FrancophonIA/ELRC3.0 huggingface dataset:
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 v obdobju trženja zdravila.
English: After dilution, immediate use is recommended.
Slovenian: Priporoča se, da razredčeno raztopino takoj uporabite.
English: 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.
Slovenian: Z jemanjem zdravila TYSABRI je povezano povečanje tveganja za PML, oportunistično okužbo, ki jo povzroča JCV, ki lahko povzroči smrt ali hudo prizadetost.
English: • That the aim of the treatment initiation form is to provide patients with information on PML
Slovenian: • da je namen obrazca za uvedbo zdravljenja posredovati bolnikom informacije o PML in IRIS,
English: Efficacy has been modelled for patients who switch to longer dosing after ≥1 year of approved TYSABRI dosing and who did not experience a relapse in the year prior to switching.
Slovenian: Učinkovitost temelji na bolnikih, ki so prešli na daljše intervale odmerjanja po ≥ 1 letu odobrenega odmerjanja zdravila TYSABRI in pri katerih v letu pred prehodom na daljše intervale odmerjanja ni prišlo do recidiva.
English: o Patients, their partners and care givers are advised of symptoms that may be indicative of early PML and the need for counseling on the need to be vigilant for these symptoms while on TYSABRI treatment, and also for approximately 6 months after the last dose of TYSABRI (PML has also been reported up to 6 months following the last dose of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation).
Slovenian: o Bolnike, njihove partnerje in skrbnike je treba seznaniti s simptomi, ki lahko kažejo na zgodnji stadij PML, in jih opozoriti na potrebo po pozornem spremljanju morebitnega pojava teh simptomov med zdravljenjem z zdravilom TYSABRI ter še približno šest mesecev po zadnjem odmerku zdravila TYSABRI (pri bolnikih, ki niso imeli znakov, ki bi ob času prekinitve zdravljenja kazali na PML, so o PML poročali še do šest mesecev po zadnjem odmerku zdravila TYSABRI).
English: Contents of the pack and other information What TYSABRI contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TYSABRI
English: The pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency has not been studied.
Slovenian: Farmakokinetike natalizumaba pri bolnikih z ledvično ali jetrno insuficienco niso raziskovali.
English: In a pre-specified, retrospective analysis of US anti-JCV antibody positive TYSABRI patients (TOUCH registry), the risk of PML was compared between patients treated with the approved dosing interval and patients treated with extended interval dosing as identified in the last 18 months of exposure (EID, average dosing intervals of approximately 6 weeks).
Slovenian: V vnaprej opredeljeni, retrospektivni analizi bolnikov iz ZDA, ki so pozitivni na protitelesa proti JCV in ki so bili zdravljeni z zdravilom TYSABRI (register TOUCH), so primerjali tveganje za PML pri bolnikih, zdravljenih z odobrenim intervalom odmerjanja, in bolnikih, zdravljenih s podaljšanim intervalom odmerjanja, kot je bilo ugotovljeno v obdobju zadnjih 18 mesecev izpostavljenosti (PIO, povprečni interval odmerjanja je bil približno 6 tednov).
English: Anti-JCV antibody prevalence in the EU was reported as ranging from 48.8% to 69.5% in the EU in a cross sectional study of MS patients irrespective of treatment.
Slovenian: V EU so v presečni študiji bolnikov z MS ne glede na način zdravljenja poročali o prevalenci protiteles proti JCV v razponu od 48,8 % do 69,5
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI
Slovenian: • informacije o PML in IRIS, vključno s tveganjem za razvoj PML med zdravljenjem z zdravilom
English: ARN has been observed in patients being administered TYSABRI and can be potentially blinding.
Slovenian: ARN so ugotavljali pri bolnikih, zdravljenih z zdravilom TYSABRI, in lahko povzroči slepoto.
English: In general, anti-JCV antibody prevalence did not appear to be affected by prior immunosuppressant use, prior exposure to TYSABRI, or duration of TYSABRI exposure.
Slovenian: JCV večinoma niso vplivali predhodna uporaba imunosupresivov, predhodna izpostavljenost zdravilu TYSABRI ali trajanje izpostavljenosti zdravilu TYSABRI.
English: o Confirmation that TYSABRI should be permanently discontinued if PML is confirmed.
Slovenian: o Potrditev trajne ukinitve zdravljenja z zdravilom TYSABRI, če je potrjena PML.
English: • A reminder of where to report side effects
Slovenian: • Opomnik o naslovu za poročanje neželenih učinkov.
English: 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.
Slovenian: Opozorilno kartico za bolnika shranite med zdravljenjem in šest mesecev po zadnjem odmerku zdravila TYSABRI, ker se lahko neželeni učinki pojavijo celo po končanem zdravljenju.
