FrancophonIA/ELRC3.0 huggingface dataset:
English: Women who are able to conceive have to use effective contraception during each treatment course with LEMTRADA and for 4 months after each course of treatment.
Croatian: Žene reproduktivne dobi moraju primjenjivati učinkovitu kontracepciju tijekom svakog ciklusa liječenja i 4 mjeseca nakon svakog ciklusa liječenja.
English: Conjunctivitis, endocrine ophthalmopathy, vision blurred
Croatian: Poremećaji oka konjunktivitis, endokrina oftalmopatija, zamagljen vid diplopija
English: • It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Croatian: • Zbog mogućeg rizika od mikrobiološkog onečišćenja, preporučuje se da lijek upotrijebite odmah nakon razrjeđivanja.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2°C - 8°C, under protection from light.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 8 sati na temperaturi od 2°C - 8°C i zaštićen od svjetlosti.
English: The patient should be reminded to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns.
Croatian: Bolesnika se mora podsjetiti da pozorno prati simptome koje bi mogao doživjeti i da u slučaju bilo kakve nedoumice odmah potraži liječničku pomoć.
English: Autoimmune disease
Croatian: Autoimuna bolest
English: To reduce this risk, you should avoid eating uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks before treatment, during the treatment and for at least one month after LEMTRADA treatment.
Croatian: mekanih sireva i nepasteriziranih mliječnih proizvoda dva tjedna prije liječenja, tijekom liječenja i barem mjesec dana nakon liječenja lijekom LEMTRADA.
English: • disodium edetate
Croatian: • dinatrijev edetat
English: Constipation, gastrooesophageal reflux disease, gingival bleeding, dry mouth, dysphagia, gastrointestinal disorder, haematochezia
Croatian: proljev, dispepsija*, stomatitis konstipacija, gastroezofagealna refluksna bolest, krvarenje iz desni, suha usta, disfagija,
English: You must NOT receive certain types of vaccines (live viral vaccines) if you have recently received LEMTRADA.
Croatian: Ako ste nedavno primili lijek LEMTRADA, NE smijete primiti određene vrste cjepiva (živa virusna cjepiva).
English: • Review the LEMTRADA Patient Guide and Package Leaflet with your patient.
Croatian: • Zajedno s bolesnikom pregledajte Vodič za bolesnike koji se liječe lijekom LEMTRADA i
English: Acquired haemophilia A
Croatian: Stečena hemofilija A
English: LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab
Croatian: LEMTRADA 12 mg koncentrat za otopinu za infuziju alemtuzumab
English: • Post-infusion: o Observation for infusion reactions is recommended for a minimum of 2 hours after LEMTRADA infusion.
Croatian: o Nakon infuzije lijeka LEMTRADA preporučeno je nadziranje radi reakcija povezanih s infuzijom najmanje 2 sata.
English: Relapse severity
Croatian: Težina relapsa
English: Haemophagocytic lymphohistiocytos is (HLH)
Croatian: Hemofagocitna limfohistiocitoza (HLH)
English: • stiffness, arms or legs discomfort
Croatian: • ukočenost, nelagoda u rukama i nogama
English: Tuberculosis has been reported for patients treated with LEMTRADA and IFNB-1a in controlled clinical trials.
Croatian: U bolesnika koji su u kontroliranim kliničkim ispitivanjima liječeni lijekovima LEMTRADA i IFNB1a, zabilježena je tuberkuloza.
English: Controlled, randomised, raterblinded
Croatian: Dizajn ispitivanja kontrolirano, randomizirano,
English: Signs and symptoms of thyroid disorders are described in section 4.
Croatian: Znakovi i simptomi poremećaja štitnjače opisani su u dijelu 4.
English: Autoimmune thyroiditis including thyroiditis subacute, goitre, anti-thyroid antibody positive
Croatian: Basedowljeva bolest, hipertireoza, hipotireoza autoimuni tireoiditis uključujući subakutni tireoiditis, guša, pozitivna protutijela na štitnjaču
English: Remind the patient to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns.
Croatian: Uputite bolesnika da pozorno prati simptome koje bi mogao doživjeti i da u slučaju bilo kakve nedoumice odmah potraži liječničku pomoć.
