FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Croatian: PRAC je zaključio da se zatraži savjet od znanstvene savjetodavne grupe (SAG-a) vezano uz čimbenike rizika i praćenje (primjerice MRI, JCV status, omjer CD4+/CD8+) bolesnika liječenih fingolimodom kako bi se savjetovalo vezano uz mogućnosti za poboljšanje prognoze bolesnika s ranom dijagnozom i kako bi se identificiralo bolesnike izložene riziku od razvoja PML-a.
English: Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Croatian: Nadalje, nositelj odobrenja treba pratiti događaje nadraženosti oka i dostaviti ažurirane podatke u sljedećem PSUR-u.
English: Natalizumab - Anaemia (EPITT no 18137)
Croatian: Natalizumab - anemija (EPITT br. 18137)
English: Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Croatian: Fingolimod - progresivna multifokalna leukoencefalopatija (PML) (EPITT br. 18241)
English: Leflunomide - Colitis (EPITT no 18189)
Croatian: Leflunomid - Kolitis (EPITT br. 18189)
English: Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Croatian: Nakon razmatranja dostupnih dokaza, uključujući i podatke dostavljene od nositelja odobrenja za stavljanje lijeka u promet, i uzimajući u obzir da je progresivna multifokalna leukoencefalopatija (PML) kompleksna bolest kojoj može trebati dulje vrijeme prije nego što postane klinički simptomatična, PRAC je zaključio da je ažuriranje informacija o lijeku opravdano.
English: Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Croatian: Nakon razmatranja dostupnih dokaza iz spontanih prijava, EudraVigilance baze i literature, PRAC smatra da je potrebno upozoriti bolesnike koji primaju Xalatan o važnosti traženja liječničkog savjeta ako osjete prekomjernu nadraženost oka.
English: Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Croatian: Učestalost "često": Kolitis, uključujući mikroskopski kolitis poput limfocitnog kolitisa, kolagenog kolitisa.
English: Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Croatian: Učestalost „nepoznata": Progresivna multifokalna leukoencefalopatija (PML) Uputa o lijeku:
English: Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Croatian: Stoga, nositelj odobrenja za fingolimod treba podnijeti izmjenu u roku od 2 mjeseca kako bi izmijenio informacije o lijeku kako je niže opisano (novi tekst je podcrtan) te uključio PML u RMP kao važan identificirani rizik (pod rizikom od infekcija).
English: Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Croatian: Nakon razmatranja podataka dostavljenih od strane nositelja odobrenja kao i dokaza iz slučajeva u EudraVigilance bazi i literature, nositelj odobrenja za lijek Tysabri treba podnijeti izmjenu u roku od 60 dana kako bi se dodale "anemija" i "hemolitička anemija" u dio 4.8 SPC-a te se sukladno tome ažurirala uputa o lijeku.
English: Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Croatian: Nakon razmatranja dostupnih dokaza iz kliničkih ispitivanja (kolitis je prijavljen u 1% do <3% u skupini koja je primala terapiju), iz spontanih prijava koje su uključivale prijavljene slučajeve povlačenja nuspojave nakon prekida davanja lijeka (pozitivan de-challenge) i ponovne pojave nuspojave kod ponovnog davanja lijeka (pozitivan re-challenge) kao i iz izvještaja iz literature koji to podupiru, PRAC je zaključio da nositelj(i) odobrenja lijekova koji sadrže leflunomid treba(ju) podnijeti izmjenu u roku od 2 mjeseca kako bi izmijenili informacije o lijeku kako je niže opisano (novi tekst je podcrtan).
English: Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Croatian: Stoga, nositelj odobrenja za lijek Xalatan (latanoprost) treba podnijeti izmjenu u roku od 2 mjeseca vezanu uz ažuriranje upute o lijeku kako je niže opisano (novi tekst je podcrtan).
English: Package Leaflet:
Croatian: Uputa o lijeku:
English: Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Croatian: Ukupno gledano, 75 % bolesnika koji su primali lijek Symtuza (77 od 103 bolesnika) postiglo je to smanjenje nakon 24 tjedna liječenja, slično kao i 74 % (37 od 50) bolesnika koji su to postigli s usporednim lijekom.
