natgillin/translations-raw huggingface dataset:
The autoimmune conditions can occur many years after treatment with LEMTRADA. 
Avtoimunske bolezni se lahko pojavijo več let po zdravljenju z zdravilom LEMTRADA.
In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities. 
V podštudiji s 13 moškimi bolniki, zdravljenimi z zdravilom LEMTRADA (zdravljenimi bodisi z 12 mg bodisi s 24 mg), ni bilo dokazov aspermije, azoospermije, stalno zmanjšanega števila spermijev, motenj gibljivosti ali povečanja morfoloških nenormalnosti semenčic.
• red and white blood cells disorders (uncommon - may affect up to 1 in 100 people): diagnosed from your blood tests. 
• bolezni rdečih in belih krvničk (občasni - pojavijo se lahko pri največ 1 od 100 bolnikov), ki se določijo na podlagi krvnih preiskav.
Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy. 
Bolniki z znano koagulopatijo, na antiagregacijskem ali antikoagulantnem zdravljenju.
Observed autoimmune thyroid disorders included hyperthyroidism or hypothyroidism. 
Ugotovljene avtoimunske bolezni ščitnice so vključevale hipertiroidizem in hipotiroidizem.
The rate of thyroid adverse reactions was highest in year three and declined thereafter. 
Delež neželenih učinkov povezan s ščitnico je bil največji tretje leto in se je nato zmanjševal.
• tears in carotid or vertebral arteries (blood vessels supplying the brain) 
• pretrganje vratnih (karotidnih) ali vretenčnih (vertebralnih) arterij (to so žile, ki oskrbujejo možgane)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
LEMTRADA depletes circulating T and B lymphocytes after each treatment course with the lowest observed values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3 studies). 
Zdravilo LEMTRADA po vsaki stopnji zdravljenja osiromaši krožeče limfocite T in B, najnižje ravni pa se pa so opazne 1 mesec po zdravljenje (najbolj zgodnja časovna točka po zdravljenju v študijah 3. faze).
Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years). 
Resne pojave ITP so opazili pri 12 (1 %) bolnikih, zdravljenih v kontroliranih kliničnih preskušanjih pri MS (to ustreza na leto preračunanemu deležu 4,7 dogodkov/1000 bolnik-let).
Annualised Relapse rate (ARR) (95% CI) 
Letna stopnja recidivov (Annualised Relapse rate - ARR) (95-odstotni IZ)
Read the summary of product characteristics (available at the EMA website mentioned above) for more information. 
Za več informacij preberite povzetek glavnih značilnosti zdravila (na voljo na zgoraj omenjeni spletni strani agencije EMA).
Reactions may occur following any of the doses during the treatment course. 
Učinki se lahko pojavijo po katerem koli odmerku med ciklusom zdravljenja.
Very Common Common 
Zelo pogosti
Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC code: L04AA34 
Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA34.
Approximately 40% of patients had total lymphocyte counts reaching the lower limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total lymphocyte counts reaching the LLN by 12 months after each course. 
Pri približno 40 % bolnikov je skupno število limfocitov doseglo spodnjo mejo normalnih vrednosti v 6 mesecih po vsaki stopnji zdravljenja, pri približno 80 % bolnikov pa je skupno število limfocitov doseglo spodnjo mejo normalnih vrednosti v 12 mesecih po vsakemzdravljenju.
DO NOT SHAKE VIALS PRIOR TO USE. 
VIALE PRED UPORABO NE PRETRESITE.
Infections were generally of typical duration and resolved following conventional medical treatment. 
Okužbe so trajale kot običajno in so po standardnem zdravljenju izzvenele.
• kidney disorders, (rare - may affect up to 1 in 1,000 people): may show as blood in the urine (your urine may be red or tea-coloured), or as swelling in your legs or feet. 
• bolezni ledvic (redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov): lahko se pokažejo kot kri v urinu (urin je rdeče barve ali barve čaja) ali kot otekanje nog ali stopal.
• excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis) 
• prekomerna aktivacija belih krvnih celic, povezanih z vnetjem (hemofagocitna limfohistiocitoza)
It is recommended that your doctor prescribes a medicine to reduce the chance of developing a herpes infection, which should be taken on the days that you receive LEMTRADA treatment, and for one month following the treatment. 
Priporočljivo je, da vam zdravnik za zmanjševanje možnosti za razvoj herpesne okužbe predpiše zdravilo, ki ga morate jemati tiste dni, ko se zdravite z zdravilom LEMTRADA, in še en mesec po zdravljenju.
