placebo [1.0 % (5/484)].
Slovenian: Pri bolnikih, zdravljenih s tolvaptanom [4,4 % (42/958)], so opazili tudi večjo incidenco pomembnih povečanj ALT v primerjavi s tistimi, ki so prejemali placebo [1,0 % (5/484)].
English: • acute liver failure (ALF)
Slovenian: acute liver failure)
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).
Slovenian: • če ste imeli v preteklosti alergijsko reakcijo na benzazepin, tolvaptan ali druge derivate benzazepina (npr. benazepril, konivaptan, fenoldopamijev mesilat ali mirtazapin), ali na ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6)
English: The frequencies of the adverse reactions from clinical trials correspond with very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
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,
Slovenian: • če ste alergični na tolvaptan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali če ste alergični na benzazepin ali derivate benzazepina ali (npr. benazepril, konivaptan,
English: If dehydration or renal dysfunction becomes evident, take appropriate action which may include the need to interrupt or reduce doses of tolvaptan and/or diuretics, increase fluid intake, evaluate and address other potential causes of renal dysfunction or dehydration.
Slovenian: Če se pri bolniku pojavi dehidracija ali ledvična disfunkcija, so potrebni ustrezni ukrepi, ki lahko vključujejo potrebo po prekinitvi ali zmanjšanju odmerka tolvaptana in/ali diuretikov, zvišanje vnosa tekočine ter ocenitev in obravnavo drugih možnih razlogov ledvične disfunkcije ali dehidracije.
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.
Slovenian: V varnostni študiji v obdobju po izdaji dovoljenja za promet z zdravilom za tolvaptan pri hiponatriemiji, sekundarni k SIADH, ki je vključevala visok delež bolnikov s tumorji (zlasti z drobnoceličnim rakom pljuč), bolnikov z nizko izhodiščno serumsko koncentracijo natrija in bolnikov, ki so sočasno uporabljali diuretike in/ali raztopino natrijevega klorida, so ugotovili, da je bila pojavnost hitrega popravka hiponatriemije višja kot v kliničnih preskušanjih.
English: In a pilot, randomized (1:1:1), double-blind trial in 30 patients with hyponatremia secondary to SIADH, the pharmacodynamics of tolvaptan following single doses of 3.75, 7.5 and 15 mg were assessed.
Slovenian: V pilotnem, randomiziranem (1:1:1), dvojno slepem preskušanju pri 30 bolnikih s hiponatriemijo, sekundarno k SIADH, so ocenjevali farmakodinamiko tolvaptana po enkratnih odmerkih 3,75, 7,5 in
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).
Slovenian: • Pomožne snovi so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, indigotin (E 132).
English: Tolvaptan was superior to placebo (p < 0.0001) for both periods in both studies.
Slovenian: Tolvaptan se je v obeh obdobjih in obeh študijah izkazal za boljšega od placeba (p < 0,0001).
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.
Slovenian: Pri bolnikih z delno obstrukcijo odvajanja urina, na primer taki s hipertrofijo prostate ali motnjo uriniranja, je tveganje razvoja akutnega zastoja večje.
English: Therefore after initiation of treatment, patients have to be closely monitored for serum sodium and volume status (see above).
Slovenian: Zato je treba po uvedbi zdravljenja pri bolnikih skrbno spremljati stanje natrija v serumu in volumna (glejte zgoraj).
English: Dialysis may not be effective in removing tolvaptan because of its high binding affinity for human plasma protein (> 98 %).
Slovenian: Dializa morda ne bo učinkovita pri odstranjevanju tolvaptana zaradi njegove visoke afinitete za vezavo na beljakovine v človeški plazmi
English: Patients with very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium.
Slovenian: Pri bolnikih z zelo nizko koncentracijo natrija v serumu ob izhodišču je večje tveganje za prehiter popravek natrija v serumu.
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.
Slovenian: Koncentracije digoksina v stanju dinamičnega ravnovesja so se zvišale (1,3-kratno zvišanje največje koncentracije v plazmi [Cmax] in 1,2-kratno zvišanje površine pod krivuljo plazemskih koncentracij učinkovine znotraj intervala odmerjanja [AUCτ]) pri sočasni uporabi z več 60-mg odmerki tolvaptana enkrat na dan.
English: Mean change from baseline in cumulative urine volume and urine excretion rates was 2-fold higher for the 15 mg dose compared to the 7.5 and 3.75 mg doses, which showed similar responses.
Slovenian: Povprečna sprememba skupnega volumna urina in hitrosti izločanja urina v primerjavi z izhodiščem je bila 2-krat višja pri odmerku 15 mg v primerjavi z odmerkoma 7,5 mg in 3,75 mg, pri katerih so se pokazali podobni odzivi.
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.
Slovenian: Koncentracije tolvaptana v plazmi so se zvišale do 5,4-krat na površini pod plazemsko koncentracijsko krivuljo v odvisnosti od časa (PKK) (AUC - area under time-concentration curve) po uporabi močnih zaviralcev CYP3A4.
English: Tablets must be swallowed without chewing with a glass of water.
Slovenian: Tablete je treba pogoltniti cele z vodo,
English: Co-administration with other treatments for hyponatremia and medicinal products that increase serum sodium concentration
Slovenian: Sočasno dajanje z drugimi oblikami zdravljenja hiponatriemije in zdravili, ki povečajo koncentracije natrija v serumu
English: If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake.
Slovenian: Če postane očitno, da je bolnik dehidriran, so potrebni ustrezni ukrepi, ki vključujejo potrebo po prekinitvi ali zmanjšanju odmerka tolvaptana in zvišanju vnosa tekočine.
English: Constipation, Diarrhoea1, Dry mouth
Slovenian: Bolezni prebavil navzea zaprtost, driska1, suha usta
English: If you stop taking Samsca
Slovenian: Če ste prenehali jemati zdravilo Samsca
English: In these patients dosing has to be managed cautiously and electrolytes and volume status must be monitored (see section 4.4).
Slovenian: Pri teh bolnikih je treba odmerjanje skrbno obravnavati in nadzirati elektrolite in stanje volumna (glejte poglavje 4.4).
English: Following single oral doses of 7.5 to 60 mg, 24-hour urine volume increased dose dependently with daily volumes ranging from 3 to 9 litres.
Slovenian: Po enkratnih peroralnih odmerkih od 7,5 mg do 60 mg se je povečala količina urina, izločenega v 24 urah, z razponom dnevnih volumnov od 3 do 9 litrov v odvisnosti od odmerka.
English: Therefore, more precautionary limits apply during the early treatment phase.
Slovenian: Zato naj bo zdravljenje v zgodnji fazi iz previdnosti omejeno.