FrancophonIA/ELRC3.0 huggingface dataset:
English: The population PK analyses showed that age, sex and weight did not influence the pharmacokinetics of pegloticase.
Slovenian: Farmakokinetične analize v populaciji niso pokazale vpliva starosti, spola in telesne mase na farmakokinetiko peglotikaze.
English: KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Slovenian: Zdravilo KRYSTEXXA morate prejeti od zdravnika ali medicinske sestre z izkušnjami z zdravljenjem hudega kroničnega protina v zdravstveni ustanovi.
English: What KRYSTEXXA is and what it is used for What you need to know before you receive KRYSTEXXA How to use KRYSTEXXA
Slovenian: Kaj je zdravilo KRYSTEXXA in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo 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.
Slovenian: Incidenca reakcij na infundiranje je bila prav tako večja pri bolnikih z velikimi titri protiteles proti peglotikazi: 46 % (18 od 39) v skupini, ki je zdravilo KRYSTEXXA prejemala vsaka 2 tedna, v primerjavi z 9 % (4 od 46) pri bolnikih z majhnimi titri protiteles ali brez protiteles.
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).
Slovenian: Obstajala je možnost za nekaj kopičenja pri režimu odmerjanja zdravila KRYSTEXXA 8 mg vsaka dva tedna zaradi dolgega razpolovnega časa peglotikaze (214 h; razpon: 123-444 h za končni razpolovni čas).
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).
Slovenian: Večina reakcij, povezanih z infundiranjem, je bila opažena po izgubi terapevtskega odziva zaradi razvoja protiteles proti peglotikazi, tj. ko so vrednosti sečne kisline v serumu nad 6 mg/dl (360 µmol/l).
English: It is therefore recommended that patients given repeat infusions of KRYSTEXXA after a treatment interruption be monitored carefully.
Slovenian: Zato je priporočljivo bolnike, ki prejmejo večkratno infundiranje zdravila KRYSTEXXA po prekinitvi zdravljenja skrbno spremljati.
English: fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
Slovenian: tekočinami, dodatnimi glukokortikoidi ali antihistaminiki ali po prekinitvi infundiranja ter po uporabi adrenalina pri anafilaktičnih reakcijah.
English: Fertility Effect on male and female fertility has not been studied.
Slovenian: Plodnost Učinka na plodnost pri moških in ženskah niso proučevali.
English: To reduce the likelihood of gout flares after initiation of KRYSTEXXA prophylaxis with colchicine or a non-steroidal anti-inflammatory drug (NSAID) is recommended.
Slovenian: Da se zmanjša verjetnost izbuhov protina med uvedbo zdravila KRYSTEXXA, se priporoča profilaksa s kolhicinom ali nesteroidnimi antirevmatiki (NSAID).
English: Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
Slovenian: koncentrat za raztopino za infundiranje Bistra do rahlo opalescentna, brezbarvna raztopina s pH 7,3 ± 0,3.
English: Because of the immunogenicity of KRYSTEXXA, patients receiving retreatment may be at increased risk of infusion-related reactions, including anaphylaxis.
Slovenian: Zaradi imunogenosti zdravila KRYSTEXXA so lahko bolniki, ki se ponovno zdravijo, izpostavljeni povečanemu tveganju za reakcije, povezane z infundiranjem vključno z anafilakso.
English: High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid (<6 mg/dl).
Slovenian: Visoki titri protiteles proti peglotikazi so bili povezani z neuspelim vzdrževanjem normalne ravni sečne kisline (< 6 mg/dl).
English: The frequency of gout flares may increase after initiation of treatment with KRYSTEXXA, despite gout prophylaxis with colchicine or NSAIDs, but the frequency and severity of gout flares diminishes after 3 months of KRYSTEXXA therapy.
Slovenian: Pogostnost napadov protina se lahko poveča po uvedbi zdravljenja z zdravilom KRYSTEXXA kljub profilaksi s kolhicinom ali nesteroidnimi antirevmatiki, vendar se njihova pogostnost in resnost zmanjšata po 3 mesecih zdravljenja z zdravilom KRYSTEXXA.
English: KRYSTEXXA can induce severe allergic responses, including anaphylactic shock with cardiac arrest.
Slovenian: Zdravilo KRYSTEXXA lahko povzroči hude alergijske reakcije, vključno z anafilaktičnim šokom s srčnim zastojem.
