natgillin/translations-raw huggingface dataset:
The use of MACI in elderly with generalised degeneration of the cartilage or osteoarthritis is not recommended. 
Uporaba zdravila MACI pri starejših bolnikih z generalizirano degeneracijo hrustanca ali osteoartritisom ni priporočljiva.
However as MACI will be implanted using invasive surgical techniques, a decision must be made whether to discontinue breastfeeding taking into account the benefits of treatment for the woman and the risk to the infant. 
Ker pa poteka vsaditev zdravila MACI z uporabo invazivne kirurške tehnike, se je treba odločiti, ali naj mati z dojenjem preneha, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
MACI is not recommended in patients with a total menisectomy unless the meniscal deficiency can be addressed with a staged or concurrent meniscal graft. 
Zdravila MACI se ne priporoča pri bolnikih s popolno meniscektomijo, razen če je mogoče okvaro meniskusa obravnavati z zaporednim ali sočasnim presadkom meniskusa.
MACI is an autologous implant and must only be administered to the patient for whom it was manufactured. 
Zdravilo MACI je avtologni vsadek, ki ga lahko dobi le bolnik, za katerega je bil izdelan.
Abnormal varus or valgus loading of the tibio-femoral joint may jeopardise the implant and should be addressed with a corrective osteotomy or similar procedure. 
Obremenitev tibiofemoralnega sklepa zaradi nenormalnega varusa ali valgusa lahko ogrozi vsadek, zato jo je treba obravnavati s korekcijsko osteotomijo ali podobnim postopkom.
There is limited experience with delivery of MACI to the knee via arthroscopy, however, arthroscopic techniques may be used to apply MACI at the discretion of the treating physician. 
Izkušnje z vstavitvijo zdravila MACI v koleno z artroskopijo so omejene, vendar pa se po presoji lečečega zdravnika lahko uporabijo artroskopske tehnike za vsaditev zdravila MACI lahko uporabijo.
There were no indications of gross inflammatory 
Znakov večje vnetne reakcije ni bilo.
INFORMATION IN BRAILLE Justification for not including Braille accepted 
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
• difficulty breathing, chest pain and palpitations • leg swelling, leg pain and redness 
• težko dihanje, bolečine v prsih in razbijanje srca (palpitacije), • otekanje noge, bolečina v nogi in rdečica.
Dulbecco's Modified Eagles Medium (DMEM; Calcium Chloride anhydrous, Ferric Nitrate.9H2O, Potassium Chloride, Magnesium Sulphate anhydrous, Sodium Chloride, Sodium Bicarbonate, Potassium Phosphate Monobasic.H2O, D-Glucose, L-Arginine.HCl, L-Cystine.2HCl, L-Glutamine, Glycine, L-Histidine.HCl.H2O, L-Isoleucine, L-Leucine, L-Lysine.HCl, L-Methionine, L-Phenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine.2Na.2H2O, L-Valine, D-Calcium Pantothenate, Choline Chloride, Folic Acid, i-Inositol, Niacinamide, Riboflavin, Thiamine.HCl, Pyridoxine.HCl) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES) adjusted for pH with HCl or NaOH and osmality with NaCl. 
Eaglov medij, modificiran po Dulbeccu (DMEM; Dulbecco's Modified Eagles Medium; brezvodni kalcijev klorid, železov nitrat.9H2O, kalijev klorid, brezvodni magnezijev sulfat, natrijev klorid, natrijev bikarbonat, monobazični kalijev fosfat.H2O, D-glukoza, L-arginin.HCl, L-cistin.2HCl, Lglutamin, glicin, L-histidin.HCl.H2O, L-izolevcin, L-levcin, L-lizin.HCl, L-metionin, L-fenilalanin, L
The use of MACI is not recommended in patients over 65 years of age who have generalised degeneration of the cartilage or osteoarthritis (disease of the joints with pain and swelling). 
Uporaba zdravila MACI se ne priporoča pri bolnikih, starejših od 65 let z generalizirano degeneracijo hrustanca ali osteoartritisom (boleznijo bolečih in oteklih sklepov).
Possible side effects 
Ti učinki se
There were no significant differences observed in the structural markers of cartilage repair between both treatments, as assessed by International Cartilage Repair Society (ICRS) II overall assessment histology scores of biopsies, and MRI defect fill scores. 
Značilnih razlik v strukturnih markerjih obnovljenega hrustanca med obema skupinama niso opazili, kar so ocenili s splošnim rezultatom histološkega rezultata biopsij po Mednarodni organizaciji za zdravljenje hrustanca (ICRS II, International Cartilage Repair Society) in rezultatu zapolnjenja okvare na MRI.
