natgillin/translations-raw huggingface dataset:
The Cmax and AUC of active metabolites increased up to 2- and 4-fold, respectively.
Cmax i AUC aktivnih metabolita povećali su se do 2, odnosno 4 puta.
The effect of febuxostat on human fertility is unknown.
Učinak febuksostata na plodnost u ljudi nije poznat.
The efficacy and safety of febuxostat in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Djelotvornost i sigurnost febuksostata u prevenciji i liječenju sindroma tumorske lize su ocijenjeni u FLORENCE (FLO-01) ispitivanju.
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
Treatment of chronic hyperuricaemia
Liječenje kronične hiperuricemije
• inflammation of the liver (hepatitis)
• upala jetre (hepatitis)
Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat.
Snažni induktori UGT enzima mogli bi dovesti do pojačana metabolizma i smanjene djelotvornosti febuksostata.
• difficulty in sleeping, sleepiness
• smetnje spavanja, pospanost
It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Također mogu biti prisutne ulceracije u ustima, ždrijelu, nosu i genitalijama te konjuktivitis (crvene i natečene oči).
Monitoring of serum uric acid is therefore recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation.
Stoga se preporučuje praćenje mokraćne kiseline u serumu 1-2 tjedna nakon početka liječenja snažnim induktorima glukuronidacije.
Keep this medicine out of the sight and reach of children.
• Lijek čuvajte izvan pogleda i dohvata djece.
Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that febuxostat does not adversely affect performance.
Bolesnici trebaju postupati s oprezom tijekom upravljanja vozilima i strojevima i sudjelovanja u opasnim aktivnostima, sve dok nisu prilično sigurni da febuksostat kod njih ne utječe negativno na provedbu tih aktivnosti.
Long-term, open label extension Studies
Dugotrajni, otvoreni produžeci ispitivanja
Atrial fibrillation, palpitations, ECG abnormal Rare
Atrijska fibrilacija, palpitacije, abnormalni EKG Rijetko
What Febuxostat Mylan is and what it is used for What you need to know before you take Febuxostat Mylan How to take Febuxostat Mylan Possible side effects
Što je Febuxostat Mylan i za što se koristi Što morate znati prije nego počnete uzimati Febuxostat Mylan Kako uzimati Febuxostat Mylan Moguće nuspojave
Febuxostat Mylan should be taken by mouth and can be taken with or without food.
Febuxostat Mylan treba uzimati na usta i može se uzimati s hranom ili bez nje.
Talk to your doctor before taking Febuxostat Mylan:
Obratite se svom liječniku prije nego uzmete Febuxostat Mylan:
In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
U slučaju slučajna predoziranja, upitajte svog liječnika za savjet, ili se obratite najbližem odjelu za hitnu pomoć.
Pancreatitis, mouth ulceration
Pankreatitis, ulceracije usta
However, weight-corrected Cmax and AUC were similar between the genders.
Međutim, Cmax i AUC korigirani u odnosu na tjelesnu težinu bili su slični kod oba spola.
These findings are considered a consequence of species specific purine metabolism and urine composition and of no relevance to clinical use.
Smatra se da su ovi nalazi posljedica metabolizma purina i sastava urina specifičnog za te vrste i nisu od značaja za kliničku primjenu.
These rates were similar to the rates reported on allopurinol (4.2%) (see section 4.4).
Te su vrijednosti bile slične vrijednostima prijavljenima kod alopurinola (4,2%) (vidjeti dio 4.4).
This medicinal product does not require any special storage conditions.
• Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
Both steps in the above transformations are catalyzed by xanthine oxidase (XO).
Oba koraka gore navedenih transformacija katalizirana su ksantin oksidazom (XO).
For any information about this medicine, please contact the local representative of the Marketing
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects.
Bolesnike treba pozorno pratiti, a dozu merkaptopurina/azatioprina potom prilagoditi na osnovu procjene terapijskog odgovora i nastupa eventualnih toksičnih učinaka.
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• povišena razina kreatin fosfokinaze u krvi (pokazatelj oštećenja mišića)
Your doctor will have prescribed the strength most suitable for you.
Vaš liječnik propisat će odgovarajuću jačinu tableta za Vas.
• weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
• smanjenje tjelesne težine, pojačani apetit, nekontrolirani gubitak apetita (anoreksija)
Sudden cardiac death*
Iznenadna srčana smrt*
Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours.
Febuksostat ima prividnu srednju vrijednost poluvremena eliminacije (t1/2) od oko 5 do 8 sati.
It is important to keep taking Febuxostat Mylan even if you have a flare, as Febuxostat Mylan is still working to lower uric acid.
Važno je da nastavite uzimati Febuxostat Mylan čak i ako imate napad, s obzirom na to da Febuxostat Mylan i dalje djeluje na snižavanje razine mokraćne kiseline.
• Azathioprine (used to reduce immune response)
• azatioprin (koristi se za smanjivanje imunološkog odgovora)
No statistically significant differences were found and no causal relationship with febuxostat was established.
Nisu zabilježene statistički značajne razlike i nije utvrđena uzročna povezanost s febuksostatom.
• If you have or have had renal disease and/or serious allergic reaction to allopurinol (a medication used for the treatment of Gout)
• ako imate ili ste imali bubrežnu bolest i/ili ozbiljnu alergijsku reakciju na alopurinol (lijek za liječenje gihta)
Febuxostat is rapidly (tmax of 1.0-1.5 h) and well absorbed (at least 84%).
Febuksostat se brzo (tmax 1,0-1,5 h) i dobro apsorbira (najmanje 84%).
INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)
UNURAŠNJA KUTIJA MULTIPAKIRANJA (BEZ PLAVE KUTIJE)
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine.
Ako se pojave osip ili navedeni kožni simptomi, odmah se obratite liječniku za savjet i obavijestite ga da uzimate ovaj lijek.
Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.
Česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i < 1/100) i rijetke ( 1/10 000 i < 1/1000) nuspojave koje se pojavljuju kod bolesnika liječenih febuksostatom su dolje navedene.
The plasma protein binding of febuxostat is approximately 99.2%, (primarily to albumin), and is constant over the concentration range achieved with 80 and 120 mg doses.
Vezanje febuksostata na proteine plazme je oko 99,2%, (ponajprije na albumin), i konstantno je u rasponu koncentracije koja se postiže dozama od 80 i 120 mg.
• rash (including various types of rash, please see below under “uncommon” and “rare”
• osip (uključujući razne vrste osipa, molimo pogledajte niže u tekstu u dijelovima «manje česte nuspojave» i «rijetke nuspojave»)
• loss of sex drive
• gubitak spolnog nagona
Start taking Febuxostat Mylan two days before chemotherapy and continue its use according to your doctor's advice.
Počnite uzimati Febuxostat Mylan dva dana prije kemoterapije i nastavite s primjenom prema uputi Vašeg liječnika.
What Febuxostat Mylan is and what it is used for
Što je Febuxostat Mylan i za što se koristi
Overall, the FLORENCE trial did not highlight any particular safety concern in addition to the previous experience with febuxostat in gout, with the exception of the following three adverse reactions (listed above in table 1).
U FLORENCE ispitivanju se, općenito, nije istaknuo niti jedan poseban sigurnosni problem uz prethodno iskustvo s febuksostatom kod gihta, osim sljedeće tri nuspojave (navedene iznad u tablici
Febuxostat Mylan should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Febuxostat Mylan treba uvesti dva dana prije početka citotoksične terapije i nastaviti s uzimanjem najmanje 7 dana; međutim liječenje može biti produljeno do 9 dana u skladu s trajanjem kemoterapije, prema kliničkoj procjeni.
Rare Tinnitus
Rijetko Tinitus
Two hundred and forty mg febuxostat (2 times the recommended highest dose) was used as a safety evaluation dose.
Dvjesto četrdeset mg (240 mg) febuksostata (2 puta više od preporučene najviše doze) korišteno je kao doza za procjenu sigurnosti.
Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.
Održavanjem dovoljno niskih razina mokraćne kiseline tijekom dovoljno dugog razdoblja mogu se smanjiti i tofi.
No dose adjustment is needed based on gender.
Nije potrebno prilagođavanje doze s obzirom na spol.
Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP.'
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake «Rok valjanosti».
A standard battery of test for genotoxicity did not reveal any biologically relevant genotoxic effects for febuxostat.
Konvencionalna ispitivanja genotoksičnosti nisu otkrila biološki relevantne genotoksične učinke febuksostata.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti i dio 4.8).
In total, 6,190 patients were followed for a median of 32 months and the median duration of exposure was 728 days for patients in febuxostat group (n 3098) and 719 days in allopurinol group (n 3092).
Ukupno je praćeno 6190 bolesnika tijekom medijana od 32 mjeseca, a medijan trajanja izloženosti bio je 728 dana u skupini na febuksostatu (n 3098) i 719 dana u skupini na alopurinolu (n 3092).
Multipack: 84 (2 packs of 42) film-coated tablets
Multipakiranje: 84 (2 pakiranja po 42) filmom obložene tablete
Following multiple oral doses of febuxostat, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Nakon višekratnih oralnih doza febuksostata, Cmax i AUC su bili 24%, odnosno 12% viši kod žena nego kod muškaraca.
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
VANJSKA KUTIJA MULTIPAKIRANJA (S PLAVOM KUTIJOM)
There was no evidence of impaired fertility, teratogenic effects, or harm to the foetus due to febuxostat.
Nema dokaza o smanjenoj plodnosti, teratogenim učincima ili štetnosti za fetus zbog primjene febuksostata.
This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome.
To nije primijećeno u pivotalnom kliničkom ispitivanju s febuksostatom kod sindroma tumorske lize.
Colchicine/indometacin/hydrochlorothiazide/warfarin
Kolhicin/indometacin/hidroklorotiazid/varfarin
The majority of adverse reactions were either mild or moderate.
Većina nuspojava bile su blage ili umjerene.
• If you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• ako ste se liječili zbog visokih razina mokraćne kiseline uzrokovanih Lesch-Nyhanovim sindromom (rijetkom nasljednom bolesti kod koje postoji prevelika količina mokraćne kiseline u krvi)
However, drugdrug and drug-disease interactions were not explored during this study.
Međutim, u ovom ispitivanju nisu istraživane interakcije lijek-lijek i lijekbolest.
It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown.
Može uzrokovati probleme s mišićima i, osobito ako se istovremeno osjećate loše ili imate visoku temperaturu,
• Mercaptopurine (used to treat cancer)
• merkaptopurin (koristi se za liječenje karcinoma)
• abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation)
• abnormalni nalaz EKG-a, nepravilni ili brzi otkucaji srca, osjećaj lupanja srca (palpitacije)
When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.
Kad se daje kemoterapija, uništavaju se stanice raka i sukladno tome raste razina mokraćne kiseline u krvi, osim ako se ne spriječi stvaranje mokraćne kiseline.
• generalised skin rashes
• generalizirani kožni osip.
Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure.
Identificirani faktori rizika kod tih bolesnika bili su aterosklerotska bolest i/ili infarkt miokarda u anamnezi, ili kongestivno zatajenje srca.
At least 65% of the patients had mild-moderate renal impairment (with creatinine clearance of 30-89 mL/min).
Najmanje 65% bolesnika imalo je blago do umjereno smanjenu bubrežnu funkciju (s klirensom kreatinina od 30 do 89 ml/min).
• If you have or have had heart failure, heart problems or stroke
• ako imate ili ste imali zatajenje srca, druge srčane bolesti ili moždani udar
• changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results)
• promjene kemijskog sastava krvi ili broja krvnih stanica ili krvnih pločica (abnormalni nalaz krvnih pretraga)
Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Sindrom tumorske lize: u pivotalnom ispitivanju faze 3 (FLORENCE) samo su ispitanici s teškom jetrenom insuficijencijom bili isklučeni iz ispitivanja.
The ability of febuxostat to lower serum uric acid levels was prompt and persistent.
Sposobnost febuksostata da snizi razinu mokraćne kiseline u serumu bila je brza i trajna.
There were no clinically significant differences in the percent decrease in serum uric acid concentration in healthy subjects irrespective of their renal function (58% in the normal renal function group and 55% in the severe renal dysfunction group).
Nisu postojale klinički značajne razlike u postotnom smanjenju koncentracije mokraćne kiseline u serumu kod zdravih ispitanika, neovisno o njihovoj bubrežnoj funkciji (58% u skupini s urednom funkcijom bubrega i 55% u skupini s teškim oštećenjem funkcije bubrega).
Carcinogenesis, mutagenesis, impairment of fertility
Kancerogeneza, mutageneza, smanjenje plodnosti
Therefore, possible interactions with any concomitantly administered cytotoxic drug cannot be ruled out.
Stoga se ne mogu isključiti moguće interakcije s istodobno primijenjenim citotoksičnim lijekom.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
Organ transplant recipients
Primatelji transplantiranih organa
The mean serum uric acid levels over time for each treatment group from the two pivotal Phase 3 studies are shown in Figure 1.
Srednje vrijednosti razine mokraćne kiseline u serumu tijekom vremena za svaku skupinu liječenja u dva pivotalna ispitivanja faze 3 prikazane su na slici 1.
The efficacy and safety of febuxostat has not been established in patients with acute severe TLS, e.g. in patients who failed on other urate lowering therapies.
Djelotvornost i sigurnost febuksostata nisu ustanovljene kod bolesnika s akutnim teškim STL-om, npr. kod bolesnika kod kojih druge terapije snižavanja urata nisu bile uspješne.
Febuxostat Mylan 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Febuxostat Mylan 120 mg tablete se koriste i za liječenje i prevenciju visoke razine mokraćne kiseline u krvi koja se može pojaviti kada počnete dobivati kemoterapiju za rak krvi.
Patients with an overdose should be managed by symptomatic and supportive care.
Predozirane bolesnike treba liječiti simptomatski i suportivnim mjerama.
• increase in gout symptoms
• pojačani simptomi gihta
Manufacturer Mylan Hungary Kft Mylan utca 1
Proizvođač Mylan Hungary Kft Mylan utca 1
Liver function test is recommended prior to the initiation of therapy with febuxostat and periodically thereafter based on clinical judgment (see section 5.1).
Preporučuje se učiniti testove funkcije jetre prije početka liječenja febuksostatom, a nakon toga periodično na temelju kliničke procjene (vidjeti dio
In healthy subjects concomitant use of febuxostat and naproxen 250 mg twice daily was associated with an increase in febuxostat exposure (Cmax 28%, AUC 41% and t1/2 26%).
Kod zdravih ispitanika istodobna primjena febuksostata i naproksena 250 mg dva puta dnevno bila je povezana s povećanjem izloženosti febuksostatu (Cmax 28%, AUC 41% i t1/2 26%).
No patients with organ transplant have been included in these studies (see section 4.2).
U ta ispitivanja nisu bili uključeni bolesnici s transplantiranim organima (vidjeti dio 4.2).
Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation.
Stevens-Johnsonov sindrom i toksična epidermalna nekroliza karakterizirani su progresivnim kožnim osipom udruženim s mjehurima ili lezijama sluznice i iritacijom očiju.
Data on a very limited number of exposed pregnancies have not indicated any adverse effects of febuxostat on pregnancy or on the health of the foetus/new born child.
Ograničeni podaci u trudnica ne ukazuju na štetne učinke febuksostata na trudnoću i na zdravlje fetusa/novorođenčeta.
• sudden cardiac death
• iznenadna srčana smrt
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Djelotvornost i sigurnost nisu u potpunosti procijenjeni kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min, vidjeti dio 5.2).
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.
Metabolizam febuksostata ovisi o uridin glukuronozil transferaza (UGT) enzimima.
Rosiglitazone/CYP2C8 substrates
Roziglitazon/supstrati CYP2C8
Medicinal product allergy / hypersensitivity
Alergija/preosjetljivost na lijek
Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels.
Febuksostat od 80 mg se može koristiti kod bolesnika istodobno liječenih teofilinom, bez rizika od porasta razine teofilina u plazmi.
Elderly No dose adjustment is required in the elderly (see section 5.2).
