FrancophonIA/ELRC3.0 huggingface dataset:
English: BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery.
Croatian: BeneFIX je ispitivan u prethodno liječenih bolesnika s umjerenom do ozbiljnom hemofilijom B za prevenciju ili liječenje epizoda krvarenja tijekom i nakon kirurškog zahvata.
English: What is the risk associated with BeneFIX?
Croatian: Koji su rizici povezani s lijekom BeneFIX?
English: The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Croatian: Djelatna tvar lijeka BeneFIX, nonakog alfa, protein je faktora koagulacije krvi (tvar koja pomaže pri grušanju krvi).
English: It is available as a powder and solvent that are mixed together to form a solution for injection.
Croatian: BeneFIX je prašak i otapalo koji se zajedno miješaju kako bi se dobila otopina za injekciju.
English: For the full list of all side effects reported with BeneFIX, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka BeneFIX potražite u uputi o lijeku.
English: Why has BeneFIX been approved?
Croatian: Zašto je lijek BeneFIX odobren?
English: What benefit has BeneFIX shown during the studies?
Croatian: Koje su koristi lijeka BeneFIX utvrđene u ispitivanjima?
English: How is BeneFIX used?
Croatian: Kako se BeneFIX koristi?
English: How has BeneFIX been studied?
Croatian: Kako je BeneFIX ispitivan?
English: What is BeneFIX used for?
Croatian: Za što se BeneFIX koristi?
English: What is BeneFIX?
Croatian: Što je BeneFIX?
English: 90 (3 x 30) tablets (multipack)
Croatian: 100 tableta 90 (3 pakiranja po 30) tableta (Multipakiranje)
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: (Invented) name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: This reduces the likelihood of a seizure occurring.
Croatian: To umanjuje vjerojatnost pojave napadaja.
English: It is currently approved only for children aged 4 years or older.
Croatian: Trenutačno je odobren za primjenu samo u djece u dobi od četiri ili više godina.
English: The CHMP considered that the data available at this point in time were not sufficient to recommend this change.
Croatian: CHMP je zaključio da trenutačno dostupni podatci nisu dostatni za davanje preporuke za tu izmjenu.
English: Inovelon contains the active substance rufinamide and has been authorised since January 2007.
Croatian: Lijek Inovelon sadrži djelatnu tvar rufinamid, a odobren je u siječnju 2007.
English: More information about Inovelon is available on EMA's website.
Croatian: Više informacija o lijeku Inovelon dostupno je na internetskoj stranici Europske agencije za lijekove.
English: 16 December 2016 EMA/848709/2016 EMEA/H/C/II/0037
Croatian: EMEA/H/C/002737/II/0037
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Croatian: Sindrom Lennox-Gastaut jedan je od najtežih oblika epilepsije u djece.
English: What is Inovelon?
Croatian: Što je Inovelon?
English: What is happening with Inovelon for the treatment of other diseases?
Croatian: Što se događa s lijekom Inovelon kada je riječ o liječenju drugih bolesti?
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information.
Croatian: Međutim, Odbor smatra da bi ti podatci mogli biti važni za zdravstvene radnike te preporučuje da se uvrste u informacije o lijeku Inovelon.
English: Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Croatian: Znakovi i simptomi uključuju više vrsta napadaja, abnormalnu električnu aktivnost u mozgu, teškoće u učenju i probleme u ponašanju.
English: The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity.
Croatian: Djelatna tvar u lijeku Inovelon, rufinamid, djeluje vezivanjem na posebne kanale na površini stanica mozga (natrijevi kanali) koji upravljaju njihovom električnom aktivnošću.
English: Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Croatian: Inovelon se primjenjuje u liječenju sindroma Lennox-Gastaut, rijetkog oblika epilepsije koji obično pogađa djecu, ali se može nastaviti i u odrasloj dobi.
