FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment Time point
Slovenian: Časovna točka ocene
English: Very limited data are available about retreatment after interruption of therapy for more than 4 weeks.
Slovenian: Podatki o ponovnem zdravljenju po več kot 4-tedenski prekinitvi zdravljenja so zelo omejeni.
English: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Park Kiryat Malachi 83104
Slovenian: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Zone P.O. Box 571
English: Prenatal and postnatal development study in rats, as well as the embryofetal development study in rabbits are ongoing.
Slovenian: Trenutno potekajo prenatalne in postnatalne študije razvoja pri podganah ter študije embriofetalnega razvoja pri kuncih.
English: Anti-pegloticase antibodies were associated with an increase in CL and Vc as determined by compartmental analysis.
Slovenian: Protitelesa proti peglotikazi so bila povezana s povečanjem CL in Vc, kot se je določilo s prostorno analizo.
English: It is recommended to start this treatment 1 week before initiation of KRYSTEXXA and continue for at least 6 months, unless medically contraindicated or not tolerated.
Slovenian: Priporočljivo je, da se to zdravljenje začne 1 teden pred uvedbo zdravila KRYSTEXXA in traja vsaj 6 mesecev, razen če je kontraindicirano ali ga bolnik ne prenaša.
English: Delayed-type hypersensitivity reactions have also been reported.
Slovenian: Poročali so tudi o zapoznelih preobčutljivostnih reakcijah.
English: Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Slovenian: Na podlagi podobnih profilov učinkovitosti in varnosti za peglotikazo pri bolnikih z očistkom kreatinina pod in nad 50 ml/min, pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerka (glejte poglavje 5.2).
English: The pharmacokinetics of KRYSTEXXA has not been studied in children and adolescents.
Slovenian: Farmakokinetike zdravila KRYSTEXXA niso proučevali pri otrocih in mladostnikih.
English: The Phase 1 pharmacokinetics showed proportionality within the dose interval (0.5 - 8 mg) as reflected in Cmax values.
Slovenian: Farmakokinetika 1. faze je pokazala sorazmernost znotraj razpona odmerka (0,5-8 mg), kar se kaže z vrednostmi Cmax.
English: If haemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
Slovenian: Če se pri bolnikih, ki prejemajo zdravilo KRYSTEXXA, pojavi hemoliza in/ali methemoglobinemija, je treba zdravljenje takoj in za stalno prekiniti ter uvesti ustrezne ukrepe.
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V posameznih razvrstitvah pogostnosti in organskih sistemih so neželene reakcije navedene po padajoči resnosti.
English: In the post-marketing setting, severe anaphylactic reactions have been reported, including loss of consciousness, circulatory collapse, and cardiac arrest, which required transfer to hospital emergency department.
Slovenian: V obdobju trženja zdravila so poročali o hudih anafilaktičnih reakcijah, vključno z izgubo zavesti, cirkulatornim kolapsom in srčnim zastojem, ki so zahtevale obisk bolnišničnega oddelka za nujno pomoč.
English: It is unknown whether pegloticase or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se peglotikaza ali njeni presnovki izločajo v materino mleko.
English: Week 25
Slovenian: Teden 25
English: The European Medicines Agency has deferred the obligation to submit the results of studies with KRYSTEXXA in one or more subset of the paediatric population in the treatment and/or prevention of hyperuricaemia related to Tumour Lysis Syndrome (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom KRYSTEXXA za eno ali več podskupin pediatrične populacije za zdravljenje in/ali preprečevanje hiperurikemije, povezane s sindromom tumorske lize (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Overall Complete Tophus Resolution (Pooled Analysis of GOUT 1 and GOUT 2)
Slovenian: Preglednica 3: Splošna popolna ozdravitev tofa (združena analiza študij GOUT 1 in GOUT 2)
English: • If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism.
Slovenian: • če imate redko krvno bolezen, imenovano pomanjkanje glukoza-6-fosfat dehidrogenaze (G6PD) ali favizem.
English: The safety and efficacy of KRYSTEXXA in children and adolescents aged below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila KRYSTEXXA pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Very common: Dermatitis, urticaria, pruritus, skin irritation, dry skin
Slovenian: Zelo pogosti: dermatitis, urtikarija, pruritus, draženje kože, suha koža
English: The embryofetal development study in rats does not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije embriofetalnega razvoja na podganah ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja in razvoja.
English: Anaphylaxis (characterized by stridor, wheezing, peri-oral/lingual oedema, or hemodynamic instability, with or without rash or urticaria) occurred in 14 (5.1%) of 273 total patients treated with KRYSTEXXA in clinical studies.
