natgillin/translations-raw huggingface dataset:
Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion. 
Iglo injekcijske brizge zabodite v vialo skozi središče gumijastega zamaška in izvlecite 15 ml koncentrata za raztopino za infundiranje.
Completing 1 years Completing 2 years 
Randomizirano Dopolnjeno 1 leto Dopolnjeni 2 leti
Patients should be instructed that if they develop any infection then they should inform their physician that they are being treated with TYSABRI. 
Bolnikom je treba naročiti, da morajo v primeru razvoja kakršnekoli okužbe svojega zdravnika obvestiti, da se zdravijo z zdravilom TYSABRI.
Combination with beta-interferons or glatiramer acetate. 
Kombinacija z interferoni beta ali glatiramer acetatom.
Keep the leaflet and Alert Card with you during treatment and for six months after the last dose of TYSABRI, since side effects may occur even after you have stopped treatment. 
Kartico s posebnimi opozorili shranite med zdravljenjem in šest mesecev po zadnjem odmerku zdravila TYSABRI, ker se lahko neželeni učinki pojavijo celo po končanem zdravljenju.
The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients. 
Učinke zamenjave plazme na očistek in farmakodinamiko natalizumaba so ocenili v študiji, kjer je sodelovalo 12 bolnikov z multiplo sklerozo.
There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI. 
Poročali so o primerih redke okužbe možganov, imenovane PML (progresivna multifokalna levkoencefalopatija), ki se je pojavila pri bolnikih, zdravljenih z zdravilom TYSABRI.
You should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment. 
Na morebiten pojav simptomov morate biti pozorni še do 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI.
After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML. 
Po 2 letih zdravljenja je treba bolnike ponovno informirati o tveganjih v zvezi z zdravilom TYSABRI, posebej še o povečanem tveganju progresivne multifokalne levkoencefalopatije (PML), skupaj z njihovimi skrbniki pa jih je treba tudi poučiti o zgodnjih znakih in simptomih PML.
When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack). 
Izbruh teh simptomov se imenuje recidiv (tudi poslabšanje bolezni ali zagon).
o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o Diagnosis and prognosis of symptomatic and asymptomatic PML differentiation between PML and MS 
o Opredelitev tveganja za razvoj PML na podlagi znanih dejavnikov tveganja in predstavitev tveganja za PML v danem časovnem intervalu zdravljenja ter kumulativno tveganje za PML o Diagnoza in prognoza simptomatske in asimptomatske PML, diferenciacija PML in multiple skleroze o Algoritem obvladovanja PML
Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine). 
Nekateri bolniki so bili morda zdravljeni z zaviralci imunskega odziva (npr. mitoksantron, ciklofosfamid, azatioprin).
The pharmacokinetics of natalizumab in paediatric MS patients or in patients with renal or hepatic insufficiency has not been studied. 
Farmakokinetike natalizumaba pri otrocih, obolelih za MS in pri bolnikih z ledvično ali jetrno insuficienco niso raziskovali.
Due to this increased risk of developing PML, the benefits and risks of TYSABRI treatment should be individually reconsidered by the specialist physician and the patient; patients must be monitored at regular intervals throughout and should be instructed together with their caregivers on early signs and symptoms of PML. 
Zaradi tega povečanega tveganja za razvoj PML, morata tako zdravnik specialist kot tudi bolnik v vsakem primeru posebej ponovno preučiti koristi in tveganja z zdravilom TYSABRI; bolnike je treba ves čas spremljati v rednih intervalih in jih skupaj z njihovimi skrbniki poučiti o zgodnjih znakih in simptomih PML.
TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks. 
Zdravilo TYSABRI 300 mg se daje kot intravenska infuzija enkrat na 4 tedne.
Uncommon side effects that may affect up to 1 in 100 people: 
Občasni neželeni učinki, ki lahko prizadenejo največ 1 od 100 bolnikov:
For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines. 
Za dodatne informacije o testiranju za protitelesa proti JCV glejte Informacije za zdravnike in smernice za zdravljenje bolezni.
Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8). 
Oportunistične okužbe so bile odkrite tudi pri bolnikih z MS, zdravljenih z zdravilom TYSABRI v obliki monoterapije (glejte poglavje 4.8).
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml). 
Vsaka 15 ml viala koncentrata vsebuje 300 mg natalizumaba (20 mg/ml).
It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose. 
Možnost, da bi natalizumab vplival na plodnost pri človeku pri uporabi največjega priporočenega odmerka, ni verjetna.
In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001). 
