natgillin/translations-raw huggingface dataset:
Additional monitoring of lipids and blood pressure is recommended in patients using sensitive CYP3A substrate lipid lowering medicines (such as lovastatin or simvastatin) or antihypertensive medicines (such as amlodipine, felodipine or nisoldipine), since their efficacy may be reduced (see section 4.5).
Preporučuje se dodatno praćenje lipida i krvnog tlaka u bolesnika koji uzimaju lijekove koji su osjetljivi supstrati CYP3A za sniženje lipida (poput lovastatina ili simvastatina) ili sniženje krvnog tlaka (poput amlodipina, felodipina ili nisoldipina), s obzirom da njihova djelotvornost može biti smanjena (vidjeti dio 4.5).
In interaction studies conducted in healthy subjects with Zurampic and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine.
U ispitivanjima interakcija provedenima na zdravim ispitanicima s lijekom Zurampic i supstratima CYP3A, lesinurad je smanjio koncentracije sildenafila i amlodipina u plazmi.
The recommended minimum dose of allopurinol is 300 mg, or 200 mg for patients with moderate renal impairment (creatinine clearance [CrCL] of 30-59 mL/min).
Preporučena minimalna doza alopurinola je 300 mg, ili 200 mg za bolesnike s umjerenim oštećenjem funkcije bubrega (klirens kreatinina [CrCL] od 30 do 59 ml/min).
Experience with Zurampic in patients with an estimated CrCL (eCrCL) less than 45 mL/min is limited; therefore, Zurampic should be used with caution in patients with a CrCL from 30 mL/min to less than 45 mL/min.
Iskustvo s lijekom Zurampic u bolesnika s procijenjenim CrCL-om (eCrCL) manjim od 45 ml/min je ograničeno; stoga se Zurampic mora primjenjivati s oprezom u bolesnika s CrCL od 30 ml/min do 45 ml/min.
You must use Zurampic together with either allopurinol or febuxostat.
Zurampic morate uzimati zajedno s alopurinolom ili febuksostatom.
An induction effect of lesinurad should be anticipated after 2 to 3 weeks of continuous co-administration of Zurampic.
Indukcijski učinak lesinurada treba se očekivati nakon 2 do 3 tjedna kontinuirane istodobne primjene s lijekom Zurampic.
- acetylsalicylic acid - to relieve fever and pain - at doses above 325 mg per day - medicines to treat high blood pressure, e.g. amlodipine - medicines to treat high cholesterol levels, e.g. simvastatin - fluconazole - to treat fungal infections - amiodarone -to treat heart rhythm problems - valproic acid,valpromideor carbamazepine -to treatfits (seizures), mood disorders and prevent migraines - sildenafil - to treat erectile dysfunction - contraceptives-used to preventpregnancy,including oralcontraception (such as ‘the pill'),
- acetilsalicilatna kiselina -za ublažavanje vrućice i bolova -u dozama većim od 325 mg nadan - lijekovi za liječenje visokog krvnog tlaka, npr. amlodipin - lijekovi za liječenje visokih razina kolesterola, npr. simvastatin - flukonazol - za liječenje gljivičnih infekcija - amiodaron-za liječenje problema srčanog ritma - valproatna kiselina, valpromid ili karbamazepin -za liječenje napadaja i poremećaja raspoloženja te sprječavanje migrena - sildenafil -za liječenje erektilne disfunkcije - kontraceptivi-koriste se za sprječavanje trudnoće, uključujući oralnu kontracepciju (poput
Placebo + febuxostat 80 mg N=51
Vremenska točka Placebo + febuksostat 80 mg N=51
System Organ Classification Common
Klasifikacija organskih sustava
Effect of other medicinal products on lesinurad
Učinci drugih lijekova na lesinurad
Oval, 5.7 x 12.9 mm, blue tablets.
Ovalne tablete plave boje, dimenzija 5,7 x 12,9 mm.
All studies were of 12 months duration and patients received prophylaxis for gout flares with colchicine or NSAIDs during the first 5 months of lesinurad treatment.
Sva ispitivanja trajala su 12 mjeseci i u bolesnika je primijenjeno profilaktičko liječenje akutnih napadaja gihta kolhicinom ili NSAIL-ovima tijekom prvih 5 mjeseci liječenja lesinuradom.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ako Vam je Vaš liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije nego uzmete ovaj lijek.
