FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Mylan.
Croatian: Ispitivanja omjera koristi i rizika djelatnih tvari u odobrenim primjenama već su provedena s referentnim lijekom Adenuric i ne treba ih ponavljati za lijek Febuxostat Mylan.
English: What measures are being taken to ensure the safe and effective use of Febuxostat Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Febuxostat Mylan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Mylan 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 Febuxostat Mylan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What is Febuxostat Mylan and what is it used for?
Croatian: Što je Febuxostat Mylan i za što se koristi?
English: Febuxostat Mylan febuxostat
Croatian: Febuxostat Mylan febuksostat
English: For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Mylan is 80 mg once a day.
Croatian: Za liječenje dugotrajne hiperuricemije preporučena doza lijeka Febuxostat Mylan iznosi 80 mg jedanput na dan.
English: Keeping uric acid levels low for long enough can also shrink tophi.
Croatian: Zadržavanjem mokraćne kiseline na nižoj razini tijekom dužeg vremena može doći do i smanjenja tofija.
English: Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.
Croatian: Liječenje lijekom Febuxostat Mylan nije potrebno prekinuti u slučaju napada gihta.
English: By reducing the production of uric acid, Febuxostat Mylan can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Croatian: Smanjivanjem proizvodnje mokraćne kiseline Febuxostat Mylan može sniziti razine mokraćne kiseline u krvi i održavati ih na niskoj razini, zaustavljajući nakupljanje kristala.
English: The Committee recommended that Febuxostat Mylan be approved for use in the EU.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Febuxostat Mylan u promet u EU-u.
English: Febuxostat Mylan is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Croatian: Febuxostat Mylan primjenjuje se u bolesnika sa znakovima stvaranja kristala, uključujući urični artritis (bol i upala u zglobovima) ili tofa („kamenci”, veće nakupine kristala urata koje mogu uzrokovati oštećenje zglobova i kosti).
English: What are the benefits and risks of Febuxostat Mylan?
Croatian: Koje su koristi i rizici lijeka Febuxostat Mylan?
English: For more information about treatment with Febuxostat Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Febuxostat Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Croatian: Djeluje tako da inhibira enzim ksantin oksidazu, koji je potreban za stvaranje mokraćne kiseline.
English: It is not intended to provide practical advice on how to use Febuxostat Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Febuxostat Mylan.
English: Febuxostat Mylan is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Croatian: Mylan lijek je koji se primjenjuje u liječenju odraslih osoba s dugotrajnom hiperuricemijom (visoke razine mokraćne kiseline ili „urata” u krvi).
English: Febuxostat Mylan is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Croatian: Mylan isto se tako primjenjuje za liječenje i sprečavanje visokih razina mokraćne kiseline u krvi u odraslih osoba s rakom krvi koje primaju kemoterapiju (lijekovi za liječenje raka) te kod kojih postoji rizik od sindroma tumorske lize (komplikacija uslijed raspada stanica raka koja uzrokuje nagli porast mokraćne kiseline u krvi, a što može uzrokovati oštećenje bubrega).
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Croatian: Hiperuricemija može uzrokovati stvaranje i nakupljanje kristala urata u zglobovima i bubrezima.
English: Other information about Febuxostat Mylan
Croatian: Ostale informacije o lijeku Febuxostat Mylan
English: For practical information about using Febuxostat Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Febuxostat Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Adenuric, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Adenuric.
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Croatian: Očekuje se da će se smanjivanjem razina mokraćne kiseline u krvi u bolesnika koji primaju kemoterapiju smanjiti rizik od pojave sindroma tumorske lize.
English: The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid.
Croatian: Djelatna tvar lijeka Febuxostat Mylan, febuksostat, smanjuje stvaranje mokraćne kiseline.
English: Why is Febuxostat Mylan approved?
Croatian: Zašto je lijek Febuxostat Mylan odobren?
English: How is Febuxostat Mylan used?
