natgillin/translations-raw huggingface dataset:
• The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132). 
Drugi sastojci su laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza, hidroksipropilceluloza, magnezijev stearat, indigo carmine aluminium lake (E 132)
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. 
Razina pri kojoj nisu opažene nuspojave (engl. no observed adverse effects level, NOAEL) na reproduktivnu funkciju ženki (100 mg/kg/dan) bila je otprilike 8 puta viša od ukupne dnevne doze od 60 mg/dan na temelju mg/m2.
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. 
U ispitivanju sigurnosti primjene tolvaptana kod hiponatremije zbog SIADH-a provedenom nakon stavljanja lijeka u promet, koje je uključivalo velik udio bolesnika s tumorima (osobito rakom pluća malih stanica), bolesnike s niskom početnom razinom natrija, kao i bolesnike koji su istodobno primali diuretike i/ili otopinu natrijevog klorida, pronašlo se da je incidencija prebrze korekcije hiponatremije bila viša nego u kliničkim ispitivanjima.
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. 
U zdravih odraslih ispitanika, peroralno davanje doza tolvaptana od 7,5 do 120 mg dovelo je do znatnog povećanja brzine izlučivanja urina u roku od 2 sata nakon doziranja.
Generalised rash 
generalizirani osip
• 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) 
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na benzazepin ili derivate benzazepina (vidjeti dio 4.4)
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). 
Istodobna primjena Samsce s drugim načinima liječenja hiponatremije ili drugim lijekovima koji povećavaju koncentraciju serumskog natrija može povećati opasnost od razvoja prebrze korekcije serumskog natrija (vidjeti dio 4.4) pa se stoga ne preporučuje za vrijeme početnog liječenja ili za druge bolesnike s vrlo niskim početnim koncentracijama serumskog natrija gdje prebrza korekcija može predstavljati opasnost od osmotske demijelinizacije (vidjeti dio 4.4).
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. 
U 2 pivotalna, dvostruko slijepa klinička ispitivanja kontrolirana placebom, ukupan broj od 424 bolesnika s euvolemičnom ili hipervolemijskom hiponatremijom (serumski natrij < 135 mEq/l) iz raznih razloga (zatajenje srca, ciroza jetre, SIADH i drugi) liječen je 30 dana sa tolvaptanom (n = 216)
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. 
U populacijskoj farmakokinetičkoj analizi kod bolesnika s edemom jetre, AUC tolvaptana kod bolesnika s teškim (Child-Pugh stadij C) te blagim ili umjerenim (Child-Pugh stadij A i B) oštećenjem jetre bio je 3,1 odnosno 2,3 puta veći nego kod zdravih ispitanika.
Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake (E 132) 
6.1 Popis pomoćnih tvari kukuruzni škrob hidroksipropilceluloza laktoza hidrat magnezijev stearat celuloza, mikrokristalična indigo carmine aluminium lake (E 132)
Samsca is contraindicated during pregnancy (see section 4.3). 
Samsca je kontraindicirana za vrijeme trudnoće (vidjeti dio 4.3).
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 
U populacijskoj farmakokinetičkoj analizi kod bolesnika sa zatajenjem srca, koncentracije tolvaptana kod bolesnika s blago (klirens kreatinina [Ccr] 50 do 80 ml/min) ili umjereno (Ccr 20 do 50 ml/min)
Urinary output must be secured. 
Nužno je osigurati izmokravanje izlučenog urina.
• raised levels of creatinine in the blood. 
• povišena razina jetrenih enzima u krvi • povišene razine kreatinina u krvi.
Co-administration with other treatments for hyponatremia and medicinal products that increase serum sodium concentration 
Istodobna primjena s drugim načinima liječenja hiponatremije i lijekovima koji povećavaju koncentraciju serumskog natrija
• Hypernatremia 
• Hipernatremija
No information is available in patients with severe hepatic impairment (Child-Pugh class C). 
Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetre (Child-Pugh stadij C).
It is unknown whether tolvaptan is excreted in human milk. 
