natgillin/translations-raw huggingface dataset:
In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3).
Plodnost Ispitivanje utjecaja na reprodukciju kod životinja, u dozama do 48 mg/kg/dnevno, nisu pokazala štetni učinak na plodnost ovisan o dozi (vidjeti dio 5.3).
You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.
Nemojte uzimati ADENURIC ako dojite ili planirate dojiti.
Each tablet contains 76.50 mg of lactose (as monohydrate)
Jedna tableta sadrži 76,50 mg laktoze (u obliku hidrata)
Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow:
Prestanite uzimati ovaj lijek i odmah se javite svom liječniku ili otiđite u najbližu ustanovu hitne medicinske pomoći ako se pojave sljedeće rijetke nuspojave (mogu se pojaviti kod manje od 1 na
No data comparing ADENURIC with rasburicase are currently available.
Trenutno nema dostupnih podataka o usporedbi ADENURICA i razburikaze.
Thus, ADENURIC may be taken without regard to food.
Dakle, ADENURIC se može uzimati neovisno o hrani.
The primary endpoint in CARES was the time to first occurrence of MACE, a composite of non-fatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization.
Primarna mjera ishoda u CARES-u bilo je vrijeme do prve pojave velikog kardiovaskularnog štetnog događaja (MACE), što je uključivalo nefatalni infarkt miokarda, nefatalni moždani udar, KV smrt i nestabilnu anginu s hitnom koronarnom revaskularizacijom.
Each tablet contains 114.75 mg of lactose (as monohydrate)
Jedna tableta sadrži 114,75 mg laktoze (u obliku hidrata).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ACLAR/ALUMINIUM OR PVC/PE/PVDC/ALUMINIUM BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC/ACLAR/ALUMINIJ ILI PVC/PE/PVDC/ALUMINIJ
Co-administration of febuxostat 80 mg and theophylline 400mg 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).
Tabulated list of adverse reactions Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)
Tablični prikaz nuspojava 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.
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 majčino mlijeko i da je usporen razvoj dojenih mladunaca.
ADENURIC is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
ADENURIC je indiciran za prevenciju i liječenje hiperuricemije kod odraslih bolesnika koji su podvrgnuti kemoterapiji za hematološke zloćudne bolesti i imaju srednje visoki do visoki rizik za nastajanje sindroma tumorske lize (STL).
• anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
• anafilaktičke reakcije, preosjetljivost na lijek (vidjeti i dio 2. Budite posebno oprezni s
ADENURIC works by reducing uric acid levels.
ADENURIC djeluje tako da smanjuje razinu mokraćne kiseline.
The efficacy of ADENURIC 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 ADENURICA 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.
*** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies.
*** Vidjeti dio 5.1 za incidenciju napada gihta u pojedinim randomiziranim ispitivanjima faze 3
If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Ako ste zaboravili uzeti tabletu ADENURICA, uzmite je čim se sjetite, osim ako je uskoro vrijeme za sljedeću tabletu.
Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies
Prosječne vrijednosti razine mokraćne kiseline u serumu u kombiniranim pivotalnim ispitivanjima faze 3
FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing ADENURIC 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level.
FLORENCE je bilo randomizirano (1:1), dvostruko slijepo pivotalno ispitivanje faze 3 u kojem se uspoređivao ADENURIC 120 mg jednom dnevno s alopurinolom 200 do 600 mg dnevno (srednja dnevna doza alopurinola [± standardna devijacija]: 349,7 ± 112,90 mg) s obzirom na kontrolu razine mokraćne kiseline u serumu.
In a study in healthy subjects, 120 mg ADENURIC QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo.
Tijekom ispitivanja na zdravim ispitanicima primjena 120 mg ADENURICA jednom dnevno dovela je do srednjeg povećanja od 22% površine ispod krivulje (AUC-a) desipramina, supstrata CYP2D6, što upućuje na moguće blago inhibicijsko djelovanje febuksostata na enzim CYP2D6 in vivo.
If you forget to take ADENURIC
Ako ste zaboravili uzeti ADENURIC
The 120 mg film-coated tablets are marked on one side with ‘120'.
