FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/003
English: Follow these steps each time you take Lacosamide UCB: Put the oral syringe into the adaptor opening (figure 4).
Croatian: • Postavite štrcaljku za usta u otvor nastavka (slika 4).
English: Muscle spasms
Croatian: Omaglica Tinitus
English: Excipients which may cause intolerance
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 50 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 50 mg tablets lacosamide
Croatian: Lakozamid UCB 50 mg filmom obložene tablete <Za 56 i 14 filmom obloženu tabletu> Lakozamid UCB 50 mg tablete lakozamid
English: Lacosamide UCB 50 mg 1 film-coated tablet contains 50 mg lacosamide.
Croatian: 1 filmom obložena tableta sadrži 50 mg lakozamida.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 16 December 2015.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su 16. prosinca 2015.
English: These were measured before and after 26 weeks of treatment.
Croatian: To je izmjereno prije i nakon 26 tjedana liječenja.
English: This effect was maintained for up to four years.
Croatian: Taj je učinak održan tijekom razdoblja do četiri godine.
English: It is intended for long-term use.
Croatian: Namijenjen je za dugoročnu primjenu.
English: The effect of these on the safety and effectiveness of the medicine is not fully known.
Croatian: Nije potpuno poznat njihov učinak na sigurnost i učinkovitost lijeka.
English: This summary was last updated in 11-2015.
Croatian: Ovaj sažetak posljednji je put ažuriran u 11.2015.
English: Aldurazyme laronidase
Croatian: Aldurazyme laronidaza
English: The full EPAR for Aldurazyme can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Aldurazyme nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Some of these are severe, but the number of side effects tends to decrease with time.
Croatian: Neke od njih su teške, ali se broj nuspojava smanjuje s vremenom.
English: Aldurazyme is given once a week as an infusion into a vein.
Croatian: Aldurazyme se primjenjuje jednom tjedno kao infuzija u venu.
English: This means that substances called glycosaminoglycans (GAGs) are not broken down, so they build up in most of the organs in the body and damage them.
Croatian: To znači da se tvari koje se nazivaju glikozaminoglikani (GAG-i) ne razgrađuju, pa se nakupljaju u većini organa u tijelu i oštećuju ih.
English: Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme).
Croatian: Gotovo svi bolesnici koji primaju Aldurazyme razviju antitijela (proteine koji se proizvode kao reakcija na Aldurazyme).
English: Half of the children treated had a normal size liver at the end of the study.
Croatian: Polovica liječene djece po završetku ispitivanja imala je jetru normalne veličine.
English: Aldurazyme was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Croatian: Aldurazyme je prvobitno odobren u „iznimnim okolnostima” zbog toga što su u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije jer je bolest rijetka.
English: Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year.
Croatian: Aldurazyme je također ispitan u 20 djece mlađe od pet godina koja su Aldurazyme primala jednu godinu.
English: The study was looking mainly at the safety of the medicine, but it also measured its ability to reduce the levels of GAGs in the urine and the size of the liver.
Croatian: Ispitivanjem se uglavnom istraživala sigurnost lijeka, ali je također mjerena njegova sposobnost smanjivanja razina GAG-a u urinu i veličine jetre.
English: Aldurazyme should be given in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction.
Croatian: Aldurazyme se mora primijeniti u bolnici ili klinici gdje je dostupna oprema za reanimaciju, a bolesnici će možda trebati primiti određene lijekove prije infuzije radi sprječavanja alergijske reakcije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aldurazyme on 10 June 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Aldurazyme na snazi u Europskoj uniji od 10. lipnja 2003.
English: In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60%.
Croatian: U djece mlađe od pet godina Aldurazyme je smanjio razine GAG-a u urinu za otprilike 60 %.
English: Other information about Aldurazyme
Croatian: Ostale informacije o lijeku Aldurazyme
English: Aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients.
Croatian: Aldurazyme se ne smije koristiti u ljudi koji su izrazito alergični na laronidazu ili bilo koji drugi sastojak.
English: After this, the study continued for up to four years and all of the patients were treated with Aldurazyme.
Croatian: Nakon toga, ispitivanje je nastavljeno tijekom razdoblja do četiri godine te su svi bolesnici liječeni lijekom Aldurazyme.
English: This is a summary of the European public assessment report (EPAR) for Aldurazyme.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aldurazyme.
English: The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks.
Croatian: Ispitivanje je pokazalo da je Aldurazyme poboljšao FVC i sposobnost hodanja bolesnika nakon 26 tjedana.
English: For more information about treatment with Aldurazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Aldurazyme pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: It is produced by a method known as ‘recombinant DNA technology': the enzyme is made by cells into which a gene (DNA) has been introduced that makes them able to produce laronidase.
Croatian: Proizvodi se metodom poznatom kao „tehnologija rekombinantne DNK”: enzim tvore stanice u koje je unesen gen (DNK) koji im omogućuje proizvodnju laronidaze.
English: Aldurazyme is used in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; α L iduronidase deficiency) to treat the non-neurological symptoms of the disease (symptoms that are not connected with the brain or nerves).
Croatian: Aldurazyme se koristi u bolesnika s potvrđenom dijagnozom mukopolisaharidoze I (MPS I; deficijencija -L-iduronidaze) za liječenje simptoma bolesti koji nisu neurološki (simptomi koji nisu povezani s mozgom ni živcima).
English: MPS I is a rare, inherited disease, in which the level of α L iduronidase enzyme activity is much lower than normal.
Croatian: MPS I je rijetka, nasljedna bolest u koje je razina aktivnosti enzima -Liduronidaze mnogo niža od normalne.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aldurazyme.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Aldurazyme.
English: What is the risk associated with Aldurazyme?
Croatian: Koji su rizici povezani s lijekom Aldurazyme?
English: The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints that make moving more difficult, reduced lung volume, heart disease and eye disease.
Croatian: Simptomi bolesti MPS I koji nisu neurološki mogu biti povećana jetra, ukočeni zglobovi koji otežavaju kretanje, smanjen obujam pluća, bolest srca i bolest oka.
English: The most common side effects in patients over the age of five years (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal pain (stomach ache), rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion.
Croatian: Najčešće nuspojave u bolesnika starijih od pet godina (zapažene u više od 1 na 10 bolesnika) su glavobolja, mučnina (osjećaj slabosti), abdominalna bol (trbobolja), osip, artropatija (oštećenje zglobova), artralgija (bol u zglobovima), bol u leđima, bol u ekstremitetima (šakama i stopalima), crvenilo, pireksija (vrućica) i reakcije na mjestu infuzije.
English: Why has Aldurazyme been approved?
Croatian: Zašto je Aldurazyme odobren?
English: The active substance in Aldurazyme, laronidase, is a copy of the human enzyme α L iduronidase.
Croatian: Djelatna tvar u lijeku Aldurazyme, laronidaza, kopija je humanog enzima -L-iduronidaze.
English: Aldurazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS I or other inherited metabolic diseases.
Croatian: Liječenje lijekom Aldurazyme mora nadzirati liječnik s iskustvom u liječenju bolesnika oboljelih od MSP I ili drugih nasljednih metaboličkih bolesti.
English: Aldurazyme is a solution for infusion (drip) into a vein that contains the active substance laronidase.
Croatian: Aldurazyme je otopina za infuziju (drip) u venu koja sadrži djelatnu tvar laronidazu.
English: In patients under five years of age, the most common side effects (seen in more than 1 patient in 10) are increased blood pressure, decreased oxygen saturation (a measure of how well the lungs are working), tachycardia (rapid heart rate), pyrexia and chills.
Croatian: U bolesnika mlađih od pet godina najčešće nuspojave (zapažene u više od 1 na 10 bolesnika) su povišeni krvni tlak, smanjena saturacija kisika (mjerilo kvalitete funkcioniranja pluća), tahikardija (brz rad srca), pireksija i zimica.
English: Most of the side effects seen with Aldurazyme are reactions caused by the infusion procedure rather than the medicine itself.
Croatian: Većina nuspojava zapaženih pri primjeni lijeka Aldurazyme reakcije su prouzročene postupkom infuzije, a nesamim lijekom.
English: What is Aldurazyme?
Croatian: Što je Aldurazyme?
English: Laronidase is used as ‘enzyme replacement therapy', which means that it replaces the enzyme that is missing in patients with MPS I. This controls the symptoms of MPS I, improving the patient's quality of life.
Croatian: Laronidaza se upotrebljava kao „enzimska nadomjesna terapija”, što znači da zamjenjuje enzim koji nedostaje u bolesnika s MPS I.
English: What benefit has Aldurazyme shown during the studies?
Croatian: Koje su koristi lijeka Aldurazyme utvrđene u ispitivanjima?
English: The CHMP decided that Aldurazyme gives effective control of the symptoms of MPS I. The Committee decided that Aldurazyme's benefits are greater than its risks and recommended that Aldurazyme be given marketing authorisation.
Croatian: Odbor je odlučio da koristi lijeka Aldurazyme nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka Aldurazyme u promet.
English: For the full list of all side effects reported with Aldurazyme, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Aldurazyme potražite u uputi o lijeku.
English: What is Aldurazyme used for?
Croatian: Za što se Aldurazyme koristi?
English: How does Aldurazyme work?
Croatian: Kako Aldurazyme djeluje?
English: Aldurazyme has been compared with placebo (a dummy treatment) in 45 patients aged six years and over with a confirmed diagnosis of MPS I. The main measure of effectiveness was the forced vital capacity (FVC, a measure of how well the lungs are working) and the distance the patients could walk over six minutes.
Croatian: Aldurazyme je uspoređen s placebom (prividnim liječenjem) u 45 bolesnika u dobi od šest godina i više s potvrđenom dijagnozom bolesti MPS I.
English: How has Aldurazyme been studied?
Croatian: Kako je Aldurazyme ispitivan?
English: How is Aldurazyme used?
Croatian: Kako se Aldurazyme koristi?
English: Content (concentration)
Croatian: Put primjene Unutarnje pakiranje Sadržaj (koncentracija)
English: Immediate packaging
Croatian: Veličina pakiranja
English: Skin reactions are seen in more than 80% of patients.
Croatian: Kožne reakcije uočene su u više od 80% bolesnika.
English: Erbitux is given once a week.
Croatian: Erbitux se daje jednom na tjedan.
English: Patients must also be closely observed for any signs of allergic reaction for at least one hour after the end of the infusion.
Croatian: Bolesnici se moraju također pažljivo promatrati kako bi se uočili bilo kakvi znakovi alergijskih reakcija najmanje jedan sat nakon završetka infuzije.
English: This summary was last updated in 12-2013.
Croatian: Sažetak je posljednji put ažuriran: 12.2013.
English: Erbitux is given in the following ways:
Croatian: Erbitux se primjenjuje na sljedeće načine:
English: Between 79 and 89% of colorectal cancers and more than 90% of squamous cell cancers of the head and neck have EGFR on their cell surfaces.
Croatian: Između 79 i 89% kolorektalnih karcinoma i više od 90% karcinoma skvamoznih stanica vrata i glave imaju EGFR na površini svojih stanica.
English: The following infusions are 250 mg/m2 given over one hour.
Croatian: Naredne infuzije daju se u dozi od 250 mg/m2 tijekom jednog sata.
English: The full EPAR for Erbitux 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 Erbitux nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux on 29 June 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Erbitux vrijedi na prostoru Europske unije od 29. lipnja 2004.
English: The first infusion is given at a dose of 400 mg per square metre body surface area (calculated using the patient's height and weight) over two hours.
Croatian: Prva se infuzija daje u dozi od 400 mg po metru kvadratnom tjelesne površine (izračunato pomoću visine i tjelesne težine bolesnika) tijekom razdoblja od dva sata.
English: All of the studies looked at how long the patients lived without their cancer getting worse or how long they survived.
Croatian: Sva su ispitivanja istražila koliko su dugo bolesnici živjeli, a da se karcinom nije pogoršao ili koliko su dugo preživjeli.
English: Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given.
Croatian: Erbitux se može povezati s ozbiljnim reakcijama tijekom infuzije, tako da se bolesnici moraju pažljivo pratiti tijekom davanja lijeka.
English: Other information about Erbitux
Croatian: Ostale informacije o lijeku Erbitux
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Erbitux.
English: Before receiving Erbitux, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction.
Croatian: Prije nego što primi Erbitux, bolesniku se mora dati antihistamin i kortikosteroid kako bi se spriječila alergijska reakcija.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Croatian: Monoklonalno protutijelo je protutijelo (tip protein) koje je dizajnirano kako bi prepoznalo i vezalo se na posebne strukture (naziva antigen) u tijelu.
English: When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.
Croatian: Ako se koristi s radioterapijom, s primjenom lijeka Erbitux treba započeti jedan tjedan prije početka radioterapije i nastaviti sve dok se radioterapija ne završi.
English: This is a summary of the European public assessment report (EPAR) for Erbitux.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Erbitux.
English: For more information about treatment with Erbitux, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Erbitux pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: • on its own when previous treatment containing oxaliplatin and irinotecan has failed and the patient cannot receive irinotecan.
Croatian: • samostalno u slučajevima kada prethodna terapija koja je sadržavala oksaliplatin i irinotekan nije bila uspješna i bolesnici ne mogu uzimati irinotekan.
English: The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), mild or moderate reactions linked to the infusion (such as fever, chills, dizziness and difficulty breathing), mucositis (inflammation of the lining of the mouth) and raised levels of some liver enzymes.
Croatian: Najčešće nuspojave lijeka Erbitux (kod više od 1 na 10 osoba) su kožne reakcije poput osipa, hipomagnezemije (niskih razina magnezija u krvi), blagih ili umjerenih reakcija povezanih s infuzijom (poput groznice, drhtavice, vrtoglavice i otežanog disanja), mukozitisa (upale sluznice usta) i povišenih razina enzima jetre.
English: • together with anticancer treatments containing irinotecan;
Croatian: • zajedno s antineoplastičkim terapijama koje sadrže irinotekan;
English: EPAR summary for the public cetuximab
Croatian: EPAR, sažetak za javnost cetuksimab
English: Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain ‘wild-type' (non-mutated) versions of a family of genes called ‘RAS'.
Croatian: Erbitux se koristi u bolesnika čije tumorske stanice sadrže protein na površini naziva receptor za epidermalni faktor rasta (EGFR) i sadrži verzije „divljeg (nemutiranog) tipa” obitelji gena naziva „RAS”.
English: In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Croatian: U slučaju karcinoma koji su se lokalno razvili (u slučaju kada je tumor narastao, no nije se raširio), Erbitux se primjenjuje u kombinaciji s radioterapijom (liječenjem zračenjem).
English: EGFR is involved in switching on genes called RAS that are involved in the growth of cells; by attaching to EGFR, cetuximab prevents this from happening in the tumour cells and helps stop them growing.
Croatian: EGFR je uključen u aktiviranje gena naziva RAS koji su uključeni u rast stanica; vezivanjem na EGFR, cetuksimab sprječava da se to dogodi u tumorskim stanicama te pomaže pri zaustavljanju njihova rasta.
English: The CHMP decided that Erbitux's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Erbitux nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: • together with the oxaliplatin-containing treatment FOLFOX in patients who have not been treated before;
Croatian: • zajedno s liječenjem koje sadrži oksaliplatin FOLFOX u bolesnika koji nisu prethodno liječeni;
English: These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx (voice box).
Croatian: Ovi tipovi karcinoma utječu na stanice sluznice usta ili grla ili organa poput larinksa (grkljana).
English: One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene.
Croatian: Jedno od ispitivanja je također zasebno istražilo rezultate prikupljene u bolesnika čiji su tumori nosili oblike divljega tipa svih RAS gena i bolesnika s mutiranim oblicima bilo kojeg RAS gena.
English: • two studies involved 1,535 patients who had not received chemotherapy before, looking at the effects of adding Erbitux to a treatment combination containing either irinotecan or oxaliplatin (FOLFOX); a third study looked also at the effects of adding Erbitux to two treatment combinations containing oxaliplatin (one of which was similar to FOLFOX) in 1,630 patients.
Croatian: • dva su ispitivanja obuhvatila 1 535 bolesnika koji ranije nisu primili kemoterapiju, te je istraženo djelovanje dodavanja lijeka Erbitux u terapijsku kombinaciju koja je sadržavala irinotekan ili oksaliplatin (FOLFOX); treće je ispitivanje istražilo djelovanje dodavanja lijeka Erbitux u dvije terapijske kombinacije koje su sadržavale oksaliplatin (od kojih je jedna slična FOLFOX-u) u 1 630 bolesnika.
English: Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Croatian: Cetuksimab je dizajniran za vezanje na EGFR, koji se nalazi na površini pojedinih tumorskih stanica.
English: • three studies involved 2,199 patients whose disease had got worse while they were on previous treatment including irinotecan, oxaliplatin or both, or who could not receive these medicines.
Croatian: • tri su ispitivanja obuhvatila 2 199 bolesnika čija se bolest pogoršala tijekom ranije terapije irinotekanom, oksaliplatinom ili obama lijekovima, ili bolesnike koji nisu mogli primiti ove lijekove.
English: Erbitux must not be used with oxaliplatin-containing chemotherapy for metastatic colorectal cancer in patients with mutated RAS or for whom RAS status is unknown.
Croatian: Erbitux se ne smije koristiti zajedno s kemoterapijom koja sadrži oksaliplatin za metastatski kolorektalni karcinom u bolesnika s mutiranim RAS-om ili za koje status RAS-a nije poznat.
English: In cancer that is recurrent (when it has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination (including medicines such as cisplatin or carboplatin).
Croatian: U slučaju rekurentnog karcinoma (ako se vratio nakon prethodnog liječenja) ili metastatskog karcinoma, Erbitux se koristi kao kombinacija antineoplastičkih lijekova „baziranih na platini” (uključujući lijekove poput ciplastina ili karboplatina).
English: For cancers of the head and neck, Erbitux was investigated in two main studies:
Croatian: U slučaju karcinoma glave i vrata, Erbitux je ispitan u dva glavna ispitivanja:
English: Erbitux is also used to treat ‘squamous cell' cancers of the head and neck.
Croatian: Erbitux se također koristi za liječenje karcinoma „skvamoznih stanica” glave i vrata.
English: What is the risk associated with Erbitux?
Croatian: Koji su rizici povezani s lijekom Erbitux?
English: Erbitux should only be given under the supervision of a doctor who has experience in the use of anticancer medicines in a setting where facilities for resuscitation are available.
Croatian: Erbitux se mora primijeniti pod nadzorom liječnika iskusnog u primjeni antineoplastičkih lijekova u okruženju u kojem je dostupna opreme za oživljavanje.
English: The active substance in Erbitux, cetuximab, is a monoclonal antibody.
Croatian: Djelatna stvar u lijeku Erbitux, cetuksimab, je monoklonalno protutijelo.