Pri podskupini bolnikov, pri katerih je bilo indicirano zdravljenje hitro razvijajoče se hude recidivne remitentne MS (bolniki z najmanj 2 recidivoma in vsaj 1 lezijo, vidno z gadolinijem), je letna stopnja recidivov pri skupini, ki je prejemala zdravilo TYSABRI (n = 148) znašala 0,282, in pri skupini, ki je prejemala placebo (n = 61) 1,455 (p <0,001).
Anti-JCV antibody testing 
Testiranje za protitelesa proti JCV
Store in a refrigerator (2˚C - 8˚C). 
Shranjujte v hladilniku (2 ˚C - 8 ˚C).
For storage conditions after dilution of the medicinal product see section 6.3. 
Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
• If you are taking either beta-interferon or glatiramer acetate. 
• če jemljete bodisi interferon beta ali glatiramer acetat.
Other opportunistic infections have been reported with use of TYSABRI, primarily in patients with Crohn's disease who were immunocompromised or where significant co-morbidity existed, however increased risk of other opportunistic infections with use of the medicinal product in patients without these co-morbidities cannot currently be excluded. 
Okužbe, vključno z drugimi oportunističnimi okužbami Poročali so o drugih oportunističnih okužbah v zvezi z uporabo zdravila TYSABRI, primarno pri bolnikih s Crohnovo boleznijo z oslabljenim imunskim sistemom, ali pri katerih je obstajala znatna so-obolevnost, vendar pa povečanega tveganja drugih oportunističnih okužb pri uporabi zdravila pri bolnikih brez so-obolenj trenutno ni mogoče izključiti.
• If you have antibodies to the JC virus in your blood. 
• Če imate v krvi protitelesa proti virusu JC.
15 ml concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap. 
15 ml koncentrat v viali (steklo vrste I) z brombutilnim gumijastim zamaškom in aluminijastim zapiralom z dvižno zaporko.
Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended. 
Priporoča se testiranje na serumska protitelesa proti JCV pred uvedbo zdravljenja z zdravilom TYSABRI ali pri bolnikih, ki zdravilo prejemajo, če status protiteles še ni znan.
Natalizumab is excreted in human milk. 
Natalizumab se izloča v materino mleko.
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance). 
V primeru dvoma je treba razmisliti o nadaljnji ocenitvi, vključno z MRS po možnosti s kontrastom (primerjalno z izhodiščnim MRS prejšnjega stanja), testiranjem CSF glede JC virusne DNK in ponovno nevrološko ocenitvijo, kot je opisano v informacijah za zdravnika in smernicah za obvladovanje bolezni (glejte smernice za usposabljanje).
Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it. 
Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI Preden začnete z zdravljenjem z zdravilom TYSABRI, je pomembno, da se z zdravnikom pogovorite o pričakovanih koristih tega zdravljenja in o tveganjih, ki so z njim povezana.
Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment. 
Testiranje za protitelesa proti JCV daje podporne informacije za opredelitev tveganja zdravljenja z zdravilom TYSABRI.
If a patient receiving TYSABRI develops an opportunistic infection, dosing of the medicinal product must be permanently discontinued. 
Če bolnik, ki prejema zdravilo TYSABRI, razvije oportunistično okužbo, je treba zdravljenje z zdravilom trajno prekiniti.
Following reconstitution of the immune system in immunocompromised patients with PML improved outcome has been seen. 
Po ponovni vzpostavitvi imunskega sistema pri bolnikih z oslabljenim imunskim sistemom s PML so opazili stabilizacijo ali izboljšan izid.
Infusion reactions 
Reakcije na infuzijo
No clastogenic or mutagenic effects of natalizumab were observed in the Ames or human chromosomal aberration assays. 
Klastogeni ali mutageni učinek natalizumaba pri Amesovem preskusu ali v metodi človeške kromosomske aberacije ni bil ugotovljen.
Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3). 
Zdravnik mora oceniti vsak posamični primer, da ugotovi znake poslabšanja imunske odzivnosti, preden se začne zdravljenje z zdravilom TYSABRI (glejte poglavje 4.3).
The Marketing Authorisation Holder must, following discussions and agreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements: 
Imetnik dovoljenja za promet z zdravilom mora, po dogovoru in soglasju s pristojnimi organi v vsaki državi članici, v kateri se trži zdravilo TYSABRI, zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo TYSABRI, dobili informacije, ki bodo vključevale naslednje elemente: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
If an opportunistic infection is suspected, dosing with TYSABRI is to be suspended until such infections can be excluded through further evaluations. 
Pri sumu na oportunistično okužbo je treba zdravljenje z zdravilom TYSABRI prekiniti, dokler okužbe ni mogoče dejansko izključiti z nadaljnjim vrednotenjem.
Hypersensitivity reactions usually occurred during the infusion or within the 1-hour period after the completion of the infusion (See section 4.4). 
