FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V farmakokinetični analizi populacije pri bolnikih z edemom jeter je bil AUC tolvaptana pri bolnikih z blago okvaro jeter (razred 3 po Child-Pughu) 3,1-krat ali in pri bolnikih z zmerno okvaro jeter (razreda A in B po Child-Pughu) 2,3-krat višji kot pri zdravih bolnikih.
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.
Slovenian: Pri sumu na poškodbo jeter je treba z uporabo tolvaptana takoj prenehati in uvesti ustrezno zdravljenje ter s preiskavami ugotoviti možni vzrok.
English: Tolvaptan has linear pharmacokinetics for doses of 7.5 to 60 mg.
Slovenian: Tolvaptan kaže linearno farmakokinetiko za odmerke 7,5 do 60 mg. Farmakokinetika pri posebnih skupinah bolnikov
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).
Slovenian: Pri bolnikih, pri katerih obstaja tveganje prehitrega popravka natrija, npr. pri bolnikih z onkološkimi obolenji, zelo nizkim izhodiščnim natrijem, tistih, ki jemljejo diuretike, ali tistih, ki jemljejo dodatek natrija, je treba razmisliti o odmerku 7,5 mg (glejte poglavje 4.4).
English: • excessive drinking of water
Slovenian: • pretirano pitje vode • izguba vode
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).
Slovenian: Teratogenost je bila zaznana pri kuncih, ki so prejemali 1.000 mg/kg/dan (do 15-krat večja izpostavljenost kot pri ljudeh pri odmerku 60 mg na podlagi AUC).
English: • increase in liver enzymes.
Slovenian: • zvišane ravni jetrnih encimov
English: • barbiturates (used to treat epilepsy/seizures and some sleep disorders),
Slovenian: • barbiturati (uporabljajo se za zdravljenje epilepsije/napadov in nekaterih motenj spanja), • rifampicin (proti tuberkulozi).
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.
Slovenian: 30 mg tolvaptana s standardno oskrbo (SO), 2.061 pa jih je s SO prejemalo placebo.
English: • rapid rise in level of sodium.
Slovenian: • hitro zvišanje ravni natrija
English: In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported (see section 4.8).
Slovenian: Pri izkušnjah s tolvaptanom po začetku trženja pri bolnikih z ADPKD so poročali o akutni odpovedi jeter, ki zahteva presaditev jeter (glejte poglavje 4.8).
English: What Samsca looks like and contents of the pack
Slovenian: Izgled zdravila Samsca in vsebina pakiranja
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, several cases of hepatic disorders and elevated transaminases were observed (see section 4.8).
Slovenian: V varnostni študiji v obdobju po izdaji dovoljenja za promet z zdravilom za tolvaptan pri hiponatriemiji, sekundarni k SIADH, so opazili več primerov jetrnih bolezni in zvečanih vrednosti transaminaz (glejte poglavje 4.8).
English: Urgent need to raise serum sodium acutely
Slovenian: Nujnost akutnega zvišanja natrija v serumu
English: Caution has to be exercised in co-administering CYP3A4 inducers (e.g. rifampicin, barbiturates) with tolvaptan.
Slovenian: Pri sočasni uporabi induktorjev CYP3A4 (npr. rifampicina, barbituratov) s tolvaptanom je potrebna previdnost.
English: Caution should be exercised in coadministering CYP3A4 inhibitors (e.g. ketoconazole, macrolide antibiotics, diltiazem) with tolvaptan (see section 4.4).
Slovenian: Pri sočasni uporabi zaviralcev CYP3A4 (npr. ketokonazola, makrolidnih antibiotikov, diltiazema) s tolvaptanom je potrebna previdnost (glejte poglavje 4.4).
English: Tolvaptan may cause hyperglycemia (see section 4.8).
Slovenian: Tolvaptan lahko povzroči hiperglikemijo (glejte poglavje 4.8).
English: • if you suffer from liver disease
Slovenian: • če imate bolezen jeter
English: Urinary output must be secured.
Slovenian: Obstrukcija odvajanja urina Zagotoviti je treba odvajanje urina.
English: Based on the data available, no dose adjustment is required in those with mild to moderate renal impairment.
Slovenian: Na podlagi razpoložljivih podatkov pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic odmerka ni treba prilagajati.
English: • Swallow the tablet without chewing, with a glass of water.
Slovenian: • Tableto pogoltnite celo z vodo in je ne žvečite.
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.
Slovenian: V teh kliničnih preskušanjih so pri 3 bolnikih, zdravljenih s tolvaptanom, opazili klinično pomembno povečanje (več kot 3-kratnik zgornje normalne vrednosti) serumske alanin aminotransferaze (ALT), skupaj s klinično pomembnim povečanjem (več kot 2-kratnik zgornje normalne vrednosti) skupnega serumskega bilirubina.
