FrancophonIA/ELRC3.0 huggingface dataset:
English: There was a statistically significant improvement in PFS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Croatian: U bolesnika liječenih kombinacijom Abraxane/gemcitabin zabilježeno je statistički značajno poboljšanje u preživljenju bez progresije bolesti nasuprot onih liječenih samo gemcitabinom, uz povećanje medijana preživljenja bez progresije bolesti od 1,8 mjeseci.
English: 20.6 [15.6, 25.9] (n = 131)
Croatian: > 1. linije terapije 20,6 [15,6; 25,9] (n = 131)
English: Overall Response Rate Confirmed complete or partial overall response, n (%)
Croatian: Sveukupno preživljenje Broj smrti, n (%)
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Croatian: Standardized MedDRA Query) (SMQ je skupina od nekoliko standardnih izraza MedDRA-e kojima se opisuje neki medicinski pojam).
English: *Median progression free survival [95% CI] (weeks)
Croatian: *Medijan preživljenja bez progresije bolesti [95% CI] (tjedni)
English: Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Croatian: Kada se periferna neuropatija poboljša na stupanj 0 ili 1, ponovno treba uvesti Abraxane u smanjenoj dozi (vidjeti dio 4.2).
English: Uncommon: Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis
Croatian: Manje često: iritacija oka, bol u oku, abnormalni vid, smanjena vidna oštrina, konjunktivitis, poremećaji vida, svrbež oka, keratitis Rijetko: cistoidni makularni edem2
English: Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Croatian: U skupini koja je primala Abraxane/gemcitabin 32% bolesnika u usporedbi s 15% bolesnika iz skupine koja je primala gemcitabin, primalo je terapiju 6 mjeseci ili više.
English: OR Nadir ANC <500/mm3 for > 1 week
Croatian: Najniža vrijednost ABN < 500/mm3 tijekom > 1 tjedna Najniža vrijednost trombocita < 50 000/mm3
English: • Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function,
Croatian: • povećana tjelesna težina, povišena razina laktatdehidrogenaze u krvi, smanjena funkcija bubrega, povišeni šećer u krvi, povišena razina fosfora u krvi
English: Grade 3-4
Croatian: 3. - 4. stupanj
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Croatian: Tijekom postmarketinškog praćenja lijeka Abraxane zabilježeni su paraliza kranijalnih živaca, pareza glasnica i rijetki slučajevi teških reakcija preosjetljivosti.
English: What Abraxane is and what it is used for
Croatian: Što je Abraxane i za što se koristi
English: Very common: Fatigue, asthenia, pyrexia Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Croatian: Često: periferni edem, upala sluznice, bol, tresavica, edem, slabost, pogoršano opće stanje, bol u prsima, bolest nalik gripi, malaksalost, letargija, hiperpireksija
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Croatian: Pomoćne tvari: otopina ljudskog albumina (koja sadrži natrij, natrijev kaprilat i N-acetil DL triptofanat).
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
Croatian: Općenito, u bolesnika koji su primali Abraxane, učestalost i težina neurotoksičnosti bile su ovisne o dozi.
English: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.
Croatian: Uporabom sterilne štrcaljke, 50 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) za infuziju treba polako injicirati u bočicu lijeka Abraxane od 250 mg tijekom najmanje 1 minute.
English: Hepatobiliary disorders Common: Cholangitis
Croatian: Poremećaji jetre i žuči Često: kolangitis
English: Very common: Dyspnoea
Croatian: Vrlo često: dispneja
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.
Croatian: Uporabom sterilne štrcaljke, 20 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) za infuziju treba polako injicirati u bočicu lijeka Abraxane od 100 mg tijekom najmanje 1 minute.
English: ≤ Grade 1; resume at next lower dose levela
Croatian: Obustava doza do poboljšanja na ≤ 1. stupnja; nastaviti sa sljedećom nižom razinom dozea
English: There have been reports of tumour lysis syndrome during treatment with Abraxane.