Slovenian: Anafilaksa (za katero so značilni stridor, sopenje, perioralni/lingvalni edem ali hemodinamska nestabilnost z izpuščajem ali urtikarijo ali brez njiju) se je pojavila pri 14 (5,1 %) od skupno 273 bolnikov, zdravljenih z zdravilom KRYSTEXXA v kliničnih študijah.
English: Pegloticase is used to treat severe long-term gout in adult patients who also have one or more painful deposits of uric acid crystals under the skin that cause difficulty in carrying out daily activities and who do not respond or cannot take other anti-gout medicines.
Slovenian: Peglotikaza se uporablja za zdravljenje hudega dolgotrajnega protina pri odraslih bolnikih, ki imajo enega ali več bolečih depozitov kristalov sečne kisline pod kožo, ki povzročajo težave pri opravljanju vsakodnevnih dejavnosti in se ne odzivajo na druga zdravila proti protinu ali jih ne prenašajo.
English: The effect of treatment on tophi was assessed using standardized digital photography and image analysis by a Central Reader blinded to treatment assignment.
Slovenian: Učinkovitost zdravljenja proti tofom so ocenili s standardizirano digitalno fotografijo in analizo slik s pomočjo centra za osrednje analize (Central Reader), ki ni bil seznanjen z razporeditvijo zdravljenja.
English: The solution should be used within 4 hours of dilution.
Slovenian: Raztopino je treba uporabiti v 4 urah po redčenju.
English: Crealta Pharmaceuticals Ireland Limited
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Crealta Pharmaceuticals Ireland Limited
English: For instructions on the preparation of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave zdravila pred dajanjem glejte poglavje 6.6.
English: The efficacy and safety of KRYSTEXXA was assessed in two replicate Phase III pivotal trials (GOUT 1 and GOUT 2) that were conducted in 212 adult patients with chronic gout refractory to allopurinol.
Slovenian: Učinkovitost in varnost zdravila KRYSTEXXA so ocenili v dveh repliciranih ključnih preskušanjih 3. faze (GOUT 1 in GOUT 2), ki sta bili opravljeni pri 212 odraslih bolnikih s kroničnim protinom, neodzivnim na alopurinol.
English: Week 13
Slovenian: Teden 13
English: The PK/PD analysis showed that higher doses were associated with lower uric acid levels and a more rapid decrease in these levels than lower doses.
Slovenian: Farmakakokinetična/farmakodinamična analiza je pokazala, da so bili večji odmerki povezani z nižjimi ravnmi sečne kisline in hitrejšim zniževanjem teh ravni v primerjavi z manjšimi odmerki.
English: KRYSTEXXA is not recommended during pregnancy.
Slovenian: Uporaba zdravila KRYSTEXXA ni priporočljiva med nosečnostjo.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki in škatli poleg oznake „Uporabno do“.
English: Therefore, in view of available data regarding anaphylaxis and infusion reactions, the Pharmacovigilance Risk Assessment Committee considered that changes to the product information were warranted.
Slovenian: Ob upoštevanju razpoložljivih podatkov glede anafilakse in reakcij zaradi infundiranja je Odbor za oceno tveganja na področju farmakovigilance ocenil, da so ocene za spremembo informacij za zdravilo utemeljene.
English: 8 mg Pegloticase Every 2 Weeks (N = 62)
Slovenian: 8 mg peglotikaze vsaka 2 tedna (N = 62)
English: The revised order of the two corresponding paragraphs is to emphasize the correlation between concomitant medication with urate lowering products and serum uric acid measurement.
Slovenian: Popravljen vrstni red dveh zadevnih odstavkov poudarja korelacijo med sočasnim zdravljenjem z zdravili za zniževanje ravni uratov in merjenjem sečne kisline.
English: The duration of treatment should be based upon maintenance of response (serum uric acid levels < 6 mg/dl) and clinical judgment.
Slovenian: Trajanje zdravljenja mora temeljiti na vzdrževanju odziva (ravni sečne kisline v serumu < 6 mg/dl) in na klinični presoji.
English: The vial should not be shaken.
Slovenian: Viala se ne sme pretresti.
English: Before you start treatment with KRYSTEXXA, your doctor may recommend that you take other medicines (such as an antihistamine, paracetamol and a corticosteroid) to help reduce the risk that you will get infusion-related reactions due to this treatment.
