natgillin/translations-raw huggingface dataset:
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.
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.
• The active substance is pegloticase.
• Zdravilna učinkovina je peglotikaza.
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.
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.
The first infusion reaction usually occurs after the 2
Prva reakcija na infundiranje se navadno pojavi po 2. do 4. infundiranju.
The most commonly reported serious side effects are: severe acute allergic reactions (common), infusion reactions (very common), and gout flares (very common).
Resni neželeni učinki, o katerih so poročali najpogosteje, so: hude akutne alergijske reakcije (pogoste), reakcije na infundiranje (zelo pogoste) in napadi protina (zelo pogosti).
KRYSTEXXA has no or negligible influence on the ability to drive and use machines.
Zdravilo KRYSTEXXA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Name and address of the manufacturer(s) of the biological active substance
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout.
Zdravljenje mora uvesti ter nadzorovati specialist z izkušnjami z diagnosticiranjem in zdravljenjem hudega refraktarnega kroničnega protina.
The mean Cmax calculated on the last infusion was 2.17 µg/ml (range: 1.25 - 4.77).
Povprečni Cmax, izračunan ob zadnjem infundiranju, je bil 2,17 µg/ml (razpon: 1,25-4,77).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Navedba smiselno ni potrebna.
Continuous treatment with pegloticase decreases frequency and intensity of gout flares.
Neprekinjeno zdravljenje s peglotikazo zmanjša pogostnost in intenzivnost napadov protina.
There were no effects on the fertility of male or female rats.
Učinkov na plodnost podganjih samic in samcev ni bilo.
KRYSTEXXA in a vial or in an intravenous infusion fluid must never be subjected to artificial heating (e.g., hot water, microwave).
Zdravilo KRYSTEXXA v viali ali v obliki intravenske infuzijske tekočine ne sme nikoli biti izpostavljeno umetnemu segrevanju (npr. vroči vodi, mikrovalovni pečici).
• a shortness of breath, wheezing or breathing problems
• kratko sapo, sopenje ali težave z dihanjem,
What KRYSTEXXA is and what it is used for
Kaj je zdravilo KRYSTEXXA in za kaj ga uporabljamo
Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation).
Sečna kislina odlaga kristale v sklepih, ledvicah in drugih organih, kar lahko povzroči hudo bolečino, rdečino in otekanje (vnetje).
KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine.
Zdravilo KRYSTEXXA vsebuje encim, imenovan urikaza, ki sečno kislino pretvori v snov, imenovano alantoin, ki se zlahka odstrani z urinom.
Close monitoring is required during the infusion and for at least 2 hours after the end of the infusion.
Med infundiranjem in vsaj dve uri po koncu infundiranja je potrebno skrbno spremljanje.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenj(-a) za promet z zdravilom.
Very common: Infusion related reaction Common: Anaphylaxis, influenza like illness
Zelo pogosti: reakcija, povezana z infundiranjem Pogosti: anafilaksa, gripi podobna bolezen
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.
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.
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
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)
Severe allergic reactions (common) include fainting, sudden drop in blood pressure, and cardiac arrest.
Hude alergijske reakcije (pogosto) vključujejo omedlevico, nenaden padec krvnega tlaka in srčni zastoj.
The recommended dose is 8 mg pegloticase given as an intravenous infusion every two weeks.
Odmerjanje Priporočeni odmerek je 8 mg peglotikaze v obliki intravenskega infundiranja vsaka dva tedna.
Uncommon: Cellulitis
Občasni: celulitis
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).
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).
Antibodies to pegloticase associated with clearance of pegloticase resulted in a small stimulation in the elimination of urate.
Protitelesa proti peglotikazi, povezana z očistkom peglotikaze, so povzročila majhno stimulacijo izločanja urata.
The strength indicates the quantity of the uricase moiety of pegloticase without consideration of the PEGylation.
Jakost pomeni količino funkcionalnih skupin urikaze v peglotikazi brez upoštevanja PEGilacije.
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.
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.
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.
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.
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.
Če se med uporabo pojavi reakcija na infundiranje, se lahko infundiranje upočasni ali prekine ter ponovno začne z manjšo hitrostjo, o čemer odloča zdravnik.
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.
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.
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).
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).
The population PK analyses showed that age, sex and weight did not influence the pharmacokinetics of pegloticase.
Farmakokinetične analize v populaciji niso pokazale vpliva starosti, spola in telesne mase na farmakokinetiko peglotikaze.
KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Zdravilo KRYSTEXXA morate prejeti od zdravnika ali medicinske sestre z izkušnjami z zdravljenjem hudega kroničnega protina v zdravstveni ustanovi.
What KRYSTEXXA is and what it is used for What you need to know before you receive KRYSTEXXA How to use KRYSTEXXA
Kaj je zdravilo KRYSTEXXA in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo KRYSTEXXA
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.
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.
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).
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).
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).
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).
It is therefore recommended that patients given repeat infusions of KRYSTEXXA after a treatment interruption be monitored carefully.
Zato je priporočljivo bolnike, ki prejmejo večkratno infundiranje zdravila KRYSTEXXA po prekinitvi zdravljenja skrbno spremljati.
fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
tekočinami, dodatnimi glukokortikoidi ali antihistaminiki ali po prekinitvi infundiranja ter po uporabi adrenalina pri anafilaktičnih reakcijah.
Fertility Effect on male and female fertility has not been studied.
