FrancophonIA/ELRC3.0 huggingface dataset:
English: LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.
Croatian: LEMTRADA nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina, jer nije ispitivana u bolesnika s multiplom sklerozom mlađih od 18 godina.
English: However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
Croatian: No istraživanja ukazuju na imunomodulatorne učinke putem deplecije i repopulacije limfocita, uključujući:
English: E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
Croatian: E339, dinatrijev edetat, E508, E340, E433, natrijev klorid, voda za injekcije
English: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgium
Croatian: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgija
English: The majority of these may be due to cytokine release during infusion.
Croatian: Većina tih reakcija može biti uzrokovana otpuštanjem citokina tijekom infuzije.
English: Follow-up month
Croatian: Mjesec praćenja
English: Doses higher than the recommended dose may result in more serious or longer lasting infusion reactions (see section 4) or a stronger effect on the immune system.
Croatian: Doze veće od preporučenih mogu prouzročiti ozbiljnije ili dugotrajnije reakcije na infuziju (vidjeti dio 4.) ili jači utjecaj na imunološki sustav.
English: In most cases, these are mild but serious infections can occur.
Croatian: U većini su slučajeva blage, no mogu se razviti i ozbiljne infekcije.
English: The initial treatment you will receive will consist of one infusion per day for 5 days (course 1) and one infusion per day for 3 days one year later (course 2).
Croatian: Početno liječenje koje ćete primati sastojat će se od jedne infuzije na dan tijekom 5 dana (1. ciklus) i jedne infuzije na dan tijekom 3 dana godinu kasnije (2.ciklus).
English: Recommended laboratory tests for monitoring patients
Croatian: Preporučene laboratorijske pretrage za praćenje bolesnika
English: Animal data have shown effects on fertility in humanised mice (see section 5.3), however a potential impact on human fertility during the period of exposure is unknown based on the available data.
Croatian: Podaci dobiveni na životinjama pokazali su učinke na plodnost u humaniziranih miševa (vidjeti dio 5.3), no na temelju dostupnih podataka nije poznat potencijalan utjecaj na plodnost u ljudi tijekom razdoblja izloženosti.
English: It can also help to slow down or reverse some of the signs and symptoms of MS.
Croatian: Također može pomoći usporiti napredak nekih znakova i simptoma multiple skleroze ili ih ukloniti.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • sensation of spinning or loss of balance, migraine
Croatian: • osjećaj vrtnje ili gubitak ravnoteže, migrena
English: In clinical trials, there were 2 cases of anti-GBM disease.
Croatian: U kliničkim su ispitivanjima zabilježena dva slučaja anti-GBM bolesti.
English: It is very important that you are properly treated for a thyroid disorder, especially if you become pregnant after using LEMTRADA.
Croatian: Vrlo je važno da se poremećaj štitnjače pravilno liječi, osobito ako zatrudnite nakon što ste uzimali lijek LEMTRADA.
English: Reactions may occur following any of the doses during the treatment course.
Croatian: Reakcije se mogu javiti nakon bilo koje doze tijekom ciklusa liječenja.
English: Missed doses should not be given on the same day as a scheduled dose.
Croatian: Propuštene doze ne smiju se primijeniti istoga dana kada i doza predviđena po rasporedu.
English: Early detection and treatment of nephropathies may decrease the risk of poor outcomes.
Croatian: Rano otkrivanje i liječenje nefropatija može smanjiti rizik od loših ishoda.
English: A clear, colourless to slightly yellow concentrate with pH 7.0 - 7.4.
Croatian: Bistar, bezbojan do blijedožuti koncentrat pH vrijednosti od 7,0 - 7,4.
English: Each vial is intended for single use only.
Croatian: Jedna je bočica namijenjena samo za jednokratnu uporabu.
English: During post-marketing use, rare, serious, sometimes fatal and unpredictable adverse events from various organ systems have been reported.
Croatian: Tijekom primjene lijeka nakon stavljanja u promet prijavljeni su slučajevi rijetkih, ozbiljnih, ponekad smrtonosnih i nepredvidivih štetnih događaja vezanih uz razne organske sustave.
English: • During infusion: o Perform continuous/frequent (at least every hour) monitoring of heart rate, blood pressure and overall clinical status of the patients Discontinue the infusion
Croatian: • Tijekom infuzije: o Potrebno je kontinuirano/često (barem svakih sat vremena) nadzirati puls, krvni tlak i ukupno kliničko stanje bolesnika Infuziju je potrebno prekinuti
English: • tears in carotid or vertebral arteries (blood vessels supplying the brain)
Croatian: • rascjepi u karotidnim ili vertebralnim arterijama (krvne žile koje opskrbljuju mozak)
English: 1 Co-primary endpoints: ARR & CDW.
