natgillin/translations-raw huggingface dataset:
The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Imetnik dovoljenja za promet z zdravilom uveljavlja dogovorjene ukrepe za nadzor v časovnem okviru, določenem v dogovoru z nacionalnimi pristojnimi organi.
Retesting low index patients who have no history of prior immunosuppressant use every 6 months once they reach the 2 year treatment point is recommended.
Ponovno testiranje bolnikov z nizkim indeksom, ki v anamnezi nimajo predhodne uporabe imunosupresivov, se priporoča vsakih 6 mesecev, ko dosežejo časovno točko 2-letnega zdravljenja.
These studies showed no evidence of teratogenic effects or effects on growth of offspring.
Študije niso pokazale teratogenih učinkov ali učinkov na rast ploda.
PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 x 15 ml viala
A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Analiza populacijske farmakokinetike se je izvajala na vzorcih več kot 1100 bolnikov z MS, ki so prejemali odmerke od 3 do 6 mg/kg natalizumaba.
No effects on abortion rates were noted in any other study.
V nobeni drugi študiji niso ugotovili učinka na stopnjo abortusa.
In post-marketing experience, there have also been reports of eosinophilia (eosinophil count >1,500/mm3) without clinical symptoms.
Iz izkušenj v obdobju trženja so tudi poročali o eozinofiliji (število eozinofilcev >1.500/mm3) brez kliničnih simptomov.
The European Medicines Agency has deferred the obligation to submit the results of studies with TYSABRI in one or more subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom TYSABRI za eno ali več podskupin pediatrične populacije za multiplo sklerozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
• If your doctor tells you that you have a serious problem with your immune system (due to disease for example, HIV or due to a medicine you are taking or have previously taken, e.g. mitoxantrone or cyclophosphamide).
• če vam je zdravnik povedal, da imate resne težave s svojim imunskim sistemom (na primer zaradi bolezni kot so levkemija in HIV ali zaradi zdravil, ki jih jemljete ali ste jih jemali, npr. mitoksantron ali ciklofosfamid).
Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Zdravnik bo preverjal prisotnost alergijske reakcije med infundiranjem in 1 uro po njenem zaključku.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Will TYSABRI always work?
Ali zdravilo TYSABRI vedno deluje?
• Patient alert card
• Opozorilna kartica za bolnika
Of these, 581 patients received a fixed 300 mg dose as monotherapy.
581 teh bolnikov je prejemalo stalen 300 mg odmerek v obliki monoterapije.
Anaemia and haemolytic anaemia
Anemija in hemolitična anemija
If, after approximately 6 months of therapy, persistent antibodies are suspected, either due to reduced efficacy or due to occurrence of infusion-related events, they may be detected and confirmed with a subsequent test 6 weeks after the first positive test.
Če obstaja po približno 6 mesecih zdravljenja sum na obstojna protitelesa, bodisi zaradi zmanjšane učinkovitosti ali zaradi pojava z infuzijo povezanih dogodkov, jih je mogoče odkriti in potrditi s ponovnim testom 6 tednov po prvem pozitivnem testu.
After dilution, do not shake.
Po razredčenju ne stresajte.
Elevations in neutrophils were not seen.
Povišano število nevtrofilcev ni bilo opaženo.
These medicines are for MS and cannot be used with TYSABRI (see Using other medicines, below).
Ta zdravila se uporabljajo za MS in jih ne morete uporabljati z zdravilom TYSABRI (glejte Druga zdravila in zdravilo TYSABRI, spodaj).
Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest an effect of TYSABRI exposure on pregnancy outcomes.
Podatki iz kliničnih preskušanj, prospektivnega registra nosečnosti, primerov v obdobju trženja in iz razpoložljive literature ne kažejo, da bi izpostavljenost zdravilu TYSABRI vplivala na izide nosečnosti.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• Patient details, signature and date
• podatki o bolniku, podpis in datum
Educational guidance
Smernice za usposabljanje
The analysis explored the effects of selected covariates including body weight, age, gender, hepatic and renal function, and presence of anti-natalizumab antibodies upon pharmacokinetics.
