FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Therapeutic radiopharmaceuticals, other therapeutic radiopharmaceuticals, various therapeutic radiopharmaceuticals, ATC code: V10XX03
Croatian: Farmakoterapijska skupina: terapijski radiofarmaceutici, ostali terapijski radiofarmaceutici, razni terapijski radiofarmaceutici, ATK oznaka: V10XX03.
English: Care should be used when handling materials, such as bed linen, that come into contact with such body fluids.
Croatian: Mora se primijeniti oprez pri rukovanju materijalima, poput posteljine, koji dolaze u kontakt s tim tjelesnim tekućinama.
English: The external radiation exposure associated with handling of patient doses is considerably lower in comparison to other radiopharmaceuticals for therapeutic purposes as the administered radioactivity will usually be below 8 MBq.
Croatian: Izloženost vanjskom zračenju povezana s rukovanjem dozama za bolesnika znatno je niža u usporedbi s drugim radiofarmaceuticima koji se primjenjuju u terapijske svrhe, jer će primijenjena radioaktivnost obično biti ispod 8 MBq.
English: - Xofigo is not recommended if cancer in your bones is not causing symptoms, such as pain.
Croatian: - Xofigo se ne preporučuje ako Vam rak u kostima ne izaziva simptome kao što je bol.
English: Before starting treatment and before each subsequent dose your doctor will perform blood tests.
Croatian: Prije početka liječenja i prije svake sljedeće doze, liječnik će Vam napraviti krvne pretrage.
English: Children and adolescents This medicine is not for use in children and adolescents.
Croatian: Ovaj lijek nije za primjenu u djece i adolescenata.
English: The amount of radioactivity in the dispensed volume shall be confirmed by measurement in a properly calibrated activimeter.
Croatian: Količina radioaktivnosti u izdanom volumenu potvrdit će se mjerenjem u ispravno baždarenom mjeraču aktivnosti.
English: Subgroup survival analysis
Croatian: Analiza preživljenja po podskupinama
English: Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting.
Croatian: Bolesnike je potrebno upozoriti da zatraže medicinski savjet ako im se javi teški ili dugotrajni proljev, mučnina, povraćanje.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovim lijekom će rukovati i davat će Vam ga samo osobe koje su obučene i kvalificirane za njegovu sigurnu primjenu.
English: What Xofigo looks like and contents of the pack
Croatian: Kako Xofigo izgleda i sadržaj pakiranja
English: Osteosarcomas were not observed in dog studies.
Croatian: Osteosarkomi nisu bili opaženi u ispitivanjima na psima.
English: Xofigo is only used when the disease has spread to the bone but is not known to have spread to other internal organs, and is causing symptoms (e.g. pain).
Croatian: Xofigo se primjenjuje samo kada se bolest proširila na kosti, ali nije poznato da se proširila na unutarnje organe, i uzrokuje simptome (npr. bol).
English: Table 4: Calculated absorbed radiation doses to organs Target Organ
Croatian: Tablica 4: Izračunate apsorbirane doze zračenja u organima Ciljni organ
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike moraju primati, koristiti i primjenjivati samo ovlaštene osobe u za to određenim kliničkim uvjetima.
English: At 4 hours, about 4% of the injected activity remained in the blood, decreasing to less than 1% at 24 hours after the injection.
Croatian: Nakon 4 sata, u krvi je ostalo oko 4% ubrizgane aktivnosti, koja se 24 sata nakon injekcije smanjuje na manje od 1%.
English: The exact mechanism for induction of retinal detachment is unknown, but literature data suggests that radium is specifically taken up in the tapetum lucidum of the canine eye.
Croatian: Točan mehanizam izazivanja odvajanja mrežnice nije poznat, ali podaci iz literature ukazuju na to da radij posebno ulazi u tapetum lucidum oka kod pasa.
English: However, in keeping with the ALARA (“As Low As Reasonably Achievable”) principle, for minimisation of radiation exposure, it is recommended to minimise the time spent in radiation areas, to maximise the distance to radiation sources, and to use adequate shielding.
Croatian: Međutim, sukladno načelu ALARA (“As Low As Reasonably Achievable” - što je razumno moguće niže), za smanjenje izlaganja zračenju preporučuje se smanjiti vrijeme koje se provodi u području zračenja, povećati udaljenost od izvora zračenja i koristiti odgovarajuću zaštitnu opremu.
English: Male patients should seek advice on conservation of sperm prior to treatment.
