FrancophonIA/ELRC3.0 huggingface dataset:
English: If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.
Croatian: Ako broj krvnih stanica padne prenisko ili ako se u bolesnika pojave problemi s bubrezima, treba odgoditi sljedeći ciklus terapije ili primijeniti manju dozu.
English: The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza lijeka Vidaza iznosi 75 mg po kvadratnom metru tjelesne površine (izračunato prema visini i tjelesnoj težini bolesnika).
English: The main measure of effectiveness was how long the patients survived.
Croatian: Osnovno mjerilo djelotvornosti bilo je preživljenje bolesnika.
English: It is available as a powder to be made up into a suspension for injection.
Croatian: Dostupan je u obliku praška koji se koristi za pripremu suspenzije za injekciju.
English: Vidaza was more effective than conventional care in extending survival.
Croatian: Lijek Vidaza bio je djelotvorniji od konvencionalne terapije u produljivanju preživljenja.
English: It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Croatian: Smatra se da djeluje izmjenjujući način na koji stanica uključuje i isključuje gene, kao i interferirajući s proizvodnjom novih RNK i DNK.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vidaza.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Vidaza.
English: Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;
Croatian: Vidaza se koristi u bolesnika sa srednjim do visokim rizikom progresije do AML-a ili smrti;
English: Vidaza treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Croatian: Terapiju lijekom Vidaza treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv karcinoma.
English: The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Croatian: Najčešće nuspojave lijeka Vidaza u više od 60 % bolesnika s mijelodisplastičnim sindromima, CMMLom ili AML-om (20 do 30 % abnormalnih stanica) jesu krvne reakcije, uključujući trombocitopeniju (mali broj trombocita), neutropeniju (male koncentracije neutrofila, vrste bijelih krvnih stanica) i leukopeniju (mali broj bijelih krvnih stanica), nuspojave koje zahvaćaju želudac i crijeva, uključujući mučninu i povraćanje, te reakcije na mjestu injekcije.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Vidaza can be found on the Agency's website: here (myelodysplastic syndromes) and here (AML).
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Vidaza možete naći na internetskim stranicama Agencije: ovdje (mijelodisplastični sindromi) i ovdje (AML).
English: Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA).
Croatian: Azacitidin je analog citidina, što znači da je ugrađen u genetski materijal stanica (RNK i DNK).
English: Both studies compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient's condition).
Croatian: U obama je ispitivanjima lijek Vidaza uspoređen s konvencionalnom terapijom (terapija odabrana za svakog bolesnika na osnovi lokalne prakse i stanja bolesnika).
English: Because the number of patients with these diseases is low, the diseases are considered ‘rare', and Vidaza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML.
Croatian: Budući da je broj bolesnika s ovim bolestima nizak, bolesti se smatraju „rijetkima” te se Vidaza označava kao lijek za liječenje rijetkih bolesti od 2. veljače 2002. za mijelodisplastične sindrome i od 29. studenog 2007. za AML.
English: Vidaza has been studied in two main studies.
Croatian: Lijek Vidaza ispitan je u dvama glavnim ispitivanjima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vidaza have 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 Vidaza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: This is a summary of the European public assessment report (EPAR) for Vidaza.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vidaza.
English: For more information about treatment with Vidaza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vidaza pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Other information about Vidaza
Croatian: Ostale informacije o lijeku Vidaza
English: Vidaza is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Croatian: Lijek Vidaza koristi se za terapiju odraslih osoba sa sljedećim bolestima, ako se ne mogu podvrgnuti transplantaciji hematopoetskih matičnih stanica (kada bolesnik primi matične stanice kako bi se obnovila sposobnost koštane srži da proizvodi zdrave krvne stanice):
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Croatian: • AML-om koji se razvio iz mijelodisplastičnog sindroma, a koštana srž sastoji se od 20 do 30 % abnormalnih stanica;
English: Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Croatian: Vidaza se koristi kada se u koštanoj srži nalazi od 10 do 29 % abnormalnih stanica, a koštana srž ne proizvodi veliki broj bijelih krvnih stanica;
English: These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Croatian: Smatra se da se takvim djelovanjem ispravljaju problemi sa sazrijevanjem i rastom mladih krvnih stanica u koštanoj srži koji uzrokuju mijelodispastične poremećaje i da se uništavaju stanice raka u slučaju leukemije.
English: Patients should receive medicines to prevent nausea (feeling sick) and vomiting before giving Vidaza.
