FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using Vylaer Spiromax .
Croatian: Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka Vylaer Spiromax razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
Croatian: Držite svoj inhalator s poluprozirnim poklopcem nastavka za usta u boji crvenog vina prema dolje
English: If you forget to use Vylaer Spiromax
Croatian: Ako ste zaboravili primijeniti Vylaer Spiromax
English: Vylaer Spiromax is indicated in adults 18 years of age and older only.
Croatian: Vylaer Spiromax indiciran je samo u odraslih u dobi od 18 godina i starijih.
English: If either of these symptoms occur, stop using Vylaer Spiromax straightaway and use your ‘reliever inhaler'.
Croatian: Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Vylaer Spiromax i primijenite svoj “inhalator za brzo ublažavanje simptoma“.
English: Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Vylaer Spiromax remains optimal.
Croatian: Bolesnike mora redovito procijenjivati liječnik koji im propisuje lijekove/pružatelj zdravstvene skrbi kako bi doza inhalatora Vylaer Spiromax ostala optimalna.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Croatian: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Nizozemska
English: Asthma Using Vylaer Spiromax and a separate ‘reliever inhaler'
Croatian: Astma Primjena lijeka Vylaer Spiromax i zasebnog 'inhalatora za brzo ublažavanje simptoma'
English: When it is appropriate to titrate down to a lower strength than is available for Vylaer Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Croatian: Kad je primjereno titriranje doze na nižu jačinu od one koja je dostupna u inhalatoru Vylaer Spiromax, potrebna je promjena na drugi kombinirani lijek s fiksnom dozom budezonida i formoterol fumarata, koji sadrži nižu dozu inhalacijskog kortikosteroida.
English: The safety and efficacy of Vylaer Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Vylaer Spiromax u djece stare 12 godina i mlađe, te u adolescenata, od 13 do 17 godina nisu još ustanovljene.
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Croatian: Vylaer Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder
Croatian: Vylaer Spiromax 320 mikrograma/9 mikrograma prašak inhalata
English: Package leaflet: Information for the patient Vylaer Spiromax 320 micrograms/9 micrograms, inhalation powder
Croatian: Uputa o lijeku: Informacija za bolesnika Vylaer Spiromax 320 mikrograma/9 mikrograma prašak inhalata
English: Package leaflet: Information for the patient Vylaer Spiromax 160 micrograms/4.5 micrograms, inhalation powder
Croatian: Uputa o lijeku: Informacija za bolesnika Vylaer Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem,The Netherlands
Croatian: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Nizozemska.
English: Vylaer Spiromax pharmacokinetic profile
Croatian: Farmakokinetički profil lijeka Vylaer Spiromax
English: How to use Vylaer Spiromax
Croatian: Kako primjenjivati Vylaer Spiromax
English: How to store Vylaer Spiromax
Croatian: Kako čuvati Vylaer Spiromax
English: What you need to know before you use Vylaer Spiromax (page 5) 3.
Croatian: Što je Vylaer Spiromax i za što se koristi (stranica 3) Što morate znati prije nego počnete primjenjivati Vylaer Spiromax (stranica 5) Kako primjenjivati Vylaer Spiromax (stranica 8) Moguće nuspojave (stranica 16)
English: Vylaer Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Croatian: Vylaer Spiromax NIJE indiciran za primjenu u djece s navršenih 12 godina i mlađu niti za adolescente u dobi od 13 do 17 godina.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax.
Croatian: Kada su simptomi astme kontrolirani, može se razmotriti postupno smanjenje doze lijeka Vylaer Spiromax.
English: Vylaer Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Croatian: Vylaer Spiromax nije indiciran za primjenu u djece, u dobi od 12 godina i mlađe, niti za adolescente u dobi od 13 do 17 godina.
English: How to store Vylaer Spiromax (page 21) 6.
Croatian: Kako čuvati Vylaer Spiromax (stranica 21) Sadržaj pakiranja i druge informacije (stranica 22)
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: Vylaer Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: Vylaer Spiromax is indicated for use in adults 18 years of age and older only.
Croatian: Primjena lijeka Vylaer Spiromax indicirana je samo za odrasle u dobi od 18 i više godina.
English: If either of these symptoms occur, stop using Vylaer Spiromax straightaway and use your 'reliever inhaler' Contact your doctor immediately as you may need to have your treatment changed.
Croatian: Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Vylaer Spiromax i primijenite svoj „inhalator za brzo ublažavanje simptoma“.
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Croatian: Vylaer Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: How to store Vylaer Spiromax (page 19) 6.