Croatian: Kako se Febuxostat Mylan koristi?
English: How does Febuxostat Mylan work?
Croatian: Kako djeluje Febuxostat Mylan?
English: Febuxostat Mylan contains the active substance febuxostat and is a ‘generic medicine'.
Croatian: Mylan sadržava djelatnu tvar febuksostat te je „generički lijek”.
English: How has Febuxostat Mylan been studied?
Croatian: Kako je lijek Febuxostat Mylan ispitivan?
English: MA (EU) number (Invented) name
Croatian: Broj EU odobrenja (Novoizumljen o) ime
English: The procedure should be carried out under sterile conditions.
Croatian: Postupak se mora provoditi u sterilnim uvjetima.
English: Jetrea ocriplasmin
Croatian: Jetrea okriplazmin
English: The full EPAR for Jetrea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Jetrea nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The other eye should not be treated with Jetrea for at least 7 days.
Croatian: Drugo se oko ne smije tretirati lijekom Jetrea najmanje 7 dana.
English: What is Jetrea and what is it used for?
Croatian: Što je Jetrea i za što se koristi?
English: After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81).
Croatian: Nakon 28 dana, rezultati su pokazali da je adhezija nestala u 25 % i 28 % bolesnika koji su primili injekciju lijeka Jetrea (61 od 219 i 62 od 245), u usporedbi s 13 % i 6 % bolesnika koji su primili placebo (14 od 107 i 5 od 81).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Jetrea na snazi u Europskoj uniji od 13. ožujka 2013.
English: What measures are being taken to ensure the safe and effective use of Jetrea?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jetrea?
English: This is a summary of the European public assessment report (EPAR) for Jetrea.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Jetrea.
English: Other information about Jetrea
Croatian: Ostale informacije o lijeku Jetrea
English: The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated.
Croatian: Preporučena doza iznosi 0,125 mg, a primjenjuje se u jednoj injekciji u zahvaćeno oko i ne smije se ponoviti.
English: What are the risks associated with Jetrea?
Croatian: Koji su rizici povezani s lijekom Jetrea?
English: Why is Jetrea approved?
Croatian: Zašto je lijek Jetrea odobren?
English: It contains the active substance ocriplasmin.
Croatian: Sadrži djelatnu tvar okriplazmin.
English: It is not intended to provide practical advice on how to use Jetrea.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Jetrea.
English: Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery.
Croatian: Iako je dokazano djelovanje bilo skromno (rješavanje poremećaja vitreomakularne adhezije u četvrtine bolesnika), zaključeno je da je djelovanje značajno, budući da terapija može poboljšati vid i spriječiti potrebu za kirurškim zahvatom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Jetrea nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).
Croatian: U dva glavna ispitivanja koja su obuhvatila 652 odrasle osobe s vitreomakularnom adhezijom i smanjenim vidom, bolesnici su primili jednu intravitrealnu injekciju od 0,125 mg lijeka Jetrea ili injekciju placeba (prividnog liječenja).
English: The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.
Croatian: Rizik od ozbiljnijih nuspojava poput nepovratnog smanjenja vida ili drugih promjena u funkciji mrežnice ili potpornih struktura leće čini se malim.
English: Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.
Croatian: Jetrea se ne smije koristiti u bolesnika koji imaju ili za koje se sumnja da imaju infekcije oka ili oko oka.
English: Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself.
Croatian: U pogledu sigurnosti lijeka, najčešće nuspojave bile su kratkoga vijeka i moglo ih se kontrolirati, te su često nastupile kao odgovor na postupak ubrizgavanja injekcije ili su bile povezane sa samim povlačenjem bolesti.
English: The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.
Croatian: Oftalmolog može propisati antibiotske kapi za oči prije i nakon terapije lijekom Jetrea za sprječavanje očne infekcije.
English: Jetrea is a solution for injection into the eye.