Analiza je raziskala učinke izbranih sospremenljivk, vključno s telesno maso, starostjo, spolom, jetrnim in ledvičnim delovanjem in prisotnostjo proti-natalizumabnih protiteles na farmakokinetiko.
In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals.
Pri opicah cynomolgus, tretiranih z natalizumabom do skotitve, so bile nizke ravni natalizumaba ugotovljene v opičjem mleku nekaterih živali..
The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Mehanizem izločanja in rezultati populacijske farmakokinetike kažejo, da prilagajanje odmerka za bolnike z okvarami ledvic ali jeter morda ne bo potrebno.
Colourless, clear to slightly opalescent solution.
Brezbarvna, bistra do rahlo opalescentna raztopina.
If herpes encephalitis or meningitis occurs, the medicinal product should be discontinued, and appropriate treatment for herpes encephalitis or meningitis should be administered.
Če pride do herpesnega encefalitisa ali meningitisa, je treba zdravljenje z zdravilom prekiniti in začeti ustrezno zdravljenje herpesnega encefalitisa ali meningitisa.
Use of these medicinal products soon after the discontinuation of natalizumab may lead to an additive immunosuppressive effect.
Uporaba teh zdravil kmalu po prenehanju dajanja natalizumaba lahko povzroči dodatni učinek zaviranja imunskega odziva.
The physician information about TYSABRI shall contain the following key elements:
Informacije o zdravilu TYSABRI za zdravnike naj vsebujejo naslednje ključne elemente:
• Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
• Informacije za zdravstveno osebje o pripravi in dajanju zdravila TYSABRI so na koncu tega navodila.
RRMS (McDonald criteria)
Bolniki z RRMS (recidivna remitentna multipla skleroza) (McDonaldovi kriteriji)
In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/kg treatment groups versus matching control groups.
V eni študiji z opicami se je število abortusov obravnavanih opic podvojilo pri dajanju 30 mg/kg natalizumaba v primerjavi z ujemajočimi kontrolnimi skupinami.
1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
1Napredovanje prizadetosti je bilo definirano s povečanjem na EDSS za vsaj 1,0 točke, od izhodiščne EDSS >=1,0, v trajanju vsaj 12 ali 24 tednov, ali s povečanjem na EDSS za vsaj 1,5 točke, od izhodiščne EDSS =0, v trajanju vsaj 12 ali 24 tednov.
Resources for the management of hypersensitivity reactions should be available.
Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami.
Once the clinician has excluded PML and/or JCV GCN (if necessary, by repeating clinical, imaging and/or laboratory investigations if clinical suspicion remains), dosing of TYSABRI may resume.
Ko zdravnik izključi PML in/ali JCV GCN (po potrebi s ponovnimi kliničnimi, slikovnimi in/ali laboratorijskimi preiskavami, če klinični dvom ni odstranjen), je mogoče nadaljevati z odmerjanjem zdravila TYSABRI.
This reduces nerve damage caused by MS.
Poškodbe živčnih celic, ki jih povzroča MS, se tako zmanjšajo.
These reactions usually occurred during the infusion or up to 1 hour after completion of the infusion.
Reakcije so se običajno pojavile med infundiranjem ali do 1 uro po zaključenem infundiranju.
• Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
• potrditev, da bolniki razumejo tveganje PML in so prejeli kopijo obrazca in opozorilno kartico za bolnika
Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Monoterapija; randomizirano, dvojno slepo, s placebom kontrolirano, vzporedno, 120-tedensko preskušanje
PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown.
PML je povezana z nenadziranim povečanjem števila virusov JC v možganih, čeprav razlog za to povečanje pri nekaterih bolnikih, zdravljenih z zdravilom TYSABRI, ni znan.
The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Bolnike so randomizirali v razmerju 2:1 za dajanje zdravila TYSABRI 300 mg (n = 627) ali placeba (n = 315) vsake 4 tedne do 30 infuzij.
Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that you speak to your doctor as soon as possible.
