FrancophonIA/ELRC3.0 huggingface dataset:
English: The final concentration of Defitelio should be in the concentration range of 4 mg/mL - 20 mg/mL (see section 6.3).
Croatian: Konačna koncentracija lijeka Defitelio mora biti u koncentracijskom rasponu od 4 mg/ml do 20 mg/ml (vidjeti dio 6.3).
English: Defitelio pharmacokinetic parameters after intravenous infusion of 6.25 mg/kg to healthy subjects.
Croatian: Tablica 3: Farmakokinetički parametri lijeka Defitelio nakon intravenske infuzije doze od 6,25 mg/kg u zdravih ispitanika
English: The final concentration of Defitelio should be in the range of 4 mg/mL to 20 mg/mL.
Croatian: Konačna koncentracija lijeka Defitelio mora biti u rasponu od 4 mg/ml do 20 mg/ml.
English: The amount of defibrotide excreted in urine over 24 hrs was about 5% of the total dose administered in those with renal impairment versus about 12% in healthy subjects.
Croatian: Količina defibrotida koja se izlučila u urinu tijekom 24 sata iznosila je 5% ukupno primijenjene doze u ispitanika s oštećenjem funkcije bubrega naspram približno 12% u zdravih ispitanika.
English: In the paediatric prevention study at 25 mg/kg/day there was an increased incidence of any bleeding events in the defibrotide group compared with the treatment group.
Croatian: U ispitivanju prevencije u pedijatrijskoj populaciji uz dozu od 25 mg/kg na dan postojala je povećana incidencija bilo kojeg događaja krvarenja u skupini koja je primala defibrotid u usporedbi s terapijskom skupinom.
English: Defitelio 6.25 mg/kg was administered intravenously over 2 hours to subjects every 6 hours.
Croatian: Defitelio 6,25 mg/kg primijenjen je u ispitanika intravenski u trajanju od 2 sata svakih 6 sati.
English: Compared to healthy controls, subjects with renal impairment demonstrated 1.6- and 1.4-fold increases in AUC and Cmax, respectively and a half-life of about twice that of healthy subjects.
Croatian: U usporedbi sa zdravom kontrolnom skupinom, ispitanici s oštećenjem bubrežne funkcije imali su povećanu vrijednost AUC-a 1,6 puta i povećanu vrijednost Cmax 1,4 puta, a poluvijek je bio otprilike dvostruko veći u odnosu na zdrave ispitanike.
English: The solution for infusion should be mixed gently.
Croatian: Otopinu za infuziju treba lagano promiješati.
English: Repeated intravenous administration of defibrotide, at doses below and close to the human therapeutic dose, to juvenile rats resulted in a delay in the mean age of preputial separation, suggesting a delay in the onset of male puberty in rats.
Croatian: Ponovljena intravenska primjena defibrotida u mladih štakora u dozama nižim i blizu terapijske doze u ljudi, rezultirala je u odgođenoj prosječnoj dobi odvajanja prepucija, što upućuje na odgođeni početak puberteta u mužjaka štakora.
English: Difference in exposure is not considered clinically relevant and so dose adjustment is not advised for patients with renal impairment (see section 4.2).
Croatian: Razlika u izloženosti ne smatra se klinički značajnom pa se ne preporučuje prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: Defitelio has been used in clinical trials in patients with hepatic impairment without dose adjustment with no major safety issues identified (see section 4.2).
Croatian: Defitelio je primijenjen u kliničkim ispitivanjima u bolesnika s oštećenjem funkcije jetre bez prilagodbe doze, a da nisu opaženi veliki problemi vezani uz sigurnost (vidjeti dio 4.2).
English: No formal pharmacokinetic studies have been performed in patients with hepatic impairment; however, the medicinal product has been used in clinical trials of patients developing hepatic impairment without dose adjustment with no safety issues identified.
