FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of Tysabri was initiated on 7 May 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Tysabri se je pričel 7. maja 2015 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Keep this card with you and make sure your partner or carer is aware of its content.
Slovenian: Kartico hranite in poskrbite, da vaš partner oz. negovalec pozna njeno vsebino.
English: Index 0.9 or less
Slovenian: Indeks 0,9 ali manj
English: • have been treated with Tysabri for more than 2 years, and
Slovenian: • so se več kot 2 leti zdravili z zdravilom Tysabri, in
English: No index value
Slovenian: Brez indeksne vrednosti
English: Considering these factors, your doctor will be able to advise you about your risk of developing PML.
Slovenian: Ob upoštevanju teh dejavnikov vam bo zdravnik svetoval glede vašega tveganja za razvoj PML.
English: In these patients, treatment with Tysabri should only be continued if benefits outweigh the risks.
Slovenian: Pri teh bolnikih je treba zdravljenje z zdravilom Tysabri nadaljevati le, če so koristi večje od tveganj.
English: PML is a rare brain infection caused by John Cunningham (JC) virus.
Slovenian: PML je redka možganska okužba, ki jo povzroča virus Johna Cunninghama (JC).
English: Your doctor will also check for signs and symptoms suggestive of PML.
Slovenian: Vaš zdravnik bo tudi preveril, ali so prisotni znaki in simptomi, ki kažejo na PML.
English: New recommendations have been issued which may help early detection of PML and improve patients' outcomes.
Slovenian: Izdana so bila nova priporočila, ki lahko pomagajo pri zgodnjem odkrivanju PML in izboljšajo bolnikovo prognozo.
English: EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Priporočila agencije EMA temeljijo na začetnem pregledu, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: In light of the new evidence, patients are considered at higher risk of developing PML if they:
Slovenian: Ob upoštevanju novih podatkov se šteje, da so bolniki s povečanim tveganjem za razvoj PML, če:
English: This protein is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Slovenian: Ta se nahaja na površini večine levkocitov (belih krvnih celic v krvi, ki sodelujejo pri vnetju).
English: The CHMP's opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Slovenian: Mnenje odbora CHMP je bilo nato poslano Evropski komisiji, ki je izdala pravno zavezujočo odločbo, ki je veljavna v vsej EU.
English: Patients should be instructed to seek medical advice if they think their disease is getting worse, or if they notice any new or unusual symptoms.
Slovenian: Bolnike je treba poučiti, naj v primeru slabšanja bolezni, ali kadar opazijo nov ali nenavaden simptom, poiščejo medicinsko pomoč.
English: It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
Slovenian: Uporablja se, kadar se bolezen ne odzove na zdravljenje z beta-interferonom in glatiramer acetatom (drugima vrstama zdravil za zdravljenje multiple skleroze), ali kadar je bolezen resna in se hitro poslabšuje.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 25/04/2016 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Slovenian: Najpogostejši simptomi PML so napredujoča šibkost, težave pri govoru in komuniciranju, spremembe vida in včasih spremembe razpoloženja ali vedenja.
English: • Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Slovenian: • Testiranje na protitelesa proti virusu JC je treba pri bolnikih, ki so na protitelesa negativni, izvesti vsakih 6 mesecev.
English: Prior use of immunosuppressants
Slovenian: Predhodna uporaba imunosupresivov
English: If you believe your disease is getting worse or if you notice any new or unusual symptoms while using Tysabri and for up to 6 months after stopping Tysabri, speak to your doctor as soon as possible.
Slovenian: Če menite, da se vaša bolezen slabša, ali če pri jemanju zdravila Tysabri ali do 6 mesecev po prenehanju jemanja, opazite nove ali nenavadne simptome, se čim prej pogovorite s svojim zdravnikom.
English: • have tested positive for JC virus, and
Slovenian: • so bili njihovi testi za virus JC pozitivni,
English: On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Slovenian: Dne 25. februarja 2016 je agencija EMA zaključila pregled znanega tveganja za progresivno multifokalno levkoencefalopatijo (PML) pri uporabi zdravila Tysabri (natalizumab) za spreminjanje poteka multiple skleroze in potrdila začetna priporočila1, namenjena zmanjševanju tveganja.
