FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
Croatian: Vaš liječnik može Vam propisati lijekove za smanjenje vjerojatnosti pogoršanja gihta nakon početka liječenja lijekom KRYSTEXXA.
English: What KRYSTEXXA is and what it is used for What you need to know before you receive KRYSTEXXA How to use KRYSTEXXA
Croatian: Što je KRYSTEXXA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek KRYSTEXXA Kako primjenjivati lijek KRYSTEXXA Moguće nuspojave
English: • tightness of the throat, hoarse voice or trouble swallowing
Croatian: • stezanje u grlu, promukli glas ili poteškoće s gutanjem
English: No formal studies were conducted to examine the effects of hepatic impairment.
Croatian: Nisu provedena službena ispitivanja kako bi se procijenili učinci oštećenja jetre.
English: This dose is not adjusted for weight, age or kidney disease.
Croatian: Ova doza nije prilagođena tjelesnoj težini, dobi ili bolesti bubrega.
English: Uncommon: Cellulitis
Croatian: Manje često: celulitis
English: The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
Croatian: Djelatna tvar peglotikaza je kovalentni konjugat urikaze dobivene genetski modificiranim sojem bakterije Escherichia coli i monometoksipolija (etilen glikola).
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.
Croatian: U kliničkim ispitivanjima 91% bolesnika koji su iskusili infuzijske reakcije imali su serumske razine mokraćne kiseline iznad 6 mg/dl (360 µmol/l) zbog razvoja protutijela na peglotikazu.
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.
Croatian: Fizikalna i kemijska stabilnost lijeka KRYSTEXXA razrijeđene u 250 ml otopine 4,5 mg/ml (0,45%) ili 9 mg/ml (0,9%) natrijevog klorida dokazana je tijekom 4 sata pri temperaturi od 2 °C do 8 °C i pri sobnoj temperaturi (20 °C do 25 °C) ako je otopina pripremljena kako je opisano u dijelu 6.6.
English: An increase in gout flares is frequently observed upon treatment initiation, probably as a result of mobilization of urate from tissue deposits.
Croatian: Nakon početka liječenja uočena su jača pogoršanja gihta, vjerojatno kao rezultat mobilizacije urata iz tkivnih depozita.
English: KRYSTEXXA contains the active substance pegloticase.
Croatian: KRYSTEXXA sadrži djelatnu tvar peglotikazu.
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.
Croatian: Lijek KRYSTEXXA će primjenjivati liječnik ili medicinska sestra koja će Vas nadzirati u slučaju da se pojave nuspojave dok primate lijek KRYSTEXXA te neko vrijeme nakon toga.
English: Pack size: 1 vial
Croatian: Veličina pakovanja: 1 bočica
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.
Croatian: S obzirom da istovremena primjena peroralnih lijekova za snižavanje urata može maskirati porast serumskih razina mokraćne kiseline s gubitkom odgovora na liječenje, bolesnici koji istovremeno uzimaju peroralne lijekove za snižavanje urata mogu biti pod povećanim rizikom od infuzijskih reakcija i/ili anafilaksije.
English: Antibodies to pegloticase associated with clearance of pegloticase resulted in a small stimulation in the elimination of urate.
Croatian: Protutijela na peglotikazu povezana s uklanjanjem peglotikaze rezultirala su slabom stimulacijom eliminacije urata.
English: Allantoin is eliminated by renal excretion, thereby lowering serum uric acid.
Croatian: Alantoin se eliminira izlučivanjem putem bubrega i tako smanjuje serumsku razinu mokraćne kiseline.
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.
Croatian: U kliničkim ispitivanjima 34% (29 od 85) bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka dva tjedna imali su 65 godina i više, a 12% (10 od 85) ih je bilo staro 75 godina i više.
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
Croatian: Bolesnici s manjkavim podacima smatrani su neuspjehom p-vrijednosti određene su Fisherovim egzaktnim testom za usporedbu peglotikaze naspram placeba
English: Neither body weight nor baseline creatinine clearance had a significant effect on the PD response.
Croatian: Ni tjelesna težina ni početne vrijednosti klirensa kreatinina nisu imale značajan učinak na farmakodinamički odgovor.
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.
Croatian: Za smanjenje vjerojatnosti pogoršanja gihta nakon početka liječenja lijekom KRYSTEXXA preporučuje se profilaksa kolhicinom ili nesteroidnim protuupalnim lijekovima (NSAIL).
English: Caution should be exercised in patients who have congestive heart failure and patients should be monitored closely following infusion.
Croatian: Potreban je oprez u liječenju bolesnika s kongestivnim zatajenjem srca te ih treba pažljivo nadzirati nakon infuzije.
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).
