FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Slovenian: Varnost in učinkovitost zdravila TYSABRI v kombinaciji z drugimi imunosupresivi in antineoplastičnimi zdravili ni bila povsem ugotovljena.
English: Monitoring for potential signs of return of MS disease activity in patients switching dosing intervals.
Slovenian: Spremljanje morebitnih znakov ponovitve MS pri bolnikih, ki menjujejo intervale odmerjanja.
English: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
Slovenian: • bolniki z zelo aktivno boleznijo, kljub celotnemu in ustreznemu poteku zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezni (DMT-disease modifying therapy) (za izjeme in podatke o vmesnih obdobjih brez zdravljenja glejte poglavji 4.4 in 5.1);
English: As scientific and medical knowledge, including both diagnostic criteria and management of IRIS is rapidly evolving, please contact Medical affairs in your country for the most up to date information on treatment recommendations.
Slovenian: vključno z diagnostični merili in obvladovanjem IRIS, hitro napredujejo, se obrnite na zdravstvene organe v svoji državi za najnovejše informacije glede priporočil za zdravljenje.
English: 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
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
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: Povišanje limfocitov, monocitov, eozinofilcev in bazofilcev od izhodišča je bilo 35 % do 140 % za posamezne tipe celic, toda povprečno število celic je ostalo v normalnem razponu.
English: Following discontinuation of fingolimod, lymphocyte count progressively returns to normal range within 1 to 2 months after stopping therapy.
Slovenian: Po ukinitvi fingolimoda se število limfocitov postopoma vrne v normalno območje v 1 do 2 mesecih po prekinitvi zdravljenja.
English: No information on the severity of the relapses before inclusion of patients in the study is available.
Slovenian: Informacije o resnosti recidivov, pred vključitvijo bolnikov v študijo,
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 opozorilni kartici za bolnika, ki vam jo je dal vaš zdravnik.
English: 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:
Slovenian: 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:
English: • A description of PML, potential symptoms and management of PML
Slovenian: • Opis PML, morebitni simptomi in obvladovanje PML.
English: Use of plasmapheresis (PLEX) or intravenous immunoglobulin (IVIg) can affect meaningful interpretation of serum antiJCV antibody testing.
Slovenian: Uporaba plazmafereze (PLEX) ali intravenskega imunoglobulina (IVIg) lahko vpliva na smiselno razlago testov za serumska protitelesa proti JCV.
English: The treatment reported in these cases included anti-viral therapy and in some cases, surgery (see section 4.4).
Slovenian: Zdravljenje, o katerem so poročali pri teh primerih, je vključevalo protivirusno zdravljenje in v nekaterih primerih operacijo (glejte poglavje 4.4).
English: A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Slovenian: Analiza populacijske farmakokinetike se je izvajala na vzorcih več kot 1100 bolnikov z MS, ki so prejemali odmerke od 3 mg/kg do 6 mg/kg natalizumaba.
English: 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.
Slovenian: Podatki iz kliničnih preskušanj, prospektivnega registra nosečnosti, primerov v obdobju trženja zdravila in iz razpoložljive literature ne kažejo, da bi izpostavljenost zdravilu TYSABRI vplivala na izide nosečnosti.
English: As the actual duration of these effects is unknown, initiating treatment with TYSABRI after alemtuzumab is not recommended unless the benefits clearly outweigh the risks for the individual patient.
Slovenian: Ker dejansko trajanje teh učinkov ni znano, po alemtuzumabu ni priporočljivo začeti zdravljenja z zdravilom TYSABRI, razen če koristi očitno odtehtajo tveganja za posameznega bolnika.
English: Patients presenting with eye symptoms such as decreased visual acuity, redness and painful eye should be referred for retinal screening for ARN.
Slovenian: Bolnike, ki pridejo na pregled z očesnimi simptomi, kot so zmanjšana ostrina vida, rdečina in bolečine v očesu, je treba napotiti na retinalni presejalni pregled za ARN.
English: Although the inflammatory reaction following immune reconstitution may be a necessary step to remove JCV-infected cells, it may become necessary to treat the active immune reaction to prevent potential damage caused by IRIS (Talan 2009; Elston and Thacker 2009) and can be life-threatening and may therefore require management in an intensive care unit.
