FrancophonIA/ELRC3.0 huggingface dataset:
English: Busulfan Fresenius Kabi must always be added to the diluent, not the diluent to the Busulfan Fresenius Kabi.
Croatian: Busulfan Fresenius Kabi se uvijek mora dodati otapalu, a ne otapalo u koncentrat.
English: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with Busulfan Fresenius Kabi.
Croatian: Moguće je da nakon liječenja busulfanom više nećete moći ostvariti trudnoću (neplodnost).
English: Skin desquamation Erythema Pigmentation disorder
Croatian: Poremećaj pigmentacije
English: - 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time).
Croatian: sata čuvanja na temperaturi od 25°C ± 2°C (uključujući vrijeme infuzije).
English: Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Croatian: Izračun količine lijeka Busulfan Fresenius Kabi koju je potrebno razrijediti i količine otapala Prije upotrebe, lijek Busulfan Fresenius Kabi se mora razrijediti otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion Busulfan
Croatian: Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju busulfan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Croatian: Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u 10 ml).
English: How to use Busulfan Fresenius Kabi
Croatian: Kako primjenjivati Busulfan Fresenius Kabi
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use after dilution.
Croatian: Prije uporabe pročitajte Uputu o lijeku Primjena u venu nakon razrjeđivanja.
English: • Quantity of diluent: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent
Croatian: • Količina otapala: (A ml Busulfan Fresenius Kabi) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml busulfana u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tna otopina glukoze za injekciju) Priprema otopine za infuziju
English: Hepatic veno-occlusive disease is a major complication that can occur during treatment with busulfan.
Croatian: Glavna komplikacija koja se može pojaviti tijekom liječenja busulfanom je vensko-okluzivna bolest jetre.
English: Diluted Busulfan Fresenius Kabi is a clear colourless solution.
Croatian: Razrijeđeni Busulfan Fresenius Kabi je bistra, bezbojna otopina.
English: When diluted Busulfan Fresenius Kabi is a clear colourless viscous solution.
Croatian: Kada je razrijeđen, Busulfan Fresenius Kabi je bistra, bezbojna, viskozna otopina.
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: Konačni volumen distribucije
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany 12.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Croatian: TVARI Jedan ml koncentrata sadrži 6 mg busulfana i nakon razrjeđivanja osigurava 0,5 mg/ml busulfana POPIS POMOĆNIH TVARI Pomoćne tvari: dimetilacetamid i makrogol 400
English: Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Croatian: Prije upotrebe, Busulfan Fresenius Kabi je potrebno razrijediti s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
English: Busulfan Fresenius Kabi destroys the original bone marrow before the transplant.
Croatian: Busulfan uništava izvornu koštanu srž prije presađivanja.
English: NAME OF THE MEDICINAL PRODUCT Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan
Croatian: Uputa o lijeku: Informacija za korisnika Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju busulfan
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for:
Croatian: Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju dokazana je za: - 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 25°C ±
English: Blood urea increased GGT increased
Croatian: Povišena mokraćna kiselina u krvi Povišena urea u krvi Povišeni GGT Povećanje tjelesne težine
English: To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Croatian: • Količina otapala: (A ml lijeka Busulfan Fresenius Kabi) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml lijeka Busulfan Fresenius Kabi u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tne otopine glukoze za injekciju) Priprema otopine za infuziju
English: Stomatitis Diarrhoea Abdominal pain Nausea
Croatian: Bol u abdomenu Mučnina Povraćanje Dispepsija Ascites
English: the calculated volume of Busulfan Fresenius Kabi must be removed from the vial.
Croatian: iz bočice se mora ukloniti izračunati volumen lijeka Busulfan Fresenius Kabi.
English: Busulfan Fresenius Kabi in combination with cyclophosphamide: - The recommended dose of Busulfan Fresenius Kabi is 0.8 mg/kg
Croatian: Busulfan u kombinaciji s ciklofosfamidom: - Preporučena doza lijeka Busulfan Fresenius Kabi je 0,8 mg/kg - Svaka infuzija trajat će 2 sata - Busulfan Fresenius Kabi će se primjenjivati svakih 6 sati tijekom 4 uzastopna dana prije presađivanja.