English: A description of the sign and symptoms of autoimmune risks A description of the best course of action if sign and symptoms of those risks present themselves (e.g. How to reach your doctors) Recommendations for the planning of the monitoring schedule The patient alert card shall contain the following key messages: A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient has been treated with LEMTRADA That LEMTRADA treatment may increase the risk of: Immune mediated reactions such as thyroid disorders, Immune Thrombocytopenic Purpura (ITP).
Croatian: Kartica s upozorenjima za bolesnika mora sadržavati sljedeće ključne poruke: Poruku upozorenja za zdravstvene radnike koji liječe bolesnika u bilo koje vrijeme, uključujući u hitnim slučajevima, da je bolesnik liječen lijekom LEMTRADA Da liječenje lijekom LEMTRADA može povećati rizik od:
English: Follow-up after treatment with LEMTRADA
Croatian: sata nakon liječenja lijekom LEMTRADA.
English: Blood and lymphatic system disorders Severe bleeding reactions have been reported in non-MS patients.
Croatian: U bolesnika koji ne boluju od multiple skleroze prijavljene su teške reakcije krvarenja.
English: Some patients have had serious or life-threatening reactions after LEMTRADA infusion, including bleeding in the lung, heart attack, stroke or tears in blood vessels supplying the brain.
Croatian: LEMTRADA, uključujući krvarenje u plućima, srčani udar, moždani udar ili rascjepe krvnih žila koje opskrbljuju mozak.
English: Infections with a virus called cytomegalovirus have been reported in patients treated with LEMTRADA.
Croatian: U bolesnika koji se liječe lijekom LEMTRADA prijavljene su infekcije virusom zvanim citomegalovirus.
English: It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Croatian: Zbog mogućeg rizika od mikrobiološkog onečišćenja, preporučuje se lijek upotrijebiti odmah nakon razrjeđivanja.
English: Package leaflet: Information for the patient LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacija za bolesnika LEMTRADA 12 mg koncentrat za otopinu za infuziju alemtuzumab
English: • Autoimmune conditions
Croatian: • Autoimune bolesti
English: Through all available follow-up, including patients who received additional treatment courses, the most common IARs included headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnoea, dysgeusia, chest discomfort, generalised rash, tachycardia, bradycardia, dyspepsia, dizziness, and pain.
Croatian: Kroz sva dostupna praćenja, uključujući bolesnike koji su primili dodatni ciklus liječenja, najčešće reakcije povezane s infuzijom uključivale su glavobolju, osip, pireksiju, mučninu, urtikariju, pruritus, nesanicu,
English: • The vial contents should be inspected for particulate matter and discolouration prior to administration.
Croatian: • Sadržaj bočice prije primjene treba vizualno pregledati kako bi se utvrdilo sadrži li čestice i je li promijenio boju.
English: Reduced gestational weight gain relative to the vehicle controls was observed in pregnant mice dosed with 10 mg/kg/day.
Croatian: U skotnih ženki miševa, koje su primale doze od 10 mg/kg na dan, opažen je smanjen gestacijski prirast težine u odnosu na kontrolnu skupinu koja je primala vehikulum.
English: Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Croatian: (jajnici kineskog hrčka) u hranjivom mediju tehnologijom rekombinantne DNK.
English: Sanofi S.p.A Tel: +39 02 39394275
Croatian: Tel: +39 02 39394275
English: Haemorrhagic stroke**, cervicocephalic arterial dissection**
Croatian: hiperestezija, tenzijska glavobolja hemoragijski moždani udar**, disekcija cervikocefaličnih arterija**
English: Renal or hepatic impairment LEMTRADA has not been studied in patients with renal or hepatic impairment.
Croatian: LEMTRADA nije ispitivana u bolesnika s oštećenjem bubrežne ili jetrene funkcije.
English: A “Frequently asked questions” section The prescriber checklist shall contain the following key messages: Lists of tests to be conducted for the initial screening of the patient Vaccination course to be completed 6 weeks before treatment
Croatian: Popis pretraga koje je potrebno provesti za početni probir bolesnika
English: • Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least
Croatian: • Treći ili četvrti ciklus: 12 mg/dan tijekom 3 uzastopna dana (ukupna doza od 36 mg) primijenjeno najmanje 12 mjeseci nakon prethodnog ciklusa liječenja (vidjeti dijelove 4.1,
English: As for any immune modulating medicinal product, before initiating a course of LEMTRADA treatment, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV.
Croatian: bolesnike koji prethodno nisu imali vodene kozice ili nisu cijepljeni protiv varičela zoster virusa (VZV), treba testirati na protutijela na VZV.
