FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of 12 mg/day resulted in a mean Cmax of 3014 ng/ml on day 5 of the initial treatment course, and 2276 ng/ml on day 3 of the second treatment course.
Croatian: Nakon primjene doze od 12 mg/dan srednja vrijednost Cmax iznosila je 3014 ng/ml 5. dana prvog ciklusa liječenja te 2276 ng/ml 3. dana drugog ciklusa liječenja.
English: Once you have received LEMTRADA, you will need to undergo regular tests to ensure that any potential side effects can be diagnosed and treated promptly.
Croatian: Praćenje nakon liječenja lijekom LEMTRADA Nakon što primite lijek LEMTRADA, morat ćete obavljati redovite pretrage kako bi se sve moguće nuspojave mogle pravodobno dijagnosticirati i liječiti.
English: Patients who developed anti-alemtuzumab antibodies did so by 15 months from initial exposure.
Croatian: U bolesnika s pozitivnim nalazom protutijela na alemtuzumab, ona su se razvila do 15 mjeseci nakon prvog izlaganja lijeku.
English: Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Croatian: o koagulopatijom, u bolesnika koji primaju antitrombotsku ili antikoagulantnu terapiju,
English: You will be given a Patient Alert Card and a Patient Guide with further information.
Croatian: Vodič za bolesnika s dodatnim informacijama.
English: Rare (may affect up to 1 in 1000 people)
Croatian: Rijetko (može se javiti u manje od 1 na 1000 osoba)
English: A positive Coombs test has been reported in an alemtuzumab-treated oncology patient.
Croatian: U jednog je onkološkog bolesnika liječenog alemtuzumabom zabilježen pozitivan nalaz Coombsova testa.
English: • increased sensation, sensory disturbance such as numbness, tingling and pain, tension headache
Croatian: • poremećaj nalaza vaginalnog brisa • pojačani osjeti, poremećaj osjeta kao npr. utrnulost, trnci i bol, tenzijska glavobolja
English: Contusion, infusion related reaction
Croatian: Reakcije povezane s infuzijom
English: Commonly, patients have developed a bleeding disorder caused by a low level of blood platelets, called immune thrombocytopenic purpura (ITP).
Croatian: Bolesnici su često razvili poremećaj krvarenja poznat kao imuna trombocitopenijska purpura (ITP), koji uzrokuje niska koncentracija trombocita u krvi.
English: Through 6 years from initial LEMTRADA treatment, patients continuing in follow-up showed rates of MS relapse, brain lesion formation on MRI, and brain volume loss consistent with LEMTRADA's treatment effects during Studies 1 and 2 as well as predominantly stable or improved disability scores.
Croatian: Kroz 6 godina od početka liječenja lijekom LEMTRADA, bolesnici koji su nastavili s praćenjem pokazali su stope relapsa multiple skleroze, stvaranje lezija na mozgu na magnetskoj rezonanciji i gubitak volumena mozga u skladu s učincima liječenja lijekom LEMTRADA tijekom Ispitivanja 1 i 2
English: indigestion, chest discomfort, pain, dizziness, altered taste, difficulty sleeping, difficulty breathing or shortness of breath, low blood pressure, infusion site pain.
Croatian: • reakcije na infuziju, koje se mogu javiti tijekom infuzije ili unutar 24 sata nakon nje:,probavne smetnje, nelagoda u prsištu, bol, omaglica, izmijenjen osjet okusa, tegobe sa spavanjem, otežano disanje ili nedostatak zraka, nizak krvni tlak, bol na mjestu infuzije.
English: There were no external, soft tissue, or skeletal malformations or variations observed at doses up to 10 mg/kg/day.
Croatian: Pri dozama do 10 mg/kg na dan nisu primijećene malformacije ni varijacije vanjskih struktura, mekoga tkiva ni kostiju.
English: • LEMTRADA Health Care Professional Guide
Croatian: • Vodič o lijeku LEMTRADA za zdravstvene radnike
English: Pneumonitis (inflammation of lung tissue) has been reported in LEMTRADA treated patients.
