natgillin/translations-raw huggingface dataset:
In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course. 
U kliničkim su ispitivanjima tijekom prva 3 dana svakog ciklusa liječenja lijekom LEMTRADA bolesnici primili premedikaciju metilprednizolonom u dozi od 1000 mg.
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. 
Trenutačno nije poznato uzrokuje li lijek LEMTRADA veći rizik za razvoj malignih bolesti štitnjače,
Read the summary of product characteristics (available at the EMA website mentioned above) for more information. 
Za više informacija pročitajte sažetak opisa svojstava lijeka (dostupan na prethodno navedenoj internetskoj stranici Europske Agencije za lijekove).
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. 
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:
It is recommended that patients be premedicated to ameliorate the effects of infusion reactions (see section 
Kako bi se ublažile reakcije povezane s infuzijom, preporučuje se premedikacija bolesnika (vidjeti dio
Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting. 
Simptomi akutnog akalkuloznog kolecistitisa uključuju bol u abdomenu, osjetljivost abdomena na dodir, vrućicu,
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. 
(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.
The active substance is alemtuzumab. 
Djelatna tvar je alemtuzumab.
Several of the patients reported were below 40 years of age and had no risk factors for ischemic heart disease. 
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.
Injury, poisoning and procedural complications 
Ozljede, trovanja i proceduralne komplikacije kontuzija, reakcija povezana s infuzijom
LEMTRADA contains sodium and potassium 
LEMTRADA sadrži natrij i kalij
MS relapse, dizziness*, hypoaesthesia, paraesthesia, tremor, dysgeusia*, migraine* 
Poremećaji živčanog sustava glavobolja* relaps multiple skleroze, omaglica*, hipoestezija, parestezija, tremor, disgeuzija*, migrena*
Lymphadenopath y, immune thrombocytopeni c purpura, thrombocytopeni a, anaemia haematocrit decreased, leukocytosis 
Limfadenopatija, imuna trombocitopenijsk a purpura, trombocitopenija, anemija, smanjene vrijednosti hematokrita, leukocitoza pancitopenija,
Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases, has been reported in LEMTRADA-treated patients. 
U bolesnika liječenih lijekom LEMTRADA prijavljena je reaktivacija Epstein-Barr virusa (EBV), uključujući i slučajeve teškog EBV hepatitisa.
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. 
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.
There is no known antidote for alemtuzumab over dosage. 
Za predoziranje alemtuzumabom ne postoji poznati protulijek.
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. 
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.
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 
gljivična infekcija kože, tonsilitis, akutni sinusitis, celulitis, pneumonitis, tuberkuloza, citomegalovirusn a infekcija listerioza/meningi tis uzrokovan listerijom, reaktivacija Epstein-Barr virusa (EBV)
o Other autoimmune conditions 
o Ostale autoimune bolesti
• abnormalities that can be found during examinations: blood or protein in urine, decreased heart rate, 
• 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,
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. 
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.
Placental transfer and potential pharmacologic activity of alemtuzumab were observed during gestation and following delivery in mice. 
Opaženo je da alemtuzumab prolazi kroz placentu i ima potencijalno farmakološko djelovanje u miševa tijekom gestacije i nakon okota.
Clinical endpoints 
Klinički ishodi
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane smanjeni apetit
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. 
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
A fatal event of transfusion associated graft versus host disease has been reported in an alemtuzumab-treated oncology patient. 
U jednog je onkološkog bolesnika liječenog alemtuzumabom prijavljena smrt prilikom transfuzije povezana s reakcijom presatka protiv primatelja.
Observation for infusion reactions is recommended during and for at least 2 hours after LEMTRADA infusion. 
Preporučuje se motriti bolesnika tijekom infuzije i najmanje 2 sata nakon infuzije lijeka LEMTRADA, zbog pojave reakcija na infuziju.
Patients treated with LEMTRADA are at a higher risk of developing herpes infection (e.g. a cold sore). 