Nije potrebno prilagođavanje doze kod starijih osoba (vidjeti dio 5.2).
As there has been no experience in organ transplant recipients, the use of febuxostat in such patients is not recommended (see section 5.1).
Budući da nema iskustva o primjeni lijeka kod primatelja transplantiranih organa, ne preporučuje se primjena febuksostata kod tih bolesnika (vidjeti dio 5.1).
Primary endpoints were serum uric acid area under the curve (AUC sUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Primarni ishodi bili su površina ispod krivulje za mokraćnu kiselinu u serumu (AUC sMK1-8) i promjena razine serumskog kreatinina (sK), oboje od početnih vrijednosti do dana 8.
Keeping uric acid levels low by taking Febuxostat Mylan once every day stops crystals building up, and over time it reduces symptoms.
Održavanjem niskih razina mokraćne kiseline uzimanjem lijeka Febuxostat Mylan jednom dnevno sprječava se nakupljanje kristala urata, a simptomi se s vremenom smanjuju.
An interaction study in healthy subjects has been performed with febuxostat to evaluate whether the inhibition of XO may cause an increase in the theophylline circulating levels as reported with other XO inhibitors.
Provedeno je ispitivanje interakcija s febuksostatom u zdravih ispitanika kako bi se ustanovilo može li inhibicija XO dovesti do povećanja razine cirkulirajućeg teofilina kao što je izviješteno kod primjene s drugim inhibitorima XO.
Thirst
Žeđ
There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of febuxostat in elderly as compared to younger healthy subjects.
Nisu uočene značajne promjene AUC-a febuksostata ili njegovih metabolita nakon primjene višekratnih oralnih doza febuksostata kod starijih bolesnika u odnosu na mlađe, zdrave ispitanike.
• changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis)
• promjena ili smanjenje količine mokraće zbog upale bubrega (tubulointersticijski nefritis)
Plasma protein binding of the active metabolites ranges from about 82% to
Vezanje aktivnih metabolita na proteine plazme je u rasponu od oko 82% do 91%.
• If you have or have had liver disease or liver function test abnormalities
• ako imate ili ste imali bolest jetre ili abnormalne rezultate pretraga funkcije jetre
Conversely, cessation of treatment of an inducer might lead to increased plasma levels of febuxostat.
Suprotno, prestanak liječenja nekim od induktora mogao bi dovesti do povećanih razina febuksostata u plazmi.
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside first before starting treatment with Febuxostat Mylan.
Ako trenutačno imate napad gihta (nagla pojava jake boli, osjetljivosti, crvenila, topline i otoka zgloba), pričekajte da se napad gihta smiri prije nego što počnete liječenje lijekom Febuxostat Mylan.
There was high dose maternal toxicity accompanied by a reduction in weaning index and reduced development of offspring in rats at approximately 4.3 times human exposure.
Postojala je maternalna toksičnost praćena smanjenim indeksom odvajanja i smanjenim razvojem mladunaca kod štakora kod doza oko 4,3 puta većih od izloženosti kod ljudi.
In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events.
U kliničkim ispitivanjima primjena naproksena, ili drugih nesteroidnih protuupalnih lijekova/inhibitora Cox-2, nije bila povezana s klinički značajnim povećanjem učestalosti štetnih događaja.
Tumor Lysis Syndrome
Sindrom tumorske lize
Desipramine/CYP2D6 substrates
Desipramin/supstrati CYP2D6
In vitro studies with human liver microsomes showed that those oxidative metabolites were formed primarily by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and febuxostat glucuronide was formed mainly by UGT 1A1, 1A8, and 1A9.
Ispitivanja in vitro s humanim jetrenim mikrosomalnim enzimima pokazala su da prvenstveno CYP1A1, CYP1A2, CYP2C8 ili CYP2C9 stvaraju te oksidacijske metabolite, a UGT 1A1, 1A8, i 1A9 prvenstveno stvaraju febuksostat glukuronid.
42 film-coated tablets
42 filmom obložene tablete
Febuxostat should not be used during pregnancy.
Febuksostat ne treba koristiti tijekom trudnoće.