Uncommon - may affect up to 1 in 100 people - kidney stones, - dehydration (loss of too much fluid from your body).
Manje često - mogu se javiti u do 1 na 100 osoba - bubrežni kamenci, - dehidracija (gubitak prevelike količine tekućine iz tijela).
Lesinurad at doses up to 1,600 mg did not demonstrate an effect on ECG parameters (including QTc interval) in healthy subjects.
U zdravih ispitanika, lesinurad u dozama do 1600 mg nije pokazao učinak na EKG parametre (uključujući QTc interval).
The most commonly reported adverse reactions during treatment with Zurampic 200 mg are influenza, gastro-oesophageal reflux disease, headache and blood creatinine increased.
Najčešće prijavljivane nuspojave tijekom liječenja lijekom Zurampic u dozi od 200 mg su gripa, gastroezofagealna refluksna bolest, glavobolja i povišen kreatinin u krvi.
For cardiovascular patients in a stable condition, the benefit/risk balance should be assessed for each individual patient on an ongoing basis, taking into account the benefits of lowering urate levels versus a potential increase in cardiac risk (see section 4.8).
Za kardiovaskularne bolesnike čije je stanje stabilno, mora se redovito provoditi procjena omjera koristi i rizika za svakog pojedinog bolesnika, uzimajući u obzir koristi sniženja razine urata naspram mogućeg povećanja srčanih rizika (vidjeti dio 4.8).
Sixty-six percent of patients had mild or moderate renal impairment.
Šezdeset i šest posto bolesnika imalo je blago ili umjereno oštećenje funkcije bubrega.
Failure to follow these instructions may increase the risk of kidney side effects (see section 4).
Nepridržavanje ovih uputa može povećati rizik od nuspojava bubrega (vidjeti dio 4).
In addition, lesinurad is an in vitro inducer of CYP2B6 and CYP3A via CAR/PXR.
Dodatno, lesinurad je in vitro induktor CYP2B6 i CYP3A preko CAR/PXR.
In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing Zurampic therapy.
U kliničkim ispitivanjima, većina je nuspojava bila blagog do umjerenog intenziteta i razriješena je uz nastavak liječenja lijekom Zurampic.
If you stop taking your xanthine oxidase inhibitor medicine, you must also stop taking Zurampic.
Ako prestanete uzimati lijek koji je inhibitor ksantin oksidaze, morate također prestati uzimati i Zurampic.
Fifty percent of patients had a baseline sUA ≥5.0 mg/dL, which was after 3 weeks of treatment with febuxostat alone.
Pedeset posto bolesnika imalo je početnu razinu sUA od ≥5,0 mg/dl, postignutu nakon 3 tjedna liječenja samo s febuksostatom.
If this happens, keep taking Zurampic and talk to your doctor or pharmacist.
Ako do toga dođe, nastavite uzimati Zurampic i obratite se svom liječniku ili ljekarniku.
Common - may affect up to 1 in 10 people - flu (influenza), - headache, - increase in the amount of creatinine in your blood -shown in tests, - heartburn(acid reflux).
Često - mogu se javiti u do 1 na 10 osoba - gripa, - glavobolja, - povećanje količine kreatinina u krvi -vidljivou pretragama, - žgaravica (vraćanje kiseline).
The target serum uric acid level is less than 6 mg/dL (360 µmol/L).
Ciljna razina mokraćne kiseline u serumu je manje od 6 mg/dl (360 µmol/l).
Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.
Lesinurad također inhibira OAT4, transporter mokraćne kiseline uključen u hiperuricemiju uzrokovanu diuretikom.
Zurampic should not be administered with inhibitors of mEH.
Zurampic se ne smije primjenjivati istodobno s inhibitorima mEH.
- the other ingredients are: - tablet core: hypromellose, microcrystalline cellulose, lactose monohydrate (see section 2),
- drugi sastojci su: - jezgra tablete:hipromeloza, mikrokristalična celuloza, laktoza hidrat(vidjeti dio2), krospovidon,
Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with Zurampic.
Prema tome, preporučuje se pratiti bolesnike zbog smanjene djelotvornosti supstrata CYP2B6 (npr. bupropion, efavirenz) prilikom istodobne primjene s lijekom Zurampic.
In rats, there was no effect on mating or fertility with lesinurad (see section 5.3).