English: The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
Croatian: U ispitivanju se istraživala sigurnost lijeka Inovelon, kao i njegovo djelovanje na bihevioralni i emocionalni razvoj djece, koji je procjenjivao roditelj ili skrbnik bolesnika prema standardiziranom sustavu bodovanja.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Croatian: Nema posljedica povezanih s ishodom ovog zahtjeva za bolesnike koji u ovom trenutku sudjeluju ili će sudjelovati u kliničkim ispitivanjima lijeka Inovelon.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) završio je pregled zahtjeva za proširenje primjene lijeka Inovelon za liječenje epilepsije u djece u dobi od jedne do četiri godine.
English: Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group.
Croatian: U pogledu podataka koje je tvrtka upotrijebila za predviđanje primjene u djece u dobi od jedne do četiri godine, CHMP je zaključio da su potrebne dodatne analize za donošenje preporuka o doziranju za mlađu dobnu skupinu.
English: However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them.
Croatian: Međutim, CHMP je zaključio da bi uvrštenje podataka prikupljenih u djece u informacije o lijeku Inovelon moglo pomoći zdravstvenim radnicima koji provode liječenje.
English: While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Croatian: Iako je ispitivanje pokazalo da je sigurnost primjene lijeka Inovelon u bolesnika u dobi od jedne do četiri godine u skladu s već poznatim sigurnosnim profilom u starije djece, CHMP je zaključio da ispitivanje nije bilo dovoljno opsežno za donošenje zaključaka o djelotvornosti lijeka.
English: The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older.
Croatian: Tvrtka je također predložila način za predviđanje primjene lijeka Inovelon u djece u dobi od jedne do četiri godine na temelju postojećih podataka u bolesnika u dobi od četiri ili više godina.
English: What was Inovelon expected to be used for?
Croatian: Za što se lijek Inovelon trebao koristiti?
English: The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Croatian: Stoga je CHMP zaključio da na temelju trenutačno dostupnih podatka nije moguće izdati odobrenje za primjenu lijeka Inovelon u bolesnika sa sindromom Lennox-Gastaut mlađih od četiri godine.
English: The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Croatian: Tvrtka je predočila podatke iz ispitivanja u kojem je 37 djece u dobi od jedne do četiri godine sa sindromom Lennox-Gastaut primalo lijek Inovelon ili drugi lijek za liječenje epilepsije kao dodatak postojećem liječenju.
English: By attaching to these channels, rufinamide prevents them from becoming activated.
Croatian: rufinamid sprječava njihovo aktiviranje.
English: How does Inovelon work?
Croatian: Kako djeluje lijek Inovelon?
English: Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Croatian: Lijek Inovelon označen je kao lijek za liječenje rijetkih bolesti 20. listopada 2004. za liječenje sindroma Lennox-Gastaut.
English: and prevents abnormal electrical activity from spreading through the brain.
Croatian: Time se smanjuje aktivnost stanica mozga i sprječava širenje abnormalne električne aktivnosti mozgom.
English: There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Croatian: Nema posljedica za primjenu lijeka Inovelon u bolesnika sa sindromom Lennox-Gastaut u dobi od četiri ili više godina.
English: The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years.
Croatian: Tvrtka koja lijek Inovelon stavlja u promet podnijela je zahtjev za primjenu lijeka u liječenju sindroma Lennox-Gastaut u djece u dobi od jedne do četiri godine.
English: Further information on the orphan designation can be found here.
Croatian: Ovdje možete pronaći dodatne informacije o lijekovima za rijetke bolesti.
English: EMA/848709/2016
Croatian: 16. prosinca 2016.
English: It is used when the cancer:
Croatian: Koristi se kada se rak:
English: MedDRA = Medical Dictionary for Regulatory Activities.
Croatian: MedDRA = Medicinski rječnik za regulatorne poslove.
English: The recommended dose is one capsule each day.
Croatian: Preporučena doza je jedna kapsula svaki dan.
English: Talk to your doctor if you wish to have children in the future.
Croatian: Razgovarajte s liječnikom ako želite imati djecu u budućnosti.
English: Many of these genes are involved in proliferation, survival, and differentiation.