Croatian: Muški bolesnici trebaju potražiti savjet o pohrani sperme prije liječenja.
English: • 87% of patients enrolled had an ECOG performance status score of 0-1.
Croatian: • 87% uključenih bolesnika imalo je opće stanje prema ECOG-u 0-1.
English: Xofigo should be handled in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Lijekom Xofigo treba rukovati na način koji zadovoljava i zahtjeve radiološke sigurnosti i zahtjeve farmaceutske kakvoće.
English: 1As there was no uptake of radium-223 in most of the soft tissues observed, the alpha contribution to the total organ dose was set to zero for these organs.
Croatian: 1 Budući da nije bilo ulaska radija-223 u većinu promatranih mekih tkiva, alfa doprinos ukupnoj dozi po organu je za te organe bila postavljena na nulu.
English: No clinical interaction studies have been performed.
Croatian: Nisu provedena klinička ispitivanja interakcija.
English: - If you have any further questions, ask your doctor who will supervise the procedure.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku koji će nadgledati postupak.
English: Due to the presence of osteolysis of trabecular bone in other bone locations of treated animals in varying degree, a spontaneous fracture in the context of osteolysis cannot be excluded.
Croatian: Zbog prisustva osteolize trabekularne kosti različitih stupnjeva na drugim kostima tretiranih životinja, ne može se isključiti spontana fraktura u kontekstu osteolize.
English: Safety and effectiveness of Xofigo have not been studied in children and adolescents below 18 years of age.
Croatian: Sigurnost i učinkovitost lijeka Xofigo nisu bile ispitane u djece i adolescenata mlađih od 18 godina.
English: The study was unblinded early based on an Independent Data Monitoring Committee Recommendation.
Croatian: Ispitivanje je demaskirano ranije na osnovu preporuke Neovisnog povjerenstva za praćenje podataka (engl.
English: Linearity/non-linearity
Croatian: Linearnost / nelinearnost
English: Distribution and organ uptake
Croatian: Distribucija i ulazak u organe
English: Embryotoxicity / Reproduction toxicity
Croatian: Embriotoksičnost / reproduktivna toksičnost
English: In clinical studies, patients with fewer than 6 bone metastases had an increased risk of fractures and did not have a statistically significant survival benefit.
Croatian: U kliničkim su ispitivanjima bolesnici s manje od 6 koštanih metastaza imali povećan rizik prijeloma i nisu imali statistički značajnu korist za preživljenje.
English: Other factors such as concomitant use of steroids may further increase the risk of fracture.
Croatian: Ostali čimbenici, kao što je istodobna primjena steroida, mogu još više povećati rizik od prijeloma.
English: Pharmacokinetic, biodistribution and dosimetry data have been obtained from 3 phase I studies.
Croatian: Farmakokinetički, biodistribucijski i dozimetrijski podaci dobiveni su iz 3 ispitivanja faze I.
English: • in combination with abiraterone and prednisone/prednisolone (which are used together to treat prostate cancer).
Croatian: • u kombinaciji s abirateronom i prednizonom/prednizolonom (koji se zajedno koriste u liječenju raka prostate).
English: What Xofigo is and what it is used for 2.
Croatian: Što je Xofigo i za što se koristi 2.
English: In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken.
Croatian: U slučaju nehotičnog predoziranja potrebno je primijeniti opće potporne mjere, uključujući praćenje zbog moguće hematološke i gastrointestinalne toksičnosti.
English: Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo.
Croatian: Zbog mogućih učinaka na spermatogenezu povezanih sa zračenjem, muškarce se mora savjetovati da koriste učinkovite metode kontracepcije tijekom i do 6 mjeseci nakon liječenja lijekom Xofigo.
English: No differences in haematological laboratory values were apparent between the two groups.
Croatian: Između te dvije skupine nije bilo vidljivih razlika u laboratorijskim hematološkim vrijednostima.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Croatian: Ovaj lijek se čuva u odgovarajućim prostorijama, za što je odgovoran specijalist.
English: Genotoxicity / Carcinogenicity
Croatian: Genotoksičnost / Kancerogenost
English: Osteosarcomas, a known effect of bone-seeking radionuclides, were observed at clinically relevant doses in rats 7 - 12 months after start of treatment.
Croatian: Osteosarkomi, poznati učinak radionuklida koji se nakupljaju u kosti, bili su opaženi pri klinički relevantim dozama u štakora 7-12 mjeseci nakon početka liječenja.