Missing * KOOS Response Rate: Responder is defined as an improvement of the Knee Injury and Osteoarthritis Outcome Score from baseline of minimal 10 points of a scale of 100. 
* Stopnja odziva po lestvici KOOS: Kot odzivni bolnik je opredeljen bolnik z izboljšanjem izida poškodbe kolena in osteoartritisa od izhodiščne vrednosti za vsaj 10 točk na 100-točkovni lestvici.
Implantation of MACI is performed using sterile surgical techniques and requires both the preparation of the defect bed and the application of fibrin sealant to the base and rim of the defect in order to secure the implant. 
Vsaditev zdravila MACI se izvede s sterilno kirurško tehniko in zahteva pripravo ležišča okvare in uporabo fibrinskih lepil na bazi in robu območja okvare, da se vsadek dobro pritrdi.
Given the local nature of the medicinal product, adverse reactions of MACI on pregnancy are not anticipated. 
Zaradi lokalne narave zdravila neželenih reakcij zaradi zdravila MACI na nosečnost ne pričakujemo.
In rare cases the cell processing facility will not be able to produce MACI from your cells. 
V redkih primerih v laboratoriju za obdelavo celic ne bodo uspeli izdelati zdravila MACI iz vaših celic.
To create a favourable environment for healing, concomitant pathologies must be addressed prior to or concurrent with implantation of MACI. 
Da ustvarite ugodno okolje za celjenje, je treba sočasne patologije obravnavati pred vsaditvijo zdravila MACI ali sočasno.
Complications related to knee surgery in general may also include deep vein thrombosis and pulmonary embolism. 
Zapleti, na splošno povezani z operacijo kolena, lahko vključujejo globoko vensko trombozo in pljučno embolijo.
Complications related to knee surgery in general may include deep vein thrombosis (blood clotting in a deep vein) and pulmonary embolism (blood clotting in the lung due to blockage of a lung artery). 
Zapleti, ki so v splošnem povezani z operacijo kolena, lahko vključujejo globoko vensko trombozo (krvne strdke v globokih venah) in pljučni embolizem (krvni strdek v pljučih zaradi zamašitve pljučne arterije).
Therefore, it may occur that MACI cannot be delivered. 
Zato se lahko zgodi, da zdravila MACI ne bo mogoče
A rabbit study demonstrated that at 3 months post-implantation, minimal numbers of inflammatory cells were present in the vicinity of the defect, with variable chondrogenesis. 
Študija pri kuncih je dokazala, da je bilo v 3 mesecih po vsaditvi prisotno minimalno število vnetnih celic v bližini okvare s spremenljivo hondrogenezo.
The final MACI implant will be sent back to your surgeon. 
Končni vsadek zdravila MACI se vrne kirurgu.
Thromboprophylaxis should be administered according to local guidelines. 
Tromboprofilakso je treba dati v skladu z lokalnimi smernicami.
If you notice any of the following, please contact your doctor immediately, since these may be symptoms of blood clotting: 
Če opazite katero koli od naslednjih stanj, se nemudoma posvetujte z zdravnikom, saj so lahko to
• have severe osteoarthritis of the knee (disease of the joints with pain and swelling) 
• če imate hud osteoartritis kolena (bolezen bolečih in oteklih sklepov);
• That MACI is an autologous product and should only be administered to the patient that the biopsy was taken from. 
• Da je zdravilo MACI avtologni izdelek in da se uporablja le pri bolnikih, ki so jim z biopsijo odvzeli hrustanec.
The implantation matrix is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down. 
Kirurg obreže matriks za vsaditev na velikost in obliko okvare, pri čemer zagotovi, da je poškodovani predel v celoti prekrit in da je stran z vsajenimi celicami obrnjena navzdol.
What MACI looks like and contents of the pack 
Izgled zdravila MACI in vsebina pakiranja
• Educational material on appropriate follow-up The educational material for surgeons and other healthcare professionals involved in the surgical treatment of patients receiving MACI shall include the following key messages: 
• Izobraževalno gradivo o ustreznem postopku spremljanja bolnika Izobraževalno gradivo za kirurge in drugo zdravstveno osebje, ki je odgovorno za kirurško zdravljenje bolnikov z zdravilom MACI, mora vsebovati naslednja ključna sporočila:
Characterised viable autologous chondrocytes expanded ex vivo expressing chondrocyte-specific marker genes, seeded onto a CE marked porcine derived Type I/III collagen membrane. 