Če imate občutek, da se vaša MS slabša ali opazite nove simptome, medtem ko se zdravite z zdravilom TYSABRI ali še do 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI, je zelo pomembno, da nemudoma govorite z zdravnikom.
This should be considered if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
These symptoms may be caused by an infection of the brain (encephalitis) or its covering layer (meningitis).
Te simptome lahko povzroča okužba možganov (encefalitis) ali njihovih ovojnic (meningitis).
Based on how patients treated with TYSABRI are currently monitored at national level, the Marketing Authorisation Holder (MAH) shall discuss and agree with the National Competent Authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Na osnovi tega, kako so bolniki, zdravljeni z zdravilom TYSABRI, trenutno nadzirani na nacionalni ravni, se imetnik dovoljenja za promet z zdravilom po potrebi dogovarja in usklajuje z nacionalnimi pristojnimi organi glede ukrepov za nadaljnje povečanje tega nadzora (npr. registri in študije v obdobju trženja).
Relapse rate derived variables / MRI-derived variables
Iz stopnje recidivov izpeljane spremenljivke / iz MRTizpeljane spremenljivke
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Neporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
All physicians who intend to prescribe TYSABRI must ensure they are familiar with the Physician Information and Management Guidelines.
Vsi zdravniki, ki nameravajo predpisovati zdravilo TYSABRI, morajo zagotoviti, da so seznanjeni z informacijami za zdravnike in smernicami za obvladovanje bolezni.
Anti-JCV antibody testing should not be performed during, or for at least two weeks following, plasma exchange due to the removal of antibodies from the serum.
Testiranja za protitelesa proti JCV ne opravite med zamenjavo plazme ali še vsaj dva tedna po tem, saj so bila iz seruma odstranjena protitelesa.
TYSABRI is for intravenous use.
Zdravilo TYSABRI je za intravensko uporabo.
Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving TYSABRI and the presence of antiJohn Cunningham virus (JCV) antibodies (see section 4.4.
Bolnika je treba ponovno informirati o dejavnikih tveganja za PML, kot so trajanje zdravljenja, uporaba imunosupresivov pred prejemanjem zdravila TYSABRI in prisotnost protiteles proti virusu John Cunningham (JCV) (glejte poglavje 4.4).
• Adult patients aged 18 years and over with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
• odrasli bolniki, stari 18 let in več, s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo, ki se kaže z 2 ali več recidivi prizadetosti v enem letu ter z 1 ali več lezijami, vidnimi z gadolinijem pri MRS možganov ali znatnim povečanjem površine lezij T2 v primerjavi s predhodnim nedavnim MRS.
MRI (0-2 years) Median % change in T2hyperintense lesion volume
MRS (0-2 let) Mediana % sprememba v obsegu hiperintenzivne lezije T2 (mm3)
The physician should be particularly alert to symptoms suggestive of PML or JCV GCN that the patient may not notice (e.g. cognitive, psychiatric symptoms or cerebellar syndrome).
Zdravnik mora biti še posebno pozoren na simptome, ki nakazujejo PML ali JCV GCN, katerih bolnik sam morda ne opazi (npr. kognitivni, psihiatrični simptomi ali cerebelarni sindrom).
Physicians should counsel patients on the importance of uninterrupted dosing, particularly in the early months of treatment (see hypersensitivity).
Zdravniki morajo bolnikom razložiti, da je neprekinjeno odmerjanje izjemno pomembno, še posebej v prvih mesecih zdravljenja (glejte odstavek o preobčutljivosti).
Current evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years (see the Physician Information and Management Guidelines for further information).
Trenutni podatki kažejo, da je tveganje za PML nizko pri indeksu 0,9 ali manj in močno naraste nad 1,5 za bolnike, ki so se z zdravilom TYSABRI zdravili dlje kot 2 leti (za več informacij glejte Informacije za zdravnike in smernice za zdravljenje bolezni).
Subjects
Predmeti
The change in clearance was not clinically significant.
Sprememba v očistku ni bila statistično značilna.
