FrancophonIA/ELRC3.0 huggingface dataset:
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton.
Croatian: Boca od polietilena visoke gustoće (HDPE) sa polipropilenskim sigurnosnim zatvaračem za djecu i zaštitnom folijom na grlu bočice, koja sadrži molekularno sito kao sredstvo za sušenje i pamuk.
English: Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration
Croatian: Mučnina Konstipacija Povraćanje Dispepsija Bol u abdomenu Flatulencija
English: The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Croatian: Uobičajena preporučena početna doza odgovara 1500 mg željeza na dan (3 tablete).
English: The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Croatian: Preporučena početna doza lijeka Velphoro je 1500 mg željeza (3 tablete) na dan, podijeljeno po obrocima tijekom dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - 30 TABLETA ZA ŽVAKANJE (5 BLISTERA SA PO 6 TABLETA ZA ŽVAKANJE), DIO VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: (listed in section 6) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron.
Croatian: (naveden u dijelu 6.) - Ako u povijesti bolesti imate poremećaj abnormalnog nakupljanja željeza u organima
English: Adult patients with hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting dose of 1,000 mg iron/day followed by an 8-week dose titration period.
Croatian: Odrasli bolesnici s hiperfosfatemijom (razine fosfora u serumu ≥ 1,94 mmol/l) liječeni su lijekom Velphoro uz početnu dozu od 1000 mg željeza/dan nakon čega je uslijedilo 8­tjedno razdoblje titracije doze.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and a foil induction seal, or in child resistant aluminium blister.
Croatian: Tablete su pakirane u bocama od polietilena visoke gustoće s polipropilenskim zatvaračem sigurnim za djecu i zaštitnom folijom na grlu bočice ili u aluminijskom blister pakiranju sigurnom za djecu.
English: At the end of week 24, 93 patients on hemodialysis whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks.
Croatian: Po završetku 24. tjedna, 93 bolesnika na hemodijalizi, čije su razine fosfora u serumu bile kontrolirane (< 1,78 mmol/l) lijekom Velphoro u prvom dijelu ispitivanja, ponovno su randomizirana da bi u naredna 3 tjedna nastavili terapiju njihovom dozom održavanja iz 24. tjedna (n=44) ili neučinkovitom niskom kontrolnom dozom lijeka Velphoro (250 mg željeza na dan, n=49).
English: In rats, there was a slightly increased incidence of benign C-cell adenoma in the thyroid of male rats given the highest dose of sucroferric oxyhydroxide.
Croatian: Postojala je blago povišena incidencija benignog adenoma C stanica štitnjače mužjaka štakora kojima je dana najviša doza saharoželjezovog(III) oksihidroksida.
English: Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Croatian: Razine vitamina D i 1,25­dihidroksi vitamina
English: Velphoro is for oral administration only and must be taken with meals.
Croatian: Velphoro je namijenjen samo za peroralnu primjenu i mora se uzimati uz obrok.
English: In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.
Croatian: U ispitivanjima provedenim na životinjama u kojima je u štakora i pasa peroralno primijenjen lijek Fe­Velphoro otkriveno je radioaktivno označeno željezo u fecesu, ali ne i u urinu.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) chewable tablets.
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 90 (3 pakiranja od 30) tableta za žvakanje.
English: In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2 - 4-week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
Croatian: U ispitivanju­05A 1055 bolesnika na hemodijalizi (n=968) ili peritonealnoj dijalizi (n=87) s razinom fosfora u serumu ≥ 1,94 mmol/l, nakon perioda ispiranja vezača fosfata od 2 - 4 tjedna, randomizirano je i liječeno lijekom Velphoro u početnoj dozi od 1000 mg željeza na dan (n=707), ili aktivnom kontrolom (sevelamerkarbonat, n=348) u trajanju od 24 tjedna.