Croatian: Kako čuvati Vylaer Spiromax (stranica 19) Sadržaj pakiranja i druge informacije (stranica 19)
English: Vylaer Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: Vylaer Spiromax 160 μg/4,5 μg prašak inhalata budezonid/formoterolfumarat dihidrat
English: Inhalation powder 1 inhaler containing 60 doses.
Croatian: 1 inhalator sa 60 doza.
English: Vylaer Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Vylaer Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid / formoterolfumarat dihidrat NAVOĐENJE DJELATNE/IH
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Vylaer Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat NAVOĐENJE DJELATNE/IH
English: EU/1/15/1050/001 IONSYS 40 µg/dose
Croatian: EU/1/15/1050/001 IONSYS 40 µg/doza
English: MA (EU) number (Invented) name
Croatian: MA (EU) broj
English: 80 doses per transdermal system
Croatian: 80 doza po transdermalnom sustavu
English: Immediate Packaging
Croatian: Neposredno pakiranje
English: Transdermal use sachet (nylon/alu/copoly mer of polyethylene and polymethacrylic acid)
Croatian: (najlon/aluminij/k opolimer od polietilena i polimetakrilne kiseline)
English: 6 transdermal systems
Croatian: 6 transdermalnih sustava
English: Pack size
Croatian: Veličina pakiranja
English: Older people (over 65 years of age)
Croatian: Starije osobe (u dobi iznad 65 godina)
English: Microfracture N=72
Croatian: Mikrofraktura N=72
English: DK - 2770 Kastrup
Croatian: DK - 2770 Kastrup Danska
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek jer sadrži Vama važne podatke.
English: If you notice any of the following, please contact your doctor immediately, since these may be symptoms of blood clotting:
Croatian: Ako primijetite bilo koji od sljedećih simptoma, molimo odmah se obratite svome liječniku, jer to mogu biti simptomi krvnih ugrušaka:
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: Bleeding through the subchondral plate should be avoided, but if it occurs, it must be controlled.
Croatian: Krvarenje kroz subhondralnu ploču treba izbjeći, ali ako do njega dođe, mora ga se kontrolirati.
English: You may require more surgery to correct this
Croatian: Možda će Vam trebati dodatan kirurški zahvat kako bi bi se to ispravilo.
English: • Details of the rehabilitation program
Croatian: • Detalje o programu rehabilitacije
English: Visit 10 (Week 104) Unstratified
Croatian: 10. posjet (104. tjedan) nestratificirano
English: What MACI is and what it is used for
Croatian: Što je MACI i za što se koristi
English: Seventy-two patients received MACI, and 72 were treated with microfracture.
Croatian: Sedamdeset i dvoje bolesnika primilo je MACI, a 72 liječeno je mikrofrakturama.
English: The implantation should be followed by an appropriate rehabilitation schedule (see section 4.4).
Croatian: Nakon implantacije mora uslijediti odgovarajući program rehabilitacije (vidjeti dio 4.4).
English: • the cells cannot be grown in the laboratory
Croatian: • ako se stanice ne mogu uzgojiti u laboratoriju
English: It is important that you closely follow the rehabilitation programme recommended by your doctor.
Croatian: Važno je da se strogo pridržavate programa rehabilitacije koji Vam je preporučio liječnik.
English: Your doctor may give you other medicines to help reduce any side effects (see section 2 “Warnings and precautions”).
Croatian: Liječnik Vam može dati i druge lijekove za ublažavanje bilo kakvih nuspojava (pogledajte dio 2. „Upozorenja i mjere opreza”).
English: • Details on how to recognise the signs and symptoms of important identified or potential risks of the product
Croatian: • Detalje o tome kako prepoznati znakove i simptome važnih identificiranih ili potencijalnih rizika povezanih s implantatom
English: MACI should be used within 6 days after the date of release.
Croatian: MACI se mora upotrijebiti unutar 6 dana od datuma puštanja u promet.
English: Final sterility test results are not available at the time of shipping.
Croatian: Konačni rezultati testa sterilnosti nisu dostupni u vrijeme isporuke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 June 2013
Croatian: Datum prvog odobrenja: 27. lipnja 2013.
English: Like all medicines, MACI can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, MACI može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Your doctor will discuss with you the specific rehabilitation programme that follows your surgery.
Croatian: Vaš će liječnik s Vama razgovarati o posebnom programu rehabilitacije nakon kirurškoga zahvata.
