FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is considered necessary in patients with hepatic impairment.
Croatian: Smatra se da nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
English: Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
Croatian: Jedan ml otopine sadrži 1100 kBq radijevog Ra 223 diklorida (radij-223 diklorid), što odgovara 0,58 ng radija-223 na referentni datum.
English: SSE = symptomatic skeletal event a Defined as occurrence of any of the following: external beam radiotherapy to relieve pain, or pathologic fracture, or spinal cord compression, or tumor-related orthopedic surgical intervention.
Croatian: ALP = alkalna fosfataza; CI = interval pouzdanosti; NE = ne može se procijeniti; PSA = prostata specifičan antigen; SSE = simptomatski događaj povezan s kostima a Definirano kao pojava bilo čega od sljedećeg: radioterapija vanjskim snopom za smanjenje boli ili patološki prijelom ili kompresija kralježnične moždine ili ortopedsko-kirurška intervencija zbog tumora.
English: Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
Croatian: Trombocitopenija stupnja 3 i 4 uočena je u 5,9% bolesnika liječenih lijekom Xofigo i u 6,7% bolesnika koji su primali placebo (vidjeti dio
English: Thrombocytopenia
Croatian: GDC3 stijenka
English: Bone fractures
Croatian: Prijelomi kostiju
English: Gamma emission (Gy/MBq)
Croatian: Gama zračenje (Gy/MBq)
English: Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio < 1 favours Xofigo p-value
Croatian: Analiza vremena do događaja (95% CI) [br. (%) bolesnika] [medijan br. mjeseci]
English: An increased risk of death and fractures was observed in a clinical study, where Xofigo was added to abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration resistant prostate cancer.
Croatian: U kliničkom ispitivanju u kojem je Xofigo dodan abirateronacetatu i prednizonu/prednizolonu u bolesnika s asimptomatskim ili blago simptomatskim rakom prostate rezistentnim na kastraciju uočen je povećan rizik od smrti i prijeloma.
English: How Xofigo is stored
Croatian: Kako čuvati Xofigo
English: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported in patients treated with Xofigo (see section 4.8).
Croatian: U bolesnika liječenih lijekom Xofigo prijavljena je supresija koštane srži, prvenstveno trombocitopenija, neutropenija, leukopenija i pancitopenija (vidjeti dio 4.8).
English: Neutropenia Pancytopenia Leukopenia
Croatian: Štitna žlijezda Stijenka mokraćnog mjehura
English: SSE components
Croatian: Prijelomi kosti
English: How Xofigo is used
Croatian: Kako primjenjivati Xofigo
English: Beta emission (Gy/MBq)
Croatian: Beta zračenje (Gy/MBq)
English: A risk of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) cannot be excluded (see section 4).
Croatian: Rizik od osteonekroze čeljusti (mrtvo tkivo u kosti čeljusti koje se uglavnom vidi u bolesnika koji su bili liječeni s bisfosfonatima) ne može se isključiti (vidjeti dio 4). - Xofigo pridonosi Vašoj ukupnoj dugotrajnoj kumulativnoj izloženosti zračenju.
English: The MAH shall conduct and submit the results of a phase IV biodistribution study according to an agreed protocol in order to further characterize correlation between the extent of the disease, the dose and the distribution of radium-223 in bone metastases versus sites of impaired bone health (e.g. osteoporosis) versus normal bone structure.
Croatian: prema dogovorenom protokolu kako bi se bolje definirala povezanost između proširenosti bolesti, doze i distribucije radija-223 u koštane metastaze naspram mjesta koštanih oštećenja (npr. osteoporoze) naspram normalne koštane strukture.
English: Due to the faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease.
Croatian: Zračenje može dovesti do pogoršanja akutne upalne bolesti crijeva, s obzirom da se Xofigo izlučuje stolicom.
English: Therefore, haematological evaluation of patients must be performed at baseline and prior to every dose of Xofigo.
Croatian: Stoga se na početku i prije primjene svake doze lijeka Xofigo mora napraviti hematološka procjena bolesnika.
English: b not estimable owing to insufficient events after the median c Defined as ≥ 25% increase compared to baseline/nadir.
Croatian: b Ne može se procijeniti zahvaljujući nedovoljnom broju događaja nakon medijana.
English: No case of osteosarcoma has been reported in clinical studies with Xofigo.