Croatian: 1 Primarni ishodi: ARR i CDW.
English: ‡ Study primary endpoint was scored at 3 years.
Croatian: ‡ Mjera primarnog ishoda ispitivanja je postignuta u 3 godine.
English: There are no adequate clinical safety data on the effect of LEMTRADA on fertility.
Croatian: Nema odgovarajućih kliničkih sigurnosnih podataka o učinku lijeka LEMTRADA na plodnost.
English: CAMMS323 (CARE-MS I)
Croatian: CAMMS323 (CARE-MS
English: Other treatments to limit these reactions can also be given before the infusion or when you experience symptoms.
Croatian: Za ograničavanje navedenih reakcija mogu se dati i drugi lijekovi, i to prije infuzije ili kada se pojave simptomi.
English: Alemtuzumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Croatian: Alemtuzumab je protein za koji se očekuje metabolizam razgradnjom u male peptide i pojedinačne aminokiseline putem široko rasprostranjenih proteolitskih enzima.
English: Disease history
Croatian: Povijest bolesti
English: If you live in a region where tuberculosis infections are common, you may be at greater risk of infection with tuberculosis.
Croatian: Ako živite u području u kojem je česta tuberkuloza, rizik da dobijete tuberkulozu za Vas može biti povećan.
English: You will also find this information in the Patient Alert Card and Patient Guide that you have been given by your doctor.
Croatian: Ove informacije pronaći ćete i u Kartici za bolesnika te Vodiču za bolesnike koje Vam je dao liječnik.
English: Patients with 6-month CDW (95% CI)
Croatian: Bolesnici sa 6-mjesečnim CDW-om (95% CI)
English: Active and latent tuberculosis, including a few cases of disseminated tuberculosis, have been reported in 0.3% of the patients treated with LEMTRADA, most often in endemic regions.
Croatian: Aktivna i latentna tuberkuloza, uključujući i nekoliko slučajeva diseminirane tuberkuloze, zabilježene su u 0,3% bolesnika liječenih lijekom LEMTRADA, najčešće u endemskim regijama.
English: • Other medicinal products should not be added to the LEMTRADA infusion solution or simultaneously infused though the same intravenous line.
Croatian: • Drugi lijekovi ne smiju se miješati s LEMTRADA otopinom za infuziju niti istodobno primjenjivati istom intravenskom linijom.
English: Most events were mild to moderate in severity.
Croatian: Većina događaja bila je blage do umjerene težine.
English: As with all therapeutic proteins, there is potential for immunogenicity.
Croatian: Kao i svi terapijski proteini, ovaj je lijek potencijalno imunogen.
English: Symptoms have been reported to occur within a few months to four years following the initiation of treatment.
Croatian: Simptomi se javljaju unutar nekoliko mjeseci do četiri godine nakon započinjanja liječenja.
English: You should also continue looking for signs and symptoms of side effects beyond four years as detailed in your patient guide, and you should continue carrying the Patient Alert Card with you.
Croatian: Morate nastaviti pratiti pojavu znakova i simptoma nuspojava nakon više od četiri godine, kao što je detaljno opisano u Vašem vodiču za bolesnika, te morate i dalje sa sobom nositi karticu za bolesnika.
English: • It is extremely important that your patient understands the commitment to having periodic testing performed (for 4 years after last infusion) even if they are asymptomatic and their MS disease is well controlled.
Croatian: • Iznimno je važno da bolesnik razumije svoju obvezu da provodi periodične pretrage (tijekom 4 godine nakon posljednje infuzije), čak i ako nema simptoma i ako mu je multipla skleroza pod kontrolom.
English: • feelings of anxiety, depression
Croatian: • osjećaj tjeskobe, depresija
English: Another side effect is an increased risk of infections (see below for information on how often patients experience infections).
Croatian: Još jedna nuspojava je povećan rizik od infekcija (pogledajte u nastavku informacije o tome koliko često se u bolesnika javljaju infekcije).
English: If ITP is suspected a complete blood count should be obtained immediately.
Croatian: Ako se sumnja na ITP, treba odmah napraviti kompletnu krvnu sliku.
English: In general, once a patient has had a herpes infection, they have an increased risk of developing another one.
Croatian: Općenito, ukoliko je bolesnik u prošlosti dobio infekciju herpesom, sada ima povećani rizik od razvoja druge infekcije.