English: No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
Slovenian: Za MS bolnike ni podatkov v zvezi s sočasno izpostavljenostjo zdravilom, ki zavirajo imunski odziv.
English: In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Slovenian: Poleg teh navodil boste prejeli tudi opozorilno kartico za bolnika, ki vsebuje pomembne informacije v zvezi z varnostjo, za katere morate vedeti, preden začnete z zdravljenjem z zdravilom TYSABRI
English: No cases of PML were identified in the meta-analysis, however, PML has been reported in natalizumab treated paediatric patients in the post-marketing setting.
Slovenian: V metaanalizi niso ugotovili nobenega primera PML, vendar so o PML poročali pri pediatričnih bolnikih, zdravljenih z natalizumabom, v obdobju trženja zdravila.
English: No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Slovenian: Študij vpliva na sposobnost vožnje in upravljanja strojev za zdravilo TYSABRI niso izvedli.
English: Although JC viral load in the CSF might be expected to decline in the setting of IRIS, it is also possible that due to the breakdown of the blood brain barrier (BBB) and release of JCV from cells lysed during IRIS, it can be increased.
Slovenian: Čeprav naj bi se ob pojavu IRIS v CSF virusno breme JC po pričakovanjih zmanjšalo, se lahko kljub vsemu poveča zaradi razgradnje hematoencefalne pregrade (BBB) in sproščanja JCV iz celic, liziranih med IRIS.
English: TYSABRI contains the active substance (natalizumab).
Slovenian: Zdravilo TYSABRI vsebuje učinkovino (natalizumab).
English: 15 ml concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.
Slovenian: 15 ml koncentrat v viali (steklo vrste I) s klorobutilnim gumijastim zamaškom in aluminijastim zapiralom z dvižno zaporko.
English: What you need to know before you use TYSABRI
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI
English: If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Slovenian: Razredčeno raztopino, ki je ne porabite takoj, morate shraniti pri temperaturi med 2 ˚C in 8 ˚C in infundirati v roku 8 ur po razredčitvi.
English: • Present data from PK/PD/efficacy modelling from the RESTORE study which indicates that risk of return of MS disease activity more likely with increased body weight (>80kg) or longer dosing intervals (>7 weeks).
Slovenian: • Trenutni podatki modeliranja FK/FD ter modeliranja učinkovitosti na podlagi študije RESTORE kažejo, da je tveganje za ponovitev MS bolj verjetno v primeru povečane telesne mase (> 80 kg) ali daljših intervalov odmerjanja (> 7 tednov).
English: • If you do not have antibodies to the JC virus in your blood OR
Slovenian: • nimate protiteles proti virusu JC v krvi ALI
English: Side effects are listed below by how commonly they have been reported in clinical trials:
Slovenian: V nadaljevanju so po pogostnosti našteti neželeni učinki, o katerih so poročali v kliničnih preskušanjih:
English: Resources for the management of hypersensitivity reactions and access to MRI should be available.
Slovenian: Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRS.
English: Your doctor should do a blood test in order to test for abnormalities and whether you have antibodies to the JC virus.
Slovenian: Zdravnik mora narediti krvne preiskave, da ugotovi, ali obstajajo bolezenski znaki in ali imate protitelesa proti virusu JC.
English: • Present data from PK/PD/efficacy modelling from clinical trial data that suggests efficacy of 6 week dosing more similar to 4 weeks if occurs >1 year of 4 weekly treatment
Slovenian: • Trenutni podatki modeliranja FK/FD ter modeliranja učinkovitosti na podlagi podatkov kliničnih preskušanj kažejo, da je učinkovitost šesttedenskega odmerjanja bolj podobna štiritedenskemu odmerjanju, če štiritedensko odmerjanje traja več kot eno leto.
English: Acute retinal necrosis (ARN) is a rare fulminant viral infection of the retina caused by the family of herpes viruses (e.g. varicella zoster).
Slovenian: Akutna nekroza mrežnice (ARN-acute retinal necrosis) je redka fulminantna virusna okužba mrežnice, ki jo povzroči skupina virusov herpesa (npr. varicella zoster).
English: Package leaflet: Information for the patient TYSABRI 300 mg concentrate for solution for infusion natalizumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Following clinical diagnosis of ARN, discontinuation of TYSBABRI should be considered in these patients.
Slovenian: Po postavitvi klinične diagnoze ARN je pri teh bolnikih treba razmisliti o prekinitvi zdravljenja z zdravilom TYSABRI.
English: The limited sample size and shorter duration of TYSABRI exposure for this subgroup of patients should be considered when interpreting these data.
Slovenian: Pri razlagi teh podatkov moramo upoštevati omejeno velikost vzorca in krajše trajanje izpostavljenosti zdravilu TYSABRI pri tej podskupini bolnikov.
