FrancophonIA/ELRC3.0 huggingface dataset:
English: Wilzin 25 mg hard capsules
Slovenian: Wilzin 25 mg trde kapsule
English: Adverse drug reactions
Slovenian: Neželeni učinki zdravila
English: Breast-feeding Breast-feeding should be avoided if you are on Wilzin therapy.
Slovenian: Dojenje Če se zdravite z Wilzinom, se izogibajte dojenju.
English: B. PACKAGE LEAFLET
Slovenian: B. NAVODILO ZA UPORABO
English: Oral use.
Slovenian: NAVODILO ZA UPORABO
English: Caution should be exercised when switching patients with portal hypertension from a chelating agent to Wilzin, when such patients are doing well and the treatment is tolerated.
Slovenian: Kadar bolnikom s portalno hipertenzijo, ki se zdravijo s kakim kelatorjem, ki jim gre dobro in ki dobro prenašajo zdravljenje, zamenjujemo kelator z Wilzinom, je potrebna previdnost.
English: Excipients: Each capsule contains 1.75 mg of sunset yellow FCF (E110)
Slovenian: Ena kapsula vsebuje 1,75 mg vsebuje barvilo oranžno FCF (E110) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Wilzin 50 mg hard capsules Zinc
Slovenian: Wilzin 50 mg trde kapsule cink
English: Wilzin 25 mg hard capsules Zinc
Slovenian: Wilzin 25 mg trde kapsule cink
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: SEZNAM POMOŽNIH SNOVI
English: You should check with your doctor or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: - Keep this leaflet.
Slovenian: - Navodilo shranite.
English: 6.3 Shelf life
Slovenian: 6.3 Rok uporabnosti
English: Annex IV
Slovenian: Priloga IV
English: It is noted that in some cases increase of blood pressure was documented.
Slovenian: Treba je opozoriti, da so v nekaterih primerih dokumentirali zvišanje krvnega tlaka.
English: These safety concerns are related to:
Slovenian: Varnostni pomisleki so povezani z naslednjimi pojavi:
English: Scientific conclusions
Slovenian: Znanstveni zaključki
English: Overall summary of the scientific evaluation by the PRAC
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora PRAC
English: Immune-mediated reactions
Slovenian: Imunsko posredovane reakcije
English: In addition, the EC requested the Agency to give its opinion, as soon as possible, as to whether provisional measures were necessary to ensure the safe and effective use of this medicinal product.
Slovenian: Poleg tega je agencijo prosila, naj čim prej poda mnenje o tem, ali so potrebni začasni ukrepi za zagotovitev varne in učinkovite uporabe tega zdravila.
English: Fatal cases
Slovenian: Smrtni primeri
English: The EC requested the Agency to give its opinion on whether the marketing authorisation for this product should be maintained, varied, suspended or revoked.
Slovenian: Evropska komisija je agencijo zaprosila za mnenje o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: • In addition, several fatal cases were identified both in the literature and in the Eudravigilance database.
Slovenian: • poleg tega so v literaturi in v zbirki podatkov Eudravigilance našli več smrtnih primerov.
English: Despite these recommendations, in the majority of cases it was not possible to predict these cardiovascular reactions prior to hospital discharge, and reactions occurred outside a hospital setting.
Slovenian: Kljub tem priporočilom v večini primerov teh srčno-žilnih reakcij ni bilo mogoče napovedati pred odpustom iz bolnišnice, reakcije pa so se pojavile zunaj bolnišničnega okolja.
English: Information from some fatal cases indicates that current recommendations for monitoring may be insufficient.
Slovenian: Informacije o nekaterih smrtnih primerih kažejo, da so trenutna priporočila za spremljanje morda nezadostna;
English: The cases of HLH and AIH suggest that despite the recommendations for intensive monitoring and alertness to immune mediated reactions until 48 months following last treatment course, it has not been possible to take adequate measures to detect them early enough.
Slovenian: Primeri HLH in AIH kažejo, da kljub priporočilom za intenzivno spremljanje in pozornosti na imunsko posredovane reakcije še 48 mesecev po zadnjem ciklu zdravljenja ni bilo mogoče ustrezno ukrepati in jih odkriti še dovolj zgodaj.
English: Several of the serious risks in relation to alemtuzumab resulted in fatal outcomes despite monitoring of the patients and adherence to the current risk minimisation measures such as pre-medication.