English: • Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Slovenian: • Simptomi PML so lahko podobni simptomom napada multiple skleroze, in obsegajo napredujočo šibkost, težave pri govoru in komuniciranju, težave z vidom in včasih spremembo vedenja ali razpoloženja.
English: 2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
Slovenian: Ocene tveganja za PML so bile izdelane po metodi življenjske preglednice na osnovi kohorte 21 696 bolnikov, ki so sodelovali v kliničnih raziskavah STRATIFY-2, TOP, TYGRIS in STRATA.
English: EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
Slovenian: EMA potrjuje priporočila za zmanjševanje tveganja za možgansko okužbo PML pri uporabi zdravila Tysabri
English: Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Slovenian: Zdravilo Tysabri je zdravilo, ki se uporablja za zdravljenje odraslih z zelo aktivno multiplo sklerozo (MS), boleznijo živcev, pri kateri vnetje uniči zaščitno ovojnico, ki obdaja živčne celice.
English: No prior use of immunosuppressants
Slovenian: Brez predhodne uporabe imunosupresivov
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki jih je potrdil in sprejel svoje končno mnenje.
English: • Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
Slovenian: • Vaše tveganje za PML je odvisno od več dejavnikov, med drugim od tega, ali imate v krvi protitelesa proti virusu JC (znak, da ste bili izpostavljeni virusu, ki povzroča PML) in kolikšna je njihova raven, kako dolgo ste se zdravili z zdravilom Tysabri in ali ste se pred začetkom jemanja zdravila Tysabri zdravili z zdravili, ki zavirajo vaš imunski sistem.
English: • More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
Slovenian: • Več informacij o tveganju za PML pri zdravilu Tysabri je vključenih na opozorilni kartici, ki vam jo je dal vaš zdravnik.
English: The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Slovenian: Navedene posodobljene ocene tveganja kažejo, da je tveganje za razvoj PML majhno in manjše od pričakovanega, z vrednostmi protitelesnega indeksa 0,9 ali manj, in z bistvenimi povečanji pri bolnikih z indeksnimi vrednostmi nad 1,5, ki se z zdravilom Tysabri zdravijo več kot 2 leti.
English: In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Slovenian: Pri bolnikih, pri katerih so bili testi za protitelesa proti virusu JC negativni, ostaja tveganje za PML nespremenjeno pri 0,1 od 1 000 bolnikov.
English: More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Slovenian: Več podatkov o stratifikaciji tveganja, diagnozi in zdravljenju PML bo vključenih v posodobljenih Informacijah za zdravnike in smernicah za ravnanje z zdravilom Tysabri.
English: • During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Slovenian: • Med zdravljenjem z zdravilom Tysabri je treba bolnike redno spremljati za pojavljanje znakov in simptomov nove nevrološke disfunkcije, v času zdravljenja pa je treba vsaj enkrat letno izvesti tudi MRS celotnih možganov.
English: • PML should be considered in the differential diagnosis of any patient presenting with neurological symptoms and/or new brain lesions on MRI.
Slovenian: • PML je treba upoštevati v diferencialni diagnozi pri vsakem bolniku z nevrološkimi simptomi oz. novimi možganskimi lezijami pri MRS.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Slovenian: Zdravilna učinkovina zdravila Tysabri, natalizumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano za prepoznavo in vezavo na specifičen del beljakovine α4β1-integrin.
English: • Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
Slovenian: • Pred začetkom zdravljenja z zdravilom Tysabri je treba bolnike in negovalce seznaniti s tveganjem za PML.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
English: By attaching to the integrin, natalizumab stops the leucocytes from going from the blood into the brain, thereby reducing the inflammation and nerve damage caused by MS.
Slovenian: Natalizumab z vezavo na integrin levkocitom prepreči prehod iz krvi v možgane in s tem zmanjša vnetje in okvaro živcev, ki jo povzroča multipla skleroza.