English: Or
Croatian: Bol
English: SPECIAL STORAGE CONDITIONS
Croatian: Uvjeti čuvanja
English: Hyperventilation Respiratory failure
Croatian: Respiratorno zatajenje Alveolarna krvarenja
English: Respiratory, thoracic and mediastinal disorders:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: B. PACKAGE LEAFLET
Croatian: 1. PAKIRANJE
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan
Croatian: Busulfan Fresenius Kabi 6 mg/ml sterilni koncentrat busulfan i.v. primjena nakon razrjeđivanja
English: Asthenia Oedema Pain
Croatian: Stanjivanje rožnice
English: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent
Croatian: A ml lijeka Busulfan Fresenius Kabi potrebnog za razrjeđivanje 6 (mg/ml)
English: 1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case
Croatian: 1 boca + 30 štrcaljki + 1 adapter za štrcaljku + 1 kutija za nošenje
English: Oral solution bottle (glass)
Croatian: Boca (staklena)
English: 1 mg/ml
Croatian: EU/1/01/171/001 Rapamune 1 mg/ml
English: EU Number
Croatian: <EMEA broj> <EU broj>
English: Your doctor will be able to decide what is suitable for you.
Croatian: Liječnik će odlučiti što će za Vas biti odgovarajuće.
English: • if you are pregnant
Croatian: • ako ste trudni
English: These measures will help protect the environment.
Croatian: Ove će mjere pomoći u zaštititi okoliša.
English: • allergic reactions (see above)
Croatian: • alergijske reakcije (pogledajte gore)
English: • macrolide antibiotics,
Croatian: • makrolidni antibiotici,
English: • Take the tablets once a day preferably in the morning with or without food.
Croatian: • Uzmite tablete jednom dnevno po mogućnosti ujutro, sa ili bez hrane.
English: • rifampicin (against tuberculosis).
Croatian: • rifampicin (protiv tuberkuloze).
English: That can lead to difficulties in concentration and memory, or in keeping your balance.
Croatian: To može dovesti do poteškoća s koncentracijom i pamćenjem ili održavanjem ravnoteže.
English: • low blood pressure when standing up
Croatian: • niski krvni tlak pri ustajanju
English: • if your kidneys do not work (no urine production)
Croatian: • ako Vam bubrezi ne rade (nema stvaranja urina)
English: If you do not take your tablet on one day, take your normal dose on the next day.
Croatian: Ako niste uzeli tabletu jedan dan, uzmite svoju normalnu dozu sljedeći dan.
English: • Treatment with Samsca will be initiated in hospital.
Croatian: • Liječenje Samscom će se započeti u bolnici.
English: It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.
Croatian: Zato je važno da imate pristup vodi i da ste u mogućnosti piti dostatne količine kad osjetite žeđ.
English: • if you have a condition which is associated with a very low blood volume
Croatian: • ako imate stanje povezano s vrlo niskim volumenom krvi
English: • if you cannot drink enough water or if you are fluid restricted
Croatian: • ako ne možete piti dovoljno vode ili ako Vam je ograničen unos tekućine
English: If you take more Samsca than you should
Croatian: Ako uzmete više Samsce nego što ste trebali
English: Samsca is not suitable for children and adolescents (under age 18).
Croatian: Samsca nije prikladna za djecu i adolescente (ispod 18 godina).
English: If you forget to take your medicine you have to take the dose as soon as you remember on the same day.
Croatian: Ako zaboravite uzeti svoj lijek, uzmite dozu čim se sjetite tog istog dana.
English: What Samsca is and what it is used for
Croatian: Što je Samsca i za što se koristi
English: However, you may occasionally feel dizzy or weak or you may faint for a short period.
Croatian: Međutim, možete povremeno osjećati omaglicu ili slabost, ili se možete nakratko onesvijestiti.
English: This includes all medicines obtained without a prescription.
Croatian: To uključuje sve lijekove koje ste dobili bez recepta.
English: • if you do not realise when you are thirsty
Croatian: • ako ne primjećujete da ste žedni
English: If you notice any of the following side effects, you may need urgent medical attention.
