FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Stoga je PRAC preporučio da se novo liječenje lijekom Lemtrada može započeti samo u odraslih bolesnika s relapsno-remitirajućom multiplom sklerozom u kojih je bolest visoko aktivna usprkos potpunom i odgovarajućem ciklusu liječenja barem dvjema terapijama koje mijenjaju tijek bolesti, ili u odraslih bolesnika s visoko aktivnom relapsno-remitirajućom multiplom sklerozom u kojih su sve druge terapije koje mijenjaju tijek bolesti kontraindicirane ili su iz drugih razloga neprikladne.
English: Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system that is characterized by inflammation, demyelination and neuronal loss.
Croatian: Multipla skleroza (MS) upalna je i neurodegenerativna bolest središnjeg živčanog sustava koju obilježavaju upala, demijelinizacija i gubitak neurona.
English: Lemtrada (alemtuzumab) is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Croatian: Lijek Lemtrada (alemtuzumab) indiciran je za odrasle bolesnike s relapsno-remitirajućom multiplom sklerozom (RRMS) koji imaju aktivnu bolest definiranu kliničkim značajkama ili značajkama vidljivima u pretragama oslikavanja.
English: New life-threatening and potentially fatal immune- mediated reactions were identified.
Croatian: Utvrđene su nove, po život opasne i potencijalno smrtonosne imunosno posredovane reakcije.
English: Cases of Haemophagocytic lymphohistocytosis (HLH) were identified.
Croatian: Utvrđeni su slučajevi hemofagocitne limfohistiocitoze (HLH).
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.
Croatian: S obzirom na ozbiljnost primijećenih događaja, PRAC je stoga preporučio privremene izmjene informacija o lijeku kako bi se u novih bolesnika ograničila primjena alemtuzumaba na odrasle osobe s relapsno-remitirajućom multiplom sklerozom u kojih je bolest visoko aktivna usprkos potpunom i odgovarajućem ciklusu liječenja barem dvjema terapijama koje mijenjaju tijek bolesti, ili na odrasle osobe s visoko aktivnom relapsno-remitirajućom multiplom sklerozom u kojih su sve druge terapije koje mijenjaju tijek bolesti kontraindicirane ili su iz drugih razloga neprikladne.
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.
Croatian: Te su slučajeve obilježile specifične lezije utvrđene oslikavanjem magnetskom rezonancijom i neočekivano visok ukupan broj B limfocita, što može ukazivati na aktivaciju bolesti posredovanu B limfocitima.
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.
Croatian: PRAC je također uočio da su u nedavno objavljenim izvješćima iz literature istaknute lezije središnjeg živčanog sustava posredovane B limfocitima s vremenom nastupanja od šest mjeseci nakon infuzije alemtuzumaba.
English: - Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre syndrome.
Croatian: - imunosno posredovane bolesti kao što je autoimuni hepatitis, oštećenje jetre, bolesti središnjeg živčanog sustava posredovane autoimunim poremećajima i Guillain-Barréov sindrom.
English: This temporal relationship to alemtuzumab infusions is suggestive of a causal association.
Croatian: Ta vremenska povezanost s infuzijama alemtuzumaba upućuje na uzročnu povezanost.
English: Cardiovascular (including cerebrovascular) reactions temporally associated with alemtuzumab administration
Croatian: kardiovaskularne reakcije (uključujući cerebrovaskularne događaje) koje su vremenski povezane s primjenom alemtuzumaba
English: Several cases with various cardiovascular reactions with close temporal relationship with alemtuzumab administration were identified.
Croatian: Utvrđeno je nekoliko slučajeva s različitim kardiovaskularnim reakcijama u uskoj vremenskoj povezanosti s primjenom alemtuzumaba.
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.
Croatian: • Iako je djelotvornost alemtuzumaba u bolesnika s relapsno-remitirajućom multiplom sklerozom provjerena, PRAC je zamijetio da te nove i ozbiljne zabrinutosti u pogledu sigurnosti mogu utjecati na omjer koristi i rizika lijeka Lemtrada te je kao privremenu mjeru potrebno ograničiti izloženost bolesnika alemtuzumabu dok se ne dovrši detaljan pregled podataka.