English: Patients should be pre-treated with antihistamines, corticosteroids, and paracetamol, and closely monitored for the onset of adverse reactions suggesting severe hypersensitivity reactions including anaphylaxis for at least 1 hour after the end of the infusion (see section 4.8).
Slovenian: Bolnike je treba predhodno zdraviti z antihistaminiki, kortikosteroidi in paracetamolom ter jih skrbno spremljati za pojav neželenih učinkov, ki kažejo hude preobčutljivostne reakcije, vključno z anafilakso, vsaj 1 uro po koncu infundiranja (glejte poglavje 4.8).
English: If you do not feel well, experience symptoms such as dizziness or headache, or are tired after receiving KRYSTEXXA, you should not drive or operate any machines.
Slovenian: Če se po prejemu zdravila KRYSTEXXA ne počutite dobro, imate simptome, kot je omotica ali glavobol, ali ste utrujeni, ne smete upravljati vozil ali strojev.
English: In clinical trials, 91% of patients who experienced an infusion-related reaction had a serum uric acid level above 6 mg/dl (360 μmol/L) due to the development of anti-pegloticase antibodies.
Slovenian: V kliničnih preskušanjih je imelo 91 % bolnikov, ki je imelo reakcijo, povezano z infundiranjem, raven sečne kisline v serumu nad 6 mg/dl (360 μmol/l) zaradi razvoja protiteles proti peglotikazi.
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.
Slovenian: Pri vsakem bolniku je treba sproti ocenjevati razmerje med tveganji in koristmi, pri čemer je treba upoštevati učinek na zdravljenje tofov ter tveganje za reakcije na infundiranje, napade protina in morebitno povečano tveganje za srce.
English: Plasma uric acid decreased with increasing pegloticase dose or concentration.
Slovenian: Raven sečne kisline v plazmi se je znižala z večanjem odmerka ali koncentracije peglotikaze.
English: • Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature.
Slovenian: • Pred uporabo je treba počakati, da zdravilo KRYSTEXXA doseže sobno temperaturo.
English: KRYSTEXXA will be administered by a doctor or nurse who will monitor you for side effects while you receive KRYSTEXXA and for some time afterwards.
Slovenian: Zdravilo KRYSTEXXA vam bosta dala zdravnik ali medicinska sestra, ki bosta spremljala neželene učinke med prejemanjem zdravila KRYSTEXXA in nekaj časa po njem.
English: Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
Slovenian: Zdravnik vam lahko predpiše zdravila, s katerimi se bo zmanjšala verjetnost napadov protina po uvedbi zdravila KRYSTEXXA.
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.
Slovenian: 2-mililitrska viala (steklo tipa I) z zamaškom iz bromobutilne gume, prevlečenim s teflonom, in aluminijastim tesnilom s polipropilensko zaporko, ki vsebuje 1 ml koncentrata za raztopino za infundiranje.
English: KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Slovenian: Uporabo zdravila KRYSTEXXA je treba prekiniti, če je bila dvakrat zaporedoma izmerjena raven nad 6 mg/dl.
English: Physical and chemical stability of KRYSTEXXA diluted in 250 ml sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) has been demonstrated for 4 hours at 2°C to 8°C and at room temperature (20°C to 25°C), if the solution is prepared as described in section 6.6.
Slovenian: Fizikalna in kemična stabilnost zdravila KRYSTEXXA, razredčenega v 250 ml natrijevega klorida 4,5 mg/ml (0,45 %) ali 9 mg/ml (0,9 %), je bila prikazana za 4 ure pri temperaturi od 2 °C do 8 °C in pri sobni temperaturi (od 20 °C do 25 °C), če je bila raztopina pripravljena, kot je opisano v poglavju 6.6.
English: KRYSTEXXA is a clear to slightly opalescent colourless solution.
Slovenian: Zdravilo KRYSTEXXA je bistra do rahlo opalescentna brezbarvna raztopina.
English: Caution should be exercised in patients who have congestive heart failure and patients should be monitored closely following infusion.
Slovenian: Previdnost je potrebna pri bolnikih s kongestivnim srčnim popuščanjem, ki jih je treba po infundiranju skrbno spremljati.
English: Also, high titres of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group (see section 4.8).
