FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Prije početka liječenja lijekom KRYSTEXXA, Vaš liječnik može preporučiti uzimanje drugih lijekova (poput antihistaminika, paracetamola i kortikosteroida) kako bi Vam se pomoglo smanjiti rizik od infuzijskih reakcija koje mogu nastati tijekom ovog liječenja.
English: It is therefore recommended that patients given repeat infusions of KRYSTEXXA after a treatment interruption be monitored carefully.
Croatian: Stoga se preporučuje da se bolesnici kojima se daju ponovljene infuzije lijeka KRYSTEXXA nakon prekida liječenja pažljivo nadziru.
English: There were no effects on the fertility of male or female rats.
Croatian: Nije bilo učinaka na mušku ili žensku plodnost štakora.
English: The recommended dose is 8 mg pegloticase given as an intravenous infusion every two weeks.
Croatian: Preporučena doza je 8 mg peglotikaze u obliku intravenske infuzije svaka dva tjedna.
English: The duration of treatment should be based upon maintenance of response (serum uric acid levels < 6 mg/dl) and clinical judgment.
Croatian: Trajanje liječenja treba temeljiti na održavanju odgovora (serumske razine mokraćne kiseline <6 mg/dl) i na kliničkoj procjeni.
English: Many infusion-related reactions resolved with slowing, or stopping the infusion, before restarting the infusion at a slower rate.
Croatian: Mnoge infuzijske reakcije povukle su se s usporavanjem ili obustavom infuzije prije ponovnog početka infuzije pri nižoj brzini.
English: The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4).
Croatian: Odluku o liječenju lijekom KRYSTEXXA treba temeljiti na tekućim procjenama dobrobiti i rizika za pojedinog bolesnika (vidjeti dio 4.4).
English: The solution should be used within 4 hours of dilution (see section 6.6).
Croatian: Otopinu treba upotrijebiti unutar 4 sata nakon razrjeđivanja (vidjeti dio 6.6).
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).
Croatian: Na temelju sličnih profila djelotvornosti i sigurnosti peglotikaze u bolesnika s klirensom kreatinina ispod i iznad 50 ml/min, nije potrebna prilagodba doze za bolesnike s oštećenjem bubrega (vidjeti dio
English: Week 19
Croatian: Tjedan 19
English: The effect of treatment on tophi was assessed using standardized digital photography and image analysis by a Central Reader blinded to treatment assignment.
Croatian: Učinak liječenja na tofe procijenjen je primjenom standardizirane digitalne fotografije i analize slike koji provodi središnja služba za očitavanje slika kojoj nije poznato koje je liječenje primao bolesnik.
English: The mean Cmax calculated on the last infusion was 2.17 µg/ml (range: 1.25 - 4.77).
Croatian: Prosječna Cmax izračunata za posljednju infuziju iznosila je 2,17 µg/ml (raspon: 1,25-4,77).
English: Your doctor may test you for G6PD before you start KRYSTEXXA.
Croatian: Vaš liječnik može Vas testirati na G6PD prije početka liječenja lijekom KRYSTEXXA.
English: Plasma uric acid decreased with increasing pegloticase dose or concentration.
Croatian: Plazmatske razine mokraćne kiseline smanjivale su se s porastom doze ili koncentracije peglotikaze.
English: Other medicines and KRYSTEXXA
Croatian: Drugi lijekovi i KRYSTEXXA
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.
Croatian: Kako je prikazano u tablici 3 u 6. mjesecu, postotak bolesnika koji su postigli potpuni odgovor tofa (definiran kao 100%-tno otapanje najmanje jednog ciljnog tofa bez pojave ijednog novog tofa ili napredovanja postojećih tofa) iznosio je 29,0% u bolesnika liječenih s 8 mg peglotikaze svaka dva tjedna u usporedbi sa 6,9% u bolesnika koji su primali placebo, isključujući bolesnike za koje nedostaju podaci i koji su smatrani neuspjehom.
English: High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid (<6 mg/dl).
Croatian: Visoki titri protutijela na peglotikazu bili su povezani sa neuspjehom održavanja normalizacije razine mokraćne kiseline (<6 mg/dl).
English: KRYSTEXXA has no or negligible influence on the ability to drive and use machines.
Croatian: KRYSTEXXA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: • The active substance is pegloticase.