Croatian: Nisu provedena službena farmakokinetička ispitivanja u bolesnika s oštećenjem funkcije jetre, međutim, lijek je u kliničkim ispitivanjima primjenjivan u bolesnika koji su razvili oštećenje funkcije jetre bez prilagodbe doze, i nisu bili opaženi problemi vezani uz sigurnost.
English: The total volume of infusion should be determined based on the individual patient's weight.
Croatian: Ukupni volumen infuzije mora se odrediti na temelju tjelesne težine svakog pojedinog bolesnika.
English: Defitelio is not recommended in children less than 1 month of age.
Croatian: Primjena lijeka Defitelio ne preporučuje se u djece mlađe od jednog mjeseca.
English: The tabulated list of adverse reactions incorporates the ADRs observed in study 2005-01 [ADR = any event reported as possibly related on at least two occasions] and TEAEs observed in T-IND 2006-05 study [TEAE = any AE that started or worsened in severity after the first dose of defibrotide].
Croatian: Tablični popis nuspojava obuhvaća nuspojave koje su opažene u ispitivanju 2005-01 [nuspojava = svaki događaj ocijenjen kao moguće povezan s uzimanjem lijeka, zabilježen u najmanje dva navrata] i štetne događaje nastale tijekom liječenja opažene u ispitivanju liječenja novim lijekom, T-IND 200605 [štetni događaj nastao tijekom liječenja = svaki štetni događaj koji je nastao ili se pogoršao nakon prve doze defibrotida].
English: Defitelio is a medicine that contains the active substance defibrotide.
Croatian: Defitelio je lijek koji sadrži djelatnu tvar defibrotid.
English: The total volume of infusion should be determined based on the individual's patient weight.
Croatian: Ukupni volumen za infuziju mora se odrediti na temelju tjelesne težine svakog pojedinog bolesnika.
English: The safety and efficacy of defibrotide in children aged less than 1 month has not yet been established.
Croatian: Sigurnost i djelotvornost defibrotida u djece mlađe od 1 mjeseca nisu još ustanovljene.
English: Defibrotide has demonstrated antithrombotic and fibrinolytic effects in vitro and in vivo by: increasing systemic tissue factor pathway inhibitor (TFPI), tissue plasminogen activator (t-PA) and thrombomodulin (TM) expression; decreasing von Willebrand factor (vWF) and plasminogen activator inhibitor-1 (PAI-1) expression; and enhancing the enzymatic activity of plasmin to hydrolyse fibrin clots.
Croatian: Defibrotid je pokazao antitrombotski i fibrinolitički učinak in vitro i in vivo putem povećanja sistemske ekspresije inhibitora puta tkivnog faktora (engl. tissue factor pathway inhibitor, TFPI), tkivnog aktivatora plazminogena (t-PA) i trombomodulina (TM); smanjenja ekspresije von Willebrandovog faktora (vWF) i inhibitora aktivatora plazminogena 1 (PAI-1); te pojačanja enzimske aktivnosti plazmina za hidrolizu fibrinskih ugrušaka.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary
Croatian: Europska agencija za lijekove svake će godine procjenjivati sve nove informacije koje postanu dostupne te će se tekst sažetka opisa svojstava lijeka ažurirati prema potrebi.
English: • bleeding from the eye
Croatian: • krvarenje iz oka
English: In vitro and in vivo studies have demonstrated that defibrotide inhibits leukocyte and platelet adhesion to endothelium by: suppressing P-selectin and vascular cell adhesion molecule-1 (VCAM)-1; interfering with lymphocyte function-associated antigen 1-intercell adhesion molecule (LFA-1-ICAM) mediated leukocyte transmigration; and increasing nitric oxide (NO), Prostaglandin I2 (PGI2) and Prostaglandin E2 (PGE2).