Slovenian: Prav tako je bil delež visokih titrov protiteles proti peglotikazi in reakcij, povezanih z infundiranjem, večji pri bolnikih v skupini s to telesno maso (glejte poglavje 4.8).
English: Those subjects that did not have anti- pegloticase antibodies that cleared pegloticase had a significant effect on the stimulation in the elimination of urate.
Slovenian: Pri bolnikih, ki niso imeli protiteles proti peglotikazi, ki izločijo peglotikazo, se je pojavil pomemben učinek na stimulacijo izločanja urata.
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).
Slovenian: Pred začetkom zdravljenja in zlasti pred spremljanjem ravni kisline v serumu morajo bolniki prekiniti jemanje peroralnih zdravil za zniževanje ravni uratov in med jemanjem zdravila KRYSTEXXA se teh zdravil ne sme uvesti (glejte poglavje 4.4).
English: Instructions for preparation of the solution for infusion:
Slovenian: Navodila za pripravo raztopine za infundiranje:
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.
Slovenian: Primarni opazovani dogodek v obeh preskušanjih je bil delež bolnikov z odzivom, ki so dosegli raven sečne kisline v plazmi, manjšo od 0,36 mmol/l (6 mg/dl), vsaj 80 % časa med 3. in 6. mesecem.
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.
Slovenian: Peglotikaza katalizira pretvorbo sečne kisline v inertni, izjemno vodotopen presnovek alantoin, pri čemer sta stranska produkta oksidacije vodikov peroksid in ogljikov dioksid.
English: Only solutions which are clear to slightly opalescent, colourless and free of visible particles should be used.
Slovenian: Uporabiti se sme samo bistra do rahlo opalescentna brezbarvna raztopina brez vidnih delcev.
English: Do not use this medicine if you notice any particles or discolouration in the diluted solution.
Slovenian: To zdravilo se ne sme uporabiti, če so v razredčeni raztopini vidni kakršni koli delci ali razbarvanje.
English: Sustained decrease in plasma uric acid below the solubility concentration of 6 mg/dl was observed for more than 12 days with single doses of 8 mg and 12 mg.
Slovenian: Stalno znižanje ravni sečne kisline v serumu pod koncentracijo topnosti 6 mg/dl so pri enkratnih odmerkih 8 in 12 mg opažali več kot 12 dni.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za priporočilo za spremembo pogojev dovoljenja za promet z
English: KRYSTEXXA was administered by intravenous infusion with a Tmax of 2.25 h (range: 1.92 - 4.25 h for initial dose).
Slovenian: Zdravilo KRYSTEXXA se je dajalo z intravenskim infundiranjem s Tmax 2,25 h (razpon: 1,92-4,25 h za prvi odmerek).
English: Uncommon: Exacerbation of congestive heart failure
Slovenian: Občasni: poslabšanje kongestivnega srčnega popuščanja
English: Neither body weight nor baseline creatinine clearance had a significant effect on the PD response.
Slovenian: Telesna masa in izhodiščni očistek kreatinina nista imela pomembnega učinka na farmakodinamični odziv.
English: Since concomitant use of oral urate-lowering therapy may potentially mask the rise of serum uric acid associated with the loss of response, patients taking concomitant oral urate-lowering therapy may be at increased risk of infusion reactions and/or anaphylaxis.
Slovenian: Ker lahko sočasna uporaba peroralnega zdravljenja za zniževanje ravni uratov prikrije povečanje vrednosti sečne kisline v serumu, povezano z izgubo odziva, so lahko bolniki, ki sočasno prejemajo peroralno zdravljenje za zniževanje ravni uratov, izpostavljeni povečanemu tveganju za reakcije na infundiranje in/ali anafilakso.
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).
Slovenian: Povprečna površina pod krivuljo za koncentracijo zdravila KRYSTEXXA v plazmi v primerjavi s časovno krivuljo v stanju dinamičnega ravnovesja (AUC0-t) je bila 445 h*µg/ml (razpon: 223-1040 h*µg/ml).
English: A total of 32% (27 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks had a creatinine clearance of ≤62.5 ml/min.
Slovenian: Skupno 32 % (27 od 85) bolnikov, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, je imelo očistek kreatinina ≤ 62,5 ml/min.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared to manage anaphylaxis and infusion reactions.
Slovenian: Zdravilo morajo v zdravstveni ustanovi uporabljati zdravstveni delavci, ki so pripravljeni na obravnavo anafilakse in reakcij na infundiranje.