English: Peritonitis, gastric and hepatic disorders and gastrointestinal surgery Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic disorders and patients with major gastrointestinal surgery have not been included in clinical studies with Velphoro.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Peritonitis, želučani i jetreni poremećaji i operativni zahvati na probavnom sustavu Bolesnici s nedavnom anamnezom peritonitisa (unazad 3 mjeseca), značajnih želučanih ili jetrenih poremećaja i bolesnici koji su imali veći operativni zahvat na probavnom sustavu nisu bili uključeni u klinička ispitivanja s lijekom Velphoro.
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Croatian: OBLIK I SADRŽAJ 30 tableta za žvakanje
English: There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Croatian: Nema dostupnih kliničkih podataka o primjeni saharoželjezovog(III) oksihidroksida u trudnica.
English: Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Croatian: Pakiranja od 30 × 1 ili višestruko pakiranje od 90 (3 pakiranja od 30 × 1) tableta za žvakanje
English: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Croatian: Velphoro je indiciran za kontrolu razine fosfora u serumu u odraslih bolesnika s kroničnom bolešću bubrega (KBB) na hemodijalizi (HD) ili peritonealnoj dijalizi (PD).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta za žvakanje sadrži 500 mg željeza u obliku saharoželjezovog(III) oksihidroksida koji je poznat i kao smjesa polinuklearnog željezovog(III) oksihidroksida, saharoze i škrobova.
English: See section 2 for further information on sucrose and starches.
Croatian: Dodatne informacije o saharozi i škrobovima pogledajte u dijelu 2.
English: Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Croatian: Razina fosfora u serumu smanjuje se kao posljedica smanjene apsorpcije fosfata iz prehrane.
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
Croatian: OBLIK I SADRŽAJ 30 × 1 tableta za žvakanje
English: Each tablet also contains 750 mg sucrose and 700 mg starches.
Croatian: 750 mg saharoze i 700 mg škrobova.
English: Serum phosphorus levels and calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
Croatian: Razine fosfora u serumu te razine produkta kalcija i fosfora smanjile su se kao posljedica smanjene apsorpcije fosfata iz prehrane.
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANCE
Croatian: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex Francuska
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
Croatian: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANCUSKA
English: LIST OF EXCIPIENTS Contains sucrose, potato starch and pregelatinised maize starch.
Croatian: Sadrži saharozu, krumpirov škrob i prethodno gelirani kukuruzni škrob.
English: Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches.
Croatian: Velphoro je lijek koji sadrži djelatnu tvar saharoželjezov(III) oksihidroksid, koja se sastoji od željeza, šećera (saharoze) i škrobova.
English: Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Croatian: Velphoro ne utječe na testove okultnog krvarenja u stolici: gvajak­test (Haemoccult) ili imunološki test (iColo Rectal i Hexagon Obti).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (VIŠESTRUKO PAKIRANJE) - 90 (3 PAKIRANJA OD 30) TABLETA ZA ŽVAKANJE
English: Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches.
Croatian: Velphoro sadrži smjesu polinuklearnog željezovog(III) oksihidroksida (pn­FeOOH), saharoze i škrobova.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/943/001 30 tableta za žvakanje
English: Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L).
Croatian: Srednje razine fosfora u serumu za Velphoro iznosile su 2,5 mmol/l na početku ispitivanja i 1,8 mmol/l u 12. tjednu (smanjenje za 0,7 mmol/l).
English: - When taking Velphoro you should adhere to your recommended diet and treatments prescribed by your doctor such as calcium supplements, vitamin D3 or calcimimetics.
