FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date stated on the label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk.
Slovenian: Po 2 letih nadaljevanja zdravljenja se je treba odločati na podlagi ponovnega ovrednotenja potencialnih koristi in tveganj.
English: There were 316 live births, 29 of which were reported to have birth defects.
Slovenian: Živorojenih je bilo 316 otrok, od katerih so pri 29 poročali o prirojenih okvarah.
English: This should be carefully considered on a case-by-case basis, and a wash-out period of natalizumab might be appropriate.
Slovenian: O tem je treba razmisliti na osnovi vsakega primera posebej in morda bo primerno upoštevati dobo izpiranja natalizumaba.
English: • If you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
Slovenian: • če imate aktivnega raka (razen v primeru tipa kožnega raka, ki se imenuje bazocelularni karcinom).
English: It is given as a drip into a vein (by intravenous infusion), usually in your arm.
Slovenian: Zdravilo se daje s kapljanjem v veno (z intravensko infuzijo), običajno v roko.
English: PML usually leads to severe disability or death (see section 4.4).
Slovenian: PML navadno vodi do hude prizadetosti ali smrti (glejte poglavje 4.4).
English: The completed prospective TYSABRI pregnancy registry contained 355 pregnancies with available outcomes.
Slovenian: V dokončan prospektivni register nosečnosti za zdravilo TYSABRI je bilo vključenih 355 nosečnosti z znanimi izidi.
English: PML and IRIS (Immune Reconstitution Inflammatory Syndrome)
Slovenian: PML in IRIS (Immune Reconstitution Inflammatory Syndrome - vnetni sindrom imunske obnove)
English: Some infections other than PML may also be serious and can be due to viruses, bacteria, or other causes.
Slovenian: Resne so lahko tudi nekatere okužbe, ki niso PML, in nastanejo zaradi virusov, bakterij ali drugih vzrokov.
English: Body weight was found to influence clearance in a less-thanproportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance.
Slovenian: Ugotovili so, da telesna masa vpliva na očistek manj kot sorazmerno, pri čemer povzroči 43 % sprememba telesne mase 31 % do 34 % spremembo očistka.
English: RESULTS Annual relapse rate After one year (primary endpoint) After two years One year
Slovenian: REZULTATI Letna stopnja recidivov Po enem letu (primarni opazovani dogodki) Po dveh letih Eno leto
English: • If you have previously taken a medicine called an immunosuppressant.
Slovenian: • Če ste pred tem jemali zdravilo, ki se imenuje imunosupresiv.
English: TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila TYSABRI ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: MS causes inflammation in the brain that damages the nerve cells.
Slovenian: MS povzroča vnetje v možganih, ki poškoduje živčne celice.
English: • The recommended dose for adults is 300 mg given once every 4 weeks.
Slovenian: • Priporočeni odmerek za odrasle je 300 mg na vsake štiri tedne.
English: TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population.
Slovenian: Jemanje zdravila TYSABRI se ne priporoča pri bolnikih, starejših od 65 let, ker so podatki za to populacijo pomanjkljivi.
English: See section 4.3.
Slovenian: Glejte poglavje 4.3.
English: Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Slovenian: Podatki o varnosti in učinkovitosti natalizumaba po 2 letih so bili pridobljeni v kontroliranih, dvojno slepih študijah.
English: Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Slovenian: Kartico pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju, ne samo vašemu nevrologu.
English: The risk of PML with TYSABRI is higher:
Slovenian: Tveganje PML z zdravilom TYSABRI je večje:
English: Under normal conditions, VCAM-1 is not expressed in the brain parenchyma.
Slovenian: V normalnih pogojih molekule VCAM-1 niso izražene v možganskem parenhimu.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Slovenian: Svojega zdravnika nemudoma obvestite, če ste noseči, ali mislite, da ste noseči, ali če načrtujete nosečnost.