Croatian: U kliničkim ispitivanjima lijeka Xofigo nije zabilježen nijedan slučaj osteosarkoma.
English: Animal reproduction studies have not been conducted with Xofigo.
Croatian: Nisu provedena ispitivanja učinka lijeka Xofigo na reprodukciju u životinja.
English: No case of retinal detachment has been reported in clinical trials.
Croatian: U kliničkim ispitivanjima nije zabilježen nijedan slučaj odvajanja mrežnice.
English: Hepatic impairment
Croatian: Nadbubrežne žlijezde
English: STATEMENT OF ACTIVE SUBSTANCE
Croatian: 3. POPIS POMOĆNIH TVARI
English: Heart wall Kidneys
Croatian: Srčana stijenka Bubrezi
English: Pain relief
Croatian: OLOVNA POSUDA
English: However, since excretion in urine is minimal and the major route of elimination is via the faeces, renal impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Croatian: Međutim, ne očekuje se da će oštećenje funkcije bubrega utjecati na farmakokinetiku radijevog-223 diklorida budući da je izlučivanje u urin minimalno i da je glavni put eliminacije putem stolice.
English: Subsequent treatment with cytotoxic substances
Croatian: Daljnje liječenje citotoksičnim tvarima
English: Common
Croatian: stabilan
English: Bone fracture
Croatian: Oštećenje funkcije bubrega
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: OD LIJEKA, AKO JE POTREBNO 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: The European Commission issued a decision on 22 October 2015.
Croatian: Europska komisija odluku je donijela 22. listopada 2015.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
Croatian: Ovo je postupak u kojem jedna država članica ("referentna država članica", u ovom slučaju Ujedinjena Kraljevina) ocjenjuje veterinarsko medicinski proizvod u pogledu izdavanja odobrenja za stavljanje lijeka u promet koje će biti valjano u ovoj državi kao i u drugim državama članicama (državama članicama u postupku, u ovom slučaju Austriji, Belgiji, Bugarskoj, Cipru, Češkoj Republici, Danskoj, Estoniji, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji i Španjolskoj).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. listopada 2015.
English: What are the conclusions of the CVMP?
Croatian: Koje je zaključke donio CHMP?
English: On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
Croatian: Dana 6. lipnja 2015., Europska agencija za lijekove (Agencija) završila je arbitražni postupak nastavno na neslaganje država članica Europske unije (EU) u vezi s odobrenjem veterinarsko-medicinskog proizvoda Gutal 1000 g/kg premiksa za ljekovitu hranu za praščiće.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Croatian: Na temelju ocjene aktualno dostupnih podatak i znanstvenih rasprava unutar Odbora, CVMP je zaključio kako je rizik za okoliš identificiran uslijed akumulacije cinka, no da postoji više nesigurnosti povezanih sa skalom ovog rizika.
English: Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Croatian: Stoga je CVMP zaključio da zabrinutosti koje su iznijele Francuska i Nizozemska ne smiju spriječiti izdavanje odobrenja za stavljanje lijeka u promet i preporučio odobrenje za stavljanje lijeka u promet odobrenog u dotičnim državama članicama.
English: Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Croatian: Gutal je generički veterinarsko-medicinski proizvod koji se temelji na referentnom proizvodu ZincoTec cinkov oksid 100% premiks za ljekovitu hranu za praščiće, koji je odobren u Ujedinjenoj Kraljevini.
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Croatian: No, države članice nisu bile u stanju postići dogovor, te je 30. rujna 2014 Uprava za veterinarsko medicinske proizvode Ujedinjene Kraljevine dotični predmet uputila CVMP-u na arbitražu.
English: The active substance of Gutal is zinc oxide.
Croatian: Djelatna tvar VMP-a Gutal je cinkov oksid.
English: Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Croatian: NV dostavila je prijavu za izdavanje odobrenja za stavljanje u promet VMP-a Gutal u Ujedinjenoj Kraljevini putem decentraliziranog postupka.
English: The CVMP also recommended that the product information for Gutal be amended.
Croatian: CVMP je također preporučio dopunu informacija o VMP-u Gutal.