Karakterizirani viabilni avtologni hondrociti, ekspandirani ex vivo, ki izražajo hondrocitsko specifične markerske gene, nacepljeni na kolagensko membrano tipa I/III, pridobljeno iz prašiča, z oznako CE.
• Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation 
• Vnetni artritis, vnetna bolezen sklepov ali nekorigirane prirojene motnje strjevanja krvi.
MACI will be sent back to the surgeon. 
Zdravilo MACI bo vrnjeno kirurgu.
• If you have any further questions, ask your doctor, surgeon or physical therapist. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, kirurgom ali fizioterapevtom.
• have a known, uncorrected bleeding disorder 
• če imate neobravnavano motnjo strjevanja krvi;
Cases in which MACI cannot be supplied 
Primeri, ko zdravila MACI ni mogoče priskrbeti
The minimum amount of time is 6 weeks; however, cells can also be cryopreserved and held in storage for up to 24 months until a surgical date is established. 
Najkrajši čas je 6 tednov, vendar pa je mogoče celice z liofilizacijo shraniti do 24 mesecev, dokler se ne določi dan posega.
On average this will be 6 weeks, however, cells can also be frozen and held in storage for up to 2 years until a convenient date for surgery is agreed between you and your surgeon. 
To povprečno traja 6 tednov, vendar pa je mogoče celice zamrzniti za obdobje do 2 let, dokler se s kirurgom ne dogovorite za ustrezen datum operacije.
Typical clinical pharmacokinetic (ADME) studies have not been performed on MACI. 
Z zdravilom MACI niso opravili običajnih kliničnih farmakokinetičnih študij (ADME).
MACI has been investigated in a parallel, randomised, open-label trial in 144 patients with Outerbridge Grade III or IV focal cartilage defects of the knee of 3-20 cm 
Zdravilo MACI so preučili v paralelnem, randomiziranem, odprtem preskušanju s 144 bolniki s fokalno okvaro hrustanca kolena III. ali IV. stopnje po Outerbridgu, velikosti 3-20 cm
Your surgeon can explain these to you. 
Kirurg vam bo razložil tveganja.
• Hypersensitivity to any of the excipients listed in section 6.1, or porcine products, or any residual component carried over from manufacture of MACI, including bovine serum, and gentamicin. 
• Preobčutljivost na katero koli pomožno snov, navedeno v poglavju 6.1, pripravke iz prašičev ali preostanke snovi, ki nastanejo v postopku izdelave zdravila MACI, vključno z govejim
Medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas (see Annex I: Summary of Product Characteristics, section 4.2). 
Zdravilo je namenjeno uporabi samo za določena specialistična zdravljenja (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje
This package is enclosed in an outer carton insulated with ambient gel packs. 
To pakiranje je spravljeno v zunanjo škatlo, izolirano z gelnimi vložki okoliške temperature.
Any spillage or waste material should be disposed as surgical waste material in compliance with local practice. 
Razlit ali odpadni material odstranite kot kirurški odpadni material v skladu z lokalno prakso.
In a horse study, signs of a minor inflammatory response, characterised by a slight increase in synovial fluid volume and a mild lymphoid accumulation in the synovium, were observed at 3 months. 
V študiji s konji so pri 3 mesecih opazili znake manjše vnetne reakcije, za katero je bilo značilno manjše zvišanje količine sinovijske tekočine in blago limfoidno kopičenje v sinoviji.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGAIN
MACI must only be implanted by surgeons who have been specifically trained for this kind of surgery. 
Zdravilo MACI lahko vsadijo le za to vrsto posegov posebej usposobljeni kirurgi.
On average this will be 6 weeks, however, cells can also be cryopreserved and held in storage for up to 2 years until a convenient date for surgery is agreed between the patient and surgeon. 
To povprečno traja 6 tednov, vendar pa je mogoče celice shraniti z liofilizacijo za obdobje do 2 let, dokler se kirurg in bolnik ne dogovorita za ustrezen dan za operacijo.
Each dish is sealed in a gamma-irradiated clear plastic bag. 
Vsaka posoda je zatesnjena v prozorni plastični vreči, obsevani z gama žarki.
Administration of pain relievers into the joint is not recommended. 
Dajanje protibolečinskih blokad v sklepe ni priporočljivo.
Dulbecco's Modified Eagles Medium (DMEM) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES) 
Eaglov medij, modificiran po Dulbeccu (DMEM) s 4-(2-hidroksietil)piperazin-1-etansulfonska kislina
The timing between the removal of the biopsy and MACI implantation can vary depending on logistical factors in addition to the quality and number of cells obtained from the biopsy. 