U štakora, primjena lesinurada nije imala učinak na parenje ili plodnost (vidjeti dio 5.3).
In vivo, lesinurad is neither an inhibitor nor an inducer of CYP2C9 and 2C8, but a mild to moderate inducer of CYP3A.
In vivo, lesinurad nije ni inhibitor ni induktor CYP2C9 i 2C8, ali je blagi do umjereni induktor CYP3A.
Since the incidence of severe renal-related adverse events was increased with the monotherapy as compared to the combination therapy with a xanthine oxidase inhibitor, Zurampic should not be used as monotherapy (see sections 4.2 and 5.1).
S obzirom da je incidencija teških nuspojava povezanih s bubrezima bila povećana tijekom monoterapije, u usporedbi s kombiniranom terapijom s inhibitorom ksantin oksidaze, Zurampic se ne smije primjenjivati kao monoterapija (vidjeti dijelove 4.2 i 5.1).
Zurampic must be taken together with allopurinol or febuxostat, which are medicines called ‘xanthine oxidase inhibitors' and are also used to treat gout by lowering the amount of uric acid in your blood.
Zurampic se mora primjenjivati zajedno s alopurinolom ili febuksostatom, lijekovima koji se nazivaju „inhibitori ksantin oksidaze“ i također se primjenjuju za liječenje gihta tako što smanjuju količinu mokraćne kiseline u Vašoj krvi.
In clinical trials, Zurampic was administered with food, because the serum uric acid lowering was improved under fed conditions.
U kliničkim ispitivanjima, Zurampic je primjenjivan s hranom jer je sniženje razine mokraćne kiseline u serumu bilo poboljšano u uvjetima sitosti.
Approximately half of an oral dose of lesinurad is cleared via CYP2C9 metabolism.
Otprilike polovica oralne doze lesinurada se izlučuje metabolizmom putem CYP2C9.
The serious adverse reactions renal failure, renal impairment and nephrolithiasis have occurred uncommonly (less than 1 case per 100 patients) (see Table 1).
Ozbiljne nuspojave: zatajenje bubrega, oštećenje funkcije bubrega i nefrolitijaza su se javile manje često (manje od jedan slučaj na 100 bolesnika) (vidjeti Tablicu 1).
Pack size of 100 x 1 film-coated tablet in perforated unit dose blisters.
Veličina pakiranja od 100 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivima na jedinične doze.
Zurampic 200 mg + febuxostat 80 mg N=59
Zurampic 200 mg + febuksostat 80 mg N=59
100 x 1 film-coated tablets
100 x 1 filmom obložena tableta
Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter URAT1.
Lesinurad je selektivni inhibitor ponovne apsorpcije mokraćne kiseline koji inhibira transporter mokraćne kiseline URAT1.
In the fed state, after a single dose of lesinurad 200 mg, geometric mean lesinurad Cmax and AUC were 6 μg/mL and 29 μg/hr/mL, respectively.
U stanju sitosti, nakon jednokratne doze lesinurada od 200 mg, geometrijske srednje vrijednosti Cmax i AUC lesinurada bile su 6 µg/ml odnosno 29 µg/sat/ml.
Zurampic is not recommended in patients with unstable angina, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or with a recent event of myocardial infarction, stroke, or deep venous thrombosis within the last 12 months, due to insufficient data.
Zbog nedostatka podataka, Zurampic se ne preporučuje u bolesnika s nestabilnom anginom, zatajenjem srca NYHA (New York Heart Association) stadija III ili IV, nekontroliranom hipertenzijom ili nedavnim infarktom miokarda, moždanim udarom ili dubokom venskom trombozom unutar posljednjih 12 mjeseci.
Zurampic 200 mg tablets are available in clear blisters in pack sizes of 10, 28, 30 or 98 non-perforated blisters and 100 x 1 perforated unit dose blisters.
Zurampic 200 mg tablete su dostupne u prozirnim blisterima u pakiranjima veličine od 10, 28, 30 ili 98 tableta u neperforiranim blisterima ili 100 x 1 tableta u perforiranim blisterima djeljivim na jedinične doze.
A causal relationship with Zurampic has not been established.
Uzročna povezanost s lijekom Zurampic još nije ustanovljena.