Croatian: Bolesnike prethodno treba liječiti anthistaminicima, kortikosteroidima i paracetamolom te pomno nadzirati za slučaj pojave nuspojava koje ukazuju na teške reakcije preosjetljivosti uključujući anafilaksiju tijekom najmanje sat vremena nakon završetka infuzije (vidjeti dio 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.
Croatian: U ispitanika koji nisu imali protutijela na peglotikazu koja su uklanjala peglotikazu učinak na stimulaciju eliminacije urata bio je značajan.
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.
Croatian: Budući da se razvoj ovih štetnih događaja mogao spriječiti barem u nekim slučajevima da bolesnici nisu bili istovremeno liječeni primjenom tvari za snižavanje urata, potrebno je napraviti izmjenu u sažetku opisa svojstava lijeka usmjerenu na važnost prestanka liječenja lijekovima za snižavanje mokraćne kiseline s obzirom na maskiranje rezultata mjerenja vrijednosti mokraćne kiseline u serumu (i tako povećavanja rizika od infuzijskih reakcija i anafilaktičkih reakcija).
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.
Croatian: U ovom periodičkom izvješću o neškodljivosti podnijete su prijave reakcija povezanih s infuzijom ili anafilaksije koje su se podudarile s istovremenom peroralnom primjenom lijekova za snižavanje urata, s time da su infuzijske reakcije prijavljene u 28 slučajeva, a anafilaktičke reakcije u 9 slučajeva.
English: Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: It is therefore recommended to discontinue oral urate-lowering medications before starting treatment and not institute therapy with oral uratelowering agents while taking KRYSTEXXA.
Croatian: Stoga se preporučuje prekinuti peroralnu primjenu lijekova za snižavanje urata prije početka liječenja i ne započinjati liječenje peroralnim lijekovima za snižavanje urata dok uzimate lijek KRYSTEXXA.
English: Anti-PEG antibodies also developed in 41% of patients treated with KRYSTEXXA 8 mg every 2 weeks.
Croatian: Protutijela na PEG razvila su se također u 41% bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka dva tjedan.
English: • a shortness of breath, wheezing or breathing problems
Croatian: • zadihanost, zviždanje ili probleme s disanjem,
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.
Croatian: Učestalost pogoršanja može se povećati nakon početka liječenja lijekom KRYSTEXXA usprkos profilaksi gihta kolhicinom ili nesteroidnim protuupalnim lijekovima, ali učestalost i težina pogoršanja gihta smanjuju se nakon tri mjeseca liječenja lijekom KRYSTEXXA.
English: Only solutions which are clear to slightly opalescent, colourless and free of visible particles should be used.
Croatian: Treba koristiti samo otopine koje su bistre do blago zamućene, bezbojne te bez vidljivih čestica.
English: For the full list of excipients see section 6.1
Croatian: Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1
English: KRYSTEXXA does not need to be interrupted because of a gout flare, which should be managed concurrently as appropriate for the individual patient.
Croatian: Liječenje lijekom KRYSTEXXA ne treba prekidati zbog pogoršanja, nego ga treba liječiti istovremeno i prikladno za pojedinog bolesnika.
English: Acute gouty attacks (gout flare)
Croatian: Akutni napadaji gihta (pogoršanje gihta)
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.
Croatian: U kontroliranim kliničkim ispitivanjima najčešće prijavljene ozbiljne nuspojave bile su anafilaksija koja se javljala s učestalošću od 6,5% (8/123) u bolesnika liječenih s 8 mg lijeka svaka dva tjedna; infuzijske reakcije koje su se javljale s učestalošću od 26% i pogoršanja gihta koje je bilo češće tijekom prva tri mjeseca liječenja.
English: Therefore, monitoring of serum uric acid level is required prior to each infusion.
Croatian: Zbog toga je potreban nadzor serumske razine mokraćne kiseline prije infuzije.
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.
Croatian: Ukupno 32% (27 od 85) bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka 2 tjedna imalo je klirens kreatinina ≤62,5 ml/min.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se svom(joj) liječniku, ljekarniku ili medicinskoj sestri.
English: Anti-pegloticase antibodies were associated with an increase in CL and Vc as determined by compartmental analysis.
Croatian: Protutijela na peglotikazu povezana su s porastom klirensa i Vc vrijednosti, određeno prostornim modelom.
English: The most common signs and symptoms of generalised infusion reactions were: hives, shortness of breath, redness in the face, sweating, chest discomfort or pain, chills, and high blood pressure.
Croatian: Najčešći znakovi i simptomi generalizirane infuzijske reakcije bili su: koprivnjača, zadihanost, crvenilo lica, znojenje, nelagoda u prsima ili bol, zimica i visoki krvni tlak.