Časovni razmik med odvzemom biopsije in vsaditvijo zdravila MACI se razlikuje glede na logistične dejavnike in glede na kakovost in število celic, pridobljenih v biopsiji.
The implant is an opaque, off-white membrane supplied in 18 ml of colourless solution in a dish. 
Vsadek je neprozorna, belkasta membrana, na voljo v 18-mililitrski brezbarvni raztopini v posodici.
MACI is supplied in 1 to 2 dishes, which are placed into a 95kPa pouch (outer bag) with absorbent material for transport. 
Zdravilo MACI je na voljo v 1 do 2 posodah, ki sta spravljeni v vrečo (zunanja vreča) s 95 kPa z
Any unused medicinal product or waste material should be disposed of as surgical waste in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material zavrzite kot kirurški odpadek v skladu z lokalnimi predpisi.
Do not use MACI after the expiry date which is stated on the outer carton and the dish after EXP. Do not refrigerate or freeze. 
Zdravila MACI ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in posodici poleg oznake EXP.
The length of time between your biopsy and the implantation of MACI can vary depending on the procedure date and the quality and number of cells in the biopsy. 
Čas med biopsijo in vsaditvijo zdravila MACI se razlikuje glede na datum postopka in kakovost števila celic v biopsiji.
MACI is used in adults to repair cartilage defects in your knee joint. 
Zdravilo MACI se uporablja pri odraslih za zdravljenje okvar hrustanca v kolenskem sklepu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, OUTER BAG 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA, ZUNANJA VREČA
Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control. 
Pooperativna hemartroza se pojavi predvsem pri bolnikih, nagnjenih h krvavitvam, ali pri neustreznem kirurškem nadzoru krvavitve.
Name and address of the manufacturer of the biological active substance Genzyme Biosurgery ApS 
Ime in naslov izdelovalca biološke zdravilne učinkovine
The surgeon will organise the date for MACI implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative. 
Kirurg bo določil dan za ponovno vsaditev zdravila MACI v dogovoru z imetnikom dovoljenja za promet ali njegovim lokalnim predstavnikom.
MACI is indicated for the repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm in skeletally mature adult patients. 
Zdravilo MACI je indicirano za popravljanje simptomatskih okvar kolenskega hrustanca po vsej debelini (III. in IV. stopnje Modificirane lestvice Outerbridge, angl. Modified Outerbridge Scale) v pri odraslih bolnikih z zrelim okostjem.
If this occurs, the surgeon will advise the patient on the best course of action. 
V tem primeru bo kirurg bolniku svetoval najprimernejši nadaljnji potek.
Infections and infestations 
• okužba,
The surgical procedure will have a major impact on your ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Kirurški poseg bo bistveno vplival na vašo sposobnost vožnje ali upravljanja strojev.
What you need to know before you use MACI Do NOT use MACI if you: 
Kaj morate vedeti, preden boste uporabili zdravilo MACI
In rare cases the MAH will not be able to produce a MACI implant from the available cells. 
V redkih primerih imetnik dovoljenja za promet ne bo uspel izdelati vsadka zdravila MACI iz razpoložljivih celic.
When treating trochlear and patellar defects, abnormal patellar tracking must be corrected, prior to or concurrent with MACI implantation. 
Pri zdravljenju trohlearnih in patelarnih okvar je treba nenormalno sledenje pogačice popraviti pred vsaditvijo zdravila MACI ali sočasno ob vsaditvi.
• currently suffer from inflammatory arthritis or inflammatory joint disease of the knee 
• če imate trenutno vnetni artritis ali vnetno bolezen kolenskega sklepa;
Conventional reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the medicinal product. 
Zaradi narave in nameravane klinične uporabe zdravila običajne študije vpliva na razmnoževanje in razvojno toksičnost niso relevantne.
Each implant contains matrix applied characterised autologous cultured chondrocytes. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak vsadek vsebuje na matriks nanesene karakterizirane avtologne gojene hondrocite.
If you get any side effects, talk to your doctor, surgeon or physical therapist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, kirurgom ali fizioterapevtom.
The surgeon will organise the date for implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative. 
Kirurg bo določil dan za vsaditev zdravila MACI po dogovoru z imetnikom dovoljenja za promet z zdravilom ali njegovim lokalnim predstavnikom.
Clinical pharmacology studies have not been conducted on MACI. 
Običajne farmakološke študije za zdravilo MACI niso bile izvedene.
At the surgeon's discretion, a few interrupted absorbable sutures may also be used to provide 
Za dodatno varnost lahko kirurg po lastni presoji uporabi nekaj prekinjenih razgradljivih šivov.