Croatian: Bolesnici trebaju uzimati lijekove kako bi spriječili mučninu i povraćanje prije davanja lijeka Vidaza.
English: In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Croatian: U drugom ispitivanju provedenom u bolesnika s više od 30 % abnormalnih stanica, bolesnici koji su primili lijek Vidaza preživjeli su u prosjeku 10,4 mjeseci, u usporedbi sa 6,5 mjeseci u bolesnika koji su primili konvencionalnu terapiju.
English: In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Croatian: U prvom ispitivanju su bolesnici koji su primili lijek Vidaza preživjeli u prosjeku 24,5 mjeseci, u usporedbi s 15,0 mjeseci u bolesnika s konvencionalnom terapijom.
English: What is the risk associated with Vidaza?
Croatian: Koji su rizici povezani s lijekom Vidaza?
English: The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation.
Croatian: Drugo je ispitivanje obuhvatilo 488 bolesnika s AML-om u dobi od 65 godina ili starijih koji se nisu mogli podvrgnuti transplantaciji hematopoetskih matičnih stanica.
English: Why has Vidaza been approved?
Croatian: Zašto je lijek Vidaza odobren?
English: The CHMP decided that Vidaza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Vidaza nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Vidaza is a medicine that contains the active substance azacitidine.
Croatian: Vidaza je lijek koji sadrži djelatnu tvar azacitidin.
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant.
Croatian: Prvo je ispitivanje obuhvatilo 358 odraslih osoba s mijelodisplastičnim sindromima srednjeg do visokog rizika, CMML-om ili AML-om, za koje nije bilo izgledno da će se podvrgnuti transplantaciji matičnih stanica.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Croatian: • mijelodisplastičnim sindromima, grupom stanja u kojima koštana srž proizvodi premalo krvnih stanica.
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Croatian: • kroničnom mijelomonocitnom leukemijom (CMML-om, tipom raka koji zahvaća bijele krvne stanice zvane monociti).
English: What is Vidaza?
Croatian: Što je Vidaza?
English: Vidaza must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Croatian: Lijek Vidaza ne smije se koristiti u bolesnika s uznapredovalim rakom jetre ili tijekom dojenja.
English: The active substance in Vidaza, azacitidine, belongs to the group ‘anti-metabolites'.
Croatian: Djelatna tvar lijeka Vidaza, azacitidin, ubraja se u skupinu „antimetabolita”.
English: In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).
Croatian: U pojedinim slučajevima mijelodisplastični sindromi mogu rezultirati akutnom mijeloidnom leukemijom (AML-om, rakom koji zahvaća bijele krvne stanice zvane mijeloidne stanice).
English: At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.
Croatian: U trenutku označavanja lijeka kao lijeka za liječenje rijetkih bolesti, CMML je bio klasificiran kao tip mijelodisplastičnog sindroma.
English: What is Vidaza used for?
Croatian: Za što se Vidaza koristi?
English: The liver, kidneys and blood should be checked before each cycle.
Croatian: Prije svakog ciklusa potrebno je obaviti pretrage jetre, bubrega i krvi.
English: What benefit has Vidaza shown during the studies?
Croatian: Koje su koristi lijeka Vidaza utvrđene u ispitivanjima?
English: • AML, when the bone marrow has more than 30% abnormal cells.
Croatian: • AML-om pri kojem koštana srž ima više od 30 % abnormalnih stanica.
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Croatian: Slične nuspojave zabilježene su u bolesnika s AML-om koji imaju više od 30 % abnormalnih stanica.
English: How does Vidaza work?
Croatian: Kako djeluje Vidaza?
English: How is Vidaza used?
Croatian: Kako se Vidaza koristi?
English: The patients' bone marrow contained up to 30% abnormal cells.
Croatian: U koštanoj srži bolesnika bilo je do 30 % abnormalnih stanica.
English: Their bone marrow contained more than 30% abnormal cells.
Croatian: U njihovoj koštanoj srži bilo je više od 30 % abnormalnih stanica.
English: For the full list of all side effects reported with Vidaza, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vidaza potražite u uputi o lijeku.
English: See the summary of product characteristics (also part of the EPAR) for full details.
Croatian: Za dodatne informacije vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
English: How has Vidaza been studied?
Croatian: Kako je lijek Vidaza ispitivan?
English: However, knowledge on the long-term effects of the medicine is still awaited.