Bolesnici liječeni lijekom LEMTRADA imaju veći rizik od razvoja infekcije herpesom (npr.
Pancytopenia, haemolytic anaemia, acquired haemophilia A 
hemolitička anemija, stečena hemofilija A
Liver function tests should beperformed before initial treatment and at monthly intervals until at least 48 months after the last infusion. 
Potrebno je provesti ispitivanje funkcije jetre prije početka liječenja i u mjesečnim intervalima sve do najmanje 48 mjeseci nakon posljednje infuzije.
There is no LEMTRADA treatment between the two courses. 
Između ta dva ciklusa nećete biti liječeni lijekom LEMTRADA.
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. 
Žene reproduktivne dobi moraju primjenjivati učinkovitu kontracepciju tijekom svakog ciklusa liječenja i 4 mjeseca nakon svakog ciklusa liječenja.
Conjunctivitis, endocrine ophthalmopathy, vision blurred 
Poremećaji oka konjunktivitis, endokrina oftalmopatija, zamagljen vid diplopija
• It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination. 
• Zbog mogućeg rizika od mikrobiološkog onečišćenja, preporučuje se da lijek upotrijebite odmah nakon razrjeđivanja.
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. 
Pripremljeni lijek ne bi se smio čuvati dulje od 8 sati na temperaturi od 2°C - 8°C i zaštićen od svjetlosti.
The patient should be reminded to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns. 
Bolesnika se mora podsjetiti da pozorno prati simptome koje bi mogao doživjeti i da u slučaju bilo kakve nedoumice odmah potraži liječničku pomoć.
Autoimmune disease 
Autoimuna bolest
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. 
mekanih sireva i nepasteriziranih mliječnih proizvoda dva tjedna prije liječenja, tijekom liječenja i barem mjesec dana nakon liječenja lijekom LEMTRADA.
• disodium edetate 
• dinatrijev edetat
Constipation, gastrooesophageal reflux disease, gingival bleeding, dry mouth, dysphagia, gastrointestinal disorder, haematochezia 
proljev, dispepsija*, stomatitis konstipacija, gastroezofagealna refluksna bolest, krvarenje iz desni, suha usta, disfagija,
You must NOT receive certain types of vaccines (live viral vaccines) if you have recently received LEMTRADA. 
Ako ste nedavno primili lijek LEMTRADA, NE smijete primiti određene vrste cjepiva (živa virusna cjepiva).
• Review the LEMTRADA Patient Guide and Package Leaflet with your patient. 
• Zajedno s bolesnikom pregledajte Vodič za bolesnike koji se liječe lijekom LEMTRADA i
Acquired haemophilia A 
Stečena hemofilija A
LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab 
LEMTRADA 12 mg koncentrat za otopinu za infuziju alemtuzumab
• Post-infusion: o Observation for infusion reactions is recommended for a minimum of 2 hours after LEMTRADA infusion. 
o Nakon infuzije lijeka LEMTRADA preporučeno je nadziranje radi reakcija povezanih s infuzijom najmanje 2 sata.
Relapse severity 
Težina relapsa
Haemophagocytic lymphohistiocytos is (HLH) 
Hemofagocitna limfohistiocitoza (HLH)
• stiffness, arms or legs discomfort 
• ukočenost, nelagoda u rukama i nogama
Tuberculosis has been reported for patients treated with LEMTRADA and IFNB-1a in controlled clinical trials. 
U bolesnika koji su u kontroliranim kliničkim ispitivanjima liječeni lijekovima LEMTRADA i IFNB1a, zabilježena je tuberkuloza.
Controlled, randomised, raterblinded 
Dizajn ispitivanja kontrolirano, randomizirano,
Signs and symptoms of thyroid disorders are described in section 4. 
Znakovi i simptomi poremećaja štitnjače opisani su u dijelu 4.
