FrancophonIA/ELRC3.0 huggingface dataset:
English: Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not beyond the expiry date.
Croatian: Cablivi se može čuvati na temperaturi do najviše 25 °C jednokratno do 2 mjeseca, ali ne dulje od roka valjanosti.
English: Pre-filled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of water for injections.
Croatian: Napunjena štrcaljka (stakleni uložak, staklo tip I, zatvoren bromobutilnim gumenim čep) s 1 ml vode za injekcije.
English: • With the syringe still connected to the vial adapter, gently swirl the vial with connected syringe until the powder is dissolved.
Croatian: • Sa štrcaljkom i dalje priključenom na nastavak bočice, lagano vrtite bočicu s pričvršćenom štrcaljkom sve dok se prašak ne otopi.
English: If at the end of this treatment period there was evidence of persistent underlying disease activity (indicative of an imminent risk for recurrence), treatment could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Croatian: Ako je nakon završetka ovog razdoblja liječenja još uvijek postojao dokaz aktivnosti osnovne bolesti (što je pokazatelj neposrednog rizika za ponavljanje bolesti), liječenje se moglo produžiti u tjednim razdobljima do najviše 4 tjedna uz prilagodbu imunosupresije.
English: N Mean (SE)
Croatian: N srednja vrijednost (SE)
English: The first injection of Cablivi into your vein must be given by a healthcare professional.
Croatian: Prvu injekciju lijeka Cablivi u venu mora primijeniti zdravstveni radnik.
English: If more than 12 hours have passed since the dose should have been given, do not take the missed dose, but inject the next dose at the usual time.
Croatian: Ako je prošlo više do 12 sati od predviđenog vremena primjene, nemojte primijeniti dozu već je primijenite u iduće predviđeno vrijeme.
English: Cablivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj.zanemarive količine natrija.
English: First dose Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Croatian: Prva doza Intravenska injekcija od 10 mg kaplacizumaba prije izmjene plazme.
English: Because von Willebrand factor acts as a carrier for factor VIII, reduced von Willebrand factor antigen levels resulted in a similar reduction in factor VIII:C levels.
Croatian: Budući da von Willebrandov faktor djeluje kao nosač za faktor VIII, smanjenje razine antigena von Willebrandovog faktora rezultiralo je sličnim smanjenjem razine faktora VIII:C.
English: Step 3 - Disinfect the rubber stopper
Croatian: Korak 3 - Dezinficiranje gumenog čepa
English: As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
Croatian: Na taj način, kaplacizumab sprječava masivnu adheziju trombocita posredovanu von Willebrandovim faktorom koja je karakteristična za aTTP.
English: If at the end of this treatment period there were was evidence of ongoing underlying disease, open-label treatment with caplacizumab could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Croatian: Ako je nakon završetka ovog razdoblja liječenja postojao dokaz o aktivnosti osnovne bolesti, liječenje kaplacizumabom moglo se produžavati u tjednim razdobljima do najviše 4 tjedna uz optimalnu prilagodbu imunosupresije.
English: • are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots).
Croatian: • uzimate antitrombocitne lijekove kao što je acetilsalicilatna kiselina, ili niskomolekularni heparin (što sprječava stvaranje ugrušaka).
English: For both intravenous and subcutaneuous administration,reconstitute the powder contained in the vial using the vial adapter and all solvent in the pre-filled syringe.
Croatian: Za intravensku i supkutanu primjenu rekonstituirajte prašak sadržan u bočici pomoću nastavka koristeći cjelokupan sadržaj otapala iz napunjene štrcaljke.
English: Step 6 - Connect syringe with adapter and vial
Croatian: Korak 6 - Spajanje štrcaljke na nastavak i bočicu
English: This was followed by daily subcutaneous injections of 10 mg caplacizumab or placebo after completion of each plasma exchange for the duration of the daily plasma exchange period and for 30 days thereafter.
Croatian: Nakon toga su svakodnevno primali supkutanu injekciju 10 mg kaplacizumaba ili placeba nakon dovršetka svake izmjene plazme tijekom razdoblja liječenja dnevnom izmjenom plazme te 30 dana nakon toga.