Croatian: Ispitivanja in vitro i in vivo pokazala su da defibrotid inhibira adheziju leukocita i trombocita za endotel: supresijom P-selektina i vaskularne stanične adhezijske molekule 1 (engl. vascular cell adhesion molecule-1, VCAM-1), ometanjem transmigracije leukocita posredovane međustaničnom adhezijskom molekulom 1 leukocitnog funkcijskog antigena (engl. lymphocyte function-associated antigen 1-intercell adhesion molecule, LFA-1-ICAM) i povećanjem dušikovog oksida (NO), prostaglandina I2 (PGI2) i prostaglandina E2 (PGE2).
English: Do not use Defitelio after the expiry date which is stated on the carton and vial label after EXP.
Croatian: Defitelio se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti” odnosno „EXP”.
English: Volume of distribution is around 10 L. In vitro studies demonstrate that 93% of Defitelio is bound to plasma proteins.
Croatian: In vitro ispitivanja pokazala su da se 93% lijeka Defitelio veže za proteine plazme.
English: • bleeding in the lungs
Croatian: • krvarenje u plućima
English: Embryo-foetal developmental toxicology studies in pregnant rats and rabbits of defibrotide doses close to the recommended therapeutic human dose, revealed a high rate of haemorrhagic abortion (see section 5.3).
Croatian: Ispitivanja toksičnosti za embriofetalni razvoj u skotnih štakorica i kunića s dozama defibrotida sličnim preporučenoj terapijskoj dozi u čovjeka, otkrila su visoku stopu pobačaja s krvarenjem (vidjeti dio 5.3).
English: Pharmaswiss Hellas A.E.
Croatian: Ελλάδα, Κύπρος Pharmaswiss Hellas A.E.
English: The use of Defitelio rescue treatment for all patients who developed VOD meant that the study was not designed to assess any survival advantage and none was seen in this study.
Croatian: Primjena lijeka Defitelio za hitno ublažavanje simptoma za sve bolesnike u kojih se razvila veno-okluzivna bolest značilo je da ispitivanje nije bilo osmišljeno kako bi se procjenjivala bilo kakva prednost u preživljenju te nije opažena u ovom ispitivanju.
English: Defibrotide protects ECs from damage and promotes tissue homeostasis by decreasing fludarabine-mediated apoptosis of EC while maintaining its anti-leukemic effect and by inhibiting the expression of heparanase, shown in in vitro and in vivo studies respectively.
Croatian: Defibrotid štiti endotelne stanice od oštećenja i potiče tkivnu homeostazu smanjenjem fludarabinom posredovane apoptoze endotelnih stanica, pri čemu zadržava antileukemijsko djelovanje, i inhibicijom ekspresije heparanaze, kako su pokazala ispitivanja in vitro odnosno in vivo.
English: Blood and lymphatic system disorders Common
Croatian: Poremećaji krvi i limfnog sustava Često koagulopatija
English: If you experience any of these side effects, you should contact your doctor immediately.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je odmah obavijestiti liječnika.
English: • bleeding into the skin
Croatian: • krvarenje u kožu
English: Administration of defibrotide to patients who have haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support, is not recommended.
Croatian: Primjena defibrotida ne preporučuje se u bolesnika koji su hemodinamski nestabilni, a hemodinamska nestabilnost podrazumijeva nemogućnost održavanja prosječnog arterijskog tlaka pomoću jednog vazopresora.
English: Defitelio should be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion (see section 6.3 for concentration range and stability of the diluted solution) to a suitable concentration to permit 2 hours infusion time (see section 4.2).
Croatian: Defitelio se mora razrijediti 0,9%-tnom otopinom natrijeva klorida za infuziju (9 mg/ml) ili 5%-tnom otopinom glukoze za infuziju (vidjeti dio 6.3 za raspon koncentracija i stabilnost razrijeđene otopine) do odgovarajuće koncentracije kako bi se omogućilo vrijeme infuzije od 2 sata (vidjeti dio 4.2).
English: From a microbiological point of view, after dilution, the reconstituted medicinal product should be used immediately.
