FrancophonIA/ELRC3.0 huggingface dataset:
English: Data on the long-term safety and efficacy of tolvaptan were assessed for up to 106 weeks in a clinical trial in patients (any aetiology) who had previously completed one of the pivotal hyponatremia trials.
Croatian: Podaci o dugoročnoj sigurnosti i djelotvornosti tolvaptana bili su procijenjeni u kliničkom ispitivanju do 106 tjedna s bolesnicima (bilo koje etiologije) koji su prethodno završili jedno od pivotalnih ispitivanja hiponatremije.
English: Therefore, the effect of vasopressin analogues such as desmopressin may be attenuated in patients using such analogues to prevent or control bleeding when co-administered with tolvaptan.
Croatian: Prema tome, učinak vazopresinskih analoga, kao što je dezmopresin, može biti smanjen kod bolesnika koji koriste takve analoge za sprječavanje ili kontroliranje krvarenja ako se daju istovremeno s tolvaptanom.
English: Samsca is unlikely to adversely affect your ability to drive or to operate machinery.
Croatian: Samsca najvjerojatnije neće negativno utjecati na vašu sposobnost da vozite ili rukujete strojevima.
English: This effect continued as on Day 30, when more tolvaptan than placebo patients still had normal concentrations (60 % vs. 27 %).
Croatian: Taj se učinak nastavio do 30. dana kada je više bolesnika koji su primali tolvaptan nego placebo još uvijek imalo normalne koncentracije (60 % prema 27 %).
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.
Croatian: Za bolesnike sa adekvatnim povećanjem serumskog natrija, postojeću bolest i razine serumskog natrija mora se pratiti u redovnim intervalima kako bi se procijenila daljnja potreba za liječenjem tolvaptanom.
English: Based on the data available, no dose adjustment is required in those with mild to moderate renal impairment.
Croatian: Na temelju dostupnih podataka, nije potrebno prilagođavati dozu kod onih s blagim do umjerenim oštećenjem bubrega.
English: Elevation (>3 × ULN) of serum aspartate aminotransferase (AST) was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Croatian: Povišena (> 3 × GGN) aspartat aminotransferaza (AST) u serumu opažena je u 3,1 % (30/958) bolesnika na tolvaptanu i u 0,8 % (4/484) bolesnika na placebu.
English: • excessive drinking of water
Croatian: • pretjerano pijenje vode • gubitak vode
English: If you stop taking Samsca
Croatian: Ako prestanete uzimati Samscu
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.
Croatian: Tolvaptan je selektivni antagonist vazopresinskih V2 receptora koji specifično blokira vezanje argininvazopresina (AVP) na V2 receptore u distalnim dijelovima nefrona.
English: • if you suffer from a kidney disease called autosomal dominant polycystic kidney disease
Croatian: • ako bolujete od bubrežne bolesti pod nazivom autosomno dominantna policistična bolest bubrega (ADPBB)
English: If fluid restricted patients are treated with tolvaptan, extra caution has to be exercised to ensure that patients do not become overly dehydrated.
Croatian: Ako se bolesnici s ograničenim pristupom tekućini liječe tolvaptanom, mora se posvetiti dodatna pažnja kako bi se spriječilo da bolesnici ne postanu previše dehidrirani.
English: You have been prescribed this medicine because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water.
Croatian: Ovaj lijek Vam je propisan jer imate smanjene razine natrija u krvi kao posljedicu bolesti koja se zove „sindrom neodgovarajućeg lučenja antidiuretskog hormona“ kada bubrezi zadržavaju previše vode.
English: These patients should be monitored more frequently regarding their serum sodium and administration of hypotonic fluid is recommended.
Croatian: Ove bolesnike bi trebalo češće nadzirati radi njihovog serumskog natrija i preporučuje se davanje hipotonične otopine.
English: Patients receiving digoxin should therefore be evaluated for excessive digoxin effects when treated with tolvaptan.
Croatian: Stoga, bolesnike koji primaju digoksin treba procijeniti za prekomjerne učinke digoksina dok se liječe tolvaptanom.