English: Haematoma*
Croatian: Hematom*
English: Injection site haemorrhage*, injection site pruritus, injection site erythema, injection site reaction
Croatian: Krvarenje na mjestu injekcije*, svrbež na mjestu injekcije, eritem na mjestu injekcije, reakcija na mjestu injekcije
English: Cablivi contains the active substance caplacizumab.
Croatian: Cablivi sadrži djelatnu tvar kaplacizumab.
English: Subarachnoid haemorrhage*
Croatian: Subarahnoidno krvarenje*
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Croatian: Nuspojave su navedene u nastavku prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: Marketing Authorisation Holder and Manufacturer Ablynx NV
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Ablynx NV
English: Dyspnoea, Haemoptysis*
Croatian: Dispneja, hemoptizija*
English: How to use Cablivi
Croatian: Kako čuvati Cablivi
English: The reduced von Willebrand factor antigen and FVIII:C levels were transient and returned to baseline upon cessation of treatment.
Croatian: Smanjenje razina antigena von Willebrandovog faktora i faktora VIII:C bilo je prolazno i vratilo su se na početnu vrijednost nakon prestanka liječenja.
English: • black, tarry stools
Croatian: • crna stolica poput katrana
English: • blood in the stools
Croatian: • krv u stolici
English: It also affects the disposition of von Willebrand factor, leading to transient reductions of total von Willebrand factor antigen levels and to concomitant reduction of factor VIII:C levels during treatment.
Croatian: Također utječe na raspoloživost von Willebrandovog faktora i dovodi do prolaznog smanjenja ukupnih razina antigena von Willebrandovog faktora te istodobnog smanjenja razina faktora VIII:C tijekom liječenja.
English: Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3).
Croatian: Ispitivanja na zamorcima nisu pokazala utjecaj kaplacizumaba na ženke i fetuse (vidjeti dio 5.3).
English: • bleeding from eye
Croatian: • krvarenje iz oka
English: A follow-up toxicokinetic study in pregnant guinea pigs assessed exposure of caplacizumab in the dams and foetuses.
Croatian: Toksokinetička ispitivanja praćenja kod skotnih zamoraca procijenjivala su izloženost kaplacizumabu ženki i fetusa.
English: Step 9 - Prepare the syringe for administration
Croatian: Korak 9 - Pripremanje štrcaljke za primjenu
English: In the setting of concomitant use of anti-platelet agents and / or low molecular weight heparin (LMWH)
Croatian: Low Molecular Weight Heparin, LMWH)
English: LIST OF EXCIPIENTS Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: saharoza, bezvodna citratna kiselina, trinatrij citrat dihidrat, polisorbat 80.
English: Step 5 - Prepare the syringe
Croatian: Korak 5 - Priprema štrcaljke
English: • Make sure the kit package is complete.
Croatian: • Uvjerite seda je paket sa setom cjelovit.
English: No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
Croatian: Farmakokinetika kaplacizumaba pokazala se kao neproporcionalna dozi i ovisila je o raspoloživosti ciljnog proteina.
English: Step 12 - Administration
Croatian: Korak 12 - Primjena
English: Place the syringe on the clean flat surface.
Croatian: Postavite štrcaljku na čistu ravnu površinu.
English: • Slowly press the syringe's plunger fully down.
Croatian: • Lagano pritisnite klip štrcaljke u potpunosti prema dolje.
English: What Cablivi contains
Croatian: Cablivi sadrži natrij
English: 1 vial with powder 1 syringe with solvent 1 sterile vial adapter 1 sterile needle 2 alcohol swabs
Croatian: 1 bočica s praškom 1 štrcaljka s otapalom 1 sterilni nastavak za bočicu 1 sterilna igla
English: • bleeding from the stomach
Croatian: • krvarenje u trbuhu
English: • Place all components of the kit on the clean flat surface.
Croatian: • Postavite sve dijelove seta na čistu ravnu podlogu.