English: Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Croatian: Više informacija o lijeku Symtuza dostupno je na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/symtuza.
English: What is Symtuza and what is it used for?
Croatian: Što je Symtuza i za što se koristi?
English: This overview was last updated in 07-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 7. 2019.
English: Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Croatian: Lijek Symtuza dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 21. rujna 2017.
English: Other information about Symtuza
Croatian: Ostale informacije o lijeku Symtuza
English: What measures are being taken to ensure the safe and effective use of Symtuza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Symtuza?
English: It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects.
Croatian: Također se ne smije uzimati s određenim lijekovima koji mogu smanjiti djelotvornost lijeka Symtuza, kao ni s lijekovima koji mogu povećati rizik od ozbiljnih nuspojava.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml.
Croatian: Djelotvornost se ocjenjivala na temelju smanjenja virusnog opterećenja (količina virusa HIV-1 u krvi) na manje od 50 kopija/ml.
English: Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Symtuza ne liječi infekciju virusom HIV-1 ni AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: Symtuza contains four active substances which work in different ways against HIV:
Croatian: Symtuza sadržava četiri djelatne tvari koje djeluju protiv HIV-a na različite načine:
English: Symtuza must not be taken by patients with severely reduced liver function.
Croatian: Lijek Symtuza ne smiju uzimati bolesnici sa znatno smanjenom jetrenom funkcijom.
English: The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash.
Croatian: Najčešće nuspojave lijeka Symtuza (koje se mogu javiti u više od 1 na 10 osoba) su proljev, glavobolja i osip.
English: Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Symtuza pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Symtuza?
Croatian: Koji su rizici povezani s lijekom Symtuza?
English: The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Symtuza nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
Croatian: Blokirajući proteazu Symtuza smanjuje količinu virusa HIV-1 u krvi te je održava na niskoj razini.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symtuza 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 Symtuza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Symtuza authorised in the EU?
Croatian: Zašto je lijek Symtuza odobren u EU-u?
English: • Darunavir is a type of antiviral agent called a ‘protease inhibitor'.
Croatian: • Darunavir je vrsta antivirusnog lijeka naziva „inhibitor proteaze”.
English: An overview of Symtuza and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Symtuza i zašto je odobren u EU-u
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: -1 je virus koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood as the active substances given separately.
Croatian: Budući da je djelotvornost pojedinačnih djelatnih tvari lijeka Symtuza prethodno utvrđena te da je odobrena njihova primjena u liječenju infekcije HIV-om, ispitivanja su uglavnom provedena kako bi se dokazalo da lijek Symtuza proizvodi razine djelatnih tvari u krvi koje su slične zasebnoj primjeni djelatnih tvari.
English: Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Croatian: Lijek je dostupan u obliku tableta koje sadržavaju 800 mg darunavira, 150 mg kobicistata, 200 mg emtricitabina i 10 mg tenofoviralafenamida.
English: Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)
Croatian: Symtuza (darunavir/kobicistat/emtricitabin/tenofoviralafenamid
English: As for all medicines, data on the use of Symtuza are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Symtuza kontinuirano se prate.
English: For more information about using Symtuza, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Symtuza pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: For more information on the medicines that should not be taken with Symtuza, see the package leaflet.
Croatian: Više informacija o lijekovima koji se ne smiju uzimati s lijekom Symtuza potražite u uputi o lijeku.
English: Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Croatian: Lijek se izdaje samo na recept, a liječenje treba započeti liječnik s iskustvom u liječenju infekcije HIVom.
English: It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected.
Croatian: On blokira proteazu, enzim virusa koji omogućuje virusu da se množi u stanicama koje je zarazio.
English: Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.
Croatian: Budući da je tenofoviralafenamid djelotvoran pri manjoj dozi od tenofovirdizoproksila, lijek Symtuza nudi mogućnost blažih nuspojava.
English: • Cobicistat acts as a ‘booster' to increase the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging its antiviral activity in the body.
Croatian: • Kobicistat djeluje kao „pojačivač” učinka darunavira tako što usporava razgradnju darunavira te stoga produljuje njegovo antivirusno djelovanje u tijelu.