If untreated it can cause kidney failure requiring dialysis or transplantation, and may lead to death. 
Če ni zdravljena, lahko povzroči ledvično odpoved z dializo ali presaditvijo in lahko vodi v smrt.
Carcinogenesis and mutagenesis 
Kancerogenost in mutagenost
If you notice any of these signs or symptoms, call your doctor right away to report them. 
Če opazite katerega od teh znakov ali simptomov, nemudoma pokličite svojega zdravnika in jih navedite.
Most cases occurred within two months of alemtuzumab dosing. 
Večina primerov se je pojavila v dveh mesecih po odmerku alemtuzumaba.
% receiving ≥2 prior MS 
% oseb, ki so opravile ≥ 2 predhodni zdravljenji MS
o Perform laboratory tests (complete blood count with differential, serum transaminases, serum creatinine, test of thyroid function and urinanalysis with microscopy). 
o Opraviti je treba laboratorijske preiskave (celotno krvno sliko z diferencialno krvno sliko, serumske transaminaze, kreatinin v serumu, preiskave delovanja ščitnice in analizo urina, vključno z mikroskopskim pregledom).
Patients with new T1 hypointense lesions through Year 2 
Bolniki z novo hipointenzivno lezijo T1 v 2. letu
• Pre-infusion evaluations: o Obtain a baseline ECG and vital signs, including heart rate and blood pressure measurement. 
• Ovrednotenje pred infundiranjem: o Opraviti je treba EKG in preveriti vitalne znake, vključno z meritvijo srčne frekvence in krvnega tlaka.
Non-interventional post-authorisation safety study (PASS): In order to investigate the incidence of mortality in patients treated with Lemtrada compared to a relevant patient population, the MAH shall submit the results of a post-authorisation safety study 
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za proučitev pojavnosti umrljivosti med bolniki, zdravljenimi z zdravilom Lemtrada, v primerjavi z relevantno populacijo bolnikov bo imetnik dovoljenja za promet z zdravilom predložil neintervencijsko študijo o varnosti zdravila
The most important side effects are the autoimmune conditions described in section 2 which include: 
Najpomembnejši resni neželeni učinki so avtoimunske bolezni, ki so opisane v poglavju 2 in obsegajo:
Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. 
Vbrizgajte v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze (5 %) za infundiranje.
Through 2 treatment courses, there was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions. 
V dveh ciklih zdravljenja prisotnosti protiteles proti alemtuzumabu ali zaviralnih protiteles proti alemtuzumabu nista bili povezani z z zmanjšanjem učinkovitosti, spremembo farmakodinamike ali pojavnostjo neželenih učinkov, vključno z reakcijami, povezanimi z infuzijo.
Terms marked with two asterisks (**) in Table 1 include adverse reactions observed in the post marketing setting which have occurred in the majority of cases with time to onset within 1-3 days of LEMTRADA infusion, following any of the doses during the treatment course. 
Izrazi, ki so v preglednici 1 označeni z dvema zvezdicama (**), vključujejo neželene učinke, zabeležene v obdobju po prihodu zdravila na trg, ki so se v večini primerov pojavili v 1 do 3 dneh po infundiranju zdravila LEMTRADA in po katerem koli odmerku med ciklusom zdravljenja.
Table 1: Adverse reactions in study 1, 2, 3 and 4 observed in LEMTRADA 12 mg treated patients and post-marketing surveillance 
Preglednica 1: Neželeni učinki v študijah 1, 2, 3 in 4, opaženi pri bolnikih, zdravljenih z 12 mg odmerkom zdravila LEMTRADA in v okviru spremljanja po prihodu zdravila na trg
Some of the IARs (e.g. dizziness) could temporarily impact the patient's ability to drive or use machines and caution should be exercised until these are resolved. 
Nekatere z infuzijo povezane reakcije (npr. omotica) lahko začasno vplivajo na bolnikovo sposobnost vožnje in upravljanja s stroji, zato je treba biti do prenehanja teh učinkov previden.
Study 4, was a Phase 3, multicenter, open-label, rater-blinded, efficacy and safety extension study for patients with RRMS who participated in Study 1, 2, or 3 (prior phase 3 and 2 studies) to assess long-term efficacy and safety of LEMTRADA. 
4. študija je bila multicentrično podaljšanje študije učinkovitosti in varnosti 3. faze z načrtom odprtega zdravljenja in slepljenim ocenjevalcem; zajela je bolnike z RRMS, ki so sodelovali v 1., 2. ali 3. študiji (predhodne študije 2. in 3. faze), in je bila namenjena oceni dolgoročne učinkovitosti in varnosti zdravila LEMTRADA.