Autoimmune thyroiditis including thyroiditis subacute, goitre, anti-thyroid antibody positive 
Basedowljeva bolest, hipertireoza, hipotireoza autoimuni tireoiditis uključujući subakutni tireoiditis, guša, pozitivna protutijela na štitnjaču
Remind the patient to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns. 
Uputite bolesnika da pozorno prati simptome koje bi mogao doživjeti i da u slučaju bilo kakve nedoumice odmah potraži liječničku pomoć.
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). 
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:
Follow-up after treatment with LEMTRADA 
sata nakon liječenja lijekom LEMTRADA.
Blood and lymphatic system disorders Severe bleeding reactions have been reported in non-MS patients. 
U bolesnika koji ne boluju od multiple skleroze prijavljene su teške reakcije krvarenja.
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. 
LEMTRADA, uključujući krvarenje u plućima, srčani udar, moždani udar ili rascjepe krvnih žila koje opskrbljuju mozak.
Infections with a virus called cytomegalovirus have been reported in patients treated with LEMTRADA. 
U bolesnika koji se liječe lijekom LEMTRADA prijavljene su infekcije virusom zvanim citomegalovirus.
It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination. 
Zbog mogućeg rizika od mikrobiološkog onečišćenja, preporučuje se lijek upotrijebiti odmah nakon razrjeđivanja.
Package leaflet: Information for the patient LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacija za bolesnika LEMTRADA 12 mg koncentrat za otopinu za infuziju alemtuzumab
• Autoimmune conditions 
• Autoimune bolesti
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. 
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,
• The vial contents should be inspected for particulate matter and discolouration prior to administration. 
• Sadržaj bočice prije primjene treba vizualno pregledati kako bi se utvrdilo sadrži li čestice i je li promijenio boju.
Reduced gestational weight gain relative to the vehicle controls was observed in pregnant mice dosed with 10 mg/kg/day. 
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.
Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology. 
(jajnici kineskog hrčka) u hranjivom mediju tehnologijom rekombinantne DNK.
Haemorrhagic stroke**, cervicocephalic arterial dissection** 
hiperestezija, tenzijska glavobolja hemoragijski moždani udar**, disekcija cervikocefaličnih arterija**
Renal or hepatic impairment LEMTRADA has not been studied in patients with renal or hepatic impairment. 
LEMTRADA nije ispitivana u bolesnika s oštećenjem bubrežne ili jetrene funkcije.
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 
Popis pretraga koje je potrebno provesti za početni probir bolesnika
• Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least 
• 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,
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. 
bolesnike koji prethodno nisu imali vodene kozice ili nisu cijepljeni protiv varičela zoster virusa (VZV), treba testirati na protutijela na VZV.
• Haemophagocytic lymphohistiocytosis 
• Hemofagocitna limfohistiocitoza
If severe infusion reactions occur, the intravenous infusion should be discontinued immediately. 
Ako je potrebno, treba se razmotriti produljeno vrijeme motrenja (hospitalizacija) U slučaju pojave teških reakcija, treba odmah prekinuti infuziju.
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. 
Alfa poluvijek iznosio je približno 4-5 dana i bio je sličan u ciklusima liječenja,
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. 
Bilo koje cjepivo morat ćete primiti najmanje 6 tjedana prije početka ciklusa liječenja lijekom LEMTRADA.
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. 
hemoragijski moždani udar, disekcija cervikocefaličnih arterija ili plućno alveolarno krvarenje) potrebno je pomno nadzirati sve do izlječenja simptoma.
Patients should be pre-treated with corticosteroids immediately prior to LEMTRADA administration on each of the first 3 days of any treatment course. 
Bolesnici moraju tijekom svakog od prva 3 dana bilo kojeg ciklusa liječenja primiti premedikaciju kortikosteroidima neposredno prije primjene lijeka LEMTRADA.
o Liver inflammation 
• Upala žučnog mjehura
VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA. 
U bolesnika koji nemaju protutijela, mora se razmotriti cijepljenje protiv VZV-a prije početka liječenja lijekom LEMTRADA.