English: Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Croatian: Samsca je indicirana u odraslih za liječenje hiponatremije zbog sindroma neodgovarajućeg lučenja antidiuretskog hormona (SIADH).
English: Tolvaptan has linear pharmacokinetics for doses of 7.5 to 60 mg.
Croatian: Tolvaptan ima linearnu farmakokinetiku za doze od 7,5 do 60 mg.
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Croatian: Nakon jedne oralne doze od ≥ 300 mg, čini se da vršna koncentracija plazme postiže plato, vjerojatno radi saturacije apsorpcije.
English: This medicine may lower the effect of the following medicines: • desmopressin (used to increase blood clotting factors).
Croatian: Ovaj lijek može smanjiti učinke sljedećih lijekova: • dezmopresin (koristi se za povećanje faktora zgrušavanja krvi).
English: Mean maximal changes in serum sodium were highest following the 15 mg dose (7.9 mmol/L) but median maximal changes were highest for the 7.5 mg dose (6.0 mmol/L).
Croatian: Srednja vrijednost najveće promjene natrija u serumu bila je najviša pri dozi od 15 mg (7,9 mmol/l), ali medijan najveće promjene bio je najviši pri dozi od 7,5 mg (6,0 mmol/l).
English: The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium.
Croatian: Ta se doza može povećati na najviše 60 mg jednom dnevno, ovisno o toleranciji, kako bi se postigla željena razina serumskog natrija.
English: conivaptan, fenoldopam mesylate or mirtazapine)
Croatian: fenoldopammesilat ili mirtazapin)
English: If you forget to take Samsca
Croatian: Ako ste zaboravili uzeti Samscu
English: Samsca is used to treat low serum sodium levels in adults.
Croatian: Samsca se koristi za liječenje niskih razina natrija u serumu kod odraslih.
English: • if you suffer from liver disease
Croatian: • ako imate bolest jetre
English: Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists.
Croatian: Samsca sadrži djelatnu tvar tolvaptan i pripada skupini lijekova koji se zovu antagonisti vazopresina.
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).
Croatian: Ta bolest uzrokuje neodgovarajuće stvaranje hormona vazopresina što je dovelo do toga da su razine natrija u Vašoj krvi postale preniske (hiponatremija).
English: • find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Croatian: • Vam otekne lice, usne ili jezik, imate svrbež, generalizirani osip ili jako piskanje odnosno nedostatak zraka (simptomi alergijske reakcije).
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).
Croatian: Primjena tolvaptana u kombinaciji s drugim opcijama može povećati opasnost od prebrze korekcije serumskog natrija (vidjeti dijelove 4.4 i 4.5).
English: If you stop taking Samsca this may lead to reoccurrence of your low sodium.
Croatian: Ako prestanete uzimati Samscu, to može ponovo dovesti do niske razine natrija.
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01
Croatian: Farmakoterapijska skupina: diuretici, antagonisti vazopresina, ATK oznaka C03XA01 Mehanizam djelovanja
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)].
Croatian: Uz to, kod bolesnika liječenih tolvaptanom zapažena je povećana incidencija značajno povišenih ALT [4,4 % (42/958)] u usporedbi s onima koji su primali placebo [1,0 % (5/484)].
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i posebne mjere opreza pri uporabi
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.
Croatian: Profil nuspojava tolvaptana kod SIADH-a bazira se na bazi podataka kliničkih ispitivanja koja sadrži 3294 bolesnika liječena tolvaptanom i u skladu je sa farmakologijom djelatne tvari.
English: Fluid and electrolyte status has to be monitored in all patients and particularly in those with renal and hepatic impairment.
Croatian: Ravnoteža tekućina i elektrolita Status tekućina i elektrolita mora se nadzirati kod svih bolesnika, a naročito kod onih s oštećenjima jetre i bubrega.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznaka „Rok valjanosti“ i „EXP“.
English: Tolvaptan is extensively metabolised by the liver.
Croatian: Tolvaptan se opsežno metabolizira u jetri.
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.