Slovenian: Več resnih tveganj v povezavi z alemtuzumabom je privedlo do smrtnih izidov kljub spremljanju bolnikov in upoštevanju trenutnih ukrepov za zmanjšanje tveganja, kot je premedikacija.
English: Common to these cardiovascular reactions was a close temporal relationship to an alemtuzumab infusion, as the majority of cases occurred during the treatment course or within 1-3 days after the last infusion.
Slovenian: Skupna tem srčno-žilnim reakcijam je bil tesna časovna povezava z infuzijo alemtuzumaba, saj se je večina primerov pojavila med ciklom zdravljenja ali v 1-3 dneh po zadnji infuziji.
English: Many of these cases were life-threatening or fatal.
Slovenian: Številni od teh primerov so bili smrtno nevarni ali usodni.
English: In view of the seriousness of the events observed and until a thorough review of the data is finalised, it is appropriate to limit exposure of new patients to alemtuzumab by introducing amendments to the product information.
Slovenian: Glede na resnost opaženih dogodkov in dokler ne bo končan temeljit pregled podatkov, je primerno omejiti izpostavljenost novih bolnikov alemtuzumabu z uvedbo sprememb informacij o zdravilu.
English: During the assessment procedure of the periodic safety update report (PSUSA) for Lemtrada covering the period between 13 September 2017 and 12 September 2018, limited information was available on new emerging and serious safety concerns, including lack of detailed information on the individual cases, precluding a thorough evaluation.
Slovenian: Med postopkom ocenjevanja rednega posodobljenega poročila o varnosti zdravila (PSUSA) za zdravilo Lemtrada, ki je zajemalo obdobje med 13. septembrom 2017 in 12. septembrom 2018, so bile na voljo omejene informacije o novo nastalih in resnih varnostnih pomislekih, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, kar je preprečilo temeljito ovrednotenje.
English: - Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
Slovenian: - Smrtni primeri: V postopku PSUSA je bilo ugotovljenih več smrtnih primerov, kar kaže, da so trenutna priporočila za spremljanje morda nezadostna.
English: Many of those were life-threatening or fatal.
Slovenian: Številne med njimi so bile smrtno nevarne ali usodne.
English: During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Slovenian: Med ocenjevanjem rednega posodobljenega poročila o varnosti zdravila (PSUSA) za zdravilo Lemtrada (EMEA/H/C/PSUSA/00010055/201809) so bili poleg že znanega varnostnega profila alemtuzumaba poudarjeni naslednji novo nastali in resni varnostni pomisleki, kar je pri Odboru za oceno tveganja na področju farmakovigilance (PRAC) vzbudilo večjo zaskrbljenost:
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Lemtrada, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Slovenian: • odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil v zvezi z zdravilom Lemtrada začet na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004, ob upoštevanju razlogov iz člena 116 Direktive 2001/83/ES;
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Lemtrada (alemtuzumab).
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Lemtrada (alemtuzumab).
English: In view of the above, the European Commission (EC) initiated on 11 April 2019 a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess the above safety concerns and their impact on the benefit-risk balance for the centrally authorised medicinal product Lemtrada.
Slovenian: Na podlagi zgornjih podatkov je Evropska komisija 11. aprila 2019 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in od agencije zahtevala, da oceni zgornje pomisleke o varnosti in njihov vpliv na razmerje med tveganji in koristmi zdravila Lemtrada, odobrenega po centraliziranem postopku.
English: as to whether the risk minimisation measures currently in place are sufficient to adequately manage the risks associated to alemtuzumab in the current target population.
Slovenian: obstajajo resni dvomi, ali so trenutno uveljavljeni ukrepi za zmanjšanje tveganja zadostni za ustrezno obvladovanje tveganj, povezanih z alemtuzumabom, pri trenutni ciljni populaciji.
English: It is therefore questioned whether the current risk minimisation measures are able to mitigate the risk of occurrence of these cardiovascular reactions.
Slovenian: Zato je vprašljivo, ali je s trenutnimi ukrepi za zmanjšanje tveganja mogoče zmanjšati tveganje za pojav teh srčno-žilnih reakcij.
English: Autoimmune disorders are an important identified risk for alemtuzumab.
Slovenian: Avtoimunske bolezni so pomembno ugotovljeno tveganje pri alemtuzumabu.
English: The current recommendation relates only to provisional measures recommended by the PRAC for Lemtrada based on the preliminary data available at this time.