English: • Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
Slovenian: • Progresivna multifokalna levkoencefalopatija (PML, resna možganska okužba) je pri zdravilu za spreminjanje poteka multiple skleroze Tysabri redko tveganje.
English: • either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Slovenian: • so jemali imunosupresiv pred začetkom zdravljenja z zdravilom Tysabri ali pa imunosupresivov niso jemali in imajo visok indeks protiteles proti virusu JC.
English: months *from Tysabri Physician Information and Management Guidelines
Slovenian: 72 mesecev *iz Informacij za zdravnike in smernic za ravnanje z zdravilom Tysabri
English: All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Slovenian: Pri vseh bolnikih, ki jemljejo zdravilo Tysabri, je treba vsaj enkrat letno opraviti MRS celotnih možganov, na osnovi novih podatkov pa je agencija EMA priporočila, da se pri bolnikih z večjim tveganjem MRS izvaja pogosteje (tj. vsakih 3 do 6 mesecev) s skrajšanimi protokoli.
English: Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Slovenian: Nedavne raziskave so pokazale, da lahko zgodnje odkritje in zdravljenje PML pri asimptomatski bolezni (tj. v začetnih stadijih, ko še ni simptomov) izboljšata bolnikovo prognozo.
English: Index 0.9 to
Slovenian: Indeks od 0,9 do 1,5
English: Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Slovenian: Nadaljnja stratifikacija tveganja za PML z intervalom indeksa protiteles proti virusu JC za bolnike brez predhodne uporabe imunosupresivov je bila izvedena z združitvijo celotnega letnega tveganja in razporeditve indeksa protiteles.
English: • After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
Slovenian: • Po dveh letih zdravljenja je treba bolnike ponovno poučiti o tveganju za razvoj PML pri zdravljenju z zdravilom Tysabri.
English: Based on these data, updated risk estimates for PML2 in JC virus antibody-positive patients treated with Tysabri are available, as shown in Table 1 below:
Slovenian: Na osnovi teh podatkov so na voljo posodobljene ocene tveganja za PML2 pri bolnikih, ki so pozitivni na protitelesa proti virusu JC , zdravljenih z zdravilom Tysabri, kot je prikazano v preglednici 1 spodaj:
English: • Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Slovenian: • Pred začetkom zdravljenja z zdravilom Tysabri in med njim bo vaš zdravnik opravil krvne teste za merjenje ravni protiteles za virus JC in MR slikanje za spremljanje vašega stanja.
English: Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Slovenian: Znani dejavniki tveganja za razvoj PML pri bolnikih, zdravljenih z zdravilom Tysabri, so prisotnost protiteles proti virusu JC, več kot dve leti trajajoče zdravljenje z zdravilom Tysabri in predhodna uporaba imunosupresivov.
English: New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Slovenian: Novi podatki iz velikih kliničnih raziskav kažejo tudi, da je pri bolnikih, ki pred začetkom zdravljenja z zdravilom Tysabri niso bili zdravljeni z imunosupresivi (zdravili, ki zmanjšujejo dejavnost imunskega sistema), raven protiteles proti virusu JC v krvi („protitelesni indeks“) povezana s stopnjo tveganja za PML.
English: Index more than 1.5
Slovenian: Indeks več kot
English: • Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
Slovenian: • Pred začetkom zdravljenja mora biti kot referenca na voljo izhodiščno MRS (običajno ne starejše od 3 mesecev), izvesti pa je treba tudi izhodiščni test protiteles proti virusu JC za podporo stratifikacije tveganja za PML.
English: • Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
Slovenian: • Bolnikom in negovalcem je treba svetovati, da so na pojav znakov in simptomov PML pozorni še do 6 mesecev po prenehanju zdravljenja z zdravilom Tysabri.
English: Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
Slovenian: Strokovnjaki za MRS in multiplo sklerozo se strinjajo, da lahko skrajšani protokoli MRS (ki omogočajo krajše postopke in tudi zmanjšujejo obremenitev slikanih bolnikov) omogočajo odkrivanje lezij PML.