Effect of lesinurad on other medicinal products
Učinci lesinurada na druge lijekove
Zurampic 200 mg + allopurinol N=405
Zurampic 200 mg + alopurinol N=405
The population pharmacokinetic analysis of clinical data in gout patients treated for up to 12 months estimated increases in lesinurad exposure of approximately 12%, 31% and 65% in patients with mild, moderate, and severe renal impairment, respectively, compared with patients with normal renal function.
Analiza populacijske farmakokinetike kliničkih podataka u bolesnika s gihtom liječenih do 12 mjeseci procijenila je povećanja u izloženosti lesinuradu od otprilike 12%, 31% odnosno 65% u bolesnika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega, u usporedbi s bolesnicima s normalnom funkcijom bubrega.
Lesinurad exposure is expected to decrease when it is co-administered with inducers of CYP2C9 (e.g. carbamazepine, a moderate CYP2C9 inducer).
Očekuje se smanjenje izloženosti lesinuradu kada se primjenjuje istodobno s induktorima CYP2C9 (npr. karbamazepin, umjereni induktor CYP2C9).
In vitro, lesinurad is an inhibitor of CYP2C8, but not of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and mEH.
In vitro, lesinurad je inhibitor CYP2C8, ali ne i CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 i mEH.
Taking this medicine - take in the morning with food and water - takeZurampic at the same time as yourmorning dose of‘xanthine oxidase inhibitor' medicine allopurinol or febuxostat.
Uzimanje ovog lijeka - uzmite lijek ujutro s hranom i vodom - uzmiteZurampicu isto vrijeme kada i Vašu jutarnju dozu inhibitora ksantin oksidaze alopurinola ili febuksostata.
The effect of CYP2C9 genotype on the pharmacokinetics of lesinurad was studied in 8 healthy subjects and 59 patients with gout following daily dosing of lesinurad ranging from 200 mg to 600 mg in the absence or presence of a xanthine oxidase inhibitor.
Učinak CYP2C9 genotipa na farmakokinetiku lesinurada ispitivan je u 8 zdravih ispitanika i 59 bolesnika s gihtom, nakon doziranja lesinurada jedanput dnevno u dozama od 200 mg do 600 mg, uz odsutnost ili prisutnost inhibitora ksantin oksidaze.
The recommended dose of Zurampic is 200 mg once daily in the morning.
Preporučena doza lijeka Zurampic je 200 mg jedanput dnevno, ujutro.
crospovidone, magnesium stearate - film-coating:hypromellose, titanium dioxide, triacetin, indigo carmine, brilliant blue FCF.
magnezijev stearat - film-ovojnica:hipromeloza, titanijevdioksid, triacetin, boja indigo carmine,bojabrilliant blue
Serious side effects - Uncommon - may affect up to 1 in 100 people Stop taking Zurampic and see a doctor straight away if you notice any of the following side effects, as these may be signs of a problem with your kidneys - you may need urgent medical treatment:
Prestanite uzimati Zurampic i odmah posjetite liječnika ako primijetite bilo koju od sljedećih nuspojava, jer to mogu biti znakovi problema s Vašim bubrezima - možda Vam je potrebno hitno medicinsko liječenje:
Rifampin, an inhibitor of OATPs and an inducer of CYP2C9, decreased lesinurad exposure and slightly reduced the amount of lesinurad excreted unchanged in urine with no clinically relevant effect.
Rifampicin, inhibitor OATP-a i induktor CYP2C9, smanjio je izloženost lesinuradu i blago je smanjio količinu nepromijenjenog lesinurada izlučenog u mokraći bez klinički značajnog učinka.
Tablet core hypromellose microcrystalline cellulose lactose monohydrate crospovidone type A magnesium stearate
Jezgra tablete hipromeloza mikrokristalična celuloza laktoza hidrat krospovidon tipa
Adverse reactions are classified according to frequency and System Organ Class.
Nuspojave su klasificirane prema učestalosti i organskim sustavima.
This medicinal product does not require any special storage conditions.
Ovaj lijek ne zahtijeva posebne mjere pri čuvanju lijeka.
All patients with a Major Adverse Cardiovascular Event treated with Zurampic 200 mg had a history of heart failure, stroke or myocardial infarction.
Svi bolesnici koji su imali MACE događaj liječeni lijekom Zurampic u dozi od 200 mg imali su i zatajenje srca, moždani udar ili infarkt miokarda u anamnezi.
Lesinurad is not an in vitro inhibitor of P-glycoprotein, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 and MATE2-K.