Nije poznato izlučuje li se tolvaptan u majčino mlijeko.
Samsca causes water loss because it increases your urine production. 
Pijte dovoljno vode Samsca uzrokuje gubitak vode jer povećava stvaranje urina.
Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration. 
Lijekovi s visokim sadržajem natrija kao što su šumeći pripravci protiv boli i određeni oblici liječenja dispepsije koji sadrže natrij, također mogu povećati koncentraciju serumskog natrija.
In these patients dosing has to be managed cautiously and electrolytes and volume status must be monitored (see section 4.4). 
Kod tih se bolesnika doziranje mora pažljivo provoditi, te nadzirati elektrolite i volumski status (vidjeti dio 4.4).
• Pregnancy (see section 4.6) 
• Trudnoća (vidjeti dio 4.6) • Dojenje (vidjeti dio 4.6)
How to take Samsca 
Kako uzimati Samscu
Co-administration with vasopressin analogues 
Istovremeno davanje s vazopresinskim analozima
In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported (see section 4.8). 
Tijekom iskustva s primjenom tovaptana u liječenju ADPBB-a u razdoblju nakon stavljanja lijeka u promet zabilježeno je akutno zatajenje jetre koje je zahtijevalo transplantaciju jetre (vidjeti dio 4.8).
No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). 
Nije potrebno prilagođavati dozu kod bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A i B).
During titration, patients must be monitored for serum sodium and volume status (see section 4.4). 
Za vrijeme titracije, bolesnicima se mora nadzirati serumski natrij i volumski status (vidjeti dio 4.4).
Caution has to be exercised in co-administering CYP3A4 inducers (e.g. rifampicin, barbiturates) with tolvaptan. 
Treba biti oprezan kada se induktor CYP3A4 (npr: rifampicin, barbiturat) daje istovremeno s tolvaptanom.
How to store Samsca 
Kako čuvati Samscu
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). 
Teratogenost je primijećena kod kunića koji su primili 1000 mg/kg/dan (do 15 puta veća izloženost nego u ljudi pri primjeni doze od 60 mg, na temelju AUC).
Keep this medicine out of the sight and reach of children. 
Kako čuvati Samscu Lijek čuvajte izvan pogleda i dohvata djece.
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). 
U bolesnika u kojih postoji rizik od prebrze korekcije natrija, npr. u bolesnika s onkološkim bolestima, vrlo niskom početnom razinom natrija, onih koji uzimaju diuretike ili nadomjeske natrija, potrebno je razmotriti primjenu doze od 7,5 mg (vidjeti dio 4.4).
In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of tolvaptan. 
Anafilaksija (uključujući anafilaktički šok i generalizirani osip) je, prema iskustvima nakon stavljanja lijeka na tržište, vrlo rijetko zabilježena nakon primjene tolvaptana.
Constipation, Diarrhoea1, Dry mouth 
Poremećaji probavnog sustava mučnina konstipacija, proljev1, suha usta
Therefore, more precautionary limits apply during the early treatment phase. 
Stoga se kao mjera opreza tijekom rane faze liječenja primjenjuju veća ograničenja.
The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF. Tolvaptan treatment had no statistically significant favourable or unfavourable effects on overall survival or the combined endpoint of CV mortality or HF hospitalisation, and did not provide convincing evidence for clinically relevant benefit. 
Primarni cilj ispitivanja bilo je usporediti učinke tolvaptana + SNJ sa placebom +SNJ na vrijeme do smrtnosti od bilo kojeg uzroka i na vrijeme do prve pojave kardiovaskularne (KV) smrtnosti ili hospitalizacije zbog zatajenja srca.
Samsca contains lactose 
Samsca sadrži laktozu.
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). 
Kod kunića nije primijećen teratogeni učinak kod 300 mg/kg/dan (do 5 puta veća izloženost nego u ljudi pri primjeni doze od 60 mg, na temelju AUC).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTERI S JEDINIČNIM DOZAMA
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. 