Croatian: Stabilnost lijeka u primjeni nakon prvog otvaranja i/ili razrjeđivanja S mikrobiološkog stajališta, nakon razrjeđivanja rekonstituirani lijek mora se upotrijebiti odmah.
English: Piazza XX Settembre 2 Villa Guardia 22079 Italy
Croatian: Piazza XX Settembre 2 Villa Guardia 22079 Italija
English: • bleeding from the mouth
Croatian: • krvarenje iz usta
English: There is currently no reported experience in patients on the concomitant treatment with Low Molecular Weight Heparins (LMWHs), warfarin or the concomitant treatment with direct thrombin inhibitors (e.g., dabigatran) or direct Factor Xa inhibitors (e.g., rivaroxaban and apixaban).
Croatian: Do sada nema zabilježenih iskustava s istodobnom primjenom niskomolekularnih heparina, varfarina, izravnih inhibitora trombina (npr. dabigatran) ili izravnih inhibitora faktora Xa (npr. rivaroksaban i apiksaban).
English: Dose adjustment is not required for patients with renal impairment or who are on intermittent haemodialysis (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega ili na intermitentnoj hemodijalizi (vidjeti dio 5.2).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Defitelio must be prescribed and administered to patients by specialised physicians experienced in the diagnosis and treatment of complications of HSCT.
Croatian: Defitelio mora propisivati i primjenjivati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju komplikacija povezanih s transplantacijom hematopoetskih matičnih stanica.
English: How to store Defitelio
Croatian: Kako čuvati Defitelio
English: The concentrate solution for infusion has to be diluted using aseptic technique.
Croatian: Koncentrat za otopinu za infuziju treba prije primjene razrijediti primjenom aseptičkog postupka.
English: Open Label Treatment IND (25mg/kg/day)
Croatian: Otvoreno ispitivanje liječenja novim lijekom (IND) (25 mg/kg na dan)
English: Non-defibrotide treated Defibrotide treated
Croatian: Skupina liječena defibrotidom
English: Driving and using machines It is not expected that Defitelio will affect your ability to drive and operate machines.
Croatian: Ne očekuje se da će Defitelio utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
Croatian: Defitelio je indiciran za liječenje teške veno-okluzivne bolesti jetre, poznate i pod nazivom sindrom opstrukcije jetrenih sinusoida koja se može razviti za vrijeme liječenja transplantacijom hematopoetskih matičnih stanica.
English: In a sub-study it was shown that haemodialysis did not remove defibrotide (see section 4.2)
Croatian: U podispitivanju se pokazalo da se defibrotid ne uklanja hemodijalizom (vidjeti dio 4.2).
English: Phone: +39 031 5373200 Fax: +39 031 5373241 info@gentium.it
Croatian: Telefon: +39 031 5373200 Faks: +39 031 5373241 info@gentium.it
English: It can be diluted with 5% glucose solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion, to a suitable concentration to permit infusion over 2 hours.
Croatian: Može se razrijediti 5%-tnom otopinom glukoze za infuziju ili 0,9%-tnom otopinom natrijeva klorida (9 mg/ml) za infuziju, do odgovarajuće koncentracije koja će omogućiti infuziju u trajanju od 2 sata.
English: Effective contraception is required for patients and partners of patients during exposure to Defitelio and for one week subsequent to discontinuation.
Croatian: Bolesnici i njihovi partneri moraju upotrebljavati učinkovitu kontracepciju za vrijeme izlaganja lijeku Defitelio te još jedan tjedan nakon prestanka primjene lijeka.
English: Each 2.5 mL vial contains 200 mg defibrotide.
Croatian: Jedna bočica od 2,5 ml sadrži 200 mg defibrotida.
English: For patients treated with Defitelio the following side effects were reported.
Croatian: U bolesnika liječenih lijekom Defitelio prijavljene nuspojave navedene su u nastavku.
English: Each 2.5 mL vial contains 200 mg defibrotide and each mL solution contains 80 mg defibrotide.