English: What KRYSTEXXA looks like and contents of the pack
Slovenian: Izgled zdravila KRYSTEXXA in vsebina pakiranja
English: Very common: Nausea
Slovenian: Zelo pogosti: navzeja Pogosti: bruhanje
English: The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
Slovenian: Zdravilna učinkovina peglotikaza je kovalentni konjugat urikaze, proizveden z genetsko spremenjenim sevom Escherichia coli in monometoksipoli (etilenglikolom).
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.
Slovenian: Bolniki so billi v razmerju 2 : 2 : 1 naključno razporejeni v skupine, ki so 6 mesecev prejemale 8 mg vsaka 2 tedna ali vsake 4 tedne ali placebo.
English: As the development of these adverse events may have been prevented in at least some of these cases if the patients would not have been treated with concomitant urate lowering substances, an amendment of the summary of product characteristics focusing on the importance of stopping treatment with uric acid lowering agents with regard to masking the results of serum uric acid values (and therefore increasing the risk for infusion reactions and anaphylactic reactions) should be implemented.
Slovenian: Ker bi bilo morda možno v nekaterih primerih razvoj teh neželenih učinkov preprečiti, če bolniki ne bi bili sočasno zdravljeni s peroralnimi zdravili za zniževanje ravni uratov, je potrebna uvedba spremembe povzetka glavnih značilnosti zdravila, ki naj se osredotoči na pomen ustavitve zdravljenja z zdravili za zniževanje ravni uratov, saj lahko prikrijejo vrednosti rezultatov sečne kisline v serumu (in s tem povečajo tveganje za reakcije zaradi infundiranja in anafilaktične reakcije).
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
Slovenian: Ena viala vsebuje 8 mg peglotikaze (8 mg/ml koncentrat).
English: Other medicines and KRYSTEXXA
Slovenian: Druga zdravila in zdravilo KRYSTEXXA
English: As anti-pegloticase antibodies can bind to the PEG moiety of KRYSTEXXA, there may be potential for binding to other PEGylated products.
Slovenian: Ker se lahko protitelesa proti peglotikazi vežejo na funkcionalno skupino PEG zdravila KRYSTEXXA, se morda lahko vežejo na druga PEGilirana zdravila.
English: No formal studies were conducted to examine the effects of renal insufficiency on pegloticase pharmacokinetics.
Slovenian: Študij za preučevanje učinkov ledvične insuficience na farmakokinetiko peglotikaze niso izvedli.
English: KRYSTEXXA does not need to be interrupted because of a gout flare, which should be managed concurrently as appropriate for the individual patient.
Slovenian: Zaradi napada protina ni treba prekiniti uporabe zdravila KRYSTEXXA, temveč ga je treba obravnavati sočasno, kot je primerno za posameznega bolnika.
English: One patient treated with KRYSTEXXA 8 mg every 4 weeks experienced a delayed type hypersensitivity reaction.
Slovenian: Pri enem bolniku, ki se je zdravil z 8 mg zdravila KRYSTEXXA vsake 4 tedne, se je pojavila zapoznela preobčutljivostna reakcija.
English: KRYSTEXXA 8 mg concentrate for solution for infusion is supplied in 2 ml glass vials containing 1 ml concentrate.
Slovenian: Zdravilo KRYSTEXXA 8 mg koncentrat za raztopino za infundiranje je na voljo v 2-mililitrskih steklenih vialah, ki vsebujejo 1 ml koncentrata.
English: Acute gouty attacks (gout flare)
Slovenian: Akutni napadi protina (napadi protina)
English: In controlled clinical trials, the most commonly reported serious adverse reactions were anaphylaxis, which occurred at a frequency of 6.5% (8/123) in patients treated with 8 mg every 2 weeks; infusion reactions, which occurred at a frequency of 26% and gout flares, which were more common during the first 3 months of treatment.
Slovenian: V nadzorovanih kliničnih preskušanjih so bili neželeni učinki, o katerih so poročali najpogosteje, anafilaksa s pogostnostjo 6,5 % (8/123) pri bolnikih, zdravljenih z 8 mg vsaka 2 tedna, reakcije na infundiranje s pogostnostjo 26 % in napadi protina, ki so bili pogostejši v prvih 3 mesecih zdravljenja.