Croatian: • Djelatna tvar je peglotikaza.
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).
Croatian: Peglotikaza je enzim urikaza konjugiran s mPEG pri prosječnom stupnju supstitucije od 40,8 mola mPEG/molu proteina (10,2 mola mPEG/monomerne podjedinice zrelog homotetramernog proteina urikaze).
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.
Croatian: Ako prestanete uzimati lijek KRYSTEXXA i potom se opet počnete liječiti, možete biti pod povećanim rizikom od infuzijskih reakcija uključujući teške akutne alergijske reakcije (anafilaksija) tako da će Vas Vaš liječnik nadzirati kada ponovno počnete s liječenjem.
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.
Croatian: Podnositelj zahtjeva treba provesti dugoročno opservacijsko ispitivanje na području EU do kraja prosinca 2018. godine o neškodljivosti primjene peglotikaze u odraslih bolesnika s hiperuricemijom i teškim onesposobljavajućim kroničnim gihtom s tofima te dobiti podatke o djelotvornosti i neškodljivosti za bolesnike koji su bili ponovno izloženi lijeku.
English: • Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature.
Croatian: • Prije primjene potrebno je omogućiti da razrijeđena otopina lijeka KRYSTEXXA dosegne sobnu temperaturu.
English: • a rash, itching or hives tell your doctor or nurse IMMEDIATELY, since any of these may be signs of a serious allergic reaction.
Croatian: ODMAH obavijestite svog liječnika ili medicinsku sestru s obzirom da bilo što od navedenog može biti znak ozbiljne alergijske reakcije.
English: No case of overdose with KRYSTEXXA has been reported during clinical development.
Croatian: Nije zabilježen nijedan slučaj predoziranja lijekom KRYSTEXXA tijekom kliničkog razvoja lijeka.
English: There was potential for some accumulation with the KRYSTEXXA 8 mg every two weeks dosing regimen due to the long half-life of pegloticase (214 h; range: 123 - 444 h for terminal half-life).
Croatian: Postojao je potencijal za određenu akumulacija uz liječenje lijekom KRYSTEXXA 8 mg svaka dva tjedna zbog dugog poluživota peglotikaze (214 sati; raspon: 123-444 sata za terminalni poluživot).
English: Very common: Infusion related reaction Common: Anaphylaxis, influenza like illness
Croatian: Vrlo često: reakcije povezane s infuzijom Često: anafilaksija, bolest nalik influenci
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakovanju iza „EXP“ / „Rok valjanosti“.
English: If the diluted solution is not used immediately, it can be stored refrigerated (2°C to 8°C).
Croatian: Ako se razrijeđena otopina ne primijeni odmah, može se čuvati u hladnjaku (2 °C-8 °C).
English: The infusion bag containing diluted KRYSTEXXA should not be shaken.
Croatian: Vrećicu za infuziju koja sadrži razrijeđeni lijek KRISTEXXA ne smijete tresti.
English: One patient treated with KRYSTEXXA 8 mg every 4 weeks experienced a delayed type hypersensitivity reaction.
Croatian: Jedan bolesnik liječen lijekom KRYSTEXXA 8 mg svaka 4 tjedna doživio je odgođenu reakciju preosjetljivosti.
English: KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Croatian: Lijek KRYSTEXXA treba davati liječnik ili sestra iskusni u liječenju teškog kroničnog gihta u zdravstvenom centru.
English: • The infusion bag containing the diluted KRYSTEXXA solution should be inverted a number of times gently to ensure thorough mixing.
Croatian: • Vrećicu za infuziju koja sadrži razrijeđenu otopinu lijeka KRYSTEXXA treba okrenuti nekoliko puta kako bi se osiguralo temeljito miješanje.
English: The most commonly reported serious side effects are: severe acute allergic reactions (common), infusion reactions (very common), and gout flares (very common).
Croatian: Najčešće prijavljene ozbiljne nuspojave su: teške akutne alergijske reakcije (često), infuzijske reakcije (vrlo često) i pogoršanja gihta (vrlo često).
English: In repeated dose toxicity studies with KRYSTEXXA in rats and dogs, the occurrence of pegloticase-containing vacuoles was observed in different tissues.