Croatian: Vam je propisao liječnik, kao što je nadomjestak kalcija, vitamin D3 ili kalcimimetici.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - 30 TABLETA ZA ŽVAKANJE (5 BLISTERA SA PO 6 TABLETA ZA ŽVAKANJE)
English: Package leaflet: Information for the patient Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Croatian: Uputa o lijeku: Informacije za bolesnika Velphoro 500 mg tablete za žvakanje željezo u obliku saharoželjezovog(III) oksihidroksida
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOCA S 30 I 90 TABLETA ZA ŽVAKANJE
English: However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
Croatian: Međutim, u kliničkim ispitivanjima s lijekom Velphoro nisu primijećeni dokazi o oštećenju funkcije jetre ili znatnim promjenama jetrenih enzima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - BOCA S 30 I 90 TABLETA ZA ŽVAKANJE
English: No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
Croatian: U profilu nuspojava na lijek Velphoro nisu uočeni trendovi ovisni o dozi.
English: There are no available clinical data from the use of Velphoro in breast-feeding women.
Croatian: Nema dostupnih kliničkih podataka o primjeni lijeka Velphoro u dojilja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta za žvakanje sadrži 500 mg željeza u obliku saharoželjezovog(III) oksihidroksida.
English: Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
Croatian: Velphoro je indiciran za kontrolu razina fosfora u serumu u odraslih bolesnika s kroničnom bolešću bubrega na hemodijalizi ili peritonealnoj dijalizi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/943/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/943/003
English: How to store Velphoro
Croatian: Kako čuvati lijek Velphoro
English: - The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Croatian: Što Velphoro sadrži - Djelatna tvar je željezo u obliku saharoželjezovog(III) oksihidroksida koji je poznat i kao mješavina polinuklearnog željezovog(III) oksihidroksida, saharoze i škrobova.
English: Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Croatian: Jedna tableta za žvakanje sadrži 500 mg željeza u obliku saharoželjezovog oksihidroksida.
English: Neohesperidin-dihydrochalcone Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari aroma šumskih bobica neohesperidindihidrohalkon magnezijev stearat bezvodni koloidni silicijev dioksid
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Croatian: Velphoro 500 mg tablete za žvakanje željezo u obliku saharoželjezovog(III) oksihidroksida
English: Colloidal anhydrous silica 6.2 Incompatibilities
Croatian: 6.2 Inkompatibilnosti
English: Including fatal outcome.
Croatian: Uključujući smrtni ishod.
English: Very limited data are available.
Croatian: . Dostupni su vrlo ograničeni podaci..
English: YERVOY should not be frozen.
Croatian: YERVOY se ne smije zamrzavati.
English: You will also have blood tests during treatment.
Croatian: Također ćete tijekom liječenja raditi krvne pretrage.
English: None of the events were fatal.
Croatian: Nijedan od događaja nije doveo do smrtnog ishoda.
English: Human IgG1 crosses the placental barrier.
Croatian: Ljudski IgG1 prelazi placentalnu barijeru.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Croatian: Liječnik će o tome razgovarati s vama i objasniti Vam rizike i koristi liječenja.
English: Duration of follow-up ranged up to 55 months.
Croatian: Trajanje praćenja iznosilo je do 55 mjeseci.
English: All patients were followed for at least 1 year.
Croatian: Svi bolesnici su praćeni barem 1 godinu.
English: Also tell your doctor if you are taking or have recently taken any other medicines.
Croatian: Također obavijestite svog liječnika ako uzimate, nedavno ste uzeli bilo koje druge lijekove.
English: Tell your doctor immediately if you have any of these signs or symptoms or they get worse.
Croatian: Odmah obavijestite liječnika ako imate neke od ovih znakova ili simptoma ili se oni pogoršavaju.
English: Number of Patients (%)
Croatian: Broj bolesnika (%)
English: In CA184178, deaths were reported at least 90 days of the last dose.
Croatian: U CA184178, smrt je prijavljena u najmanje 90 dana od posljednje doze.
English: Before treatment, your doctor will check your general health.
Croatian: Prije liječenja liječnik će Vam provjeriti opće zdravstveno stanje.
English: The primary efficacy endpoint was 1-year survival rate.
Croatian: Primarna mjera ishoda bilo je 1-godišnje preživljavanje.
