FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients continuing from controlled clinical studies and who did not receive any additional LEMTRADA after the initial 2 treatment courses, the rate (events per person-year) of most adverse reactions was comparable to or reduced in years 3-6 as compared to years 1 and 2.
Croatian: U bolesnika koji su nastavili liječenje iz kontroliranih kliničkih ispitivanja, a koji nisu dodatno primili lijek LEMTRADA nakon početna 2 ciklusa liječenja, stopa (nuspojave po osobi-godina) najčešćih nuspojava bila je usporediva ili smanjena od 3. do 6. godine u usporedbi s 1. i 2. godinom.
English: It is recommended that patients have completed local immunisation requirements at least 6 weeks prior to treatment with LEMTRADA.
Croatian: Preporučuje se da bolesnici dovrše sva cijepljenja predviđena lokalnim programom najmanje 6 tjedana prije liječenja lijekom LEMTRADA.
English: There is no evidence that LEMTRADA has an impact on male fertility.
Croatian: Nema dokaza da LEMTRADA utječe na plodnost u muškaraca.
English: Cardiac disorders Tachycardia* Bradycardia*, palpitations*
Croatian: Srčani poremećaji tahikardija* bradikardija*, palpitacije*
English: These tests must continue until 4 years after your last infusion and are described in section 4 most important side-effects.
Croatian: 4 godine nakon posljednje infuzije, a opisane su u dijelu 4. - najvažnije nuspojave.
English: Patients who were accidentally given too much LEMTRADA in one infusion have experienced serious reactions, such as headache, rash, low blood pressure or increased heart rate.
Croatian: U bolesnika koji su slučajno primili previše lijeka LEMTRADA u jednoj infuziji javile su se ozbiljne reakcije, poput glavobolje, osipa, niskog krvnog tlaka ili ubrzanih otkucaja srca.
English: Therefore, regardless of pretreatment anti-TPO antibody status patients may develop a thyroid adverse reaction and must have all tests periodically performed as described above.
Croatian: neovisno o statusu protutijela anti-TPO prije liječenja, bolesnici mogu razviti štetan događaj povezan sa štitnjačom pa se moraju provoditi redovito sva testiranja kako je prethodno opisano.
English: The cumulative annualised rate of infections was 0.99 through a median of 6.1 years (maximum 12 years) of follow-up from the first LEMTRADA exposure, as compared to 1.27 in controlled clinical trials.
Croatian: Kumulativna godišnja stopa infekcija bila je 0,99 kroz medijan praćenja od 6,1 godine (maksimalno 12 godina) od prvog izlaganja lijeku LEMTRADA, u usporedbi s 1,27 u kontroliranim kliničkim ispitivanjima.
English: • Complete blood count with differential, serum transaminases and serum creatinine levels (prior to treatment initiation and at monthly intervals thereafter).
Croatian: • Kompletna krvna slika s diferencijalnom krvnom slikom, serumske transaminaze i razina kreatinina u serumu (prije početka liječenja i u mjesečnim intervalima nakon toga)
English: • Infusion reactions
Croatian: • Reakcije na infuziju
English: Concomitant use of LEMTRADA with any of these therapies could increase the risk of immunosuppression.
Croatian: Istodobna primjena lijeka LEMTRADA s bilo kojim od navedenih lijekova može povećati rizik od imunosupresije.
English: In each year of Study 4, patients from both studies continued to show a low risk of forming new T2 (27.4% to 33.2%) or gadolinium-enhancing lesions (9.4% to 13.5%), and the median annual percent change in brain parenchymal fraction ranged from 0.19% to -0.09%.
Croatian: U svakoj godini tijekom Ispitivanja 4, bolesnici iz oba ispitivanja su nastavili pokazivati smanjen rizik od stvaranja novih T2 lezija (27,4% do 33,2%) ili lezija naglašenih gadolinijem (9,4% do 13,5%), te je medijan godišnje postotne promjene frakcije moždanog parenhima bio u rasponu od 0,19% do
English: Initiation of treatment with LEMTRADA should be delayed in patients with severe active infection until resolution.
Croatian: Početak liječenja lijekom LEMTRADA treba odgoditi u bolesnika s teškom aktivnom infekcijom sve do izlječenja.
English: Approximately 40% of patients had total lymphocyte counts reaching the lower limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total lymphocyte counts reaching the LLN by 12 months after each course.