S jedne strane filmom obloženih tableta od 120 mg nalazi se oznaka „120“.
The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 µg⋅h/mL in the normal renal function group to 13.2 µg.h/mL in the severe renal dysfunction group.
Srednji ukupni AUC febuksostata povećao se za oko 1,8 puta, sa 7,5 µg⋅h/ml u skupini s urednom funkcijom bubrega na 13,2 µg.h/ml u skupini s teškim oštećenjem funkcije bubrega.
ADENURIC 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).
ADENURIC 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).
Following multiple doses of 80 mg of ADENURIC in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function.
Nakon višekratnih doza od 80 mg ADENURICA kod bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, Cmax febuksostata nije bio promijenjen u odnosu na ispitanike s urednom funkcijom bubrega.
In the FLORENCE study ADENURIC demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug.
U FLORENCE ispitivanju ADENURIC je pokazao superiornu kontrolu razine mokraćne kiseline u serumu u odnosu na bolesnike na alopurinolu kod bolesnika koji su bili planirani za liječenje alopurinolom.
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 double-blind study medication.
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.
Following multiple doses of 80 mg of ADENURIC in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Nakon višekratnih doza od 80 mg ADENURICA kod bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre, Cmax i AUC febuksostata i njegovih metabolita nije bio značajno promijenjen u odnosu na ispitanike s urednom funkcijom jetre.
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.
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.
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side and a score line on the other side.
Blijedožute do žute, filmom obložene tablete u obliku kapsule, s utisnutom oznakom „80” s jedne strane i urezom na drugoj strani.
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side
Blijedožute do žute, filmom obložene tablete u obliku kapsule, s utisnutom oznakom „120” s jedne strane.
The 80 mg film-coated tablets are marked on one side with ‘80' and on the other side with a score line.
S jedne strane filmom obloženih tableta od 80 mg nalazi se oznaka „80“, a s druge strane se nalazi urez.
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.).
• 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 (leukocytosis, with or without eosinophilia)
• 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)
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 je u rasponu od 29 do 75 l nakon peroralno primijenjenih doza od 10 do 300 mg.
How to take ADENURIC
Kako uzimati ADENURIC
Mean (±SEM) Serum Uric Acid Level (mg/dL)
dnja vrijednost (±SEM) razine mokraćne kiseline u serumu (mg/dL)
• reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
• crvenilo kože (eritem), razne vrste osipa (npr. sa svrbežom, bijelim mrljama, mjehurima, mjehurima koji sadrže gnoj, ljuštenjem kože te osip poput ospica), rasprostranjeno crvenilo, nekroza i odvajanje gornjeg sloja kože i sluznica sa stvaranjem mjehura, što rezultira ljuštenjem i mogućom sepsom (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza)
Uncommon Blood thyroid stimulating hormone increased
Povišen tiroidni stimulirajući hormon u krvi
Serum urate levels were maintained over time (i.e. 91% and 93% of patients on initial treatment with febuxostat 80 mg and 120 mg, respectively, had sUA <6 mg/dL at Month 36).
Razine urata u serumu bile su održavane tijekom vremena (to jest 81% i 93% bolesnika koji su inicijalno liječeni febuksostatom 80 mg, odnosno 120 mg imali su mokraćnu kiselinu u serumu nižu od 6 mg/dl u 36. mjesecu).
Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic*, rash erythematous, rash morbillifom, alopecia, hyperhidrosis
angioedem*, reakcija na lijek s eozinofilijom i sustavnim simptomima*, generalizirani osip (ozbiljni)*, eritem, eksfolijativni osip, folikularni osip, vezikularni osip, pustularni osip, pruritični osip*, eritematozni osip, morbiliformni osip, alopecija, hiperhidroza
1 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.
1 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.
Gout: The recommended oral dose of ADENURIC is 80 mg once daily without regard to food.
Giht: preporučena peroralna doza ADENURICA je 80 mg jednom dnevno, neovisno o unosu hrane.
Primary endpoint in the sub-group of patients with renal impairment
Primarni ishod u podskupini bolesnika s oštećenjem funkcije bubrega
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.
