FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandimmun and Sandimmun Neoral are available as capsules (10, 25, 50 and 100 mg) and oral solution (100 mg/ml).
Croatian: Sandimmun i Sandimmun Neoral dostupni su kao kapsule (10, 25, 50 i 100 mg) i oralna otopina (100 mg/ml).
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue.
Croatian: Autoimuna bolest je bolest koju uzrokuje napad vlastitog obrambenog sustava tijela na normalno tkivo.
English: Both medicines are available in the EU under other trade names: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral and Sandimmune.
Croatian: Oba su lijeka dostupna u EU pod trgovačkim nazivima: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral i Sandimmune.
English: Information on how to switch between different ciclosporin medicines was also included in the product information of these medicines.
Croatian: Informacije o načinu prebacivanja s jednog lijeka koji sadrži ciklosporin na drugi, također, su uključene u informacije o proizvodu za ove lijekove.
English: They are also used to treat autoimmune diseases.
Croatian: Ovi se lijekovi također primjenjuju za liječenje autoimunih bolesti.
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Croatian: To je rezultiralo divergencijom između država članica u načinu moguće primjene lijekova, što je vidljivo u razlikama sažetaka opisa svojstava lijeka, etiketama i uputama o lijeku u državama u kojima se lijekovi stavljaju u promet.
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should be used in the following indications, which were already approved in several but not all EU Member States:
Croatian: CHMP je suglasan da se Sandimmun i Sandimmun Neoral moraju koristiti za sljedeće indikacije, koje su već odobrene u nekoliko država članica, no ne u svim država članicama EU:
English: The package leaflet was amended accordingly.
Croatian: Prema tome uputa o lijeku je izmijenjena.
English: However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.
Croatian: No, dok je Sandimmun formulacija ciklosporina na bazi ulja, Sandimmun Neoral je mikroemulgirana formulacija, što omogućuje tijelu ravnomjerniju apsorpciju ciklosporina.
English: Sandimmun and Sandimmun Neoral are authorised in the EU via national procedures.
Croatian: Sandimmun i Sandimmun Neoral odobreni su u EU nacionalnim postupcima.
English: Sandimmun is also available as a concentrate for solution for infusion (50
Croatian: Sandimmun je također dostupan kao koncentrat za otopinu za infuziju (50 mg/ml).
English: They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).
Croatian: Ne smiju se primjenjivati zajedno s biljnim lijekom naziva Gospina trava (koristi se za liječenje depresije) ili s lijekovima, čije se koncentracije u krvi mogu povisiti ciklosporinom, što može rezultirati ozbiljnim nuspojavama, poput dabigatran eteksilatoma (koristi se za sprječavanje formiranja krvnih ugrušaka nakon kirurškog zahvata) ili bosentanoma i aliskirena (koriste se za liječenje visokog krvnog tlaka).
English: EMA/391239/2013 Rev. 1 EMEA/H/A-30/1300
Croatian: EMA/391239/2013 Rev.
English: The CHMP did not recommend use in aplastic anaemia (a blood disorder in which the bone marrow doesn't make enough new blood cells), which was approved in only one Member State.
Croatian: CHMP nije preporučio primjenu u aplastičnoj anemiji (poremećaju krvi pri kojem koštana srž ne stvara dovoljno novih krvnih stanica).
English: What are Sandimmun and Sandimmun Neoral?
Croatian: Što su Sandimmun i Sandimmun Neoral?
English: • Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
Croatian: • endogenog uveitis (upale uveje, srednjeg sloja oka);
English: • Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
Croatian: • teškog reumatoidnog artritisa (bolesti koja uzrokuje oštećenje i upalu u zglobovima);
English: • Solid organ transplantation (for the prevention and treatment of graft rejection);
Croatian: • transplantacija organa (za prevenciju i liječenje odbacivanja presatka);
English: Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences).
Croatian: Sandimmun i Sandimmun Neoral su imunosuprezivi (lijekovi koji smanjuju aktivnost imunosnog sustava, prirodne obrambene tijela).
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should not be used in patients who are hypersensitive (allergic) to the active substance.
Croatian: CHMP je suglasan da se Sandimmun i Sandimmun Neoral ne smiju koristiti u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da postoji potreba za usklađivanjem informacija za propisivanje lijekova Sandimmun i Sandimmun Neoral u Europskoj uniji (EU).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Povjerenstva, mišljenje je CHMP-a da se sažetci opisa svojstava lijekova, etikete i upute za lijekove moraju uskladiti na razini EU.
English: On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral.