It is recommended that HPV screening be completed annually for female patients. 
Pri bolnicah je priporočljivo izvajanje presejanja za HPV vsako leto.
Thyroid disease poses special risks in women who are pregnant (see section 4.6). 
Bolezni ščitnice so posebej nevarne za nosečnice (glejte poglavje 4.6).
Non-interventional post-authorisation safety study (PASS): In order to assess compliance with the therapeutic indication and effectiveness of measures to minimise the risk of cardiovascular and cerebrovascular adverse events in close temporal association with Lemtrada infusion and immune-mediated adverse reactions, the MAH shall submit the results of a drug utilisation study. 
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za oceno kompliance s terapevtsko indikacijo in učinkovitosti ukrepov za zmanjšanje tveganja za srčno-žilne in možganskožilne neželene učinke, časovno tesno povezane z infundiranjem zdravila Lemtrada, in imunsko pogojenih neželenih učinkov bo imetnik dovoljenja za promet predložil rezultate študije uporabe zdravila.
The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed. 
Priporočeni odmerek alemtuzumaba je 12 mg/dan in se daje z intravensko infuzijo v 2 začetnih ciklih zdravljenja z do 2 dodatnima cikloma zdravljenja, če je potrebno.
• First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose) 
• Prvi cikel zdravljenja: 12 mg/dan 5 zaporednih dni (skupni odmerek 60 mg)
Time to onset of symptoms ranged from less than 24 hours to 2 months after LEMTRADA infusion. 
Simptomi so se pojavili v razponu od manj kot 24 ur do 2 meseca po infuziji zdravila LEMTRADA.
All of these serious side effects can start many years after you have received LEMTRADA. 
Vsi ti resni neželeni učinki lahko nastopijo več let po prejemu zdravila LEMTRADA.
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. 
Vaš zdravnik se bo želel tudi prepričati, da pred začetkom zdravljenja z zdravilom LEMTRADA nimate določenih bolezni ali motenj.
To try to reduce infusion reactions, your doctor will give you medicine (corticosteroids) before each of the first 3 infusions of a LEMTRADA course. 
Vaš zdravnik bo poskušal zmanjšati z infuzijo povezane reakcije tako, da vam bo dal zdravilo (kortikosteroide) pred vsako od prvih treh infuzij v postopku zdravljenja z zdravilom LEMTRADA.
The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections. 
Najpogostejši neželeni učinki zdravila LEMTRADA (pri ≥ 20 % bolnikov) so bili izpuščaj, glavobol, pireksija in okužbe dihal.
To assist in the education of patients regarding potential side-effects and instructions on what to do in case of certain side-effects, the following risk minimisation materials are available: 
V pomoč pri izobraževanju bolnikov o možnih neželenih učinkih in ukrepih v primeru pojava določenih neželenih učinkov je na voljo naslednje gradivo za zmanjšanje tveganja:
As with other immunomodulatory therapies, caution should be exercised in initiating LEMTRADA therapy in patients with pre-existing and/or an on-going malignancy. 
Kot pri drugih imunomodulacijskih zdravljenjih je treba previdno začeti zdravljenje z zdravilom LEMTRADA pri bolnikih, ki so že imeli in/ali še prebolevajo maligno bolezen.
Clinical manifestations of nephropathy may include elevation in serum creatinine, haematuria, and/or proteinuria. 
Klinične manifestacije nefropatije lahko vključujejo zvišanje serumske ravni kreatinina, hematurijo in/ali proteinurijo.
Approximately half (51.2%) of patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 who enrolled in Study 4, received only the initial 2 courses of LEMTRADA and no other disease modifying treatment throughout 6 years of follow-up. 
Približno polovica (51,2 %) bolnikov, uvodoma zdravljenih z 12 mg zdravila LEMTRADA na dan v 1. in 2. študiji, ki so bili vključeni v 4. študijo, je prejela le uvodna 2 cikla zdravila LEMTRADA in nobenih drugih imunomodulirajočih zdravil med 6-letnim spremljanjem.
You will also have regular blood and urine tests to ensure that if you develop any of these conditions, they are treated promptly. 
Redno boste opravljali preiskave krvi in urina, da se zagotovi hitro zdravljenje, če se pri vas pojavi katera od omenjenih bolezni.
Nevertheless, please note that in case of missed dose, this should not be given on the same day as a scheduled dose. 