English: • decreased/weak immune system
Croatian: • oslabljen/slab imunološki sustav • tuberkuloza
English: The reduction in the level of circulating B and T cells by LEMTRADA and subsequent repopulation, may reduce the potential for relapse, which ultimately delays disease progression.
Croatian: Smanjenje razine cirkulirajućih B i T stanica primjenom lijeka LEMTRADA, te njihova kasnija repopulacija, mogu smanjiti mogućnost relapsa, što u konačnici usporava napredovanje bolesti.
English: Patients who develop autoimmunity should be assessed for other autoimmune mediated conditions (see section 4.3).
Croatian: Kod bolesnika koji razviju autoimunost treba procijeniti postojanje drugih stanja posredovanih autoimunošću (vidjeti dio 4.3).
English: It was noted that in some of the patients, blood pressure and /or heart rate was temporarily abnormal during the infusion.
Croatian: Primijećeno je da je u nekih bolesnika krvni tlak i/ili puls bio privremeno poremećen tijekom infuzije.
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC code: L04AA34
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA34
English: 3 years‡
Croatian: 3 godine‡
English: The damage done to your nerves during this inflammation may be reversible, but as your disease progresses the damage may accumulate and become permanent.
Croatian: Vaš živčani sustav pretrpi tijekom te upale može biti privremena, no s napretkom bolesti oštećenja se mogu nakupiti i postati trajna.
English: Other medicines and LEMTRADA
Croatian: Drugi lijekovi i LEMTRADA
English: • You should monitor their test results and remain vigilant for symptoms of adverse events.
Croatian: • Morate kontrolirati nalaze njihovih pretraga i pažljivo pratiti moguću pojavu simptoma nuspojava.
English: Genzyme Limited 37 Hollands Road Haverhill Suffolk
Croatian: Genzyme Limited 37 Hollands Road Haverhill
English: • potassium chloride (E508)
Croatian: • kalijev klorid (E508)
English: Reactions attributed to anaphylaxis have been reported rarely in contrast to infusion associated reactions.
Croatian: Reakcije koje se pripisuju anafilaksiji rijetko su prijavljene, za razliku od reakcija povezanih s infuzijom.
English: If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver), extra caution is needed before you receive LEMTRADA treatment as it is unknown if treatment could lead to activation of the hepatitis infection which could subsequently damage your liver.
Croatian: Ako ste nositelj infekcije hepatitisom B ili hepatitisom C (oni utječu na jetru), potreban je poseban oprez prije nego što primite liječenje lijekom LEMTRADA, jer nije poznato može li liječenje dovesti do aktivacije hepatitisa koji bi zatim mogao oštetiti jetru.
English: Results for Studies 1 and 2 are shown in Table 3.
Croatian: Rezultati Ispitivanja 1 i 2 prikazani su u Tablici 3
English: If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section 4.4).
Croatian: Ako se primjenjuje treći ili četvrti ciklus, praćenje sigurnosti nastavlja se najmanje do 48 mjeseci nakon posljednje infuzije (vidjeti dio 4.4).
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of infusion associated reactions, but would tend to be more severe or potentially life-threatening.
Croatian: Kliničke manifestacije anafilaksije mogu se pojaviti slično kao kliničke manifestacije reakcija povezanih s infuzijom, no imaju tendenciju biti teže ili potencijalno opasne po život.
English: The type of adverse reactions including seriousness and severity observed in LEMTRADA treatment groups through all available follow-up including patients who received additional treatment courses were similar to those in the active-controlled studies.
Croatian: Vrste nuspojava, uključujući ozbiljnost i težinu, zapažene u skupinama liječenim lijekom LEMTRADA kroz sva dostupna praćenja uključujući bolesnike koji su primili dodatni ciklus liječenja bile su slične onima iz aktivno kontroliranih ispitivanja.
English: In RRMS patients experience relapses followed by periods of recovery.
Croatian: Bolesnici s RRMS-om doživljavaju relapse nakon kojih slijede razdoblja oporavka.
English: To help you better understand the duration of the effects of treatment and the length of required follow-up, please refer to the diagram below.
Croatian: Da biste bolje razumjeli trajanje učinaka liječenja i duljinu potrebnog razdoblja praćenja, pogledajte dijagram u nastavku.
English: 4 years * Defined as patients having experienced at least 1 relapse during treatment with beta interferon or glatiramer acetate after having been on therapy with medicinal product for at least 6 months.