Plodnost Učinka na plodnost pri moških in ženskah niso proučevali.
To reduce the likelihood of gout flares after initiation of KRYSTEXXA prophylaxis with colchicine or a non-steroidal anti-inflammatory drug (NSAID) is recommended.
Da se zmanjša verjetnost izbuhov protina med uvedbo zdravila KRYSTEXXA, se priporoča profilaksa s kolhicinom ali nesteroidnimi antirevmatiki (NSAID).
Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
koncentrat za raztopino za infundiranje Bistra do rahlo opalescentna, brezbarvna raztopina s pH 7,3 ± 0,3.
Because of the immunogenicity of KRYSTEXXA, patients receiving retreatment may be at increased risk of infusion-related reactions, including anaphylaxis.
Zaradi imunogenosti zdravila KRYSTEXXA so lahko bolniki, ki se ponovno zdravijo, izpostavljeni povečanemu tveganju za reakcije, povezane z infundiranjem vključno z anafilakso.
High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid (<6 mg/dl).
Visoki titri protiteles proti peglotikazi so bili povezani z neuspelim vzdrževanjem normalne ravni sečne kisline (< 6 mg/dl).
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.
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.
KRYSTEXXA can induce severe allergic responses, including anaphylactic shock with cardiac arrest.
Zdravilo KRYSTEXXA lahko povzroči hude alergijske reakcije, vključno z anafilaktičnim šokom s srčnim zastojem.
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).
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).
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.
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.
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.
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.
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.
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.
Plasma uric acid decreased with increasing pegloticase dose or concentration.
Raven sečne kisline v plazmi se je znižala z večanjem odmerka ali koncentracije peglotikaze.
• Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature.
• Pred uporabo je treba počakati, da zdravilo KRYSTEXXA doseže sobno temperaturo.
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.
Zdravilo KRYSTEXXA vam bosta dala zdravnik ali medicinska sestra, ki bosta spremljala neželene učinke med prejemanjem zdravila KRYSTEXXA in nekaj časa po njem.
Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
Zdravnik vam lahko predpiše zdravila, s katerimi se bo zmanjšala verjetnost napadov protina po uvedbi zdravila KRYSTEXXA.
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.
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.
KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Uporabo zdravila KRYSTEXXA je treba prekiniti, če je bila dvakrat zaporedoma izmerjena raven nad 6 mg/dl.
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.
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.
KRYSTEXXA is a clear to slightly opalescent colourless solution.
Zdravilo KRYSTEXXA je bistra do rahlo opalescentna brezbarvna raztopina.
Caution should be exercised in patients who have congestive heart failure and patients should be monitored closely following infusion.
Previdnost je potrebna pri bolnikih s kongestivnim srčnim popuščanjem, ki jih je treba po infundiranju skrbno spremljati.
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).
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).
Those subjects that did not have anti- pegloticase antibodies that cleared pegloticase had a significant effect on the stimulation in the elimination of urate.
Pri bolnikih, ki niso imeli protiteles proti peglotikazi, ki izločijo peglotikazo, se je pojavil pomemben učinek na stimulacijo izločanja urata.
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).
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).
Instructions for preparation of the solution for infusion:
Navodila za pripravo raztopine za infundiranje:
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.
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.
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.
Peglotikaza katalizira pretvorbo sečne kisline v inertni, izjemno vodotopen presnovek alantoin, pri čemer sta stranska produkta oksidacije vodikov peroksid in ogljikov dioksid.
Only solutions which are clear to slightly opalescent, colourless and free of visible particles should be used.
Uporabiti se sme samo bistra do rahlo opalescentna brezbarvna raztopina brez vidnih delcev.
Do not use this medicine if you notice any particles or discolouration in the diluted solution.
To zdravilo se ne sme uporabiti, če so v razredčeni raztopini vidni kakršni koli delci ali razbarvanje.
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.
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.
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Znanstveni zaključki in podlaga za priporočilo za spremembo pogojev dovoljenja za promet z
KRYSTEXXA was administered by intravenous infusion with a Tmax of 2.25 h (range: 1.92 - 4.25 h for initial dose).
Zdravilo KRYSTEXXA se je dajalo z intravenskim infundiranjem s Tmax 2,25 h (razpon: 1,92-4,25 h za prvi odmerek).
Uncommon: Exacerbation of congestive heart failure
Občasni: poslabšanje kongestivnega srčnega popuščanja
Neither body weight nor baseline creatinine clearance had a significant effect on the PD response.
Telesna masa in izhodiščni očistek kreatinina nista imela pomembnega učinka na farmakodinamični odziv.
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.
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.
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).
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).
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.
Skupno 32 % (27 od 85) bolnikov, zdravljenih z 8 mg zdravila KRYSTEXXA vsaka 2 tedna, je imelo očistek kreatinina ≤ 62,5 ml/min.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared to manage anaphylaxis and infusion reactions.
Zdravilo morajo v zdravstveni ustanovi uporabljati zdravstveni delavci, ki so pripravljeni na obravnavo anafilakse in reakcij na infundiranje.
What KRYSTEXXA looks like and contents of the pack
Izgled zdravila KRYSTEXXA in vsebina pakiranja
Very common: Nausea
Zelo pogosti: navzeja Pogosti: bruhanje
The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
Zdravilna učinkovina peglotikaza je kovalentni konjugat urikaze, proizveden z genetsko spremenjenim sevom Escherichia coli in monometoksipoli (etilenglikolom).
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.
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.