Slovenian: Čeprav je lahko vnetna reakcija, ki sledi imunski rekonstituciji, nujen korak pri odstranjevanju celic, okuženih z JCV, bo aktivno imunsko reakcijo morda treba zdraviti zaradi preprečevanja morebitnih posledic IRIS (Talan 2009; Elston in Thacker 2009), saj je lahko življenje ogrožajoča in zahteva zdravljenje na oddelku za intenzivno nego.
English: When switching patients from another DMT to TYSABRI, the half-life and mode of action of the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Slovenian: Pri prehajanju bolnikov z druge DMT na zdravilo TYSABRI je treba upoštevati razpolovni čas in način delovanja drugega zdravljenja, da se izognemo aditivnemu imunskemu učinku, hkrati pa kar najbolj zmanjšamo tveganje za reaktivacijo bolezni.
English: - 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: - 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: Initiating treatment with TYSABRI after alemtuzumab is generally not recommended.
Slovenian: Uvedbe zdravljenja z zdravilom TYSABRI po alemtuzumabu na splošno ni priporočljivo.
English: Within this analysis, a limited subset of patients with data available prior to treatment (158 of the 621 patients) demonstrated a reduction in ARR from 1.466 (95% CI 1.337, 1.604) prior to treatment to 0.110 (95% CI 0.094, 0.128).
Slovenian: Znotraj te analize je omejena podskupina bolnikov s podatki, ki so bili na voljo pred zdravljenjem (158 od 621 bolnikov), pokazala zmanjšanje ARR z 1,466 (95-% IZ: 1,337; 1,604) pred zdravljenjem na 0,110 (95-% IZ: 0,094; 0,128).
English: A post-marketing meta-analysis was conducted using data from 621 paediatric MS patients treated with TYSABRI (median age 17 years, range was 7-18 years, 91% aged ≥14 years).
Slovenian: Opravili so metaanalizo obdobja trženja zdravila, za katero so uporabili podatke 621 pediatričnih bolnikov z MS, zdravljenih z zdravilom TYSABRI (mediana starost 17 let, razpon je bil 7-18 let, 91 % jih je bilo starih ≥14 let).
English: If further deterioration occurs during steroid taper and this is judged to be due to continuing or new inflammatory reactions a further course of higher dose steroids may be necessary.
Slovenian: Če se med postopnim zmanjševanjem odmerka steroidov pojavi nadaljnje poslabšanje, ki naj bi bilo posledica dolgotrajne ali nove vnetne reakcije, bodo morda še naprej potrebni višji odmerki steroidov.
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 opozorilni kartici za bolnika, ki vam jo je dal vaš zdravnik.
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Slovenian: • če se zdravite dlje kot 2 leti in imate nižje ravni protiteles proti virusu JC v krvi.
English: TYSABRI is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:
Slovenian: Zdravilo TYSABRI je indicirano kot terapija, ki spreminja potek bolezni pri odraslih z zelo aktivno recidivno remitentno multiplo sklerozo, za sledeči skupini bolnikov:
English: For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Slovenian: Zdravnik lahko teste pri bolnikih, pri katerih je tveganje za PML manjše, redno ponavlja, da ugotovi, ali se je kaj spremenilo, če:
English: In order to improve traceability of biological medicinal products, the product name (Tysabri) and batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime zdravila (Tysabri) in številko serije uporabljenega zdravila.
English: • Reminder to show the card to patients and caregivers and provides a list of symptoms that may be associated with the development of PML
Slovenian: • Navodilo, da je treba kartico pokazati partnerjem in skrbnikom, skupaj s seznamom simptomov, ki so lahko povezani s pojavom PML.
English: • Patients 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: • bolniki 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
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 strojev.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Slovenian: MRS (0-2 leti) Mediana % sprememba v obsegu hiperintenzivne lezije T2 (mm3)
English: − A patient alert card including a core text agreed by the CHMP
Slovenian: − opozorilno kartico za bolnika, vključno z osrednjim besedilom, ki ga je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP).
English: 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.
Slovenian: 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.
English: If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if a switch to TYSABRI is appropriate for you.
Slovenian: Če ste se zdravili z alemtuzumabom, bosta za odločitev o tem, ali je za vas prehod na zdravilo TYSABRI primeren, potrebna temeljita ocena in pogovor z zdravnikom.
