FrancophonIA/ELRC3.0 huggingface dataset:
English: Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Croatian: Nedavna ispitivanja upućuju na to da rano otkrivanje i liječenje PML-a kada je bolest asimptomatska (još u početnim fazama i nema vidljivih simptoma) može poboljšati ishode u bolesnika.
English: All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Croatian: Svi bolesnici koji uzimanju Tysabri trebali bi najmanje jedanput godišnje otići na snimanje MR-om, a EMA je na temelju novih podataka preporučila da je u bolesnika s povećanim rizikom od PML-a potrebno razmotriti češće snimanje MR-om (npr. svakih 3 do 6 mjeseci) primjenom pojednostavljenih protokola.
English: More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Croatian: Detaljnije informacije o stratifikaciji rizika, dijagnozi i liječenju PML-a bit će uvrštene u ažurirane Informacije za liječnike i smjernice za liječenje lijekom Tysabri.
English: EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
Croatian: EMA potvrđuje preporuke za minimizaciju rizika od PML-a povezanog s lijekom Tysabri
English: Index 0.9 to
Croatian: Indeks od 0,9 do 1,5
English: No prior use of immunosuppressants
Croatian: Bez prethodne uporabe imunosupresiva
English: In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Croatian: U bolesnika s negativnim testom na JCV protutijela procjena rizika od PML-a ostaje nepromijenjena, odnosno 0,1 na 1 000 bolesnika.
English: Prior use of immunosuppressants
Croatian: Uz prethodnu uporabu imunosupresiva
English: Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
Croatian: Asimptomatski slučajevi PML-a mogu se otkriti magnetskom rezonancijom (MR), a stručnjaci u području MR-a i multiple skleroze slažu se da pojednostavljeni protokoli za MR (u kojima je postupak snimanja kraći, čime se dodatno smanjuje opterećenje za bolesnike koji idu na snimanje) omogućuju otkrivanje lezija u PML-u.
English: On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Croatian: EMA je dovršila pregled poznatog rizika od progresivne multifokalne leukoencefalopatije (PML) povezane s lijekom Tysabri (natalizumab) za liječenje multiple skleroze te je potvrdila početne preporuke1 u cilju minimizacije tog rizika.
English: • Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
Croatian: • Progresivna multifokalna leukoencefalopatija (PML, ozbiljna infekcija mozga) rijedak je rizik povezan s primjenom lijeka Tysabri za liječenje multiple skleroze.
English: • During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Croatian: • Bolesnike je tijekom liječenja lijekom Tysabri potrebno pratiti u redovitim razmacima kako bi se uočili znakovi i simptomi nove neurološke disfunkcije te je potrebno napraviti snimanje MR-om cijelog mozga najmanje jedanput godišnje tijekom trajanja liječenja.
English: • either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Croatian: • prije uporabe lijeka Tysabri upotrebljavali imunosupresive ili nisu upotrebljavali imunosupresive, a imaju visok indeks JCV protutijela.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Croatian: Djelatna tvar lijeka Tysabri jest natalizumab, monoklonsko protutijelo (vrsta bjelančevina) koje prepoznaje i veže se na specifični dio bjelančevine koja se naziva α4ß1 integrin.
English: • Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
Croatian: • Bolesnike i njegovatelje potrebno je savjetovati da budu na oprezu zbog rizika od PML-a do šest mjeseci nakon prekida liječenja lijekom Tysabri.
English: The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Croatian: Prethodno navedene ažurirane procjene rizika pokazuju mali rizik od razvoja PML-a, pa i niži od prethodno procijenjenoga, u bolesnika s vrijednosti indeksa protutijela od 0,9 ili manje te znatnije povećanje u bolesnika s vrijednosti indeksa iznad 1,5 koji su lijekom Tysabri liječeni dulje od dvije godine.
English: • After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
Croatian: • Nakon dvije godine liječenja bolesnike je potrebno ponovno obavijestiti o riziku od PML-a uz primjenu lijeka Tysabri.
English: • Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
Croatian: • Prije početka liječenja lijekom Tysabri bolesnike i njegovatelje potrebno je savjetovati o riziku od PML-a.
English: These tests may be done more often if you are considered at higher risk for PML.
Croatian: Ti testovi češće će se provoditi ako bolesnik ima povećan rizik od PML-a.
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Croatian: Tysabri se upotrebljava za liječenje bolesnika s vrstom multiple skleroze poznate kao „relapsno-remitentna”, pri čemu bolesnik ima napadaje (relapse) između razdoblja smanjenih simptoma (remisija).
English: • More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
Croatian: • Više informacija o riziku od PML-a uz liječenje lijekom Tysabri uključeno je u karticu s upozorenjima za bolesnika koji je izdao liječnik.
English: • Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
Croatian: • Prije početka liječenja treba biti dostupan osnovni nalaz MR-a (obično unutar 3 mjeseca) kao referencija te je potrebno napraviti osnovno testiranje na JCV protutijela kako bi se poduprla stratifikacija rizika od PML-a.