Croatian: 4 godine * Definirani kao bolesnici koji su doživjeli najmanje jedan relaps tijekom liječenja beta interferonom ili glatiramer acetatom, nakon što su prethodno najmanje 6 mjeseci primali lijek.
English: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation.
Croatian: Kod multiple skleroze imunološki sustav greškom napada zaštitni sloj (mijelin) oko živčanih vlakana, što uzrokuje upalu.
English: Autoimmunity
Croatian: Autoimunost
English: The pharmacokinetics of alemtuzumab in RRMS has not been studied in patients aged 55 years and older.
Croatian: Farmakokinetika alemtuzumaba u relapsno-remitentnoj multiploj sklerozi (RRMS) nije ispitivana u bolesnika u dobi od 55 godina i starijih.
English: Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 3 years.
Croatian: U Ispitivanju 3 (ispitivanje faze 2 CAMMS223) ocjenjivala se sigurnost i djelotvornost lijeka LEMTRADA u bolesnika oboljelih od RRMS-a tijekom razdoblja od 3 godine.
English: o Kidney disease (such as anti-GBM disease)
Croatian: o Bolest bubrega (poput anti-GBM bolesti)
English: It is recommended that HPV screening be completed annually for female patients.
Croatian: Preporučuje se jednom godišnje u bolesnica provesti probir na HPV.
English: Most patients were treated conservatively with antibiotics and recovered without surgical intervention, whereas others underwent cholecystectomy.
Croatian: Većina je bolesnika liječena konzervativno antibioticima i oporavila se bez kirurške intervencije, dok su ostali podvrgnuti kolecistektomiji.
English: To try to reduce infusion reactions, your doctor will give you medicine (corticosteroids) before each of the first 3 infusions of a LEMTRADA course.
Croatian: Da bi pokušao ublažiti reakcije na infuziju, liječnik će Vam dati lijekove (kortikosteroide) prije svake od prve 3 infuzije u sklopu ciklusa liječenja lijekom LEMTRADA.
English: Do not use if particulate matter is present or the concentrate is discoloured.
Croatian: Ne smije se upotrijebiti ako su prisutne čestice ili je koncentrat promijenio boju.
English: Lymphocytes repopulate over time with B-cell recovery usually completed within 6 months.
Croatian: S vremenom dolazi do repopulacije limfocita ,uz oporavak B-stanica koji obično završava u roku od 6 mjeseci.
English: Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism.
Croatian: Ako se hipotireoza tijekom trudnoće ne liječi, postoji povećan rizik od spontanog pobačaja i štetnih učinaka na plod, kao što su mentalna retardacija i patuljast rast.
English: Observed autoimmune thyroid disorders included hyperthyroidism or hypothyroidism.
Croatian: Primijećeni autoimuni poremećaji štitnjače uključivali su hipertireozu ili hipotireozu.
English: 1.5/1.3 years
Croatian: 1,5/1,3 godina
English: Table 3: Key Clinical and MRI Endpoints from Studies 1 and 2 Study 1
Croatian: Tablica 3: Ključni klinički i MRI ishodi iz Ispitivanja 1 i 2 Ispitivanje 1
English: The most important side effects are the autoimmune conditions described in section 2 which include:
Croatian: Najvažnije ozbiljne nuspojave su autoimune bolesti opisane u dijelu 2., koje obuhvaćaju sljedeće:
English: Most cases occurred within the first month after treatment with LEMTRADA.
Croatian: Većina slučajeva dogodila se u prvom mjesecu nakon liječenja lijekom LEMTRADA.
English: If you are using such a medicine, your doctor may ask you to stop this medicine before starting treatment with LEMTRADA.
Croatian: Ako primjenjujete takav lijek, liječnik može zatražiti da prekinete s upotrebom tog lijeka prije početka liječenja lijekom LEMTRADA.
English: If you become pregnant after treatment with LEMTRADA and experience a thyroid dirorder during pregnancy, extra caution is needed.
Croatian: Ako zatrudnite nakon liječenja lijekom LEMTRADA i tijekom trudnoće dođe do poremećaja štitnjače, potreban je dodatan oprez.
English: • inflammation of the gallbladder with or without gallstones
Croatian: • upala žučnog mjehura sa ili bez pojave žučnih kamenaca
English: It is associated with high mortality rates if not recognized early and treated.
Croatian: Povezana je s visokom stopom smrtnosti ukoliko se ne prepozna i liječi u ranoj fazi.
English: No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Croatian: Nema podataka o povezanosti lijeka LEMTRADA s reaktivacijom virusa hepatitisa B (HBV) ili virusa hepatitisa C (HCV), jer su bolesnici koji su pokazivali znakove aktivne ili kronične infekcije bili isključeni iz kliničkih ispitivanja.