English: a gp100 peptide vaccine is an experimental control.
Croatian: a gp100 peptidno cjepivo je pokusna kontrola.
English: The primary endpoints were safety and pharmacokinetics (PK).
Croatian: Primarne mjere ishoda su bile sigurnost i farmakokinetika (PK).
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Croatian: Općenito nisu zabilježene razlike u djelotvornosti i sigurnosti primjene između starijih (≥ 65 godina) i mlađih bolesnika (< 65 godina).
English: Do not try to treat your symptoms with other medicines.
Croatian: Nemojte pokušavati liječiti svoje simptome drugim lijekovima.
English: Age 12 to < 18 years
Croatian: Dob 12 do < 18 godina
English: Children younger than 12 years of age
Croatian: Djeca mlađa od 12 godina
English: No new or unexpected irARs were observed in this study.
Croatian: Nisu primjećeni novi ili neočekivani irAR-ovi u ovom ispitivanju.
English: Table 9: Overall survival in observational studies
Croatian: Tablica 9: Ukupno preživljenje u opservacijskim ispitivanjima
English: How YERVOY is given YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Croatian: Kako se primjenjuje YERVOY YERVOY će Vam se davati u bolnici ili klinici pod nadzorom iskusnog liječnika.
English: At the time of this analysis, medians were not reached for patients with CR or PR.
Croatian: U vrijeme kad se radila ova analiza, u bolesnika nisu dosegnuti medijani za CR ili PR.
English: Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
Croatian: Atributi za ipilimumab prijavljeni kao as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
English: The effect of race was not examined as there was insufficient data in non-Caucasian ethnic groups.
Croatian: Utjecaj rase nije se ispitivao, jer nije bilo dovoljno podataka za nebjelačke etničke skupine.
English: Only very limited data are available in children younger than 12 years of age.
Croatian: Dostupni su samo vrlo ograničeni podaci u djece mlađe od 12 godina.
English: In Phase 2 studies, this increase was dose-dependent.
Croatian: U ispitivanjima faze II, to je povećanje bilo ovisno o dozi.
English: Do not drive, cycle or use machines after you have been given YERVOY unless you are sure you are feeling well.
Croatian: Nemojte upravljati vozilima, biciklima, niti raditi na strojevima nakon što ste primili YERVOY, osim ako niste sigurni da se dobro osjećate.
English: Stopping your treatment may stop the effect of the medicine.
Croatian: Prestanak liječenja može zaustaviti djelovanje ovog lijeka.
English: Warnings and precautions Talk to your doctor before using YERVOY as it may cause:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primite YERVOY jer on može uzrokovati:
English: You must use effective contraception while you are being treated with YERVOY if you are a woman who could become pregnant.
Croatian: Morate koristiti učinkovitu kontracepciju za vrijeme liječenja lijekom YERVOY ako ste žena koja može zatrudnjeti.
English: Because of the limited number of patients in these analyses, no definitive conclusion regarding the efficacy of ipilimumab re-treatment can be drawn.
Croatian: Zbog ograničenog broja bolesnika u ovim analizama ne može se izvesti konačni zaključak o djelotvornosti ponovnog liječenja ipilimumabom.
English: if you are taking any medicines that stop your blood from clotting (anticoagulants).
Croatian: ako uzimate bilo koje lijekove koji sprječavaju zgrušavanje krvi (antikoagulanse).
English: Adrenal crisis as a cause of the patient's symptoms must be excluded.
Croatian: Mora se isključiti adrenalna kriza kao uzrok simptoma bolesnika.
English: DRESS may be characterized by a long latency (two to eight weeks) between medicinal product exposure and disease onset.
Croatian: DRESS može biti karakteriziran s dugom latencijom (dva do osam tjedana) između izloženosti lijeku i pojave bolesti.
English: Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Croatian: Podaci prikazani u tim dijelovima primarno pokazuju iskustvo iz ispitivanja faze III, MDX010-20.