(više od 3 × od gornje granice normalnih vrijednosti (GGN)) povišenja vrijednosti alanin aminotransferaze (ALT) u serumu, kao i klinički značajan porast (veći od 2 × od gornje granice normalnih vrijednosti) serumskog bilirubina.
Anaphylactic shock, 
Poremećaji imunološkog sustava anafilaktički šok,
• sense of taste altered • kidney problems 
• promijenjen osjet okusa
Tolvaptan has not been studied in patients with severe renal failure. 
Tolvaptan nije ispitivan kod bolesnika s teškim zatajenjem bubrega.
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. 
Iako se čini da istovremena upotreba tolvaptana s diureticima Henleove petlje i tiazidnim diureticima nema sinergistički ili aditivni učinak, svaka od ovih klasa lijekova može dovesti do teške dehidracije,
• general feeling of being unwell 
• općenito loše osjećanje
Each tablet contains 7.5 mg tolvaptan. 
Svaka tableta sadrži 7,5 mg tolvaptana.
• patchy bleeding in the skin 
• krvarenja u obliku mrlja po koži
Clinical efficacy and safety 
Klinička djelotvornost i sigurnost Hiponatremija
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). 
Ne preporučuje se istodobna primjena Samsce s drugim načinima liječenja hiponatremije i s lijekovima koji povećavaju koncentracije serumskog natrija za vrijeme početnog liječenja ili za druge bolesnike s vrlo niskim početnim koncentracijama serumskog natrija (vidjeti dio 4.5).
Block-7, City North Business Campus, Stamullen, Co.Meath, K32 YD60 Ireland 
Meath, K32 YD60
Samsca is contraindicated during breast-feeding (see section 4.3). 
Samsca je kontraindicirana za vrijeme dojenja (vidjeti dio 4.3).
Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely. 
Hitna potreba za akutnim podizanjem serumskog natrija Tolvaptan nije ispitivan u situacijama hitne potrebe akutnog podizanja serumskog natrija.
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). 
Kod dugotrajne primjene tolvaptana u dozama višim od onih za odobrenu indikaciju, u kliničkim ispitivanjima druge indikacije (autosomno dominantna policistična bolest bubrega, ADPBB) zapažena su oštećenja jetre uzrokovana tolvaptanom (vidjeti dio 4.8).
• tiredness, general weakness 
• umor, opća slabost
The elevations gradually improved after discontinuation of tolvaptan. 
Nakon prekida davanja tolvaptana povišene vrijednosti su se postupno smanjivale.
Samsca contains lactose as an excipient. 
Samsca sadrži laktozu kao pomoćnu tvar.
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. 
je bilo dvostruko slijepo, kontrolirano kliničko ispitivanje dugoročnih ishoda kod bolesnika hospitaliziranih radi pogoršanja zatajenja srca te znakova i simptoma volumnog preopterećenja.
Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets 
Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete
Clearance of tolvaptan is not significantly affected by age. 
Dob Životna dob ne utječe značajno na klirens tolvaptana.
Samsca 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan. 
Samsca 7,5 mg tablete Svaka tableta sadrži 7,5 mg tolvaptana.
Package leaflet: Information for the user Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan 
Uputa o lijeku: Informacije za korisnika Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete tolvaptan
Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters 
Samsca 15 mg i Samsca 30 mg tablete dostupne su kao 10 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama
Excipient with known effect 70 mg lactose (as monohydrate) per tablet 
70 mg laktoze (u obliku hidrata) po tableti
In healthy subjects, tolvaptan, a CYP3A4 substrate, had no effect on the plasma concentrations of some other CYP3A4 substrates (e.g. warfarin or amiodarone). 
Kod zdravih ispitanika, tolvaptan, supstrat CYP3A4 ne djeluje na koncentraciju nekih drugih supstrata
• barbiturates (used to treat epilepsy/seizures and some sleep disorders), 
Sljedeći lijekovi mogu smanjiti učinak ovog lijeka: • barbiturati (primjenjuju se za liječenje epilepsije/napadaja i nekih poremećaja spavanja),
Samsca is not recommended in the paediatric age group. 