English: Crohn's disease and ulcerative colitis
Croatian: Crohnova bolest i ulcerozni kolitis
English: Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
Croatian: Dodatni učinci na tumorski mikrookoliš uključujući osteoblaste i osteoklaste također doprinose in vivo djelotvornosti.
English: A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L.
Croatian: Unaprijed određena analiza podskupina također je pokazala da se ukupno preživljenje u bolesnika s ukupnim ALP-om < 220 U/l nije značajno poboljšalo.
English: The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study.
Croatian: Ukupni sigurnosni profil lijeka Xofigo temelji se na podacima od 600 bolesnika liječenih lijekom Xofigo u ispitivanju faze III.
English: Time to event data on ALP progression were supported by statistically significant advantage with respect to ALP normalisation and ALP responses at week 12.
Croatian: Podaci koji pokazuju vrijeme do događaja s obzirom na progresiju ALP bili su poduprijeti statistički značajnom prednošću s obzirom na normalizaciju ALP i odgovore ALP u 12. tjednu.
English: Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
Croatian: Radij-223 je emiter alfa čestica uz poluvrijeme raspada od 11,4 dana.
English: This may be related to spatial distribution of alpha particle radiation resulting in non-uniform radiation dose to the red marrow.
Croatian: To može biti povezano s prostornom raspodjelom zračenja alfa-čestica koja rezultira neujednačenom dozom ozračenja crvene koštane srži.
English: - The other ingredients are: water for injections, sodium citrate, sodium chloride and hydrochloric acid (see end of Section 2 for further information on sodium).
Croatian: Drugi sastojci su: voda za injekcije, natrijev citrat, natrijev klorid i kloridna kiselina (vidjeti na kraju dijela 2 za dodatne informacije o natriju).
English: Xofigo is a clear and colourless solution for injection.
Croatian: Xofigo je bistra i bezbojna otopina za injekciju.
English: The following information is intended for healthcare professionals only The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima Potpuni sažetak opisa svojstava lijeka za Xofigo dostupan je kao dio koji se može otkinuti na kraju tiskane upute u pakiranju lijeka, s ciljem da se zdravstvenim radnicima pruže ostale dodatne znanstvene i praktične informacije o primjeni i uporabi ovog radiofarmaceutika.
English: The alpha particle range from radium-223 is less than 100 µm (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.
Croatian: Domet alfa-čestica iz radija-223 manji je od 100 µm (manje od promjera 10 stanica) što smanjuje oštećenje okolnog normalnog tkiva.
English: - Decay correction (DK) factor to correct for physical decay of radium-223.
Croatian: - faktora korekcije raspada (DK) za korekciju fizikalnog raspada radija-223.
English: The combination of radium-223 with other systemic cancer therapies other than LHRH analogues is therefore not recommended.
Croatian: Zbog toga se kombinacija radija-223 s drugim sistemskim terapijama protiv raka osim analoga LHRH ne preporučuje.
English: Other medicines and Xofigo No interaction studies with other medicines have been done.
Croatian: Drugi lijekovi i Xofigo Nisu provedena ispitivanja interakcija s drugim lijekovima.
English: b Hazard ratio (Xofigo over placebo) < 1 favours Xofigo.
Croatian: b Omjer hazarda (Xofigo nad placebom) < 1 u korist lijeka Xofigo.
English: Health Related Quality of Life (HRQOL) was assessed in the phase III ALSYMPCA study using specific questionnaires: the EQ-5D (generic instrument) and the FACT-P (prostate cancer specific instrument).
Croatian: Health Related Quality of Life) bila je procijenjena u ispitivanju faze III ALSYMPCA pomoću posebnih upitnika: EQ-5D (generički instrument) i FACT-P (instrument specifičan za karcinom prostate).
English: Main secondary endpoints included time to symptomatic skeletal events (SSE), time to progression of total alkaline phosphatase (ALP), time to progression of prostate specific antigen (PSA), response of total ALP and normalisation of total ALP.
Croatian: Glavni sekundarni ishodi uključivali su vrijeme do simptomatskih događaja povezanih s kostima, vrijeme do progresije ukupne alkalne fosfataze (ALP), vrijeme do progresije prostata specifičnog antigena (PSA), odgovor ukupnog ALP i normalizaciju ukupnog ALP.
English: Xofigo is for intravenous use.
Croatian: Xofigo je za intravensku primjenu.