English: Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
Slovenian: Poročali so o primerih asimptomatske PML, ugotovljene po MR-posnetkih in pozitivni DNK virusa JC v cerebrospinalni tekočini (CSF).
English: • If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Slovenian: • Ob sumu na PML je treba protokol MRS razširiti, tako da vključuje s kontrastom izboljšano T1-obteženo slikanje in test CSF na prisotnost DNA virusa JC z uporabo visoko občutljive PCR.
English: If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Slovenian: Če se ugotovijo lezije, ki kažejo na PML, je treba protokol MRS razširiti, tako da vključuje „T1-obteženo MRS z izboljšanim kontrastom“, in premisliti o ugotavljanju prisotnosti virusa JC v spinalni tekočini.
English: Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Slovenian: Preglednica 1: Ocena tveganja za PML na 1 000 bolnikov, pri bolnikih, pozitivnih na protitelesa proti virusu JC*
English: Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Slovenian: Zbrani podatki iz velikih kliničnih raziskav kažejo, da se pri bolnikih brez predhodne uporabe imunosupresivov raven odziva protiteles virusa JC (indeks) povezuje s tveganjem za PML.
English: This virus is very common in the general population and is normally harmless; however, it can lead to PML in persons whose immune system is weakened.
Slovenian: Ta virus je med prebivalstvom zelo pogost in običajno neškodljiv.
English: These tests may be done more often if you are considered at higher risk for PML.
Slovenian: Če obstaja večje tveganje za PML, se lahko ti testi izvedejo pogosteje.
English: Patients who have low index values and no history of prior immunosuppressant use should also be retested every 6 months once they reach the 2-year treatment point.
Slovenian: Potem, ko dosežejo dveletno točko zdravljenja, je treba vsakih 6 mesecev testirati tudi bolnike, pri katerih so indeksne vrednosti nizke in ki imunosupresivov doslej niso uporabljali.
English: If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Slovenian: Če sum na PML obstaja v katerem koli trenutku, je treba zdravljenje z zdravilom Tysabri do izključitve PML prekiniti.
English: • If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
Slovenian: • Če bo zdravnik posumil na PML, vas bo prenehal zdraviti z zdravilom Tysabri, dokler ne bo PML izključen.
English: • If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Slovenian: • Če sum na PML obstaja v katerem koli trenutku, je treba zdravljenje z zdravilom Tysabri do izključitve PML prekiniti.
English: More frequent MRI scans should be considered for patients at higher risk
Slovenian: Pri bolnikih s povečanim tveganjem je treba razmisliti o pogostejšem magnetnoresonačnem slikanju.
English: • For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
Slovenian: • Pri bolnikih s povečanim tveganjem za PML je treba premisliti o pogostejšem MRS (npr. na 3 do 6 mesecev) z uporabo skrajšanega protokola (npr. FLAIR, T2-obteženo in DW-slikanje), saj je pri zgodnejšem odkritju PML pri asimptomatskih bolnikih prognoza PML boljša.
English: This is expected to help to prevent organ damage.
Slovenian: To naj bi pomagalo preprečevati poškodbe organov.
English: London, 19 March 2008 Doc.
Slovenian: London, 19.03.2008 Sklic dok.
English: Ref. EMEA/136938/2008
Slovenian: EMEA/180150/2008
English: International non-proprietary name (INN): eprodisate sodium
Slovenian: Mednarodno nelastniško ime (INN): natrijev eprodizat
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več podatkov o svojem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Slovenian: Družba je zahtevala ponovno preučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
English: The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je ledvična funkcija po dveh letih zdravljenja močno poslabšala ali pa so umrli.
English: What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Kiacta?
English: The effects of Kiacta were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Kiacta so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Slovenian: Čeprav je bilo videti, da bi zdravilo Kiacta lahko učinkovalo, pa je Odbor menil, da bi bila za dokaz učinkovitosti zdravila potrebna še druga študija.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
Slovenian: VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom KIACTA
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Kiacta, namenjenim zdravljenju amiloidoze AA.