Croatian: U ispitivanjima toksičnosti ponovljenih doza lijeka KRYSTEXXA u štakora i pasa, u različitim tkivima uočena je pojava vakuola koje sadrže peglotikazu.
English: Severe allergic reactions (common) include fainting, sudden drop in blood pressure, and cardiac arrest.
Croatian: Teške alergijske reakcije (često) uključuju nesvjesticu, iznenadni pad krvnog tlaka i srčani arest.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout.
Croatian: Liječenje treba započeti i nadzirati liječnik specijalist iskusan u dijagnosticiranju i liječenju teškog, refraktornog, kroničnog gihta.
English: The average number of gout flares per patient was 10 during the 18 months prior to study entry.
Croatian: Prosječan broj pogoršanja gihta po bolesniku bio je 10 tijekom 18 mjeseci prije ulaska u ispitivanje.
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.
Croatian: Peglotikaza se koristi za liječenje teškog, dugotrajnog gihta u odraslih bolesnika, koji imaju jedan ili više bolnih depozita kristala urične kiseline pod kožom koji uzrokuju poteškoće u svakodnevnim aktivnostima, i koji ne reagiraju na ili ne mogu primati lijekove protiv gihta.
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti i klasifikacije organskih sustava nuspojave su prikazane prema opadajućoj ozbiljnosti.
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.
Croatian: Promijenjeni redoslijed ta dva odgovarajuća odlomka teksta ima svrhu naglasiti korelaciju između istovremene primjene lijekova za snižavanje urata i mjerenja mokraćne kiseline u serumu.
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.
Croatian: Infuzijske reakcije mogu se javiti nakon početka bilo koje infuzije usprkos premedikaciji bolesnika peroralnim antihistaminicima, intravenskim kortikosteroidima i/ili paracetamolom te općenito tijekom ili unutar sat vremena nakon dovršetka infuzije.
English: They were reported in 54% of the patients in the 70 to ≤100 kg weight group, 70% of the patients in the >100 to ≤120 kg weight group, and 75% of patients in the >120 kg weight group, respectively.
Croatian: Prijavljene su u 54% bolesnika iz skupine sa 70 do ≤100 kg težine, u 70% bolesnika u skupini s tjelesnom težinom od >100 kg do ≤120 kg odnosno 75% bolesnika u skupini bolesnika težih od 120 kg.
English: This compared with flare rates of 41%and 67% in the same groups in the subsequent 3 months, and gout flares were infrequent in patients that received pegloticase 8 mg every 2 weeks for over one year.
Croatian: To je uspoređeno sa stopama pogoršanja od 41% i 67% u istim skupinama u iduća tri mjeseca, dok su pogoršanja giht bila rijetka u bolesnika koji su primali peglotikazu 8 mg svaka 2 tjedna dulje od godine dana.
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).
Croatian: Prije infuzije bolesnici trebaju primiti premedikaciju kako bi se minimizirao rizik od reakcija povezanih s infuzijom, primjerice antihistaminike večer prije i ponovno približno pola sata prije infuzije, kao i paracetamol i kortikosteroide neposredno prije svake infuzije (vidjeti dio 4.4).
English: Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
Croatian: Bistra do blago zamućena, bezbojna otopina s pH od 7,3±0,3.
English: • 1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Croatian: • 1 ml lijeka KRYSTEXXA treba navući iz bočice u sterilnu štrcaljku.
English: As anti-pegloticase antibodies can bind to the PEG moiety of KRYSTEXXA, there may be potential for binding to other PEGylated products.
Croatian: S obzirom da se protutijela na peglotikazu mogu vezati na PEG dio lijeka KRYSTEXXA, može nastati potencijal za vezivanje na druge PEGilirane lijekove.
English: KRYSTEXXA was administered by intravenous infusion with a Tmax of 2.25 h (range: 1.92 - 4.25 h for initial dose).
Croatian: KRYSTEXXA se primjenjivala intravenskom infuzijom s Tmax od 2,25 h (raspon: 1,92-4,25 h za početnu dozu).
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).
Croatian: KRYSTEXXA je indicirana za liječenje teškog, onesposobljavajućeg kroničnog gihta s tofima u odraslih bolesnika koji također mogu imati erozivne promjene na zglobovima i koji nisu uspjeli normalizirati serumske razine mokraćne kiseline inhibitorima ksantin oksidaze pri maksimalnoj odgovarajućoj dozi ili u bolesnika kod kojih su ovi lijekovi kontraindicirani (vidjetio dio 4.4).