If a decision is made to stop treatment with natalizumab, the physician needs to be aware that natalizumab remains in the blood, and has pharmacodynamic effects (e.g increased lymphocyte counts) for approximately 12 weeks following the last dose.
V primeru odločitve, da se zdravljenje z natalizumabom prekine, mora zdravnik vedeti, da ostane natalizumab v krvi in ima farmakodinamične učinke (npr. v obliki povečanega števila limfocitov) še približno 12 tednov po zadnjem odmerku.
When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
TYSABRI morda ne boste opazili izboljšanja, vendar lahko zdravilo TYSABRI še vedno preprečuje poslabšanje MS.
Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Natalizumab onemogoči interakcijo integrina α4β7 z mukozno adresinsko celično adhezijsko molekulo-1 (MadCAM-1).
After 2 years all patients should be re-informed about the risk of PML with TYSABRI.
Po 2 letih je treba bolnike ponovno obvestiti o tveganju za PML z zdravilom TYSABRI.
IRIS may lead to your condition getting worse, including worsening of brain function.
se vam bolezen lahko poslabša, kar vključuje tudi poslabšano delovanje možganov.
• The longer that you are on treatment especially if you have been on treatment for more than two years.
• S trajanjem zdravljenja, zlasti še, če se zdravite že več kot dve leti.
Patients treated with TYSABRI must be given the patient alert card and be informed about the risks of the medicinal product (see also package leaflet).
Bolnikom, ki se zdravijo z zdravilom TYSABRI, je treba dati bolnikovo opozorilno kartico in jih informirati o tveganjih v zvezi z zdravilom (glejte tudi Navodilo za uporabo).
In a few patients who use TYSABRI, over time the body's natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
Pri nekaterih bolnikih, ki se zdravijo z zdravilom TYSABRI, lahko naravni obrambni mehanizem telesa sčasoma prepreči pravilno delovanje zdravila TYSABRI (telo razvije protitelesa na zdravilo TYSABRI).
Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
Vaš zdravnik lahko te krvne preiskave med zdravljenjem z zdravilom TYSABRI ponovi, da ugotovi, ali se je kaj spremenilo.
If you have any further questions on TYSABRI, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila TYSABRI, se posvetujte s svojim zdravnikom.
• Adult patients aged 18 years and over with high disease activity despite treatment with a betainterferon or glatiramer acetate.
• odrasli bolniki, stari 18 let in več, z zelo aktivno boleznijo, kljub zdravljenju z interferonom beta ali glatiramer acetatom.
• Unusual darkening of the urine.
• nenavadno temen urin
A few patients have had an allergic reaction to TYSABRI.
Nekaj bolnikov je doživelo alergijsko reakcijo na zdravilo TYSABRI.
Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Neželeni učinki zdravila, o katerih so poročali pri natalizumabu z 0,5 % višjo incidenco kot je bila poročana pri placebu, so prikazani spodaj.
If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Če opazite delce in/ali če raztopina v viali ni brezbarvna, bistra do rahlo opalescentna, viale ne smete uporabiti.
• The presence of anti-JCV antibodies.
• Prisotnost protiteles proti JCV.
The risk for hypersensitivity was greatest with early infusions and in patients re-exposed to TYSABRI following an initial short exposure (one or two infusions) and extended period (three months or more) without treatment.
Tveganje preobčutljivosti je bilo največje pri zgodnjih infuzijah in pri bolnikih, ki so bili po kratkotrajni začetni izpostavljenosti (po eni ali dveh infuzijah) in daljšem obdobju (tri mesece ali več) brez zdravljenja ponovno izpostavljeni zdravilu TYSABRI.
In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the humoral immune response to a recall antigen (tetanus toxoid) and only slightly slower and reduced humoral immune response to a neoantigen (keyhole limpet haemocyanin) was observed in patients who were treated with TYSABRI for 6 months compared to an untreated control group.