Croatian: Dana 27. lipnja 2013., Europska agencija za lijekove završila je pregled lijekova Sandimmun i Sandimmun Neoral.
English: Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graftversus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Croatian: Sandimmun i Sandimmun Neoral primjenjuju se u bolesnika s transplantatom kako bi se spriječilo odbacivanje (slučajevi kada imunosni sustav napada presađeni organ) te za liječenje ili sprječavanje bolesti presatka protiv primatelja (kada imunosni sustav presađenog organa napada tkiva bolesnika).
English: The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in autoimmune diseases, normal tissue.
Croatian: Djelatna tvar u lijekovima Sandimmun i Sandimmun Neoral, ciklosporin, djeluje na određene posebne stanice u imunosnom sustavu naziva T stanice koje su odgovorne za napadanje presađenih organa, ili, u slučaju autoimune bolesti, normalnog tkiva.
English: On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.
Croatian: Dana 15. prosinca 2011., Europska je komisija uputila postupak CHMP-u sa ciljem usklađivanja odobrenja za stavljanje u promet lijekova Sandimmun i Sandimmun Neoral u EU.
English: • Severe psoriasis (a disease causing red, scaly patches on the skin);
Croatian: • teške psorijaze (bolesti koja uzrokuje crvenkasta žarišta pokrivena ljuščicama na koži);
English: • Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).
Croatian: • transplantacija koštane srži (za prevenciju odbacivanja presatka te prevenciju i liječenje bolesti presatka protiv primatelja).
English: • Nephrotic syndrome (a kidney disease);
Croatian: • nefrotskog sindroma (bolesti bubrega);
English: • Severe atopic dermatitis (eczema, an itchy red rash of the skin).
Croatian: • teškog atopičkog dermatitisa (ekcema, crveni osip na koži popraćen svrbežom).
English: Sandimmun and Sandimmun Neoral should only be prescribed by, or in close collaboration with, a doctor experienced in the diseases that these medicines are used to treat.
Croatian: Sandimmun i Sandimmun Neoral smiju propisivati samo liječnici iskusni u liječenju bolesti za čije se liječene ovaj lijek koristi ili se ovi lijekovi propisuju u uskoj suradnji s istima.
English: Why were Sandimmun and Sandimmun Neoral reviewed?
Croatian: Zašto je proveden pregled lijekova Sandimmun i Sandimmun Neoral?
English: Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) identificirala je potrebu za usklađivanjem lijekova Sandimmun i Sandimmun Neoral).
English: Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected.
Croatian: Bolesnici mogu biti izloženi riziku od početka liječenja i tijekom nekoliko mjeseci nakon završetka liječenja, a nije moguće predvidjeti koji će bolesnici biti zahvaćeni.
English: As the medicine is no longer authorised in the EU no further action will be taken by the European Commission.
Croatian: Budući da lijek više nije odobren u EU-u, Europska komisija neće poduzeti daljnje mjere.
English: The PRAC report will be sent to EMA's Committee for Medicinal Products for Human Use (CHMP).
Croatian: Izvješće PRAC-a bit će poslano EMAinu Odboru za lijekove za humanu uporabu (CHMP).
English: 18 March 2018 EMA/286850/2018
Croatian: EMA/286850/2018
English: The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Croatian: Europska komisija donijela je pravno obvezujuću odluku o obustavi odobrenja za stavljanje u promet 8. ožujka 2018.
English: To date over 10,000 patients have been treated with Zinbryta worldwide.
Croatian: Dosad je više od 10 000 bolesnika diljem svijeta liječeno lijekom Zinbryta.
English: Zinbryta is no longer available in hospitals and pharmacies in the EU.
Croatian: Lijek Zinbryta više nije dostupan u bolnicama i ljekarnama u EU-u.
English: Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Croatian: Zinbryta je lijek koji je odobren 2016. za liječenje relapsnih oblika multiple skleroze.
English: Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.
Croatian: Zdravstveni radnici trebaju nastaviti s praćenjem bolesnika koji su liječeni lijekom Zinbryta u skladu s preporukama izdanim u ožujku 2018.
English: Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
Croatian: Lijek za multiplu sklerozu više nije odobren i povučen je iz bolnica i ljekarni
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Croatian: EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) potvrdio je da lijek za multiplu sklerozu pod nazivom Zinbryta (daklizumab beta) predstavlja rizik od teških i potencijalno smrtonosnih reakcija imunosnog sustava koje utječu na mozak, jetru i druge organe.
English: The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Zinbryta započeto je 26. veljače 2018. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: EMA review of Zinbryta confirms medicine's risks outweigh its benefits EMA/286850/2018
Croatian: Ocjenjivanje lijeka Zinbryta koje je provela EMA potvrđuje da rizici od lijeka nadmašuju njegove koristi EMA/286850/2018
English: There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.
