FrancophonIA/ELRC3.0 huggingface dataset:
English: 109/L and <0.8 x 109/L for at least six months; 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy.
Croatian: U kliničkim ispitivanjima (i kontroliranima i nekontroliranima), 9% bolesnika imalo je broj limfocita ≥0,5x109/l i <0,8x109/l najmanje šest mjeseci; 2% bolesnika imalo je broj limfocita <0,5x109/l najmanje šest mjeseci, a u toj je skupini broj limfocita većinom ostao na vrijednostima <0,5x109/l uz nastavak terapije.
English: In monkeys that received daily oral doses of dimethyl fumarate for 12 months, single cell necrosis was observed at 2 times the recommended dose based on AUC.
Croatian: U majmuna koji su dnevne oralne doze dimetilfumarata primali 12 mjeseci, nekroza pojedinih stanica opažena je na temelju AUC-a pri dozi 2 puta većoj od preporučene.
English: In an ongoing long-term extension study, in which 1736 MS patients are treated with Tecfidera, approximately 5% experienced one or more events of herpes zoster, the majority of which were mild to moderate in severity.
Croatian: U dugotrajnom nastavku kliničkog ispitivanja, koje je u tijeku, lijek Tecfidera primalo je 1736 bolesnika s multiplom sklerozom, od čega je u približno njih 5% jedanput ili više puta došlo do pojave herpes zostera.
English: The benefit/risk in patients with lymphocyte counts ≥0.5 x 109/L and <0.8 x 109/L for more than six months should be assessed.
Croatian: Potrebno je procijeniti omjer koristi i rizika u bolesnika s brojem limfocita ≥0,5x109/l i <0,8x109/l dulje od šest mjeseci.
English: The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Croatian: Incidencija ozbiljnih gastrointestinalnih smetnji, uključujući gastroenteritis i gastritis, primijećena je u 1%
English: Severe active gastrointestinal disease
Croatian: Teška aktivna bolest probavnog sustava
English: Immune system disorders
Croatian: Učinci na imunološki sustav
English: Hypotension1
Croatian: nepoznato hipotenzija1
English: Oral administration of dimethyl fumarate at 25, 75, and 150 mg/kg/day to pregnant rabbits during organogenesis had no effect on embryo-fetal development and resulted in reduced maternal body weight at 7 times the recommended dose and increased abortion at 16 times the recommended dose, on an AUC basis.
Croatian: Peroralna primjena dimetilfumarata od 25, 75 i 150 mg/kg/dan gravidnim ženkama kunića tijekom organogeneze nije imala utjecaja na embriofetalni razvoj i rezultirala je smanjenjem majčine tjelesne težine pri dozi 7 puta većoj od preporučene i povećanom pobačaju kod doze 16 puta veće od preporučene na temelju AUC-a.
English: Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Croatian: Podaci o apsolutnom broju limfocita u bolesnika s herpes zoster infekcijom iz razdoblja nakon stavljanja lijeka u promet su ograničeni.
English: If herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
Croatian: U slučaju pojave herpes zostera, potrebno je primijeniti odgovarajuće liječenje.
English: This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
Croatian: To uključuje razmatranje koristi dojenja za Vaše dijete i koristi liječenja za Vas.
English: Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during Tecfidera therapy.
Croatian: Tijekom terapije Tecfiderom mogu se razmotriti istodobna cijepljenja neživim cjepivima prema nacionalnom programu cijepljenja.
English: It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation.
Croatian: Prije nego dođe u sistemski krvotok, dimetilfumarat se početno metabolizira esterazama koje su rasprostranjene u gastrointestinalnom traktu, krvi i tkivima.
English: Tecfidera 240 mg dimethyl fumarate
Croatian: Tecfidera 240 mg dimetilfumarat
English: Gastro-resistant hard capsule
Croatian: Tvrda želučanootporna kapsula
English: Tecfidera 120 mg dimethyl fumarate
Croatian: Tecfidera 120 mg dimetilfumarat
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines, in particular: - medicines that contain fumaric acid esters (fumarates) used to treat psoriasis
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, a naročito: lijekove koji sadrže estere fumaratne kiseline (fumarate) a koriste se za liječenje psorijaze lijekove koji utječu na tjelesni imunološki sustav uključujući druge lijekove koji se koriste za liječenje MS-a, kao fingolimod, natalizumab, teriflunomid, alemtuzumab, okrelizumab ili kladribin ili neke uobičajene lijekove protiv raka (rituksimab ili mitoksantron)
English: Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Croatian: Tecfidera 240 mg: Jedna kapsula sadrži 240 mg dimetilfumarata.