English: • Haemophagocytic lymphohistiocytosis
Croatian: • Hemofagocitna limfohistiocitoza
English: If severe infusion reactions occur, the intravenous infusion should be discontinued immediately.
Croatian: Ako je potrebno, treba se razmotriti produljeno vrijeme motrenja (hospitalizacija) U slučaju pojave teških reakcija, treba odmah prekinuti infuziju.
English: The alpha half-life approximated 4-5 days and was comparable between courses leading to low or undetectable serum concentrations within approximately 30 days following each treatment course.
Croatian: Alfa poluvijek iznosio je približno 4-5 dana i bio je sličan u ciklusima liječenja,
English: In particular, your doctor will consider vaccinating you against chickenpox if you have never had it. Any vaccination will need to be given to you at least 6 weeks before starting a LEMTRADA treatment course.
Croatian: Bilo koje cjepivo morat ćete primiti najmanje 6 tjedana prije početka ciklusa liječenja lijekom LEMTRADA.
English: Patients with clinical symtoms suggesting development of a serious adverse event temporarily associated with the infusion (myocardial ischemia, haemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage) should be closely monitored until complete resolution of the symptoms.
Croatian: hemoragijski moždani udar, disekcija cervikocefaličnih arterija ili plućno alveolarno krvarenje) potrebno je pomno nadzirati sve do izlječenja simptoma.
English: Patients should be pre-treated with corticosteroids immediately prior to LEMTRADA administration on each of the first 3 days of any treatment course.
Croatian: Bolesnici moraju tijekom svakog od prva 3 dana bilo kojeg ciklusa liječenja primiti premedikaciju kortikosteroidima neposredno prije primjene lijeka LEMTRADA.
English: o Liver inflammation
Croatian: • Upala žučnog mjehura
English: VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA.
Croatian: U bolesnika koji nemaju protutijela, mora se razmotriti cijepljenje protiv VZV-a prije početka liječenja lijekom LEMTRADA.
English: Reported autoimmune conditions, include thyroid disorders, immune thrombocytopenic purpura (ITP), nephropathies (e.g. anti-glomerular basement membrane disease), autoimmune hepatitis (AIH), and acquired haemophilia A. In the post-marketing setting, patients developing multiple autoimmune disorders after LEMTRADA treatment have been observed.
Croatian: Prijavljena autoimuna stanja uključuju poremećaje štitnjače, imunu trombocitopenijsku purpuru (ITP), nefropatije (npr. bolest s protutijelima na glomerularnu bazalnu membranu), autoimuni hepatitis i stečenu hemofiliju A.
English: Urinalysis with microscopy should be obtained prior to initiation and at monthly intervals thereafter until at least 48 months after the last infusion.
Croatian: Mikroskopsku analizu mokraće treba provoditi prije početka liječenja i u mjesečnim intervalima nakon toga, najmanje do 48 mjeseci nakon posljednje infuzije.
English: Pre-treatment
Croatian: Premedikacija
English: Concentrate for solution for infusion 1 vial
Croatian: Koncentrat za otopinu za infuziju
English: Sanofi S.p.A. Tel: 800536389
Croatian: Tel: 800536389
English: Urticaria*, rash*, pruritus*,
Croatian: Poremećaji kože i potkožnog tkiva urtikarija*, osip*, pruritus*, generalizirani osip*
English: Complete blood count results (see above under ITP) should be used to monitor for cytopenias, including neutropenia.
Croatian: kontrolira se nalazima kompletne krvne slike (vidjeti gore pod ITP).
English: Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA.
Croatian: LEMTRADA tek prolazno utječe na neutrofile, monocite, eozinofile, bazofile i NK stanice.
English: Thrombocytopenia
Croatian: • Cjepiva
English: SANOFI BULGARIA EOOD
Croatian: Sanofi Belgium Leonardo Da Vincilaan 19
English: • difficulty swallowing, throat irritation, productive cough
Croatian: • otežano gutanje, nadraženost grla, iskašljavanje
English: 29% of patients treated with LEMTRADA reached CDI in Study 2, while only 13% of subcutaneous IFNB1a treated patiets reached this endpoint.