English: The potential risk of treatment to the developing foetus is unknown.
Croatian: Mogući rizik liječenja za fetus u razvoju nije poznat.
English: What you need to know before you use YERVOY
Croatian: Što morate znati prije nego počnete primati YERVOY
English: Calculating the dose:
Croatian: Izračunavanje doze:
English: Unopened vial 3 years
Croatian: Neotvorena bočica: 3 godine
English: YERVOY is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the clinical benefit outweighs the potential risk.
Croatian: YERVOY se ne preporučuje tijekom trudnoće ili u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju, osim ukoliko klinička korist nije veća od mogućeg rizika.
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
Croatian: Datum posljednje obnove odobrenja: 21. travnja 2016.
English: Sensory neuropathy may also occur.
Croatian: Može nastupiti i senzorna neuropatija.
English: Rare proteinuriad
Croatian: Rijetko proteinurijad
English: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool.
Croatian: MedDRA v.17.0 za CA184070, v.19.0 za CA184178, i V.12.1 za zbirne sigurnosne podatke u odraslih.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Croatian: Ako propustite termin, zamolite liječnika da dogovorite novi termin za sljedeću dozu.
English: Please note that the reaction called DRESS may develop weeks or months after your last dose.
Croatian: Imajte na umu da se DRESS reakcija može razviti tjednima ili mjesecima nakon Vaše zadnje doze.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
Croatian: Nositelj odobrenja će osigurati da svi liječnici za koje se očekuje da će propisivati YERVOY dobiju sljedeće:
English: Other medicines and YERVOY
Croatian: Drugi lijekovi i YERVOY
English: Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose.
Croatian: Smrti kod pedijatrijskih bolesnika su one koje su se desile u ispitivanju događaji unutar 30 dana od zadnje doze osim pod "Sve smrti" koje su nastupile >30 dana nakon posljednje doze.
English: Treatment-Related Deaths, n
Croatian: Smrt povezana s liječenjem, n
English: All patients were HLA-A2*0201 type; this HLA type supports the immune presentation of gp100.
Croatian: Svi su bolesnici bili HLA-A2*0201 tip; ovaj HLA tip podržava imunološko izražavanje gp100.
English: Not reached (5.2, NE)
Croatian: Nije dostignuto (5,2, NP)
English: - inflammation of the eyes.
Croatian: - upala očiju.
English: Tumor assessment was performed at Week 12.
Croatian: Procjena tumora je rađena u 12. tjednu.
English: Based on this prescribed dose, calculate the total dose to be given.
Croatian: Na temelju ove propisane doze, izračunajte ukupnu dozu koja se mora dati.
English: Patients with autoimmune disease
Croatian: Bolesnici s autoimunim bolestima
English: What YERVOY is and what it is used for 2.
Croatian: Što je YERVOY i za što se koristi 2.
English: Dose escalation or reduction is not recommended.
Croatian: Ne preporučuje se povećavati niti smanjivati dozu.
English: Ask your doctor if you can breast-feed during or after treatment with YERVOY.
Croatian: Upitajte svog liječnika smijete li dojiti za vrijeme ili nakon liječenja lijekom YERVOY.
English: widespread/intense pruritus regardless of etiology
Croatian: prošireni/intenzivni svrbež bez obzira na uzrok
English: The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age.
Croatian: Ispitivanje je uključivalo 13 bolesnika < 12 godina i 20 bolesnika ≥12 godina.
English: Before you are given YERVOY, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids.
Croatian: Prije nego što primite YERVOY, obavijestite svog liječnika ako uzimate bilo koje lijekove koji potiskuju imunološki sustav, kao što su kortikosteroidi.
English: No specific dose adjustment is necessary in this population (see section 5.1).
Croatian: Nisu potrebne nikakve posebne prilagodbe doze u toj populaciji (vidjeti dio 5.1).