Croatian: U približno 40% bolesnika, ukupan broj limfocita doseže donju granicu normale (DGN) do 6. mjeseca nakon svakog ciklusa liječenja, a u otprilike 80% bolesnika ukupan broj limfocita doseže DGN do 12. mjeseca nakon svakog ciklusa liječenja.
English: Referral to a haematologist for management should be considered.
Croatian: Treba se razmotriti upućivanje hematologu za njeno zbrinjavanje.
English: Table 1: Adverse reactions in study 1, 2, 3 and 4 observed in LEMTRADA 12 mg treated patients and post-marketing surveillance
Croatian: Tablica 1: Nuspojave u ispitivanjima 1, 2, 3 i 4 primijećene u bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg i nadzor nakon stavljanja lijeka u promet
English: Patients with new T1 hypointense lesions through Year 2
Croatian: Bolesnici s novim hipointenzivnim T1 lezijama tijekom 2. godine
English: Through 2 treatment courses, there was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions.
Croatian: Tijekom 2 ciklusa liječenja nije zabilježena veza između prisutnosti protutijela na alemtuzumab ili inhibicijskih protutijela na alemtuzumab i smanjena djelotvornosti, promjene farmakodinamike ili pojave nuspojava, uključujući reakcije povezane s infuzijom.
English: • autoimmune disorder characterized by bleeding (acquired haemophilia A)
Croatian: • autoimuni poremećaj kod kojeg se javlja krvarenje (stečena hemofilija A)
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: The ability to generate an immune response to any vaccine following LEMTRADA treatment has not been studied.
Croatian: Nije ispitana sposobnost stvaranja imunološkog odgovora ni na koje cjepivo nakon liječenja lijekom LEMTRADA.
English: Pack size: carton with 1 vial.
Croatian: Veličina pakiranja: kutija s 1 bočicom.
English: Duration
Croatian: Trajanje
English: Talk to your doctor before LEMTRADA is given.
Croatian: Obratite se liječniku prije nego primite lijek LEMTRADA.
English: • kidney disorders, (rare - may affect up to 1 in 1,000 people): may show as blood in the urine (your urine may be red or tea-coloured), or as swelling in your legs or feet.
Croatian: • poremećaji bubrega (rijetko - mogu se javiti u manje od 1 na 1000 osoba): može se manifestirati kao krv u mokraći (mokraća može biti crvena ili boje čaja), ili kao oticanje nogu ili stopala.
English: Similar improvements in ARR, mean EDSS score, and T2 and gadolinium-enhancing lesions were seen after Course 4 when compared with the prior year.
Croatian: Slična poboljšanja ARR-a, srednje vrijednosti EDSS rezultata, te T2 lezija i lezija naglašenih gadolinijem uočena su nakon ciklusa 4 u usporedbi sa prethodnom godinom.
English: Terms marked with two asterisks (**) in Table 1 include adverse reactions observed in the post marketing setting which have occurred in the majority of cases with time to onset within 1-3 days of LEMTRADA infusion, following any of the doses during the treatment course.
Croatian: Pojmovi označeni s dvije zvjezdice (**) u Tablici 1 obuhvaćaju nuspojave primijećene nakon stavljanja lijeka u promet, a koje su u najvećem broju slučajeva nastupile unutar 1-3 dana nakon primjene infuzije lijeka LEMTRADA, nakon bilo koje doze tijekom ciklusa liječenja.
English: Information from use of alemtuzumab prior to the marketing authorisation of LEMTRADA outside of company-sponsored studies
Croatian: Podaci o primjeni alemtuzumaba prije stavljanja u promet lijeka LEMTRADA prikupljene izvan ispitivanja koja je sponzorirala kompanija
English: The European Medicines Agency has waived the obligation to submit the results of studies with alemtuzumab in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s alemtuzumabom kod djece od rođenja do manje od 10 godina u liječenju multiple skleroze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections.
Croatian: Najčešće nuspojave lijeka LEMTRADA (u ≥ 20% bolesnika) bile su osip, glavobolja, pireksija i infekcije dišnih puteva.
English: Patients should be informed about symptoms of HLH and time to onset.
Croatian: Bolesnike treba informirati o simptomima HLH i vremenu do njihovog nastanka.
English: Cases of cervicocephalic arterial dissections, including multiple dissections, have been reported both within the first days after the LEMTRADA infusion or later on within the first month after the infusion.
Croatian: Disekcija cervikocefaličnih arterija Slučajevi disekcija cervikocefaličnih arterija, uključujući višestruke disekcije, prijavljeni su unutar prvih nekoliko dana nakon infuzije lijeka LEMTRADA te kasnije, unutar prvih mjesec dana nakon primjene.
