FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients received either Adenuric or allopurinol for 7 to 9 days.
Croatian: Bolesnici su primali Adenuric ili alopurinol tijekom 7 do 9 dana.
English: The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/dl.
Croatian: Glavni pokazatelj djelotvornosti bio je broj bolesnika u kojih su posljednje tri razine mokraćne kiseline u krvi bile niže od 6 mg/dl.
English: What measures are being taken to ensure the safe and effective use of Adenuric?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Adenuric?
English: For more information about treatment with Adenuric, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Adenuric pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite se svom liječniku ili ljekarniku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adenuric.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Adenuric.
English: In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg.
Croatian: U oba ispitivanja korištene su doze od 300 mg alopurinola jedanput na dan, osim u ispitanika s bubrežnim problemima, koji su uzimali 100 mg.
English: Other information about Adenuric
Croatian: Ostale informacije o lijeku Adenuric
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric.
Croatian: Tijekom prvih nekoliko mjeseci liječenja može doći do napada gihta te se preporučuje uzimanje drugih lijekova za sprječavanje napada gihta tijekom najmanje prvih šest mjeseci liječenja Adenuricom.
English: Adenuric treatment should not be stopped if an attack of gout occurs.
Croatian: Liječenje Adenuricom ne treba prekidati u slučaju napada gihta.
English: A risk management plan has been developed to ensure that Adenuric is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Adenuric.
English: Adenuric is a medicine that contains the active substance febuxostat.
Croatian: Adenuric je lijek koji sadrži djelatnu tvar febuksostat.
English: This is a summary of the European public assessment report (EPAR) for Adenuric.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Adenuric.
English: In patients with blood cancer who were undergoing chemotherapy, Adenuric was as effective as allopurinol in controlling blood levels of uric acid: in 98.3 % of patients (170 out of 173) on Adenuric blood levels of uric acid normalised compared with 96 % (166 out of 173) of patients on allopurinol.
Croatian: U bolesnika s rakom krvi koji su primali kemoterapiju, Adenuric je bio jednako djelotvoran kao alopurinol u kontroli razine mokraćne kiseline u krvi: razina mokraćne kiseline u krvi normalizirala se u 98,3 % bolesnika (170 od 173) koji su uzimali Adenuric, u usporedbi s 96 % (166 od 173) bolesnika koji su uzimali alopurinol.
English: Blood uric acid levels were measured every month.
Croatian: Mjerenja razine mokraćne kiseline u krvi provodila su se svaki mjesec.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom decilitru) nakon dva do četiri tjedna.
English: For the treatment of long-term hyperuricaemia, the recommended dose of Adenuric is 80 mg once a day.
Croatian: Za liječenje dugotrajne hiperuricemije preporučena doza Adenurica iznosi 80 mg jedanput na dan.
English: This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo.
Croatian: Ti rezultati uspoređeni su s 22 % bolesnika koji su uzimali alopurinol (60 od 268) i nijednim od 134 bolesnika koji su uzimali placebo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adenuric, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Adenuric nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Croatian: Adenuric se koristi za liječenje odraslih osoba s dugotrajnom hiperuricemijom (visoka razina mokraćne kiseline ili „urata” u krvi).
English: The main measure of effectiveness was based on their blood uric acid levels.
Croatian: Glavni pokazatelj djelotvornosti temeljio se na razini mokraćne kiseline u krvi.
English: In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements.
Croatian: U prvom ispitivanju, u 48 % bolesnika koji su uzimali 80 mg Adenurica jedanput na dan (126 od 262) i u 65 % bolesnika koji su uzimali 120 mg jedanput na dan (175 od 269) razine mokraćne kiseline bile su niže od 6 mg/dl u posljednja tri mjerenja.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Croatian: Za sprječavanje i liječenje hiperuricemije u bolesnika podvrgnutih kemoterapiji preporučena doza iznosi 120 mg jedanput na dan.
English: Adenuric is used in patients who already 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: Adenuric se koristi u bolesnika koji već pokazuju znakove nakupljanja kristala, uključujući urični artritis (bol i upala zglobova) ili tofi („kamenac”, veće nakupine kristala urata koje mogu izazvati oštećenje zglobova i kosti).
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Croatian: Hiperuricemija može dovesti do stvaranja kristala urata i njihovog nakupljanja u zglobovima i bubrezima.
English: The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia).
Croatian: U prvom ispitivanju, koje je obuhvaćalo 1072 bolesnika, uspoređivane su tri doze Adenurica (80, 120 i 240 mg jedanput na dan) s placebom (liječenje bez djelatne tvari) i alopurinolom (drugi lijek za liječenje hiperuricemije).
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Croatian: U bolesnika koji su podvrgnuti kemoterapiji, očekuje se da se smanjenjem razine mokraćne kiseline smanji opasnost od sindroma tumorske lize.