Croatian: Tijekom liječenja lijekom Abraxane prijavljeni su slučajevi sindroma lize tumora.
English: 250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Croatian: Bočica od 250 mg: Uporabom sterilne štrcaljke, 50 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) za infuziju treba polako injicirati u bočicu s lijekom Abraxane tijekom najmanje 1 minute.
English: 100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Croatian: Bočica od 100 mg: Uporabom sterilne štrcaljke, 20 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) za infuziju treba polako injicirati u bočicu s lijekom Abraxane tijekom najmanje 1 minute.
English: First Second
Croatian: 1. godini
English: Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Svaka bočica sadrži 250 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: • Coughing up blood
Croatian: • iskašljavanje krvi
English: • Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood,
Croatian: • infekcija, vrućica s padom broja jedne vrste bijelih krvnih stanica (neutrofila) u krvi, crvenilo uz osjećaj vrućine, afte, teške infekcije krvi koje mogu biti uzrokovane smanjenim brojem bijelih krvnih stanica
English: Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Croatian: Supresija koštane srži (primarno neutropenija) česta je pojava u liječenju lijekom Abraxane.
English: Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
Croatian: Da biste izbjegli unos tih vlakana, primjenjujte Abraxane s pomoću kompleta za infuziju opremljenog filtrom od 15 µm.
English: Table 6: Adverse reactions reported with Abraxane monotherapy at any dose in clinical studies Infections and infestations
Croatian: Tablica 6: Nuspojave zabilježene u kliničkim ispitivanjima uz bilo koju dozu lijeka Abraxane primijenjenog kao monoterapija
English: • Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Croatian: • Ako imate metastatski rak gušterače (karcinom pankreasa) Abraxane se koristi zajedno s lijekom koji se naziva gemcitabin.
English: Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Svaka bočica sadrži 100 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Croatian: Ako je potrebno daljnje smanjenje doze
English: Delay of next cycle due to persistent neutropenia2 (Nadir ANC <1500/mm3)
Croatian: Odgoda sljedećeg ciklusa zbog ustrajne neutropenije2 (najniža vrijednost ABN
English: Breast Cancer
Croatian: Rak dojke
English: Common: Stomatitis, dyspepsia, abdominal pain, dysphagia Hepatobiliary disordesrs Common: Hyperbilirubinaemia Skin and subcutaneous tissue disorders
Croatian: Često: bol u abdomenu, distenzija abdomena, bol u gornjem dijelu abdomena, dispepsija, gastroezofagealna refluksna bolest, oralna hipoestezija
English: • Restlessness
Croatian: • manjak eritrocita
English: Abraxane was administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and
Croatian: Abraxane je bio primijenjen bolesnicima (N = 521) kao intravenska infuzija tijekom 30 minuta u dozi od 100 mg/m2 davanoj 1., 8. i 15. dana svakog 21-dnevnog ciklusa bez premedikacije sterodima i bez profilaktičke primjene G-CSF-a.
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Croatian: Ako suspenzija dođe u dodir sa sluznicama, potrebno ih je temeljito isprati vodom.
English: Overall Survival Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Croatian: Sveukupno preživljenje Broj smrti (%) Medijan sveukupnog preživljenja, mjeseci (95% CI)
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with Abraxane.
Croatian: Tijekom liječenja lijekom Abraxane prijavljeni su rijetki slučajevi smanjene oštrine vida zbog cistoidnog makularnog edema.
English: Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population)
Croatian: Tablica 11: Rezultati djelotvornosti dobiveni u randomiziranom ispitivanju u bolesnika s adenokarcinomom pankreasa (populacija s namjerom liječenja) Abraxane(125 mg/m2)/gemcitabin (N = 431)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 100 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: Return to the Day 1 dose levels and follow with WBC Growth Factors OR Treat with same doses as Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000 Treat with Day 8 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses
Croatian: Liječenje istim dozama kao 8. dana i zatim primjena čimbenika rasta bijelih krvnih stanica ILI smanjenje razine doza 8. dana za 1 razinu
English: Nadir platelets <50,000/mm3
Croatian: < 1500/mm3)
English: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Croatian: Celgene Europe B.V.