English: Avoid drinking grapefruit juice when taking Samsca.
Slovenian: Med jemanjem zdravila Samsca se izogibajte pitju soka grenivke.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in karcinogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Very limited information is available in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Pri bolnikih s hudo okvaro delovanja jeter so na voljo le zelo omejeni podatki (razred C po Child-Pughu).
English: The dose could be increased to 30 and 60 mg/day depending on response using a 3 day titration scheme.
Slovenian: Odmerek so lahko v 3-dnevnem režimu titriranja zvišali do 30 in 60 mg/dan v odvisnosti od odziva.
English: Samsca is contraindicated during pregnancy (see section 4.3).
Slovenian: Zdravilo Samsca je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
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.
Slovenian: Peroralna uporaba odmerkov tolvaptana od 7,5 mg do 120 mg je pri zdravih odraslih osebah povzročila povečanje izločanja urina v 2 urah od uporabe.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati (razreda A in B po Child-Pughu).
English: • Hypovolemic hyponatremia
Slovenian: • hipovolemičnost • hipovolemična hiponatriemija
English: Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers.
Slovenian: Zdravi prostovoljci so v kliničnih preskušanjih dobro prenašali enkratne odmerke do 480 mg in večkratne odmerke do 300 mg na dan, ki so jih prejemali 5 dni.
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).
Slovenian: Idiosinkratična jetrna toksičnost V kliničnih preskušanjih, kjer so preučevali drugo indikacijo (avtosomalna dominantna policistična bolezen ledvic [ADPKD]) pri dolgotrajni uporabi tolvaptana pri odmerkih, ki so bili višji kot za odobreno indikacijo, so opazili poškodbe jeter zaradi tolvaptana (glejte poglavje 4.8).
English: • tiredness, general weakness
Slovenian: • utrujenost, splošna oslabelost
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.
Slovenian: Bolnike, ki so pred začetkom zdravljenja z zdravilom Samsca prejemali druge oblike zdravljenja za hiponatriemijo ali druga zdravila, ki povečujejo koncentracije natrija v serumu (glejte poglavje 4.5), je treba obravnavati zelo skrbno.
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
Slovenian: Okvara ledvic V analizi o farmakokinetiki prebivalstva pri bolnikih s srčnim popuščanjem koncentracije tolvaptana pri bolnikih z blago (očistek kreatinina [Ccr] 50 do 80 ml/min) ali zmerno (Ccr 20 do 50 ml/min) okvarjenim delovanjem ledvic ni bilo pomembnih razlik v koncentracijah tolvaptana pri bolnikih z normalnim delovanjem ledvic (Ccr 80 do 150 ml/min).
English: Anaphylactic shock,
Slovenian: Bolezni imunskega sistema anafilaktični šok,
English: Dysgeusia
Slovenian: disgevzija
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).
Slovenian: Sočasna uporaba zdravila Samsca z drugimi oblikami zdravljenja hiponatriemije ali drugimi zdravili, ki povečujejo koncentracije natrija v serumu, lahko povzroči večje tveganje za razvoj prehitrega popravka natrija v serumu (glejte poglavje 4.4), zato ni priporočljiva med začetnim zdravljenjem ali za druge bolnike z zelo nizko koncentracijo natrija v serumu ob izhodišču,
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake (E 132)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob hidroksipropilceluloza laktoza monohidrat magnezijev stearat mikrokristalna celuloza indigotin (E 132)
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.
Slovenian: Če se pojavijo simptomi, kot so utrujenost, izguba apetita, nelagodje v zgornjem desnem predelu trebuha, temen urin ali zlatenica (porumenelost kože ali oči), se posvetujte z zdravnikom.
English: Talk to your doctor or pharmacist before taking Samsca:
Slovenian: Pred začetkom jemanja zdravila Samsca se posvetujte z zdravnikom ali farmacevtom:
English: During titration, patients must be monitored for serum sodium and volume status (see section 4.4).
Slovenian: Med titriranjem je treba pri bolnikih nadzirati natrij v serumu in stanje volumna (glejte poglavje 4.4).
English: No information is available in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Za bolnike z resno okvaro jeter (razred C po Child-Pughu) podatkov ni na voljo.
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).
Slovenian: Specifičnega antidota za zastrupitev s tolvaptanom ni. Pričakovati je, da bodo znaki in simptomi akutnega prevelikega odmerjanja pretirani farmakološki učinki: zvišanje koncentracij natrija v serumu, poliurija, žeja in dehidracija/hipovolemija
English: • patchy bleeding in the skin
Slovenian: • krvavenje kože v obliki zaplat
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).
Slovenian: Sočasna uporaba zdravila Samsca z drugimi oblikami zdravljenja hiponatriemije ali zdravili, ki povečujejo koncentracije natrija v serumu, ni priporočljiva med začetnim zdravljenjem ali za druge bolnike z zelo nizko koncentracijo natrija v serumu ob izhodišču (glejte poglavje 4.5).