Croatian: Pneumonitis (upala plućnog tkiva) prijavljen je u bolesnika liječenih lijekom LEMTRADA.
English: This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po infuziji, tj. zanemarive količine natrija.
English: Haemophagocytic lymphohistiocytosis (HLH)
Croatian: hemofagocitna limfohistiocitoza (HLH)
English: Epstein-Barr Virus-associated lymphoproliferative disorders Epstein-Barr Virus-associated lymphoproliferative disorders have been observed outside company-sponsored studies.
Croatian: Limfoproliferacijski poremećaji povezani s Epstein-Barrovim virusom Izvan opsega ispitivanja koje je sponzorirala kompanija primijećeni su limfoproliferacijski poremećaji povezani s Epstein-Barrovim virusom.
English: Study design/demographics for Studies 1, 2, 3 and 4 are shown in Table 2 Table 2: Study Design and Baseline Characteristics for Studies 1, 2, 3 and 4 Study 1
Croatian: Plan ispitivanja/demografski podaci za ispitivanja 1, 2, 3 i 4 prikazani su u Tablici 2.
English: Superficial fungal infections, especially oral and vaginal candidiasis, occurred more commonly in LEMTRADA -treated patients (12%) than in patients treated with IFNB-1a (3%) in controlled clinical trials in MS.
Croatian: Površinske gljivične infekcije, naročito oralna i vaginalna kandidijaza, češće su se javljale u bolesnika koji su u kontroliranim kliničkim ispitivanjima multiple skleroze liječeni lijekom LEMTRADA (12%), nego u onih koji su primali IFNB-1a (3%).
English: A reproductive toxicity study in pregnant mice exposed to intravenous doses of alemtuzumab up to 10 mg/kg/day (AUC 2.4 times the human exposure at the recommended dose of 12 mg/day) for 5 consecutive days during gestation resulted in significant increases in the number of dams with all conceptuses dead or resorbed, along with a concomitant reduction in the number of dams with viable foetuses.
Croatian: Ispitivanje reproduktivne toksičnosti na skotnim ženkama miševa, koje su primale intravenski alemtuzumab u dozama do 10 mg/kg na dan (AUC 2,4 puta veći od izloženosti u ljudi pri preporučenoj dnevnoj dozi od 12 mg/dan) tijekom 5 uzastopnih dana za vrijeme gestacije, uzrokovalo je značajno povećanje broja ženki u kojih su svi plodovi odumrli ili su bili resorbirani te istodobno smanjenje broja ženki s vijabilnim plodovima.
English: • swelling of arms and/or legs
Croatian: • oticanje ruku i/ili nogu
English: Pretreatment with antihistamines and/or antipyretics prior to LEMTRADA administration may also be considered.
Croatian: Može se razmotriti i premedikacija antihistaminicima i/ili antipireticima prije primjene lijeka LEMTRADA.
English: Patients who participated in CAMMS223, CAMMS323, or CAMMS32400507 (see baseline characteristics above)
Croatian: Dizajn ispitivanja nekontrolirani nastavak ispitivanja u kojem ocjenjivači ne znaju koji bolesnik prima koji lijek Ispitivana populacija bolesnici koji su sudjelovali u ispitivanjima CAMMS223, CAMMS323 ili CAMMS32400507 (vidjeti gore navedena početna obilježja)
English: LEMTRADA is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate) that comes in a glass vial with stopper.
Croatian: LEMTRADA je bistar, bezbojan do blijedožut koncentrat za otopinu za infuziju (sterilni koncentrat),
English: Pretreatment with antihistimines and/or antipyretics prior to LEMTRADA administration may also be considered.
Croatian: Osim toga, može se razmotriti i premedikacija antihistaminicima i/ili antipireticima prije primjene lijeka LEMTRADA.
English: LEMTRADA contains potassium and sodium
Croatian: LEMTRADA sadrži kalij i natrij
English: Erythema*, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis
Croatian: eritem*, ekhimoza, alopecija, hiperhidroza, akne, kožne lezije, dermatitis mjehurići, noćno znojenje, oticanje lica, ekcem
English: Placental transfer and potential pharmacologic activity of LEMTRADA were observed in mice during gestation and following delivery.