Samsca se ne preporučuje za primjenu kod djece.
10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters 
10 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama 30 × 1 tableta u PVC/Al perforirani blister s jediničnim dozama
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) 
Samsca 7,5 mg tablete EU/1/09/539/005 (10 tablete) EU/1/09/539/006 (30 tablete) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
Samsca 7.5 mg tablets tolvaptan 
Samsca 7,5 mg tablete tolvaptan
Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. 
Samsca 30 mg: plave, okrugle, blago konveksne tablete dimenzija Ø8 × 3,0 mm, s utisnutim „OTSUKA“ i „30“ s jedne strane.
• other products which increase the salt in your blood or which contain large amounts of salt. 
• diltiazem (za liječenje visokog krvnog tlaka i bola u prsnom košu), • drugi lijekovi koji povećavaju količinu soli u krvi ili koji sadrže velike količine soli.
Samsca 15 mg and Samsca 30 mg tablets 
Samsca 15 mg i Samsca 30 mg tablete
• Anuria 
• Anurija
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. 
Farmakodinamika tolvaptana nakon jednokratnih doza od 3,75, 7,5 i 15 mg procijenjena je u randomiziranom (1:1:1), dvostruko slijepom, pilot-ispitivanju u 30 bolesnika s hiponatremijom zbog
Otsuka Pharmaceutical Italy S.r.l. 
Otsuka Pharmaceutical Netherlands B.V.
• find it difficult to urinate 
• imate poteškoće s mokrenjem
Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. 
Plave, okrugle, blago konveksne tablete dimenzija Ø8 × 3,0 mm, s utisnutim oznakama „OTSUKA“ i „30“ na jednoj strani.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS AND PERFORATED UNIT DOSE BLISTERS 
BLISTERI I PERFORIRANI BLISTERI S JEDINIČNIM DOZAMA
Samsca 7.5 mg tablets 
Samsca 7,5 mg tablete
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). 
U ispitivanju sigurnosti primjene tolvaptana kod hiponatremije zbog SIADH-a provedenom nakon stavljanja lijeka u promet opaženo je nekoliko slučajeva poremećaja jetre i povišenih transaminaza
Samsca 7.5 mg tablets 5 years 
Samsca 7,5 mg tablete 5 godina
Samsca 15 mg tablets tolvaptan 
Samsca 15 mg tablete tolvaptan
Syncope1, Headache1, Dizziness1 
Poremećaji živčanog sustava sinkopa1, glavobolja1, omaglica1
Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP. 
receptor je 1,8 puta veći nego afinitet prirodnog AVP-a.
Samsca 30 mg tablets tolvaptan 
Samsca 30 mg tablete tolvaptan
Samsca 30 mg tablets 
Samsca 30 mg tablete
Asthenia, Pyrexia, Malaise1 
Opći poremećaji i reakcije na mjestu primjene žeđ astenija, pireksija, malaksalost1
Each Samsca 30 mg tablet contains 30 mg tolvaptan. 
Jedna tableta Samsce od 30 mg sadrži 30 mg tolvaptana.
Samsca 15 mg tablets and Samsca 30 mg tablets 4 years 
Samsca 15 mg tablete i Samsca 30 mg tablete 4 godine
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. 
Samsca 15 mg: plave, trokutaste, blago konveksne tablete dimenzija 6,58 × 6,2 × 2,7 mm, s utisnutim „OTSUKA“ i „15“ s jedne strane.
Samsca 15 mg tablets 
Samsca 15 mg tablete
Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side. 
Plave, trokutaste, blago konveksne tablete dimenzija 6,58 × 6,2 × 2,7 mm, s utisnutim oznakama „OTSUKA“ i „15“ na jednoj strani.
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. 
Samsca 7,5 mg: plave, pravokutne, blago konveksne tablete dimenzija 7,7 × 4,35 × 2,5 mm, s utisnutim „OTSUKA“ i „7.5“ s jedne strane.
Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side. 