Croatian: Ako primijetite neku od sljedećih nuspojava, možda će Vam trebati hitna medicinska pomoć.
English: Samsca with food and drink
Croatian: Samsca s hranom i pićem
English: Stop taking Samsca and immediately contact a doctor or go to the nearest hospital if you:
Croatian: Prestanite uzimati Samscu i odmah se javite liječniku ili otiđite u najbližu bolnicu ako:
English: Do not take this medicine if you are pregnant or breast-feeding.
Croatian: Nemojte uzimati ovaj lijek ako ste trudni ili dojite.
English: To monitor the effects of Samsca your doctor will do regular blood tests.
Croatian: Kako bi pratio učinke Samsce, liječnik će Vam redovito raditi pretrage krvi.
English: Tolvaptan was superior to placebo (p < 0.0001) for both periods in both studies.
Croatian: Tolvaptan je bio bolji od placeba (p < 0,0001) tijekom oba perioda u oba ispitivanja.
English: Most of the liver enzyme abnormalities were observed during the first 18 months of treatment.
Croatian: Većina nenormalnih vrijednosti jetrenih enzima zabilježena je tijekom prvih 18 mjeseci liječenja.
English: Tolvaptan is only a minor component in plasma (3 %).
Croatian: Tolvaptan je samo manja komponenta u plazmi (3 %).
English: The efficacy and safety in this population is not well established.
Croatian: Djelotvornost i sigurnost primjene kod ove populacije nije dobro utvrđena.
English: The efficacy and safety of tolvaptan in those with a creatinine clearance < 10 mL/min has not been evaluated and is therefore unknown.
Croatian: Djelotvornost i sigurnost tolvaptana kod osoba sa klirensom kreatinina < 10 ml/min nije procijenjena i stoga nije poznata.
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Croatian: Manje od 1 % početne djelatne tvari izlučuje se neizmijenjeno u urinu.
English: Avoid drinking grapefruit juice when taking Samsca.
Croatian: Izbjegavajte piti sok od grejpfruta dok uzimate Samscu.
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Croatian: Ne zaboravite uzeti kutiju lijeka kako bi bilo jasno što ste uzeli.
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014
Croatian: Datum posljednje obnove odobrenja: 19. lipnja 2014.
English: The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost tolvaptana u djece i adolescenata mlađih od 18 godina nije još ustanovljena.
English: There is no specific antidote for tolvaptan intoxication.
Croatian: Nema specifičnog antidota za intoksikaciju tolvaptanom.
English: Therefore, patients must have access to water and be able to drink sufficient amounts of water.
Croatian: Stoga bolesnici moraju imati pristup vodi i piti dovoljne količine vode.
English: Elevated transaminases2
Croatian: povišene transaminaze2
English: The absolute bioavailability of tolvaptan is about 56 %.
Croatian: Apsolutna bioraspoloživost tolvaptana je oko 56 %.
English: Administration preferably in the morning, without regard to meals.
Croatian: Preporučuje se uzimati ujutro, bez obzira na obroke.
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Croatian: Ako ste uzeli više tableta nego što je doza koju Vam je propisao liječnik, popijte puno vode i javite se odmah svom liječniku ili lokalnoj bolnici.
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).
Croatian: Učestalost nuspojava iz kliničkih ispitivanja izražena je kao vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Adequate contraceptive measures must be used during use of this medicine.
Croatian: Moraju se koristiti odgovarajuće mjere kontracepcije tijekom primjene ovog lijeka.
English: Consequently, the frequency of these adverse reactions is qualified as "not known".
Croatian: Posljedično tome, učestalost ovih nuspojava navodi se kao „nepoznato“.
English: • if you have a condition which increases the salt in your blood (“hypernatremia”)
Croatian: • ako imate stanje s povećanom razinom soli u krvi („hipernatremija“)
English: Therefore, you should only stop taking Samsca if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Croatian: Stoga, trebate prestati uzimati Samscu jedino ako primijetite nuspojave koje trebaju hitnu medicinsku pomoć (pogledajte dio 4) ili ako Vam to kaže liječnik.