Croatian: Opaženo je da LEMTRADA prolazi kroz placentu i ima potencijalno farmakološko djelovanje u miševa tijekom gestacije i nakon okota.
English: • vision problems, conjunctivitis, eye disease associated with thyroid disease
Croatian: • tegobe s vidom, upala očne spojnice (konjunktivitis), bolesti oka povezane s bolesti štitnjače
English: Including follow-up in Study 4, patients originally treated with LEMTRADA in Studies 1 and 2, respectively, had ARRs 0.17 and 0.23, CDW was seen in 22.3% and 29.7%, while 32.7% and 42.5% achieved CDI.
Croatian: 0,17 odnosno 0,23, CDW je uočen u 22,3% odnosno 29,7%, dok je 32,7% odnosno 42,5% postiglo
English: 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom
Croatian: Suffolk CB9 8PU Ujedinjeno Kraljevstvo
English: The safety and efficacy of alemtuzumab in MS were evaluated in 3 randomised, rater-blinded, activecomparator clinical trials and 1 uncontrolled, rater-blinded extension study in patients with RRMS.
Croatian: Sigurnost i djelotvornost alemtuzumaba kod multiple skleroze (MS) ocijenjena je u tri randomizirana klinička ispitivanja s bolesnicima oboljelima od RRMS-a, u kojima ocjenjivači nisu znali koji bolesnik prima koji lijek i u kojima je primjenjivan aktivni usporedni lijek i u jednom nekontroliranom nastavku ispitivanja u kojem ocjenjivači nisu znali koji bolesnik prima koji lijek.
English: Cervical human papilloma virus (HPV) infection, including cervical dysplasia and anogenital warts, has also been reported in patients treated with LEMTRADA 12 mg (2%).
Croatian: U bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg također je zabilježena infekcija cerviksa humanim papiloma virusom (HPV), uključujući cervikalnu displaziju i anogenitalne bradavice (2%).
English: Infections occurred in 71% of patients treated with LEMTRADA 12 mg as compared to 53% of patients treated with subcutaneous interferon beta-1a [IFNB 1a](44mcg 3-times weekly) in controlled clinical trials in MS up to 2 years in duration and were predominantly mild to moderate in severity.
Croatian: U kontroliranim kliničkim ispitivanjima multiple skleroze, u trajanju do 2 godine, infekcije su se javile u 71% bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg, u odnosu na 53% bolesnika liječenih supkutanim interferonom beta-1a [IFNB-1a] (44 µg triput tjedno), a pretežno su bile blage do umjerene.
English: Other serious reactions temporally associated with LEMTRADA infusion
Croatian: Druge ozbiljne nuspojave vremenski povezane s primjenom infuzije lijeka LEMTRADA
English: Complete blood counts with differential should be obtained prior to initiation of treatment and at monthly intervals thereafter until at least 48 months after the last infusion.
Croatian: Kompletnu krvnu sliku s diferencijalnom krvnom slikom treba napraviti prije početka liječenja i u mjesečnim intervalima nakon toga, sve do najmanje 48 mjeseci nakon posljednje infuzije.
English: The following adverse reactions were identified prior to registration of LEMTRADA during use of alemtuzumab for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL), as well as for the treatment of other disorders, generally at higher and more frequent doses (e.g. 30 mg) than that recommended in the treatment of MS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to alemtuzumab exposure.
Croatian: Sljedeće su nuspojave utvrđene prije registracije lijeka LEMTRADA, tijekom primjene alemtuzumaba za liječenje B-stanične kronične limfocitne leukemije (B-KLL) kao i za liječenje drugih poremećaja, obično u većim i češćim dozama (npr. 30 mg) od one preporučene za liječenje multiple skleroze.
English: Therefore, women of childbearing potential have to use effective contraception when receiving a course of treatment with LEMTRADA and up to 4 months after each course of treatment.
Croatian: Stoga žene u reproduktivnoj dobi moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom LEMTRADA i do 4 mjeseca nakon svakog ciklusa liječenja.