Slovenian: Preden začnete zdravljenje z zdravilom KRYSTEXXA, bo zdravnik morda priporočil, da vzamete druga zdravila (kot so antihistaminik, paracetamol in kortikosteroid), ki bodo pomagala zmanjšati tveganje za reakcije, povezane z infundiranjem.
English: Week 19
Slovenian: Teden 19
English: Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolysis and methemoglobinemia.
Slovenian: Pomanjkanje glukoze-6-fosfat dehidrogenaze (G6PD) ali druge celularne presnovne motnje, za katere je znano, da povzročajo hemolizo in methemoglobinemijo.
English: This dose is not adjusted for weight, age or kidney disease.
Slovenian: Ta odmerek ni prilagojen telesni masi, starosti ali ledvični bolezni.
English: An increase in gout flares is frequently observed upon treatment initiation, probably as a result of mobilization of urate from tissue deposits.
Slovenian: Med uvedbo zdravljenja se pogosto opazi povečanje napadov protina, kar je verjetno posledica mobilizacije urata naloženega v tkivu.
English: Pegloticase belongs to the class anti-gout medicines.
Slovenian: Peglotikaza spada v skupino zdravil proti protinu.
English: For the PEG moiety, urinary excretion is likely to be the major route of elimination.
Slovenian: Pri skupini PEG je verjetno glavna pot izločanja z urinom.
English: In repeated dose toxicity studies with KRYSTEXXA in rats and dogs, the occurrence of pegloticase-containing vacuoles was observed in different tissues.
Slovenian: V študijah toksičnosti z večkratnim odmerjanjem zdravila KRYSTEXXA pri podganah in psih so v različnih tkivih opazili vakuole, ki so vsebovale peglotikazo.
English: - if you are currently taking other medicines to lower your uric acid level - if you have been told you have heart failure - if you have ever been told you have an enzyme deficiency that causes anaemia - if you weigh over 100 kg - if you have been treated with KRYSTEXXA before
Slovenian: - če trenutno jemljete druga zdravila za zniževanje ravni sečne kisline; - če so vam povedali, da imate srčno popuščanje; - če so vam povedali, da imate pomanjkanje encima, ki povzroča anemijo; - če tehtate več kot 100 kg;
English: Pegloticase is a uricase enzyme conjugated with mPEG at an average degree of substitution of 40.8 moles of mPEG/mole of protein (10.2 moles of mPEG/monomeric sub-unit of the mature homotetrameric uricase protein).
Slovenian: Peglotikaza je encim urikaze, konjugiran z mPEG pri povprečni stopnji substitucije 40,8 mola mPEG/mol proteina (10,2 mola mPEG/monomerne podenote zrelega homotetramernega proteina urikaze).
English: Many infusion-related reactions resolved with slowing, or stopping the infusion, before restarting the infusion at a slower rate.
Slovenian: Mnoge reakcije, povezane z infundiranjem, so izginile ob upočasnitvi ali prekinitvi infundiranja, preden se je infundiranje ponovno začelo z manjšo hitrostjo.
English: The applicant should conduct a long-term EU observational study to end December 2018 on safety of pegloticase use in adult hyperuricemic patients with severe debilitating chronic tophaceous gout and efficacy and safety data in reexposed patients.
Slovenian: M0402: Opazovalna študija peglotikaze v obdobju trženja v EU Predlagatelj mora opraviti dolgotrajno opazovalno študijo v EU do konca decembra 2018 glede varnosti uporabe peglotikaze pri odraslih hiperuremičnih bolnikih s hudim onesposabljajočim kroničnim protinom s tofi ter podatkov o učinkovitosti in varnosti pri ponovno izpostavljenih bolnikih.
English: KRYSTEXXA should not be administered if two consecutive levels above 6 mg/dl (360 µmol/L) have been measured (see section 4.4).
Slovenian: Zdravilo KRYSTEXXA se ne sme uporabiti, če sta bili izmerjeni dve zaporedni ravni nad 6 mg/dl (360 µmol/l) (glejte poglavje 4.4).
English: As shown in Table 3 at Month 6, the percentage of patients who achieved complete tophus response (defined as 100% resolution of at least one target tophus, without the appearance of any new tophi or any progression of existing tophi) was 29.0% in patients treated with 8 mg pegloticase every 2 weeks compared to 6.9% in placebo patients excluding patients with missing data, who were considered as a failure.