English: Patients typically present with spontaneous subcutaneous haematomas and extensive bruising although haematuria, epistaxis, gastrointestinal or other types of bleeding may occur.
Croatian: Kod bolesnika su obično prisutni spontani supkutani hematomi i pojačano stvaranje modrica iako se mogu pojaviti hematurija, epistaksa, gastrointestinalno ili druge vrste krvarenja.
English: • First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose)
Croatian: • Prvi ciklus liječenja: 12 mg/dan tijekom 5 uzastopnih dana (ukupna doza 60 mg)
English: LEMTRADA may increase your chance of getting inflammation of the gallbladder.
Croatian: LEMTRADA može povećati mogućnost da razvijete upalu žučnog mjehura.
English: • Acquired haemophilia A (a type of bleeding disorder), (uncommon - may affect up to 1 in 100
Croatian: • Stečena hemofilija A (vrsta poremećaja krvarenja), (manje često - može se javiti u manje od 1
English: Specialists and equipment required for the timely diagnosis and management of adverse reactions, especially myocardial ischaemia and myocardial infarction, cerebrovascular adverse reactions, autoimmune conditions, and infections, should be available.
Croatian: Specijalisti i oprema potrebni za pravovremenu dijagnozu i liječenje nuspojava, naročito ishemije miokarda i infarkta miokarda, cerebrovaskularnih nuspojava, autoimunih stanja i infekcija, moraju biti dostupni.
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years.
Croatian: Bolesnici s aktivnom multiplom sklreozom, definiranom kao najmanje 2 relapsa unutar prethodne dvije godine
English: After having a course of treatment with LEMTRADA you may be at greater risk of developing other autoimmune conditions, or experiencing serious infections.
Croatian: Nakon ciklusa liječenja lijekom LEMTRADA, može postojati povećan rizik od razvoja drugih autoimunih stanja ili ozbiljnih infekcija.
English: Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with LEMTRADA (see also under ‘Infections' in section 4.4).
Croatian: U svih se bolesnika mora primijeniti peroralna profilaksa za infekciju herpesom, koja počinje prvog dana svakog ciklusa liječenja i traje još najmanje mjesec dana nakon liječenja lijekom LEMTRADA (vidjeti i "Infekcije" u dijelu 4.4).
English: In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Croatian: U kliničkim su ispitivanjima bolesnici dobivali aciklovir u dozi od 200 mg dvaput na dan ili ekvivalent.
English: Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years).
Croatian: Ozbiljni slučajevi ITP-a zabilježeni su u 12 (1%) liječenih bolesnika u kontroliranim kliničkim ispitivanjima multiple skleroze (odgovara godišnjoj stopi od 4,7 slučaja/1000 bolesnik-godina).
English: Symptoms of ITP could include (but are not limited to) easy bruising, petechiae, spontaneous mucocutaneous bleeding (e.g., epistaxis, haemoptysis), heavier than normal or irregular menstrual bleeding.
Croatian: Simptomi ITP-a mogu uključivati (no nisu ograničeni na) podložnost nastanku modrica, petehije, spontano krvarenje iz sluznica (npr. epistaksa, hemoptiza), menstrualno krvarenje koje je obilnije nego uobičajeno ili neredovito.
English: If ITP onset is confirmed, appropriate medical intervention should be promptly initiated, including immediate referral to a specialist.
Croatian: Ako se ITP potvrdi, treba odmah započeti s odgovarajućom medicinskom intervencijom, uključujući trenutačno upućivanje bolesnika specijalistu.
English: o Platelet count should be obtained immediately after infusion on Days 3 and 5 of the first infusion course, as well as immediately after infusion on Day 3 of any subsequent course.
Croatian: Potrebno je napraviti pretragu broja trombocita neposredno nakon infuzije 3. i 5. dan prvog ciklusa liječenja, kao i neposredno nakon infuzije 3. dan bilo kojeg sljedećeg ciklusa liječenja.
English: Several of the patient reported were below 50 years of age and had no history of hypertension, bleeding disorders or concomitant anticoagulants or platelet inhibitors.
Croatian: Nekoliko bolesnika kod kojih je prijavljen hemoragijski moždani udar bilo je mlađe od 50 godina i nisu imali u povijesti bolesti hipertenziju, poremećaj krvarenja ili istodobnu primjenu antikoagulansa ili inhibitora aktivacije trombocita.
English: The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed (see posology) with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course.