Croatian: Jedna bočica od 2,5 ml sadrži 200 mg defibrotida, a jedan ml otopine sadrži 80 mg defibrotida.
English: The safety data from the pivotal study are supported and confirmed with data from the completed Treatment-IND study.
Croatian: Podatke o sigurnosti iz pivotalnog ispitivanja podupiru i potvrđuju podaci iz dovršenog ispitivanja liječenja novim lijekom, T-IND.
English: The solution is clear light yellow to brown, free from particulate matter or turbidity.
Croatian: Otopina je bistra, svijetložute do smeđe boje, bez vidljivih čestica ili zamućenosti.
English: NAME OF THE MEDICINAL PRODUCT Defitelio 80 mg/mL concentrate for solution for infusion
Croatian: NAZIV LIJEKA Defitelio 80 mg/ml koncentrat za otopinu za infuziju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Defitelio 80 mg/mL sterile concentrate defibrotide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Defitelio 80 mg/ml sterilni koncentrat defibrotid i.v. primjena
English: No formal pharmacokinetic studies have been performed in hepatic impaired patients.
Croatian: Nisu provedena službena farmakokinetička ispitivanja u bolesnika s oštećenjem funkcije jetre.
English: After the infusion is complete, the intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Croatian: Poslije dovršene infuzije, intravenska linija mora se isplahnuti 0,9%-tnom otopinom natrijeva klorida za infuziju (9 mg/ml) ili 5%-tnom otopinom glukoze za infuziju.
English: Defitelio 80 mg/mL concentrate for solution for infusion defibrotide
Croatian: Defitelio 80 mg/ml koncentrat za otopinu za infuziju defibrotid
English: Prior to use the solution should be visually inspected for particulate matter.
Croatian: Prije primjene otopinu treba vizualno pregledati kako ne bi sadržavala vidljive čestice.
English: Pack size of 10 vials.
Croatian: Pakiranje sadrži 10 bočica.
English: However, patients would not be expected to drive or operate machinery due to the nature of the underlying disease.
Croatian: Međutim, zbog osnovne bolesti, ne očekuje se da će bolesnici upravljati vozilima ili rukovati strojevima.
English: Hypersensitivity Anaphylactic reaction
Croatian: Poremećaji imunološkog sustava Manje često preosjetljivost anafilaktična reakcija
English: Potential interactions with other medicinal products Defibrotide does not inhibit or induce CYP450s (see section 5.2).
Croatian: Defitelio ne inhibira niti ne inducira enzime CYP450 (vidjeti dio 5.2).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Cerebral haemorrhage
Croatian: Oštećenje bubrega
English: Skin and subcutaneous tissue disorders Common
Croatian: Poremećaji kože i potkožnog tkiva Često osip pruritus petehije
English: The combined volumes of Defitelio should be added to the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Croatian: Sjedinjene volumene lijeka Defitelio treba dodati 0,9%-tnoj otopini natrijeva klorida za infuziju (9 mg/ml) ili 5%-tnoj otopini glukoze za infuziju.
English: • Data analysis from CIBMTR for patients treated and not treated with defibrotide
Croatian: Center for international blood and marrow transplant research, CIBMTR) za bolesnike koji su liječeni defibrotidom, i za one koji to nisu.
English: Gastrointestinal haemorrhage Vomiting
Croatian: Poremećaji probavnog sustava Često gastrointestinalna hemoragija povraćanje proljev mučnina hematemeza hemoragija usne šupljine
English: What Defitelio looks like and contents of the pack Defitelio is a clear light yellow to brown concentrate for solution for infusion, free from particulate matter or turbidity.
Croatian: Defitelio je bistri svijetložuti do smeđi koncentrat za otopinu za infuziju, bez vidljivih čestica ili zamućenosti.
English: A volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion from the infusion bag should be withdrawn and discarded, equal to the total volume of Defitelio solution to be added.