English: • Volume depletion
Croatian: • Deplecija volumena
English: For such patients, alternative treatment has to be considered.
Croatian: Za takve bolesnike moraju se uzeti u obzir drugi načini liječenja.
English: • increased need to urinate, or to urinate more frequently
Croatian: • povećana potreba za mokrenjem, ili češće mokrenje
English: Talk to your doctor or pharmacist before taking Samsca:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Samscu:
English: • Patients who cannot perceive thirst
Croatian: • Bolesnici koji ne primjećuju da su žedni
English: A total of 111 patients started tolvaptan treatment in an open-label, extension trial, regardless of their previous randomisation.
Croatian: Ukupno 111 bolesnika počelo je liječenje tolvaptanom u otvorenom produžetku ispitivanja, bez obzira na njihovu prethodnu randomizaciju.
English: Contents of the pack and other information What Samsca contains
Croatian: Sadržaj pakiranja i druge informacije Što Samsca sadrži
English: To achieve the desired level of serum sodium your doctor can give in some instances a lower dose of 7.5 mg.
Croatian: Da bi se postigla željena razina natrija u serumu, liječnik Vam u nekim slučajevima može dati nižu dozu od 7,5 mg.
English: This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood.
Croatian: To dovodi do smanjivanja količine vode u tijelu povećanjem stvaranja urina, a posljedica toga je povećanje razine ili koncentracije natrija u krvi.
English: What Samsca is and what it is used for What you need to know before you take Samsca How to take Samsca
Croatian: Što je Samsca i za što se koristi Što morate znati prije nego počnete uzimati Samscu Kako uzimati Samscu
English: Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output.
Croatian: Vazopresin je hormon koji pomaže spriječiti gubitak vode iz tijela tako što smanjuje izlučivanje urina.
English: This condition should be excluded prior and during treatment with tolvaptan.
Croatian: To stanje bi trebalo isključiti prije i za vrijeme liječenja tolvaptanom.
English: In particular this applies to patients with inadequately controlled type II diabetes.
Croatian: To se posebno odnosi na bolesnike kod kojih dijabetes tipa II nije dobro kontroliran.
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces where unchanged tolvaptan accounted for 32 % of radioactivity.
Croatian: Pokusi s radioaktivno obilježenim tolvaptanom pokazali su da je 40 % radioaktivnosti pronađeno u urinu, a 59 % je pronađeno u fecesu gdje je neizmijenjeni tolvaptan predstavljao 32 % radioaktivnosti.
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.
Croatian: Pojedinačne doze do 480 mg i višestruke doze do 300 mg na dan tijekom 5 dana, bile su dobro tolerirane u kliničkim ispitivanjima na zdravim dobrovoljcima.
English: Tablets must be swallowed without chewing with a glass of water.
Croatian: Tablete se moraju progutati bez žvakanja, uz čašu vode.
English: These patients may be at higher risk for developing rapid correction of serum sodium during the first 1-2 days of treatment due to potential additive effects.
Croatian: Kod tih bolesnika može postojati veća opasnost od razvoja ubrzane korekcije serumskog natrija tijekom prvih 1-2 dana liječenja radi potencijalno aditivnih učinaka.
English: Improvements in serum sodium levels were observed as early as the first day after dosing and continued for on-treatment assessments up to Week 106.
Croatian: Poboljšanja u razinama serumskog natrija primijećena su već prvog dana nakon doziranja i nastavila su se tijekom procjena liječenja sve do 106. tjedna.
English: During the first 1-2 days and until the tolvaptan dose is stabilised serum sodium and volume status must be monitored at least every 6 hours.
Croatian: Tijekom prvih 1 do 2 dana i sve dok se doza tolvaptana ne stabilizira, serumski natrij i volumski status moraju se nadzirati barem svakih 6 sati.
English: What Samsca looks like and contents of the pack
Croatian: Kako Samsca izgleda i sadržaj pakiranja
English: These responses were seen in patients independent of the underlying disease.
Croatian: Ti odgovori su se vidjeli kod bolesnika bez obzira na postojeću bolest.