Croatian: Jetrea je otopina za injekciju koja se daje u oko.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jetrea have also 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 Jetrea također se nalaze sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye).
Croatian: Najčešće nuspojave su opaciteti u staklovini (male, često nepravilne, tamne mrlje u vidnom polju), bol u oku i fotopsija (bljeskovi svjetla u vidnom polju), kao i konjunktivno krvarenje (krvarenje membrane koja prekriva bijeli dio oka).
English: Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.
Croatian: Jetrea je lijek koji se koristi za liječenje odraslih osoba oboljelih od vitreomakularne trakcije, očne bolesti koja uzrokuje ozbiljne poremećaje vida.
English: The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.
Croatian: Tvrtka koja stavlja lijek Jetrea u promet treba osigurati da svi zdravstveni radnici od kojih se očekuje primjena lijeka Jetrea prime sažetak opisa svojstava lijeka, dok je bolesnicima potrebno dostaviti informacijski paket o lijeku.
English: For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Jetrea pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Jetrea have been shown in studies?
Croatian: Koje su koristi lijeka Jetrea utvrđene u ispitivanjima?
English: How is Jetrea used?
Croatian: Kako se Jetrea koristi?
English: Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction.
Croatian: Ispitivanja su pokazala da je lijek Jetrea učinkovit u liječenju vitreomakularne adhezije te da se stoga očekuje da će biti djelotvoran i u sprječavanju pogoršanja vida koje može nastupiti s neliječenom i progresivnom vitreomakularnom trakcijom.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye).
Croatian: Izdaje se samo na liječnički recept te ga smije davati kvalificirani oftalmolog (specijalist za oči) s iskustvom u davanju intravitrealnih injekcija (injekcija u staklasto tijelo, želatinasti materijal u stražnjem dijelu oka).
English: Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.
Croatian: Uspješno liječenje vitreomakularne adhezije može pomoći pri otklanjanju poremećaja vida uzrokovanog vitreomakularnom trakcijom, te spriječiti gubitak vida uslijed neliječene i progresivne trakcije mrežnice.
English: Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye).
Croatian: Vitreomakularnu trakciju uzrokuje vitreomakularna adhezija pri čemu se staklasto tijelo abnormalno snažno veže za središnji dio mrežnice (membrana osjetljiva na svjetlo u pozadini oka).
English: For practical information about using Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Jetrea pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.
Croatian: Djelatna tvar lijeka Jetrea, okriplazmin, sličan je ljudskom plazminu, enzimu koji se prirodno pojavljuje u oku, koji može razgrađivati bjelančevine između staklastog tijela i mrežnice koje uzrokuju adheziju, te stoga smanjuje oticanje mrežnice i poboljšava vid.
English: The side effects seen with Jetrea affect the eye.
Croatian: Nuspojave uočene s lijekom Jetrea zahvaćaju oko.
English: Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.
Croatian: U ispitivanjima je dokazano da je lijek Jetrea djelotvoran u uklanjanju adhezije između staklastog tijela i mrežnice, smanjujući potrebu za kirurškim zahvatom.
English: When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.
Croatian: Ako se staklasto tijelo smanjuje s godinama s godinama, ovo snažno prianjanje vuče mrežnicu, što za posljedicu ima oticanje mrežnice i dovodi do zamućenog ili iskrivljenog vida.
English: How does Jetrea work?
Croatian: Kako djeluje Jetrea?
English: For the full list of all side effects reported with Jetrea, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Jetrea potražite u uputi o lijeku.
English: Member State (in EEA)
Croatian: Država članica (u EGP-u)
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Croatian: Prilog I Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
English: 4 mg/40 mg tablet
Croatian: 4 mg/40 mg tableta
English: (Invented) Name Strength
Croatian: (Zaštićeno) ime Jačina
English: 0.10 g/1 g per 100 ml oral solution
Croatian: 0.10 g/1 g per 100 ml oralna otopina
English: Marketing Authorisaton Holder
Croatian: Nositelj odobrenja
English: Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja
English: Immediate packaging
Croatian: Put primjene Pakovanje Veličina pakovan ja
English: The company withdrew before the European Commission had issued a decision on this opinion.