Croatian: U perinatalnom i postnatalnom ispitivanju na štakorima, odgođeno okoštavanje i smanjena težina mladunčadi je primijećena kod visoke doze od 1000 mg/kg/dan.
English: When treatment was discontinued, serum sodium concentrations decreased to approximately baseline values, despite the reinstatement of standard care therapy.
Croatian: Kada je liječenje prekinuto, koncentracije serumskog natrija smanjile su se do otprilike početnih vrijednosti, bez obzira na to što su bolesnici vraćeni na standardno liječenje.
English: 10 × 1 tablet 30 × 1 tablet
Croatian: 10 × 1 tableta 30 × 1 tableta
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je lijecnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: This effect was seen in all patients, the severe (serum sodium: < 130 mEq/L) and mild (serum sodium: 130 -< 135 mEq/L) subsets and for all disease aetiology subsets (e.g. HF, cirrhosis, SIADH/other).
Croatian: To se primijetilo kod svih bolesnika, u teškoj (serumski natrij: < 130 mEq/l) i blagoj (serumski natrij: 130 - < 135 mEq/l) podskupini i za sve podskupine etiologije bolesti (npr. zatajenje srca, ciroza, SIADH/drugo).
English: Administration of tolvaptan may cause too rapid increases in serum sodium (≥ 12 mmol/L per 24 hours, please see below); therefore, monitoring of serum sodium in all patients must start no later than 4-6 hours after treatment initiation.
Croatian: Primjena tolvaptana može dovesti do prebrzog povećanja serumskog natrija (≥ 12 mmol/l u 24 sata, molimo pogledajte ispod); stoga, u svih bolesnika mora se početi nadzirati serumski natrij ne kasnije od 4-6 sati nakon početka liječenja.
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 %).
Croatian: Nakon 3 dana liječenja, zbirna analiza dva ispitivanja otkrila je peterostruko više bolesnika na tolvaptanu nego na placebu postiglo normalizaciju koncentracije serumskog natrija (49 % prema 11 %).
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Croatian: Terminalni poluvijek eliminacije iznosi oko 8 sati, a koncentracije tolvaptana u stanju dinamičke ravnoteže postižu se nakon prve doze.
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.
Croatian: Ako korekcija natrija prelazi 6 mmol/l tijekom prvih 6 sati davanja ili 8 mmol/l tijekom prvih 6-12 sati, tim redoslijedom, treba uzeti u obzir mogućnost da je korekcija serumskog natrija prebrza.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Samsca in one or more subsets of the paediatric population in treatment of dilutional hyponatremia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Samsca u jednoj ili više podskupina pedijatrijske populacije u liječenju dilucijske hiponatremije (vidjeti dio 4.2
English: Samsca must not be taken with grapefruit juice (see section 4.5).
Croatian: Samsca se ne smije uzimati sa sokom od grejpfruta (vidjeti dio 4.5).
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, dry mouth and dehydration (see section 4.8).
Croatian: Tolvaptan može uzrokovati nuspojave vezane za gubitak vode kao što su žeđ, suha usta i dehidracija (vidjeti dio 4.8).
English: No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Croatian: Nisu se primijetile nikakve klinički značajne promjene u klirensu kod doza u rasponu od 5 do 60 mg.
English: Diabetic patients with an elevated glucose concentration (e.g. in excess of 300 mg/dL) may present with pseudo-hyponatremia.
Croatian: Diabetes mellitus Kod bolesnika s dijabetesom koji imaju povišenu koncentraciju glukoze (npr. više od 300 mg/dl) može se pojaviti pseudohiponatremija.
English: If liver injury is suspected, tolvaptan must be promptly discontinued, appropriate treatment has to be instituted, and investigations have to be performed to determine the probable cause.
Croatian: Ako se sumnja na oštećenje jetre, mora se odmah prekinuti primjena tolvaptana, uspostaviti odgovarajuće liječenje, te provesti ispitivanja kako bi se ustanovio vjerojatan uzrok.
English: Tolvaptan treatment is expected to last until the underlying disease is adequately treated or until such time that hyponatremia is no longer a clinical issue.