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.
Croatian: Iako je djelotvornost alemtuzumaba u bolesnika s relapsno-remitirajućom multiplom sklerozom provjerena, te nove i ozbiljne zabrinutosti u pogledu sigurnosti mogu utjecati na omjer koristi i rizika lijeka Lemtrada.
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.
Croatian: Alemtuzumab se veže na CD52, antigen na površini stanice prisutan u visokim koncentracijama na T i B limfocitima i u nižim koncentracijama na NK stanicama, monocitima i makrofagima.
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.
Croatian: U izvješćima iz literature1, 2, 3 istaknute su lezije središnjeg živčanog sustava posredovane B limfocitima s vremenom nastupa od šest mjeseci nakon infuzije alemtuzumaba.
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.
Croatian: • PRAC je pregledao i dostupne podatke o imunosno posredovanim štetnim događajima, uključujući podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet u okviru
English: New life-threatening and potentially fatal immune-mediated adverse reactions were identified, including haemophagocytic lymphohistocytosis and autoimmune hepatitis.
Croatian: Utvrđene su nove po život opasne i potencijalno smrtonosne imunosno posredovane nuspojave, uključujući hemofagocitnu limfohistiocitozu i autoimuni hepatitis.
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.
Croatian: - kardiovaskularni štetni događaji u bliskoj vremenskoj povezanosti s infuzijama lijeka Lemtrada (npr. srčana ishemija i infarkt miokarda, ishemijski i hemoragijski moždani udar, arterijska disekcija, plućno krvarenje i embolija, vaskulitis i trombocitopenija), uključujući mogući mehanistički odnos s tim štetnim događajima.
English: There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Croatian: CD52 nije uopće prisutan ili je prisutan u vrlo niskim koncentracijama na neutrofilima, stanicama plazme ili matičnim stanicama u koštanoj srži.
English: Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes.
Croatian: Alemtuzumab djeluje putem stanične citolize ovisne o protutijelima i lize posredovane komplementom, nakon vezivanja na T i B limfocite na površini stanice.
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.
Croatian: • PRAC je nadalje smatrao važnim i da se mjere svođenja rizika na najmanju moguću mjeru koje se preporučuju u procjeni u okviru trenutačnog PSUSA postupka provode zajedno s privremenim mjerama.
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No 726/2004.
Croatian: Tim privremenim mjerama ne dovodi se u pitanje ishod pregleda na temelju postupka iz članka 20.
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.
Croatian: PRAC je nadalje smatrao važnim i da se mjere svođenja rizika na najmanju moguću mjeru koje se preporučuju u procjeni u okviru trenutačnog PSUSA postupka provode zajedno s privremenim mjerama.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ova preporuka ne dovodi u pitanje konačne zaključke postupka koji je u tijeku temeljem članaka 20.
English: New warnings on autoimmune hepatitis, hepatic injury and haemophagocytic lymphohistiocytosis are also added.
Croatian: Dodana su i nova upozorenja koja se odnose na autoimuni hepatitis, oštećenje jetre i hemofagocitnu limfohistiocitozu.
English: Common to these cardiovascular reactions was a close temporal relationship to an alemtuzumab infusion, which is suggestive of a causal association.
Croatian: Uska vremenska povezanost s infuzijom alemtuzumaba zajednička je tim kardiovaskularnim reakcijama, što upućuje na uzročnu povezanost.
English: The PRAC recommended as part of the PSUSA procedure the addition of warnings related to serious reactions temporally associated with alemtuzumab infusion including pulmonary alveolar haemorrhage, myocardial infarction, stroke (including ischaemic and haemorrhagic stroke), cervicocephalic (e.g. vertebral, carotid) arterial dissection.