English: After this period of time, testing should be performed based on clinical findings suggestive of ITP.
Croatian: Nakon tog vremenskog razdoblja, treba provesti testiranje, ovisno o kliničkim znakovima koji ukazuju na ITP.
English: 0.545], p<0.0006) and reduced the ARR by 67% (rate ratio 0.33 [95% CI: 0.196, 0.552], p<0.0001) as compared to subcutaneous IFNB-1a.
Croatian: Nakon 3 godine LEMTRADA je smanjila rizik od 6-mjesečnog CDW-a za 76% (omjer hazarda 0,24 [95% CI: 0,110, 0,545], p<0,0006) i ARR-a za 67% (omjer stopa 0,33 [95% CI: 0,196, 0,552], p<0,0001) u usporedbi sa supkutano primijenjenim IFNB-1a.
English: Cytomegalovirus infections (CMV) including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Croatian: U bolesnika liječenih lijekom LEMTRADA prijavljene su citomegalovirusne (CMV) infekcije, uključujući slučajeve reaktivacije CMV-a.
English: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy have been reported in alemtuzumab-treated non-MS patients.
Croatian: U bolesnika liječenih alemtuzumabom, koji nemaju multiplu sklerozu, prijavljene su ozbiljne i ponekad smrtonosne autoimune pojave, uključujući autoimunu hemolitičku anemiju, autoimunu trombocitopeniju, aplastičnu anemiju, Guillain-Barréov sindrom i kroničnu upalnu demijelinizirajuću poliradikuloneuropatiju.
English: It is recommended that you do not breast-feed during each course of treatment with LEMTRADA and for 4 months after each treatment course.
Croatian: Preporučuje se prekinuti dojenje tijekom svakog ciklusa liječenja lijekom LEMTRADA i tijekom 4 mjeseca nakon svakog ciklusa liječenja.
English: Reactions have occurred following any of the doses and also after course number 2.
Croatian: Nuspojave su se javile nakon bilo koje doze te također nakon drugog ciklusa liječenja.
English: • LEMTRADA Training Module
Croatian: • Modul za obuku o lijeku LEMTRADA
English: Investigations
Croatian: Pretraga
English: 91.8% of the patients treated with LEMTRADA 12 mg in Studies 1 and 2 entered Study 4.
Croatian: 91,8% bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg u Ispitivanjima 1 i 2 pristupili su Ispitivanju 4. 82,7% tih bolesnika završilo je ispitivanje.
English: • thyroid disorders (very common - may affect more than 1 in 10 people): may show as excessive sweating; unexplained weight-loss or gain; eye swelling; nervousness; fast heartbeat; feeling cold; worsening tiredness; or newly occurring constipation.
Croatian: • poremećaji štitnjače (vrlo često - mogu se javiti u više od 1 na 10 osoba): može se manifestirati kao pojačano znojenje; neobjašnjivo smanjenje ili povećanje tjelesne težine; oticanje očiju;
English: • swollen glands
Croatian: • žgaravica
English: LEMTRADA 12 mg concentrate for solution for infusion
Croatian: LEMTRADA 12 mg koncentrat za otopinu za infuziju
English: • muscular and bone pain, chest discomfort
Croatian: • bol u mišićina i kostima, nelagoda u prsima
English: Also, tell your doctor if you are suffering from a serious infection before the start of your LEMTRADA
Croatian: Isto tako,obavijestite svog liječnika ako prije početka liječenja lijekom LEMTRADA postoji ozbiljna infekcija zbog koje bi liječnik trebao odgoditi liječenje sve dok se infekcija ne izliječi.
English: In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.
Croatian: U kliničkim su ispitivanjima tijekom prva 3 dana svakog ciklusa liječenja lijekom LEMTRADA bolesnici primili premedikaciju metilprednizolonom u dozi od 1000 mg.
English: It is not currently known if LEMTRADA confers a higher risk for developing thyroid malignancies, since thyroid autoimmunity may itself be a risk factor for thyroid malignancies.