English: • If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
Slovenian: • če vam je zdravnik povedal, da imate PML (progresivno multifokalno levkoencefalopatijo).
English: PML may lead to severe disability or death.
Slovenian: PML lahko povzroči hudo prizadetost ali smrt.
English: The symptoms of MS vary from patient to patient, and you may experience some or none of them.
Slovenian: Simptomi MS so različni pri različnih bolnikih, morda boste vi doživeli nekatere ali nobenega.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Slovenian: Bolniku je treba svetovati naj svojega partnerja ali negovalca o zdravljenju obvesti, ker le-ta lahko opazi simptome, katerih se bolnik sam morda ne zaveda.
English: Estimates of the total natalizumab removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Slovenian: Ocenjena celotna izločitev natalizumaba po 3 zamenjavah plazme (v intervalih 5-8 dni) je bila približno 70-80 %.
English: Therefore, it is recommended that newborns of women exposed to the medicinal product during the third trimester of pregnancy are monitored for potential haematological abnormalities.
Slovenian: Zato se priporoča, da se novorojenčke žensk, ki so izpostavljene zdravilu v tretjem trimesečju nosečnosti, spremlja zaradi možnih hematoloških nenormalnosti.
English: The impact of plasma exchange on the restitution of lymphocyte migration and ultimately its clinical usefulness is unknown.
Slovenian: Vpliv zamenjave plazme na obnovitev migracije limfocitov in s tem njena klinična koristnost ni znana.
English: Proportion progressed1(24-week confirmation)
Slovenian: Delež napredovanja1 (potrditev po 24 tednih)
English: In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Slovenian: Pri kliničnih preskušanjih je zdravilo TYSABRI približno prepolovilo napredovanje uničujočih učinkov MS in zmanjšalo tudi število zagonov MS za približno dve tretjini.
English: See section 4.8 for how to report adverse reactions
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih.
English: The effect of natalizumab on newborn/infants is unknown.
Slovenian: Učinek natalizumaba na dojene novorojence/otroke ni znan.
English: If you have all three risks described above your chance of getting PML is higher.
Slovenian: Če imate vse tri zgoraj opisane dejavnike tveganja, so vaše možnosti, da dobite PML, večje.
English: However, the risk of hypersensitivity reactions should be considered for every infusion administered.
Slovenian: Kljub temu je treba tveganje preobčutljivostnih reakcij upoštevati pri vsaki dani infuziji.
English: TYSABRI is used to treat multiple sclerosis (MS).
Slovenian: Zdravilo TYSABRI se uporablja za zdravljenje multiple skleroze (MS).
English: • The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes).
Slovenian: • Simptomi PML so lahko podobni simptomom recidiva MS (npr. šibkost ali spremembe vida).
English: A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
Slovenian: »Neodzivni bolnik« je lahko tudi bolnik z nespremenjenim ali povečanim številom recidivov ali neprestanimi hudimi recidivi, v primerjavi s prejšnjim letom.
English: This active ingredient is called a monoclonal antibody.
Slovenian: Ta zdravilna učinkovina se imenuje monoklonsko protitelo.
English: Relapses in previous 12 months, median (range)
Slovenian: Recidivi v preteklih 12 mesecih, mediana (razpon)
English: These liver injuries may occur at any time during treatment, even after the first dose.
Slovenian: Do okvare jeter lahko pride kadar koli med zdravljenjem, tudi po prvem odmerku.
English: The effect of natalizumab on reproduction was evaluated in 5 studies, 3 in guinea pigs and 2 in cynomolgus monkeys.
Slovenian: Učinek natalizumaba na razmnoževanje so ocenili v 5 študijah, 3 na budrah in 2 na opicah cynomolgus.
English: Each vial is for single-use only.
Slovenian: Vsaka viala je samo za enkratno uporabo.