Lesinurad nije in vitro inhibitor P-glikoproteina, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 i MATE2-K.
This is due to reduction in serum uric acid levels resulting in mobilisation of urate from tissue deposits.
Do toga dolazi zbog smanjenja razina mokraćne kiseline u serumu, što rezultira mobilizacijom urata iz zaliha u tkivima.
The ratio of atropisomer 1 to atropisomer 2 AUC(0-24) was 44:56 because atropisomer 1 undergoes more extensive metabolism than atropisomer 2, causing atropisomer 1 to have lower plasma exposure than atropisomer 2.
Omjer AUC(0-24) vrijednosti za atropoizomer 1 naspram atropoizomera 2 bio je 44:56 zbog toga što se atropoizomer 1 opsežnije metabolizira u odnosu na atropoizomer 2, zbog čega atropoizomer 1 ima manju izloženost u plazmi od atropoizomera 2.
What Zurampic looks like and contents of the pack Zurampic 200 mg: a blue, oval, dimensions 5.7 x 12.9 mm, film-coated tablet, engraved with “LES200” on one side.
Zurampic 200 mg: plave, ovalne filmom obložene tablete, dimenzija 5,7 x 12,9 mm, s utisnutom oznakom “LES200” na jednoj strani.
Zurampic slightly decreased exposure of oxypurinol (a URAT1 substrate), the major metabolite of allopurinol; however, the uric acid-lowering effect of the combination with allopurinol was significantly greater than for either substance alone.
Zurampic blago smanjuje izloženost oksipurinolu (supstratu URAT1), glavnom metabolitu alopurinola; međutim, učinak na sniženje razine mokraćne kiseline bio je značajno veći za kombinaciju s alopurinolom nego za pojedinačne lijekove.
The primary efficacy endpoint in both CLEAR1 and CLEAR2 was the proportion of patients achieving a serum uric acid target level of less than 6 mg/dL by Month 6.
Primarni ishod djelotvornosti u CLEAR1 i CLEAR2 ispitivanjima bio je udio bolesnika koji su postigli ciljnu razinu mokraćne kiseline u serumu manju od 6 mg/dl do šestog mjeseca.
The medicine is still working to lower uric acid.
Ovaj lijek i dalje djeluje kako bi smanjio razinu mokraćne kiseline.
Driving and using machines Zurampic is not expected to affect you being able to drive a car or use any tools or machines.
Ne očekuje se da će Zurampic utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Across both studies, 61% of patients had mild or moderate renal impairment and 19% had tophi at baseline.
U oba ispitivanja, 61% bolesnika imalo je blago do umjereno oštećenje funkcije bubrega, a 19% ih je imalo tofe na početku ispitivanja.
Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicines that are sensitive substrates of CYP3A.
Blaga do umjerena indukcija CYP3A lesinuradom može smanjiti izloženost istodobno primjenjivanim lijekovima u plazmi, koji su osjetljivi supstrati CYP3A.
Based on pharmacokinetic modelling simulations, patients with moderate renal impairment and reduced CYP2C9 activity (co-administration of a CYP2C9 inhibitor or a CYP2C9 poor metabolizer) are predicted to have an increase in AUC of approximately 200% in comparison to normal renal function and unimpaired CYP2C9 activity.
Na temelju simulacija farmakokinetičkog modeliranja, predviđa se da će u bolesnika s umjerenim oštećenjem funkcije bubrega i smanjenom aktivnosti CYP2C9 (istodobna primjena inhibitora CYP2C9 ili je osoba spori CYP2C9 metabolizator) biti prisutno povećanje vrijednosti AUC od približno 200%, u usporedbi s normalnom funkcijom bubrega i nepromijenjenom aktivnosti CYP2C9.
Although other doses have been studied, the recommended dose of Zurampic is 200 mg once daily in combination with a xanthine oxidase inhibitor.
Iako su ispitivane druge doze, preporučena doza lijeka Zurampic je 200 mg jedanput dnevno, u kombinaciji s inhibitorom ksantin oksidaze.
Lesinurad is rapidly absorbed after oral administration.
Lesinurad se brzo apsorbira nakon peroralne primjene.
Female patients of childbearing age should practice additional methods of contraception and not rely on hormonal contraception alone when taking Zurampic (see sections 4.5 and 4.6).