Croatian: U Ispitivanju 2 CDI je postiglo 29% bolesnika liječenih lijekom LEMTRADA, dok je isti ishod postiglo samo
English: Cytopenias
Croatian: Suffolk
English: Myalgia, muscle weakness, arthralgia, back pain, pain in extremity, muscle spasms, neck pain, musculoskeletal pain
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva mialgija, slabost mišića, artralgija, bol u leđima, bol u udovima,
English: Serious infections occurred in 2.7% of patients treated with LEMTRADA as compared to 1% of patients treated with IFNB-1a in controlled clinical trials in MS. Serious infections in the LEMTRADA group included: appendicitis, gastroenteritis, pneumonia, herpes zoster, and tooth infection.
Croatian: Ozbiljne infekcije javile su se u 2,7% bolesnika liječenih lijekom LEMTRADA, u usporedbi s 1% bolesnika koji su primali IFNB-1a u kontroliranim kliničkim ispitivanjima multiple skleroze.
English: • autoimmune over-active or under-active thyroid gland, thyroid antibodies or goitre (swelling of the thyroid gland in the neck)
Croatian: • autoimuna prekomjerno aktivna ili premalo aktivna štitnjača, protutijela štitnjače ili gušavost
English: • general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu, hiccups
Croatian: • općenita nelagoda, slabost, povraćanje, proljev, bol u trbuhu, želučana viroza, štucanje • poremećaj nalaza jetrenih testova
English: Your doctor will perform blood tests before you start treatment with LEMTRADA.
Croatian: Prije nego započnete liječenje lijekom LEMTRADA, Vaš će liječnik napraviti krvne pretrage.
English: Aspartate aminotransferase increased, alanine aminotransferase increase
Croatian: Poremećaji jetre i žuči povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti alanin aminotransferaze kolecistitis uključujući akalkulozni kolecistitis i akutni akalkulozni kolecistitis autoimuni hepatitis
English: Ask your doctor if you have any questions.
Croatian: U slučaju bilo kakvih pitanja, obratite se svom liječniku.
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba)
English: LEMTRADA Patient Guide.
Croatian: Početna obilježja bolesnika
English: changes in heart rate, headache, rash, rash over your body, fever, hives, chills, itching, reddening of the face and neck, feeling tired, nausea
Croatian: • Reakcije na infuziju, koje se mogu javiti tijekom infuzije ili unutar 24 sata nakon nje: promjene u otkucajima srca, glavobolja, osip, osip po tijelu, vrućica, koprivnjača, zimica, svrbež, crvenilo lica i vrata, umor, mučnina
English: Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in alemtuzumab-treated non-MS patients previously treated with potentially cardiotoxic agents.
Croatian: U bolesnika bez multiple skleroze, koji su liječeni alemtuzumabom, a prethodno su primali potencijalno kardiotoksične lijekove, prijavljeni su kongestivno zatajenje srca, kardiomiopatija i smanjena ejekcijska frakcija.
English: A coagulopathy panel including aPTT must be obtained in all patients that present with such symptoms.
Croatian: Kod svih bolesnika kod kojih su prisutni takvi simptomi, moraju se napraviti koagulacijske pretrage koje uključuju aktivirano parcijalno tromboplastinsko vrijeme (aPTV).
English: • Complete baseline tests and screening as decribed in SmPC section 4.
Croatian: • Treba provesti sve početne pretrage i probire, kako je opisano u dijelu 4. Sažetka opisa svojstava lijeka.
English: Study population
Croatian: Edukacijski program
English: • Second treatment course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
Croatian: • Drugi ciklus liječenja: 12 mg/dan tijekom 3 uzastopna dana (ukupna doza 36 mg)
English: - Alterations in the number, proportions, and properties of some lymphocyte subsets post-treatment - Increased representation of regulatory T cell subsets - Increased representation of memory T- and B-lymphocytes - Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)
Croatian: - Povećanje udjela podskupina regulatornih T stanica - Povećanje udjela memorijskih T i B limfocita
English: Sensory disturbance, hyperaesthesia, tension headache
Croatian: poremećaj probavnog sustava, hematohezija
English: If it is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2oC to 8oC, under protection from light.
Croatian: Ako se ne upotrijebi odmah, trajanje i uvjeti čuvanja lijeka do uporabe odgovornost su korisnika.
English: Listeriosis/listeri a meningitis, Epstein-Barr infection, herpes virus infection,1
Croatian: Infekcije i infestacije infekcija gornjih dišnih putova, infekcija mokraćnih putova, infekcija herpes virusom1
English: Thyroid disorders
Croatian: Trombocitopenija
English: Serious and sometimes fatal IARs including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome , respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency, and cardiac arrest have been observed in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS.