English: In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of tolvaptan.
Slovenian: V izkušnjah iz obdobja trženja so zelo redko po dajanju tolvaptan poročali o anafilaksi (vključno z anafilaktičnim šokom in generaliziranim izpuščanjem).
English: This effect continued as on Day 30, when more tolvaptan than placebo patients still had normal concentrations (60 % vs. 27 %).
Slovenian: Ta učinek se je nadaljeval do 30. dneva, ko je še vedno imelo normalne koncentracije več bolnikov, zdravljenih s tolvaptanom, kot zdravljenih s placebom
English: Each tablet contains 7.5 mg tolvaptan.
Slovenian: Ena tableta vsebuje 7,5 mg tolvaptana.
English: Hyponatremia
Slovenian: Hiponatriemija
English: • raised levels of creatinine in the blood.
Slovenian: • zvišana koncentracija kreatinina v krvi
English: • Hypernatremia
Slovenian: • hipernatriemija
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).
Slovenian: (npr. benazepril, konivaptan, fenoldopamijev mesilat ali mirtazapin) obstaja nevarnost za pojav preobčutljivostnih reakcij na tolvaptan (glejte poglavje 4.3 Kontraindikacije).
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.
Slovenian: Pri bolnikih, ki uporabljajo tolvaptan, in ki poročajo o simptomih, ki lahko nakazujejo na poškodbo jeter, vključno z utrujenostjo, anoreksijo, nelagodjem v zgornjem desnem predelu trebuha, temnim urinom ali zlatenico, je treba takoj opraviti teste delovanja jeter.
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.
Slovenian: Izkušenj iz kontroliranih kliničnih preskušanj sočasne uporabe zdravila Samsca in drugih oblik zdravljenja hiponatriemije, kot so hipertonična raztopina natrijevega klorida, peroralne oblike natrija in zdravila, ki povečajo koncentracije natrija v serumu, ni. Tudi zdravila z visoko vsebnostjo natrija, kot so šumeči protibolečinski pripravki in nekatere oblike zdravil proti dispepsiji, lahko povečajo koncentracije natrija v serumu.
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.
Slovenian: V 2 osrednjih, dvojno slepih, s placebom nadziranih kliničnih preskušanjih so v obdobju 30 dni s tolvaptanom (n = 216) ali placebom (n = 208) z začetnim odmerkom 15 mg/dan zdravili skupno
English: How to store Samsca
Slovenian: Shranjevanje zdravila Samsca
English: 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Slovenian: 10 × 1 tableta v perforiranih pretisnih omotih za enkratni odmerek PVC/Al 30 × 1 tableta v perforiranih pretisnih omotih za enkratni odmerek PVC/Al
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).
Slovenian: Pri kuncih niso opazili teratogenega učinka pri 300 mg/kg/dan (do 5-krat večja izpostavljenost kot pri ljudeh pri odmerku
English: How to take Samsca
Slovenian: Kako jemati zdravilo Samsca
English: Clearance of tolvaptan is not significantly affected by age.
Slovenian: Starost Starost nima pomembnega vpliva na očistek tolvaptana.
English: Hepatic disorders2 Acute hepatic failure3
Slovenian: žolčnika in žolčevodov bolezni jeter2, akutna odpoved jeter3
English: Samsca is contraindicated during breast-feeding (see section 4.3).
Slovenian: Zdravilo Samsca je kontraindicirano med dojenjem (glejte poglavje 4.3).
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).
Slovenian: Ta učinek so opazili pri vseh bolnikih, v podskupini s hudimi znaki (natrij v serumu: < 130 mEq/l) in blagimi znaki (natrij v serumu:
English: Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets
Slovenian: Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete
English: Generalised rash
Slovenian: generalizirani izpuščaj
English: Samsca 7.5 mg tablets EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Slovenian: Samsca 7,5 mg tablete EU/1/09/539/005 (10 tablet) EU/1/09/539/006 (30 tablet) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
English: Samsca 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan.
Slovenian: Samsca 7,5 mg tablete Ena tableta vsebuje 7,5 mg tolvaptana.
English: Samsca 7.5 mg tablets 5 years
Slovenian: Samsca 7,5 mg tablete 5 let
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Samsca Vsebina pakiranja in dodatne informacije
English: Samsca contains lactose
Slovenian: Zdravilo Samsca vsebuje laktozo.
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.
Slovenian: (glejte poglavje 4.4) skrbno nadzirati, je treba zdravljenje z zdravilom Samsca začeti v bolnišnici.
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.
Slovenian: glejte spodaj); zato je treba z nadziranjem natrija v serumu pri vseh bolnikih začeti najkasneje 4-6 ur po uvedbi zdravljenja.