English: Consistent with efficacy results observed for patients switching from beta interferon or glatiramer acetate to TYSABRI, for patients switching from fingolimod (n=147) to TYSABRI, a significant decrease in annualised relapse rate (ARR) was observed, which remained stable over 2 years, and mean EDSS scores remained similar from baseline to Year 2.
Slovenian: Skladno z rezultati učinkovitosti, ugotovljenimi pri bolnikih, ki so prešli z interferona beta ali glatiramer acetata na zdravilo TYSABRI, so pri bolnikih, ki so prešli s fingolimoda (n = 147) na zdravilo TYSABRI, opazili pomembno zmanjšanje letne stopnje recidivov (ARR-annualised relapse rate), ki je ostala stabilna 2 leti, srednji rezultati EDSS pa so bili podobni od izhodišča do 2. leta.
English: Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies (see 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) (glejte poglavji 4.4 in
English: • Reminder to keep the card with them for 6 months after the last dose of Tysabri
Slovenian: • Navodilo, da morajo imeti opozorilno kartico pri sebi še šest mesecev po zadnjem odmerku zdravila Tysabri.
English: The clinical worsening is a result of local inflammatory reaction, including oedema, and manifests as a worsening of neurological symptoms including hemiparesis, ataxia, speech abnormalities, visual disturbance, cognitive/behavioural changes and seizure (dependent on the site of IRIS).
Slovenian: Klinično poslabšanje je posledica lokalne vnetne reakcije, vključno z edemom, kar se kaže kot poslabšanje nevroloških simptomov, vključno s hemiparezo, ataksijo, motnjami govora, motnjami vida,
English: Irrespective of the presence or absence of PML risk factors, heightened clinical vigilance for PML should be maintained in all patients treated with TYSABRI and for 6 months following discontinuation of therapy.
Slovenian: Ne glede na prisotnost ali odsotnost dejavnikov tveganja za PML je še šest mesecev po prekinitvi zdravljenja treba zelo pozorno klinično spremljati vse bolnike, ki so se zdravili z zdravilom TYSABRI.
English: In 2-year controlled clinical trials in MS patients TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
Slovenian: V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bilo zdravljenje z zdravilom TYSABRI povezano s povišanim obtokom limfocitov, monocitov, eozinofilcev, bazofilcev in eritrocitov z jedrom.
English: Each ml of concentrate contains 20 mg of natalizumab.
Slovenian: En ml koncentrata vsebuje 20 mg natalizumaba.
English: 1 case of herpes meningitis was reported in the meta-analysis.
Slovenian: V metaanalizi so poročali o enem primeru herpetičnega meningitisa.
English: 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).
Slovenian: 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, pri skupini, ki je prejemala placebo (n = 61), pa 1,455 (p <0,001).
English: − A copy of the treatment initiation form
Slovenian: − kopijo obrazca za uvedbo zdravljenja,
English: • Inform about an ongoing study assessing the efficacy, tolerability and safety of switching to EID after at least 12 months on approved dosing.
Slovenian: • Seznanitev s potekajočo študijo za oceno učinkovitosti, prenašanja in varnosti prehoda na PIO
English: treatment stratified by prior treatment with immunosuppressants and JCV infection.
Slovenian: TYSABRI, razčlenjeno glede na predhodno zdravljenje z imunosupresivi in okužbo z JCV,
English: TYSABRI is a clear, colourless to slightly cloudy liquid.
Slovenian: Zdravilo TYSABRI je bistra, brezbarvna ali rahlo motna tekočina.
English: Other medicines and TYSABRI
Slovenian: Druga zdravila in zdravilo TYSABRI
English: What TYSABRI looks like and contents of the pack
Slovenian: Izgled zdravila TYSABRI in vsebina pakiranja
English: Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Slovenian: Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti opozorilno kartico za bolnika.
English: Interim analysis of results (as of May 2015) from the ongoing TYSABRI Observational Program (TOP), a phase 4, multicentre, single-arm study (n=5770) demonstrated that patients switching from beta interferon (n= 3255) or glatiramer acetate (n= 1384) to TYSABRI showed a sustained, significant decrease in annualised relapse rate (p< 0.0001).
Slovenian: (TOP-TYSABRI Observational Program), multicentrične študije 4. faze z enim krakom (n = 5770), je pokazala, da so bolniki, ki so prešli z interferona beta (n = 3255) ali glatiramer acetata (n = 1384) na zdravilo TYSABRI, pokazali dolgotrajno pomembno zmanjšanje letne stopnje recidivov (p< 0,0001).
English: A Complete Blood Count (CBC, including lymphocytes) is recommended prior to initiating TYSABRI to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Slovenian: Pred uvedbo zdravila TYSABRI je priporočljivo narediti kompletno krvno sliko (vključno z limfociti), da zagotovimo, da so imunski učinki predhodnega zdravljenja (npr. citopenija) izzveneli.