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.
Croatian: KRYSTEXXA sadrži enzim zvan urikaza koji pretvara mokraćnu kiselinu u tvar zvanu alantoin koja se može jednostavno izlučiti mokraćom.
English: The benefit/risk balance should be assessed for each individual patient on an on-going basis considering the effect on tophus resolution as well as the risk of infusion reactions, gout flares, and potentially increased cardiac risk.
Croatian: Omjer dobrobiti/rizika treba procijeniti za svakog pojedinog bolesnika za svaki dan liječenja uzimajući u obzir učinak na otapanje tofa kao i rizik od infuzijskih reakcija, pogoršanja gihta i mogućeg povećanog rizika za srce.
English: Patients were randomised in a 2:2:1 ratio to receive 8 mg every 2 weeks or every 4 weeks or placebo for 6 months.
Croatian: Bolesnici su bili randomizirani u omjeru 2:2:1 kako bi primali 8 mg svaka 2 tjedna ili svaka 4 tjedna ili placebo tijekom 6 mjeseci.
English: 2 ml vial (Type I glass) with a Teflon coated bromobutyl rubber stopper and aluminium seal with polypropylene flip-off cap, containing 1 ml concentrate for solution for infusion.
Croatian: Bočica od 2 ml (staklo tipa I) s teflonom obloženim čepom od bromobutilne gume i aluminijskim poklopcem s polipropilenskim zatvaračem koja sadrži 1 ml koncentrata za otopinu za infuziju.
English: Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation).
Croatian: Mokraćna kiselina taloži se u zglobovima, bubrezima i drugim organima što može uzrokovati izrazitu bol, crvenilo i oticanje (upalu).
English: The primary endpoint in both trials was the proportion of responder patients that achieved plasma uric acid (PUA) less than 0.36 mmol/L (6 mg/dl) for at least 80% of the time during Month 3 and Month 6.
Croatian: Primarna završna točka u oba ispitivanja bila je udio bolesnika koji su odgovorili na liječenje te postigli plazmatske razine mokraćne kiseline (PUA) manje od 0,36 mmol/l (6 mg/dl) tijekom najmanje 80% vremena tijekom mjeseca 3 i 6.
English: Pegloticase catalyses the conversion of uric acid into the inert highly water-soluble metabolite allantoin, with hydrogen peroxide and carbon dioxide as oxidative by-products.
Croatian: Peglotikaza katalizira konverziju mokraćne kiseline u inertni, u vodi visoko topljivi metabolit alantoin, s vodikovim peroksidom i ugljikovim dioksidom kao oksidativnim nusproduktima.
English: The degree of vacuolization and the number of tissues affected appeared to be dependent both on the applied pegloticase dose and the duration of exposure.
Croatian: Čini se da su stupanj vakuolizacije i broj tkiva koja su bila zahvaćena ovisni i o dozi i o trajanju izloženosti peglotikazi.
English: Instructions for preparation of the solution for infusion:
Croatian: Upute za pripremu otopine za infuziju:
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.
Croatian: To smanjenje stvara gradijent koncentracije između serumske razine mokraćne kiseline i depozita mononatrijevog urata u tkivima/zglobovima što rezultira migracijom urata iz tkiva/zglobova i čini ga dostupnim konverziji u alantoin.
English: Most infusion-related reactions have been observed after loss of therapeutic response due to the development of anti-pegloticase antibodies, i.e. when serum uric acid values were above 6 mg/dl (360 µmol/L).
Croatian: Većina infuzijskih reakcija uočena je nakon gubitka terapijskog odgovora zbog razvoja protutijela na peglotikazu, tj. kad su serumske vrijednosti mokraćne kiseline bile iznad 6 mg/dl (360 µmol/l).
English: KRYSTEXXA should not be administered if two consecutive levels above 6 mg/dl (360 µmol/L) have been measured (see section 4.4).
Croatian: Lijek KRYSTEXXA ne treba primjenjivati ako su izmjerene dvije uzastopne razine lijeka iznad 6 mg/dl (360 µmol/l) (vidjeti dio 4.4).
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.