English: In the setting of concomitant use of oral anticoagulants or high dose heparin Due to a potential increased risk of bleeding, initiation or continuation of treatment with oral anticoagulants or high dose heparin requires a benefit/risk assessment and close clinical monitoring.
Croatian: Zbog potencijalno povećanog rizika od krvarenja, početak ili nastavak liječenja oralnim antikoagulansima ili visokim dozama heparina zahtijeva procjenu omjera koristi i rizika i strogo kliničko praćenje.
English: Disconnect the filled syringe from the adapter by holding the adapter in one hand and gently turning the syringe counter-clockwise.
Croatian: Odvojite napunjenu štrcaljku s nastavka tako što ćete držati bočicu s nastavkom jednom rukom, a drugom lagano okretati štrcaljku u smjeru obrnutom od kazaljke na satu.
English: Each vial of powder contains 10 mg of caplacizumab*.
Croatian: Jedna bočica praška sadrži 10 mg kaplacizumaba*.
English: • Do not touch the syringe tip or allow it to touch the surface.
Croatian: • Nemojte dodirivati vrh štrcaljke niti dodirivati s njim druge površine.
English: • to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. accident) to inform physicians about the medical blockage of the von Willebrand Factor.
Croatian: • Kako bi smanjili rizik od ozbiljnog krvarenja posebice u hitnim situacijama (npr. nesreća)
English: Step 13 - After administration
Croatian: Korak 13 - Nakon injektiranja
English: Full inhibition of von Willebrand factor-mediated platelet aggregation by caplacizumab is indicated by RIPA and RICO levels dropping below 10% and 20%, respectively.
Croatian: Na kaplacizumabom uzrokovanu potpunu inhibiciju nakupljanja trombocita posredovanog von Willebrandovim faktorom ukazivao je pad razine RIPA ispod 10 % i RICO-a ispod 20 %.
English: NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection
Croatian: NAZIV LIJEKA Cablivi 10 mg prašak i otapalo za otopinu za injekciju
English: • single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
Croatian: • pojedinačnim pakiranjima od kojih svaki sadrži 1 bočicu s kaplacizumabom u obliku praška, 1 napunjenu štrcaljku s otapalom, 1 nastavak za bočicu, 1 iglu i 2 jastučića natopljena alkoholom
English: Step 10 - Attach the needle
Croatian: Korak 10 - Postavljanje igle
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: 7 vials with powder 7 syringes with solvent 7 sterile vial adapters 7 sterile needles 14 alcohol swabs
Croatian: 7 bočica s praškom 7 štrcaljki s otapalom 7 sterilnih nastavaka za bočicu 7 sterilnih igala
English: Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Croatian: Cablivi 10 mg prašak i otapalo za otopinu za injekciju kaplacizumab
English: It is unknown whether caplacizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se kaplacizumab u majčino mlijeko.
English: • Pull out the needle at the same angle you inserted it. Do not rub the injection site.
Croatian: • Izvadite iglu pod istim kutom pod kojim ste je uveli.
English: Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Croatian: Nadalje, farmakološki vezano smanjenje antigena von Willebrandovog faktora i posljedično faktora VIII:C, uočeno je kod makaki majmuna i u manjoj mjeri za faktor VIII:C kod zamoraca.
English: Gingival bleeding* Haematemesis*, haematochezia*, melaena*, upper gastrointestinal haemorrhage*, haemorrhoidal haemorrhage*, rectal haemorrhage *, abdominal wall haematoma*
Croatian: Poremećaji probavnog sustava Krvarenje iz desni* Hematemeza*, hematohezija i melena*, krvarenje u gornjem dijelu probavnog sustava*, krvarenje hemeroida*, krvarenje iz rektuma*, hematom abdominalne stijenke*
English: • multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.
Croatian: • višedoznim pakiranjima od kojih svaki sadrži 7 bočica s kaplacizumabom u obliku praška, 7 napunjenih štrcaljki s otapalom, 7 nastavaka za bočicu, 7 igala i 14 jastučića natopljenih alkoholom.
English: Your doctor may decide that you or your caregiver may inject Cablivi.