Slovenian: Trenutno priporočilo se nanaša zgolj na začasne ukrepe, ki jih je za zdravilo Lemtrada priporočil odbor PRAC na osnovi predhodnih podatkov, ki so ob tem času na voljo.
English: In addition, several cases of autoimmune hepatitis (AIH) including fatalities were reported.
Slovenian: Poleg tega so poročali o več primerih avtoimunskega hepatitisa (AIH), vključno s smrtnimi primeri.
English: Limited information, including lack of detailed information on the individual cases, precluded a thorough evaluation of their impact on the benefit risk of Lemtrada in view of the time constraints for the PSUSA assessment.
Slovenian: Zaradi omejenih informacij, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, ni bilo mogoče temeljito ovrednotiti njihovega vpliva na razmerje med tveganji in koristmi zdravila Lemtrada glede na časovne omejitve ocenjevanja PSUSA.
English: In view of the above, the Committee considers that the benefit-risk balance of Lemtrada (alemtuzumab) remains favourable subject to the agreed provisional amendments to the product information.
Slovenian: Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Lemtrada (alemtuzumab) še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
English: Although efficacy of alemtuzumab in RRMS patients is well established, these emerging and serious safety concerns may impact the benefit-risk balance of Lemtrada.
Slovenian: Čeprav je učinkovitost alemtuzumaba pri bolnikih z RRMS dobro dokazana, lahko ti porajajoči se in resni varnostni pomisleki vplivajo na razmerje med tveganji in koristmi zdravila Lemtrada.
English: On this basis, the authors of the papers hypothesise that an autoimmune reaction could be directed at CNS in rare cases.
Slovenian: Na podlagi tega so avtorji člankov postavili hipotezo, da je v redkih primerih avtoimunska reakcija lahko usmerjena proti centralnemu živčnemu sistemu.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Slovenian: To priporočilo ne posega v končne zaključke potekajočega postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Thus, it is questioned whether the current risk minimisation measures are effective.
Slovenian: Zato je učinkovitost trenutnih ukrepov za zmanjšanje tveganja vprašljiva.
English: New life-threatening and potentially fatal immune- mediated reactions were identified.
Slovenian: Ugotovljene so bile nove smrtno nevarne in potencialno usodne imunsko posredovane reakcije.
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Ti začasni ukrepi ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Cases of Haemophagocytic lymphohistocytosis (HLH) were identified.
Slovenian: Ugotovljeni so bili primeri hemofagocitne limfohistocitoze (HLH).
English: These cases are characterised by specific MRI lesions and unexpected high total B cell count which may suggest a B-cell-mediated activation of disease.
Slovenian: Za te primere so značilne posebne lezije, vidne z MRS, in nepričakovano veliko skupno število celic B, kar lahko kaže na s celicami B posredovano aktivacijo bolezni.
English: The temporal onset corresponded to the time of reconstitution of the immune system after depletion of B- and T-lymphocytes following Lemtrada treatment.
Slovenian: Časovni pojav se je skladal s časom rekonstitucije imunskega sistema po depleciji limfocitov B in T po zdravljenju z zdravilom Lemtrada.
English: Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system that is characterized by inflammation, demyelination and neuronal loss.
Slovenian: Multipla skleroza je vnetna in nevrodegenerativna bolezen centralnega živčnega sistema, za katero so značilni vnetje, demielinizacija in propadanje nevronov.
English: • The PRAC noted that although efficacy of alemtuzumab in relapsed remitting multiple sclerosis patients is well established, these emerging and serious safety concerns can impact the benefit-risk balance of Lemtrada, and that until a thorough review is finalised, it would be appropriate as a provisional measure to limit the patients exposed to alemtuzumab.
Slovenian: • odbor PRAC je opozoril, da lahko kljub dobro dokazani učinkovitosti alemtuzumaba pri bolnikih z recidivno-remitentno multiplo sklerozo ti porajajoči se in resni varnostni pomisleki vplivajo na razmerje med tveganji in koristmi zdravila Lemtrada in da je primerno omejiti izpostavljenost bolnikov alemtuzumabu, dokler ne bo končan temeljit pregled podatkov.