Croatian: Očekuje se da liječenje tolvaptanom traje dok se postojeća bolest ne izliječi na adekvatni način ili dok hiponatremija ne prestane biti klinički problem.
English: Polydipsia, Dehydration, Hyperkalemia, Hyperglycemia, Hypoglycemia1, Hypernatremia1, Hyperuricemia1, Decreased appetite
Croatian: Poremećaji metabolizma i prehrane polidipsija, dehidracija, hiperkalemija, hiperglikemija, hipoglikemija1, hipernatremija1, hiperuricemija1, smanjeni apetit
English: Blood urine present1, Alanine aminotransferase increased (see section 4.4)1, Aspartate aminotransferase increased (see section 4.4)1, Blood creatinine
Croatian: povišena alanin aminotransferaza (vidjeti dio 4.4)1, povišena aspartat aminotransferaza (vidjeti dio 4.4)1, povišen kreatinin u krvi povišen bilirubin (vidjeti dio 4.4)1
English: There are no or limited amount of data from the use of tolvaptan in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni tolvaptana u trudnica ograničeni.
English: Other side effects Very common (may affect more than 1 in 10 people)
Croatian: Druge nuspojave Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: In case of inadequate improvement in serum sodium levels, other treatment options have to be considered, either in place of or in addition to tolvaptan.
Croatian: U slučaju da se razine serumskog natrija ne poprave adekvatno, treba uzeti u obzir druge opcije, bilo kao zamjena ili kao dodatak tolvaptanu.
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).
Croatian: Taj gubitak vode može rezultirati nuspojavama kao što su suha usta ili žeđ ili čak teže nuspojave poput poteškoća s bubrezima (pogledajte dio 4).
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.
Croatian: Kod bolesnika kod kojih postoji viši rizik od sindroma demijelinizacije, na primjer kod onih s hipoksijom, alkoholizmom ili malnutricijom, odgovarajuća brzina korekcije natrija može biti manja nego kod bolesnika bez tog faktora rizika; stoga s tim bolesnicima treba vrlo pažljivo postupati.
English: • rapid rise in level of sodium.
Croatian: • brzi porast razine natrija.
English: The primary endpoint for these trials was the average daily AUC for change in serum sodium from baseline to Day 4 and baseline to Day 30.
Croatian: Primarni ishod za ova ispitivanja je prosječna dnevna AUC za promjene u serumskom natriju između početne vrijednosti i 4. dana i početne vrijednosti i 30. dana.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tolvaptan in breast milk (for details see 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci iz ispitivanja na životinjama pokazuju da se tolvaptan izlučuje u majčino mlijeko (za detalje vidjeti dio 5.3).
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.
Croatian: Nakon jednokratnih peroralnih doza od 7,5 do 60 mg, 24-satni volumen urina povećavao se ovisno o dozi, a raspon dnevnog volumena iznosio je 3 do 9 litara.
English: However, when driving or using machines it should be taken into account that occasionally dizziness, asthenia or syncope may occur.
Croatian: Međutim, pri upravljanju vozilima ili rukovanju strojevima potrebno je uzeti u obzir da se može pojaviti povremena omaglica, astenija ili sinkopa.
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.
Croatian: Učinak blagog ili umjerenog oštećenja funkcije jetre (Child-Pugh stadij A i B) na farmakokinetiku tolvaptana istražen je u 87 bolesnika s bolestima jetre različitog porijekla.
English: Co-administration of grapefruit juice and tolvaptan resulted in a 1.8-fold increase in exposure to tolvaptan.
Croatian: Istovremeno davanje soka od grejpfruta i tolvaptana dovelo je do 1,8 puta većeg povećanja izloženosti tolvaptanu.
English: The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia (profuse and prolonged aquaresis).
Croatian: Znakovi i simptomi akutnog predoziranja mogu se predvidjeti kao pretjeran farmakološki učinak: porast serumske koncentracije natrija, poliurija, žeđ i dehidracija/hipovolemija
English: Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca has to be initiated in hospital.