Croatian: Ako se tijekom primjene dogodi infuzijska reakcija , infuziju se može usporiti ili obustaviti te pokrenuti pri nižoj brzini, a prema odluci liječnika.
English: Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
Croatian: Vaš liječnik će Vam testirati krv kako bi izmjerio razine mokraćne kiseline prije svake doze kako bi se uvjerio da trebate nastaviti primati lijek KRYSTEXXA.
English: There was also a higher incidence of infusion reactions in patients with high anti-pegloticase antibody titres: 46% (18 of 39) in the KRYSTEXXA every 2 weeks group compared to 9% (4 of 46) in patients with low or no antibody titres.
Croatian: Također je u bolesnika s visokim titrima protutijela na peglotikazu bila viša incidencija infuzijskih reakcija: 46% (18 od 39) u skupini koja je primala lijek KRYSTEXXA svaka dva tjedna u usporedbi s 9% (4 od 46) u bolesnika s niskim tirom protutijela ili bez njih.
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.
Croatian: Nakon stavljanja lijeka u promet prijavljeno je nekoliko teških anafilaktičkih reakcija uključujući gubitak svijesti, kolaps krvotoka i srčani arest koji je zahtijevao hitno bolničko liječenje.
English: The vial should not be shaken.
Croatian: Bočica se ne smije tresti.
English: Before starting the treatment and especially before monitoring the serum uric acid levels, patients should discontinue oral urate-lowering medication and not institute therapy with oral urate-lowering medication while taking KRYSTEXXA (see section 4.4).
Croatian: Prije početka liječenja i osobito prije nadzora serumske razine mokraćne kiseline, bolesnici trebaju prekinuti peroralnu primjenu lijekova za snižavanje urata i ne započinjati liječenje peroralnim lijekovima za snižavanje urata dok uzimaju lijek KRYSTEXXA (vidjeti dio 4.4).
English: KRYSTEXXA 8 mg concentrate for solution for infusion is supplied in 2 ml glass vials containing 1 ml concentrate.
Croatian: KRYSTEXXA 8 mg koncentrat za otopinu za infuziju isporučuje se u staklenim bočicama od 2 ml koje sadrže 1 ml koncentrata.
English: Infusion-related reactions showed a tendency to occur in a greater proportion of patients with over 100 kg bodyweight.
Croatian: Infuzijske reakcije pokazale su tendenciju pojave u većim udjelima u skupini bolesnika koji su teži od 100 kg.
English: No formal studies were conducted to examine the effects of renal insufficiency on pegloticase pharmacokinetics.
Croatian: Nisu provedena službena ispitivanja učinaka bubrežne insuficijencije na farmakokinetiku peglotikaze.
English: For instructions on the preparation of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o pripremi lijeka prije primjene, vidjeti dio 6.6.
English: Monitoring of serum uric acid level is required prior to each infusion.
Croatian: Potreban je nadzor serumske razine mokraćne kiseline prije svake infuzije.
English: Because of the immunogenicity of KRYSTEXXA, patients receiving retreatment may be at increased risk of infusion-related reactions, including anaphylaxis.
Croatian: Zbog imunogenosti lijeka KRYSTEXXA, bolesnici koji se ponovo liječe mogu biti pod povećanim rizikom od infuzijskih reakcija, uključujući i anafilaksiju.
English: Do not use this medicine if you notice any particles or discolouration in the diluted solution.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje razrijeđene otopine.
English: The solution should be used within 4 hours of dilution.
Croatian: Otopinu treba upotrijebiti unutar 4 sata nakon razrjeđivanja.
English: The mean area under the KRYSTEXXA plasma concentration versus time curve at steady-state (AUC0-t) was 445 h*µg/ml (range: 223 - 1040 h*µg/ml).
Croatian: Prosječno područje ispod krivulje plazmatske koncentracije lijeka KRYSTEXXA naspram krivulje vremena u ravnotežnom stanju (AUC0-t) iznosilo je 445 h*µg/ml (raspon: 223-1040 h*µg/ml).
English: On the basis of the scientific conclusions for pegloticase the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing pegloticase is favourable subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za peglotikazu, CHMP smatra da je omjer koristi i rizika lijeka koji sadrži djelatnu tvar peglotikazu povoljan, uz predložene izmjene informacija o lijeku.