Preobčutljivostne reakcije so se običajno pojavile med infundiranjem ali do 1 uro po zaključenem infundiranju (glejte poglavje 4.4).
Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median (range) 
Starost v letih, mediana (razpon) Zgodovina obolelosti za MS v letih, mediana (razpon)
A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells. 
Nadaljnji mehanizem delovanja natalizumaba je lahko zaviranje tekoče vnetne reakcije v obolelem tkivu s preprečevanjem interakcije levkocitov z izraženimi α4 integrini, z njihovimi ligandi v ekstracelularnem prostoru in na parenhimskih celicah.
If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution. 
Razredčeno raztopino, ki je ne porabite takoj, morate hraniti na 2 ˚C do 8 ˚C in infundirati v roku 8 ur po razredčitvi.
Proportion progressed1(12-week confirmation; primary outcome) 
12 tednih; primarni izid)
Patients who are anti-JCV antibody positive are at an increased risk of developing PML compared to patients who are anti-JCV antibody negative. 
Pri bolnikih, ki so pozitivni na protitelesa proti JCV, je tveganje za razvoj PML večje v primerjavi z bolniki, ki so negativni za protitelesa proti JCV.
Anti-JCV antibody negative patients may still be at risk of PML for reasons such as a new JCV infection, fluctuating antibody status or a false negative test result. 
Pri bolnikih, ki so negativni na protitelesa proti JCV, še vedno obstaja tveganje za PML zaradi nove okužbe z JCV, stanja nihanja protiteles ali lažno negativnega rezultata testa.
Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology. 
Natalizumab je rekombinantno humanizirano anti-α4-integrin protitelo, proizvedeno na celični liniji miši in podgan z uporabo tehnologije rekombinantne DNA.
In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body. 
Pri bolnikih s PML obstaja možnost, da se po zdravljenju PML pojavi reakcija, imenovana IRIS (vnetni sindrom imunske obnove), ker se zdravilo TYSABRI odstrani iz telesa.
PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI. 
Pri diferencialni diagnozi je treba na PML pomisliti pri vseh bolnikih z MS, ki jemljejo zdravilo TYSABRI in pri katerih so prisotni nevrološki simptomi in/ali nove lezije na možganih na MRS.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4). 
TYSABRI pred začetkom bolezni je trajalo od nekaj mesecev do več let (glejte poglavje 4.4).
The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established. 
Sočasno ali predhodno zdravljenje z zaviralci imunskega odziva Varnost in učinkovitost zdravila TYSABRI v kombinaciji z drugimi zaviralci imunskega odziva in antineoplastičnimi zdravili ni bila povsem ugotovljena.
A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights. 
Študija na brejih opicah cynomolgus je na plodu pokazala spremembe, povezane z natalizumabom, ki so vključevale blago anemijo, zmanjšano število trombocitov, povečano maso vranice in zmanjšano maso jeter in priželjca.
Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome). 
Simptomi JCV GCN so podobni simptomom PML (tj. cerebelarni sindrom).
The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions. 
Neželeni učinki, ki so jo ugotovili v preskušanjih, kontroliranih s placebom, pri bolnikih z multiplo sklerozo, ki so prejemali priporočeni odmerek natalizumaba, o katerih so poročali z največjo incidenco, so bili omotica, navzea, urtikarija in rigor, povezan z infuzijami.
However, in the presence of pro-inflammatory cytokines, VCAM-1 is upregulated on endothelial cells and possibly on glial cells near the sites of inflammation. 
Vendar pa se lahko v prisotnosti provnetnih citokinov poveča število VCAM-1 molekul na endotelijskih celicah, morda pa tudi na celicah glie blizu vnetnih žarišč.
Immunosuppressant treatment prior to the use of TYSABRI 
Zdravljenje z imunosupresivi pred začetkom uporabe zdravila TYSABRI
Re-testing of anti-JCV antibody negative patients every 6 months is recommended. 
Vsakih 6 mesecev se priporoča ponovno testiranje bolnikov, ki so negativni na protitelesa proti JCV.
For medicinal products such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials. 
V kliničnih preskušanjih sočasna izpostavljenost zdravilom, kot sta interferon in glatiramer acetat, v tem času ni pokazala povezave s tveganjem za varnost.
PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. 
Po prekinitvi uporabe zdravila TYSABRI so pri bolnikih, ki niso imeli izvidov, ki bi ob času prekinitve kazali na PML, poročali o PML.
Instructions for use: 
NAVODILA ZA UPORABO
TYSABRI stops the cells that cause inflammation from going into your brain. 
