natgillin/translations-raw huggingface dataset:
Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
Pokazalo se da istodobni unos antacida koji sadržavaju magnezijev hidroksid i aluminijev hidroksid odgađa apsorpciju febuksostata (za oko 1 sat) i dovodi do 32-postotnog smanjenja Cmax, ali nisu uočene značajne promjene AUC-a.
Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with febuxostat 40-240 mg QD.
Farmakokinetičke/farmakodinamičke analize provedene su na populaciji od 211 bolesnika s hiperuricemijom i gihtom, liječenih febuksostatom 40-240 mg jednom dnevno.
Antacids
Antacidi
The endpoints (primary and secondary) were analysed according to the intention-to-treat (ITT) analysis including all subjects who were randomized and received at least one dose of doubleblind study medication.
Mjere ishoda (primarne i sekundarne) analizirane su u populaciji predviđenoj za liječenje (engl. intent to treat, ITT), koja je uključivala sve ispitanike koji su bili randomizirani i koji su primili barem jednu dozu lijeka u dvostruko slijepom ispitivanju.
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Terapijski cilj je smanjiti i održavati razine mokraćne kiseline u serumu ispod 6 mg/dl (357 μmol/l).
The rash may progress to widespread blistering or peeling of the skin.
Osip može napredovati do pojave mjehura rasprostranjenih svuda po koži ili do ljuštenja kože.
Febuxostat at oral doses up to 48 mg/kg/day was found to have no effect on fertility and reproductive performance of male and female rats.
Utvrđeno je da febuksostat u oralnim dozama od 48 mg/kg/dnevno nema utjecaja na plodnost i reproduktivnu učinkovitost mužjaka i ženki štakora.
These tophi may cause joint and bone damage.
Tofi mogu uzrokovati oštećenje zglobova i kostiju.
Naproxen and other inhibitors of glucuronidation
Naproksen i drugi inhibitori glukuronidacije
Gout flares were commonly observed soon after the start of treatment and during the first months.
Napadi gihta su često primijećeni odmah na početku i tijekom prvih mjeseci liječenja.
Therefore no special caution is advised when febuxostat 80 mg and theophylline are given concomitantly.
Stoga nema posebnih mjera opreza pri istodobnoj primjeni febuksostata od 80 mg i teofilina.
If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Mylan at any time.
Ako se tijekom primjene febuksostata razvio Stevens-Johnsonov sindrom, ne smijete više nikada započeti terapiju lijekom Febuxostat Mylan.
In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3).
Ispitivanje utjecaja na reprodukciju kod životinja, u dozama do 48 mg/kg/dnevno, nisu pokazala nepovoljan učinak na plodnost ovisan o dozi (vidjeti dio 5.3).
Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Mokraćna kiselina je krajnji proizvod metabolizma purina kod ljudi i stvara se u kaskadi hipoksantin → ksantin → mokraćna kiselina.
Weight decrease, increase appetite, anorexia
Smanjenje tjelesne težine, pojačan apetit, anoreksija
Xanthine deposition
Taloženje ksantina
In each phase 3 pivotal study, febuxostat demonstrated superior ability to lower and maintain serum uric acid levels compared to allopurinol.
U svakom pivotalnom ispitivanju faze 3, febuksostat je pokazao superiornu sposobnost snižavanja i održavanja razina mokraćne kiseline u serumu u usporedbi s alopurinolom.
In patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Kod bolesnika kod kojih je brzina stvaranja urata znatno povećana (npr. maligna bolest i njezino liječenje, Lesch-Nyhanov sindrom), apsolutna koncentracija ksantina u urinu u rijetkim se slučajevima može povećati u dovoljnoj mjeri da uslijedi njegovo taloženje u urinarnom traktu.
Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Febuksostat se opsežno metabolizira konjugacijom putem sustava enzima uridin difosfat glukuronoziltransferaze (UDPGT) i oksidacijom putem sustava citokroma P450 (CYP).