English: Continuous treatment with pegloticase decreases frequency and intensity of gout flares.
Croatian: Neprekidno liječenje peglotikazom smanjuje učestalost i intenzitet pogoršanja gihta.
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.
Croatian: Uočeno je kontinuirano održavanje plazmatskih razina mokraćne kiseline ispod granice topljivosti od 6 mg/dl tijekom više od 12 dana s pojedinačnim dozama od 8 i 12 mg.
English: Very common side effects (may affect more than 1 in 10 people): hives, skin rash, itchy, dry or irritated skin, nausea
Croatian: Vrlo česte nuspojave (mogu zahvatiti više od 1 na 10 osoba): koprivnjača, osip na koži, svrbež, suha ili nadražena koža, mučnina
English: Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
Croatian: Česte nuspojave (mogu zahvatiti do 1 na 10 osoba): visoke razine šećera u krvi, povraćanje, oticanje zglobova, simptomi nalik gripi.
English: The following information is intended for healthcare professionals only: KRYSTEXXA must be prepared as follows:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima:
English: KRYSTEXXA is a clear to slightly opalescent colourless solution.
Croatian: KRYSTEXXA je bistra do blago zamućena bezbojna otopina.
English: • KRYSTEXXA vial should be visually inspected for particles and discolouration prior to dilution and administration.
Croatian: • Bočicu lijeka KRYSTEXXA treba vizualno provjeriti na prisutnost čestica i promjenu boje prije razrjeđenja i primjene.
English: Among the other secondary endpoints, reduction from baseline in the number of tender and swollen joints were observed in patients treated with KRYSTEXXA every 2 weeks while there was little change in patients on placebo.
Croatian: Od drugih sekundarnih završnih točaka uočeno je smanjenje broja osjetljivih i otečenih zglobova u odnosu na početne vrijednosti u bolesnika liječenih lijekom KRYSTEXXA svaka dva tjedna dok je u bolesnika liječenih placebom bilo malo promjena.
English: Very common: Dermatitis, urticaria, pruritus, skin irritation, dry skin
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često: dermatitis, urtikarija, pruritus, iritacija kože, suha koža
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
Croatian: 95%-tni interval pouzdanosti za razlike u stupnju odgovora između skupine koja je primala peglotikazu i skupine koja je primala placebo p-vrijednost određena Fisherovim egzaktnim testom za usporedbu skupine koja je primala peglotikazu naspram skupine koja je primala placebo
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 8 mg / 1 ml
English: Fertility Effect on male and female fertility has not been studied.
Croatian: Plodnost Nisu proučavani učinci lijeka na mušku i žensku plodnost.
English: Plasma Uric Acid < 6 mg/dl for at Least 80% of the Time During Months 3 and 6 Treatment Group
Croatian: Tablica 2. Plazmatske razine mokraćne kiseline <6 mg/dl najmanje 80% vremena tijekom 3. i 6. mjeseca
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.
Croatian: Kako je prikazano u Tablici 2, veći udio bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka 2 tjedna odgovorio je na liječenje u odnosu na bolesnike koji su primali placebo.
English: Infusion-related reactions / Anaphylaxis
Croatian: Infuzijske reakcije/anafilaksija
English: Clearance was 0.0145 L/h with a range of 0.00904 - 0.0229 for no increase in anti-pegloticase antibodies and 0.0193 L/h with a range of 0.00675 - 0.0340 for an increase in anti-pegloticase antibodies.
Croatian: Klirens je iznosio 0,0145 l/h s rasponom 0,00904-0,0229 u bolesnika bez porasta razine protutijela na peglotikazu i 0,0193 l/h s rasponom 0,00675-0,0340 u bolesnika s porastom razine protutijela na peglotikazu.
English: KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
Croatian: KRYSTEXXA sadrži natrij KRYSTEXXA sadrži 4,2 mg natrija po dozi što znači da u biti ne sadrži natrij.
English: Pegloticase 8 mg every 2 weeks Pegloticase 8 mg every 4 weeks Placebo
Croatian: Peglotikaza 8 mg svaka 2 tjedna 42 Peglotikaza 8 mg svaka 4 tjedna 43 Placebo
English: What you need to know before you receive KRYSTEXXA Do not use KRYSTEXXA
Croatian: Što morate znati prije nego počnete primjenjivati lijek KRYSTEXXA
English: KRYSTEXXA does not need to be discontinued because of a gout flare.
Croatian: Liječenje lijekom KRYSTEXXA ne treba prekinuti zbog pogoršanja gihta.
English: The most common signs and symptoms of local infusion reactions are: erythema, pruritus, and rash.
Croatian: Najčešći znakovi i simptomi lokalne infuzijske reakcije su: eritem, pruritus i osip.
