natgillin/translations-raw huggingface dataset:
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).
Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov - gripa (influenca), - glavobol, - povečanje količine kreatinina v krvi - pokaže se na krvnih preiskavah, - zgaga (refluks kisline).
Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Zurampic is co-administered.
Hormonski kontraceptivi, vključno s tabletami, injekcijami, transdermalnimi oblikami in vsadki, so med sočasno uporabo z zdravilom Zurampic lahko nezanesljivi.
Pack sizes of 10, 28, 30, 98 in non-perforated blisters.
Velikosti pakiranj z 10, 28, 30, 98 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
Rare - may affect up to 1 in 1000 people - skin reactions, including redness, itchy skin, lumpy rash (hives) and skin rash on exposure to sunshine.
Redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov - kožne reakcije, vključno s pordelostjo, srbenjem, dvignjenim izpuščajem (koprivnico) in izpuščajem na koži po izpostavljenosti soncu.
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.
Zdravilo Zurampic vsebuje zdravilno učinkovino lesinurad in se uporablja za zdravljenje protina pri odraslih bolnikih, ker zniža raven sečne kisline v krvi.
If this happens, keep taking Zurampic and talk to your doctor or pharmacist.
Če se to zgodi, še naprej jemljite zdravilo Zurampic in se posvetujte z zdravnikom ali farmacevtom.
Oval, 5.7 x 12.9 mm, blue tablets.
modre tablete ovalne oblike, velikosti 5,7 x 12,9 mm
Zurampic should not be restarted without another explanation for the serum creatinine abnormalities.
Zdravljenja z zdravilom Zurampic se ne sme znova uvesti, če ni kakšne druge razlage za ugotovljene nenormalne vrednosti kreatinina v serumu.
Effect of other medicinal products on lesinurad
Vpliv drugih zdravil na lesinurad:
Pre-existing cardiovascular disease
Že obstoječa srčno-žilna bolezen
Lesinurad is a mild to moderate inducer of CYP3A and therefore may lower plasma concentrations of some hormonal contraceptives, thereby decreasing contraceptive effectiveness (see sections 4.4 and
Lesinurad blago do zmerno inducira CYP3A in zato lahko zniža plazemsko koncentracijo nekaterih hormonskih kontraceptivov ter tako zmanjša njihovo kontracepcijsko učinkovitost (glejte poglavji 4.4 in 4.6).
In rats, there was no effect on mating or fertility with lesinurad (see section 5.3).
Pri podganah lesinurad ni vplival na parjenje ali plodnost (glejte poglavje 5.3).
Some people may have more gout attacks (gout flares) when they start using Zurampic and during the first weeks or months of treatment.
Nekateri bolniki imajo lahko po začetku uporabe zdravila Zurampic in v prvih tednih ali mesecih zdravljenja več napadov protina.
If you stop taking Zurampic Do not stop taking Zurampic without the advice of your doctor even if you feel better.
Če ste prenehali jemati zdravilo Zurampic Tudi če se počutite bolje, ne prenehajte jemati zdravila Zurampic, če vam tega ne svetuje zdravnik.
Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicines that are sensitive substrates of CYP3A.
Blaga do zmerna indukcija CYP3A, ki jo povzroči lesinurad, lahko zmanjša plazemsko izpostavljenost sočasno uporabljenim zdravilom, ki so občutljivi substrati CYP3A.
The target serum uric acid level is less than 6 mg/dL (360 µmol/L).
Ciljna koncentracija sečne kisline v serumu je manj kot 6 mg/dl (360 µmol/l).
Lesinurad should only be used in combination with a xanthine oxidase inhibitor because combination use reduces the amount of uric acid available for excretion and decreases the risk of renal-related events.
Lesinurad se sme uporabljati samo v kombinaciji z zaviralcem ksantin-oksidaze, ker kombinirana uporaba zmanjša količino sečne kisline, ki je na voljo za izločanje in zmanjša tveganje za ledvične dogodke.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Zurampic.
Če kaj od naštetega velja za vas (ali če niste prepričani), se pred jemanjem zdravila Zurampic posvetujte z zdravnikom ali farmacevtom.
Other moderate CYP2C9 inhibitors, such as amiodarone, would also be expected to affect lesinurad pharmacokinetics to a similar degree.
Pričakovati je mogoče, da v podobni meri vplivajo na farmakokinetiko lesinurada tudi drugi zmerni zaviralci CYP2C9, npr. amiodaron.