Croatian: Preporučuje se liječenje u obliku početnog liječenja od 2 ciklusa te ako je potrebno do 2 dodatna ciklusa liječenja (vidjeti doziranje), uz praćenje bolesnika radi utvrđivanja sigurnosti od početka prvog ciklusa liječenja najmanje do 48 mjeseci nakon posljednje infuzije drugog ciklusa liječenja.
English: Educational programme Prior to launch in each Member State the MAH shall agree an educational programme for HCPs and patients with the National Competent Authority.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti edukacijski program za zdravstvene radnike i bolesnike.
English: If you develop one or more of the following symptoms report this to your doctor: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, or bleeding or bruising more easily than normal.
Croatian: Ako se kod Vas razvije jedan ili više navedenih simptoma obavijestite svog liječnika: mučnina, povraćanje, bol u trbuhu, umor, gubitak apetita, žuta boja kože ili očiju, tamna mokraća te ako krvarite ili Vam se lakše stvaraju modrice nego što je to uobičajeno.
English: Additionally, the observed incidence of antibody (including inhibitory antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicines, and underlying disease.
Croatian: Osim toga, na opaženu incidenciju pozitivnih nalaza protutijela (uključujući inhibicijska protutijela) može utjecati nekoliko čimbenika, uključujući metodologiju testiranja, rukovanje uzorkom, vrijeme prikupljanja uzorka,
English: In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
Croatian: podispitivanju, u kojem je sudjelovalo 13 bolesnika muškoga spola liječenih lijekom LEMTRADA (u dozama od 12 mg ili 24 mg), nisu pronađeni dokazi aspermije, azoospermije, stalno smanjenog broja spermija, poremećaja pokretljivosti niti povećanja morfoloških anomalija spermija.
English: Patients should be informed about the risk of autoimmune hepatitis, hepatic injury and related symptoms.
Croatian: Bolesnici trebaju biti upućeni u rizik od autoimunog hepatitisa, oštećenja jetre i prateće simptome.
English: LEMTRADA has not been administered for treatment of MS concomitantly with or following antineoplastic or immunosuppressive therapies.
Croatian: LEMTRADA se za liječenje multiple skleroze nije primjenjivala istodobno s antineoplastičnim ili imunosupresivnim lijekovima, niti nakon njih.
English: You should report to your doctor symptoms like shortness of breath, cough, wheezing, chest pain or tightness and coughing up blood, as these could be caused by pneumonitis.
Croatian: Trebate prijaviti svom liječniku simptome kao što su nedostatak zraka, kašalj, zviždanje pri disanju, bol ili stezanje u prsnom košu i iskašljavanje krvi jer oni mogu biti uzrokovani pneumonitisom.
English: It is important that you keep the Patient Alert Card with you during treatment and for 4 years after your last infusion with LEMTRADA, because side effects may occur many years after treatment.
Croatian: Važno je da tijekom liječenja i 4 godine nakon posljednje infuzije lijeka LEMTRADA sa sobom nosite Karticu za bolesnika, jer se nuspojave mogu pojaviti i više godina nakon liječenja.
English: The treatment consists of stopping LEMTRADA administration and treating the symptoms.
Croatian: Liječenje se sastoji od prekida primjene lijeka LEMTRADA i liječenja tih simptoma.
English: = 205) and 0.51 (95% CI: 0.40, 0.64) in the IFNB-1a group (n = 102) (p<0.0001).
Croatian: (95% CI: 0,40; 0,64) u skupini liječenoj s IFNB-1a (n = 102) (p<0,0001).
English: LEMTRADA may cause different types of thyroid disorders, including: Over-active thyroid gland (hyperthyroidism) when the thyroid produces too much hormone Under-active thyroid gland (hypothyroidism) when the thyroid does not produce enough hormone.
Croatian: LEMTRADA može uzrokovati različite vrste poremećaja štitnjače, uključujući: prekomjernu aktivnost štitnjače (hipertireozu), kod koje štitnjača stvara previše hormona premalu aktivnost štitnjače (hipotireozu), kod koje štitnjača ne stvara dovoljno hormona.
English: • Infections
Croatian: • Infekcije
English: Therefore, regular blood and urine tests are needed until 4 years after your last infusion.
Croatian: Stoga je potrebno provoditi redovite pretrage krvi i mokraće još 4 godine nakon posljednje infuzije.
English: Some of the IARs (e.g. dizziness) could temporarily impact the patient's ability to drive or use machines and caution should be exercised until these are resolved.