English: Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported.
Croatian: Bolesnike koji uzimaju lijek Tecfidera potrebno je pratiti na pojavu znakova i simptoma herpes zostera, osobito ako je istodobno prisutna i limfocitopenija.
English: In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes.
Croatian: PML, treba odmah provesti snimanje MR-om u dijagnostičke svrhe.
English: 14 gastro-resistant hard capsules
Croatian: 14 tvrdih želučanootpornih kapsula
English: In dogs that received daily oral doses of dimethyl fumarate for 11 months, the margin calculated for cortical atrophy was observed at 3 times the recommended dose based on AUC.
Croatian: U pasa koji su dnevne oralne doze dimetilfumarata primali 11 mjeseci, granica izračunata za kortikalnu atrofiju opažena je na temelju
English: Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Croatian: Tecfidera 120 mg: Jedna kapsula sadrži 120 mg dimetilfumarata.
English: Oral administration of dimethyl fumarate to female rats at 25, 100, and 250 mg/kg/day prior to and during mating, and continuing to Day 7 of gestation, induced reduction in the number of estrous stages per 14 days and increased the number of animals with prolonged diestrus at the highest dose tested (11 times the recommended dose on an AUC basis).
Croatian: Peroralna primjena dimetilfumarata na ženkama štakora od 25, 100 i 250 mg/kg/dan prije i za vrijeme parenja, i nastavkom do 7. dana gestacije, izazvala je smanjenje broja estrus faza po 14 dana, a povećala je broj životinja s duljim diestrusom pri najvišoj testiranoj dozi (11 puta veće od preporučene doze na temelju AUC-a).
English: Drug-induced liver injury, including liver enzyme increase (≥ 3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 ULN) can result from treatment with dimethyl fumarate.
Croatian: Liječenje dimetilfumaratom može za posljedicu imati oštećenje jetre izazvano lijekom, uključujući povišenje jetrenih enzima (≥3 puta iznad gornje granice normale (GGN)) i povišenje razina ukupnog bilirubina (≥2 GGN).
English: Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Croatian: Nakon toga, dimetilfumarat se metabolizira u ciklusu trikarboksilatne kiseline bez posredovanja citokrom P450 (CYP) sustava.
English: For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8).
Croatian: Uzimanje Tecfidere s hranom može poboljšati podnošljivost u bolesnika koji imaju navale crvenila ili nuspojave probavnog sustava (vidjeti dijelove 4.4, 4.5 i 4.8).
English: PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of moderate to severe prolonged lymphopenia.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Slučajevi PML-a pojavili su se tijekom primjene dimetilfumarata i drugih lijekova koji sadrže fumarate u stanju umjerene do teške i produljene limfopenije.
English: Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percentage decrease from baseline at 2 years of 25% versus 15%, respectively) and levels of parathyroid hormone (PTH) increased in Tecfidera treated patients relative to placebo (median percentage increase from baseline at 2 years of 29% versus 15%, respectively).
Croatian: D smanjivale su se u bolesnika liječenih Tecfiderom u odnosu na placebo (medijan postotka smanjenja od početne vrijednosti nakon 2 godine bio je 25% odnosno 15%), a razine paratiroidnog hormona (PTH) povećale su se u bolesnika liječenih
English: Findings in the forestomach of mice and rats consisted of squamous epithelial hyperplasia and hyperkeratosis; inflammation; and squamous cell papilloma and carcinoma in studies of 3 months or longer in duration.
Croatian: U ispitivanjima u trajanju od 3 mjeseca mjeseca ili duljim, predželudac miševa i štakora sastojao se od hiperplazija pločastog epitela i hiperkeratoza, upala te papiloma pločastih stanica i karcinoma.
English: Assessment of serum aminotransferases (e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
Croatian: aspartat aminotransferaze (AST)) i razine ukupnog bilirubina kako je klinički indicirano.
English: Patients with serious infections should not start treatment with Tecfidera until the infection(s) is resolved.
Croatian: Bolesnici s ozbiljnim infekcijama ne smiju započeti liječenje
English: Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen.
Croatian: U terapijskom režimu s višestrukim dozama dimetilfumarata ne dolazi do nakupljanja izvornog lijeka ili monometilfumarata.
English: The mechanism of dimethyl fumarate induced anaphylaxis is unknown.
Croatian: Mehanizam kojim dimetilfumarat izaziva anafilaksiju nije poznat.
English: This resulted in a minimal accumulation of exposure yielding an increase in the median Cmax of 12% compared to the twice daily dosing (1.72 mg/l for twice daily compared to 1.93 mg/l for three times daily) with no safety implications.
Croatian: (1,72 mg /l za dva puta dnevno u usporedbi sa 1,93 mg /l za tri puta dnevno) bez sigurnosnih implikacija.
English: Consider withholding Tecfidera treatment in patients with serious infections until the infection has resolved (see section 4.8).
Croatian: U bolesnika s ozbiljnim herpes zoster infekcijama potrebno je razmotriti prekid liječenja lijekom Tecfidera dok se infekcija ne razriješi (vidjeti dio 4.8).
English: Oral administration of dimethyl fumarate at 25, 100, and 250 mg/kg/day to rats during pregnancy and lactation resulted in lower body weights in the F1 offspring, and delays in sexual maturation in F1 males at 11 times the recommended dose on an AUC basis.
Croatian: Peroralna primjena dimetilfumarata od 25, 100 i 250 mg/kg/dan štakoricama tijekom gravidnosti i laktacije rezultirala je nižim tjelesnim težinama u F1 potomstvu i kašnjenjem u seksualnom sazrijevanju mužjaka F1 potomstva kod doze 11 puta veće od preporučene na temelju AUC-a.
English: Administration of dimethyl fumarate at oral doses of 25, 100, and 250 mg/kg/day to pregnant rats during the period of organogenesis resulted in maternal adverse effects at 4 times the recommended dose on an AUC basis, and low fetal weight and delayed ossification (metatarsals and hindlimb phalanges) at 11 times the recommended dose on an AUC basis.
Croatian: Primjena dimetilfumarata u oralnim dozama od 25, 100 i 250 mg/kg/dan gravidnim štakoricama tijekom razdoblja organogeneze rezultirala je nuspojavama kod majke pri dozi 4 puta većoj od preporučene na temelju AUC-a i niskoj težini fetusa i usporenom okoštavanju (metatarzalne falange i falange stražnjih nogu) pri dozi 11 puta većoj od preporučene na temelju AUC-a.
English: Herpes zoster infections have been reported with Tecfidera use.
Croatian: Uz primjenu lijeka Tecfidera prijavljeni su slučajevi herpes zoster infekcija.
English: Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone
Croatian: celuloza, mikrokristalična karmelozanatrij, umrežena talk silicijev dioksid, koloidni bezvodni magnezijev stearat trietilcitrat metakrilatna kiselina - metilmetakrilat kopolimer (1:1) metakrilatna kiselina - etilakrilat kopolimer (1:1) 30% disperzija simetikon natrijev laurilsulfat polisorbat 80
English: Keep this medicine out of the sight and reach of children.
Croatian: Prije uporabe pročitajte uputu o lijeku Čuvati izvan pogleda i dohvata djece
English: Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Croatian: U placebom kontroliranim ispitivanjima nisu opažena povišenja transaminaza ≥3 puta GGN s istodobno povišenim razinama ukupnog bilirubina >2 puta GGN.
English: Cases of anaphylaxis/anaphylactoid reaction have been reported following Tecfidera administration in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi anafilaksije/anafilaktoidne reakcije nakon primjene Tecfidere.
English: In the majority of patients who experienced flushing, it was mild or moderate in severity.
Croatian: većine bolesnika kod kojih se pojavila navala crvenila, ona je bila blaga ili umjerena.
English: Tel: +385 (0) 1 230 34 46
Croatian: Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46
English: The incidence of serious flushing, which may be characterised by generalised erythema, rash and/or pruritus, was seen in less than 1% of patients treated with Tecfidera (see sections 4.2, 4.4 and 4.5).
Croatian: Incidencija ozbiljne navale crvenila, koje se može karakterizirati kao generalizirani eritem, osip i/ili pruritus, javila se u manje od 1% bolesnika liječenih
English: If you have a serious infection (such as pneumonia), talk to your doctor immediately proteins (albumin) in urine increase in levels of liver enzymes (ALT, AST) in the blood
Croatian: - proteini (albumin) u mokraći - povišena razina jetrenih enzima (ALT, AST) u krvi
English: Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).
Croatian: (vidjeti dio 5.1 za važne informacije o populacijama za koje je ustanovljena djelotvornost).
English: Treatment initiation
Croatian: Način primjene
English: Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine.
Croatian: Konzumiranje više nego samo malih količina (više od 50 ml) jakih alkoholnih pića (s više od 30%
English: Tecfidera has not been studied in patients with renal or hepatic impairment.
Croatian: Oštećenje bubrega i jetre Tecfidera nije ispitivana u bolesnika s oštećenjem bubrega ili jetre.
English: Leucopenia
Croatian: Limfopenija
English: Dyspnoea1
Croatian: nepoznato dispneja1
English: The apparent volume of distribution following oral administration of 240 mg dimethyl fumarate varies between 60 L and 90 L. Human plasma protein binding of monomethyl fumarate generally ranges between 27% and 40%.
Croatian: Distribucija Prividni volumen distribucije nakon peroralne primjene 240 mg dimetilfumarata varira između 60 l i
English: If you forget or miss a dose, do not take a double dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
Croatian: Jedna tvrda želučanootporna kapsula sadrži 240 mg dimetilfumarata
English: Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Croatian: Među ispitanicima s istodobnom limfocitopenijom prevladavala je limfopenija 2. i 3. stupnja.
English: The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the microtablets prevents irritant effects on the gut.
Croatian: Kapsulu ili njezin sadržaj ne smije se zdrobiti, razdijeliti, otopiti,
English: If you have taken too many capsules, talk to your doctor straight away.
Croatian: Ako imate ozbiljnu infekciju (kao što je upala pluća), razgovarajte odmah sa svojim liječnikom.
English: RRMS aged 13 to 17 years (4 patients aged ≤14 years).
Croatian: Tecfidera je procijenjena u prospektivnom otvorenom nekontroliranom ispitivanju u 22 pedijatrijska bolesnika s RRMS-om u dobi od 13 do 17 godina (4 bolesnika u dobi od ≤14 godina).
English: Side effects which may show up in your blood or urine tests low levels of white blood cells (lymphopenia, leucopenia) in the blood.
Croatian: - niska razina bijelih krvnih stanica (limfopenija, leukopenija) u krvi.
English: Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules
Croatian: Tecfidera 120 mg tvrde želučanootporne kapsule Tecfidera 240 mg tvrde želučanootporne kapsule
English: Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera in patients with Relapsing Remitting MS. Long term (> 4 weeks) continuous use of acetylsalicylic acid has not been studied (see sections 4.4 and 4.8).
Croatian: Dugotrajna (> 4 tjedna) neprekidna upotreba acetilsalicilatne kiseline nije ispitana (vidjeti dijelove 4.4 i 4.8).
English: Severe renal and hepatic impairment
Croatian: Teško oštećenje bubrega i jetre
English: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Croatian: Jedna tvrda želučanootporna kapsula sadrži 120 mg dimetilfumarata
English: Renal tubular hyperplasia was observed in rats with life time dosing (2-year study).
Croatian: U štakora s doživotnim doziranjem (2-godišnje ispitivanje) primijećena je bubrežna tubularna hiperplazija.
English: Feeling hot
Croatian: Česte nuspojave
English: Starting dose 120 mg twice a day.
Croatian: 120 mg dva puta na dan
English: Hypoxia1
Croatian: nepoznato hipoksija1
English: Tecfidera 240mg gastro-resistant hard capsules
Croatian: Tecfidera 240 mg tvrde želučanootporne kapsule
English: Contents of the pack and other information
Croatian: Kako čuvati Tecfideru Sadržaj pakiranja i druge informacije
English: MT Ltd. Tel: +356 21337008
Croatian: Tel: +356 21337008
English: Biogen Hungary Kft. Tel: + 36 1 899 9883
Croatian: Tel: + 36 1 899 9883
English: Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Croatian: Tecfidera 120 mg tvrde želučanootporne kapsule Tecfidera 240 mg tvrde želučanootporne kapsule dimetilfumarat (dimethylis fumaras)
English: Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Croatian: Tecfidera 240 mg tvrde želučanootporne kapsule dimetilfumarat
English: Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate
Croatian: Tecfidera 120 mg tvrde želučanootporne kapsule dimetilfumarat
English: Morning Evening Mon.