Croatian: Ne postoje trenutačne posljedice PRAC-ova ocjenjivanja jer lijek Zinbryta više nije odobren u EU-u.
English: The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Croatian: Stoga je PRAC potvrdio svoj prethodni zaključak da rizici od lijeka Zinbryta nadmašuju njegove koristi za bolesnike s multiplom sklerozom.
English: On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Croatian: Dana 6. ožujka 2018., tijekom ocjenjivanja, EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) preporučio je obustavu odobrenja za stavljanje u promet lijeka Zinbryta i povlačenje proizvoda.
English: The PRAC has now concluded its review of the available evidence on Zinbryta.
Croatian: PRAC je proveo ocjenjivanje dostupnih dokaza o lijeku Zinbryta.
English: On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Croatian: Dana 27. ožujka 2018. povučeno je odobrenje za stavljanje u promet na zahtjev društva Biogen Idec Ltd, koje je stavilo lijek u promet.
English: On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Croatian: Europska komisija povukla je odobrenje za stavljanje u promet lijeka na zahtjev nositelja odobrenja za stavljanje u promet, društva Biogen Idec Ltd.
English: EMA review of Zinbryta confirms medicine's risks outweigh its benefits
Croatian: potvrđuje da rizici od lijeka nadmašuju njegove koristi
English: 0.5 mL (0.5 mg/mL) 5 pre-filled syringes
Croatian: 0,5 ml (0,5 mg/ml) 5 napunjenih štrcaljki
English: 0.5 mL (0.5 mg/mL) 1 pre-filled syringe
Croatian: 0,5 ml (0,5 mg/ml) 1 napunjena štrcaljka
English: EU/1/14/965 /001 Ketoconazole HRA 200 mg Tablet
Croatian: EU/1/14/965 /001 Ketoconazole HRA 200 mg Tableta
English: Oral use blister (PVC/alu)
Croatian: Blister (PVC/aluminij)
English: EMA Number
Croatian: EMA broj postupka
English: (Invented) name Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik Put primjene
English: References.
Croatian: Reference.
English: Healthcare professionals should follow these recommendations:
Croatian: Zdravstveni djelatnici moraju se pridržavati ovih preporuka:
English: • If you have any questions, you should contact your doctor or pharmacist.
Croatian: • Ako imate bilo kakvih pitanja, kontaktirajte sa svojim liječnikom ili ljekarnikom.
English: 11 October 2013 EMA/584237/2013
Croatian: 11. listopada 2013. EMA/584237/2013
English: European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
Croatian: Europsko zakonodavstvo zahtijeva koordinirani europski pristup ako jedna država članica poduzme regulatornu radnju s obzirom na lijek koji je odobren u više od jedne države.
English: The Committee also considered the advice from a group of experts in the treatment of infections.
Croatian: Odbor je također uzeo u obzir savjet grupe stručnjaka s područja liječenja infekcija.
English: In order to ensure that these patients will not be left without treatment, national competent authorities may make these medicines available under controlled conditions.
Croatian: Kako bi se osiguralo da ovi bolesnici ne ostanu bez liječenja, nacionalna nadležna tijela smiju učiniti ove lijekove dostupnima u kontroliranim uvjetima.
English: The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled oralnog ketokonazola pokrenut je u srpnju 2011. na zahtjev Francuske, u skladu sa člankom 13. Direktive 2001/83/EC.
English: Oral formulations of ketoconazole have been authorised in the EU via national procedures, and are currently available in several EU Member States under various trade names, including Nizoral and Fungoral.
Croatian: Oralne formulacije ketokonazola odobrene su u EU-u putem nacionalnih postupaka, a trenutno su dostupne u nekoliko država članica EU-a pod različitim trgovačkim nazivima, uključujući Nizoral i Fungoral.
English: • The risk minimisation measures proposed, such as limiting the treatment duration or restricting the use to patients refractory or intolerant to alternative treatments and to physicians experienced in treating rare fungal infections, were not considered sufficient to reduce the risk of hepatotoxicity to an acceptable level.
Croatian: • Predložene mjere za smanjivanje rizika, poput ograničavanja trajanja liječenja ili ograničavanja uporabe na bolesnike rezistentne ili netoleratne na alternativne terapije i na liječnike koji imaju iskustva u liječenju rijetkih gljivičnih infekcija, ne smatraju se dostatnima za smanjivanje rizika od hepatotoksičnosti na prihvatljivu razinu.
English: The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France.