Hepatitis, jaundice*, liver injury*
Hepatitis, žutica*, oštećenje jetre*
Mean (±SEM) Serum Uric Acid Level (mg/dL)
Srednja vrijednost (±SEM) razine mokraćne kiseline u serumu (mg/dL)
FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
FOCUS ispitivanje (TMX-01-005) bilo je otvoreno, multicentrično, produljeno ispitivanje sigurnosti faze 2 u trajanju od 5 godina za bolesnike koji su završili 4 tjedna dvostruko slijepog ispitivanja doziranja febuksostata TMX-00-004.
These adverse reactions were mostly mild or moderate in severity.
Ove nuspojave su većinom bile blage ili umjerene.
Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase
Dijabetes melitus, hiperlipidemija, smanjen apetit, povećanje tjelesne težine
Other medicines and Febuxostat Mylan
Drugi lijekovi i Febuxostat Mylan
If you take more Febuxostat Mylan than you should
Ako uzmete više lijeka Febuxostat Mylan nego što ste trebali
No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C).
Nisu provedena ispitivanja kod bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
Incidence of overall treatmentemergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively.
Incidencija svih znakova i simptoma te nuspojava opaženih nakon početka liječenja bila je 67,6% naspram 64,7% i 6,4% naspram 6,4% na febuksostatu odnosno na alopurinolu.
Nervousness
Nervoza
Teratology studies, performed in pregnant rats at approximately 4.3 times and pregnant rabbits at approximately 13 times human exposure did not reveal any teratogenic effects.
U ispitivanjima teratogenosti, provedenima na gravidnim štakoricama uz dozu od oko 4,3 puta veću od izloženosti kod ljudi i na gravidnim zečicama uz dozu oko 13 puta veću od izloženosti kod ljudi, nisu otkriveni teratogeni učinci.
Continue to take Febuxostat Mylan every day even when you are not experiencing gout flare or attack.
Nastavite uzimati Febuxostat Mylan svaki dan, čak i ako nemate napade gihta.
Gout flare prophylaxis is recommended (see section 4.2 and 4.4).
Preporučuje se profilaksa napadaja gihta (vidjeti dijelove 4.2 i 4.4).
Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity.
Inhibicija XO febuksostatom može uzrokovati porast koncentracije tih lijekova u plazmi, što dovodi do toksičnosti.
Rare Pancytopenia, thrombocytopenia, agranulocytosis*
Pancitopenija, trombocitopenija, agranulocitoza*
• liver damage
• oštećenje jetre
Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate/high risk of Tumor Lysis Syndrome were included.
Ukupno je bilo uključeno 346 bolesnika s hematološkim zloćudnim bolestima koji su podvrgnuti kemoterapiji i imaju srednje visoki/visoki rizik od nastajanja sindroma tumorske lize.
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Kako nema iskustva o primjeni febuksostata, ne preporučuje se njegova primjena kod bolenika s Lesch-Nyhanovim sindromom.
In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group.
U randomiziranom, dvostruko slijepom pivotalnom ispitivanju faze 3 FLORENCE (FLO-01) u kojem se uspoređivao febuksostat i alopurinol (346 bolesnika podvrgnutih kemoterapiji za hematološke zloćudne bolesti i sa srednje visokim do visokim rizikom od nastajanja STL-a), samo je ukupno 22 (6,4%) bolesnika imalo nuspojave, to jest po 11 (6,4%) u svakoj terapijskoj skupini.
What Febuxostat Mylan looks like and contents of the pack
Kako Febuxostat Mylan izgleda i sadržaj pakiranja
In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
U dodatnom ispitivanju faze 3, CONFIRMS, za koje su rezultati postali dostupni nakon odobrenja za stavljanje febuksostata u promet, primarni ishod ispitivanja bio je omjer bolesnika kod kojih je na zadnjoj kontroli razina urata u serumu bila < 6,0 mg/dl.
Effects in non-clinical studies were generally observed at exposures in excess of the maximum human exposure.
U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi.
• hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, seen only in patients taking chemotherapy for blood disorders)
• navale vrućine ili navale crvenila (npr. crvenilo lica ili vrata), povišen krvni tlak, krvarenje (hemoragija, primijećeno samo kod bolesnika koji dobivaju kemoterapiju za poremećaje krvi)
However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested (80 mg multiple dose).
Međutim, tijekom ispitivanja nije uočena klinički značajna promjena postotka sniženja koncentracije mokraćne kiseline u serumu kad je bila ispitivana (višekratne doze od 80 mg).
Marketing Authorisation Holder Mylan S.A.S.
Nositelj odobrenja za stavljanje lijeka u promet Mylan S.A.S.
Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis.
Liječenje febuksostatom treba odmah prekinuti ukoliko se pojave ozbiljne alergijske reakcije/reakcije preosjetljivosti, uključujući Stevens-Johnsonov sindrom, jer je raniji prekid liječenja povezan s boljom prognozom.
Drug interaction studies of febuxostat with drugs (except theophylline) that are metabolized by XO have not been performed in humans.
Nisu provedena ispitivanja interakcije febuksostata i lijekova (osim teofilina) koji se metaboliziraju posredstvom XO u ljudi.
Rash (including various types of rash reported with lower frequencies, see below)
Osip (uključujući razne tipove osipa s manjom učestalošću, vidjeti niže u tekstu)
• localised swelling due to retention of fluids in tissues (oedema)
• lokalizirano oticanje radi zadržavanja tekućina u tkivima (edem).
Animal studies have shown excretion of this active substance in breast milk and an impaired development of suckling pups.
Ispitivanja na životinjama pokazala su da se ta djelatna tvar izlučuje u mlijeko i da je usporen razvoj dojenih mladunaca.
However, no dose adjustment is necessary in patients with mild or moderate renal impairment.
Međutim, nije potrebno prilagođavanje doze kod bolesnika s blagim ili umjerenim oštećenjem bubrega.
Febuxostat C showed a superior and faster urate lowering activity compared to allopurinol.
Febuksostat C je pokazao superiorno i brže djelovanje na sniženje urata u odnosu na alopurinol.
• nervousness
• nervoza
In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with febuxostat for Tumor Lysis Syndrome.
Kod bolesnika s vrlo visokom razinom urata (npr. onih koji su podvrgnuti kemoterapiji za rak), liječenje lijekovima koji snižavaju razinu mokraćne kiseline može dovesti do porasta ksantina u mokraćnom sustavu, s mogućim stvaranjem kamenaca, iako to nije opaženo kod bolesnika liječenih febuksostatom kod sindroma tumorske lize.
CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia.
CONFIRMS ispitivanje: CONFIRMS ispitivanje bilo je randomizirano, kontrolirano ispitivanje faze 3 u trajanju od 26 tjedana, kako bi se procijenile sigurnost i djelotvornost febuksostata od 40 mg i 80 mg u odnosu na alopurinol od 300 mg ili 200 mg kod bolesnika s gihtom ili hiperuricemijom.
In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
U pivotalnom ispitivanju sindroma tumorske lize primjenjivao se febuksostat u dozi od 120 mg dnevno kod bolesnika koji su podvrgnuti različitim kemoterapijskim režimima, uključujući i monoklonska protutijela.
Prevention and treatment of hyperuricaemia in patients at risk of TLS
Prevencija i liječenje hiperuricemije kod bolesnika koji imaju rizik od nastajanja STL-a
Increased TSH values (>5.5 µIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) in the long term open label extension studies.
Povećane vrijednosti TSH-a (>5,5 µIU/ml) uočene su kod bolesnika dugotrajno liječenih febuksostatom (5,5%) tijekom dugoročnih produljenih otvorenih ispitivanja.
A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Brojčano veća incidencija kardiovaskularnih APTC događaja koje su prijavili ispitivači (definirane mjere ishoda Anti-Platelet Trialists' Collaboration (APTC), uključujući kardiovaskularnu smrt, nefatalni infarkt miokarda, nefatalni moždani udar) uočena je u ukupnoj skupini koja je primala febuksostat, u usporedbi sa skupinom koja je primala alopurinol, u ispitivanjima APEX i FACT (1,3 u odnosu na 0,3 događaja na 100 bolesnik/godina), ali ne i u CONFIRMS ispitivanju (vidjeti dio 5.1 za detaljne karakteristike ispitivanja).
Febuxostat Mylan works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Febuxostat Mylan djeluje dovoljno brzo da se ponovno mjerenje mokraćne kiseline u serumu može provesti nakon 2 tjedna.
Thus, co-administration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Zato se ne očekuje da će istodobna primjena febuksostata s drugim supstratima CYP2D6 zahtijevati prilagođavanje doze tih spojeva.
Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).
Ovojnica: hipromeloza, titanijev dioksid (E171), etilceluloza, žuti željezov oksid (E172), triacetin i crni željezov oksid (E172).
Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Potreban je oprez pri primjeni febuksostata kod bolesnika s promijenjenom funkcijom štitne žlijezde (vidjeti dio 5.1).
If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat Mylan 120 mg once daily may be considered.
Ako je nakon 2 do 4 tjedna mokraćna kiselina u serumu > 6 mg/dl (357 µmol/l), može se razmotriti primjena 120 mg lijeka Febuxostat Mylan jednom dnevno.
• decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels, weight increase
• smanjen apetit, promjene razine šećera u krvi (dijabetes), simptom kojeg može biti jaka žeđ,
Febuxostat Mylan tablets contain lactose.
Febuxostat Mylan tablete sadrže laktozu.
• Theophylline (used to treat asthma)
• teofilin (koristi se za liječenje astme).
Co-administration of febuxostat 80 mg and theophylline 400 mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5).
Istodobna primjena 80 mg febuksostata i jednokratne doze teofilina od 400 mg kod zdravih ispitanika pokazala je da nema farmakokinetičkih interakcija (vidjeti dio 4.5).
Tubulointerstitial nephritis*, micturition urgency
Tubulointersticijalni nefritis*, urgencija mokrenja
Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Primjena febuksostata (80 mg ili 120 mg jednom dnevno) s varfarinom nije utjecala na farmakokinetiku varfarina kod zdravih ispitanika.
Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies
Srednje vrijednosti razine mokraćne kiseline u serumu u kombiniranim pivotalnim ispitivanjima faze 3
Febuxostat Mylan is indicated in adults.
Febuxostat Mylan je indiciran kod odraslih.
After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.05.3 µg/mL, respectively.
Nakon jednokratne ili višekratne doze od 80 i 120 mg primijenjene peroralno jednom dnevno Cmax je oko 2,8-3,2 µg/ml, odnosno 5,0-5,3 µg/ml.
These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack).
Nakupljanje kristala urata može uzrokovati naglo nastalu jaku bol, crvenilo, toplinu i oticanje zgloba (što je poznato kao napad gihta).
Gout flare prophylaxis of at least 6 months is recommended (see section 4.4).
Preporučuje se profilaksa napada gihta u trajanju od najmanje 6 mjeseci (vidjeti dio 4.4).
As there has been no experience with febuxostat, its use in these populations is not recommended.
Kako nema iskustva o primjeni febuksostata, ne preporučuje se njegova primjena kod te populacije bolesnika.
Increased TSH values (>5.5 µIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) and patients with allopurinol (5.8%) in the long term open label extension studies (see section 4.4).
Povećane vrijednosti TSH-a (>5,5 µIU/ml) uočene su kod bolesnika na dugotrajnom liječenju febuksostatom (5,5%) i kod bolesnika liječenih alopurinolom (5,8%) u dugoročnim, otvorenim, produljenim ispitivanjima (vidjeti dio 4.4).
Febuxostat Mylan tablets contain lactose (a type of sugar).
Febuxostat Mylan tablete sadrže laktozu (vrstu šećera).
Eligible patients had to be candidates for allopurinol treatment or have no access to rasburicase.
Bolesnici koji su zadovoljavali uvjete uključivanja u ispitivanje morali su biti kandidati za liječenje alopurinolom ili nisu imali pristup razburikazi.