Bolesnice reproduktivne dobi trebaju koristiti dodatne metode kontracepcije i ne smiju se pouzdati samo na hormonsku kontracepciju tijekom uzimanja lijeka Zurampic (vidjeti dijelove 4.5 i 4.6).
After continued treatment of up to 24 months on Zurampic 200 mg in combination with febuxostat, the proportion of subjects who experienced complete resolution of at least one target tophus increased to 53% of subjects.
Nakon nastavka liječenja lijekom Zurampic u dozi od 200 mg u kombinaciji s febuksostatom tijekom 24 mjeseca, udio bolesnika u kojih je došlo do potpunog povlačenja najmanje jednog ciljnog tofa povećao se na 53%.
Clinical outcomes - gout flares requiring treatment The rates of gout flare requiring treatment were low and comparable to placebo in the last 6 months of the randomised trials (after gout flare prophylaxis was discontinued) with median scores of zero.
Klinički ishodi - akutni napadaji gihta koja zahtijevaju liječenje Stope akutnih napadaja gihta koje je potrebno liječiti bile su niske i usporedive s placebom u posljednjih 6 mjeseci randomiziranih ispitivanja (nakon što je prekinuto profilaktičko liječenje akutnih napadaja), uz medijan rezultata jednak nuli.
If treatment with the xanthine oxidase inhibitor is interrupted, Zurampic dosing must also be interrupted.
Ako se privremeno prekine liječenje inhibitorom ksantin oksidaze, također se mora prekinuti i doziranje lijeka Zurampic.
Zurampic 200mg + Allopurinol
Zurampic 200mg + Alopurinol
In vitro, lesinurad is an inhibitor of OATP1B1, OAT1, OAT3, OAT4 and OCT1 at clinically relevant plasma concentrations.
In vitro, lesinurad je inhibitor OATP1B1, OAT1, OAT3, OAT4 i OCT1, pri klinički relevantnim koncentracijama u plazmi.
By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers serum uric acid (sUA).
Inhibicijom URAT1, lesinurad povećava izlučivanje mokraćne kiseline i time snižava razinu mokraćne kiseline u serumu (sUA, od engl. serum uric acid).
Zurampic contains the active ingredient lesinurad and is used to treat gout in adult patients by lowering the levels of uric acid in the blood.
Zurampic sadrži djelatnu tvar lesinurad i primjenjuje se za liječenje gihta u odraslih bolesnika tako što smanjuje razine uratne (mokraćne) kiseline u krvi.
Zurampic tablets must be co-administered at the same time as the morning dose of a xanthine oxidase inhibitor, i.e. allopurinol or febuxostat.
Zurampic tablete se moraju primijeniti u isto vrijeme s jutarnjom dozom inhibitora ksantin oksidaze, tj. alopurinola ili febuksostata.
Patients with a history of kidney stones were permitted entry into the 12-month studies of Zurampic in combination with a xanthine oxidase inhibitor.
Bolesnicima s anamnezom bubrežnih kamenaca bilo je dozvoljeno uključivanje u 12-mjesečna ispitivanja lijeka Zurampic u kombinaciji s inhibitorom ksantin oksidaze.
The mean steady state volume of distribution of lesinurad was approximately 20 L following intravenous dosing.
Srednji volumen distribucije lesinurada u stanju dinamičke ravnoteže nakon intravenske primjene bio je otprilike 20 litara.
At the 400 mg dose, when compared with extensive CYP2C9 metabolisers (CYP2C9 *1/*1 [N=41]), increased lesinurad exposures were observed in intermediate CYP2C9 metabolisers (CYP2C9 *1/*3 [N=4], approximately 22% increase in AUC) and in poor CYP2C9 metabolisers (CYP2C9 *3/*3 [N=1], approximately 111% increase in AUC) accompanied with higher lesinurad renal excretion.
Pri dozi od 400 mg, kada se uspoređuje s brzim CYP2C9 metabolizatorima (CYP2C9 *1/*1 [N = 41]), opažena je povišena izloženost lesinuradu u intermedijarnih CYP2C9 metabolizatora (CYP2C9 *1/*3 [N = 4], povećanje AUC od otprilike 22%) te u sporih CYP2C9 metabolizatora (CYP2C9 *3/*3 [N = 1], povećanje AUC od otprilike 111%) praćena povećanim izlučivanjem lesinurada putem bubrega.