Croatian: Mnogi od ovih gena uključeni su u proliferaciju, preživljenje i diferencijaciju stanica.
English: Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite uzimati Erivedge i odmah potražite liječničku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: In vivo interaction data is not available.
Croatian: Podaci o interakcijama in vivo nisu dostupni.
English: • every month during treatment.
Croatian: ● svaki mjesec za vrijeme trajanja liječenja.
English: Erivedge may affect a woman's ability to have children.
Croatian: Erivedge može utjecati na ženinu sposobnost da ima djecu.
English: If this happens to you, it is not known if your periods will come back.
Croatian: Ako se to dogodi Vama, nije poznato hoćete li kasnije ponovno imati mjesečnice.
English: (see section 5.2)
Croatian: (vidjeti dio 5.2)
English: You must also use one barrier method, such as:
Croatian: Također morate primjenjivati i jednu metodu barijere, poput:
English: Objective response was defined as a complete or partial response determined on two consecutive assessments separated by at least 4 weeks.
Croatian: Objektivni odgovor definiran je kao potpuni ili djelomičan odgovor utvrđen na dvije uzastopne procjene u razmaku od najmanje 4 tjedna.
English: • If she misses her expected menstrual period,
Croatian: ● ako joj izostane očekivana menstruacija,
English: • has menstruated at any time during the previous 12 consecutive months,
Croatian: ● koja je imala menstruaciju bilo kada tijekom prethodnih 12 uzastopnih mjeseci,
English: This interaction is not expected to be clinically significant.
Croatian: Ne očekuje se da će ta interakcija biti klinički značajna.
English: Hard capsule (capsule).
Croatian: OBLIK Tvrda kapsula (kapsula).
English: • Swallow the capsule whole with a drink of water.
Croatian: ● Kapsulu progutajte cijelu, s čašom vode.
English: • Information on the recommended forms of contraception both for women and men
Croatian: ● informacije o preporučenim oblicima kontracepcije i za žene i muškarce
English: No correlative histopathologic changes were observed.
Croatian: Nisu primijećene popratne histopatološke promjene.
English: Time to maximum tumour reduction
Croatian: Vrijeme do maksimalnog smanjenja veličine tumora
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svoga liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
Croatian: Nemojte prestati uzimati ovaj lijek bez prethodnog razgovora sa svojim liječnikom jer to može smanjiti učinkovitost liječenja.
English: • Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Similar findings were not observed after a 16 week recovery period.
Croatian: Slični nalazi nisu opaženi nakon 16-tjednog razdoblja oporavka.
English: Key data are summarised in Table 2:
Croatian: Ključni podaci sažeti su u Tablici 2.
English: The size of the capsule is ‘Size 1' (dimensions 19.0 x 6.6 mm).
Croatian: Veličina kapsule je 1 (dimenzije 19,0 x 6,6 mm).
English: Do not take this medicine if any of the above apply to you.
Croatian: Nemojte uzimati ovaj lijek ako se nešto od navedenoga odnosi na Vas.
English: Erivedge is indicated for the treatment of adult patients with:
Croatian: Erivedge je indiciran za liječenje odraslih bolesnika sa:
English: Effects on specific enzymes and transporters
Croatian: Učinci na specifične enzime i prijenosnike
English: • Emergency contact phone numbers
Croatian: ● brojeve telefona za hitne slučajeve
English: Educational material
Croatian: Edukacijski materijali
English: This may slow down or stop the growth of the cancer cells, or may kill them.
Croatian: Na taj način može usporiti ili zaustaviti rast stanica raka ili ih može uništiti.
English: Due to safety concerns (see sections 4.4 and 5.3), this medicinal product should not be used in children and adolescents aged below 18 years.
Croatian: Zbog sigurnosnih razloga (vidjeti dijelove 4.4 i 5.3), ovaj lijek se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: Please refer to these documents for further information.
Croatian: Za dodatne informacije molimo pročitajte navedene dokumente.
English: This will prevent misuse and help to protect the environment.
Croatian: To će pomoći u sprječavanju zlouporabe i očuvanju okoliša.