English: Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Slovenian: Le-ta lahko opazi simptome, katerih se sami morda ne zavedate, kot so spremembe v razpoloženju ali vedenju, izguba spomina, težave z govorom in komuniciranjem, ki jih mora zdravnik podrobneje raziskati, da izključi PML.
English: The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Slovenian: Interakcija med α4β1 in njegovimi tarčami je pomembna komponenta patološkega vnetja v možganih, zato prekinitev te interakcije zmanjša vnetje.
English: • That the aim of the treatment initiation form is to provide patients with information on PML and IRIS
Slovenian: • da je namen obrazca za začetek zdravljenja posredovati bolnikom informacije o PML in IRIS
English: Anaphylactic/anaphylactoid reactions occurred in less than 1% of patients receiving TYSABRI.
Slovenian: Anafilaktična/anafilaktoidna reakcija se je pojavila pri manj kot 1 % bolnikov, ki so prejemali zdravilo TYSABRI.
English: The majority of patients did not interrupt natalizumab therapy during infections and recovery occurred with appropriate treatment.
Slovenian: Večina bolnikov med okužbami ni prekinila zdravljenja z natalizumabom in je z ustreznim zdravljenjem okrevala.
English: Known active malignancies, except for patients with cutaneous basal cell carcinoma.
Slovenian: Znane aktivne maligne tvorbe razen pri bolnikih z bazocelularnim karcinomom kože.
English: The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Slovenian: Imetnik dovoljenja za promet z zdravilom uveljavlja dogovorjene ukrepe za nadzor v časovnem okviru, določenem v dogovoru z nacionalnimi pristojnimi organi.
English: 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.
Slovenian: 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.
English: These studies showed no evidence of teratogenic effects or effects on growth of offspring.
Slovenian: Študije niso pokazale teratogenih učinkov ali učinkov na rast ploda.
English: PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 x 15 ml viala
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 do 6 mg/kg natalizumaba.
English: No effects on abortion rates were noted in any other study.
Slovenian: V nobeni drugi študiji niso ugotovili učinka na stopnjo abortusa.
English: In post-marketing experience, there have also been reports of eosinophilia (eosinophil count >1,500/mm3) without clinical symptoms.
Slovenian: Iz izkušenj v obdobju trženja so tudi poročali o eozinofiliji (število eozinofilcev >1.500/mm3) brez kliničnih simptomov.
English: 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).
Slovenian: 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).
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 s svojim zdravnikom, preden vzamete to zdravilo.
English: • 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).
Slovenian: • 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).
English: Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Slovenian: Zdravnik bo preverjal prisotnost alergijske reakcije med infundiranjem in 1 uro po njenem zaključku.
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Will TYSABRI always work?
Slovenian: Ali zdravilo TYSABRI vedno deluje?
English: • Patient alert card
Slovenian: • Opozorilna kartica za bolnika
English: Of these, 581 patients received a fixed 300 mg dose as monotherapy.
Slovenian: 581 teh bolnikov je prejemalo stalen 300 mg odmerek v obliki monoterapije.
English: Anaemia and haemolytic anaemia
Slovenian: Anemija in hemolitična anemija
English: 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.
Slovenian: 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.
English: After dilution, do not shake.
Slovenian: Po razredčenju ne stresajte.
English: Elevations in neutrophils were not seen.
Slovenian: Povišano število nevtrofilcev ni bilo opaženo.
English: These medicines are for MS and cannot be used with TYSABRI (see Using other medicines, below).
Slovenian: Ta zdravila se uporabljajo za MS in jih ne morete uporabljati z zdravilom TYSABRI (glejte Druga zdravila in zdravilo TYSABRI, spodaj).
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 in iz razpoložljive literature ne kažejo, da bi izpostavljenost zdravilu TYSABRI vplivala na izide nosečnosti.
English: 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).
Slovenian: 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).
English: • Patient details, signature and date
Slovenian: • podatki o bolniku, podpis in datum
English: Educational guidance
Slovenian: Smernice za usposabljanje
English: 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.
