FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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).
English: • 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.
Slovenian: • 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.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Slovenian: MRS (0-2 let) Mediana % sprememba v obsegu hiperintenzivne lezije T2 (mm3)
English: 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).
Slovenian: 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).
English: Physicians should counsel patients on the importance of uninterrupted dosing, particularly in the early months of treatment (see hypersensitivity).
Slovenian: Zdravniki morajo bolnikom razložiti, da je neprekinjeno odmerjanje izjemno pomembno, še posebej v prvih mesecih zdravljenja (glejte odstavek o preobčutljivosti).
English: 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).
Slovenian: 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).
English: Subjects
Slovenian: Predmeti
English: The change in clearance was not clinically significant.
Slovenian: Sprememba v očistku ni bila statistično značilna.
English: 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.
Slovenian: 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.
English: When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
Slovenian: TYSABRI morda ne boste opazili izboljšanja, vendar lahko zdravilo TYSABRI še vedno preprečuje poslabšanje MS.
English: Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Slovenian: Natalizumab onemogoči interakcijo integrina α4β7 z mukozno adresinsko celično adhezijsko molekulo-1 (MadCAM-1).
English: After 2 years all patients should be re-informed about the risk of PML with TYSABRI.
Slovenian: Po 2 letih je treba bolnike ponovno obvestiti o tveganju za PML z zdravilom TYSABRI.
English: IRIS may lead to your condition getting worse, including worsening of brain function.
Slovenian: se vam bolezen lahko poslabša, kar vključuje tudi poslabšano delovanje možganov.
English: • The longer that you are on treatment especially if you have been on treatment for more than two years.
Slovenian: • S trajanjem zdravljenja, zlasti še, če se zdravite že več kot dve leti.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
Slovenian: Vaš zdravnik lahko te krvne preiskave med zdravljenjem z zdravilom TYSABRI ponovi, da ugotovi, ali se je kaj spremenilo.
English: If you have any further questions on TYSABRI, ask your doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila TYSABRI, se posvetujte s svojim zdravnikom.
English: • Adult patients aged 18 years and over with high disease activity despite treatment with a betainterferon or glatiramer acetate.
Slovenian: • odrasli bolniki, stari 18 let in več, z zelo aktivno boleznijo, kljub zdravljenju z interferonom beta ali glatiramer acetatom.
English: • Unusual darkening of the urine.
Slovenian: • nenavadno temen urin
English: A few patients have had an allergic reaction to TYSABRI.
Slovenian: Nekaj bolnikov je doživelo alergijsko reakcijo na zdravilo TYSABRI.
English: Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Slovenian: Neželeni učinki zdravila, o katerih so poročali pri natalizumabu z 0,5 % višjo incidenco kot je bila poročana pri placebu, so prikazani spodaj.
English: If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Slovenian: Če opazite delce in/ali če raztopina v viali ni brezbarvna, bistra do rahlo opalescentna, viale ne smete uporabiti.
English: • The presence of anti-JCV antibodies.
Slovenian: • Prisotnost protiteles proti JCV.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: These occurred in 23.1% of MS patients treated with natalizumab (placebo: 18.7%).
Slovenian: Pojavil se je pri 23,1 % bolnikov z MS, ki so dobivali natalizumab (placebo: 18,7 %).
English: What TYSABRI is and what is it used for
Slovenian: Kaj je zdravilo TYSABRI in za kaj ga uporabljamo
English: Starting other therapies during this interval will result in a concomitant exposure to natalizumab.
Slovenian: Začetek drugega zdravljenja v tem času pomeni sočasno izpostavljenost natalizumabu.
English: • Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Slovenian: • Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: 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.
Slovenian: 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.
English: Unopened vial:
Slovenian: Zaprta viala:
English: Cases of PML have been reported from clinical trials, post-marketing observational studies and postmarketing passive surveillance.
Slovenian: O primerih PML so poročali iz kliničnih preskušanj in iz opazovalnih študij ter pasivnega opazovanja po prihodu zdravila na trg.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Slovenian: To informacijo najdete tudi na kartici z opozorili za bolnika, ki vam jo je dal vaš zdravnik.
English: Pack size of one vial per carton.
Slovenian: Pakiranje z eno vialo na škatlo.
English: Signs of allergy to TYSABRI, during or shortly after your infusion:
Slovenian: Znaki alergije na zdravilo TYSABRI, ki se pojavijo med infundiranjem ali kmalu po njem:
English: 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.
Slovenian: 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.
English: However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Slovenian: Če se pojavi omotica, ki je pogost neželeni učinek, ne smete voziti ali upravljati s stroji.