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Croatian: Manje često: disfagija, flatulencija, glosodinija, suha usta, bol u desnima, tekuće stolice, ezofagitis, bol u donjem dijelu abdomena, ulceracije u ustima, bol u ustima, krvarenje iz rektuma
English: Reconstitution and administration of the product
Croatian: Rekonstitucija i primjena lijeka
English: Survival Rate % (95% CI) at 1 Year 2 Year 75th Percentile Overall
Croatian: Stopa preživljenja % (95% CI) u
English: Reduce doses 1 dose level from Day 8 doses
Croatian: Primjena razine doza 8. dana i zatim čimbenika rasta bijelih krvnih stanica ILI smanjenje razine doza 8. dana za 1 razinu
English: Uncommon: Flushing
Croatian: Rijetko: tromboza
English: Common: Haemoptysis, epistaxis, cough
Croatian: Vrlo često: osip, alopecija
English: Common: Pain in extremity, bone pain, back pain, muscle cramps, limb pain
Croatian: Često: bol u šakama i stopalima, bol u kostima, bol u leđima, grčevi u mišićima, bol u udovima
English: Solvent-based paclitaxel (200 mg/m2 every 3 weeks) + carboplatin (N=531)
Croatian: 3 tjedna) + karboplatin (N = 531)
English: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Croatian: MedDRA = skraćenica za Medical Dictionary for Regulatory Activities; Rječnik medicinskih pojmova za regulatorne poslove; SMQ = Standardizirani MedDRA upit (engl.
English: Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Abraxane in patients with hepatic impairment should be performed with caution.
Croatian: Abraxane treba oprezno primjenjivati u bolesnika s oštećenjem jetrene funkcije jer se toksičnost paklitaksela može povećati kako jetrena funkcija slabi.
English: 31 March 2026
Croatian: 31. ožujka 2026.
English: Each MAH shall conduct and submit for their medicinal product(s) the results of placebo-controlled, double-blind multicentre RCT(s) according to agreed protocols in order to further characterise the efficacy and safety, of their bacterial lysate based product(s) in their authorised indication(s).
Croatian: Svaki nositelj odobrenja za stavljanje u promet za svoj(e) lijek(ove) provodi dvostruko slijepo/a, multicentrično/a randomizirano/a kliničko/a ispitivanje/a kontrolirano/a placebom u skladu s dogovorenim protokolima kako bi se dodatno opisale djelotvornost i sigurnost njihovih lijekova na bazi bakterijskih lizata u odobrenoj/im indikaciji/ama te dostavljaju rezultate ispitivanja.
English: The study population should be representative for the authorised indication(s).
Croatian: Populacija ispitivanja trebala bi biti reprezentativna za odobrenu/e indikaciju/e.
English: The clinical study report should be submitted to the relevant National Competent Authorities by:
Croatian: Izvješće o kliničkom o ispitivanju treba dostaviti odgovarajućim nacionalnim nadležnim tijelima do:
English: The marketing authorisation holders shall complete the below condition, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Croatian: Nositelji odobrenja za stavljanje u promet moraju ispuniti uvjet u nastavku u navedenom roku, a nadležna tijela osiguravaju ispunjavanje sljedećih uvjeta:
English: The protocols should be agreed with the relevant NCAs.
Croatian: Protokole bi trebalo dogovoriti s relevantnim nacionalnim nadležnim tijelima.
English: The safety and effectiveness of the product has not changed.
Croatian: Sigurnost i djelotvornost proizvoda nije se promijenila.
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Obratite se našim službenicima za medije Monika Benstetter ili Martin Harvey
English: More about the closure of the manufacturing site
Croatian: Više o zatvaranju proizvodnog mjesta
English: The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014.