Pharmacotherapeutic group: Other Medicines for Disorders of the Musculo-Skeletal system, ATC code: M09AX02 
Farmakoterapevtska skupina: druga zdravila za zdravljenje motenj mišično-skeletnega sistema, oznaka
Each implantation matrix consists of characterised autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of 500,000 to 1,000,000 cells per cm2, to be trimmed by the surgeon to the size and shape of the defect. 
Vsak matriks za implantant sestavljajo karakterizirani avtologni hondrociti na 14,5 cm² kolagenske membrane tipa I/III, z gostoto 500.000 do 1.000.000 celic na cm2, kirurg ga obreže glede na velikost
Store below 37°C in the outer carton until ready to use. 
Do začetka uporabe shranjujte v zunanji ovojnini pri temperaturi do 37 °C do začetka uporabe.
• The importance of explaining to the patients: o The risks asociated with the surgical procedures and MACI o The need for clinical follow-up o The need for rehabilitation following articular cartilage repair 
o tveganja, ki so povezana s kirurškimi posegi in zdravilom MACI; o pomen rehabilitacije po popravilu sklepnega hrustanca.
The implant is an opaque, off-white membrane, seeded with chondrocytes, supplied in 18 ml of colourless solution in a dish. 
Vsadek je neprozorna, belkasta membrana, nacepljena s hondrociti, na voljo v 18-mililitrski
If this happens, your surgeon will advise you on the best course of action. 
V tem primeru vam bo kirurg svetoval najprimernejši nadaljnji potek.
• Clinical follow up details The training materials for healthcare professionals involved in the follow-up of patients treated with MACI shall include the following key messages: 
Izobraževalno gradivo za zdravstveno osebje, ki sodeluje pri spremljanju bolnikov, zdravljenih z zdravilom MACI, mora vsebovati naslednja ključna sporočila:
• If you get any side effects talk to your doctor, surgeon or physical therapist. 
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, kirurgom ali fizioterapevtom.
Posology 
POSODICA
During the first procedure, a sample of healthy cartilage tissue (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy. 
Med prvim postopkom se odvzame vzorec zdravega hrustančnega tkiva (biopsija) iz prizadetega sklepa v postopku artrotomije ali artroskopije.
The MACI implant will be secured in place using a fibrin sealant. 
Vsadek zdravila MACI se pritrdi s fibrinskim lepilom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISH 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the 
Drugi primeri, v katerih zdravila MACI ni mogoče dati Tudi če vam je kirurg že odvzel majhen vzorec hrustančnih celic (biopsijo), potrebnih za izdelavo vsadka zdravila MACI, morda ne boste primerni za zdravljenje z zdravilom MACI.
Fibrin sealants containing formaldehyde must not be used with MACI, since formaldehyde is cytotoxic to the chondrocytes. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Z zdravilom MACI se ne sme uporabljati fibrinskih lepil, ki vsebujejo formaldehid, ker je formaldehid
Talk to your doctor or surgeon if you are breast-feeding. 
Posvetujte se z zdravnikom ali kirurgom, če dojite.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je les posebnim režimom.
At the cell processing facility, your cartilage cells will be grown aseptically (free from germs) in culture, to increase the number of cells, and placed onto a sterile collagen membrane to make MACI. 
V laboratoriju za obdelavo celic bodo hrustančne celice aseptično (brez klic) razmnožili v mediju, da se poveča število celic, nato pa jih bodo nanesli na sterilno kolagensko membrano, da nastane zdravilo MACI.
The administered dose corresponds to 500,000 to 1,000,000 autologous cells/cm of implantation matrix. 
Dani odmerek ustreza 500.000 do 1.000.000 avtolognih celic/cm na matriksu za implantacijo.
MACI 500,000 - 1,000,000 cells/cm implantation matrix Matrix applied characterised autologous cultured chondrocytes 
IME ZDRAVILA MACI 500.000 - 1.000.000 celic/cm matriks za implantacijo na matriks naneseni karakterizirani avtologni gojeni hondrociti
Autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of between 500,000 and 1,000,000 cells per cm 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN avtologni hondrociti na 14,5 cm² kolagenske membrane tipa I/III, z gostoto 500.000 do 1.000.000 celic
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Risks involved with arthrotomy or arthroscopy or MACI 
Tveganja, povezana z artrotomijo, artroskopijo ali zdravilom MACI Vsi kirurški posegi so povezani z določenim tveganjem.
At this time MACI will be implanted into the cartilage defect in the affected joint via a second procedure. 
Zdravilo MACI se bo vsadilo v okvarjen hrustanec prizadetega sklepa v drugem postopku.