Slovenian: Kot je prikazano v preglednici 3, je bil po 6. mesecih odstotek bolnikov, ki so dosegli popoln odziv glede tofov (opredeljen kot 100-odstotna ozdravitev vsaj enega ciljnega tofa brez novih tofov ali napredovanja obstoječih tofov), 29,0 % pri bolnikih, zdravljenih z 8 mg peglotikaze vsaka 2 tedna, v primerjavi s 6,9 % bolnikov, zdravljenih s placebom, z izjemo bolnikov z manjkajočimi podatki, ki so se šteli kot neuspešni.
English: • The active substance is pegloticase.
Slovenian: • Zdravilna učinkovina je peglotikaza.
English: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but a small number of patients with pre-existing cardiovascular conditions who were treated with pegloticase in the clinical trials had exacerbations of their congestive heart failure.
Slovenian: Zdravila KRYSTEXXA niso uradno proučevali pri bolnikih s kongestivnim srčnim popuščanjem, vendar se je pri majhnem številu bolnikov z obstoječimi kardiovaskularnimi stanji, ki so se v kliničnih preskušanjih zdravili s peglotikazo, pojavilo poslabšanje kongestivnega srčnega popuščanja.
English: The first infusion reaction usually occurs after the 2
Slovenian: Prva reakcija na infundiranje se navadno pojavi po 2. do 4. infundiranju.
English: The most commonly reported serious side effects are: severe acute allergic reactions (common), infusion reactions (very common), and gout flares (very common).
Slovenian: Resni neželeni učinki, o katerih so poročali najpogosteje, so: hude akutne alergijske reakcije (pogoste), reakcije na infundiranje (zelo pogoste) in napadi protina (zelo pogosti).
English: KRYSTEXXA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo KRYSTEXXA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Name and address of the manufacturer(s) of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout.
Slovenian: Zdravljenje mora uvesti ter nadzorovati specialist z izkušnjami z diagnosticiranjem in zdravljenjem hudega refraktarnega kroničnega protina.
English: The mean Cmax calculated on the last infusion was 2.17 µg/ml (range: 1.25 - 4.77).
Slovenian: Povprečni Cmax, izračunan ob zadnjem infundiranju, je bil 2,17 µg/ml (razpon: 1,25-4,77).
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Navedba smiselno ni potrebna.
English: Continuous treatment with pegloticase decreases frequency and intensity of gout flares.
Slovenian: Neprekinjeno zdravljenje s peglotikazo zmanjša pogostnost in intenzivnost napadov protina.
English: There were no effects on the fertility of male or female rats.
Slovenian: Učinkov na plodnost podganjih samic in samcev ni bilo.
English: KRYSTEXXA in a vial or in an intravenous infusion fluid must never be subjected to artificial heating (e.g., hot water, microwave).
Slovenian: Zdravilo KRYSTEXXA v viali ali v obliki intravenske infuzijske tekočine ne sme nikoli biti izpostavljeno umetnemu segrevanju (npr. vroči vodi, mikrovalovni pečici).
English: • a shortness of breath, wheezing or breathing problems
Slovenian: • kratko sapo, sopenje ali težave z dihanjem,
English: What KRYSTEXXA is and what it is used for
Slovenian: Kaj je zdravilo KRYSTEXXA in za kaj ga uporabljamo
English: Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation).
Slovenian: Sečna kislina odlaga kristale v sklepih, ledvicah in drugih organih, kar lahko povzroči hudo bolečino, rdečino in otekanje (vnetje).
English: KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine.
Slovenian: Zdravilo KRYSTEXXA vsebuje encim, imenovan urikaza, ki sečno kislino pretvori v snov, imenovano alantoin, ki se zlahka odstrani z urinom.
English: Close monitoring is required during the infusion and for at least 2 hours after the end of the infusion.
Slovenian: Med infundiranjem in vsaj dve uri po koncu infundiranja je potrebno skrbno spremljanje.
English: The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenj(-a) za promet z zdravilom.
English: Very common: Infusion related reaction Common: Anaphylaxis, influenza like illness
Slovenian: Zelo pogosti: reakcija, povezana z infundiranjem Pogosti: anafilaksa, gripi podobna bolezen
English: Lower response rates were observed in patients over 100 kg BW; however, confounding factors in a small sample size make it unclear if in patients over 100 kg BW the dose was optimal to achieve an effect.
Slovenian: Pri bolnikih s telesno maso nad 100 kg so opazili manjši delež odziva, vendar zaradi dodatnih dejavnikov pri majhni velikosti vzorca ni jasno, ali je bil pri bolnikih s telesno maso nad 100 kg odmerek optimalen za doseganje učinka.