Croatian: Vaš liječnik može odlučiti da si sami primijenjujete injekcije lijeka Cablivi ili da Vam ih primjenjuje da Vaš njegovatelj.
English: Each pre-filled syringe of solvent contains 1 mL of water for injections.
Croatian: Jedna napunjena štrcaljka otapala sadrži 1 ml vode za injekcije.
English: • Without removing the needle cap, attach the needle to the syringe by turning clockwise until resistance is felt.
Croatian: • Bez skidanja kapice s igle, postavite iglu na štrcaljku u tako što će te ju zaviti u smjeru kazaljke na satu do kraja.
English: Step 8 - Draw up solution
Croatian: Korak 8 - Izvlačenje otopine
English: • Place the syringe on the clean flat surface.
Croatian: • Postavite štrcaljku na čistu ravnu površinu.
English: The t1/2 of caplacizumab is, therefore, concentrationand target level-dependent.
Croatian: Poluvijek kaplacizumaba je stoga ovisan o koncentraciji i razini ciljanog proteina.
English: Each vial contains 10 mg caplacizumab.
Croatian: Jedna bočica sadrži 10 mg kaplacizumaba.
English: Do not touch the adapter itself.
Croatian: Sam nastavak nemojte dodirivati.
English: • bruise
Croatian: • modrice
English: Place the tip of the syringe on the connector part of the vial adapter.
Croatian: Postavite vrh štrcaljke na priključak nastavka bočice.
English: hypodermic needle (30 gauge) and 2 alcohol swabs.
Croatian: nastavak za bočicu, 1 iglu, hipodermalnu (30 G) i 2 jastučića natopljena alkoholom.
English: The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate and polysorbate 80.
Croatian: - Drugi sastojci su saharoza, bezvodna citratna kiselina, natrij citrat i polisorbat 80.
English: • Keep the vial standing vertically on the surface with the syringe pointing downwards.
Croatian: • Držite bočicu u okomitom položaju na podlozi sa štrcaljkom usmjerenom prema dolje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON Multipack (without Blue Box) NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA Višestruko pakiranje (bez plavog okvira) NAZIV LIJEKA Cablivi 10 mg prašak i otapalo za otopinu za injekciju kaplacizumab
English: An overdose is unlikely since one vial contains only a single dose.
Croatian: Ako primijenite više lijeka Cablivi nego što ste trebali Predoziranje nije vjerojatno budući da bočica sadrži samo jednu dozu.
English: • Check the solution for particles.
Croatian: • Provjerite otopinu kako biste isključili prisutnost čestica.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON Multipack (contains Blue Box) NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA Višestruko pakiranje (sadrži plavi okvir) NAZIV LIJEKA Cablivi 10 mg prašak i otapalo za otopinu za injekciju kaplacizumab
English: Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
Croatian: Nakon prestanka liječenja dnevnom izmjenom plazme nastavlja se liječenje primjenom supkutane injekcije od 10 mg kaplacizumaba na dan tijekom 30 dana.
English: • Single pack containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1
Croatian: • Pojedinačno pakiranje sadrži 1 staklenu bočicu s praškom, 1 napunjenu štrcaljku s otapalom, 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1305/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/1/18/1305/001
English: • Press the plunger down as far as it goes.
Croatian: • Pritisnite klip do kraja.
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica s praškom sadrži 10 mg kaplacizumaba.
English: Number of days in ICU
Croatian: Broj dana na odjelu za intenzivnu njegu
English: Tell your doctor if you are breastfeeding.
Croatian: Obavijestite svog liječnika ako dojite.
English: There are no data on the use of caplacizumab in breastfeeding women.
Croatian: Nema podataka o primjeni kaplacizumaba kod dojilja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA NAZIV LIJEKA Cablivi 10 mg prašak i otapalo za otopinu za injekciju kaplacizumab
English: Leave the adapter attached to the vial, still in its outer packaging.
Croatian: Nastavak postavljen na bočicu ostavite i dalje u njegovom plastičnom pakiranju.
English: METHOD AND ROUTE OF ADMINISTRATION For single use only
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za jednokratnu primjenu.