Vendar si zapomnite, da pozabljenega odmerka ne smete vzeti na isti dan, kot naj bi vzeli predhodno planiran odmerek.
Treatment may result in the formation of autoantibodies and increase the risk of autoimmune mediated conditions which may be serious and life threatening. 
Zdravljenje lahko povzroči nastanek avtoprotiteles in poveča tveganje za avtoimunske motnje, ki so lahko resne in življenjsko nevarne.
Haemoptysis may also be indicative of ITP or acquired haemophilia A (see above), and an appropriate differential diagnosis has to be undertaken. 
Hemoptiza lahko kaže tudi na ITP ali na pridobljeno hemofilijo A (glejte zgoraj), zato je treba opraviti ustrezno diferencialno diagnostiko.
Infusion instructions to reduce serious reactions temporally associated with LEMTRADA infusion 
Navodila za infundiranje za zmanjšanje resnih reakcij, časovno povezanih z infundiranjem zdravila LEMTRADA
Cardiac disorders Tachycardia* Bradycardia*, palpitations* 
Srčne bolezni tahikardija* bradikardija*, palpitacije*
Screening for tuberculosis will be arranged by your doctor. 
Vaš zdravnik bo uredil presejalno preiskavo za tuberkulozo.
Another side effect is an increased risk of infections (see below for information on how often patients experience infections). 
Pomemben neželeni učinek je tudi povečano tveganje okužb (podatki o pogostosti okužb pri bolnikih so v nadaljevanju).
To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination. 
Da cepljenje proti virusu varicella zoster doseže polni učinek, odložite zdravljenje z zdravilom LEMTRADA za 6 tednov po cepljenju.
Several of the patient reported were below 50 years of age and had no history of hypertension, bleeding disorders or concomitant anticoagulants or platelet inhibitors. 
Več bolnikov, o katerih so poročali, je bilo mlajših od 50 let in v anamnezi niso imeli hipertenzije ali motenj strjevanja krvi in niso sočasno uporabljali antikoagulantnih ali antiagregacijskih zdravil.
o Immune Thrombocytopenic Purpura (ITP) 
Imunska trombocitopenična purpura (ITP)
Myocardial ischaemia**, myocardial infarction** 
ishemija miokarda**, miokardni infarkt**
Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes. 
Alemtuzumab deluje preko od protiteles odvisne celične citolize in s komplementom posredovane lize po vezavi na površino limfocitov T in B.
There is no relevant use of alemtuzumab in children aged from birth to less than 10 years for the treatment of multiple sclerosis. 
Pri otrocih od rojstva do manj kot 10 let starosti uporaba alemtuzumaba za zdravljenje multiple skleroze ni smiselna.
• Use aseptic techniques to withdraw 1.2 ml of LEMTRADA from the vial and inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. 
• Z aseptičnimi tehnikami povlecite 1,2 ml zdravila LEMTRADA iz viale in ga vbrizgajte v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze (5 %) za infundiranje.
Additionally, the observed incidence of antibody (including inhibitory antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicines, and underlying disease. 
Poleg tega na ugotovljeno pojavnost pozitivnosti testa za protitelesa (vključno z zaviralnimi protitelesi) lahko vpliva več dejavnikov, vključno z metodologijo testa, postopki ravnanja z vzorci, časom odvzema vzorca, sočasno uporabljenimi zdravili in osnovno boleznijo.
• ITP (bleeding disorders), (common - may affect up to 1 in 10 people): may show as small scattered red, pink or purple spots on your skin; easy bruising; bleeding from a cut that is harder to stop; heavier, longer or more frequent menstrual periods than normal; bleeding between menstrual periods; bleeding from your gums or nose that is new or takes longer than usual to stop; or coughing up blood. 
• ITP (motnja strjevanja krvi) (pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov): lahko se pokaže kot majhne razpršene rdeče, rožnate ali vijolične pike na koži; nagnjenost k pojavljanju podplutb; krvavitev iz ureznine, ki jo je težje ustaviti; menstrualna krvavitev, ki je močnejša, daljša ali pogostejša kot običajno; krvavitev med menstruacijami; krvavitev iz dlesni ali nosu, ki se še ni pojavila ali traja dlje kot običajno; ali izkašljevanje krvi.
Patients should be informed about the risk of autoimmune hepatitis, hepatic injury and related symptoms. 
Bolnike je treba seznaniti s tveganjem za avtoimunski hepatitis, okvaro jeter in s simptomi, ki so s tem povezani.
Severe anaphylaxis and other hypersensitivity reactions, including anaphylactic shock and angioedema have also been reported. 