English: If herpes encephalitis or meningitis occurs, the medicinal product should be discontinued, and appropriate treatment for herpes encephalitis or meningitis should be administered.
Slovenian: Če pride do herpetičnega encefalitisa ali meningitisa, je treba zdravljenje z zdravilom prekiniti in začeti ustrezno zdravljenje herpetičnega encefalitisa ali meningitisa.
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: • Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
Slovenian: • potrditev, da bolniki razumejo tveganje PML in so prejeli kopijo obrazca in opozorilno kartico za bolnika,
English: Short courses of corticosteroids can be used in combination with TYSABRI.
Slovenian: Kratkoročno dajanje kortikosteroidov se lahko uporablja v kombinaciji z zdravilom TYSABRI.
English: The decision to suspend TYSABRI at any stage may be based on the initial clinical presentation, MRI findings, the evolution of symptoms or signs and/or the response to corticosteroid treatment.
Slovenian: Odločitev o prekinitvi zdravljenja z zdravilom TYSABRI v kateri koli fazi lahko temelji na začetni klinični sliki, ugotovitvah na podlagi slikanja z magnetno resonanco, razvoju simptomov ali znakov in/ali odzivu na zdravljenje s kortikosteroidi.
English: If you have any further questions on TYSABRI, ask your doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila TYSABRI, se posvetujte z zdravnikom.
English: No recommendation on a posology can be made.
Slovenian: Priporočil o odmerjanju ni mogoče dati.
English: 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.
Slovenian: Glede na trenutno spremljanje bolnikov na nacionalni ravni, ki se zdravijo z zdravilom TYSABRI, se mora imetnik dovoljenja za promet z zdravilom dogovoriti in uskladiti s pristojnimi nacionalnimi organi glede ukrepov za nadaljnje povečanje tega spremljanja (npr. registri in študije v obdobju trženja zdravila), kot je primerno.
English: All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms.
Slovenian: Vse spremenjene vrednosti hematoloških spremenljivk so se vrnile na raven pred zdravljenjem, običajno 16 tednov po zadnjem odmerku zdravila.
English: Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Slovenian: Nekateri bolniki so bili morda zdravljeni z imunosupresivi (npr. mitoksantron, ciklofosfamid, azatioprin).
English: Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Slovenian: Poslabšanje bolezni ali z infuzijo povezani dogodki lahko kažejo na razvoj protiteles proti natalizumabu.
English: Clinical neurologic deterioration in patients with PML and/or JCV GCN may be caused by JCVmediated destruction of CNS tissue, or upon restoration of immune function, by an intracerebral immune inflammatory reaction known as immune reconstitution inflammatory syndrome (IRIS).
Slovenian: Do kliničnega nevrološkega poslabšanja pri bolnikih s PML in/ali JCV GCN lahko pride zaradi uničenja tkiva osrednjega živčevja (CNS) zaradi JCV oziroma ob imunski obnovi zaradi intracerebralne vnetne imunske reakcije, znane kot vnetni sindrom imunske obnove (IRIS).
English: These medicines cannot be used with TYSABRI (see Using other medicines, below).
Slovenian: Ta zdravila se ne smejo uporabljati z zdravilom TYSABRI (glejte Druga zdravila in zdravilo TYSABRI, spodaj).
English: Severe sequelae can occur including coma and death.
Slovenian: Nastanejo lahko hude posledice, vključno s komo in smrtjo.
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 opozorilno kartico za bolnika in jih informirati o tveganjih v zvezi z zdravilom (glejte tudi Navodilo za uporabo).
English: • Patient details, signature and date
Slovenian: • podatki o bolniku, podpis in datum,
English: Current pharmacokinetic/pharmacodynamic statistical modelling and simulation indicate that the risk of MS disease activity for patients switching to longer dosing intervals may be higher for patients with body weight >80kg or those with dosing intervals ≥7 weeks.
Slovenian: Trenutno farmakokinetično/farmakodinamično statistično modeliranje in simulacija kažeta, da je tveganje za aktivno multiplo sklerozo pri bolnikih, ki preidejo na daljše intervale odmerjanja, lahko večje pri bolnikih s telesno maso > 80 kg ali tistih, ki imajo intervale odmerjanja ≥ 7 tednov.