English: The fraction of energy emitted from radium-223 and its daughters as alpha-particles is 95.3% (energy range of 5.0 - 7.5 MeV).
Croatian: Udio energije u obliku alfa-čestica emitiranih iz radija-223 i njegovih kćeri je 95,3% (raspon energija od 5,0 do 7,5 MeV).
English: Xofigo and chemotherapy used together may further decrease the number of your blood cells and blood platelets.
Croatian: Xofigo i kemoterapija primijenjeni zajedno mogu dodatno smanjiti broj Vaših krvnih stanica i krvnih pločica.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, faeces, vomiting etc.
Croatian: Primjena radiofarmaceutika stvara rizik za druge osobe zbog vanjskog zračenja ili kontaminacije zbog prolijevanja mokraće, stolice, povraćanja itd.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove : http://www.ema.europa.eu.
English: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
Croatian: Xofigo smiju primjenjivati samo osobe ovlaštene za rukovanje radiofarmaceuticima u za tu svrhu namijenjenom kliničkom okruženju (vidjeti dio 6.6) i nakon procjene bolesnika od strane kvalificiranog liječnika.
English: The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
Croatian: Najozbiljnije nuspojave bile su trombocitopenija i neutropenija (vidjeti dio 4.4 i ‘Opis odabranih nuspojava' niže).
English: The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01 - 1.27 MeV).
Croatian: Udio emitiran kao beta-čestice je 3,6% (prosječne energije su 0,445 MeV i 0,492 MeV), a udio emitiran kao gama-zračenje je 1,1% (raspon energija od 0,01 do 1,27 MeV).
English: Xofigo increases the risk of bone fractures (see section 5.1).
Croatian: Xofigo povećava rizik prijeloma kostiju (vidjeti dio 5.1).
English: Any materials used in connection with the preparation or administration of Xofigo are to be treated as radioactive waste.
Croatian: Svi materijali koji su se koristili za pripremu ili primjenu lijeka Xofigo moraju se smatrati radioaktivnim otpadom.
English: Water for injections, sodium citrate, sodium chloride, hydrochloric acid.
Croatian: Voda za injekcije, natrijev citrat, natrijev klorid, kloridna kiselina.
English: Contact your doctor immediately if you notice the following symptoms as they may be signs of thrombocytopenia or neutropenia (see above): - any unusual bruising, - more bleeding than usual after injury, - fever, - or if you seem to be catching a lot of infections.
Croatian: Odmah se obratite svom liječniku ako primijetite sljedeće simptome, jer oni mogu biti znakovi trombocitopenije ili neutropenije (vidjeti gore): - bilo kakve neuobičajene modrice, - jače krvarenje nakon ozljede nego obično, - vrućicu, - ili ako Vam se čini da često imate infekcije.
English: Castration-resistant prostate cancer is a cancer of the prostate (a gland of the male reproductive system) that does not respond to treatment that reduces male hormones.
Croatian: Rak prostate rezistentan na kastraciju je rak prostate (žlijezda muškog reproduktivnog sustava) koji ne reagira na liječenje koje snižava razinu muških hormona.
English: Calculations of absorbed doses were performed using OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), a software based on the Medical Internal Radiation Dose (MIRD) algorithm, which is widely used for established beta and gamma emitting radionuclides.
Croatian: Izračunavanje apsorbiranih doza provedeno je pomoću OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), softvera koji se temelji na algoritmu za doze medicinskog unutarnjeg zračenja (Medical Internal Radiation Dose - MIRD), koji je u širokoj uporabi za radionuklide koji dokazano emitiraju beta i gama zračenje.
English: Figure 1: Radium-223 decay chain with physical half-lives and mode of decay:
Croatian: Slika 1: Lanac raspada radija-223 s fizičkim poluvremenima i načinom raspada:
English: Based on studies in animals, there is a potential risk that radiation from Xofigo could cause adverse effects on fertility (see section 5.3).
Croatian: Na temelju ispitivanja na životinjama, postoji mogući rizik da zračenje od lijeka Xofigo uzrokuje štetne učinke na plodnost (vidjeti dio 5.3).
English: - Xofigo can lead to a decrease in the number of your blood cells and blood platelets.
Croatian: - Xofigo može dovesti do smanjenja broja Vaših krvnih stanica i krvnih pločica.
English: If you are engaged in sexual activity with a woman who could become pregnant you are advised to use effective birth control methods during and up to 6 months after treatment with Xofigo.