Poročali so tudi o hudi anafilaksi in drugih preobčutljivostnih reakcijah, vključno z anafilaktičnim šokom in angioedemom.
Anti-GBM disease may lead to renal failure requiring dialysis and/or transplantation if not treated rapidly and can be life-threatening if left untreated. 
Bolezen protiteles proti glomerulni bazalni membrani lahko vodi v ledvično odpoved, ki zahteva dializo in/ali presaditev, če se ne pozdravi hitro, ter je lahko življenjsko nevarna, če je ne zdravimo.
Patients and physicians should be made aware of the potential later onset of autoimmune disorders after the 48 months monitoring period. 
Poskrbeti je treba, da se bolniki in zdravniki zavedajo možnosti za zapoznel pojav avtoimunskih motenj tudi po koncu 48-mesečnega obdobja nadzora.
If ITP onset is confirmed, appropriate medical intervention should be promptly initiated, including immediate referral to a specialist. 
Če potrdite pojav ITP, je treba takoj uvesti ustrezne medicinske postopke, vključno s takojšnjo napotitvijo k specialistu.
• It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination. 
• Priporočljivo je, da zdravilo uporabite nemudoma po redčenju zaradi možnosti mikrobne kontaminacije.
Haemoptysis may also be indicative of anti-GBM disease (see below), and an appropriate differential diagnosis has to be undertaken. 
Hemoptiza lahko kaže tudi na bolezen protiteles proti glomerulni bazalni membrani (glejte spodaj), zato je treba opraviti ustrezno diferencialno diagnostiko.
Liver inflammation can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment. 
Vnetje jeter je mogoče ugotoviti na podlagi izvidov preiskav krvi, ki jih boste redno opravljali po zdravljenju z zdravilom LEMTRADA.
After this time, if you have symptoms of ITP, kidney or thyroid disorders, your doctor will perform more tests. 
Če boste po tem času imeli simptome ITP, bolezni ledvic ali ščitnice, bo zdravnik opravil dodatne preiskave.
It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination. 
Priporočljivo je, da se zdravilo uporabi nemudoma po redčenju zaradi možnosti mikrobnega onesnaženja.
To try to reduce infusion reactions, your doctor will give you other medicine(s) (see section 4 - infusion reactions). 
Vaš zdravnik bo poskušal zmanjšati z infuzijo povezane reakcije tako, da vam bo dal drugo zdravilo ali zdravila (glejte poglavje 4 - Z infuzijo povezane reakcije).
In clinical trials, there were 2 cases of anti-GBM disease. 
V kliničnih preskušanjih sta bila 2 primera bolezni protiteles proti glomerulni bazalni membrani.
There is no evidence that LEMTRADA has an impact on male fertility. 
Ni dokazov, da bi zdravilo LEMTRADA vplivalo na moško plodnost.
Any spillage or waste material should be disposed of in accordance with local requirements. 
Razlito zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
After each infusion, the patient should be observed for 2 hours for infusion associated reactions. 
• Po infundiranju zdravila je treba bolnika še dve uri opazovati zaradi z infuzijo povezanih reakcij.
• constipation, acid reflex, dry mouth 
• zapeka, refluks želodčne kisline, suha usta
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. 
Bolnike je treba seznaniti z možnostjo za zapoznel pojav z infundiranjem povezanih reakcij in jim naročiti, da morajo o simptomih poročati in poiskati ustrezno zdravniško pomoč.
Recommendations on how to mitigate these risks through appropriate patient counselling, monitoring and management. 
priporočila o zmanjševanju teh tveganj z ustreznim svetovanjem, spremljanjem in obravnavo bolnika; poglavje „Pogosta vprašanja“.
After this period of time testing should be performed based on clinical findings suggestive of thyroid dysfunction or in case of pregnancy. 
Po tem časovnem obdobju je treba opraviti testiranje, če klinični izsledki kažejo na moteno delovanje ščitnice ali v primeru nosečnosti.
LEMTRADA adjusts your immune system to limit its attacks on your nervous system. 
Kako zdravilo LEMTRADA deluje Zdravilo LEMTRADA uravnava vaš imunski sistem in omejuje napade na živčni sistem.
Patients who are relapse free at Year 2 (95% CI) 
Bolniki, ki so brez recidiva po 2. letih (95-odstotni IZ)
The reported thrombocytopenia occurred within the first days after the infusion (unlike ITP). 
Trombocitopenija, o kateri so poročali, se je pojavila v prvih dneh po infundiranju (v nasprotju z ITP).