English: As a result, your skin cancer may shrink.
Croatian: Kao rezultat toga rak kože se može smanjiti.
English: This can happen even after stopping Erivedge.
Croatian: To se može dogoditi čak i nakon prestanka uzimanja lijeka Erivedge.
English: Talk to your doctor if you are not sure.
Croatian: Obratite se svom liječniku ako niste sigurni.
English: You must not become pregnant while taking this medicine.
Croatian: Ne smijete zatrudnjeti dok uzimate ovaj lijek.
English: The median age for all patients was 72 years.
Croatian: Medijan dobi svih bolesnika bio je 72 godine.
English: It may also lead to the death of the unborn baby.
Croatian: Također može prouzročiti smrt nerođena djeteta.
English: Your doctor will make sure to test you for pregnancy:
Croatian: Vaš će liječnik provoditi testove na trudnoću:
English: • loss of water from the body (dehydration),
Croatian: ● gubitak vode iz tijela (dehidracija),
English: OTHER SPECIAL WARNINGS, IF NECESSARY Risk of severe birth defects
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO Rizik od teških prirođenih mana
English: • within a maximum of 7 days before starting treatment - to make sure that you are not already pregnant
Croatian: ● unutar najviše 7 dana prije početka liječenja - kako bi se utvrdilo da već niste trudni
English: Ex vivo plasma protein binding in human patients is > 99 %.
Croatian: Ex vivo vezivanje za ljudske proteine plazme iznosi > 99%.
English: Note: Tumour size is based on sum of longest dimensions of target lesions.
Croatian: Napomena: Veličina tumora temelji se na zbroju najduljih dimenzija ciljnih lezija.
English: Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Erivedge ako imate pitanja o informacijama sadržanima u ovom dijelu:
English: • Information for men
Croatian: ● informacije za muškarce
English: (18.1, NE)
Croatian: (18,1; NP)
English: What you need to know before you take Erivedge
Croatian: Što morate znati prije nego počnete uzimati Erivedge
English: • The other ingredients are:
Croatian: Drugi sastojci su:
English: • Erivedge can be taken with or without food.
Croatian: Erivedge se može uzimati s hranom ili bez nje.
English: In particular, tell your doctor if you take any of the following medicines:
Croatian: Osobito je važno da kažete svom liječniku ako uzimate neki od sljedećih lijekova:
English: • National specific requirements as agreed with the National Competent Authority regarding:
Croatian: ● zahtjeve specifične za pojedinu državu dogovorene s nadležnim nacionalnim tijelom koji se odnose na:
English: • if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
Croatian: ● ako ste alergični na vismodegib ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.).
English: Induction could lead to decreases in systemic exposure of the contraceptive steroids and thereby reduced contraceptive efficacy.
Croatian: Indukcija bi mogla dovesti do smanjenja sistemske izloženosti steroidnim kontraceptivima i tako smanjiti djelotvornost kontracepcije.
English: The median duration of treatment was 12.9 months (range 0.7 to 47.8 months).
Croatian: Medijan trajanja liječenja iznosio je 12,9 mjeseci (raspon od 0,7 do 47,8 mjeseci).
English: You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Croatian: Ne smijete zatrudnjeti dok uzimate ovaj lijek (pogledajte dio 2, “Nemojte uzimati Erivedge” i “Trudnoća, dojenje i plodnost”).
English: In particular, caution should be exercised if vismodegib is administered in combination with any statin.
Croatian: Naročito je potreban oprez ako se vismodegib primjenjuje u kombinaciji s bilo kojim statinom.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: What Erivedge is and what it is used for What you need to know before you take Erivedge How to take Erivedge
Croatian: Što je Erivedge i za što se koristi Što morate znati prije nego počnete uzimati Erivedge Kako uzimati Erivedge
English: Concomitant administration should be performed with caution and a dose adjustment may be necessary.
Croatian: Istodobnu primjenu treba provoditi uz oprez, a može biti potrebna i prilagodba doze.
English: Erivedge can also affect how some other medicines work.