English: Adenuric is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy 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: Adenuric se također koristi za liječenje i sprječavanje visoke razine mokraćne kiseline u krvi u odraslih koji primaju kemoterapiju za rak krvi i kod kojih postoji opasnost od nastanka sindroma tumorske lize (komplikacija koja nastaje zbog uništavanja stanica raka, pri čemu dolazi do naglog porasta mokraćne kiseline u krvi, što može izazvati oštećenje bubrega).
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, Adenuric has been studied in one main study involving 346 adult patients undergoing chemotherapy for blood cancer.
Croatian: Za sprječavanje i liječenje hiperuricemije u bolesnika podvrgnutih kemoterapiji, provedeno je jedno glavno ispitivanje na 346 odraslih bolesnika podvrgnutih kemoterapiji za liječenje raka krvi.
English: What is the risk associated with Adenuric?
Croatian: Koji su rizici povezani s lijekom Adenuric?
English: What is Adenuric?
Croatian: Što je Adenuric?
English: The most commonly reported side effects with Adenuric are gout flare-ups, abnormal liver test results, diarrhoea, nausea (feeling sick), headache, rash and oedema (swelling).
Croatian: Najčešće prijavljivane nuspojave lijeka Adenuric su napadi gihta, poremećaji jetrene funkcije, proljev, mučnina, glavobolja, osip i edem (oteklina).
English: The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
Croatian: U drugom ispitivanju uspoređivane su dvije doze Adenurica (80 i 120 mg jedanput na dan) s alopurinolom na 762 bolesnika tijekom jedne godine.
English: For the treatment of hyperuricaemia and gout, Adenuric has been studied in two main studies involving a total of 1,834 patients.
Croatian: Za liječenje hiperuricemije i gihta provedena su dva glavna ispitivanja lijeka Adenuric na ukupno 1834 bolesnika.
English: The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels including in patients undergoing chemotherapy , but that it could carry a greater risk of side effects affecting the heart and blood vessels.
Croatian: CHMP je zaključio da je Adenuric djelotvorniji od alopurinola u smanjivanju razine mokraćne kiseline u krvi, uključujući i u bolesnika podvrgnutih kemoterapiji, no da može podrazumijevati veću opasnost od nuspojava povezanih sa srcem i krvnim žilama.
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Croatian: Nakupljanje kristala u zglobovima izaziva bol koja se naziva „giht”.
English: The Committee decided that Adenuric's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Adenuric nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Why has Adenuric been approved?
Croatian: Zašto je lijek Adenuric odobren?
English: This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120
Croatian: Time se obično smanjuje razina mokraćne kiseline u krvi unutar dva tjedna, no doza se može povećati na 120 mg jedanput na dan ako razina mokraćne kiseline u krvi ostane visoka (više od 6 mg po
English: The active substance in Adenuric, febuxostat, reduces the formation of uric acid.
Croatian: Djelatna tvar lijeka Adenuric, febuksostat, smanjuje nastajanje mokraćne kiseline.
English: Adenuric was more effective than allopurinol and placebo in treating hyperuricaemia by reducing blood uric acid levels.
Croatian: Adenuric je pokazao veću djelotvornost u liječenju hiperuricemije nego alopurinol i placebo smanjujući razinu mokraćne kiseline u krvi.
English: For the full list of all side effects and restrictions with Adenuric, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Adenuric potražite u uputi o lijeku.
English: What is Adenuric used for?
Croatian: Za što se Adenuric koristi?
English: Rare serious hypersensitivity (allergic) reactions to Adenuric have occurred post-marketing.
Croatian: Nakon stavljanja lijeka u promet rijetko su se pojavljivale ozbiljne reakcije preosjetljivosti (alergijske reakcije).
English: By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Croatian: S obzirom da inhibira stvaranje mokraćne kiseline, primjena lijeka Adenuric može dovesti do smanjenja i zadržavanja niske razine mokraćne kiseline u krvi te zaustavljanja nakupljanja kristala.
English: What benefit has Adenuric shown during the studies?
Croatian: Koje su koristi lijeka Adenuric utvrđene u ispitivanjima?
English: How is Adenuric used?
Croatian: Kako se Adenuric koristi?
English: How does Adenuric work?
Croatian: Kako djeluje Adenuric?
English: How has Adenuric been studied?
Croatian: Kako je Adenuric ispitivan?
English: Make sure you do the following:
Croatian: Svakako učinite sljedeće:
English: It is very important for you to keep all of these appointments.
Croatian: Za vas je vrlo važno da se pridržavate ovih posjeta.
English: − This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: Ask your doctor which method is best for you.
Croatian: Upitajte svog liječnika koja je metoda kontracepcije najbolja za Vas.
English: The elimination half-life in most patients is 2 to 3 hours.