--o-- Placebo + Allopurinol,
Terapevtska skupina: --o-- Placebo + Alopurinol,
All patients with a Major Adverse Cardiovascular Event treated with Zurampic 200 mg had a history of heart failure, stroke or myocardial infarction.
Vsi bolniki, ki se jim je pojavil večji srčno-žilni neželen učinek in so bili zdravljeni z 200 mg zdravila Zurampic, so imeli v anamnezi srčno popuščanje, možgansko kap ali miokardni infarkt.
Uncommon - may affect up to 1 in 100 people - kidney stones, - dehydration (loss of too much fluid from your body).
Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov - ledvični kamni, - dehidracija (prekomerna izguba tekočine iz telesa).
BLISTER NON-PERFORATED (10 TABLETS) BLISTER PERFORATED UNIT DOSE CALENDAR BLISTER (14 TABLETS)
PRETISNI OMOT, NEPERFORIRANI (10 TABLET) PRETISNI OMOT, PERFORIRANI, ZA ENKRATNI ODMEREK KOLEDARSKI PRETISNI OMOT (14 TABLET)
If you stop taking your xanthine oxidase inhibitor medicine, you must also stop taking Zurampic.
Če ste prenehali jemati zdravilo, ki zavira ksantin-oksidazo, morate prenehati jemati tudi zdravilo Zurampic.
Driving and using machines Zurampic is not expected to affect you being able to drive a car or use any tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi zdravilo Zurampic vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter URAT1.
Lesinurad je selektiven zaviralec reabsorpcije sečne kisline, ki zavira prenašalca sečne kisline URAT1.
Lesinurad exposure is expected to decrease when it is co-administered with inducers of CYP2C9 (e.g. carbamazepine, a moderate CYP2C9 inducer).
Pričakovati je, da se izpostavljenost lesinuradu zmanjša, če je uporabljen sočasno z induktorji CYP2C9 (npr. s karbamazepinom, ki je zmeren induktor CYP2C9).
Based on these studies, Zurampic is only recommended at a dose of 200 mg once daily in combination with a xanthine oxidase inhibitor (see sections 4.2 and 4.4).
Na podlagi teh študij je edini priporočeni odmerek zdravila Zurampic 200 mg enkrat na dan v kombinaciji z zaviralcem ksantin-oksidaze (glejte poglavji 4.2 in 4.4).
Mean sUA reductions following Zurampic 200 mg administration alone were approximately 46% and 26% at 6 hours and 24 hours post-dose, respectively.
Povprečno znižanje SKs po uporabi 200 mg zdravila Zurampic samega je bilo 6 ur po uporabi približno 46 % in 24 ur po uporabi približno 26 %.
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.
Med uporabo odmerka 400 mg, v primerjavi z izrazitimi metabolizatorji s CYP2C9 (CYP2C9 *1/*1 [N=41]) so opažali večjo izpostavljenost lesinuradu pri srednjih metabolizatorjih s CYP2C9 (CYP2C9 *1/*3, [N=4] približno 22 % povečanje AUC) in pri slabih metabolizatorjih s CYP2C9 (CYP2C9 *3/*3, [N=1 približno 111 % povečanje AUC); to je spremljalo večje izločanje lesinurada skozi ledvice.
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.
Tablete Zurampic 200 mg so na voljo v prozornih pretisnih omotih in v pakiranjih po 10, 28, 30 ali 98 filmsko obloženih tablet v neperforiranih pretisnih omotih in 100 x 1 filmsko obložena tableta v perforiranih enoodmernih pretisnih omotih.
Mean (SE) Serum Uric Acid (mg/dL)
Povprečna vrednost (SE) sečne kisline v serumu (mg/dl)
Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.
Lesinurad zavre tudi OAT4, prenašalec sečne kisline, vpleten v hiperurikemijo zaradi diuretikov.
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 podlagi farmakokinetičnih modelskih simulacij predvidevajo, da se pri bolnikih z zmerno okvaro ledvic in zmanjšano aktivnostjo CYP2C9 (zaradi sočasne uporabe zaviralca CYP2C9, ali ker so slabi metabolizatorji s CYP2C9) AUC poveča za približno 200 % v primerjavi z normalnim delovanjem ledvic in neprizadeto aktivnostjo CYP2C9.
Effect of CYP2C9 genotype
Vpliv genotipa CYP2C9
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 opazovani dogodek učinkovitosti v študijah CLEAR1 in CLEAR2 je bil delež bolnikov, ki so do 6. meseca dosegli ciljno koncentracijo sečne kisline manj kot 6 mg/dl.