Croatian: Tvrtka se povukla prije nego je Europska komisija izdala odluku o ovom mišljenju.
English: The evaluation had finished and the CHMP had given a positive opinion.
Croatian: Ocjenjivanje je završeno i CHMP je dao pozitivno mišljenje.
English: What is Egranli?
Croatian: Što je Egranli?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application on the basis of its marketing strategy, and that it wished to focus on other projects.
Croatian: U dopisu tvrtke kojim se obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da povlači zahtjev na temelju marketinške strategije, te da se želi usredotočiti na druge projekte.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje su posljedice ovog povlačenja za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: The main measure of effectiveness was the reduction in the duration of neutropenia and of the number of febrile neutropenia cases.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje u trajanju neutropenije i broja slučajeva febrilne neutropenije.
English: It was to be available as a solution for injection in prefilled syringes.
Croatian: Dostupan je kao otopina za injekciju u napunjenim štrcaljkama.
English: The company informed the CHMP that there is no impact on patients as there are no ongoing clinical trials or compassionate use programmes using Egranli.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike budući da nema kliničkih ispitivanja u tijeku ili programa milosrdnog davanja lijekova u kojima se koristi lijek Egranli.
English: Egranli is a medicine that contains the active substance balugrastim.
Croatian: Egranli je lijek koji sadrži djelatnu tvar balugrastim.
English: What was Egranli expected to be used for?
Croatian: Za što se Egranli trebao koristiti?
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Egranli (balugrastim)
English: On 4 November 2014, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.
Croatian: Dana 4. studenog 2014., Teva Pharma B.V. službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet lijeka Egranli, za skraćivanje trajanja neutropenije i izbijanje febrilne neutropenije u odraslih osoba oboljelih od raka.
English: 21 November 2014 EMA/705109/2014 EMEA/H/C/002637
Croatian: EMEA/H/C/002637
English: How is Egranli expected to work?
Croatian: Kako je Egranli trebao djelovati?
English: Based on the review of the data, at the time of the withdrawal the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Egranli for the reduction of the duration of neutropenia and of the occurrence of febrile neutropenia.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je dao pozitivno mišljenje, preporučujući izdavanje odobrenja za stavljanje u promet lijeka Egranli za skraćivanje trajanja neutropenije i izbijanje febrilne neutropenije.
English: Egranli was to be used to reduce the duration of neutropenia (abnormally low level of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy (medicines that treat cancer by killing cells).
Croatian: Egranli se trebao koristiti za skraćivanje trajanja neutropenije (abnormalno niskih razina neutrofila, tipa bijelih krvnih stanica koje služe borbi protiv infekcija) i izbijanje febrilne neutropenije (neutropenija s groznicom) u odraslih bolesnika oboljelih od raka koji primaju citotoksičnu kemoterapiju (lijekovi koji se koriste za liječenje raka tako što ubijaju stanice).
English: Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.
Croatian: Balugrastim djeluje na isti način kao i prirodno proizveden G-CSF, povećavajući stvaranje neutrofila te stoga pomažući pri smanjivanju trajanja neutropenije i sprječavanju febrilne neutropenije (znaka upale) u bolesnika koji se podvrgavaju kemoterapiji.
English: The active substance in Egranli, balugrastim, is made up of ‘granulocyte-colony-stimulating factor' (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow.
Croatian: Djelatna tvar lijeka Egranli, balugrastim, izrađuje se od „čimbenika koji stimulira koloniju granulocita“ (G-CSF), proteina koji se prirodno pojavljuje u tijelu, a koji promiče proizvodnju bijelih krvnih stanica uključujući i neutrofila u koštanoj moždini.