Croatian: Međutim, saznanja o dugoročnim učincima lijeka još se očekuju.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bolesnikove hrskavice.
English: It must also not be used in patients infected with hepatitis B, C and/or HIV virus.
Croatian: Također se ne smije primjenjivati u bolesnika zaraženih hepatitisom B, C i/ili virusom HIV-a.
English: The safety profile was considered acceptable; most side effects expected can be due to the surgery.
Croatian: Sigurnosni profil smatra se prihvatljivim; većina očekivanih nuspojava može se pripisati kirurškom zahvatu.
English: The company will also continue the first study to obtain more information about the long-term safety and effectiveness of Spherox.
Croatian: Tvrtka će također nastaviti prvo ispitivanje kako bi se dobilo više informacija o dugoročnoj sigurnosti i učinkovitosti lijeka Spherox.
English: The full EPAR for Spherox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) lijeka Spherox nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used where the affected area is no larger than 10 cm².
Croatian: Primjenjuje se na mjestima na kojima oštećeno područje nije veće od 10 cm2.
English: Cartilage in the knee can be damaged because of an accident, such as a fall or a sport injury.
Croatian: Hrskavica u koljenu može biti oštećena kao posljedica nezgode, kao što je pad ili sportska ozljeda.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Croatian: Riječ je o vrsti lijeka koja sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za popravak, regeneraciju ili zamjenu tkiva.
English: In this study, patients' outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment.
Croatian: U ovom ispitivanju rezultati ishoda bolesnika uz lijek Spherox poboljšali su se za 16 bodova u prvoj godini, a daljnja poboljšanja opažena su do tri godine nakon liječenja.
English: All these patients received treatment with Spherox, as microfracture is not recommended to repair large defects.
Croatian: Svi ti bolesnici liječeni su lijekom Spherox jer se mikrofraktura ne preporučuje za popravak velikih oštećenja.
English: In addition, two other studies will be carried out on the manufacture of Spherox, which will look, among other things, at the consistency of the finished product.
Croatian: Nadalje, bit će provedena dva druga ispitivanja povezana s proizvodnjom lijeka Spherox u kojima će se pratiti, između ostalog, dosljednost gotovog proizvoda.
English: Patients treated with Spherox should follow a specific rehabilitation programme, including physiotherapy.
Croatian: Bolesnici liječeni lijekom Spherox moraju se pridržavati posebnog rehabilitacijskog programa, uključujući fizioterapiju.
English: The KOOS was self-measured by patients rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.
Croatian: Pomoću ljestvice KOOS bolesnici su sami procjenjivali težinu svojih simptoma kao što su bol, utjecaj na svakodnevni život, sportske i rekreacijske aktivnosti te kvalitetu života.
English: The European Medicines Agency therefore decided that Spherox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Spherox nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility.
Croatian: Lijek se priprema za svakog pojedinog bolesnika posebno i smije ga primijeniti samo za to osposobljen liječnik u medicinskoj ustanovi.
English: Preliminary data from this study after one year show that Spherox improved by 22 points the outcome score and was as effective as microfracture.
Croatian: Preliminarni podatci dobiveni ovim ispitivanjem nakon godine dana pokazuju da je Spherox za 22 boda poboljšao rezultat ishoda te da je bio jednako učinkovit kao mikrofraktura.
English: Other information about Spherox
Croatian: Ostale informacije o lijeku Spherox
English: The chondrocyte spheroids attach to the cartilage within 20 minutes.
Croatian: Sferoidi hondrocita pričvrste se na hrskavicu unutar 20 minuta.
English: What measures are being taken to ensure the safe and effective use of Spherox?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Spherox?
English: This is a summary of the European public assessment report (EPAR) for Spherox.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Spherox.
English: Spherox is a type of advanced therapy medicine called a ‘tissue engineered product'.
Croatian: Spherox je vrsta lijeka za naprednu terapiju koji se naziva „lijek dobiven tkivnim inženjeringom”.
English: Spherox is available as a suspension for implantation into the knee joint.
Croatian: Spherox je dostupan kao suspenzija za implantaciju u zglob koljena.
English: What is Spherox and what is it used for?
Croatian: Što je Spherox i za što se koristi?
English: In the first study involving 102 patients, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage).
Croatian: U prvom ispitivanju u kojem su sudjelovala 102 bolesnika, Spherox je uspoređen s mikrofrakturom (vrsta kirurškog zahvata kojim se liječe oštećenja hrskavice).