Plave, pravokutne, blago konveksne tablete dimenzija 7,7 × 4,35 × 2,5 mm, s utisnutim oznakama „OTSUKA“ i „7.5“ na jednoj strani.
Each Samsca 15 mg tablet contains 15 mg tolvaptan. 
Jedna tableta Samsce od 15 mg sadrži 15 mg tolvaptana.
EU/1/09/539/001 (10 × 1 tablet) EU/1/09/539/002 (30 × 1 tablet) 
EU/1/09/539/001 (10 × 1 tableta) EU/1/09/539/002 (30 × 1 tableta)
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva ekhimoza, pruritus osip sa svrbežom1
Hyponatremia 
Anafilaksija
EU/1/09/539/003 (10 × 1 tablet) EU/1/09/539/004 (30 × 1 tablet) 
EU/1/09/539/003 (10 × 1 tableta) EU/1/09/539/004 (30 × 1 tableta)
Orthostatic hypotension 
Krvožilni poremećaji ortostatska hipotenzija
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) 
EU/1/09/539/005 (10 tablete) EU/1/09/539/006 (30 tablete) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
• ketoconazole (against fungal infections), 
Sljedeći lijekovi mogu pojačati učinak ovog lijeka: • ketokonazol (protiv gljivičnih infekcija),
Samsca 30 mg tablets Each tablet contains 30 mg tolvaptan. 
35 mg laktoze (u obliku hidrata) po tableti Samsca 30 mg tablete Svaka tableta sadrži 30 mg tolvaptana.
Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters 
Samsca 7,5 mg tablete 10 tablete u PP/Al blister 30 tablete u PP/Al blister
The dose could be increased to 30 and 60 mg/day depending on response using a 3 day titration scheme. 
Dozu se moglo povećati na 30 do 60 mg/dan,
• thirst 
• svrbež
Maize starch 
EVEREST (engl.
• feeling sick 
• žeđ • mučnina
Distribution, biotransformation and elimination: 
Distribucija, biotransformacija i eliminacija:
The potential risk to humans is unknown. 
Nije poznat potencijalan rizik za ljude.
Under these circumstances vision loss may be rapid and severe. 
U takvim okolnostima gubitak vida može biti brz i težak.
Please read section 2. 
Molimo pročitajte dio 2.
Your doctor may monitor this after each injection. 
Vaš će liječnik to možda kontrolirati nakon svake injekcije.
The following information is intended for healthcare professionals only: 
Sljedeće informacije namijenjene su isključivo zdravstvenim djelatnicima:
It tells you what to do if you have any of these symptoms. 
U njemu piše što morate učiniti ako se pojavi neki od navedenih simptoma.
Please do not forget to tell your doctor if you are known to be allergic to any substance. 
Nemojte zaboraviti reći liječniku ako znate da ste alergični na bilo koju tvar.
Other possible side effects are as follows: 
Druge moguće nuspojave su sljedeće:
It is important to identify and treat these types of conditions as soon as possible. 
Važno je što prije prepoznati i liječiti navedena stanja.
Your doctor will also give you some local anaesthetic (numbing medicine). 
Također, Vaš doktor će vam dati malo lokalnog anestetika (lijek koji izaziva utrnulost).
This will reduce or prevent any pain you might have with the injection. 
To će smanjiti ili spriječiti bilo kakvu bol koja bi se mogla javiti injekcijom.
Soon after the injection serious allergic reactions may occur. 
Ubrzo nakon injekcije mogu se pojaviti ozbiljne alergijske reakcije.
At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102. 
Na kraju prve godine (54. tjedan) 1053 bolesnika ponovno je randomizirano da nastave ili prekinu liječenje do 102. tjedna.
Read all of this leaflet carefully before you start your treatment with this medicine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego počnete liječenje ovim lijekom jer sadrži Vama važne podatke.
However, there was no consistent pattern among the different haemorrhages. 
Međutim, nije postojao dosljedan obrazac među različitim hemoragijama.
You must not be given Macugen: 
Ne smije Vam se dati Macugen: