FrancophonIA/ELRC3.0 huggingface dataset:
English: If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with medicines to control your thyroid disorder, and in some cases your thyroid gland may have to be removed.
Croatian: Ako razvijete poremećaj štitnjače, u većini ćete slučajeva do kraja života morati uzimati lijekove za kontrolu poremećaja štitnjače, a u nekim slučajevima će Vam štitnjača morati biti uklonjena.
English: Haemoptysis may also be indicative of anti-GBM disease (see below), and an appropriate differential diagnosis has to be undertaken.
Croatian: Hemoptiza ujedno može biti indikacija za anti-GBM bolest (vidjeti dolje), te je potrebna odgovarajuća diferencijalna dijagnoza.
English: It is recommended that your doctor prescribes a medicine to reduce the chance of developing a herpes infection, which should be taken on the days that you receive LEMTRADA treatment, and for one month following the treatment.
Croatian: Preporučuje se da Vam liječnik propiše lijekove za sprječavanje mogućnosti nastanka infekcije herpesom, koje trebate uzimati onih dana kada primate liječenje lijekom LEMTRADA, te mjesec dana nakon liječenja.
English: It is not known whether alemtuzumab can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity.
Croatian: Nije poznato može li alemtuzumab uzrokovati oštećenje ploda kada se primjenjuje u trudnica niti utječe li na sposobnost reprodukcije.
English: The mechanism by which LEMTRADA exerts its therapeutic effects in MS is not fully elucidated.
Croatian: Mehanizam kojim LEMTRADA ostvaruje svoje terapijske učinke u multiploj sklerozi nije u potpunosti razjašnjen.
English: CD3+ and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by 12months post-treatment.
Croatian: Broj CD3+ i CD4+ limfocita bilježi sporiji rast prema normalnim vrijednostima, a na početne se vrijednosti u načelu ne vraća do 12 mjeseci nakon liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE/PAKIRANJE
English: In a controlled clinical trial in MS patients recently treated with beta interferon and glatiramer acetate were required to discontinue treatment 28 days before initiating treatment with LEMTRADA.
Croatian: U kontroliranom kliničkom ispitivanju, bolesnici s MS-om nedavno liječeni beta interferonom ili glatiramer acetatom, morali su prekinuti liječenje 28 dana prije početka liječenja lijekom LEMTRADA.
English: There is a limited amount of data from the use of alemtuzumab in pregnant women.
Croatian: Ograničeni su podaci o primjeni alemtuzumaba u trudnica.
English: The most frequent side effects are infusion reactions (see below for information on how often patients experience these), which can happen at the time of the infusion or within 24 hours after the infusion.
Croatian: Najčešće nuspojave su reakcije na infuziju (pogledajte u nastavku informacije o tome koliko se često javljaju u bolesnika), koje se mogu pojaviti tijekom infuzije ili unutar 24 sata nakon nje.
English: Many patients experience side effects at the time of the infusion or within 24 hours after the infusion with LEMTRADA, and some of these, for example dizziness, could make it unsafe to drive or use machines.
Croatian: Mnogi bolesnici doživjeli su nuspojave u vrijeme infuzije ili unutar 24 sata nakon infuzije lijeka LEMTRADA, a neke od tih nuspojava, primjerice omaglica, mogu upravljanje vozilima i strojevima učiniti nesigurnim.
English: LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
Croatian: LEMTRADA sadrži djelatnu tvar alemtuzumab, koji se upotrebljava za liječenje onog oblika multiple skleroze (MS) u odraslih osoba, koji nazivamo relapsno-remitentna multipla skleroza (RRMS).
English: LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Croatian: LEMTRADA se isporučuje u prozirnoj staklenoj bočici od 2 ml, s butilnim gumenim čepom i aluminijskim zaštitnim zatvaračem s plastičnom flip-off kapicom.
English: The observation time should be extended (hospitalisation) as appropriate.
Croatian: Vrijeme nadziranja se prema potrebi treba produljiti (hospitalizacija).
English: Very commonly, patients have experienced an autoimmune disorder of the thyroid gland affecting its ability to make or control hormones that are important for your metabolism.
Croatian: U bolesnika se vrlo često javio autoimuni poremećaj štitnjače koji je utjecao na njezinu sposobnost stvaranja ili kontrole hormona važnih za metabolizam.
English: However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the suckling newborn/infant.
Croatian: koristi od imuniteta stečenog kroz majčino mlijeko mogu nadilaziti rizike od potencijalne izloženosti dojenog novorođenčeta/dojenčeta alemtuzumabu.
English: Alemtuzumab was detected in the milk and offspring of lactating female mice.
Croatian: Alemtuzumab je otkriven u mlijeku i mladunčadi ženki miševa tijekom dojenja.
English: Treatment consists of discontinuation of the medicinal product and supportive therapy.
Croatian: Liječenje se sastoji od prekida primjene lijeka i suportivnog liječenja.
English: Thyroid disease (see section 4.4 Thyroid Disorders) poses special risks in women who are pregnant.
Croatian: Bolest štitnjače (vidjeti dio 4.4 Poremećaji štitnjače) predstavlja poseban rizik za trudnice.
English: Patients and physicians should be made aware of the potential later onset of autoimmune disorders after the 48 months monitoring period.
Croatian: Bolesnike i liječnike je potrebno upozoriti na mogući kasniji nastanak autoimunih poremećaja i nakon razdoblja praćenja od 48 mjeseci.
English: Infections were generally of typical duration and resolved following conventional medical treatment.
Croatian: Infekcije su u načelu bile uobičajenog trajanja, a povukle su se nakon standardne terapije.
English: Data from clinical trials in MS has shown that adherence to the blood monitoring requirements and education relative to signs and symptoms of ITP has led to early detection and treatment of ITP with most cases responding to first-line medical therapy.
Croatian: Podaci iz kliničkih ispitivanja multiple skleroze pokazali su da pridržavanje zahtjeva za redovitom kontrolom krvne slike te edukacija o znakovima i simptomima ITP-a dovodi do ranog otkrivanja i liječenja ITP-a, koji u većini slučajeva reagira na prvu liniju liječenja.
English: Myocardial ischaemia**, myocardial infarction**
Croatian: ishemija miokarda**, infarkt miokarda**
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURSs)
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: CB9 8PU United Kingdom
Croatian: CB9 8PU
English: Water for injections
Croatian: • voda za injekcije
English: LEMTRADA does not cure MS, but it can reduce the number of MS relapses.
Croatian: LEMTRADA ne može izliječiti multiplu sklerozu, no može smanjiti broj relapsa multiple skleroze.
English: In clinical studies, patients treated with LEMTRADA had fewer relapses and were less likely to experience worsening of their disability compared to patients treated with a beta-interferon injected multiple times per week.
Croatian: U kliničkim su ispitivanjima bolesnici liječeni lijekom LEMTRADA imali smanjen broj relapsa te je kod njih postojala manja vjerojatnost pogoršanja onesposobljenosti u usporedbi s bolesnicima liječenim injekcijama beta-interferona više puta tjedno.
English: Serum concentrations were low or undetectable within approximately 30 days following each treatment course.
Croatian: Koncentracije u serumu bile su niske ili nemjerljive unutar približno 30 dana nakon svakog ciklusa liječenja.
English: As with other immunomodulatory therapies, caution should be exercised in initiating LEMTRADA therapy in patients with pre-existing and/or an on-going malignancy.
Croatian: Kao i kod svih ostalih imunomodulirajućih terapija, potreban je oprez prilikom započinjanja liječenja lijekom LEMTRADA u bolesnika s prethodno postojećom i/ili aktivnom malignom bolešću.
English: If you notice any of these signs or symptoms, call your doctor right away to report them.
Croatian: Ako primijetite bilo koji od navedenih znakova ili simptoma, odmah nazovite svog liječnika kako biste mu ih prijavili.
English: In addition, infections which can result in abnormalities of the cervix (the neck of the womb) are possible.
Croatian: Osim toga, moguće su i infekcije koje mogu dovesti do poremećaja na cerviksu (grliću maternice).
English: Some patients, if they have symptoms or signs of MS disease after the initial two courses, may receive one or two additional treatment courses consisting of one infusion per day for 3 days .
Croatian: Neki bolesnici, ukoliko imaju simptome ili znakove multiple skleroze nakon početna dva ciklusa, mogu primiti jedan ili dva dodatna ciklusa liječenja koji se sastoje od jedne infuzije na dan tijekom 3
English: Until 4 years after your last LEMTRADA infusion
Croatian: Do 4 godine nakon posljednje infuzije lijeka LEMTRADA
English: The autoimmune conditions can occur many years after treatment with LEMTRADA.
Croatian: Autoimune bolesti mogu se pojaviti i više godina nakon liječenja lijekom LEMTRADA.
English: If you have not completed the standard required vaccinations, your doctor will consider whether you should have them before your LEMTRADA treatment.
Croatian: Ako niste primili sva standardna obavezna cijepljenja, Vaš će liječnik razmotriti trebate li ih primiti prije liječenja lijekom LEMTRADA.
English: Acute acalculous cholecystitis is a condition that may be associated with high morbidity and mortality rates if not diagnosed early and treated.
Croatian: Akutni akalkulozni kolecistitis je stanje koje može biti povezano s visokim stopama morbiditeta i mortaliteta ako se rano ne dijagnosticira i liječi.
English: Screening for tuberculosis will be arranged by your doctor.
Croatian: Vaš će liječnik organizirati probir na tuberkulozu.
English: Get help right away if you have any of the following symptoms of bleeding in the lung: trouble breathing, coughing up blood, chest pain, facial drooping, sudden severe headache, weakness on one side of the body, difficulty with speech or neck pain.
Croatian: Odmah potražite pomoć ako imate neki od sljedećih simptoma krvarenja u plućima: poteškoće s disanjem, iskašljavanje krvi, bol u prsima, opuštanje mišića lica, nagle teške glavobolje, slabost u jednoj strani tijela, poteškoće s govorom ili bol u vratu.
English: The reported thrombocytopenia occurred within the first days after the infusion (unlike ITP).
Croatian: Prijavljena trombocitopenija pojavila se unutar prvih nekoliko dana nakon infuzije (za razliku od ITP).
English: High titer anti-alemtuzumab antibodies observed in some patients were associated with incomplete lymphocyte depletion following a third or fourth treatment course, but there was no clear impact of anti-alemtuzumab antibodies on the clinical efficacy or safety profile of LEMTRADA.
Croatian: Visok titar protutijela na alemtuzumab opažen kod nekih bolesnika bio je povezan s nepotpunom deplecijom limfocita nakon trećeg i četvrtog ciklusa liječenja, ali nije bilo jasnog utjecaja protutijela na alemtuzumab na kliničku djelotvornost i sigurnosni profil lijeka LEMTRADA.
English: In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Croatian: U majki s Gravesovom bolešću, majčina protutijela koja stimuliraju receptore hormona štitnjače mogu se prenijeti na plod u razvoju i uzrokovati prolaznu neonatalnu Gravesovu bolest.
English: Clinical manifestations of nephropathy may include elevation in serum creatinine, haematuria, and/or proteinuria.
Croatian: Kliničke manifestacije nefropatije mogu uključivati povišene razine kreatinina u serumu, hematuriju i/ili proteinuriju.
English: Patients with severe active infection until complete resolution.
Croatian: Bolesnici s teškom aktivnom infekcijom sve do potpunog izlječenja.
English: Alemtuzumab is an IgG1 kappa antibody with human variable framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal antibody.
Croatian: Alemtuzumab je IgG1 kapa protutijelo s humanim varijabilnim okvirom i konstantnim regijama te komplementarnim određenim regijama murinog (štakorskog) monoklonskog protutijela.
English: HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation.
Croatian: HLH je po život opasan sindrom patološke aktivacije imunološkog sustava karakteriziran kliničkim znakovima i simptomima iznimno jake sistemske upale.
English: SC IFNB-1a (N=202)
Croatian: s.c. IFNB-1a (N=202)
English: Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici bočice iza oznake „EXP“.
English: Any spillage or waste material should be disposed of in accordance with local requirements.
Croatian: Sve izljeve ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Follow-up of patients
Croatian: Praćenje bolesnika
English: • excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis)
Croatian: • pretjerana aktivacija bijelih krvnih stanica koja se povezuje s upalom (hemofagocitna limfohistiocitoza)
English: Details about the signs and symptoms, testing, and actions you need to take are described in sections 2 and 4autoimmune conditions.
Croatian: Pojedinosti o znakovima i simptomima te pretragama i mjerama koje trebate provoditi opisane su u dijelovima 2 i 4. - autoimune bolesti.
English: An additional 12 serious events of ITP has been observed through a median of 6.1 years (maximum 12 years) of follow-up (cumulative annualised rate of 2.8 events/1000 patient years).
Croatian: Dodatnih 12 ozbiljnih slučajeva ITP-a opaženo je kroz medijan praćenja od 6,1 godine (maksimalno 12 godina) (kumulativna godišnja stopa od 2,8 događaja/1000 bolesnik-godina).
English: Patients with new or enlarging T2 lesions through Year 2
Croatian: Bolesnici s novim ili povećanim T2 lezijama tijekom 2. godine
English: To help reduce the risk of some infections your doctor may consider giving you vaccination against chickenpox and/or other vaccinations that they think are necessary for you (see section 2: What you need to know before you are administered LEMTRADA - Vaccines).
Croatian: • otečene žlijezde Da bi smanjio rizik od određenih infekcija, liječnik će možda razmotriti da Vas cijepi protiv vodenih kozica i/ili primijeni druga cjepiva za koja smatra da su Vam potrebna (pogledajte dio 2.: Što morate znati prije nego počnete primati lijek LEMTRADA - cjepiva).
English: LEMTRADA depletes circulating T and B lymphocytes after each treatment course with the lowest observed values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3 studies).
Croatian: LEMTRADA smanjuje broj cirkulirajućih T i B limfocita nakon svakog ciklusa liječenja, pri čemu se najniže vrijednosti bilježe mjesec dana nakon ciklusa liječenja (najranija vremenska točka nakon liječenja u ispitivanjima faze 3).
English: The table below is based on the pooled safety data on all LEMTRADA 12 mg-treated patients during all available follow up in clinical trials.
Croatian: Tablica u nastavku temelji se na objedinjenim podacima o sigurnosti primjene u svih bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg tijekom svih dostupnih praćenja u kliničkim ispitivanjima.
English: • Other serious reactions occurring shortly after LEMTRADA infusion
Croatian: • Druge ozbiljne reakcije koje se javljaju nedugo nakon primjene infuzije lijeka LEMTRADA
English: The European Medicines Agency has deferred the obligation to submit the results of studies with LEMTRADA in one or more subsets of the paediatric population in RRMS (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka LEMTRADA u jednoj ili više podskupina pedijatrijske populacije u RRMS-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Most thyroid events were managed with conventional medical therapy however some patients required surgical intervention.
Croatian: Većina događaja povezanih sa štitnjačom liječena je standardnom medikamentoznom terapijom, no u nekih je bolesnika bila potrebna kirurška intervencija.
English: The symptoms you experience are determined by which part of your central nervous system is affected.
Croatian: Koji će se simptomi javiti ovisi o tome koji dio središnjeg živčanog sustava bolest zahvaća.
English: • heart attack
Croatian: • moždani udar
English: Treatment with LEMTRADA may increase the risk of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early.
Croatian: Liječenje lijekom LEMTRADA može povećati rizik od pretjerane aktivacije bijelih krvnih stanica koja se povezuje s upalom (hemofagocitna limfohistiocitoza), a može biti smrtonosna ukoliko se rano ne otkrije i liječi.
English: 2.0/1.6 years
Croatian: 2/1,6 godine
English: Listeriosis/Listeria meningitis has been reported in LEMTRADA treated patients, generally within one month of LEMTRADA infusion.
Croatian: Listerioza/meningitis uzrokovan listerijom prijavljeni su u bolesnika liječenih lijekom LEMTRADA, uglavnom unutar jednog mjeseca nakon infuzije lijeka LEMTRADA.
English: Data reflect the percentage of patients whose test results were considered positive for antibodies to alemtuzumab using an enzyme-linked immunosorbent assay (ELISA) and confirmed by a competitive binding assay.
Croatian: Podaci odražavaju postotak bolesnika u kojih su rezultati imunoenzimskog testa (ELISA) bili pozitivni na protutijela na alemtuzumab i potvrđeni testom kompetitivnog vezivanja.
English: o Perform laboratory tests (complete blood count with differential, serum transaminases, serum creatinine, test of thyroid function and urinanalysis with microscopy).
Croatian: o Potrebno je napraviti laboratorijske pretrage (kompletna krvna slika s diferencijalnom krvnom slikom, serumske transaminaze, kreatinin u serumu, test funkcije štitnjače i mikroskopska analiza mokraće).
English: Thyroid disease poses special risks in women who are pregnant (see section 4.6).
Croatian: Bolest štitnjače predstavlja poseban rizik u trudnica (vidjeti dio 4.6).
English: Doses of LEMTRADA greater than those tested in clinical studies may increase the intensity and/or duration of infusion-associated adverse reactions or its immune effects.
Croatian: LEMTRADA veće od onih ispitivanih u kliničkim ispitivanjima mogu pojačati intenzitet i/ili produljiti trajanje reakcija povezane s infuzijom ili njihove učinke na imunološki sustav.