English: • other products which increase the salt in your blood or which contain large amounts of salt.
Slovenian: • diltiazem (zdravljenje visokega krvnega tlaka in bolečine v prsih), • druga zdravila, ki povečujejo koncentracijo soli v krvi ali ki vsebujejo velike količine soli.
English: Samsca 7.5 mg tablets tolvaptan
Slovenian: Samsca 7,5 mg tablete tolvaptan
English: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Slovenian: Modre, okrogle, plitko konveksne tablete z dimenzijami Ø8 × 3,0 mm z vtisnjenim napisom „OTSUKA“ in „30“ na eni strani.
English: {MM/YYYY}
Slovenian: • če dojite
English: Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Slovenian: Zdravilo Samsca 30 mg: modre, okrogle, plitko konveksne tablete z dimenzijami Ø8 × 3,0 mm, z vtisnjenim napisom „OTSUKA“ in „30“ na eni strani.
English: Syncope1, Headache1, Dizziness1
Slovenian: Bolezni živčevja sinkopa1, glavobol1,
English: • Anuria
Slovenian: • anurija
English: Each Samsca 30 mg tablet contains 30 mg tolvaptan.
Slovenian: Ena tableta zdravila Samsca 30 mg vsebuje 30 mg tolvaptana.
English: Each Samsca 15 mg tablet contains 15 mg tolvaptan.
Slovenian: Ena tableta zdravila Samsca 15 mg vsebuje 15 mg tolvaptana.
English: Samsca 7.5 mg tablets
Slovenian: Samsca 7,5 mg tablete
English: Samsca 15 mg tablets tolvaptan
Slovenian: Samsca 15 mg tablete tolvaptan
English: Samsca 30 mg tablets
Slovenian: Samsca 30 mg tablete
English: Samsca 30 mg tablets tolvaptan
Slovenian: Samsca 30 mg tablete tolvaptan
English: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Slovenian: Modre, trikotne, plitko konveksne tablete z dimenzijami 6,58 × 6,2 × 2,7 mm z vtisnjenim napisom „OTSUKA“ in „15“ na eni strani.
English: For the full list of excipients, see section 6.1.
Slovenian: 70 mg laktoze (v obliki monohidrata) na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Slovenian: Modre, pravokotne, plitko konveksne tablete z dimenzijami 7,7 × 4,35 × 2,5 mm z vtisnjenim napisom „OTSUKA“ in „7.5“ na eni strani.
English: Samsca 15 mg tablets and Samsca 30 mg tablets 4 years
Slovenian: Samsca 15 mg tablete in Samsca 30 mg tablete 4 leta
English: Samsca 15 mg tablets
Slovenian: Samsca 15 mg tablete
English: Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Slovenian: Zdravilo Samsca 7,5 mg: modre, pravokotne, plitko konveksne tablete z dimenzijami 7,7 × 4,35 × 2,5 mm, z vtisnjenim napisom „OTSUKA“ in „7.5“ na eni strani.
English: Samsca contains lactose as an excipient.
Slovenian: Zdravilo Samsca vsebuje laktozo kot pomožno snov.
English: • diltiazem (treatment for high blood pressure and chest pain),
Slovenian: • desmopresin (uporablja se za zvišanje ravni faktorjev strjevanja krvi).
English: EU/1/09/539/001 (10 × 1 tablet) EU/1/09/539/002 (30 × 1 tablet)
Slovenian: EU/1/09/539/001 (10 × 1 tableta) EU/1/09/539/002 (30 × 1 tableta)
English: Rapid correction of hyponatremia
Slovenian: Opis izbranih neželenih učinkov Hiter popravek hiponatriemije
English: EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Slovenian: EU/1/09/539/005 (10 tablet) EU/1/09/539/006 (30 tablet) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
English: • ketoconazole (against fungal infections),
Slovenian: Naslednja zdravila lahko povečajo učinek tega zdravila: • ketokonazol (proti glivičnim okužbam),
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS AND PERFORATED UNIT DOSE BLISTERS
Slovenian: PRETISNI OMOTI IN PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK
English: Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Slovenian: Zdravilo Samsca 15 mg; modre, trikotne, plitko konveksne tablete z dimenzijami 6,58 × 6,2 × 2,7 mm, z vtisnjenim napisom „OTSUKA“ in „15“ na eni strani.
English: EU/1/09/539/003 (10 × 1 tablet) EU/1/09/539/004 (30 × 1 tablet)
Slovenian: EU/1/09/539/003 (10 × 1 tableta) EU/1/09/539/004 (30 × 1 tableta)
English: Package leaflet: Information for the user Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan
Slovenian: Navodilo za uporabo Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete tolvaptan
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.
Slovenian: „sindrom neustreznega izločanja antidiuretičnega hormona“ (SIADH), pri kateri ledvice zadržujejo preveč vode.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU