natgillin/translations-raw huggingface dataset:
The results of the study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline.
Rezultati ispitivanja su pokazali da istodobna primjena 80 mg febuksostata jednom dnevno i jednokratne doze teofilina od 400 mg ne utječe na farmakokinetiku ili sigurnost primjene teofilina.
Absolute bioavailability of the febuxostat tablet formulation has not been studied.
Nije ispitivana apsolutna bioraspoloživost febuksostata u obliku tableta.
CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease.
Dugotrajna ispitivanja nakon stavljanja lijeka u promet CARES ispitivanje bilo je multicentrično, randomizirano, dvostruko slijepo ispitivanje neinferiornosti koje je uspoređivalo kardiovaskularne (KV) ishode pri liječenju febuksostatom s ishodima pri liječenju alopurinolom kod bolesnika s gihtom i težom KV bolešću u anamnezi, uključujući infarkt miokarda, hospitalizaciju zbog nestabilne angine, postupak koronarne ili cerebralne revaskularizacije, moždani udar, tranzitornu ishemijsku ataku s hospitalizacijom, perifernu vaskularnu bolest ili dijabetes melitus s dokazima mikrovaskularne ili makrovaskularne bolesti.
Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Hipertenzija, naleti crvenila, naleti vrućine, krvarenje (vidjeti dio Sindrom tumorske lize)
Febuxostat is eliminated by both hepatic and renal pathways.
Febuksostat se eliminira putem jetre i bubrega.
• mouth ulceration
• ulceracije u ustima
Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Colloidal hydrated silica Colloidal anhydrous silica Crospovidone Talc
Jezgra tablete laktoza celuloza, mikrokristalična magnezijev stearat hidroksipropilceluloza karmelozanatrij, umrežena koloidni hidratizirani silicijev dioksid koloidni bezvodni silicijev dioksid krospovidon talk
Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.
Ne preporučuje se primjena febuksostata kod bolesnika istodobno liječenih merkaptopurinom/ azatioprinom, jer inhibicija ksantin oksidaze febuksostatom može uzrokovati povišene koncentracije merkaptopurina/azatioprina u plazmi, što može rezultirati teškom toksičnošću.
Febuxostat Mylan works by reducing uric acid levels.
Febuxostat Mylan djeluje tako da smanjuje razinu mokraćne kiseline.
Continuous treatment with febuxostat decreases frequency and intensity of gout flares.
Kontinuirano liječenje febuksostatom smanjuje učestalost i jačinu napada gihta.
Abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort Rare
Bol u abdomenu, distenzija abdomena, bolest gastroezofagealnog refluksa, povraćanje, suha usta, dispepsija, konstipacija, česte stolice, flatulencija, gastrointestinalna nelagoda Rijetko
Common side effects (may affect up to 1 in 10 people) are:
Česte nuspojave (mogu se pojaviti kod manje od 1 na 10 osoba) su:
The proportion of patients with serum urate levels of < 6.0 mg/dL (357 µmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively.
Udio bolesnika s razinom urata u serumu <6,0 mg/dl (357 µmol/l) na završnoj kontroli bio je 45% za febuksostat od 40 mg, 67% za febuksostat od 80 mg i 42% za alopurinol od 300/200 mg.
Rare Anaphylactic reaction*, drug hypersensitivity*
Anafilaktička reakcija*, preosjetljivost na lijek*
(PVC/oPA/Alu)/Alu blisters of 14, 28, 42 tablets, calendar blisters of 28 tablets and perforated unit dose blisters of 28 x 1 tablets and multipacks of 84 (2 packs of 42) tablets.
(PVC/oPA/Al)/Al blisteri s 14, 28, 42 tablete, kalendarski blisteri s 28 tableta i perforirani blisteri djeljivi na jedinične doze s 28 × 1 tabletom i multipakiranja s 84 (2 pakiranja po 42) tablete.
Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
Imajte na umu da tijekom liječenja možete osjetiti omaglicu, pospanost, zamućeni vid i utrnulost ili trnce.
• muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm
• grčevi u mišićima, slabost mišića, tupi bolovi/probadanje u mišićima/zglobovima, burzitis ili artritis (upala zglobova obično praćena bolovima, otokom i/ili ukočenošću), bol u udovima, bol u leđima, grč mišića
Mean AUC sUA1-8 (mgxh/dl) was significantly lower with febuxostat (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600 ; -154.988]; p < .0001).
Srednja AUC sMK1-8 (mgxh/dl) bila je značajno niža s febuksostatom (514,0 ± 225,71 naspram 708,0 ± 234,42; razlika srednjih vrijednosti procijenjena metodom najmanjih kvadrata: -196,794 [95%-tni interval pouzdanosti: -238,600 ; -154,988]; p <0,0001).
On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended.
S obzirom na mehanizam djelovanja febuksostata na inhibiciju ksantin oksidaze (XO), istodobna primjena se ne preporučuje.
Febuxostat Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Febuxostat Mylan sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Mylan je indiciran za liječenje kronične hiperuricemije, u stanjima kada je već došlo do taloženja urata (uključujući prisutnost tofa i/ili uričnog artritisa, trenutno ili u anamnezi).
Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases.
Teške reakcije preosjetljivosti, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS), su u nekim slučajevima uključivale vrućicu, hematološke promjene, zahvaćanje bubrega ili jetre.
In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble.
Kod nekih se ljudi mokraćna kiselina u krvi nakuplja u prevelikoj količini što ometa njezinu topivost.
In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat.
Kod zdravih ispitanika maksimalne koncentracije u plazmi (Cmax) i područje ispod krivulje (AUC) febuksostata povećavali su se proporcionalno dozi nakon jednokratnih i ponovljenih doza od 10 mg do 120 mg.
For oral use.
Za primjenu kroz usta.
Uncommon Blood thyroid stimulating hormone increased
Manje često Povišen tiroidni stimulirajući hormon u krvi
For bottles: After first opening use within 180 days
Za boce: nakon prvog otvaranja iskoristiti u roku od 180 dana
Patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome treated with febuxostat should be under cardiac monitoring as clinically appropriate.
Bolesnicima liječenim febuksostatom koji su podvrgnuti kemoterapiji zbog hematoloških zloćudnih bolesti i imaju srednje visoki do visoki rizik od nastajanja sindroma tumorske lize treba pažljivo pratiti rad srca kako je klinički prikladno.
Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Tablica 2 Udio bolesnika s razinama mokraćne kiseline u serumu <6,0 mg/dl (357 µmol/l) u zadnje tri mjesečne kontrole
Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness
Rabdomioliza*, ukočenost zglobova, mišićno-koštana ukočenost
Cardio-vascular disorders
Kardiovaskularni poremećaji
If you forget to take Febuxostat Mylan
Ako ste zaboravili uzeti Febuxostat Mylan
• cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis
• kašalj, nedostatak daha, nelagoda ili bolovi u prsištu, upala nosne sluznice i/ili grla (infekcija gornjega dišnog sustava), bronhitis
It is unknown whether febuxostat is excreted in human breast milk.
Nije poznato izlučuje li se febuksostat u majčino mlijeko u ljudi.
• stones in the gallbladder or in bile ducts (cholelithiasis)
• kamenci u žučnom mjehuru ili žučnim vodovima (kolelitijaza)
widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson
nekroza i odvajanje gornjeg sloja kože i sluznica sa stvaranjem mjehura, što rezultira ljuštenjem i mogućom sepsom (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza)
One thousand and seventy-two (1072) patients were randomized: placebo (n=134), febuxostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine ≤1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine >1.5 mg/dL and ≤2.0 mg/dL).
Tisuću i sedamdeset dva (1072) bolesnika su randomizirana te su primali: placebo (n = 134), febuksostat 80 mg jednom dnevno (n = 267), febuksostat 120 mg jednom dnevno (n = 269), febuksostat 240 mg jednom dnevno (n = 134) ili alopurinol (300 mg jednom dnevno [n = 258] kod bolesnika s početnom razinom kreatinina u serumu 1,5 mg/dl ili 100 mg jednom dnevno [n = 10] kod bolesnika s početnom razinom kreatinina u serumu >1,5 mg/dl i 2,0 mg/dl).
Febuxostat should not be used while breastfeeding.
Febuksostat ne treba koristiti tijekom dojenja.
Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis Rare
Artralgija, artritis, mialgija, bolovi u mišićima i kostima, slabost mišića, grčevi u mišićima, napetost mišića, burzitis Rijetko
Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. At therapeutic concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase.
U terapijskim koncentracijama febuksostat ne inhibira druge enzime uključene u metabolizam purina ili pirimidina, tj. gvanin deaminazu, hipoksantin gvanin fosforiboziltransferazu, orotat fosforiboziltransferazu, orotidin monofosfat dekarboksilazu i purin nukleozid fosforilazu.
No significant difference in mean serum creatinine change (%) occurred between febuxostat and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467 ; 8.8406]; p=0.0903).
Nije bilo značajne razlike u promjeni srednje vrijednosti serumskog kreatinina (%) između febuksostata i alopurinola (-0,83 ± 26,98 odnosno -4,92 ± 16,70); razlika srednjih vrijednosti procijenjena metodom najmanjih kvadrata: 4,0970 [95%-tni interval pouzdanosti: -0,6467 ; 8,8406]; p=0,0903).
* p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
p < 0,001 u odnosu na 80 mg
Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms and rare events of sudden cardiac death, have occurred in the post-marketing experience.
Nakon stavljanja lijeka u promet rijetko su se pojavile ozbiljne reakcije preosjetljivosti na febuksostat, od kojih su neke imale sustavne simptome, te su rijetko zabilježeni događaji iznenadne srčane smrti.
The rates of the other MACE events were similar in the febuxostat and allopurinol groups, i.e. non-fatal MI (3.6% vs. 3.8% of patients; HR 0.93; 95% CI 0.72-1.21), non-fatal stroke (2.3% vs. 2.3% of patients; HR 1.01; 95% CI 0.73-1.41) and urgent revascularization due to unstable angina (1.6% vs. 1.8% of patients; HR 0.86; 95% CI 0.59-1.26).
Stope drugih MACE događaja bile su slične u skupini febuksostata i skupini alopurinola, odnosno: nefatalni infarkt miokarda (3,6% u odnosu na 3,8% bolesnika; HR 0,93; 95% CI 0,72 - 1,21), nefatalni moždani udar (2,3% u odnosu na 2,3% bolesnika; HR 1,01; 95% CI 0,73 - 1,41) i hitna revaskularizacija zbog nestabilne angine (1,6% u odnosu na 1,8% bolesnika; HR 0,86; 95% CI 0,59 - 1,26).
116 patients were enrolled and received initially febuxostat 80 mg QD.
Bilo je uključeno 116 bolesnika koji su inicijalno dobivali febuksostat 80 mg jednom dnevno.
• blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly
• krv u mokraći, učestalo mokrenje, abnormalni nalazi mokraće (povećana razina proteina u mokraći), smanjenje bubrežne funkcije
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema.
Najčešće prijavljivane nuspojave u kliničkim ispitivanjima (4072 ispitanika primila su barem jednu dozu od 10 mg do 300 mg) i nakon stavljanja lijeka u promet su napadi gihta, poremećaji jetrene funkcije, proljev, mučnina, glavobolja, osip i edem.
Reproductive system and breast disorder
Poremećaji reproduktivnog sustava i dojki
Excipient with known effect Each tablet contains 354.0 mg of lactose
Jedna tableta sadrži 354,0 mg laktoze
Febuxostat achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups.
Febuksostat je postigao primarni ishod djelotvornosti kod 44% (80 mg jednom dnevno), 45% (120 mg jednom dnevno) i 60% (240 mg jednom dnevno) bolesnika, u usporedbi s 0% u skupinama koje su primale alopurinol 100 mg jednom dnevno i placebo.
Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects.
Tijekom posljednja 4 tjedna ispitivanja (24. - 28. tjedan) primijećeni su akutni napadi gihta kod 15% (febuksostat 80, 120 mg), 14% (alopurinol 300 mg) i 20% (placebo) ispitanika.
• high fever in combination with measles-like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood
• visoka vrućica u kombinaciji s kožnim osipom poput ospica, povećani limfni čvorovi, povećana jetra, hepatitis (sve do zatajenja jetre), povećani broj bijelih krvnih stanica (leukocitoza, s ili bez eozinofilije)
Febuxostat Mylan tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Febuxostat Mylan tablete sadrže manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
Uncommon side effects (may affect up to 1 in 100 people) are:
Manje česte nuspojave (mogu se pojaviti kod manje od 1 na 100 osoba) su:
In the analysis of the individual components of MACE, the rate of CV deaths was higher with febuxostat than allopurinol (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
U analizi pojedinačnih MACE komponenti, stopa KV smrti bila je viša na febuksostatu nego na alopurinolu (4,3% u odnosu na 3,2% bolesnika; HR 1,34; 95% CI 1,03 - 1,73).
The rate of all-cause mortality was also higher with febuxostat than allopurinol (7.8% vs. 6.4% of patients; HR 1.22; 95% CI 1.01-1.47), which was mainly driven by the higher rate of CV deaths in that group (see section 4.4).
Stopa smrtnosti zbog bilo kojeg uzroka također je bila viša u skupini febuksostata nego u skupini alopurinola (7,8% u odnosu na 6,4% bolesnika; HR 1,22; 95% CI 1,01 - 1,47), što je uglavnom bilo uzrokovano višom stopom KV smrti u toj skupini (vidjeti dio 4.4.).
Investigations
Ispitivanje
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema.
Najčešće prijavljivane nuspojave u kliničkim ispitivanjima (4072 ispitanika primila su barem jednu dozu od 10 mg do 300 mg) i nakon stavljanja lijeka u promet kod bolesnika s gihtom su napadi gihta, poremećaji jetrene funkcije, proljev, mučnina, glavobolja, osip i edem.
Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects.
Tijekom posljednja 4 tjedna ispitivanja (49. -52. tjedan) primijećeni su akutni napadi gihta kod 6 do 8% (febuksostat 80 mg, 120 mg) i 11% (alopurinol 300 mg) ispitanika.
INR and Factor VII activity were also not affected by the co-administration of febuxostat.
Nije bilo utjecaja na INR i aktivnost faktora zgrušavanja VII kod istodobne primjene febuksostata.
For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
Kod ispitanika s oštećenom funkcijom bubrega koji su randomizirani u skupinu liječenu alopurinolom, najviša doza bila je 100 mg jednom dnevno.
Each tablet contains 80 mg or 120 mg of febuxostat.
Jedna tableta sadrži 80 mg ili 120 mg febuksostata.
Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol.
Neki od tih bolesnika imali su oštećenje funkcije bubrega i/ili su ranije prijavili preosjetljivost na alopurinol.
Following an 80 mg oral dose of C- labeled febuxostat, approximately 49% of the dose was recovered in the urine as unchanged febuxostat (3%), the acyl glucuronide of the active substance (30%), its known oxidative metabolites and their conjugates (13%), and other unknown metabolites (3%).
C, oko 49% doze je nađeno u urinu u obliku nepromijenjenog febuksostata (3%), acil glukuronida djelatne tvari (30%), poznatih oksidacijskih metabolita i njihovih konjugata (13%) i drugih nepoznatih metabolita (3%).
The 120 mg tablets are marked with M on one side of the tablet and FX4 on the other side.
S jedne strane tableta od 120 mg nalazi se oznaka M, a s druge strane oznaka FX4.
Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28.
Akutni napadi gihta liječeni su kod 46% do 55% ispitanika od 8. do 28. tjedna.
Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro.
Febuksostat se in vitro pokazao kao slabi inhibitor CYP2C8.
• dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
• suha usta, bol/nelagoda u trbuhu ili vjetrovi, žgaravica/probavne tegobe, zatvor, češće stolice, povraćanje, osjećaj nelagode u želucu
Tumor Lysis Syndrome The recommended oral dose of Febuxostat Mylan is 120 mg once daily without regard to food.
Preporučena peroralna doza lijeka Febuxostat Mylan je 120 mg jednom dnevno, neovisno o unosu hrane.
• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals,
• jako oticanje dubljih slojeva kože, osobito oko usana, očiju, genitalija, ruku, stopala ili jezika, s mogućom iznenadnom pojavom otežanog disanja
Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular Rare
Dermatitis, urtikarija, pruritus, diskoloracija kože, kožne lezije, petehije, makularni osip, makulopapularni osip, papularni osip Rijetko
Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience in gout patients.
Tablica 1: Nuspojave u fazi 3 dugoročnih produžetaka ispitivanja i nakon stavljanja lijeka u promet kod bolesnika s gihtom
Oedema
Edem
Excipient with known effect Each tablet contains 236.0 mg of lactose.
Jedna tableta sadrži 236,0 mg laktoze.
Febuxostat 80 mg
Febuksostat 80 mg
How to take Febuxostat Mylan
Kako uzimati Febuxostat Mylan
Cardiac disorders: Uncommon: Left bundle branch block, sinus tachycardia
Srčani poremećaji: Manje često: blok lijeve grane snopa, sinusna tahikardija
In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0% in the placebo groups.
U ovoj podskupini febuksostat je postigao primarni ishod djelotvornosti (razina mokraćne kiseline u serumu <6,0 mg/dl kod zadnje 3 kontrole) kod 41% (80 mg jednom dnevno), 48% (120 mg jednom dnevno) i 66% (240 mg jednom dnevno) bolesnika, u usporedbi s 9% u skupini koja je primala alopurinol 300 mg/100 mg jednom dnevno i 0% u skupini koja je primala placebo.
The primary MACE endpoint occurred at similar rates in the febuxostat and allopurinol treatment groups (10.8% vs. 10.4% of patients, respectively; hazard ratio [HR] 1.03; two-sided repeated 95% confidence interval [CI] 0.87-1.23).
Primarna mjera ishoda za MACE pojavila se sa sličnom stopom u skupini na febuksostatu i skupini na alopurinolu (10,8% u odnosu na 10,4% bolesnika; omjer rizika [engl. hazard ratio, HR] 1,03; dvostrani 95% ponovljeni interval pouzdanosti [engl. confidence interval, CI] 0,87 - 1,23).
The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average postbaseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20 - Week 24 to Week 49 - 52 intervals).
Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (ispitivanja APEX i FACT) bio je brojčano manji u skupinama kod kojih je nakon početka liječenja postignuta prosječna razina urata u serumu <6,0 mg/dl, <5,0 mg/dl, ili <4,0 mg/dl, u usporedbi sa skupinom kod koje je nakon početka liječenja postignuta prosječna razina urata u serumu ≥6,0 mg/dl tijekom posljednja 32 tjedna liječenja (u intervalima od 20. - 24. tjedna do 49. - 52. tjedna).
In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively.
Tijekom dugotrajnih produžetaka kliničkih ispitivanja incidencija APTC kardiovaskularnih događaja koje su prijavili ispitivači bila je 1,2 događaja na 100 bolesnik/godina u skupini koja je primala febuksostat odnosno 0,6 događaja na 100 bolesnik/godina u skupini na alopurinolu.
The gout flare should be managed concurrently as appropriate for the individual patient.
Istodobno treba liječiti napad gihta, individualnim pristupom ovisno o bolesniku.
A yellow, capsule shaped, biconvex tablet, approximately 18 x 8 mm, debossed with M on one side of the tablet and FX4 on the other side.
Žuta, bikonveksna tableta u obliku kapsule, približne veličine 18 × 8 mm s utisnutom oznakom
When this happens, urate crystals may form in and around the joints and kidneys.
Kad se to dogodi, u zglobovima, bubrezima i okolnim tkivima se mogu stvarati kristali urata.
The 80 mg tablets are marked with M on one side of the tablet and FX3 on the other side.
S jedne strane tableta od 80 mg nalazi se oznaka M, a s druge strane oznaka FX3.
How to store Febuxostat Mylan
Kako čuvati Febuxostat Mylan