Croatian: Trenutačno nije poznato uzrokuje li lijek LEMTRADA veći rizik za razvoj malignih bolesti štitnjače,
English: Read the summary of product characteristics (available at the EMA website mentioned above) for more information.
Croatian: Za više informacija pročitajte sažetak opisa svojstava lijeka (dostupan na prethodno navedenoj internetskoj stranici Europske Agencije za lijekove).
English: The MAH shall ensure that, following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements: The Summary of Product Characteristics HCP guide Prescriber checklist Patient guide Patient alert card The HCP guide shall contain the following key messages: 1.
Croatian: nalazi na tržištu, prilikom stavljanja lijeka u promet i nakon stavljanja lijeka u promet, nositelj odobrenja mora osigurati da svi liječnici koji će propisivati lijek LEMTRADA imaju najnoviji edukacijski paket za liječnike, koji sadrži sljedeće elemente:
English: It is recommended that patients be premedicated to ameliorate the effects of infusion reactions (see section
Croatian: Kako bi se ublažile reakcije povezane s infuzijom, preporučuje se premedikacija bolesnika (vidjeti dio
English: Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting.
Croatian: Simptomi akutnog akalkuloznog kolecistitisa uključuju bol u abdomenu, osjetljivost abdomena na dodir, vrućicu,
English: These improvements were subsequently maintained, but no firm conclusions can be made with regards to the longer-term efficacy (e.g. 3 and 4 years after additional treatment courses) because many patients completed the study before reaching these time points.
Croatian: (npr. 3 i 4 godine nakon dodatnog ciklusa liječenja) jer je velik broj bolesnika završio sa ispitivanjem prije nego što su dostignute te vremenske točke.
English: The active substance is alemtuzumab.
Croatian: Djelatna tvar je alemtuzumab.
English: Several of the patients reported were below 40 years of age and had no risk factors for ischemic heart disease.
Croatian: Ishemija i infarkt miokarda Nekoliko bolesnika kod kojih su prijavljene ishemija i infarkt miokarda bilo je mlađe od 40 godina i nisu imali rizične čimbenike za ishemijsku bolest srca.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzija, reakcija povezana s infuzijom
English: LEMTRADA contains sodium and potassium
Croatian: LEMTRADA sadrži natrij i kalij
English: MS relapse, dizziness*, hypoaesthesia, paraesthesia, tremor, dysgeusia*, migraine*
Croatian: Poremećaji živčanog sustava glavobolja* relaps multiple skleroze, omaglica*, hipoestezija, parestezija, tremor, disgeuzija*, migrena*
English: Lymphadenopath y, immune thrombocytopeni c purpura, thrombocytopeni a, anaemia haematocrit decreased, leukocytosis
Croatian: Limfadenopatija, imuna trombocitopenijsk a purpura, trombocitopenija, anemija, smanjene vrijednosti hematokrita, leukocitoza pancitopenija,
English: Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases, has been reported in LEMTRADA-treated patients.
Croatian: U bolesnika liječenih lijekom LEMTRADA prijavljena je reaktivacija Epstein-Barr virusa (EBV), uključujući i slučajeve teškog EBV hepatitisa.
English: Time to onset of CDI was defined as a decrease of at least one point on the EDSS from a baseline EDSS score ≥ 2 that was sustained for at least 6 months.
Croatian: Potvrđeno poboljšanje onesposobljenosti (engl. confirmed disability improvement, CDI) Vrijeme do nastupa CDI-a definirano je kao smanjenje za najmanje 1 bod na ljestvici proširenja stupnja onesposobljenosti (EDSS) u odnosu na početni rezultat na EDSS ljestvici ≥ 2 koje se održalo tijekom najmanje 6 mjeseci.
English: There is no known antidote for alemtuzumab over dosage.
Croatian: Za predoziranje alemtuzumabom ne postoji poznati protulijek.
English: Among patients who received one or two additional LEMTRADA treatment courses, improvements were seen in relapse rate, MRI activity and mean disability scores following a first or second LEMTRADA retreatment (Courses 3 and 4) when compared with outcomes in the preceding year.