The apparent steady state volume of distribution (Vss/F) of febuxostat ranges from 29 to 75 L after oral doses of 10-300 mg.
Prividni volumen distribucije febuksostata u stanju dinamičke ravnoteže (Vss/F) je u rasponu od 29 do 75 l nakon peroralno primijenjenih doza od 10 do 300 mg.
Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets.
Febuxostat Mylan filmom obložene tablete žute su bikonveksne tablete u obliku kapsule.
• If you have thyroid problems.
• ako imate problema sa štitnjačom.
HDPE bottle with polypropylene (PP) screw cap closure with desiccant containing 28 or 84 tablets.
Boca od polietilena visoke gustoće s polipropilenskim (PP) navojnim čepom sa sredstvom za sušenje, koja sadržava 28 ili 84 tablete.
Lactose and Sodium content
Sadržaj laktoze i natrija
Febuxostat Mylan is for adults.
Mylan je za odrasle.
• increase in blood thyroid stimulating hormone (TSH) level
• povišena razina tiroidnog stimulirajućeg hormona (TSH) u krvi
Treatment with febuxostat in patients with pre-existing major cardiovascular diseases (e.g. myocardial infarction, stroke or unstable angina) should be avoided, unless no other therapy options are appropriate.
U bolesnika s postojećom težom kardiovaskularnom bolešću (npr. infarkt miokarda, moždani udar ili nestabilna angina) liječenje febuksostatom treba izbjegavati, osim u slučaju kada nijedno drugo liječenje nije prikladno.
Rare Blurred vision
Rijetko Zamagljen vid
• dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia)
• omaglica, utrnulost, trnci, smanjen ili promijenjen osjet (hipoestezija, hemipareza ili parestezija), promijenjen osjet okusa, smanjen osjet njuha (hiposmija)
EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT).
EXCEL ispitivanja (C02-021): Excel ispitivanje bilo je otvoreno, multicentrično, randomizirano ispitivanje faze 3 kontrolirano alopurinolom, produljeno ispitivanje sigurnosti za bolesnike koji su završili pivotalna ispitivanja faze 3 (APEX ili FACT).
The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study, described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Djelotvornost febuksostata dokazana je u tri pivotalna ispitivanja faze 3 (niže su opisana dva pivotalna ispitivanja APEX i FACT, i dodatno CONFIRMS ispitivanje) koja su provedena na 4101 bolesniku s hiperuricemijom i gihtom.
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Djelotvornost i sigurnost febuksostata nije ispitivana kod bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L).
Primarni ishod djelotvornosti u ispitivanjima APEX i FACT bio je omjer bolesnika kod kojih su razine mokraćne kiseline u serumu u posljednja 3 mjeseca bile < 6,0 mg/dl (357 µmol/l).
After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52).
Nakon 8 tjedana profilaktičkog razdoblja, incidencija akutnih napada gihta se povećavala i postupno smanjivala tijekom vremena (akutni napadi gihta liječeni su kod 64% i 70% ispitanika od 8. do 52. tjedna).
Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits (see sections 4.8 and 5.1).
Na početku liječenja mogu nastupiti akutni napadi gihta, zbog promjena razine mokraćne kiseline u serumu koja dovodi do mobilizacije urata nataloženih u tkivima (vidjeti dijelove 4.8 i 5.1).
(n=519) results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses.
(n=519) rezultati ispitanika koji su primali 100 mg jednom dnevno (n=10: bolesnici s kreatininom u serumu >1,5 i 2,0 mg/dl) ili 300 mg jednom dnevno (n=509) su zbrojeni za potrebe analize.
Salomone Pharma Ltd Tel: + 356 21 22 01 74
V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Flares increased following the prophylaxis period and gradually decreased over time.
Akutni napadi gihta bili su češći u profilaktičkom razdoblju, a zatim su s vremenom postupno postali rjeđi.
14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 84 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets (calendar) 84 film-coated tablets (calendar)
14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 84 filmom obložene tablete 28 × 1 filmom obložena tableta 28 filmom obloženih tableta (kalendar) 84 filmom obložene tablete (kalendar)