Croatian: Poluvijek eliminacije u većine bolesnika je 2 do 3 sata.
English: This medicine could seriously harm your baby.
Croatian: Ovaj lijek može ozbiljno naškoditi
English: The patient should be advised to limit contact with other individuals in order to reduce the risk of infection.
Croatian: Bolesniku treba savjetovati da ograniči kontakte s drugim osobama kako bi smanjio rizik od infekcije.
English: Do not change your daily dose without first talking to your doctor.
Croatian: Svoju dnevnu dozu nemojte mijenjati a da prethodno niste razgovarali s liječnikom.
English: Date of latest renewal: 21 September 2009
Croatian: Datum posljednje obnove odobrenja: 21. rujan 2009.
English: Therefore, in the event of neutropenia, rechallenge is not recommended.
Croatian: Stoga se u slučaju neutropenije ponovna primjena ne preporučuje.
English: Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Croatian: Molimo savjetujte se sa svojim liječnikom ili ljekarnikom prije nego uzmete vitamin C s Ferriproxom.
English: CY The Star Medicines Importers Co. Ltd.
Croatian: CY The Star Medicines Importers Co.
English: 2333 CN Leiden Netherlands
Croatian: 2333 CN Leiden Nizozemska
English: The response to therapy should be assessed periodically, and the occurrence of adverse events closely monitored.
Croatian: Odgovor na terapiju treba se procjenjivati periodički, a pojavu štetnih događaja pažljivo nadzirati.
English: Your doctor will also ask you to come in for tests to monitor body iron load.
Croatian: Liječnik će od Vas također tražiti da učinite pretrage za praćenje opterećenja tijela željezom.
English: (≥1/100 to <1/10)
Croatian: ČESTO (≥ 1/100 do < 1/10)
English: − if you are HIV positive or if your liver or kidney function is severely impaired, your doctor may recommend additional tests.
Croatian: − ako ste HIV pozitivni ili ako su Vaša jetra ili bubrezi teško oštećeni, Vaš liječnik može preporučiti dodatne pretrage.
English: Ferriprox will be most effective if you do not miss any doses.
Croatian: Ferriprox će biti najučinkovitiji ako ne propustite uzeti niti jednu dozu.
English: These women should be advised to take contraceptive measures and must be advised to immediately stop taking deferiprone if they become pregnant or plan to become pregnant (see section 4.3).
Croatian: Ovim ženama treba savjetovati da koriste kontraceptivne mjere i moraju se savjetovati da odmah prekinu uzimanje deferiprona ako ostanu trudne ili planiraju zatrudnjeti (vidjeti dio 4.3).
English: The amount of Ferriprox that you take will depend on your weight.
Croatian: Količina Ferriproxa koju uzimate ovisit će o Vašoj tjelesnoj težini.
English: If taken during pregnancy, Ferriprox may seriously harm the unborn baby.
Croatian: Ako se uzima tijekom trudnoće, Ferriprox može ozbiljno naškoditi nerođenom djetetu.
English: Take your first dose in the morning.
Croatian: Prvu dozu uzmite ujutro.
English: There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Croatian: Dostupni podaci o primjeni deferiprona u djece u dobi od 6 do 10 godina su ograničeni, a nema podataka o primjeni deferiprona u djece mlađe od 6 godina starosti.
English: The total daily dose should not exceed 100 mg/kg.
Croatian: Ukupna dnevna doza ne smije prekoračiti 100 mg/kg.
English: Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Croatian: Učestalosti nuspojava: vrlo često (≥1/10), često (≥1/100 do <1/10), nepoznato (ne može se utvrditi iz dostupnih podataka).
English: Use the measuring cup to measure the volume prescribed by your doctor.
Croatian: Koristite mjernu čašicu za mjerenje volumena koji je propisao liječnik.
English: *number of tablets rounded to nearest half tablet
Croatian: * broj tableta zaokružen na najbližu polovicu tablete
English: Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.
Croatian: Broj Vaših bijelih krvnih stanica treba provjeriti u roku od 24 sata kako bi se otkrila moguća agranulocitoza.
English: This may be extended to 2 hours in fed patients.
Croatian: To može biti produženo za 2 sata u bolesnika koji su jeli.
English: In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose.
Croatian: Kod nekih bolesnika može biti korisno smanjiti dozu deferiprona i zatim je postepeno povećavati do prvotne doze.
English: Combined use with other iron chelators
Croatian: U kombinaciji s drugim kelatorima željeza
English: − if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
Croatian: − ako ste alergični na deferipron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Take your third dose in the evening.
Croatian: Treću dozu uzmite navečer.
English: The Patient/Carer reminder card shall contain the following key messages:
Croatian: Kartica s podsjetnikom za bolesnika/njegovatelja sadržavat će sljedeće ključne poruke:
English: Do not take this medicine if you are pregnant or if you are trying to become pregnant.