Croatian: Pregled oralnog ketokonazola diljem EU potaknut je suspenzijom lijeka u Francuskoj.
English: • The onset of hepatotoxicity occurred generally between 1 and 6 months after starting treatment, but has also been reported earlier than 1 month after starting treatment, and at the recommended daily dose of 200 mg.
Croatian: • Nastup hepatoksičnosti s ketokonazolom obično se događa između 1 i 6 mjeseci nakon početka liječenja, no hepatotoksičnost je prijavljena i unutar razdoblja kraćeg od 1 mjeseca nakon početka liječenja, te pri preporučenoj dnevnoj dozi od 200 mg.
English: The CHMP was concerned that reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk.
Croatian: CHMP izrazio je zabrinutost zato što su izvještaji o oštećenju jetre nastali u ranoj fazi nakon početka liječenja preporučenim dozama, te nije bilo moguće identificirati mjere za primjereno smanjivanje ovog rizika.
English: Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease CHMP/EWP/1343/01 Rev. 1, Apr 2010.
Croatian: 2. Smjernica o kliničkoj procjeni sredstava protiv gljivica za liječenje i profilaksu invanzivne gljivične bolesti (Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease) CHMP/EWP/1343/01 Rev.
English: Suspension of marketing authorisations for oral ketoconazole
Croatian: Suspenzija odobrenja za stavljanje lijeka u promet za oralni ketokonazol
English: Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Croatian: Uzimajući u obzir povišene stope oštećenja jetre i dostupnost alternativnih liječenja protiv gljivica, CHMP je zaključio da koristi ne nadmašuju rizike.
English: • Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Croatian: • Formulacije ketokonazola za topikalnu primjenu imaju vrlo nizak stupanj sistemske apsorpcije i mogu se nastaviti primjenjivati kako je trenutno odobreno.
English: Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Croatian: Ketokonazol za oralnu primjenu (na usta) odobren je u EU-u od 1980., a kasnije su postale dostupne topikalne formulacije (za kožu), poput krema, masti i šampona.
English: To lift the suspension, the marketing authorisation holder for oral ketoconazole will have to provide convincing data that identify a group of patients in whom the benefits of the medicine outweigh their risks.
Croatian: Kako bi se suspenzija ukinula, nositelj odobrenja za oralni ketokonazol mora dostaviti uvjerljive podatke koji identificiraju grupu bolesnika kod kojih koristi lijeka nadmašuju rizike.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji, koja ga je potvrdila i usvojila konačnu pravno obvezujuću odluku primjenjivu na cijelom prostoru EU dana 11. listopada 2013.
English: The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Croatian: Odbor je također zaključio da je neizvjesna klinička korist oralnog ketokonazola s obzirom da su podaci o njegovoj djelotvornosti ograničeni, te ne udovoljavaju aktualnim standardima, a postoje alternativne metode liječenja.
English: The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Croatian: Pregled oralnog ketokonazola izvršilo je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Europskoj agenciji za lijekove, odgovornog za sva pitanja u vezi s lijekovima za ljudsku primjenu, koje je usvojilo završno mišljenje EMA-e.
English: • The efficacy studies on oral ketoconazole are limited and have not been carried out in line with the most recently agreed guidelines2.
Croatian: • Ispitivanja djelotvornosti oralnog ketokonazola ograničena su i nisu provedena u skladu s najnovijim usuglašenim smjernicama2.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Croatian: Preporuke Agencije temelje se na pregledu provedenom od strane Povjerenstva za lijekove za primjenu kod ljudi (CHMP), koje je razmotrilo dostupne podatke o koristima oralnog ketokonazola i riziku od hepatotoksičnosti iz predkliničkih i kliničkih ispitivanja, spontanih prikaza slučajeva nakon stavljanja lijeka u promet, epidemioloških ispitivanja i znanstvene literature.
English: There are also inadequate data to support the efficacy of ketoconazole when other treatments have failed or are not tolerated, or resistance has been detected.
Croatian: Postoje nedovoljni podaci koji potkrjepljuju djelotvornost ketokonazola u slučajevima kada druga liječenja nisu uspješna ili se ne podnose, ili ako je otkrivena otpornost.
English: • Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
Croatian: • Oralni ketokonazol (uzima se na usta) suspendiran je nakon pregleda podataka kojim je utvrđena viša toksičnost kod ovog lijeka u usporedbi s drugim lijekovima protiv gljivica.
English: Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections
Croatian: Koristi oralnog ketokonazola ne nadmašuju rizik od oštećenja jetre u slučaju gljivičnih infekcija
English: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.
Croatian: A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.