English: • Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.
Croatian: • Emtricitabin je također inhibitor reverzne transkriptaze i djeluje na isti način kao i tenofovir.
English: What benefits of Symtuza have been shown in studies?
Croatian: Koje su koristi od lijeka Symtuza utvrđene u ispitivanjima?
English: Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide.
Croatian: Lijek Symtuza bio je jednako djelotvoran kao i lijek sa sličnom kombinacijom djelatnih tvari koji umjesto tenofoviralafenamida sadržava tenofovirdizoproksil.
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: • Tenofoviralafenamid je „prolijek” tenofovira, što znači da se u tijelu pretvara u djelatnu tvar tenofovir.
English: The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment.
Croatian: Dokazana je djelotvornost djelatnih tvari lijeka Symtuza u pojedinačnoj primjeni, a njihova kombinacija u jednoj tableti pojednostavljuje liječenje.
English: Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg).
Croatian: Symtuza je antivirusni lijek koji se koristi za liječenje odraslih osoba i adolescenata starijih od 12 godina (čija je tjelesna težina najmanje 40 kilograma) zaraženih virusom humane imunodeficijencije tipa 1 (HIV
English: Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of the enzyme, reverse transcriptase, that the virus needs to reproduce itself.
Croatian: Tenofovir je inhibitor reverzne transkriptaze, što znači da blokira djelovanje enzima,
English: How does Symtuza work?
Croatian: Kako djeluje Symtuza?
English: In addition, one main study compared Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated.
Croatian: Osim toga, provedeno je jedno glavno ispitivanje na 153 odraslih bolesnika zaraženih HIV-om koji nisu prethodno liječeni u kojem je lijek Symtuza uspoređen s drugim antivirusnim lijekom koji sadržava darunavir, kobicistat, emtricitabin i tenefovirdizoproksil.
English: Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.
Croatian: Symtuza sadržava djelatne tvari darunavir, kobicistat, emtricitabin i tenofoviralafenamid.
English: How is Symtuza used?
Croatian: Kako se Symtuza primjenjuje?
English: For the full list of side effects reported with Symtuza, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Symtuza potražite u uputi o lijeku.
English: This overview was last updated in 08-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 08.2018.
English: However, given the extreme rarity of the condition, the safety database is small and rare events are not expected to be captured during the clinical studies.
Croatian: Međutim, zbog ekstremne rijetkosti ovog stanja sigurnosna je baza podataka mala te se ne očekuje da će se rijetki događaji obuhvatiti tijekom kliničkih ispitivanja.
English: Hypersensitivity (allergic) reactions can occur rarely in patients treated for bleeding disorders (in up to 1 patient in 1,000) and can be severe in some cases.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) rijetko su uočene u bolesnika liječenih od poremećaja krvarenja (u do 1 na 1000 bolesnika), a mogu biti ozbiljne u nekim slučajevima.
English: Further information on Coagadex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Coagadex možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Coagadex (human coagulation factor X)
Croatian: Coagadex (ljudski koagulacijski faktor X)
English: In a study with 9 children aged less than 12 years (4 of whom were under4 years of age), a routine preventive treatment with Coagadex over 6 months was rated as excellent in reducing or preventing bleeding episodes.
Croatian: U ispitivanju koje je obuhvaćalo devetoro djece mlađe od 12 godina (od kojih je njih četvero bilo mlađe od četiri godine), rutinsko preventivno liječenje lijekom Coagadex tijekom šest mjeseci ocijenjeno je kao izvrsno u smanjenju ili sprječavanju epizoda krvarenja.
English: The main measure of effectiveness was based on the doctor's and patient's assessment of how well the treatment worked in preventing and treating bleeding episodes.
Croatian: Glavno mjerilo učinkovitosti temeljilo se na procjeni liječnika i bolesnika o tome koliko je liječenje bilo uspješno u sprječavanju i liječenju epizoda krvarenja.
English: Coagadex is given by injection into a vein.
Croatian: Coagadex se daje injekcijom u venu.
English: What measures are being taken to ensure the safe and effective use of Coagadex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Coagadex?