English: Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Croatian: Stoga, Odbor je preporučio da se u informacije o proizvodu uključi nekoliko mjera za smanjivanje rizika, za koje se očekuje da će smanjiti akumulaciju cinka u okolišu.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da se odobrenje za izdavanje odobrenja za stavljanje VMP-a Gutal u promet može odobriti ako se preporučene mjere za smanjivanje rizika, za koje se očekuje da će smanjiti akumulaciju cinka u okolišu, dodaju u informacije o proizvodu.
English: Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Croatian: Zašto je pregledan Gutal 1000 g/kg premiks za ljekovitu hranu za praščiće?
English: What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Croatian: Što je VPM Gutal 1000 g/kg premiks za ljekovitu hranu za praščiće?
English: The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Croatian: VMP je indiciran za sprječavanje proljeva nakon faze dojenja u praščića.
English: The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Croatian: Rizici su identificirani tijekom decentraliziranog postupka kojeg su provele Francuska i Nizozemska, koje su zaključke da izdavanje odobrenja za stavljanje u promet VMP-a Gutal može predstavljati potencijalne ozbiljne rizike za okruženje, te da su mjere za smanjivanje rizika predložene za kontrolu
English: Patients will also receive a guide and a card that they should carry with them.
Croatian: Bolesnici će dobiti vodič i karticu koju trebaju nositi sa sobom.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se ovdje: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
English: Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Croatian: Više informacija o lijeku Zynteglo nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zynteglo.
English: There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Croatian: Isto tako, postoji i potencijalni rizik od krvarenja budući da lijek može prouzročiti pad broja krvnih pločica.
English: It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Croatian: Primjenjuje se infuzijom (ukapavanjem) u venu, a doza ovisi o tjelesnoj težini bolesnika.
English: In addition, the company will ensure that the medicine is only provided from approved centres.
Croatian: Uz to, tvrtka će zajamčiti da se lijek isporučuje samo u kvalificiranim centrima za liječenje.
English: Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Iako su informacije o sigurnoj primjeni lijeka ograničene zbog malog broja dosad liječenih bolesnika i nedostatka dugoročnih podataka, Europska agencija za lijekove zaključila je da koristi od lijeka Zynteglo nadmašuju s njim povezane rizike i da lijek može biti odobren za primjenu u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Zynteglo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zynteglo?
English: However, measures are in place to monitor such events through a registry of patients and a long-term study to assess patients' long-term outcomes.
Croatian: Međutim, postoje mjere za praćenje takvih događaja putem registra bolesnika i dugoročnog ispitivanja radi procjene dugoročnih ishoda liječenja u bolesnika.
English: This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
Croatian: To znači da bolesnici mogu izbjeći prekomjerno gomilanje željeza koje se javlja zbog redovitih transfuzija i koje isto tako iziskuje liječenje.
English: As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Croatian: Zbog toga ti bolesnici imaju nisku razinu crvenih krvnih stanica i često im je potrebna transfuzija.
English: Zynteglo has been given ‘conditional authorisation'.
Croatian: Za lijek Zynteglo izdano je „uvjetno odobrenje”.
English: Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
Croatian: Liječnici trebaju razmotriti mogu li bolesnici primiti neophodne tretmane prije liječenja lijekom Zynteglo.
English: Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zynteglo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Zynteglo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zynteglo i zašto je odobren u EU-u
English: Other information about Zynteglo
Croatian: Ostale informacije o lijeku Zynteglo
English: The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Croatian: Tvrtka koja lijek Zynteglo stavlja u promet dostavit će zdravstvenim radnicima za koje se očekuje da će primjenjivati lijek edukacijske materijale s informacijama o sigurnosti lijeka, uključujući i informacije o potencijalnim rizicima od raka i krvarenja, te o načinu primjene lijeka.
English: In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
Croatian: U tim ispitivanjima, od 14 bolesnika koji nisu imali potpuni nedostatak beta-globina i koji su primili lijek Zynteglo, 11 bolesnika imalo je dovoljno visoku razinu crvenih krvnih stanica i nije im bila potrebna transfuzija najmanje godinu dana nakon liječenja.
English: Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Croatian: Beta-talasemija je rijetka bolest, a lijek Zynteglo dobio je status „lijeka za rijetku bolest” 24. siječnja 2013.
English: Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Croatian: Zynteglo (autologne CD34+ stanice s genom koji kodira βA-T87Q-globin)
English: Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
Croatian: Zynteglo se ne smije primjenjivati u trudnica i dojilja, kao ni u bolesnika koji su prethodno primali gensku terapiju (lijek kojim se isporučuju geni).