English: In patients treated with TYSABRI, IRIS has occurred within days to several weeks after TYSABRI removal by plasma exchange (PLEX) or immunoabsorption (IA).
Slovenian: Pri bolnikih, ki so jih zdravili z zdravilom TYSABRI, se je IRIS pojavil v nekaj dneh do nekaj tednih po tem, ko je bilo zdravilo TYSABRI odstranjeno zaradi zamenjave plazme (PLEX) ali imunoabsorpcije (IA).
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: What TYSABRI is and what it is used for
Slovenian: Kaj je zdravilo TYSABRI in za kaj ga uporabljamo
English: TYSABRI is contraindicated in combination with other DMTs (see section 4.3).
Slovenian: Zdravilo TYSABRI je kontraindicirano v kombinaciji z drugimi DMT (glejte poglavje 4.3).
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 imunosupresive, je treba biti previden in zagotoviti dovolj časa za ponovno vzpostavitev funkcije imunskega sistema.
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
English: • Reminder not to start Tysabri if there is a serious problem with their immune system
Slovenian: • Opomnik, da se zdravljenja z zdravilom Tysabri ne sme uvesti v primeru resnih težav z imunskim sistemom.
English: An accelerated elimination procedure as defined in the teriflunomide Summary of Product Characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Slovenian: Priporočljiva je uporaba pospešenega postopka izločanja, opredeljenega v povzetku glavnih značilnosti zdravila za teriflunomid, ali pa vmesno obdobje brez zdravljenja ne sme biti krajše od 3,5 meseca.
English: The following steroid regimens have been reported for the treatment of IRIS in the literature:
Slovenian: Literatura navaja naslednje režime zdravljenja IRIS s steroidi:
English: No studies have been performed to evaluate the efficacy and safety of TYSABRI when switching patients from DMTs with an immunosuppressant effect.
Slovenian: Študij za oceno učinkovitosti in varnosti zdravila TYSABRI pri prehajanju bolnikov z DMT z imunosupresivnim učinkom niso opravili.
English: Currently available 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.
Slovenian: Trenutno razpoložljivi dokazi nakazujejo, da je tveganje za PML nizko, če je indeks enak ali nižji od 0,9, vendar se znatno poveča nad 1,5 pri bolnikih, ki so se več kot dve leti zdravili z zdravilom TYSABRI.
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 uvedbo 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: • Present the results of the TOUCH analysis which showed clinically and statistically significant reduction in PML risk in patients who are treated with EID (dosing interval 6 weeks) compared to Standard interval dosing (dosing interval 4 weeks).
Slovenian: • Predstavitev rezultatov analize TOUCH, ki je pokazala klinično in statistično pomembno zmanjšanje tveganja za PML pri bolnikih, ki so se zdravili s PIO (šesttedenskim intervalom odmerjanja), v primerjavi z odmerjanjem s standardnim intervalom (štiritedenskim intervalom odmerjanja).
English: • Details of the patient, treating doctor and date Tysabri was started
Slovenian: • Podrobnosti o bolniku in lečečem zdravniku ter datum uvedbe zdravila Tysabri.
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 strojev, dokler ta neželeni učinek ne mine.
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: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o Opportunistic infections (other than PML):
Slovenian: • Informacije, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključujejo: o Oportunistične okužbe (razen progresivne multifokalne levkoencefalopatije - PML):
English: The efficacy of TYSABRI when administered with EID has not been established, and therefore the benefit/risk balance of EID is unknown (see section 4.4).
Slovenian: Učinkovitost zdravila TYSABRI pri uporabi s PIO ni bila ugotovljena, zato je razmerje med koristmi in tveganji PIO neznano (glejte poglavje 4.4).
English: Patients can switch directly from beta interferon or glatiramer acetate to TYSABRI providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia and, lymphopenia.
Slovenian: Bolniki lahko direktno preidejo z interferona beta ali glatiramer acetata na zdravilo TYSABRI, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije in limfopenije.
English: In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
Slovenian: V s placebom kontroliranih preskušanjih pri 1.617 obolelih za MS, zdravljenih z natalizumabom do 2 leti (placebo: 1.135) je prišlo do neželenih učinkov, zaradi katerih je bilo zdravljenje prekinjeno, pri 5,8 % bolnikov, zdravljenih z natalizumabom (placebo: 4,8 %).