Croatian: Konačno mišljenje dostavljeno je Europskoj komisiji, koja je donijela pravno obvezujuću odluku 19. studenog 2014.
English: Consequently, the licence of the manufacturing site was withdrawn.
Croatian: Posljedično, povučena je dozvola za proizvodno mjesto.
English: MACI was on the market since 1998 in individual EU countries according to national procedures.
Croatian: MACI je u prometu od 1998. u pojedinim državama članicama EU-a u skladu s nacionalnim postupcima.
English: Closure of EU manufacturing site for MACI
Croatian: Zatvaranje proizvodnog mjesta u EU-u za MACI
English: Since 2013 MACI has been marketed in Denmark, Greece and the UK.
Croatian: Od 2013. MACI je u prometu u Danskoj, Grčkoj i Ujedinjenoj
English: Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met.
Croatian: Direktive 2001/83/EZ kojim se utvrđuje da odobrenje za stavljanje u promet mora biti suspendirano ako jedan od uvjeta propisanih u članku 41. (kao što je potreba za proizvodnim mjestom) više nije ispunjen.
English: • Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI.
Croatian: • Kirurzi i bolnice koje su koristile MACI obaviješteni su u lipnju 2014. da se planira zatvaranje proizvodnog mjesta za MACI u EU-u.
English: Arrangements in place for existing patients to complete their treatment
Croatian: Sporazumi na snazi kako bi postojeći bolesnici završili svoje liječenje
English: Because MACI is an advanced therapy medicine, the review was carried out by the Committee on Advanced Therapies (CAT), and was subsequently endorsed by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use.
Croatian: Budući da je MACI lijek za naprednu terapiju, pregled je proveo Odbor za napredne terapije (CAT) i kasnije potvrđen od strane Odbora za lijekove za humanu uporabu (CHMP) koji je odgovoran za pitanja vezana uz lijekove za humanu uporabu.
English: Following the closure of the manufacturing site and because EU legislation1 requires authorised medicines to have a registered manufacturing site, a review was initiated at the request of the European Commission on 10 September 2014 (under Article 20 of Regulation (EC) No 726/2004) to determine whether the marketing authorisation for MACI should be suspended or revoked.
Croatian: Nakon zatvaranja proizvodnog mjesta, a budući da propisi EU-a1 zahtijevaju da odobreni lijekovi imaju registrirano proizvodno mjesto, na zahtjev Europske komisije pokrenut je pregled 10. rujna 2014. (u skladu sa člankom 20. Uredbe (EZ) br. 726/2004) kako bi se utvrdilo treba li odobrenje za stavljanje u promet lijeka MACI suspendirati ili povući.
English: The European Medicines Agency has been working with the marketing authorisation holder since June 2014 to ensure that patients who had already started the treatment procedure were able to complete their treatment.
Croatian: Europska agencija za lijekove surađuje s nositeljem odobrenja za stavljanje lijeka u promet od srpnja 2014. kako bi se osiguralo da bolesnici koji su već započeli postupak liječenja mogu završiti svoje liječenje.
English: In addition, surgeons were asked not to start new patients on MACI.
Croatian: Nadalje, od kirurga je zatraženo da ne započinju terapiju MACI-jem kod novih
English: A letter was sent to healthcare professionals informing them of the site closure and requesting that they notify the marketing authorisation holder of those patients who wish to complete their treatment.
Croatian: Zdravstvenim djelatnicima poslano je pismo kojim ih se obavještava o zatvaranju proizvodnog mjesta i od njih se traži da obavijeste nositelja odobrenja o onim bolesnicima koji žele završiti svoje liječenje.
English: On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark.
Croatian: Dana 5. rujna 2014. nositelj odobrenja za stavljanje u promet lijeka za naprednu terapiju MACI (kultivirani karakterizirani autologni hondrociti aplicirani na matriks) zatvorio je proizvodno mjesto za taj lijek u EU-u koje se nalazi u Danskoj.