English: 1 95% confidence interval for differences in responder rate between pegloticase group vs. placebo 2 P-value using Fisher's exact test to compare pegloticase group vs. placebo 3GOUT = Gout Outcomes and Urate-lowering Therapy
Slovenian: 1 95-odstotni interval zaupanja za razlike v deležu odziva med skupino s peglotikazo in skupino s placebom Vrednost P z uporabo Fisherjevega natančnega testa za primerjavo skupine s peglotikazo in skupine s placebom GOUT = Gout Outcomes and Urate-lowering Therapy (Izidi glede protina in zdravljenje za zniževanje ravni urata)
English: Severe allergic reactions (common) include fainting, sudden drop in blood pressure, and cardiac arrest.
Slovenian: Hude alergijske reakcije (pogosto) vključujejo omedlevico, nenaden padec krvnega tlaka in srčni zastoj.
English: The recommended dose is 8 mg pegloticase given as an intravenous infusion every two weeks.
Slovenian: Odmerjanje Priporočeni odmerek je 8 mg peglotikaze v obliki intravenskega infundiranja vsaka dva tedna.
English: Uncommon: Cellulitis
Slovenian: Občasni: celulitis
English: Prior to infusion, patients should receive pre-medication to minimize the risk of infusion-related reactions, e.g. antihistamine the evening before, and again approximately 30 minutes before the infusion, as well as paracetamol and a corticosteroid immediately before each infusion (see section 4.4).
Slovenian: Pred infundiranjem morajo bolniki prejeti predzdravilo, da se zmanjša tveganje reakcij, povezanih z infundiranjem, npr. antihistaminik prejšnji večer in ponovno približno 30 minut pred infundiranjem ter paracetamol in kortikosteroid tik pred vsakim infundiranjem (glejte poglavje 4.4).
English: Antibodies to pegloticase associated with clearance of pegloticase resulted in a small stimulation in the elimination of urate.
Slovenian: Protitelesa proti peglotikazi, povezana z očistkom peglotikaze, so povzročila majhno stimulacijo izločanja urata.
English: The strength indicates the quantity of the uricase moiety of pegloticase without consideration of the PEGylation.
Slovenian: Jakost pomeni količino funkcionalnih skupin urikaze v peglotikazi brez upoštevanja PEGilacije.
English: Infusion-related reactions can occur after initiation of any infusion, in spite of patients being premedicated with oral antihistamine, intravenous corticosteroid and/or paracetamol, and generally during or within 1 hour after the infusion is completed.
Slovenian: Reakcije, povezane z infundiranjem, se lahko pojavijo po začetku katerega koli infundiranja kljub predhodnemu zdravljenju z antihistaminikom, intravenskim kortikosteroidom in/ali paracetamolom ter navadno med infundiranjem ali 1 uro po koncu infundiranja.
English: If you stop taking KRYSTEXXA, and then are treated again, you may be at increased risk of infusion reactions, including severe acute allergic reactions (anaphylaxis) so your doctor will monitor you carefully when you restart treatment.
Slovenian: Če prekinete jemanje zdravila KRYSTEXXA in se ponovno začnete zdraviti, ste lahko izpostavljeni povečanemu tveganju za reakcije na infundiranje, vključno s hudimi akutnimi alergijskimi reakcijami (anafilakso), zato vas bo zdravnik med ponovnim začetkom zdravljenja skrbno spremljal.
English: If an infusion reaction occurs during the administration, the infusion may be slowed, or stopped and restarted at a slower rate, at the discretion of the physician.
Slovenian: Če se med uporabo pojavi reakcija na infundiranje, se lahko infundiranje upočasni ali prekine ter ponovno začne z manjšo hitrostjo, o čemer odloča zdravnik.
English: This induces a concentration gradient between serum uric acid and tissue/joints deposits of monosodium urate resulting in the migration of urate from tissues/joints, which makes it accessible to conversion to allantoin.
Slovenian: To povzroči gradient koncentracije med sečno kislino v serumu in naloženem mononatrijevim uratom v tkivu/sklepih, kar vodi do migracije urata iz tkiva/sklepov in omogoči pretvorbo v alantoin.
English: C.
Slovenian: B.
English: KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4).
Slovenian: Zdravilo KRYSTEXXA je indicirano za zdravljenje hudega onesposabljajočega kroničnega protina s tofi pri odraslih bolnikih, pri katerih je lahko prizadet tudi erozivni sklep in pri katerih se vrednost sečne kisline v serumu ni normalizirala z jemanjem največjega medicinsko sprejemljivega odmerka zaviralcev ksantin-oksidaze ali pri katerih so ta zdravila kontraindicirana (glejte poglavje 4.4).