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 kliničnih podatkov bolnikov s protinom, zdravljenih do 12 mesecev, je ocenila, da je v primerjavi z bolniki z normalnim delovanjem ledvic povečanje izpostavljenosti lesinuradu pri bolnikih z blago okvaro ledvic približno 12 %, z zmerno okvaro približno 31 % in s hudo okvaro približno 65 %.
Patients with a history of kidney stones were permitted entry into the 12-month studies of Zurampic in combination with a xanthine oxidase inhibitor.
Bolniki z anamnezo ledvičnih kamnov so lahko bili vključeni v 12-mesečne študije zdravila Zurampic v kombinaciji z zaviralcem ksantin-oksidaze.
Your doctor will check how well your kidneys are working before starting and during treatment with Zurampic.
Zdravnik vam bo pred začetkom zdravljenja in med zdravljenjem z zdravilom Zurampic preverjal delovanje ledvic.
In patients with moderate renal impairment, the incidence of renalrelated adverse reactions was similar across all treatment groups: Zurampic 200 mg (12.7%), Zurampic 400 mg (16.3%) and placebo (13.3%).
Pri bolnikih z zmerno okvaro ledvic je bila incidenca neželenih učinkov na ledvicah v vseh terapevtskih skupinah podobna: Zurampic 200 mg (12,7 %), Zurampic 400 mg (16,3 %) in placebo (13,3 %).
Zurampic must never be taken without a ‘xanthine oxidase inhibitor' medicine.
Zdravila Zurampic ne smete nikdar jemati brez zdravila, ki zavira ksantinoksidazo.
Wait and take your next dose of Zurampic with your next morning dose of allopurinol or febuxostat.
Počakajte in vzemite naslednji odmerek zdravila Zurampic z naslednjim jutranjim odmerkom alopurinola ali febuksostata.
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 ni ne zaviralec ne induktor CYP2C9 in 2C8, je pa blag do zmeren induktor CYP3A.
Pack size of 100 x 1 film-coated tablet in perforated unit dose blisters.
Velikosti pakiranj s 100 x 1 filmsko obloženo tableto v perforiranih enoodmernih pretisnih omotih.
How Zurampic works:
Kako deluje zdravilo Zurampic:
By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers serum uric acid (sUA).
Z zavrtjem URAT1 lesinurad poveča izločanje sečne kisline in tako zniža sečno kislino v serumu (SKs).
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.
Izkušenj z zdravilom Zurampic pri bolnikih z ocenjenim očistkom kreatinina manj kot 45 ml/min je malo, zato je treba zdravilo Zurampic pri bolnikih z očistkom kreatinina, med 30 ml/min in manj kot 45 ml/min uporabljati previdno.
Lesinurad is not an in vitro inhibitor of P-glycoprotein, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 and MATE2-K.
Lesinurad in vitro ne zavira Pglikoproteina, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 in MATE2-K.
When Zurampic 200 mg was added to a xanthine oxidase inhibitor (i.e. febuxostat), additional 25% and 19% of sUA reductions were observed at 6 hours and 24 hours post-dose, respectively.
Če je bilo zdravilo Zurampic v odmerku 200 mg dodano zaviralcu ksantin-oksidaze (npr. febuksostatu), so po 6 oziroma 24 urah ugotovili dodatno znižanje SKs za 25 % oziroma 19 %.
Epoxide hydrolase inhibitors
Zaviralci epoksid-hidrolaze
Lesinurad is mainly metabolised by CYP2C9 and mEH, and to a lesser extent by CYP1A1, CYP2C19 and CYP3A.
Lesinurad se v glavnem presnovi s CYP2C9 in mEH in v manjši meri s CYP1A1, CYP2C19 in CYP3A.
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, ki je zaviralec proteinskega prenašalca organskih anionov (OATP - organic anion transporting protein) in induktor CYP2C9, je zmanjšal izpostavljenost lesinuradu in rahlo zmanjšal količino lesinurada, ki se je nespremenjen izločil v urinu, brez klinično pomembnega učinka.
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).
Ženske v rodni dobi morajo uporabljati dodatne načine kontracepcije in se med jemanjem zdravila Zurampic ne smejo zanašati le na hormonsko kontracepcijo (glejte poglavji 4.5 in 4.6).
Patients received febuxostat 80 mg once daily for 3 weeks and then were randomised 1:1:1 to once daily doses of Zurampic 200 mg, Zurampic 400 mg, or placebo in combination with febuxostat.