English: • Hold the adapter with the attached vial with one hand.
Croatian: • Držite u jednoj ruci nastavak s postavljenom bočicom.
English: • excessive bleeding during periods
Croatian: • pretjerano menstrualno krvarenje
English: MARKETING AUTHORISATION NUMBERS EU/1/18/1305/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1305/002
English: Step 7 - Prepare the solution
Croatian: Korak 7 - Priprema otopine
English: • Place the adapter over the vial, while keeping the adapter in its plastic packaging.
Croatian: • Postavite nastavak na bočicu ne vadeći ga iz plastičnog pakiranja.
English: If you experience any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Target-bound caplacizumab is assumed to be catabolised within the liver, whereas unbound caplacizumab is assumed to be renally cleared.
Croatian: Pretpostavlja se da se kaplacizumab vezan s ciljnim proteinom katabolizira u jetri, a nevezani kaplacizumab eliminira putem bubrega.
English: • Turn the whole - vial, adapter and syringe - upside down.
Croatian: • Okrenite cijelu bočicu, nastavak i štrcaljku naopako.
English: • Gently lock the syringe onto the vial by turning it clockwise until resistance is felt.
Croatian: • Lagano pričvrstite štrcaljku na nastavak tako što ćete je zaokrenuti u smjeru kazaljke na satu do kraja.
English: • bleeding gums
Croatian: • iskašljavanje krvi
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous and subcutaneous use For single use only
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: • Put the vial and the attached adapter into the supplied disposal container.
Croatian: • Odložite bočicu s pričvršćenim nastavkom u spremnik za odlaganje.
English: • Take the vial with the attached adapter.
Croatian: • Uzmite bočicu s postavljenim nastavkom.
English: • Press down firmly until the adapter snaps into place, with the adapter spike going through the vial stopper.
Croatian: Čvrsto pritisnite kako bi nastavak kliknuo na svoje mjesto, a šiljasti vrh nastavka probio čep.
English: • stroke
Croatian: • umor
English: Reconstituted solution
Croatian: Rekonstituirana otopina
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT SYRINGE LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cablivi
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Cablivi
English: Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Croatian: Neuraceq je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 216 dobrovoljaca podijeljenih u dvije grupe: grupu zdravih mladih ljudi i grupu bolesnika koji su se bližili završetku svojih života, koji su dali svoju suglasnost za autopsije nakon što umru; 41 dobrovoljac (10 zdravih mladih ljudi i 31 bolesnik) završilo je ispitivanje i bili su uključeni u rezultate.
English: Other information about Neuraceq
Croatian: Ostale informacije o lijeku Neuraceq
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 77.4% and a specificity of 94.2%.
Croatian: Nakon što su rezultati autopsija uspoređeni s PET skenovima, skenovi su pokazali osjetljivost od 77,4% i specifičnost od 94,2%.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neuraceq on 20 February 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Neuraceq vrijedi na prostoru Europske unije od 20. veljače 2014.
English: There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Croatian: No, postoji rizik od pogrešnih pozitivnih rezultata i stoga se Neuraceq ne smije koristiti kao jedina dijagnostička metoda demencije, već zajedno s kliničkom evaluacijom.
English: The full EPAR and risk management plan summary for Neuraceq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 04-2016.
Croatian: Sažetak je posljednji put ažuriran 02.2014.
English: These data were further supported by the results from additional patients analysed after completion of the study.
Croatian: Ovi su podaci dalje potkrijepljeni rezultatima iz dodatnih analiza bolesnika nakon završetka ispitivanja.
English: Doctors will therefore need to use the scans together with clinical evaluation.
Croatian: Liječnici stoga neće koristiti druge skenove zajedno s kliničkom evaluacijom.
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some elderly people with no symptoms.
Croatian: Beta-amiloidni plakovi su naslage ponekad prisutne u mozgu ljudi s problemima s pamćenjem koje uzrokuje demencija (poput Alzheimerove bolesti, demencije s Lewyjevim tjelešcima i demencije kod Parkinsonove bolesti), te također u mozgu pojedinih starijih osoba bez simptoma.