Croatian: Isto tako, Erivedge može utjecati na djelovanje nekih drugih lijekova.
English: Contraceptive steroids
Croatian: Steroidni kontraceptivi
English: This damage can change how certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide.
Croatian: To oštećenje može promijeniti način na koji djeluju određeni proteini u tim stanicama pa oštećene stanice postanu zloćudne i počinju rasti i dijeliti se.
English: • Hormonal depot injection,
Croatian: ● hormonska depo injekcija,
English: Although the number of identified cases is limited, the reactions are serious and the association with vismodegib is plausible.
Croatian: Premda je broj utvrđenih slučajeva ograničen, radi se o ozbiljnim reakcijama, a povezanost s vismodegibom je vjerojatna.
English: Amongst these women, amenorrhoea was observed in 3 patients (30 %).
Croatian: Među tim je ženama amenoreja primijećena u 3 bolesnice (30%).
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Croatian: Potrebno je redovito procjenjivati korist daljnjeg liječenja, a optimalno trajanje terapije razlikuje se u svakog pojedinog bolesnika.
English: Carcinogenicity studies were performed in mice and rats.
Croatian: Ispitivanja kancerogenosti provedena su na miševima i štakorima.
English: 4.1 Therapeutic indication
Croatian: 4.1 Terapijske indikacije
English: Always take Erivedge exactly as your doctor has told you.
Croatian: Kako uzimati Erivedge Uvijek uzmite Erivedge točno onako kako Vam je rekao liječnik.
English: If you are not sure, talk to your doctor or pharmacist before taking Erivedge.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Erivedge.
English: • If she becomes pregnant or think for any reason that she may be pregnant,
Croatian: ● ako zatrudni ili iz bilo kojeg razloga misli da bi mogla biti trudna,
English: Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Croatian: Pažljivo pročitajte i slijedite upute navedene u Knjižici i Kartici s podsjetnikom za bolesnika koje Vam je dao liječnik.
English: What Erivedge is and what it is used for
Croatian: Što je Erivedge i za što se koristi
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Croatian: Testovi na trudnoću moraju imati minimalnu osjetljivost od 25 mIU/ml, ovisno o dostupnosti na određenom području.
English: Do not take Erivedge
Croatian: Nemojte uzimati Erivedge
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da imate intoleranciju na neke šećere, javite se Vašem liječniku prije uzimanja ovoga lijeka.
English: • The format and content of the Healthcare professional and patient material
Croatian: ● format i sadržaj materijala za zdravstvene radnike i bolesnike
English: The capsules must not be opened, to avoid unintended exposure to patients and health care providers.
Croatian: Kapsule se ne smiju otvarati kako bi se izbjegla nenamjerna izloženost bolesnika i zdravstvenih djelatnika lijeku.
English: Other medicines and Erivedge
Croatian: Drugi lijekovi i Erivedge
English: Vismodegib is present in semen.
Croatian: Vismodegib je prisutan u spermi.
English: • a change in the way things taste or the complete loss of taste,
Croatian: ● promjene osjeta okusa ili potpuni gubitak osjeta okusa,
English: Erivedge contains a type of sugar called lactose.
Croatian: Erivedge sadrži jednu vrstu šećera koja se zove laktoza.
English: • bosentan, glibenclamide, repaglinide, valsartan,
Croatian: ● bosentan, glibenklamid, repaglinid, valsartan,
English: Based on population pharmacokinetic analysis of combined data from 121 males and 104 females, gender did not appear to affect the pharmacokinetics of vismodegib.
Croatian: Na temelju populacijske farmakokinetičke analize objedinjenih podataka prikupljenih od 121 muškarca i 104 žene, čini se da spol ne utječe na farmakokinetiku vismodegiba.
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom o tome kamo trebate vratiti kapsule.
English: • If she stops using contraception unless she commits to not having sexual intercourse (abstinence),
Croatian: ● ako prestane koristiti kontracepciju, osim ako se ne obveže na suzdržavanje od spolnih odnosa (apstinenciju),