English: The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared to manage anaphylaxis and infusion reactions.
Croatian: Lijek trebaju primjenjivati zdravstveni djelatnici pripravni na liječenje anafilaktičkih i infuzijskih reakcija u odgovarajuće opremljenim zdravstvenim ustanovama.
English: In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Croatian: U kliničkim ispitivanjima srednja vrijednost plazmatskih razina mokraćne kiseline (PUA) pala je na 0,7 mg/dl približno 24 sata nakon prve doze peglotikaze u bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka 2 tjedna u usporedbi sa srednjom vrijednošću PUA od 8,2 mg/dl u bolesnika koji su primali placebo.
English: Sodium intake KRYSTEXXA contains 4.2 mg sodium (less than 1 mmol) per dose (essentially sodium free).
Croatian: Unos natrija KRYSTEXXA sadrži 4,2 mg natrija (manje od 1 mmol) po dozi (u biti ne sadrži natrij).
English: The volume of distribution was 4.45 L with a range of 2.625.89 for no increase in anti-pegloticase antibodies and 5.77 L with a range of 2.77 - 10.6 for an increase in anti-pegloticase antibodies.
Croatian: Volumen distribucije iznosio je 4,45 l s rasponom 2,62-5,89 u bolesnika bez porasta razine protutijela na peglotikazu i 5,77 l s rasponom 2,77-10,6 u bolesnika s porastom razine protutijela na peglotikazu.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom(joj) liječniku, ljekarniku ili medicinskoj sestri.
English: • The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
Croatian: • Drugi sastojci su dinatrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, voda za injekcije.
English: KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Croatian: KRYSTEXXA, jednom razrijeđena s 250 ml otopine 4,5 mg/ml (0,45%) ili 9 mg/ml (0,9%) natrijeva klorida, primjenjuje se kao intravenska infuzija tijekom ne manje od 2 sata pri brzini od približno 2 ml/minuti.
English: KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Croatian: Liječenje lijekom KRYSTEXXA treba prekinuti ako se 2 puta uzastopno izmjere razine mokraćne kiseline iznad 6 mg/dl.
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
Croatian: Jedna bočica sadrži 8 mg peglotikaze (koncentrat 8 mg/ml).
English: infusion) and your treatment will take about 2 hours or sometimes longer.
Croatian: KRYSTEXXA se polako injicira u venu (intravenska infuzija), a infuziju ćete primati približno 2 sata ili ponekad i dulje.
English: Medicinal product subject to medical prescription.
Croatian: 14. NAČIN PROPISIVANJA LIJEKA Lijek se izdaje na recept.
English: Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
Croatian: Oni koji su odgovorili na liječenje održali su vrijednosti PUA ispod 6 mg/dl tijekom šestomjesečnog razdoblja liječenja.
English: The most common signs and symptoms of systemic infusion reactions are: urticaria, dyspnoea, flushing, hyperhidrosis, chest discomfort or pain, chills, and hypertension.
Croatian: Najčešći znakovi i simptomi sistemske infuzijske reakcije su: urtikarija, dispneja, crvenilo, hiperhidroza, nelagoda ili bol u prsima, zimica i hipertenzija.
English: Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections
Croatian: POPIS POMOĆNIH TVARI Dinatrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, voda za injekcije.
English: fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
Croatian: Druge su se povukle uz suportivno liječenje intravenskim tekućinama, dodatnim glukokortikidima ili antihistaminicima ili nakon prekida infuzije te uz primjenu adrenalina za liječenje anafilaktičkih reakcija.
English: The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Croatian: Izvješće nakon stavljanja lijeka u promet bilježi primjenu sadržaja 2 bočice (16 mg) bez ikakvih nuspojava povezanih s primjenom lijeka KRYSTEXXA.
English: How KRYSTEXXA works
Croatian: Kako KRYSTEXXA djeluje
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek KRYSTEXXA Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
Croatian: U kliničkim ispitivanjima postotak bolesnika koji su iskusili pogoršanja u prva tri mjeseca iznosio je 75% u bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka dva tjedna u usporedbi s 54% u skupini liječenoj placebom.
English: In clinical trials, anti-pegloticase antibodies (IgM and IgG) developed in 89% of patients treated with KRYSTEXXA 8 mg every 2 weeks and 15% in the placebo group.
Croatian: U kliničkim ispitivanjima protutijela na peglotikazu (IgM i IgG) razvila su se u 89% bolesnika liječenih lijekom KRYSTEXXA 8 mg svaka dva tjedna te kod 15% bolesnika iz skupine koja je primala placebo.
English: EU/1/12/810/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/12/810/001
English: Pack size of 1 vial.
Croatian: Pakovanje s jednom bočicom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE BOČICA