English: Grounds for PRAC recommendation Whereas
Slovenian: Podlaga za priporočilo odbora PRAC Ob upoštevanju naslednjega:
English: Cardiovascular (including cerebrovascular) reactions temporally associated with alemtuzumab administration
Slovenian: Srčno-žilne (vključno s možgansko-žilnimi) reakcije, časovno povezane z dajanjem alemtuzumaba
English: HLH is a life-threatening condition of severe hyperinflammation caused by uncontrolled proliferation of activated lymphocytes and macrophages.
Slovenian: HLH je smrtno nevarno stanje hudega čezmernega vnetja, ki je posledica nenadzorovanega razmnoževanja aktiviranih limfocitov in makrofagov.
English: Both T and B lymphocytes are involved in the pathogenesis of MS. Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T and B lymphocytes, and at lower levels on natural killer cells, monocytes and macrophages.
Slovenian: V patogenezo multiple skleroze so vključeni limfociti T in B. Alemtuzumab se veže na CD52, antigen celične površine, ki je v večji meri prisoten na limfocitih T in B, v manjši pa na naravnih celicah ubijalkah, monocitih in makrofagih.
English: Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy.
Slovenian: 1 Haghikia A et al. Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy.
English: Lemtrada (alemtuzumab) is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Slovenian: Zdravilo Lemtrada (alemtuzumab) je indicirano za odrasle bolnike z recidivno-remitentno multiplo sklerozo (RRMS) z aktivno boleznijo, ki je kot taka opredeljena na podlagi kliničnih ali slikovnih ugotovitev.
English: Therefore, in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to restrict use of alemtuzumab in new patients to adults with highly active relapsing remitting multiple sclerosis despite a full and adequate course of treatment with at least two other disease modifying treatments, or to adults with highly active relapsing remitting multiple sclerosis where all other disease modifying treatments are contraindicated or otherwise unsuitable.
Slovenian: Zato glede na resnost opaženih dogodkov odbor PRAC priporoča začasne spremembe informacij o zdravilu, s katerimi se uporaba alemtuzumaba pri novih bolnikih omeji le na odrasle z recidivno-remitentno multiplo sklerozo, ki je močno aktivna kljub celotnemu in ustreznemu ciklu zdravljenja z vsaj dvema drugima imunomodulirajočima zdraviloma, ali odrasle z močno aktivno recidivno-remitentno multiplo sklerozo, pri katerih so druga imunomodulirajoča zdravila kontraindicirana ali kako drugače neprimerna;
English: Therefore PRAC recommended that new treatment with Lemtrada should only be initiated in adult patients with highly active relapsing remitting multiple sclerosis despite a full and adequate course of treatment with at least two other disease modifying treatments, or in adult patients with highly active relapsing remitting multiple sclerosis where all other disease modifying treatments are contraindicated or otherwise unsuitable.
Slovenian: Zato odbor PRAC priporoča, da se novo zdravljenje z zdravilom Lemtrada uvede le pri odraslih bolnikih z recidivno-remitentno multiplo sklerozo, ki je močno aktivna kljub celotnemu in ustreznemu ciklu zdravljenja z vsaj dvema drugima imunomodulirajočima zdraviloma, ali pri odraslih bolnikih z močno aktivno recidivno-remitentno multiplo sklerozo, pri katerih so druga imunomodulirajoča zdravila kontraindicirana ali kako drugače neprimerna.
English: • The PRAC reviewed the available data on cardiovascular reactions, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
Slovenian: • odbor PRAC je pregledal razpoložljive podatke o srčno-žilnih reakcijah, vključno s podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom v sklopu postopka PSUSA.
English: - Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre syndrome.
Slovenian: - Imunsko posredovane bolezni, kot so avtoimunski hepatitis, poškodba jeter, avtoimunsko posredovana bolezen centralnega živčnega sistema in Guillain-Barréjev sindrom.
English: This temporal relationship to alemtuzumab infusions is suggestive of a causal association.
Slovenian: Ta časovna povezava z infuzijami alemtuzumaba kaže na vzročno povezavo.
English: The PRAC also noted that recent literature reports have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Slovenian: Odbor PRAC je opozoril tudi, da nedavna poročila v literaturi poudarjajo s celicami B posredovane lezije centralnega živčnega sistema, ki se pojavijo v 6 mesecih po infuziji alemtuzumaba;
English: Common to these cardiovascular reactions was a close temporal relationship to an alemtuzumab infusion, which is suggestive of a causal association.