Bolniki so 3 tedne enkrat dnevno dobivali 80 mg febuksostata, nato so jih v razmerju 1:1:1 randomizirali na 200 mg zdravila Zurampic, 400 mg zdravila Zurampic ali placebo v kombinaciji s febuksostatom.
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.
Zdravilo Zurampic zaradi nezadostnih podatkov ni priporočljivo uporabljati pri bolnikih, ki so imeli v zadnjih 12 mesecih nestabilno angino pektoris, srčno popuščanje v razredu III ali IV po Newyorškem združenju za srce (NYHA - New York Heart Association), neurejeno hipertenzijo ali nedaven miokardni infarkt, možgansko kap ali globoko vensko trombozo.
A causal relationship with Zurampic has not been established.
Vzročna povezanost z zdravilom Zurampic ni ugotovljena.
Zurampic causes an increase in renal uric acid excretion, which may lead to transient increases in serum creatinine, renal-related adverse reactions and kidney stones.
Zdravilo Zurampic poveča izločanje sečne kisline v ledvicah; to lahko povzroči prehodno zvišanje kreatinina v serumu, neželenih učinkov na ledvicah in ledvičnih kamnov.
If you are not sure, talk to your doctor or pharmacist before taking Zurampic.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Zurampic.
In vitro, lesinurad is an inhibitor of CYP2C8, but not of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and mEH.
In vitro lesinurad zavira CYP2C8, ne pa CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 in mEH.
Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.
Zdravilo Zurampic je v kombinaciji z zaviralcem ksantin-oksidaze indicirano pri odraslih za dodatno zdravljenje hiperurikemije pri tistih bolnikih s protinom (s tofi ali brez njih), ki z ustreznim odmerkom zaviralca ksantin-oksidaze samega ne dosežejo ciljne koncentracije sečne kisline v serumu.
Post-hoc analyses in a subgroup of patients with high cardiovascular risk at baseline (as defined by transient ischemic attack, angina pectoris, heart failure, myocardial infarction, peripheral vascular disease and/or stroke), showed that the incidence of Major Adverse Cardiovascular Events was 1/52 for placebo and 4/53 for Zurampic 200 mg, when used in combination with a xanthine oxidase inhibitor.
Post hoc analize v podskupini bolnikov z velikim izhodiščnim srčno-žilnim tveganjem (opredeljevali so ga tranzitorna ishemična ataka, angina pektoris, srčno popuščanje, miokardni infarkt, periferna žilna bolezen in/ali možganska kap) so pokazale, da je bila incidenca večjih neželenih srčno-žilnih učinkov (MACE) med uporabo v kombinaciji z zaviralcem ksantin-oksidaze s placebom 1/52 in z 200 mg zdravila Zurampic 4/53.
If treatment with the xanthine oxidase inhibitor is interrupted, Zurampic dosing must also be interrupted.
V primeru prekinitve zdravljenja z zaviralcem ksantin-oksidaze je treba prekiniti tudi jemanje zdravila Zurampic.
You should avoid taking Zurampic during pregnancy or if you are breast-feeding.
Ne jemljite zdravila Zurampic, če ste noseči ali če dojite.
Summary of the safety profile
Povzetek varnostnih značilnosti:
As a precautionary measure, it is preferable to avoid the use of Zurampic during pregnancy.
Zaradi previdnosti se je zdravilu Zurampic med nosečnostjo treba izogibati.
Failure to follow these instructions may increase the risk of kidney side effects (see section 4).
Neupoštevanje teh navodil lahko poveča tveganje za nastanek neželenih učinkov na ledvicah (glejte poglavje 4).
Table 2 Proportion of patients who achieved target serum uric acid levels (<6mg/dL) with Zurampic in combination with allopurinol - Pooled data from CLEAR1 and CLEAR2 studies
Preglednica 2 Delež bolnikov, ki so dosegli ciljno koncentracijo sečne kisline v serumu (< 6 mg/dl) z zdravilom Zurampic v kombinaciji z alopurinolom - kumulativni podatki študij CLEAR1 in CLEAR2
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.
Klinični izidi - napadi protina, ki so zahtevali zdravljenje Delež napadov protina, ki so zahtevali zdravljenje, je bil v zadnjih 6 mesecih randomiziranih preskušanj (po prenehanju uporabe profilakse napadov) majhen in podoben kot pri placebu; mediani seštevek je bil nič.
Table 1 lists adverse reactions identified in clinical studies with patients receiving Zurampic 200 mg once daily in combination with a xanthine oxidase inhibitor, allopurinol or febuxostat.