English: Patients should not be tested for anti-JCV antibodies within 2 weeks of PLEX due to removal of antibodies from the serum, or within 6 months of IVIg (i.e. 6 months = 5x half-life for immunoglobulins).
Slovenian: Bolnikov ne testirajte za serumska protitelesa proti JCV prej kot 2 tedna po PLEX zaradi odstranitve protiteles iz seruma ali prej kot 6 mesecev po IVIg (t.j.
English: TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Slovenian: Zdravilo TYSABRI da zdravnik z izkušnjami v zdravljenju MS.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: How to use TYSABRI
Slovenian: Kako uporabljati zdravilo TYSABRI
English: 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 Diagnosis and prognosis of symptomatic and asymptomatic PML
Slovenian: o Testiranje za protitelesa proti JCV, pogostnost testiranja, interpretacija kvalitativnih in kvantitativnih rezultatov, stopnja seroprevalence protiteles proti JCV in serokonverzije glede na čas.
English: A group of symptoms caused by a serious infection of the brain including:
Slovenian: - bolečino ali rdečino očes/-a Skupina simptomov, ki jih povzroča resna okužba možganov, vključno z/s:
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI).
Slovenian: Ni znano, ali je pri bolnikih, ki prehajajo s teh zdravljenj na zdravilo TYSABRI, tveganje za PML povečano, zato je treba te bolnike pogosteje spremljati (tj.
English: When switching from dimethyl fumarate, the washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Slovenian: Pri prehajanju z dimetilfumarata mora vmesno obdobje brez zdravljenja zadostovati, da se število limfocitov popravi, preden se začne zdravljenje z zdravilom TYSABRI.
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Slovenian: V obdobju trženja zdravila so poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih pri bolnikih z multiplo sklerozo, ki so se zdravili z zdravilom TYSABRI (glejte poglavje 4.8).
English: IRIS is generally suspected when patients with PML exhibit signs of clinical worsening usually, but not always, accompanied by gadolinium enhancement of PML lesions with or without mass effect on brain MRI.
Slovenian: IRIS večinoma obstaja pri bolnikih s PML, ki običajno kažejo znake kliničnega poslabšanja, kar se ne zgodi v vseh primerih, ter imajo lezije PML, vidne z gadolinijem, ki jih spremljajo velike spremembe na slikah možganov, pridobljenih z magnetno resonanco, ali pa so brez sprememb.
English: Relapse free
Slovenian: SPROŠČANJE SERIJ
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS disease
Slovenian: • Zdravila TYSABRI ne smete uporabljati, če se zdravite z drugimi zdravili za zdravljenje multiple skleroze.
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 zdravila 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,
English: 2) Intravenous methylprednisolone (1 g/d for 3 or 5 d) with oral taper over 2 months
Slovenian: 2) Metilprednizolon, apliciran intravensko (1 g/dan tri ali pet dni) z dvomesečnim postopnim zmanjševanjem peroralnega odmerka.
English: Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Slovenian: Sočasno jemanje teh učinkovin z zdravilom TYSABRI lahko poveča tveganje okužb, vključno z oportunističnimi okužbami, in je kontraindicirano
English: 1) Oral prednisone 1.5 mg/kg/d x 2 wks with taper over 2 months
Slovenian: 1) Peroralni prednizon 1,5 mg/kg/dan dva tedna z dvomesečnim postopnim zmanjševanjem odmerka.
English: In postmarketing experience, rare cases of ARN have been observed in patients receiving TYSABRI.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so prejemali zdravilo TYSABRI, opazili redke primere ARN.
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Slovenian: • Informacijo, da zdravljenje z zdravilom TYSABRI uvede in neprestano nadzoruje zdravnik specialist z izkušnjami v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s hitrim dostopom do MRS.
English: The washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Slovenian: Vmesno obdobje brez zdravljenja mora zadostovati, da se število limfocitov popravi, preden se začne zdravljenje z zdravilom TYSABRI.
English: TYSABRI 300 mg concentrate for solution for infusion
Slovenian: TYSABRI 300 mg koncentrat za raztopino za infundiranje
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Slovenian: Razmerje stopnje 0,32 IZ95 % 0,26; 0,40
English: 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.
Slovenian: V kliničnih preskušanjih 3. faze MS ni bila ugotovljena povečana stopnja okužb pri sočasnem zdravljenju recidivov s kratkoročnim dajanjem kortikosteroidov.
English: JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
Slovenian: JCV nevropatijo zrnatih celic (JCV GCN-granule cell neuronopathy), o kateri so poročali pri bolnikih, zdravljenih z zdravilom TYSABRI.
English: If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Slovenian: Raztopina, ki se shrani pri temperaturi 2 °C - 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.