Croatian: Neke od reakcija povezanih s infuzijom (npr. omaglica) mogle bi privremeno utjecati na bolesnikovu sposobnost upravljanja vozilima ili rada sa strojevima, pa je potreban oprez do prestanka istih.
English: Patients treated with LEMTRADA must be given the Package Leaflet, the Patient Alert Card and the Patient Guide.
Croatian: Bolesnicima koji se liječe lijekom LEMTRADA mora se dati uputa o lijeku, Kartica za bolesnika i Vodič za bolesnika.
English: Treatment may result in the formation of autoantibodies and increase the risk of autoimmune mediated conditions which may be serious and life threatening.
Croatian: Liječenje može dovesti do stvaranja protutijela na vlastiti organizam i povećati rizik od razvoja autoimuno posredovanih stanja koja mogu biti ozbiljna i opasna po život.
English: Duration of extension
Croatian: Trajanje nastavka
English: If an additional course is administered, safety-follow up should be continued until at least 48 months after the last infusion.
Croatian: Ako se primjenjuje dodatni ciklus, praćenje sigurnosti se treba nastaviti do najmanje 48 mjeseci nakon posljednje infuzije.
English: Patients treated with LEMTRADA have had infections due to a virus called Epstein-Barr virus (EBV), including cases with severe liver inflammation.
Croatian: U bolesnika liječenih lijekom LEMTRADA zabilježene su infekcije uzrokovane virusom zvanim Epstein-Barr virus (EBV), uključujući i slučajeve teške upale jetre.
English: Signs and symptoms of ITP are described in section 4.
Croatian: Znakovi i simptomi ITP-a opisani su u dijelu 4.
English: Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the 21-28 kD cell surface glycoprotein CD52.
Croatian: Alemtuzumab je humanizirano monoklonsko protutijelo dobiveno tehnologijom rekombinantne DNK, usmjereno na glikoprotein CD52 molekularne težine 21-28 kD, koji se nalazi na staničnoj površini.
English: Patients treated with LEMTRADA must be given the Patient Alert Card and Patient Guide and be informed about the risks of LEMTRADA (see also package leaflet).
Croatian: Bolesnici liječeni lijekom LEMTRADA moraju dobiti Karticu za bolesnika i Vodič za bolesnike te moraju biti informirani o rizicima povezanima s lijekom LEMTRADA (vidjeti, također, uputu o lijeku).
English: These tests are done to see whether you may take LEMTRADA.
Croatian: Te se pretrage provode kako bi se utvrdilo možete li uzimati lijek LEMTRADA.
English: During post-marketing use, HLH (including fatal cases) has been reported in patients treated with LEMTRADA.
Croatian: Tijekom primjene lijeka nakon stavljanja u promet, HLH (uključujući slučajeve sa smrtnim ishodom) je prijavljena u bolesnika liječenih lijekom LEMTRADA.
English: Infusion instructions to reduce serious reactions temporally associated with LEMTRADA infusion
Croatian: Upute za infuziju radi smanjivanja ozbiljnih nuspojava vremenski povezanih s infuzijom lijeka LEMTRADA
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
Croatian: Bolesnike u kojih se razviju rani znaci patološke aktivacije imunološkog sutava treba odmah pregledati te uzeti u obzir moguću dijagnozu HLH.
English: Patients should be advised to report symptoms of pneumonitis, which may include shortness of breath, cough, wheezing, chest pain or tightness and hemoptysis.
Croatian: Bolesnike treba savjetovati da prijave simptome pneumonitisa, što može uključivati nedostatak zraka, kašalj, piskanje pri disanju, bol ili stezanje u prsnom košu i hemoptizu.
English: Do not shake the vials prior to use.
Croatian: NE TRESTI BOČICE PRIJE UPORABE.
English: Monitoring for side effects and regular testing must continue for 4 years after the last infusion.
Croatian: Praćenje zbog mogućih nuspojava i redovite pretrage moraju se provoditi još 4 godine nakon posljednje infuzije.
English: To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination.
Croatian: Da bi cijepljenje protiv VZV-a bilo potpuno učinkovito, liječenje lijekom LEMTRADA treba odgoditi za 6 tjedana nakon cijepljenja.
English: Therefore, it is recommended that all female patients have an annual screening performed, such as a cervical smear.
Croatian: Stoga se preporučuje da se u svih bolesnica jednom godišnje provede probir, primjerice uzme bris cerviksa.
English: Insomnia*, anxiety, depression
Croatian: Psihijatrijski poremećaji nesanica*, anksioznost, depresija