With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408 ; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000).
Što se tiče sekundarnih ishoda, nisu opažene značajne razlike u incidenciji laboratorijskog STL-a (8,1% u skupini na ADENURICU, 9,2% u skupini na alopurinolu; relativni rizik 0,875 [95%-tni interval pouzdanosti: 0,4408 ; 1,7369]; p=0,8488 niti kliničkog STL-a (1,7% u skupini na ADENURICU, 1,2% u skupini na alopurinolu; relativni rizik 0,994 [95%-tni interval pouzdanosti: 0,9691 ; 1,0199]; p=1,0000).
Uncommon Dyspnoea, bronchitis, upper respiratory tract infection, cough
Dispneja, bronhitis, infekcija gornjega dišnog sustava, kašalj
Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Udio bolesnika s razinama mokraćne kiseline u serumu <6,0 mg/dl (357 µmol/l) Zadnje tri mjesečne kontrole
The recommended oral dose of ADENURIC is 80 mg once daily without regard to food.
Preporučena peroralna doza ADENURICA je 80 mg jednom dnevno, neovisno o unosu hrane.
No patients with organ transplant have been included in these studies (see section
U ta ispitivanja nisu bili uključeni bolesnici s transplantiranim organima (vidjeti dio 4.2).
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).
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).
INR and Factor VII activity were also not affected by the coadministration of febuxostat.
Nije bilo utjecaja na INR i aktivnost faktora zgrušavanja VII kod istodobne primjene febuksostata.
The 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:
Patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome treated with ADENURIC should be under cardiac monitoring as clinically appropriate.
Bolesnicima liječenim ADENURICOM 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.
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).
Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase
Manje često Dijabetes melitus, hiperlipidemija, smanjen apetit, povećanje tjelesne težine Rijetko
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).
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
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
Tumor Lysis Syndrome: The recommended oral dose of ADENURIC is 120 mg once daily without regard to food.
Sindrom tumorske lize: preporučena peroralna doza ADENURICA je 120 mg jednom dnevno,
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
Cardiac disorders: Uncommon: Left bundle branch block, sinus tachycardia
Sračani poremećaji: Manje često: blok lijeve grane snopa, sinusna tahikardija
Rare Anaphylactic reaction*, drug hypersensitivity*
Poremećaji imunološkog sustava Rijetko Anafilaktička reakcija*, preosjetljivost na lijek*
ADENURIC 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.
ADENURIC 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.
Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Povišena glukoza u krvi, produljeno aktivirano parcijalno tromboplastinsko vrijeme, smanjen broj crvenih krvnih stanica, povišena alkalna fosfataza u krvi, povišena kreatin fosfokinaza u krvi* * Nuspojave prijavljene nakon stavljanja lijeka u promet ** Neinfektivni proljev i abnormalni testovi jetrene funkcije vezani uz liječenje bili su učestaliji u kombiniranim ispitivanjima faze 3 kod bolesnika istodobno liječenih kolhicinom
Marketing Authorisation Holder Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Nositelj odobrenja za stavljanje lijeka u promet Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luksemburg
Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, magnezijev stearat, hidroksipropilceluloza, umrežena karmelozanatrij, hidratizirani koloidni silicijev dioksid.
Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and a 18% and 16% decrease in AUC, respectively.
120 mg uz obrok bogat masnoćama, došlo je do sniženja Cmax od 49%, odnosno 38%, te smanjenja AUC-a od 18%, odnosno 16%.
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.
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.
How to store ADENURIC
Kako čuvati ADENURIC
No significant difference in mean serum creatinine change (%) occurred between ADENURIC 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 ADENURICA 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;
Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients.
Tablica 1: Nuspojave u fazi 3 dugoročnih produžetaka ispitivanja i nakon stavljanja lijeka u promet kod bolesnika s gihtom
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).
Uncommon Hypertension, flushing, hot flush
Hipertenzija, naleti crvenila, naleti vrućine
In this subgroup ADENURIC 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 ADENURIC je postigao primarni ishod djelotvornosti kod 41% (80 mg jednom dnevno), 48% (120 mg jednom dnevno) i 66% (240 mg 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.