English: For these patients, the ARR declined from 0.79 in the year prior to Course 3 to 0.18 one year after, and the mean EDSS score from 2.89 to 2.69.
Croatian: Za te bolesnike, ARR se smanjio od 0,79 u godini prije početka ciklusa 3 do 0,18 nakon jedne godine, te se srednja vrijednost EDSS rezulata smanjila od 2,89
English: Some patients have developed liver inflammation after receiving LEMTRADA.
Croatian: Neki bolesnici su razvili upalu jetre nakon što su primili lijek LEMTRADA.
English: From a microbiological point of view, it is recommended that the product should be used immediately.
Croatian: S mikrobiološkog stajališta, preporučuje se lijek odmah primijeniti.
English: SC IFNB-1a (N=187)
Croatian: s.c. IFNB-1a (N=187)
English: Autoimmune hepatitis and hepatic injury
Croatian: Autoimuni hepatitis i oštećenje jetre
English: MS is an autoimmune disease that affects the central nervous system (brain and spinal cord).
Croatian: Multipla skleroza je autoimuna bolest koja utječe na središnji živčani sustav (mozak i kralježničnu moždinu).
English: For intravenous administration, withdraw 1.2 ml of LEMTRADA from the vial into a syringe using aseptic technique.
Croatian: Za intravensku primjenu izvucite 1,2 ml lijeka LEMTRADA iz bočice u štrcaljku primjenom aseptičke tehnike.
English: How LEMTRADA works
Croatian: Kako LEMTRADA djeluje
English: The percentage of patients with new or enlarging T2 lesions declined from 50.8% the year prior to Course 3 to 35.9% one year after, and new gadolinium-enhancing lesions from 32.2% to 11.9%.
Croatian: Postotak bolesnika sa novim ili povećanim T2 lezijama se smanjio se s 50,8% u godini prije početka ciklusa 3 na 35,9% nakon jedne godine, i nove lezije naglašene gadolinijem sa 32,2% na
English: This medicinal product must not be diluted with other solvents.
Croatian: Lijek se ne smije razrjeđivati drugim otapalima.
English: Approximately half (51.2%) of patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 who enrolled in Study 4, received only the initial 2 courses of LEMTRADA and no other disease modifying treatment throughout 6 years of follow-up.
Croatian: Približno polovina (51,2%) bolesnika početno liječenih lijekom LEMTRADA u dozi od 12 mg/dan u Ispitivanjima 1 i 2 koji su pristupili Ispitivanju 4 primila je samo početna 2 ciklusa lijeka LEMTRADA i niti jedno drugo liječenje koje modificira tijek bolesti tijekom 6 godina praćenja.
English: 1 Patient Alert Card: For the patient to present to other healthcare providers to alert them to the use of LEMTRADA in this patient.
Croatian: 1 Kartica s upozorenjima za bolesnika: Bolesnik je mora pokazati drugim zdravstvenim radnicima, kako bi znali da taj bolesnik prima lijek LEMTRADA.
English: To reduce the risk of infection, patients receiving LEMTRADA should avoid ingestion of uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks prior to, during, and for at least one month after LEMTRADA infusion.
Croatian: Kako bi se smanjio rizik, od infekcije bolesnici koji primaju lijek LEMTRADA trebali bi izbjegavati uzimanje sirovog ili nedovoljno kuhanog mesa, mekanih sireva i nepasteriziranih mliječnih proizvoda dva tjedna prije, tijekom i barem mjesec dana nakon infuzije lijeka LEMTRADA.
English: • fever and/or chills
Croatian: • temperaturu i/ili zimicu
English: More helpful information about these autoimmune conditions (and the testing for them) can be found in the
Croatian: Više korisnih informacija o navedenim autoimunim bolestima (i pretragama za njihovo otkrivanje)
English: Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: • Increase in white blood cells counts such as neutrophils, eosinophils (different types of white blood cells) anaemia, decrease in percentage of red blood cells, easy or excessive bruising or bleeding,
Croatian: • povišen broj bijelih krvnih stanica kao što su neutrofili, eozinofili (različite vrste bijelih krvnih stanica), anemija, smanjen udio crvenih krvih stanica, lagano ili pretjerano stvaranje modrica ili krvarenje, oticanje limfnih čvorova
English: Clinically significant thrombocytopenia needs to be followed until resolution.
Croatian: Klinički značajna trombocitopenija treba se pratiti do izlječenja.
English: • abnormally heavy, prolonged or irregular menstruation
Croatian: • preobilna, dugotrajna ili neredovita mjesečnica