Croatian: U bolesnika koji ne boluju od multiple skleroze, a liječeni su alemtuzumabom u dozama većim ili učestalijim od doza koje se primjenjuju za liječenje MS-a, primijećene su ozbiljne reakcije povezane s infuzijom, koje su ponekad imale smrtni ishod, uključujući bronhospazam, hipoksiju, sinkopu, plućne infiltrate, sindrom akutnog respiratornog distresa, respiratorni arest, infarkt miokarda, aritmije, akutno zatajenje srca i srčani arest.
English: Nervous system disorders
Croatian: Neurol Neuroimmunol Neuroinflamm.
English: The most important adverse reactions are autoimmunity (ITP, thyroid disorders, nephropathies, cytopenias), IARs, and infections.
Croatian: Najvažnije nuspojave su autoimunost (imuna trombocitopenična purpura (ITP), poremećaji štitnjače,
English: Patients in the extension study (Study 4) were eligible to receive additional as-needed LEMTRADA treatment course(s) upon documentation of resumed disease activity, defined as the occurrence of ≥1 MS relapse and/or ≥2 new or enlarging brain or spinal lesions on magnetic resonance imaging (MRI).
Croatian: definiranoj kao pojava ≥ 1 relapsa multilple skleroze i/ili ≥ 2 nove ili povećane lezije na mozgu ili kralježničkoj moždini vidljive magnetskom rezonancijom (MR).
English: Тел.
Croatian: CDI.
English: If untreated it can cause kidney failure requiring dialysis or transplantation, and may lead to death.
Croatian: Znakovi i simptomi bolesti bubrega opisani su u dijelu 4. Ako se ne liječi, može uzrokovati zatajenje bubrega, radi čega će biti potrebna dijaliza ili transplantacija, te može uzrokovati smrt.
English: The vial contents should be inspected for particulate matter and discoloration prior to administration.
Croatian: Sadržaj bočice prije primjene treba vizualno pregledati kako bi se utvrdilo sadrži li čestice i je li promijenio boju.
English: Skin papilloma
Croatian: papilomi na koži
English: • LEMTRADA Prescriber's Check-list
Croatian: • Kontrolni popis za liječnika koji propisuje lijek LEMTRADA
English: Pulmonary alveolar haemorrhage
Croatian: Hemoragijski moždani udar
English: Reported cases of temporally associated events were not related to anti-GBM disease (Goodpasteurs syndrome).
Croatian: Plućna alveolarna hemoragija Prijavljeni slučajevi vremenski povezanih događaja nisu bili povezani s anti-GBM bolešću
English: • An oral anti-herpes agent should be administered to all patients during and for 1 month following treatment.
Croatian: • Svi bolesnici moraju tijekom liječenja i 1 mjesec nakon njega uzimati peroralni lijek protiv herpesa.
English: • Infections: stomach flu, inflammation of the gums, nail fungus, tonsil inflammation, acute sinusitis,
Croatian: • infekcije: želučana viroza, upala desni, gljivice na noktima, upala krajnika, akutna upala sinusa, bakterijska infekcija kože, pneumonitis, citomegalovirusna infekcija
English: shingles, cold sore, swollen or enlarged glands, influenza, herpes zoster infection, tooth infection
Croatian: LEMTRADA uključivale su: apendicitis, gastroenteritis, upalu pluća, herpes zoster i infekciju zuba.
English: Nephrolithiasis, ketonuria, nephropathies including antiGBM disease
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija, hematurija nefrolitijaza, ketonurija, nefropatije uključujući i anti
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Most patients experience IARs which occur during or within 24 hours after treatment with LEMTRADA.
Croatian: Većina bolesnika doživljava reakcije povezane s infuzijom, koje se pojavljuju tijekom ili unutar 24
English: 3 years
Croatian: Koncentrat 3 godine
English: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischaemia, haemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage.
Croatian: Imunosno posredovanih reakcija kao što su poremećaji štitnjače, imuna trombocitopenijska purpura (ITP), nefropatije uključujući bolest s protutijelima na glomerularnu bazalnu membranu (anti-GBM), autoimuni hepatitis, stečena hemofilija A i HLH
English: • stroke
Croatian: • bradavice