Croatian: Ujutro
English: What Tecfidera is and what it is used for What you need to know before you take Tecfidera How to take Tecfidera
Croatian: Što morate znati prije nego počnete uzimati Tecfideru
English: Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events.
Croatian: bolesnika liječenih Tecfiderom prekinulo je liječenje zbog gastrointestinalnih smetnji.
English: The incidence of the adverse reactions below are expressed according to the following categories:
Croatian: Zbog dizajna ispitivanja, bolest s visokom aktivnošću je definirana kako slijedi:
English: Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg' and are available in packs containing 14 capsules.
Croatian: „BG-12 120 mg“ i dostupne su u pakiranju od 14 kapsula.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija često
English: Tecfidera 120mg gastro-resistant hard capsules
Croatian: Tecfidera 120 mg tvrde želučanootporne kapsule
English: Magnesium stearate
Croatian: Mjere ishoda MRb
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava osjećaj žarenja često
English: Flushing and gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing and gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Croatian: (prvenstveno u prvom mjesecu), a bolesnici kod kojih se pojave navala crvenila i gastrointestinalne smetnje mogu ih i dalje povremeno imati tijekom cijelog liječenja Tecfiderom.
English: Cases of herpes zoster have occurred with Tecfidera.
Croatian: Tijekom primjene lijeka Tecfidera pojavili su se slučajevi herpes zostera.
English: Herpes zoster (shingles) may occur with Tecfidera treatment.
Croatian: Tijekom liječenja lijekom Tecfidera može doći do pojave herpes zostera.
English: There was no case explicitly reporting Fanconi syndrome in the Multiple Sclerosis (MS) indication; however, it has been reported in literature that that female patients with psoriasis treated long-term with fumaric acid esters seem to be at particular risk.
Croatian: međutim, u literaturi je zabilježeno da bolesnice s psorijazom koje su dugotrajno liječene esterima fumaratne kiseline mogu biti pod osobitim rizikom.
English: Tel: +39 02 5849901
Croatian: Biogen Italia s.r.l. Tel: +39 02 5849901
English: The Package leaflet should be updated accordingly.
Croatian: U skladu s time potrebno je ažurirati i uputu o lijeku.
English: Biogen Netherlands B.V. Tel: +31 20 542 2000
Croatian: Biogen Poland Sp. z o.o. Tel: +48 22 351 51 00
English: Gelatin
Croatian: Čet
English: Rate ratio
Croatian: Prijavljivanje nuspojava
English: Burning sensation
Croatian: Tablični sažetak nuspojava
English: Tel: +421 2 323 340 08
Croatian: Biogen Slovakia s.r.o. Tel: +421 2 323 340 08
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava limfopenija često leukopenija često trombocitopenija manje često
English: Tecfidera is for oral use
Croatian: Za što se koristi Tecfidera
English: Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience
Croatian: 1 Nuspojave koje potječu samo iz iskustva nakon stavljanja lijeka u promet Opis izdvojenih nuspojava
English: Hepatic impairment
Croatian: Kliničke mjere ishodaa
English: The study lasted six months.
Croatian: Ispitivanje je trajalo šest mjeseci.
English: Similar results were seen in the second study after a year.
Croatian: Slične rezultate pokazalo je drugo ispitivanje nakon jedne godine.
English: The full EPAR for Adenuric can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Adenuric nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (80 and 120 mg).
Croatian: Dostupan je u obliku tableta (80 i 120 mg).
English: These side effects were mostly mild or moderate in severity.
Croatian: Ove su nuspojave većinom bile blage ili umjerene.
English: Adenuric should be started two days before chemotherapy and continued for at least 7 days.
Croatian: Liječenje Adenuricom treba započeti dva dana prije kemoterapije i nastaviti najmanje 7 dana.
English: Adenuric febuxostat
Croatian: Adenuric febuksostat
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Adenuric na snazi u Europskoj uniji od 21. travnja 2008.