English: What is Zynteglo and what is it used for?
Croatian: Što je Zynteglo i za što se primjenjuje?
English: Why is Zynteglo authorised in the EU?
Croatian: Zašto je lijek Zynteglo odobren u EU-u?
English: People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Croatian: Osobe s tim genetskim poremećajem ne mogu proizvesti dovoljno beta-globina, koji je sastavni dio hemoglobina, odnosno proteina u crvenim krvnim stanicama koji prenosi kisik po tijelu.
English: A small number of patients have been treated with Zynteglo to date, and the most serious side effect observed is thrombocytopenia (low blood levels of platelets, components that help the blood to clot).
Croatian: Dosad je lijekom Zynteglo liječen tek malen broj bolesnika, a najozbiljnija opažena nuspojava je trombocitopenija (niska razina krvnih pločica, koje pomažu u zgrušavanju krvi).
English: Studies show that with a one-time treatment with Zynteglo most patients no longer need blood transfusions to increase their levels of working red blood cells.
Croatian: Ispitivanja pokazuju da nakon jednokratne terapije lijekom Zynteglo većini bolesnika više nije potrebna transfuzija krvi kako bi se povisila razina funkcionalnih crvenih krvnih stanica.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynteglo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zynteglo također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Zynteglo?
Croatian: Koji su rizici povezani s lijekom Zynteglo?
English: The effects of Zynteglo are expected to last for the patient's lifetime.
Croatian: Očekuje se da će učinci lijeka Zynteglo trajati tijekom cijelog bolesnikova života.
English: Zynteglo is a medicine used to treat a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions.
Croatian: Zynteglo je lijek koji se primjenjuje za liječenje poremećaja krvi poznatog pod nazivom betatalasemija u osoba u dobi od 12 godina i starijih kojima su potrebne redovite transfuzije krvi.
English: Zynteglo is made individually for each patient out of stem cells collected from their blood, and must only be given to the patient for whom it is made.
Croatian: Zynteglo se proizvodi pojedinačno za svakog bolesnika od matičnih stanica iz krvi samog bolesnika i smije se dati samo bolesniku za kojega je proizveden.
English: As for all medicines, data on the use of Zynteglo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zynteglo kontinuirano se prate.
English: When these modified cells are given back to the patient, they are transported in the bloodstream to the bone marrow where they start to make healthy red blood cells that produce beta-globin.
Croatian: Kada se tako modificirane stanice vrate bolesniku, krvotokom se prenose u koštanu srž gdje počinju proizvoditi zdrave crvene krvne stanice koje proizvode beta-globin.
English: The company will also provide data from a registry of patients treated with Zynteglo to study its longterm safety and effectiveness, as well as further data on the tests used in the manufacturing of the medicine to ensure its quality.
Croatian: Tvrtka će dostaviti i podatke iz registra bolesnika liječenih lijekom Zynteglo kako bi se omogućilo ispitivanje njegove dugoročne sigurne primjene i učinkovitosti, kao i dodatne podatke o testiranjima provedenima tijekom faze proizvodnje lijeka s ciljem osiguranja kvalitete.
English: Since Zynteglo has been given conditional authorisation, the company that markets Zynteglo will provide results of ongoing studies to further assess the effectiveness and safety of the medicine.
Croatian: Budući da je za lijek Zynteglo izdano uvjetno odobrenje, tvrtka koja ga stavlja u promet dostavit će rezultate ispitivanja u tijeku kako bi se dodatno procijenila učinkovitost i sigurnost primjene lijeka.
English: Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Croatian: S obzirom na sigurnost primjene lijeka valja napomenuti da, budući da se Zynteglo proizvodi pomoću virusa, postoji teoretski rizik od raka uslijed neželjenih promjena genetskog materijala.
English: Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Croatian: Zynteglo se primjenjuje u bolesnika u kojih se ne radi o potpunom nedostatku beta-globina i koji su pogodni za transplantaciju matičnih stanica, ali nemaju podudarnog srodnog davatelja.
English: Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Croatian: Beta-talasemija ovisna o transfuziji teška je bolest, a mogućnosti njezina liječenja su ograničene.
English: For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Zynteglo pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: How does Zynteglo work?
Croatian: Kako djeluje Zynteglo?