English: • Speak with your partner or caregivers and inform them about your treatment.
Slovenian: • O zdravljenju se pogovorite s svojim partnerjem ali negovalcem.
English: 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.
Slovenian: Menijo, da je IRIS posledica imunske obnove pri bolnikih s PML, ki lahko privede do resnih nevroloških zapletov in celo smrti.
English: Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Slovenian: Prekinitev teh molekularnih interakcij preprečuje transmigracijo mononuklearnih levkocitov skozi endotelij do vnetega parenhimskega tkiva.
English: 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).
Slovenian: 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).
English: What TYSABRI is and what it is used for What you need to know before you use TYSABRI How to use TYSABRI
Slovenian: Kaj je zdravilo TYSABRI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI Kako uporabljati zdravilo TYSABRI
English: Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
Slovenian: Bolniki, pri katerih je povečano tveganje oportunističnih okužb, vključno z bolniki z oslabljenim imunskim sistemom (vključno s tistimi, ki so nedavno prejemali terapijo za zaviranje imunskega odziva ali tisti z oslabljenim imunskim sistemom zaradi prejšnjega zdravljenja npr. z mitoksantronom ali ciklolofosfamidom, glejte tudi poglavji 4.4 in 4.8).
English: • Treatment initiation and treatment continuation forms
Slovenian: • Obrazca za uvedbo in nadaljevanje zdravljenja
English: A group of symptoms caused by a serious infection of the brain including: - Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
Slovenian: Skupina simptomov, ki jih povzroča resna okužba možganov, vključno z/s: - spremembami osebnosti in vedenja, kot so zmedenost, delirij ali izguba zavesti, napadi (krči), glavobol, slabost/bruhanje, trd vrat, pretirana občutljivost na močno svetlobo, zvišana telesna temperatura, izpuščaj (kjer koli na telesu).
English: TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Slovenian: Zdravilo TYSABRI povečuje tveganje za razvoj encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex in varicella zoster.
English: If you have previously not been treated with immunosuppressants and have received TYSABRI for 2 years or longer, the level of your anti-JCV antibody response may be associated with the risk of getting PML.
Slovenian: Če se pred tem še niste zdravili z imunosupresivi in ste zdravilo TYSABRI prejemali 2 leti ali dlje, je lahko raven odziva protiteles proti JCV povezana s tveganjem, da dobite PML.
English: Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium-enhancing lesion.
Slovenian: Bolniki morajo imeti vsaj 1 recidiv v preteklem letu zdravljenja in vsaj 9 T2-hiperintenzivnih lezij pri kranialnem magnetnoresonančnem slikanju (MRS) ali vsaj 1 lezijo, vidno z gadolinijem.
English: • You will also find this information in the Patient Alert Card you have been given by your doctor.
Slovenian: • Te informacije najdete tudi v kartici s posebnimi opozorili za bolnika, ki vam jo je dal vaš zdravnik.
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na natalizumab ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Care should be taken with patients who have previously received immunosuppressants to allow sufficient time for immune function recovery to occur.
Slovenian: Pri bolnikih, ki so predhodno prejemali zaviralce imunskega odziva, je treba biti previden in zagotoviti dovolj časa za ponovno vzpostavitev funkcije imunskega sistema.
English: Remove flip-top from the vial.
Slovenian: Z viale odstranite dvižno zaporko.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje.
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Slovenian: • potrditev da se je zdravnik z bolnikom pogovoril o tveganju PML ter tveganju IRIS, če se zdravljenje prekine zaradi suma na PML
English: Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Slovenian: eozinofilcev in bazofilcev od izhodišča je bilo 35 % do 140 % za posamezne tipe celic, toda povprečno število celic je ostalo v normalnem razponu.
English: Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
Slovenian: V primerih iz objavljene literature so poročali o prehodni blagi do zmerni trombocitopeniji in anemiji, ki so jo opazili pri dojenčkih, ki so bili rojeni ženskam, izpostavljenim zdravilu TYSABRI v tretjem trimesečju nosečnosti.
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Slovenian: Srednji (± SD) očistek v stanju dinamičnega ravnovesja je bil 13,1 ± 5,0 ml/h, s srednjim (± SD) razpolovnim časom 16 ± 4 dni.
English: These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Slovenian: Ta zdravila lahko podaljšajo imunosupresijo tudi po prekinitvi zdravljenja.
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Slovenian: Natalizumab je selektivni zaviralec adhezijskih molekul in se veže na podenoto α4 humanega integrina, ki se v močno izraženem številu nahaja na površini vseh levkocitov razen nevtrofilcev.