Croatian: poboljšanja su bila vidljiva u stopi relapsa, aktivnosti na MR-u i srednoj vrijednosti rezultata onesposobljenosti nakon prvog ili drugog ponovnog liječenja lijekom LEMTRADA (ciklusi 3 i 4) kad se usporede s ishodima u prethodnoj godini.
English: infections, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection, pneumonia, vaginal infection, tooth infection tonsillitis, acute sinusitis, cellulitis, pneumonitis, tuberculosis, cytomegalovirus infection virus (EBV) reactivation
Croatian: gljivična infekcija kože, tonsilitis, akutni sinusitis, celulitis, pneumonitis, tuberkuloza, citomegalovirusn a infekcija listerioza/meningi tis uzrokovan listerijom, reaktivacija Epstein-Barr virusa (EBV)
English: o Other autoimmune conditions
Croatian: o Ostale autoimune bolesti
English: • abnormalities that can be found during examinations: blood or protein in urine, decreased heart rate,
Croatian: • nepravilnosti koje se mogu pronaći tijekom pretraga: krv ili bjelančevine u urinu, usporeni otkucaji srca, neredoviti ili nepravilni otkucaji srca, visok krvni tlak, smanjena funkcija bubrega,
English: Nephropathies, including anti-glomerular basement membrane (anti-GBM) disease, have been observed in 6 (0.4%) patients in clinical trials in MS through a median of 6.1 years (maximum 12 years) of follow-up and generally occurred within 39 months following the last administration of LEMTRADA.
Croatian: U kliničkim ispitivanjima multiple skleroze u 6 (0,4%) bolesnika kroz medijan praćenja od 6,1 godine (maksimalno 12 godina) primijećene su nefropatije, uključujući bolest s protutijelima na glomerularnu bazalnu membranu (anti-GBM), koje su se obično pojavljivale unutar 39 mjeseci nakon posljednje primjene lijeka LEMTRADA.
English: Placental transfer and potential pharmacologic activity of alemtuzumab were observed during gestation and following delivery in mice.
Croatian: Opaženo je da alemtuzumab prolazi kroz placentu i ima potencijalno farmakološko djelovanje u miševa tijekom gestacije i nakon okota.
English: Clinical endpoints
Croatian: Klinički ishodi
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit
English: Thyroid endocrine disorders including autoimmune thyroid disorders have been observed in 36.8% of patients treated with LEMTRADA 12 mg in clinical trials in MS with a median of 6.1 years (maximum 12 years) of follow- up from the first LEMTRADA exposure.
Croatian: 36,8% bolesnika liječenih lijekom LEMTRADA u dozi od 12 mg, u kliničkim ispitivanjima multiple skleroze, s medijanom praćenja od 6,1 godine (maksimalno 12 godina) od prvog izlaganja lijeku
English: A fatal event of transfusion associated graft versus host disease has been reported in an alemtuzumab-treated oncology patient.
Croatian: U jednog je onkološkog bolesnika liječenog alemtuzumabom prijavljena smrt prilikom transfuzije povezana s reakcijom presatka protiv primatelja.
English: Observation for infusion reactions is recommended during and for at least 2 hours after LEMTRADA infusion.
Croatian: Preporučuje se motriti bolesnika tijekom infuzije i najmanje 2 sata nakon infuzije lijeka LEMTRADA, zbog pojave reakcija na infuziju.
English: Patients treated with LEMTRADA are at a higher risk of developing herpes infection (e.g. a cold sore).
Croatian: Bolesnici liječeni lijekom LEMTRADA imaju veći rizik od razvoja infekcije herpesom (npr.
English: Pancytopenia, haemolytic anaemia, acquired haemophilia A
Croatian: hemolitička anemija, stečena hemofilija A
English: Liver function tests should beperformed before initial treatment and at monthly intervals until at least 48 months after the last infusion.
Croatian: Potrebno je provesti ispitivanje funkcije jetre prije početka liječenja i u mjesečnim intervalima sve do najmanje 48 mjeseci nakon posljednje infuzije.
English: There is no LEMTRADA treatment between the two courses.
Croatian: Između ta dva ciklusa nećete biti liječeni lijekom LEMTRADA.