English: The second study looked at 73 patients with large cartilage defects of the knee from 4 to 10 cm².
Croatian: U drugom ispitivanju, praćena su 73 bolesnika s velikim oštećenjima hrskavice koljena, veličine od 4 do 10 cm².
English: It is not intended to provide practical advice on how to use Spherox.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Spherox.
English: Spherox spheroids of human autologous matrix-associated chondrocytes
Croatian: Spherox sferoidi ljudskih autolognih hondrocita vezanih na matricu
English: The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale of 0 to 100 (where 0 means severest symptoms and 100 means no symptoms).
Croatian: Knee Injury and Osteoarthritis Outcome Score) sa stupnjevima od 0 do 100 (pri čemu 0 znači najteže simptome, a 100 znači bez simptoma).
English: The company that markets Spherox will ensure that all surgeons and other healthcare professionals handling or using the medicine receive training materials on how to use and store it.
Croatian: Tvrtka koja Spherox stavlja na tržište osigurat će da svi kirurzi i drugi zdravstveni radnici koji rukuju lijekom ili ga primjenjuju, dobiju materijal koji će ih naučiti kako primjenjivati i čuvati lijek.
English: The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids.
Croatian: Stanice hrskavice se zatim umnože u laboratoriju kako bi se pripremila suspenzija sferoida hondrocita.
English: When the spheroids are implanted into the patient's cartilage, they attach to the area of the defect and produce new tissue, thereby repairing the defects in the knee.
Croatian: Kada se sferoidi implantiraju u hrskavicu bolesnika, prianjanjem na područje oštećenja stvaraju novo tkivo i na taj način popravljaju oštećenja u koljenu.
English: The knee cartilage defects were between 1 and 4 cm2 in size.
Croatian: Oštećenja hrskavice u koljenu bila su veličine između 1 i 4 cm2.
English: Using chondrocyte spheroids that attach to the knee cartilage allows for a less invasive surgery (i.e. arthroscopy).
Croatian: Primjena sferoida hondrocita koji prianjaju uz hrskavicu koljena, omogućuje manje invazivan kirurški zahvat (tj. artroskopija).
English: Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing symptoms (such as pain and problems moving the knee).
Croatian: Spherox je lijek koji se primjenjuje za popravak oštećenja hrskavice koljena u odraslih osoba koje imaju simptome (kao što su bol i tegobe s pomicanjem koljena).
English: The materials for other healthcare professionals will include information on how to screen and handle the collected sample and prepare Spherox for implantation, and how to follow patients up and plan the recommended physiotherapy.
Croatian: Materijali za ostale zdravstvene radnike uključuju informacije o tome kako provesti probir i rukovati uzetim uzrokom i pripremiti Spherox za implantaciju, te kako pratiti bolesnike i planirati preporučenu fizioterapiju.
English: Spherox has been shown to be effective at treating defects in the knee cartilage between 1 and 10 cm2 in size.
Croatian: Pokazalo se da je Spherox učinkovit za liječenje oštećenja hrskavice koljena veličine od 1 do 10 cm2.
English: This allows the chondrocyte spheroids to fill in the cartilage defect.
Croatian: To omogućuje da sferodi hondrocita popune oštećenje u hrskavici.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spherox 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 Spherox nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The training materials for surgeons will include information on how to collect the cartilage sample from patients, perform the operation and follow up their patients.
Croatian: Edukacijski materijali za kirurge uključuju informacije o tome kako uzeti uzorak hrskavice bolesnika, provesti operaciju i pratiti bolesnike.
English: What are the risks associated with Spherox?
Croatian: Koji su rizici povezani s lijekom Spherox?
English: For more information about treatment with Spherox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Spherox pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing.
Croatian: Spherox se ne smije primjenjivati u bolesnika s primarnim generaliziranim osteoartritisom ili uznapredovalim osteoartritisom koljena (stanja koja uzrokuju oticanje i bol u zglobovima) te u bolesnika u kojih kosti u koljenskom zglobu još rastu.
English: Why is Spherox approved?
Croatian: Zašto je lijek Spherox odobren?
English: The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint.
Croatian: Najčešće nuspojave lijeka Spherox (primijećene u više od 1 na 10 bolesnika) jesu artralgija (bol u zglobu) i izljev u zglob (nakupljanje tekućine u koljenu), što može prouzročiti oticanje zgloba.