Croatian: PRAC je u okviru PSUSA postupka preporučio dodavanje upozorenja u vezi s ozbiljnim reakcijama koje su vremenski povezane s infuzijom alemtuzumaba, uključujući plućno alveolarno krvarenje, infarkt miokarda, moždani udar (uključujući ishemijski i hemoragijski moždani udar), disekciju kraniocervikalnih arterija (npr. vertebralnu ili karotidnu arterijsku disekciju).
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.
Croatian: Utvrđeno je nekoliko slučajeva s različitim kardiovaskularnim reakcijama, uključujući plućno alveolarno krvarenje, infarkt miokarda, ishemijski i hemoragijski moždani udar te arterijsku disekciju.
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.
Croatian: Nadalje, dodaju se nove nuspojave: plućno alveolarno krvarenje, hemofagocitna limfohistiocitoza, infarkt miokarda, moždani udar (uključujući ishemijski i hemoragijski moždani udar), disekcija kraniocervikalnih arterija i neutropenija.
English: EMA/513708/2016
Croatian: EMA/513708/2016 EMEA/H/C/004267
English: The recommended dose is one inhalation twice a day.
Croatian: Preporučena doza je jedna inhalacija dvaput na dan.
English: Patients should be regularly assessed by a doctor to ensure that they receive the lowest dose sufficient to control symptoms.
Croatian: Liječnik treba redovito pregledavati bolesnike kako bi osigurao da primaju najnižu dozu dovoljnu za kontrolu simptoma.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek kako bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: The full EPAR for Airexar Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Airexar Spiromax nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako proizvode iste razine djelatne tvari u tijelu.
English: Each inhalation provides a fixed dose of the medicine.
Croatian: Svaka inhalacija osigurava utvrđenu dozu lijeka.
English: For further information, see the package
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Croatian: Djeluje na sličan način kao hormoni kortikosteroida koji se prirodno pojavljuju u tijelu, smanjujući aktivnost imunosnog sustava tako što se vezuje na receptore u različitim tipovima imunosnih stanica.
English: It works by attaching to receptors known as beta-2 receptors in the muscles of the airways.
Croatian: Djeluje vezujući se na receptore poznate pod nazivom receptori beta-2 koji se nalaze u mišićima dišnih putova.
English: Salmeterol is a long-acting beta-2 agonist.
Croatian: Salmeterol je dugodjelujući beta-2 agonist.
English: This means that Airexar Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Croatian: To znači da je Airexar Spiromax sličan „referentnom lijeku” Seretide Diskus (poznatom i kao Seretide Accuhaler) koji sadrži iste djelatne tvari.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: Ovo rezultira smanjenim otpuštanjem tvari koje su uključene u upalni proces, poput histamina, te stoga pomaže u očuvanju dišnih putova čistima i omogućuje bolesniku da lakše diše.
English: It contains the active substances salmeterol (a so-called long-acting beta-2 agonist) and fluticasone
Croatian: Sadrži djelatne tvari salmeterol (tzv. dugodjelujući beta-2 agonist) i flutikazonpropionat
English: Since Airexar Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Croatian: Budući da je Airexar Spiromax dostupan samo u jednoj jačoj dozi (koja sadrži 50 mikrograma salmeterola i 500 mikrograma flutikazonpropionata), ako manja doza bude dovoljna, bolesnike treba prebaciti na drugi kombinirani lijek koji sadrži salmeterol i manju dozu flutikazonpropionata.
English: When it attaches to these receptors in the airways, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Prilikom spajanja na ove receptore, uzrokuje opuštanje mišića, što održava dišne putove otvorenima i pomaže bolesniku pri disanju.
English: Fluticasone propionate belongs to a group of anti-inflammatory medicines known as corticosteroids.
Croatian: Flutikazonpropionat se ubraja u grupu protuupalnih lijekova poznatih pod nazivom kortikosteroidi.
English: The two active substances in Airexar Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari lijeka Airexar Spiromax dobro su poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme i KOPB-a, samostalno ili u kombinaciji s drugim lijekovima.
English: Airexar Spiromax is a ‘hybrid medicine'.