English: System Organ Class
Croatian: System Organ
English: Terms marked with asterisk (*) in Table 1 include adverse reactions reported as Infusion Associated Reactions.
Croatian: Pojmovi označeni zvjezdicom (*) u Tablici 1 obuhvaćaju nuspojave prijavljene kao reakcije povezane s infuzijom.
English: The patients should be educated on the potential for delayed onset of infusion associated reactions and instructed to report symptoms and seek appropriate medical care.
Croatian: Bolesnike je potrebno educirati o mogućnosti odgođenog nastanka reakcija povezanih s infuzijom i uputiti da prijave simptome i traže prikladnu liječničku pomoć.
English: Most patients in controlled clinical trials received antihistamines and/or antipyretics before at least one LEMTRADA infusion.
Croatian: Većina bolesnika u kontroliranim kliničkim ispitivanjima primala je antihistaminike i/ili antipiretike prije barem jedne infuzije lijeka LEMTRADA.
English: Figure 1: Time to 6 Month Confirmed Disability Worsening in Study 2
Croatian: Slika 1: Vrijeme do 6 mjesečnog potvrđenog pogoršanja CDW u Ispitivanju 2
English: When you have medical treatment, even if it is not for your MS, show the Patient Alert Card to the doctor.
Croatian: Kada budete podvrgnuti liječenju, čak i ako se ne radi o liječenju multiple skleroze, pokažite liječniku Karticu za bolesnika.
English: Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Croatian: Alemtuzumab se veže na CD52, antigen na površini stanice prisutan u visokim koncentracijama na T (CD3+) i B limfocitima (CD19+) i u nižim koncentracijama na NK stanicama, monocitima i makrofagima.
English: • Decrease in white blood cell numbers (lymphocytes, leukocytes, neutrophils)
Croatian: • Smanjen broj bijelih krvnih stanica (limfocita, leukocita, neutrofila)
English: In the majority of cases reactions occurred within 1-3 days of the infusion.
Croatian: U većini slučajeva reakcije su se javile unutar 1-3 dana nakon primjene infuzije.
English: It is not known if LEMTRADA will have an effect on fertility during this period.
Croatian: Nije poznato hoće li LEMTRADA u tom razdoblju utjecati na plodnost.
English: After this time, if you have symptoms of ITP, kidney or thyroid disorders, your doctor will perform more tests.
Croatian: Nakon tog razdoblja, ako imate simptome ITP-a, poremećaja bubrega ili štitnjače, Vaš liječnik će provesti više pretraga.
English: It is not known if LEMTRADA affects your response to a vaccine.
Croatian: Nije poznato utječe li LEMTRADA na Vaš odgovor na cjepivo.
English: Information on preparing to administer LEMTRADA and patient monitoring
Croatian: Informacije o pripremi za primjenu lijeka LEMTRADA i praćenje bolesnika
English: • Previously diagnosed cancer
Croatian: • Prethodno dijagnosticiran karcinom
English: Having an untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.
Croatian: Poremećaj štitnjače koji se ne liječi može naškoditi nerođenu djetetu ili mu može naškoditi nakon rođenja.
English: Your doctor will also want to make sure that you do not have certain medical conditions or disorders before you start your treatment with LEMTRADA.
Croatian: Vaš će liječnik također htjeti isključiti postojanje određenih zdravstvenih stanja ili poremećaja prije nego što započnete liječenje lijekom LEMTRADA.
English: LEMTRADA has minor influence on the ability to drive and use machines.
Croatian: LEMTRADA malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • listeriosis/listeria meningitis
Croatian: • listerioza/meningitis uzrokovan listerijom
English: Besides LEMTRADA, there are other treatments (including those for MS, or to treat other conditions) which could affect your immune system and so could affect your ability to fight infections.
Croatian: Osim lijeka LEMTRADA, postoje drugi lijekovi (uključujući one za multiplu sklerozu ili za liječenje drugih bolesti) koji mogu djelovati na imunološki sustav i samim time na Vašu sposobnost borbe protiv infekcija.
English: Serum concentrations increased with each consecutive dose within a treatment course, with the highest observed concentrations occurring following the last infusion of a treatment course.
Croatian: Koncentracije u serumu povećavale su se sa svakom uzastopnom dozom u sklopu jednog ciklusa liječenja, a najveće su koncentracije zabilježene nakon posljednje infuzije u ciklusu liječenja.