English: If the diluted solution is not used immediately, it can be stored refrigerated (2°C to 8°C).
Slovenian: Če se razredčena raztopina ne uporabi takoj, se lahko shranjuje v hladilniku (od 2 °C do 8 °C).
English: No dose adjustment is needed for patients 65 years of age and older (see section 5.2).
Slovenian: Starejši bolniki Pri bolnikih, starih 65 let ali več, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
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
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za peglotikazo odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino peglotikazo, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: 1 Number of patients with available data 2 Patients with missing data were considered as a failure 3 p values based on Fisher's exact test to compare pegloticase versus placebo
Slovenian: Bolniki z manjkajočimi podatki, ki so se šteli za neuspešne Vrednosti p na podlagi Fisherjevega natančnega testa za primerjavo skupine s peglotikazo in skupine s placebom
English: • tightness of the throat, hoarse voice or trouble swallowing
Slovenian: • tesnost grla, hripav glas ali težave pri požiranju,
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
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.
Slovenian: V naslednjih 3 mesecih sta bila deleža napadov v istih skupinah 41 % oziroma 67 %, napadi protina pa so bili redki pri bolnikih, ki so eno leto prejemali 8 mg peglotikaze vsaka 2 tedna.
English: In the clinical studies, 34% (29 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks were 65 years of age and older and 12% (10 of 85) were 75 years of age and older.
Slovenian: V kliničnih študijah je bilo 34 % (29 od 85) bolnikov, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, starih 65 let in več, 12 % (10 od 85) pa 75 let ali več.
English: Infusion-related reactions / Anaphylaxis
Slovenian: Reakcije, povezane z infundiranjem/anafilaksa
English: • KRYSTEXXA vial should be visually inspected for particles and discolouration prior to dilution and administration.
Slovenian: • Vialo zdravila KRYSTEXXA je treba pred redčenjem in uporabo pregledati ter se prepričati, da v njej ni delcev in razbarvanja.
English: Anti-PEG antibodies also developed in 41% of patients treated with KRYSTEXXA 8 mg every 2 weeks.
Slovenian: Protitelesa proti PEG so se prav tako razvila pri 41 % bolnikov, ki so prejemali 8 mg zdravila KRYSTEXXA vsaka 2 tedna.
English: KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
Slovenian: Zdravilo KRYSTEXXA vsebuje 4,2 mg natrija na odmerek, kar pomeni, da je skoraj brez njega.
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.
Slovenian: Reakcije, povezane z infundiranjem, so se pojavile pri večjem deležu bolnikov s telesno maso nad 100 kg. O njih so poročali pri 54 % bolnikov s telesno maso od 70 do ≤ 100 kg, 70 % bolnikov s telesno maso od > 100 do ≤ 120 kg in 75 % bolnikov s telesno maso > 120 kg.
English: Infusion-related reactions
Slovenian: Reakcije, povezane z infundiranjem
English: Reports of infusion related reactions or anaphylaxis coincident with concomitant use of oral urate lowering agents were submitted in this Periodic Safety Update Report, where infusion reactions in 28 cases and 9 cases with anaphylactic reactions were reported.
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom V tem redno posodobljenem poročilu o varnosti zdravila so bila predložena poročila o reakcijah, povezanih z infuzijami, ali anafilaksi, ki sovpadajo s sočasno uporaba peroralnega zdravljenja za zniževanje ravni uratov, pri čemer je bilo 28 poročil o primerih reakcij, povezanih z infuzijami, in 9 poročil o primerih anafilaktičnih reakcij.
English: As shown in Table 2, a greater proportion of patients treated with KRYSTEXXA 8 mg every 2 weeks were responders as compared to patients receiving placebo.
Slovenian: Kot je prikazano v preglednici 2, se je odzval večji delež bolnikov, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, kot bolnikov, ki so prejemali placebo.
English: The following information is intended for healthcare professionals only: KRYSTEXXA must be prepared as follows:
Slovenian: Zdravilo KRYSTEXXA je treba pripraviti na naslednji način:
English: • 1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Slovenian: • Iz viale je treba v sterilno injekcijsko brizgo izvleči 1 ml zdravila KRYSTEXXA.
English: Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
Slovenian: Bolniki z odzivom so vrednosti sečne kisline v plazmi < 6 mg/dl vzdrževali v celotnem obdobju 6-mesečnega zdravljenja.