English: • The closure was due to commercial reasons and is not related to any change in the safety and
Croatian: • Zatvaranje je uslijedilo iz komercijalnih razloga, te nije povezano s bilo kakvim promjena u pogledu sigurnosti i djelotvornosti MACI-a.
English: Based on the draft opinion adopted by the CAT, the CHMP adopted a final opinion on 25 September 2014, recommending the suspension of the marketing authorisation for MACI until a new manufacturing site is registered in the EU.
Croatian: Na temelju nacrta mišljenja CAT-a, CHMP je donio konačno mišljenje 25. rujna 2014. kojim se preporučuje suspenzija odobrenja za stavljanje u promet lijeka MACI sve dok se novo proizvodno mjesto ne registrira u EU-u.
English: It was subsequently evaluated through the European Medicines Agency to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the Agency in order to obtain an EU-wide marketing authorisation; this was obtained in 2013.
Croatian: Naknadno je ocijenjen od strane Europske agencije za lijekove kako bi udovoljio propisima Europske unije za napredne terapije, koji zahtijevaju da se sve napredne terapije u državama članicama Europske unije podvrgnu evaluaciji od strane Agencije kako bi se izdalo odobrenje na razini EU-a.
English: MACI is an advanced therapy medicinal product called a ‘tissue engineered product'.
Croatian: Implantat MACI je vrsta lijeka za naprednu terapiju koji se naziva „lijek dobiven tkivnim inženjerstvom”.
English: • Patients who have already started treatment (i.e. those who have had their biopsies taken) should have been informed about the closure and should have discussed arrangements for completion of treatment with their treating surgeon.
Croatian: • Bolesnici koji su već započeli liječenje (primjerice oni kod kojih su već uzete biopsije) trebaju biti informirani o zatvaranju, te trebaju razmotriti opcije za završetak liječenja sa svojim kirurgom.
English: • New patients should be treated with a suitable alternative and surgeons should not order new
Croatian: • Nove bolesnike treba liječiti odgovarajućim alternativama, a kirurzi ne smiju naručivati nove komplete za biopsiju za MACI.
English: The closure was due to commercial reasons and the safety and effectiveness of
Croatian: Zatvaranje je bilo uslijed komercijalnih razloga, a sigurnost i djelotvornost MACI-a nije se promijenila.
English: 19 November 2014
Croatian: 19. studenog 2014. EMA/733307/2014
English: Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete
Croatian: Nakon zatvaranja proizvodnog mjesta, od nositelja odobrenja zatraženo je da pohrane ostale biopsije koje još nisu koristili kako bi dopustili moguće kasnije liječenje MACI-jem, osim ako bolesnici i njihovi kirurzi koji ih liječe nisu eksplicitno naglasili da ne žele završiti liječenje MACI-jem.
English: • The EU manufacturing site for MACI has been closed for commercial reasons and the product will remain unavailable for new patients in the EU until a new manufacturing site has been registered.
Croatian: • Mjesto proizvodnje u EU-u za MACI zatvoreno je iz komercijalnih razloga, te će proizvod ostati nedostupan za nove bolesnike u EU sve do registracije novog proizvodnog mjesta.
English: The site has now been closed and MACI remains unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Croatian: Proizvodno mjesto je zatvoreno, a MACI ostaje nedostupan za nove bolesnike u EU-u sve dok se ne registrira novo proizvodno mjesto u EU-u.
English: • The company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons explicitly indicated that they no longer wish
Croatian: • Tvrtka je postigla dogovor za pohranjivanje postojećih biopsija tako da se liječenje može završiti osim ako bolesnici i njihovi kirurzi koji ih liječe izričito ne naznače da ne žele završiti liječenje
English: MACI is unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Croatian: MACI nije dostupan u EU-u sve dok se ne registrira novo proizvodno mjesto u EU-u.