Croatian: Iz infuzijske vrećice treba izvući i baciti volumen 0,9%-tne otopine natrijeva klorida za infuziju (9 mg/ml) ili 5%-tne otopine glukoze za infuziju koji odgovara ukupnom volumenu otopine lijeka Defitelio koji će biti dodan.
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Concomitant use of thrombolytic therapy (e.g. t-PA) (see section 4.5).
Croatian: − Istodobna primjena trombolitičke terapije (npr. t-PA) (vidjeti dio 4.5).
English: Eye disorders Uncommon
Croatian: Poremećaji oka Manje često hemoragija konjunktive
English: Defitelio contains sodium This medicine contains less than 23 mg of sodium, which means it is essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 23 mg natrija, tj. zanemarive količine natrija.
English: Before dilution, each vial should be inspected for particles.
Croatian: Prije razrjeđivanja svaku bočicu treba pregledati da ne sadrži vidljive čestice.
English: Nervous system disorders Common
Croatian: Poremećaji živčanog sustava Često cerebralna hemoragija
English: Defitelio PK Parameters Mean ± SD
Croatian: Farmakokinetički parametri lijeka Defitelio Srednja vrijednost ± SD
English: Hepatic impairment
Croatian: Liječeni defibrotidom
English: Respiratory, thoracic and mediastinal disorders Common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često plućna hemoragija epistaksa
English: Very Common (may affect more than 1 in 10 people )
Croatian: Vrlo često (mogu se javiti u više od 1 od 10 osoba) • niski krvni tlak
English: Alive at Day +100 VOD resolved by Day +100
Croatian: Veno-okluzivna bolest izliječena do dana +100
English: However, tell your doctor or healthcare professional if you think that a dose has been forgotten.
Croatian: Međutim, ako mislite da je jedna doza zaboravljena, obratite se liječniku ili zdravstvenom radniku.
English: Six patients with an estimated glomerular filtration rate <30 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease equation) and not currently on dialysis were compared to 6 healthy subjects with similar baseline demographics.
Croatian: Modification of Diet in Renal Disease) i koji trenutno nisu na dijalizi uspoređeno je sa 6 zdravih ispitanika sa sličnim demografskim obilježjima na početku ispitivanja.
English: Dose-Finding (25mg/kg/day arm)
Croatian: Ispitivanje s povjesnom kontrolnom skupinom (25 mg/kg na dan)
English: Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat dihidrat kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: Cerebral haematoma
Croatian: Oštećenje jetre
English: Melaena
Croatian: • mučnina
English: Conjunctival haemorrhage
Croatian: Prijavljivanje nuspojava
English: Coagulopathy
Croatian: • proljev
English: • nausea
Croatian: • modrice
English: • fever
Croatian: • vrućica.
English: Contents of the pack and other information What Defitelio contains
Croatian: Što Defitelio sadrži
English: Defitelio might be considered free of proarrhythmic toxicity related to QT changes.
Croatian: S obzirom na promjene QT intervala, može se smatrati da Defitelio nema proaritmijski učinak.
English: Catheter site haemorrhage Pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene Često hemoragija na mjestu uvođenja katetera pireksija
English: Vascular disorders Very common
Croatian: Manje često hemotoraks
English: It is available as capsules (1.5, 3, 4.5 and 6 mg).
Croatian: Dostupan je u obliku kapsula (1,5, 3, 4,5 i 6 mg).
English: EMEA/H/C/002036
Croatian: EMA/383424/2015 EMEA/H/C/002036
English: Rivastigmine Actavis should be given twice a day, with morning and evening meals.
Croatian: Rivastigmin Actavis treba primjenjivati dva puta dnevno, uz jutarnji i večernji obrok.
English: The full EPAR for Rivastigmine Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Rivastigmin Actavis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Rivastigmine Actavis EMA/463551/2015
Croatian: Rivastigmin Actavis EMA/383424/2015