Slovenian: Skupno tem srčno-žilnim reakcijam je bila tesna časovna povezava z infuzijo alemtuzumaba, kar kaže na vzročno povezavo;
English: According to existing recommendations, observation for infusion associated reactions (IARs) should be undertaken during and for two hours after infusion.
Slovenian: V skladu z obstoječimi priporočili je treba med infuzijo in še dve uri po njej bolnika opazovati, da ne pride do reakcij, povezanih z infuzijo.
English: New life-threatening and potentially fatal immune-mediated adverse reactions were identified, including haemophagocytic lymphohistocytosis and autoimmune hepatitis.
Slovenian: Ugotovljene so bile nove smrtno nevarne in potencialno usodne imunsko posredovane reakcije, vključno s hemofagocitno limfohistiocitozo in avtoimunskim hepatitisom.
English: • The PRAC also reviewed the available data on immune-mediated adverse events, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
Slovenian: • odbor PRAC je pregledal tudi razpoložljive podatke o imunsko posredovanih neželenih učinkih, vključno s podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom v sklopu postopka PSUSA.
English: Literature reports1, 2, 3 have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Slovenian: Poročila v literaturi1, 2, 3 poudarjajo s celicami B posredovane lezije centralnega živčnega sistema, ki se pojavijo v 6 mesecih po infuziji alemtuzumaba.
English: Several cases with various cardiovascular reactions with close temporal relationship with alemtuzumab administration were identified.
Slovenian: Ugotovljenih je bilo več primerov z različnimi srčno-žilnimi reakcijami s tesno časovno povezavo z dajanjem alemtuzumaba.
English: - Cardiovascular adverse events in close temporal association with Lemtrada infusions (e.g. cardiac ischaemia and myocardial infarction, ischaemic and haemorrhagic stroke, arterial dissection, pulmonary haemorrhage and embolism, vasculitis and thrombocytopenia), including a possible mechanistic relation to these adverse events.
Slovenian: - Srčno-žilni neželeni dogodki v tesni časovni povezavi z infuzijami zdravila Lemtrada (npr. srčna ishemija in miokardni infarkt, ishemična in hemoragična možganska kap, arterijska disekcija, pljučna krvavitev in embolija, vaskulitis in trombocitopenija), vključno z morebitno mehanicistično povezavo s temi neželenimi dogodki.
English: New warnings on autoimmune hepatitis, hepatic injury and haemophagocytic lymphohistiocytosis are also added.
Slovenian: Dodajo se tudi nova opozorila o avtoimunskem hepatitisu, poškodbi jeter in hemofagocitni limfohistiocitozi.
English: In addition the PRAC considered important that the risk minimisation measures recommended within the assessment of the current PSUSA procedure are also implemented together with the provisional measures.
Slovenian: Poleg tega je odbor PRAC kot pomembno ocenil, da se skupaj z začasnimi ukrepi uvedejo tudi ukrepi za zmanjšanje tveganja, priporočeni v sklopu ocenjevanje trenutnega postopka PSUSA.
English: Several cases with various cardiovascular reactions were identified, including pulmonary alveolar haemorrhage, myocardial infarction, and ischaemic and haemorrhagic stroke as well as arterial dissection.
Slovenian: Ugotovljenih je bilo več primerov z različnimi srčno-žilnimi reakcijami, vključno s pljučno alveolarno krvavitvijo, miokardnim infarktom ter ishemično in hemoragično možgansko kapjo ter arterijsko disekcijo.
English: • In addition the PRAC considered important that the risk minimisation measures recommended within the assessment of the current PSUSA procedure are also implemented together with the provisional measures.
Slovenian: • odbor PRAC je kot pomembno ocenil tudi, da se skupaj z začasnimi ukrepi uvedejo tudi ukrepi za zmanjšanje tveganja, priporočeni v sklopu ocenjevanja trenutnega postopka PSUSA.
English: Furthermore, the following new adverse reactions are added: pulmonary alveolar haemorrhage, haemophagocytic lymphohistiocytosis, myocardial infarction, stroke (including ischemic and haemorrhagic stroke), cervicocephalic arterial dissection and neutropenia.
Slovenian: Poleg tega se dodajo naslednji novi neželeni učinki: pljučna alveolarna krvavitev, hemofagocitna limfohistiocitoza, miokardni infarkt, možganska kap (vključno z ishemično in hemoragično možgansko kapjo), cervikocefalična arterijska disekcija in nevtropenija.