Croatian: Ako ste spolno aktivni sa ženom koja može zatrudnjeti, savjetuje se da koristite učinkovite metode kontrole začeća tijekom i do 6 mjeseci nakon liječenja lijekom Xofigo.
English: Radium is present in the solution as a free ion.
Croatian: Radij se u otopini nalazi u obliku slobodnog iona.
English: No significant uptake was seen in other organs such as heart, liver, kidneys, urinary bladder and spleen at 4 hours post injection.
Croatian: Nije opažen značajan ulazak u druge organe poput srca, jetre, bubrega, mokraćnog mjehura i slezene 4 sata nakon injekcije.
English: CI = confidence interval a The Phase 3 study ALSYMPCA was stopped for efficacy after the interim analysis.
Croatian: CI = interval pouzdanosti a Ispitivanje faze 3 ALSYMPCA bilo je zaustavljeno zbog djelotvornosti nakon privremene analize.
English: Xofigo is a therapeutic alpha particle-emitting pharmaceutical.
Croatian: Xofigo je terapijski radiofarmaceutik koji emitira alfa čestice.
English: It is supplied in a colourless glass vial closed with a grey rubber stopper and aluminium seal.
Croatian: Isporučuje se u bočici od bezbojnog stakla zatvorenoj sivim gumenim čepom i aluminijskim prstenom.
English: The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity measurement of Xofigo and the detection of contaminations with standard instruments.
Croatian: Gama zračenje povezano s raspadom radija-223 i njegovih kćeri omogućuje mjerenje radioaktivnosti lijeka Xofigo i otkrivanje kontaminacije standardnim instrumentima.
English: They are classified according to System Organ Class.
Croatian: Klasificirane su prema klasifikaciji organskih sustava.
English: If you are taking calcium, phosphate and/or Vitamin D, your doctor will carefully consider if you need to temporarily stop taking these substances before you start treatment with Xofigo.
Croatian: Ako uzimate kalcij, fosfate i/ili vitamin D, Vaš liječnik će pažljivo razmotriti trebate li privremeno prekinuti s uzimanjem ovih tvari prije početka liječenja lijekom Xofigo.
English: Since radium-223 distributes mainly to bone, the potential risk for adverse effects in the male gonads in cancer patients with castration-resistant prostate cancer is very low, but cannot be excluded (see section 4.6).
Croatian: Budući da se radij-223 distribuira uglavnom u kost, mogući rizik za nuspojave u muškim gonadama kod bolesnika s karcinomom prostate rezistentnim na kastraciju vrlo je nizak, ali ne može se isključiti (vidjeti dio 4.6).
English: Therefore in patients with a low level of osteoblastic bone metastases radium-223 is not recommended (see section 5.1).
Croatian: Stoga se u bolesnika s malim brojem osteoblastičnih koštanih metastaza radij-223 ne preporučuje (vidjeti dio 5.1).
English: Table 1: Adverse reactions reported in clinical trials in patients treated with Xofigo System Organ Class
Croatian: Tablica 1: Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika liječenih lijekom Xofigo Klasa organskog sustava
English: No significant QTc prolonging effects were observed after intravenous injection of Xofigo in comparison with placebo in a subgroup of 29 patients in the phase III study (ALSYMPCA).
Croatian: Nisu opaženi značajni učinci na produljenje QTc intervala nakon intravenske injekcije lijeka Xofigo u usporedbi s placebom u podskupini s 29 bolesnika u ispitivanju faze III (ALSYMPCA).
English: Xofigo increases the risk of bone fractures.
Croatian: Xofigo povećava rizik prijeloma kostiju.
English: After repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months, two dogs developed non-displaced pelvic fractures.
Croatian: Nakon ponovljenih primjena klinički preporučene aktivnosti od 55 kBq po kg tjelesne težine jednom svaka 4 tjedna tijekom 6 mjeseci, 2 psa su razvila frakture zdjelice bez pomaka.
English: Best standard of care included e.g. local external beam radiotherapy, bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine or ketoconazole.
Croatian: Najbolja standardna skrb uključivala je npr., lokalnu radioterapiju vanjskim zračenjem, bisfosfonate, kortikosteroide, antiandrogene, estrogene, estramustin ili ketokonazol.
English: The intravenous access line or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo.
Croatian: Linija ili kanila za intravenski pristup mora se isprati izotoničnom otopinom natrijevog klorida od 9 mg/ml (0,9%) za injekciju prije i nakon injekcije lijeka Xofigo.