Croatian: Zbog potrebe za fazom titracije doze uz pažljiv nadzor serumskog natrija i volumskog statusa (vidjeti dio 4.4), liječenje Samscom mora započeti u bolnici.
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.
Croatian: Uz svoj bubrežni diuretski učinak, tolvaptan može blokirati vaskularne vazopresinske V2 receptore uključene u otpuštanje koagulacijskih faktora (npr., faktor von Willebrand) iz endotelnih stanica.
English: Tablet
Croatian: tableta
English: Consult your doctor if symptoms of fatigue, loss of appetite, right upper abdominal discomfort, dark urine or jaundice (yellowing of skin or eyes) occur.
Croatian: Obratite se svome liječniku ako se pojave simptomi kao što je umor, gubitak apetita, nelagoda u gornjem desnom dijelu trbuha, tamni urin ili žutica (žutilo kože i očiju).
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.
Croatian: Srednja vrijednost promjene od početne vrijednosti u kumulativnom volumenu urina i brzini izlučivanja urina bila je 2 puta veća pri dozi od 15 mg u usporedbi s dozama od 7,5 i 3,75 mg, koje su imale slične odgovore.
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.
Croatian: Kod jednokratnih doza od 60 mg do 480 mg, izlučila se srednja vrijednost od približno 7 litara tijekom 0 do 12 sati, neovisno o dozi.
English: This medicine may increase the effect of the following medicines: • digoxin (used for treatment of irregularities of heart beat and heart failure).
Croatian: Ovaj lijek može pojačati učinke sljedećih lijekova: • digoksin (primjenjuje se za liječenje nepravilnosti otkucaja srca i zatajenja srca).
English: At 7 days after discontinuing treatment, sodium values decreased to levels of placebo treated patients.
Croatian: Sedam dana nakon prestanka liječenja, vrijednosti natrija smanjile su na razine koje su imali i bolesnici koji su primali placebo.
English: Samsca has no or negligible influence on the ability to drive or use machines.
Croatian: Samsca ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Tolvaptan se ne smije bolesnicima ponovo uvesti prije nego se definitivno utvrdi da primijećeno oštećenje jetre nije u vezi s liječenjem tolvaptanom.
English: • increase in liver enzymes.
Croatian: • povišenje jetrenih enzima
English: • high levels of sodium, potassium, creatinine, uric acid and blood sugar
Croatian: • visoke razine natrija, kalija, kreatinina, mokraćne kiseline ili šećera u krvi • smanjene razine šećera u krvi
English: In the long-term outcome trial, a total of 2,072 patients received 30 mg tolvaptan with standard of care (SC) and 2,061 received placebo with SC.
Croatian: U ispitivanju dugoročnih ishoda, ukupno 2072 bolesnika primilo je 30 mg tolvaptana uz standardnu njegu (SNJ) a 2061 primilo je placebo uz standardnu njegu.
English: What you need to know before you take Samsca Do not take Samsca
Croatian: Što morate znati prije nego počnete uzimati Samscu
English: Tolvaptan may cause hyperglycemia (see section 4.8).
Croatian: Tolvaptan može uzrokovati hiperglikemiju (vidjeti dio 4.8).
English: Very limited information is available in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Vrlo ograničene informacije su dostupne kod bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C).
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.
Croatian: Ako dehidracija postane očita, treba poduzeti korake koji mogu uključivati potrebu za prekidom uzimanja ili smanjenjem doze tolvaptana i povećanim uzimanjem tekućine.
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.
Croatian: Ako dehidracija ili disfunkcija bubrega postanu očite, treba poduzeti odgovarajuće korake koji mogu uključivati potrebu za prekidom uzimanja ili smanjenjem doze tolvaptana i/ili diuretika, povećanim uzimanjem tekućine, procjenom i traženjem drugih mogućih uzroka disfunkcije bubrega ili dehidracije.
English: Elderly No dose adjustment is needed in elderly patients.
Croatian: Kod starijih bolesnika nije potrebno prilagođavati dozu.