English: • Chest pain or discomfort
Slovenian: • bolečine ali nelagodje v prsih
English: Cases of asymptomatic PML based on MRI and positive JCV DNA in the cerebrospinal fluid have been reported.
Slovenian: Poročali so o primerih asimptomatske PML na podlagi MRS in pozitivne DNK za JCV v cerebrospinalni tekočini.
English: A benefit-risk evaluation of the use of TYSABRI during pregnancy should take into account the patient's clinical condition and the possible return of disease activity after stopping the medicinal product.
Slovenian: Ocena razmerja med koristmi in tveganji uporabe zdravila TYSABRI med nosečnostjo mora upoštevati tudi klinično stanje bolnice in možno aktivacijo bolezni po prenehanju jemanja zdravila.
English: • Date treatment started
Slovenian: • datum začetka zdravljenja
English: Mean number of new or newlyenlarging T2-hyperintense lesions
Slovenian: Povprečno število novih ali na novo povečanih hiperintenzivnih lezij T2
English: In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
Slovenian: V kliničnih preskušanjih so bile okužbe s herpesom (virus Varicella-Zoster, virus Herpes-simplex) pri bolnikih, zdravljenih z natalizumabom nekoliko bolj pogoste kot pri bolnikih, zdravljenih s placebom.
English: In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following associated symptoms: hypotension, hypertension, chest pain, chest discomfort, dyspnoea, angioedema, in addition to more usual symptoms such as rash and urticaria.
Slovenian: V izkušnjah v obdobju trženja so poročali o preobčutljivostnih reakcijah, ki so se pojavile z enim ali več od naslednjih simptomov: hipotenzija, hipertenzija, bolečine v prsih, nelagodje v prsih, dispneja, angioedem, poleg bolj običajnih simptomov kot sta izpuščaj in urtikarija.
English: These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon or glatiramer acetate.
Slovenian: Bolniki, ki se niso odzivali na celoten in ustrezen potek zdravljenja (običajno najmanj eno leto zdravljenja) z interferonom beta ali glatiramer acetatom.
English: Hypersensitivity reactions have been associated with TYSABRI, including serious systemic reactions (see section 4.8).
Slovenian: Z zdravilom TYSABRI so povezane preobčutljivostne reakcije, vključno z resnimi sistemskimi reakcijami (glejte poglavje 4.8).
English: Before initiation of treatment with TYSABRI, a recent (usually within 3 months) MRI should be available as a reference, and be repeated at least on a yearly basis.
Slovenian: Pred začetkom zdravljenja z zdravilom TYSABRI morajo biti na voljo nedavno (v roku 3 mesecev) pridobljeni rezultati MRS kot referenca, preglede je treba nato ponavljati vsaj enkrat letno.
English: Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Slovenian: Dodatne reakcije zaradi infuzije, povezane z obstojnimi protitelesi, vključujejo rigor, slabost, bruhanje in vročinske valove (glejte poglavje 4.4).
English: Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Slovenian: Farmakoterapevtska skupina: Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA23.
English: However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Slovenian: Ker pa se pogosto pojavi omotica, je treba bolnikom, ki doživijo neželene učinke, svetovati, naj ne vozijo ali upravljajo s stroji, dokler ta neželeni učinek ne mine.
English: o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Possibility of other opportunistic infections o The need to inform the National Competent Authority about any cases of PML
Slovenian: Če naj bi zdravljenje trajalo dlje kot 24 mesecev, zahtevo, da se bolnike obvesti o povečanem tveganju za razvoj PML in se jim da kopijo obrazca za nadaljnje zdravljenje o Možnost drugih oportunističnih okužb o Zahtevo, da se nacionalni pristojni organ obvesti o vseh primerih PML
English: In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
Slovenian: V teh primerih je treba preveriti prisotnost protiteles in če potrditveni test po vsaj šestih tednih pokaže njihovo prisotnost, je treba zdravljenje prekiniti, saj stalna prisotnost protiteles zmanjša učinkovitost zdravila TYSABRI ter poveča pojav preobčutljivostnih reakcij (glejte poglavje 4.8).
English: Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
Slovenian: Proces migracije levkocitov skozi BBB vključuje interakcijo med adhezijskimi molekulami na vnetnih celicah in endotelijskimi celicami žilne stene.
English: TYSABRI is contraindicated in children and adolescents below the age of 18 years (see section 4.3).
Slovenian: Zdravilo TYSABRI je kontraindicirano pri otrocih, starih do 18 let (glejte poglavje 4.3).
English: Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnost je bila definirana kot sledi: Pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100).