English: For more information about using Coagadex, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Coagadex pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: These reactions have not been reported during clinical studies with Coagadex.
Croatian: Te reakcije nisu zabilježene tijekom kliničkih ispitivanja lijeka Coagadex.
English: Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency.
Croatian: Coagadex je lijek koji se upotrebljava za liječenje i sprječavanje krvarenja (uključujući tijekom i nakon operativnog zahvata) u bolesnika s nasljednim nedostatkom faktora X.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Coagadex 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 Coagadex nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Coagadex has been investigated in one main study involving 16 patients with hereditary factor X deficiency aged 12 to 58 years.
Croatian: Coagadex je ispitivan u okviru jednoga glavnog ispitivanja koje je uključivalo 16 bolesnika u dobi od 12 do 58 godina s nedostatkom faktora X.
English: Coagadex received a marketing authorisation valid throughout the EU on 16 March 2016.
Croatian: Lijek Coagadex dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 16. ožujka 2016.
English: The Agency considered the lack of specific therapies for factor X deficiency, and concluded that Coagadex was effective at treating and preventing bleeding in patients with the condition.
Croatian: Agencija je uzela u obzir manjak posebnih terapija za nedostatak faktora X i zaključila je da je lijek Coagadex učinkovit u liječenju i sprječavanju krvarenja u bolesnika s tim stanjem.
English: The active substance in Coagadex is human factor X isolated from the plasma of blood donors.
Croatian: Djelatna tvar u lijeku Coagadex jest ljudski faktor X izoliran iz plazme darivatelja krvi.
English: In total, 10 bleeds were reported in the study, of which 4 were treated with Coagadex.
Croatian: U ispitivanju je ukupno prijavljeno 10 epizoda krvarenja, od kojih su njih četiri liječene lijekom Coagadex.
English: As for all medicines, data on the use of Coagadex are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Coagadex kontinuirano se prate.
English: Other information about Coagadex
Croatian: Ostale informacije o lijeku Coagadex
English: Side effects reported with Coagadex are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Coagadex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Coagadex and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Coagadex i zašto je odobren u EU-u
English: The European Medicines Agency decided that the benefits of Coagadex are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Coagadex nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The most common side effects with Coagadex (which may affect up to 1 in 10 people) are pain or redness at the injection site, fatigue (tiredness), and back pain.
Croatian: Najčešće su nuspojave lijeka Coagadex (mogu se javiti u do 1 na 10 osoba) bol ili crvenilo na mjestu injekcije, umor i bol u leđima.
English: Coagadex can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Croatian: Coagadex se izdaje samo na liječnički recept, a liječenje mora započeti pod nadzorom liječnika iskusnog u liječenju rijetkih poremećaja krvarenja.
English: What is Coagadex and what is it used for?
Croatian: Što je Coagadex i za što se koristi?
English: The dose and frequency of the injections depend on the severity of the patient's factor X deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Croatian: Doza i učestalost ubrizgavanja injekcijom ovise o težini nedostatka faktora X u bolesnika, opsegu i mjestu krvarenja te stanju i tjelesnoj težini bolesnika.
English: For the treatment of bleeding, 187 bleeding episodes were recorded and assessed, and treatment with Coagadex was rated as ‘excellent' or ‘good' for 98.4% of bleeding episodes.
Croatian: U liječenju krvarenja zabilježeno je i procijenjeno 187 epizoda krvarenja, a u 98,4 % epizoda krvarenja liječenje lijekom Coagadex ocijenjeno je kao „izvrsno” ili „dobro”.
English: Why is Coagadex authorised in the EU?
Croatian: Zašto je lijek Coagadex odobren u EU-u?
English: Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 September 2007.
Croatian: Nedostatak faktora X je rijetka bolest, a lijek Coagadex dobio je status „lijeka za liječenje rijetkih bolesti” 14. rujna 2007.
English: A single infusion of Coagadex was sufficient to control each treated bleeding event.
Croatian: Jedna infuzija lijeka Coagadex bila je dovoljna za kontrolu svake liječene epizode krvarenja.
English: What are the risks associated with Coagadex?
Croatian: Koji su rizici povezani s lijekom Coagadex?