Croatian: Airexar Spiromax je „hibridni lijek”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Airexar Spiromax have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Airexar Spiromax nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Because Airexar Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Airexar Spiromax hibridni lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: In asthma, Airexar Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Croatian: Airexar Spiromax može se koristiti za liječenje bolesnika u kojih astma nije odgovarajuće kontrolirana primjenom kombiniranog lijeka koji sadrži beta-2 agonist i inhalacijski kortikosteroid manje jačine, ili bolesnika u kojih je astma već kontrolirana primjenom dugodjelujućeg beta-2 agonista i visoke doze
English: This is a summary of the European public assessment report (EPAR) for Airexar Spiromax.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Airexar Spiromax.
English: Airexar Spiromax is available as an inhalation powder in a portable inhaler device.
Croatian: Airexar Spiromax dostupan je kao prašak za inhalaciju u prijenosnom inhalatoru.
English: However, Airexar Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Croatian: Međutim, Airexar Spiromax dostupan je samo u jednoj jačoj dozi, dok je referentni lijek dostupan u tri doze, odnosno u dozi iste jačine i dvjema slabijim dozama.
English: What measures are being taken to ensure the safe and effective use of Airexar Spiromax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Airexar Spiromax?
English: The Committee recommended that Airexar Spiromax be approved for use in the EU.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Airexar Spiromax u promet u EU-u.
English: Airexar Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Croatian: Airexar Spiromax je lijek koji se koristi za redovito liječenje odraslih osoba s teškom astmom i za simptomatsko liječenje bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB, dugotrajna bolest kod koje su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni što dovodi do teškoća u disanju).
English: What is Airexar Spiromax and what is it used for?
Croatian: Što je Airexar Spiromax i za što se koristi?
English: It is not intended to provide practical advice on how to use Airexar Spiromax.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Airexar Spiromax.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je lijek Airexar Spiromax dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Seretide Diskus.
English: Other information about Airexar Spiromax
Croatian: Ostale informacije o lijeku Airexar Spiromax
English: What are the benefits and risks of Airexar Spiromax?
Croatian: Koje su koristi i rizici lijeka Airexar Spiromax?
English: Studies in people have been limited to tests to determine that Airexar Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Croatian: Ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li Airexar Spiromax bioekvivalentan referentnom lijeku Seretide Diskus.
English: For more information about treatment with Airexar Spiromax, read the package leaflet (also part of the EPAR) or contact your
Croatian: Više informacija o liječenju lijekom Airexar Spiromax pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: In COPD, Airexar Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Croatian: Airexar Spiromax koristi se za liječenje odraslih osoba s KOPB-om s ponavljajućim egzacerbacijama u anamnezi (bolest se pogoršala) koji imaju značajne simptome unatoč redovitom liječenju.
English: Therefore, the CHMP's view was that, as for Seretide Diskus, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Seretide Diskus.
English: As Airexar Spiromax is only available in one high strength, its use in asthma has been restricted to
Croatian: Budući da je Airexar Spiromax dostupan samo u jednoj jačoj dozi, njegova primjena u liječenju astme ograničena je na bolesnike s teškom astmom.
English: Airexar Spiromax can only be obtained with a prescription.
Croatian: Airexar Spiromax se izdaje samo na liječnički recept.
English: How is Airexar Spiromax used?
Croatian: Kako se Airexar Spiromax koristi?
English: For practical information about using Airexar Spiromax, patients should read the package leaflet or
Croatian: Praktične informacije o primjeni lijeka Airexar Spiromax bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: How has Airexar Spiromax been studied?
Croatian: Kako je Airexar Spiromax ispitivan?
English: Page 2/2
Croatian: Stranica 2/2
English: Moreover, the intended use does not require medical supervision.
Croatian: Nadalje, predviđena primjena ne zahtijeva medicinski nadzor.
English: Herbal medicine: summary for the public
Croatian: Biljni lijek: sažetak za javnost
English: These combinations are not covered in this summary.
Croatian: Te kombinacije nisu obuhvaćene ovim sažetkom.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da iako ne postoji dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način već najmanje 30 godina (uključujući najmanje 15 godina u EU-u).