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. 
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.
Urinalysis with microscopy should be obtained prior to initiation and at monthly intervals thereafter until at least 48 months after the last infusion. 
Mikroskopsku analizu mokraće treba provoditi prije početka liječenja i u mjesečnim intervalima nakon toga, najmanje do 48 mjeseci nakon posljednje infuzije.
Pre-treatment 
Premedikacija
Concentrate for solution for infusion 1 vial 
Koncentrat za otopinu za infuziju
Urticaria*, rash*, pruritus*, 
Poremećaji kože i potkožnog tkiva urtikarija*, osip*, pruritus*, generalizirani osip*
Complete blood count results (see above under ITP) should be used to monitor for cytopenias, including neutropenia. 
kontrolira se nalazima kompletne krvne slike (vidjeti gore pod ITP).
Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA. 
LEMTRADA tek prolazno utječe na neutrofile, monocite, eozinofile, bazofile i NK stanice.
Thrombocytopenia 
• Cjepiva
SANOFI BULGARIA EOOD 
Sanofi Belgium Leonardo Da Vincilaan 19
• difficulty swallowing, throat irritation, productive cough 
• otežano gutanje, nadraženost grla, iskašljavanje
29% of patients treated with LEMTRADA reached CDI in Study 2, while only 13% of subcutaneous IFNB1a treated patiets reached this endpoint. 
U Ispitivanju 2 CDI je postiglo 29% bolesnika liječenih lijekom LEMTRADA, dok je isti ishod postiglo samo
Cytopenias 
Suffolk
Myalgia, muscle weakness, arthralgia, back pain, pain in extremity, muscle spasms, neck pain, musculoskeletal pain 
Poremećaji mišićno koštanog sustava i vezivnog tkiva mialgija, slabost mišića, artralgija, bol u leđima, bol u udovima,
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. 
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.
• autoimmune over-active or under-active thyroid gland, thyroid antibodies or goitre (swelling of the thyroid gland in the neck) 
• autoimuna prekomjerno aktivna ili premalo aktivna štitnjača, protutijela štitnjače ili gušavost
• general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu, hiccups 
• općenita nelagoda, slabost, povraćanje, proljev, bol u trbuhu, želučana viroza, štucanje • poremećaj nalaza jetrenih testova
Your doctor will perform blood tests before you start treatment with LEMTRADA. 
Prije nego započnete liječenje lijekom LEMTRADA, Vaš će liječnik napraviti krvne pretrage.
Aspartate aminotransferase increased, alanine aminotransferase increase 
Poremećaji jetre i žuči povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti alanin aminotransferaze kolecistitis uključujući akalkulozni kolecistitis i akutni akalkulozni kolecistitis autoimuni hepatitis
Ask your doctor if you have any questions. 
U slučaju bilo kakvih pitanja, obratite se svom liječniku.
Common (may affect up to 1 in 10 people) 
Često (mogu se javiti u manje od 1 na 10 osoba)
LEMTRADA Patient Guide. 
Početna obilježja bolesnika
changes in heart rate, headache, rash, rash over your body, fever, hives, chills, itching, reddening of the face and neck, feeling tired, nausea 
• 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
Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in alemtuzumab-treated non-MS patients previously treated with potentially cardiotoxic agents. 
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.
A coagulopathy panel including aPTT must be obtained in all patients that present with such symptoms. 
Kod svih bolesnika kod kojih su prisutni takvi simptomi, moraju se napraviti koagulacijske pretrage koje uključuju aktivirano parcijalno tromboplastinsko vrijeme (aPTV).
• Complete baseline tests and screening as decribed in SmPC section 4. 
• Treba provesti sve početne pretrage i probire, kako je opisano u dijelu 4. Sažetka opisa svojstava lijeka.
Study population 
Edukacijski program
• Second treatment course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course. 
• Drugi ciklus liječenja: 12 mg/dan tijekom 3 uzastopna dana (ukupna doza 36 mg)