English: • Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
Croatian: • Rizik od PML-a ovisi o nekoliko čimbenika, primjerice o prisutnosti JCV protutijela u krvi (znak da je bolesnik bio izložen virusu koji uzrokuje PML) i razini tih protutijela, trajanju liječenja lijekom Tysabri te o tome je li bolesnik prije liječenja lijekom Tysabri bio liječen lijekovima koji potiskuju imunosni sustav.
English: Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Croatian: Poznati čimbenici rizika za razvoj PML-a u bolesnika liječenih lijekom Tysabri jesu prisutnost JCV protutijela, liječenje lijekom Tysabri više od dvije godine te prethodna uporaba imunosupresiva.
English: • Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Croatian: • Prije početka liječenja lijekom Tysabri, a zatim redovito tijekom liječenja, liječnik će napraviti analizu krvi kako bi se izmjerila razina JCV protutijela te snimanje MR-om kako bi se pratilo bolesnikovo stanje.
English: If you believe your disease is getting worse or if you notice any new or unusual symptoms while using Tysabri and for up to 6 months after stopping Tysabri, speak to your doctor as soon as possible.
Croatian: Potrebno je što prije obratiti se svome liječniku ako postoji sumnja da se bolest pogoršava ili ako uočite nove ili neuobičajene simptome za vrijeme uporabe lijeka Tysabri i do šest mjeseci nakon prestanka uporabe lijeka Tysabri.
English: Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
Croatian: Zabilježeni su asimptomatski slučajevi PML-a na temelju nalaza MR-a i pozitivnog testa na JCV DNK-a u cerebrosponalnom likvoru.
English: Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Croatian: Daljnja stratifikacija rizika od PML-a prema intervalu indeksa anti-JCV protutijela za bolesnike koji prethodno nisu upotrebljavali imunosupresive izvedena je kombinacijom ukupnog godišnjeg rizika i raspodjele indeksa protutijela.
English: • Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Croatian: • Bolesnike koji su negativni na protutijelo potrebno je svakih šest mjeseci testirati na JCV protutijela.
English: If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Croatian: Ako se otkriju lezije koje upućuju na PML, protokol snimanja MR-om potrebno je proširiti kako bi se uključilo T1 mjereno snimanje MR-om uz primjenu kontrasta te je potrebno razmotriti testiranje spinalnog likvora na prisutnost virusa JCV.
English: • If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Croatian: • Ako postoji sumnja na PML, protokol snimanja MR-om potrebno je proširiti kako bi se uključilo T1 mjereno snimanje MR-om uz primjenu kontrasta te je potrebno razmotriti testiranje cerebrospinalnog likvora na prisutnost JCV DNK-a metodom ultraosjetljive lančane polimeraze (PCR).
English: New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Croatian: Novi podatci iz velikih kliničkih ispitivanja također upućuju na to da se razina JCV protutijela u krvi (indeks protutijela) u bolesnika koji prije uzimanja lijeka Tysabri nisu liječeni imunosupresivima (lijekovima koji smanjuju aktivnost imunosnog sustava) povezuje s razinom rizika od PML-a.
English: If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Croatian: Ako se u bilo kojem trenutku posumnja na PML, liječenje lijekom Tysabri mora se prekinuti dok se ne isključi PML.
English: Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Croatian: Objedinjeni podaci dobiveni na temelju velikih kliničkih ispitivanja upućuju na to da je u bolesnika koji prethodno nisu upotrebljavali imunosupresive razina (indeks) odgovora na JCV protutijelo povezana s razinom rizika od PML-a.
English: months *from Tysabri Physician Information and Management Guidelines
Croatian: Trajanje uporabe lijeka Tysabri
English: • If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Croatian: • Ako se u bilo kojem trenutku posumnja na PML, liječenje lijekom Tysabri mora se prekinuti dok se ne isključi PML.
English: • If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
Croatian: • U slučaju sumnje na PML liječnik će prekinuti liječenje lijekom Tysabri dok se ne isključi mogućnost PML-a.
English: Based on these data, updated risk estimates for PML2 in JC virus antibody-positive patients treated with Tysabri are available, as shown in Table 1 below:
Croatian: Na temelju tih podataka dostupne su ažurirane procjene rizika od PML-a2 u bolesnika pozitivnih na JCV protutijela liječenih lijekom Tysabri, kao što je prikazano u tablici 1.: Tablica 1: Procjene rizika od PML-a na 1000 bolesnika u bolesnika pozitivnih na JCV protutijelo*
English: FLAIR, T2-weighted and DW imaging) should be considered, as earlier detection of PML in asymptomatic patients is associated with improved PML outcomes.
Croatian: • U bolesnika s povećanim rizikom od PML-a potrebno je razmotriti češća snimanja MR-om (npr. svakih 3 do 6 mjeseci) primjenom skraćenog protokola (npr. FLAIR, T2 mjereno snimanje i difuzijski mjereno snimanje) jer je ranije otkrivanje PML-a u asimptomatskih bolesnika povezano s poboljšanim ishodima PML-a.
English: More frequent MRI scans should be considered for patients at higher risk
Croatian: U bolesnika s povećanim rizikom potrebno je razmotriti češće snimanje magnetskom rezonancijom (MR).