Slovenian: Analiza je raziskala učinke izbranih sospremenljivk, vključno s telesno maso, starostjo, spolom, jetrnim in ledvičnim delovanjem in prisotnostjo proti-natalizumabnih protiteles na farmakokinetiko.
English: In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals.
Slovenian: Pri opicah cynomolgus, tretiranih z natalizumabom do skotitve, so bile nizke ravni natalizumaba ugotovljene v opičjem mleku nekaterih živali..
English: The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Slovenian: Mehanizem izločanja in rezultati populacijske farmakokinetike kažejo, da prilagajanje odmerka za bolnike z okvarami ledvic ali jeter morda ne bo potrebno.
English: Colourless, clear to slightly opalescent solution.
Slovenian: Brezbarvna, bistra do rahlo opalescentna raztopina.
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 herpesnega encefalitisa ali meningitisa, je treba zdravljenje z zdravilom prekiniti in začeti ustrezno zdravljenje herpesnega encefalitisa ali meningitisa.
English: Use of these medicinal products soon after the discontinuation of natalizumab may lead to an additive immunosuppressive effect.
Slovenian: Uporaba teh zdravil kmalu po prenehanju dajanja natalizumaba lahko povzroči dodatni učinek zaviranja imunskega odziva.
English: The physician information about TYSABRI shall contain the following key elements:
Slovenian: Informacije o zdravilu TYSABRI za zdravnike naj vsebujejo naslednje ključne elemente:
English: • Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
Slovenian: • Informacije za zdravstveno osebje o pripravi in dajanju zdravila TYSABRI so na koncu tega navodila.
English: RRMS (McDonald criteria)
Slovenian: Bolniki z RRMS (recidivna remitentna multipla skleroza) (McDonaldovi kriteriji)
English: In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/kg treatment groups versus matching control groups.
Slovenian: V eni študiji z opicami se je število abortusov obravnavanih opic podvojilo pri dajanju 30 mg/kg natalizumaba v primerjavi z ujemajočimi kontrolnimi skupinami.
English: 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.
Slovenian: 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.
English: Resources for the management of hypersensitivity reactions should be available.
Slovenian: Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami.
English: 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.
Slovenian: 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.
English: This reduces nerve damage caused by MS.
Slovenian: Poškodbe živčnih celic, ki jih povzroča MS, se tako zmanjšajo.
English: These reactions usually occurred during the infusion or up to 1 hour after completion of the infusion.
Slovenian: Reakcije so se običajno pojavile med infundiranjem ali do 1 uro po zaključenem infundiranju.
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: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Slovenian: Monoterapija; randomizirano, dvojno slepo, s placebom kontrolirano, vzporedno, 120-tedensko preskušanje
English: 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.
Slovenian: 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.
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: 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.
Slovenian: 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.
English: This should be considered if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: These symptoms may be caused by an infection of the brain (encephalitis) or its covering layer (meningitis).
Slovenian: Te simptome lahko povzroča okužba možganov (encefalitis) ali njihovih ovojnic (meningitis).
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: 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).
English: Relapse rate derived variables / MRI-derived variables
Slovenian: Iz stopnje recidivov izpeljane spremenljivke / iz MRTizpeljane spremenljivke
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Slovenian: Neporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
English: All physicians who intend to prescribe TYSABRI must ensure they are familiar with the Physician Information and Management Guidelines.
Slovenian: Vsi zdravniki, ki nameravajo predpisovati zdravilo TYSABRI, morajo zagotoviti, da so seznanjeni z informacijami za zdravnike in smernicami za obvladovanje bolezni.
English: 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.
Slovenian: Testiranja za protitelesa proti JCV ne opravite med zamenjavo plazme ali še vsaj dva tedna po tem, saj so bila iz seruma odstranjena protitelesa.
English: TYSABRI is for intravenous use.
Slovenian: Zdravilo TYSABRI je za intravensko uporabo.