V randomizirani, odprti študiji s 60 bolniki z recidivno remitentno multiplo sklerozo ni bilo značilne razlike v humoralnem imunskem odzivu na cepljenje s tetanusnim toksoidom (recall antigen), opazili pa so le nekoliko upočasnjen in zmanjšan humoralni imunski odziv na neoantigen (hemocianin iz školjke) pri bolnikih, ki so se 6 mesecev zdravili z zdravilom TYSABRI v primerjavi z nezdravljeno kontrolno skupino.
IRIS occurs in almost all TYSABRI PML patients after withdrawal or removal of the medicinal product, e.g. by plasma exchange (see section 5.2).
IRIS se pojavi pri skoraj vseh bolnikih s PML, zdravljenih z zdravilom TYSABRI, po prekinitvi ali odstranitvi zdravila, npr. z zamenjavo plazme (glejte poglavje 5.2).
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are typical of MS or possibly suggestive of PML or JCV GCN.
S pregledom bolnika mora zdravnik ugotoviti, ali simptomi kažejo na nevrološko disfunkcijo in, če je tako, ali so ti simptomi značilni za MS ali morda kažejo na PML ali JCV GCN.
These occurred in 23.1% of MS patients treated with natalizumab (placebo: 18.7%).
Pojavil se je pri 23,1 % bolnikov z MS, ki so dobivali natalizumab (placebo: 18,7 %).
What TYSABRI is and what is it used for
Kaj je zdravilo TYSABRI in za kaj ga uporabljamo
Starting other therapies during this interval will result in a concomitant exposure to natalizumab.
Začetek drugega zdravljenja v tem času pomeni sočasno izpostavljenost natalizumabu.
• Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
• Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Obrazec za nadaljevanje zdravljenja mora vsebovati elemente obrazca za začetek zdravljenja, poleg tega pa še navedbo, da tveganje PML narašča s trajanjem zdravljenja ter da zdravljenje, ki traja dlje kot 24 mesecev, predstavlja še dodatno tveganje.
Unopened vial:
Zaprta viala:
Cases of PML have been reported from clinical trials, post-marketing observational studies and postmarketing passive surveillance.
O primerih PML so poročali iz kliničnih preskušanj in iz opazovalnih študij ter pasivnega opazovanja po prihodu zdravila na trg.
You will also find this information in the Patient Alert Card you have been given by your doctor.
To informacijo najdete tudi na kartici z opozorili za bolnika, ki vam jo je dal vaš zdravnik.
Pack size of one vial per carton.
Pakiranje z eno vialo na škatlo.
Signs of allergy to TYSABRI, during or shortly after your infusion:
Znaki alergije na zdravilo TYSABRI, ki se pojavijo med infundiranjem ali kmalu po njem:
You should discuss with your doctor if TYSABRI is the most suitable treatment for you before you start taking TYSABRI and when you have been taking TYSABRI for more than two years.
S svojim zdravnikom se pogovorite, ali je izbira zdravila TYSABRI najbolj ustrezen način zdravljenja za vas, preden začnete zdravilo TYSABRI uporabljati, pa tudi, če zdravilo TYSABRI uporabljate več kot dve leti.
However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Če se pojavi omotica, ki je pogost neželeni učinek, ne smete voziti ali upravljati s stroji.
• Speak with your partner or caregivers and inform them about your treatment.
• O zdravljenju se pogovorite s svojim partnerjem ali negovalcem.
IRIS is thought to result from the restoration of immune function in patients with PML, which can lead to serious neurological complications and may be fatal.
Menijo, da je IRIS posledica imunske obnove pri bolnikih s PML, ki lahko privede do resnih nevroloških zapletov in celo smrti.
Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Prekinitev teh molekularnih interakcij preprečuje transmigracijo mononuklearnih levkocitov skozi endotelij do vnetega parenhimskega tkiva.
The presence of persistent antinatalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Prisotnost obstojnih proti-natalizumabnih protiteles je povečala očistek natalizumaba za približno trikrat, kar je v skladu z zmanjšanjem serumskih koncentracij natalizumaba, ugotovljenih pri bolnikih z obstojnimi proti-natalizumabnimi protitelesi (glejte poglavje 4.8).