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik
English: Treatment must not last longer than 12 weeks.
Croatian: Terapija ne smije trajati dulje od 12 tjedana.
English: They may also have episodes of depression.
Croatian: Ovi bolesnici mogu imati i epizode depresije.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: • shizofrenijom, mentalnom bolesti koja se očituje nizom simptoma, uključujući neorganiziranim razmišljanjem i govorom, halucinacijama (bolesnici čuju ili vide nešto čega nema), sumnjama i iluzijama (pogrešna vjerovanja).
English: This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Croatian: To znači da je Aripiprazole Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Abilify.
English: The full EPAR and risk management plan summary for Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Accord nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Croatian: S obzirom na to da su dopamin i 5-hidroksitriptamin uključeni u shizofreniju i bipolaran poremećaj, aripiprazol pomaže u normalizaciji moždane aktivnosti smanjujući psihotičke ili manične simptome i sprečavajući njihov povratak.
English: Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Croatian: Lijek Aripiprazole Accord dostupan je u tabletama (5, 10, 15 i 30 mg), a izdaje se samo na liječnički recept.
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Accord is broken down in the body.
Croatian: Dozu treba prilagoditi u bolesnika koji uzimaju druge lijekove koji mogu utjecati na način razgradnje lijeka Aripiprazole Accord u tijelu.
English: To prevent manic episodes in adults, the same dose should be continued.
Croatian: Kako bi se spriječile manične epizode u odraslih osoba, treba nastaviti terapiju istom dozom.
English: This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Croatian: To znači da aripiprazol djeluje kao dopamin i 5-hidroksitriptamin aktivirajući te receptore, ali manje snažno od neurotransmitera.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Croatian: Smatra se da aripiprazol djeluje uglavnom kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5-hidroksitriptamina (također zvani serotonin).
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Croatian: • kod bipolarnog poremećaja tipa I, mentalne bolesti u slučaju koje bolesnici imaju manične epizode (razdoblja abnormalno visokog raspoloženja), koje se izmjenjuju s razdobljima normalnog raspoloženja.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i u pogledu lijeka Abilify, koristi nadmašuju utvrđene rizike.
English: In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Croatian: Nadalje, proizvođač lijeka Aripiprazole Accord dostavit će edukacijske materijale za bolesnike ili njihove pružatelje skrbi i liječnike kako bi se pojasnila sigurna primjena lijeka u bolesnika u dobi između 13 i 17 godina.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aripiprazole Accord.
English: Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Croatian: Aripiprazole Accord koristi se u odraslih osoba za liječenje umjerenih do ozbiljnih maničnih epizoda i za sprječavanje novih maničnih epizoda u odraslih osoba koje su odgovorile na lijek u prošlosti.
English: Aripiprazole Accord aripiprazole
Croatian: Aripiprazole Accord aripiprazol
English: What is Aripiprazole Accord and what is it used for?
Croatian: Što je Aripiprazole Accord i za što se koristi?
English: Aripiprazole Accord is used in patients aged 15 years or over;
Croatian: Aripiprazole Accord koristi se u bolesnika u dobi od 15 godina ili starijih;
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aripiprazole Accord?
English: It is not intended to provide practical advice on how to use Aripiprazole Accord.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Aripiprazole Accord.
English: Aripiprazole Accord is a medicine used in patients with the following mental illnesses:
Croatian: Aripiprazole Accord koristi se u bolesnika sa sljedećim mentalnim bolestima:
English: The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Croatian: Odbor je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Aripiprazole Accord u EU-u.
English: A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aripiprazole Accord.
English: What are the benefits and risks of Aripiprazole Accord?
Croatian: Koje su koristi i rizici lijeka Aripiprazole Accord?
English: Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Croatian: Aripiprazole Accord se također koristi u razdoblju do 12 tjedana za liječenje umjerenih do ozbiljnih maničnih epizoda u bolesnika u dobi od 13 godina i starijih.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines.
Croatian: Za liječenje maničnih epizoda u slučaju bipolarnog poremećaja, preporučena početna doza u odraslih osoba iznosi 15 mg peroralno jednom na dan, bilo samostalno ili u kombinaciji s drugim lijekovima.
English: For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Aripiprazole Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Aripiprazole Accord contains the active substance aripiprazole and is a ‘generic medicine'.
Croatian: Aripiprazole Accord sadrži djelatnu tvar aripiprazol i predstavlja „generički lijek”.
English: Other information about Aripiprazole Accord
Croatian: Ostale informacije o lijeku Aripiprazole Accord
English: Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Croatian: U slučaju shizofrenije preporučena početna doza iznosi 10 ili 15 mg peroralno na dan za odrasle osobe, nakon čega slijedi doza „održavanja” od 15 mg jednom na dan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je u skladu sa zahtjevima EU-a potvrđeno kako Aripiprazole
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Croatian: U bolesnika u dobi između 15 i 17 godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku) i postupno se povećava do preporučene doze od 10 mg jednom na dan.
English: Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Croatian: Accord generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Abilify.
English: The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
Croatian: Aripiprazol, djelatna tvar u lijeku Aripiprazole Accord, je antipsihotik.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Accord nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.