Preglednica 1 navaja neželene učinke v kliničnih študijah pri bolnikih, ki so prejemali 200 mg zdravila Zurampic 200 mg enkrat na dan v kombinaciji z zaviralcem ksantin-oksidaze alopurinolom ali febuksostatom.
Zurampic should not be used during breast-feeding.
Zdravila Zurampic se med obdobjem dojenja ne sme uporabljati.
Approximately half of an oral dose of lesinurad is cleared via CYP2C9 metabolism.
Približno polovica peroralnega odmerka lesinurada se odstrani s presnovo s CYP2C9.
This is due to reduction in serum uric acid levels resulting in mobilisation of urate from tissue deposits.
Pojavijo se, ker znižanje koncentracije sečne kisline v serumu povzroči mobilizacijo urata iz zalog v tkivih.
- 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'),
325 mg na dan - zdravila za zdravljenje visokega krvnega tlaka, npr. amlodipin - zdravila za zdravljenje zvišanih vrednosti holesterola, npr. simvastatin - flukonazol - za zdravljenje glivičnih okužb - amiodaron - za zdravljenje motenj srčnega ritma - valprojska kislina, valpromid ali karbamazepin - za zdravljenje napadov krčev (konvulzij),
Patients continued their allopurinol dose and were randomised 1:1:1 to receive Zurampic 200 mg, Zurampic 400 mg, or placebo once daily.
Bolniki so še naprej uporabljali svoj odmerek alopurinola in so bili v razmerju 1:1:1 randomizirani na prejemanje 200 mg zdravila Zurampic, 400 mg zdravila Zurampic ali placeba enkrat na dan.
Following administration of a single dose of lesinurad at 400 mg in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, lesinurad Cmax was comparable and lesinurad AUC was 7% and 33% higher, respectively, compared to individuals with normal hepatic function.
Po uporabi enkratnega odmerka 400 mg lesinurada je bila Cmax pri bolnikih z blago (Child-Pugh razred A) oz. zmerno (Child-Pugh razred B) okvaro jeter primerljiva, AUC pa 7 % (pri prvih) oz. 33 % večja kot pri osebah z normalnim delovanjem jeter.
Effects on serum uric acid and urinary excretion of uric acid In healthy subjects, lesinurad 200 mg lowered sUA levels and increased renal clearance and fractional excretion of uric acid.
Vpliv na sečno kislino v serumu in izločanje sečne kisline v urinu Zdravim osebam je lesinurad v odmerku 200 mg znižal koncentracijo SKs in povečal ledvični očistek in frakcijsko izločanje sečne kisline.
Do not use this medicine after the expiry date which is stated on the carton or blister foil after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisni foliji poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The most frequent renal-related adverse reaction was blood creatinine increased (4.3% with Zurampic 200 mg and 7.8% with Zurampic 400 mg compared to 2.3% with placebo).
Najpogostejši z ledvicami povezani neželeni učinek je bilo zvišanje kreatinina v serumu (4,3 % z 200 mg zdravila Zurampic in 7,8 % s 400 mg zdravila Zurampic v primerjavi z 2,3 % s placebom).
No dose adjustment is necessary in patients with mild or moderate renal impairment (CrCL of 30-89 mL/min) (see sections 4.8, 5.1 and 5.2).
Bolnikom z blago ali zmerno okvaro ledvic (očistek kreatinina od 30 do 89 ml/min) odmerka ni treba prilagoditi (glejte poglavja 4.8, 5.1 in 5.2).
Treatment with lesinurad 200 mg in combination with a xanthine oxidase inhibitor was associated with an increased incidence of serum creatinine elevations, which are related to increased renal uric acid excretion.
Zdravljenje z lesinuradom 200 mg v kombinaciji z zaviralcem ksantin-oksidaze je spremljala večja incidenca zvišanj kreatinina v serumu; ta so povezana z večjim izločanjem sečne kisline v ledvicah.
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.
Zdravilo Zurampic je rahlo zmanjšalo izpostavljenost glavnemu presnovku alopurinola oksipurinolu (substrat URAT1), toda učinek na znižanje sečne kisline je bil v kombinaciji z alopurinolom bistveno večji kot z vsako posamezno zdravilno učinkovino.
In clinical trials, Zurampic was administered with food, because the serum uric acid lowering was improved under fed conditions.
V kliničnih preskušanjih so zdravilo Zurampic uporabljali s hrano, ker je bilo znižanje sečne kisline v serumu ob uporabi zdravila na poln želodec boljše.
Zurampic 200 mg + allopurinol N=405
200 mg zdravila Zurampic + alopurinol N = 405