English: In order to minimise the risk of too rapid correction of hyponatremia the increase of serum sodium should be less than 10-12 mmol/L/24 hours and less than 18 mmol/L/48 hours.
Croatian: Kako bi se minimizirao rizik od prebrze korekcije hiponatremije, povećanje serumskog natrija bi trebalo biti manje od 10-12 mmol/l/24 sata i manje od 18 mmol/l/48 sati.
English: • if you have difficulties in urination or have an enlarged prostate
Croatian: • ako imate poteškoća s mokrenjem ili imate povećanu prostatu
English: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Croatian: Iako to povećanje nije klinički značajno, ono ukazuje na to da tolvaptan potencijalno može povećati izloženost supstratima CYP3A4.
English: Tolvaptan has to be initiated at a dose of 15 mg once daily.
Croatian: Liječenje tolvaptanom mora se započeti dozom od 15 mg jednom na dan.
English: The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients.
Croatian: Farmakodinamički predvidive i najčešće prijavljene nuspojave su žeđ, suha usta i polakizurija koji se pojavljuju u otprilike 18 %, 9 % odnosno 6 % bolesnika.
English: These findings may suggest that tolvaptan has the potential to cause irreversible and potentially fatal liver injury.
Croatian: Ovi rezultati mogu ukazivati na to da tolvaptan može prouzročiti ireverzibilno i potencijalno fatalno oštećenje jetre.
English: Results were highly variable with large overlap between dose groups; changes were not significantly correlated with tolvaptan exposure.
Croatian: Rezultati su bili vrlo različiti i uvelike su se preklapali između doznih skupina; promjene nisu značajno korelirale s izloženošću tolvaptanu.
English: Lactose and galactose intolerance
Croatian: Nepodnošenje laktoze i galaktoze
English: • For treatment of your low sodium (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium.
Croatian: • Za liječenje niskog natrija (hiponatremija), liječnik će početi s dozom od 15 mg i može je potom povisiti do najviše 60 mg kako bi se postigla željena razina natrija u serumu.
English: Patients taking tolvaptan should avoid ingesting grapefruit juice.
Croatian: Bolesnici koji uzimaju tolvaptan trebaju izbjegavati konzumiranje soka od grejpfruta.
English: • Swallow the tablet without chewing, with a glass of water.
Croatian: • Progutajte tabletu bez žvakanja, uz čašu vode.
English: The results of self-assessed health status using the SF-12 Health Survey for the mental scores showed statistically significant and clinically relevant improvements for tolvaptan treatment compared to placebo.
Croatian: Rezultati samoprocjene zdravstvenog stanja korištenjem SF12 Upitnika o zdravlju za procjenu mentalnog stanja pokazali su statistički znatna i klinički značajna poboljšanja za liječenje tolvaptanom u usporedbi s placebom.
English: Markedly higher doses of tolvaptan produce more sustained responses without affecting the magnitude of excretion, as active concentrations of tolvaptan are present for longer periods of time.
Croatian: Znatno više doze tolvaptana dovode do ravnomjernije reakcije bez da djeluju na povećanje izlučivanja, jer su aktivne koncentracije tolvaptana prisutne duži period vremena.
English: Individual maximal increases in serum sodium were negatively correlated with fluid balance; mean change in fluid balance showed a dose dependent decrease.
Croatian: Pojedinačna najveća povećanja natrija u serumu negativno su korelirala s ravnotežom tekućina; srednja vrijednost promjene ravnoteže tekućina pokazala je smanjenje ovisno o dozi.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: Women of childbearing potential have to use effective contraception during tolvaptan treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja tolvaptanom.
English: It may still be alright for you to take these medicines and Samsca together.
Croatian: Bez obzira na to, možda ćete moći zajedno uzimati te lijekove i Samscu.
English: The mean serum sodium concentration at trial entry was 129 mEq/L (range 114-136).
Croatian: Srednja vrijednost koncentracije serumskog natrija na početku ispitivanja bila je 129 mEq/l (raspon 114-136).
English: For all doses, urine excretion rates returned to baseline levels after 24 hours.
Croatian: Kod svih se doza brzina izlučivanja urina vratila na početne razine nakon 24 sata.