Zdravilo TYSABRI celicam, ki povzročajo vnetje, preprečuje vstop v možgane.
• Yellowing of your skin or the whites of your eyes 
• porumenelost kože ali beločnice
During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen. 
Med zdravljenjem z zdravilom TYSABRI je bilo opaženo majhno zmanjšanje hemoglobina (povprečno zmanjšanje 0,6 g/dl), hematokrita (povprečno zmanjšanje 2 %) in števila eritrocitov (povprečno zmanjšanje 0,1 x 106/l).
Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility. 
Zmanjšanje plodnosti pri samicah budre so opazili v eni študiji z odmerki, ki so presegali odmerek pri človeku; natalizumab ni vplival na plodnost pri samcih.
In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection. 
V fazi 3 kliničnih preskušanj MS ni bila ugotovljena povečana stopnja okužb pri sočasnem zdravljenju recidivov s kratkoročnim dajanjem kortikosteroidov s povečano stopnjo okužb.
See package leaflet for further information. 
Glejte navodilo za uporabo za več informacij.
Short courses of corticosteroids can be used in combination with TYSABRI. 
Kratkoročno dajanje kortikosteroidov v kombinaciji z zdravilom TYSABRI je dovoljeno.
No data are available in MS patients regarding concomitant exposure with immunosuppressant medication. 
bolnike ni podatkov v zvezi s sočasno izpostavljenostjo zdravilom, ki zavirajo imunski odziv.
Monitoring for development of IRIS, which has occurred within days to several weeks after plasma exchange in TYSABRI treated patients with PML, and appropriate treatment of the associated inflammation during recovery from PML should be undertaken (see the Physician Information and Management Guidelines for further information). 
Pri bolnikih s PML, ki so se zdravili z zdravilom TYSABRI, je treba uvesti nadzor za razvoj IRIS (pojavi se v nekaj dneh do nekaj tednih po zamenjavi plazme) ter ustrezno zdravljenje s tem povezane vnetne reakcije v času okrevanja od PML (za nadaljnje informacije glejte Informacije za zdravnike in smernice za zdravljenje bolezni).
Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability. 
Z jemanjem zdravila TYSABRI je povezano povečanje tveganja za PML, oportunistično okužbo, ki jo povzroča JCV, ki lahko povzroči smrt ali hudo prizadetost.
Patients and physicians should continue to follow the same monitoring protocol and be alert for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI. 
Bolniki in zdravniki naj nadaljujejo s spremljanjem po istem protokolu in naj bodo še približno 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI pozorni na morebiten pojav novih znakov ali simptomov, ki bi lahko kazali na PML.
In some instances, the reaction reoccurred when TYSABRI was reintroduced. 
V nekaterih primerih so se težave pojavile pri ponovnem odmerjanju zdravila TYSABRI.
Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials. 
Pri kratkoročnem dajanju steroidov za zdravljenje recidivov ni bila ugotovljena povezava s povečanjem okužb pri kliničnih preskušanjih.
No studies on the effects on the ability to drive and use machines have been performed with TYSABRI. 
Študij vpliva na sposobnost vožnje in upravljanja s stroji za zdravilo TYSABRI niso izvedli.
Mean number of T1-hypointense lesions 
Povprečno število hipointenzivnih lezij T1
Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity. 
Natalizumab ni kazal učinkov v metodi in vitro α4-integrinpozitivne proliferacije ali citotoksičnosti tumorske linije.
o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with: 
o Testiranje za protitelesa proti JCV, pogostnost testiranja, interpretacija kvalitativnih in kvantitativnih rezultatov, stopnja seroprevalence protiteles proti JCV in serokonverzije glede na čas o Strategija spremljanja po prekinitvi zdravljenja z zdravilom TYSABRI o Zahtevo, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da: kopijo obrazca za uvedbo zdravljenja opozorilno kartico za bolnike, vključno z osnovnim besedilom, s katerim soglaša
Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card. 
Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti kartico s posebnimi opozorili.
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients. 
Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
• TYSABRI must not be mixed with other medicinal products or diluents. 
• Zdravilo TYSABRI se ne sme mešati z drugimi zdravili ali topili.
TYSABRI contains the active substance (natalizumab). 
Zdravilo TYSABRI vsebuje zdravilno učinkovino (natalizumab).
• Information about any registry or other monitoring system set up in the Member State and how to enter patients 
o reakcijah na infuzijo o preobčutljivostnih reakcijah o nastajanju protiteles • Informacije o kakršnemkoli registru ali drugem nadzornem sistemu, ki je bil uveden v državi članici in o načinu vključevanja bolnikov.
Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML. 
enkrat letno med zdravljenjem z zdravilom TYSABRI Pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z veliki tveganjem za PML.