Croatian: Nemojte uzimati ovaj lijek ako ste trudni ili nastojite zatrudnjeti.
English: Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Croatian: Slijedite gore navedene smjernice i primijenite odgovarajuću terapiju, poput faktora stimulacije granulocitnih kolonija, počevši istog dana kada se ovaj događaj utvrdi; primjenjujte svakog dana dok se stanje ne poboljša.
English: − increase in appetite
Croatian: - povećan apetit
English: Keizersgracht 311 1016 EE Amsterdam Netherlands
Croatian: Keizersgracht 311 1016 EE Amsterdam Nizozemska
English: • To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby.
Croatian: • upozorenje ženama reproduktivne dobi da ne smiju zatrudnjeti jer deferipron može uzrokovati ozbiljne štetne posljedice po nerođeno dijete.
English: Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in animals.
Croatian: Deferipron nije pokazao izravna mutagena svojstva; međutim pokazao je klastogene karakteristike u testovima in vitro i na životinjama.
English: Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Croatian: Deferipron se brzo apsorbira iz gornjeg dijela gastrointestinalnog trakta.
English: If you take more Ferriprox than you should
Croatian: Ako uzmete više Ferriproxa nego što ste trebali
English: In addition he or she might ask you to undergo liver biopsies.
Croatian: od Vas može tražiti da se podvrgnete biopsijama jetre.
English: If you have accidentally taken more than the prescribed dose, you should contact your doctor.
Croatian: Ako ste slučajno uzeli više od propisane doze, trebali biste se obratiti svome liječniku.
English: Less severe episodes of neutropenia were reported in approximately 5% of patients.
Croatian: Manje teške epizode neutropenije prijavljene su kod otprilike 5% bolesnika.
English: Dose adjustments should be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden).
Croatian: Prilagodbe doza treba raditi prema bolesnikovom individualnom odgovoru na liječenje i terapijskim ciljevima (održavanje ili snižavanje opterećenja tijela željezom).
English: Systemic exposure to the inactive 3-O-glucuronide increased with decreasing eGFR.
Croatian: Sistemska izloženost neaktivnom 3-O-glukuronidu povećavala se sa smanjenjem eGFR-a.
English: If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time.
Croatian: Ako propustite uzeti jednu dozu, uzmite je čim se sjetite, a sljedeću dozu uzmite u uobičajeno vrijeme.
English: Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Croatian: Žene reproduktivne dobi mora se savjetovati da izbjegnu trudnoću zbog klastogenih i teratogenih svojstava ovog lijeka.
English: A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
Croatian: Ukupna dnevna doza iznad 100 mg/kg tjelesne težine se ne preporučuje zbog potencijalnog povećanog rizika od nuspojava (vidjeti dijelove 4.4, 4.8, i 4.9).
English: This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Croatian: Ovaj metabolit nema sposobnost vezivanja željeza zbog inaktivacije 3-hidroksilne skupine deferiprona.
English: Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.
Croatian: Iako se agranulocitoza događa samo kod 1 do 2 na 100 korisnika, važno je redovito pratiti broj bijelih krvnih stanica.
English: The children recovered from these symptoms after Ferriprox discontinuation.
Croatian: Djeca su se oporavila od tih simptoma nakon prekida primjene lijeka Ferriprox.
English: No cases of acute overdose have been reported.
Croatian: Nisu prijavljeni slučajevi akutnog predoziranja.
English: If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule.
Croatian: Ako propustite uzeti više od jedne doze, nemojte uzeti dvostruku dozu kako biste nadoknadili propuštene doze, samo nastavite uzimati lijek prema uobičajenom rasporedu.
English: In case of overdose, close clinical supervision of the patient is required.
Croatian: U slučaju predoziranja potreban je pomni klinički nadzor bolesnika.
English: There are no adequate data from the use of deferiprone in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni deferiprona u trudnica.
English: In most cases, the pain disappeared while patients continued taking Ferriprox.
Croatian: U većini slučajeva bol je nestala dok su bolesnici nastavili uzimati Ferriprox.
English: Data from pooled clinical studies in patients with systemic iron overload show that 63% of the episodes of agranulocytosis occurred within the first six months of treatment, 74% within the first year and 26% after one year of therapy.
Croatian: Objedinjeni podaci iz kliničkih ispitivanja u bolesnika sa sistemskim preopterećenjem željezom pokazuju da se 63% epizoda agranulocitoze dogodilo tijekom prvih 6 mjeseci liječenja, 74% tijekom prve godine liječenja i 26% nakon godinu dana liječenja.
English: ((Back Cover))
Croatian: ((Stražnja strana))
English: It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Croatian: Preporučuje se da protokol takvog liječenja bude pripremljen prije početka liječenja deferipronom bilo kojeg bolesnika.