English: Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
Croatian: Budući da će se ovaj proizvod upotrijebiti tijekom kirurškog zahvata na Vašem koljenu, bolničko osoblje odgovorno je za pravilno čuvanje proizvoda prije i tijekom njegove primjene, kao i za njegovo
English: • The need to screen donors using patient questionnaires and laboratory tests for hepatitis C, hepatitis B, HIV and syphilis
Croatian: • Potrebno je napraviti probir darovatelja pomoću upitnika za bolesnike i laboratorijskih pretraga na hepatitis C, hepatitis B, HIV i sifilis
English: The median age of patients was 34 to 35 years (age range: 18 to 54), and the mean body mass index was 26.
Croatian: Medijan dobi bolesnika bio je 34 do 35 godina (dobni raspon: 18 do 54), a srednja vrijednost indeksa tjelesne mase 26.
English: The membrane is resorbed over the months following implantation.
Croatian: Membrana se resorbira mjesecima nakon implantacije.
English: Please tell your doctor, surgeon or physical therapist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika, kirurga ili fizioterapeuta ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i lijekove koje ste nabavili bez recepta.
English: What MACI looks like and contents of the pack
Croatian: Kako MACI izgleda i sadržaj pakiranja
English: Marketing Authorisation Holder Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Vericel Denmark ApS, Amaliegade 10, DK-1256 Kopenhagen K, Danska
English: Limited clinical data on exposed pregnancies are available.
Croatian: Klinički podaci o izloženosti trudnica su ograničeni.
English: The safety and efficacy of MACI in children less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost implantata MACI u djece mlađe od 18 godina nisu ustanovljene.
English: Your surgeon or anaesthetist will explain to you the risks involved with the procedures as well as any additional specific risks that are applicable to you because of your medical history and current medical
Croatian: Vaš će Vam kirurg ili anesteziolog objasniti rizike povezane sa zahvatima te sve dodatne specifične rizike primjenjive na Vas zbog Vaše povijesti bolesti i trenutnog zdravstvenog statusa.
English: Your surgeon can explain these to you.
Croatian: Kirurg Vam može objasniti te rizike.
English: What MACI contains
Croatian: Što MACI sadrži
English: 6.5 Nature and contents of container and special requirement for use, administration or
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za uporabu, primjenu ili ugradnju
English: What MACI is and what it is used for What you need to know before you use MACI How to use MACI
Croatian: Što je MACI i za što se koristi Što morate znati prije nego primite MACI
English: Please inform your doctor or surgeon if you are pregnant or think you may be pregnant.
Croatian: Obavijestite svog liječnika ili kirurga ako ste trudni ili mislite da biste mogli biti trudni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with MACI in paediatric patients from the closure of the femoral epiphyseal growth plate to less than 18 years of age.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja implantata MACI u pedijatrijskoj populaciji od zatvaranja femoralne epifizne ploče rasta do manje od 18 godina.
English: Therefore, it may occur that MACI cannot be delivered.
Croatian: Stoga se može dogoditi da se MACI ne može isporučiti.
English: Visit 10 (Week 104) Stratified by centre
Croatian: 10. posjet (104. tjedan) stratificirano
English: Your MACI implant has been manufactured specifically for you and cannot be administered to any other patient.
Croatian: Vaš MACI implantat proizveden je posebno za Vas i ne može se dati niti jednom drugom bolesniku.
English: Symptoms may include catching or pain.
Croatian: Simptomi mogu uključivati zakočenje koljena ili bol.
English: For information on preparation and handling of MACI, please refer to section 6.6.
Croatian: Za informacije o pripremi i rukovanju implantatom MACI molimo vidjeti dio 6.6.
English: Please discuss with your doctor or physical therapist when to re-start specific physical activities.
Croatian: Razgovarajte sa svojim liječnikom ili fizioterapeutom o tome kada se ponovno možete početi baviti određenim tjelesnim aktivnostima.
English: In such situations, your surgeon will be informed and might have to select an alternative treatment for
Croatian: U takvim će situacijama Vaš kirurg o tome biti obaviješten i možda će morati za Vas odabrati neko
English: The final MACI implant will be sent back to your surgeon.
Croatian: Gotov implantat MACI šalje se natrag Vašem kirurgu.
English: 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.
Croatian: Dulbecco's Modified Eagles Medium, DMEM: kalcijev klorid, bezvodni; željezov nitrat nonahidrat; kalijev klorid; magnezijev sulfat, bezvodni; natrijev klorid, natrijev hidrogenkarbonat, kalijev dihidrogenfosfat hidrat, D-glukoza, L-argininklorid, L-cistin diklorid, L-glutamin, glicin, L-histidinklorid hidrat, L-izoleucin, L-leucin, L-lizinklorid, L-metionin, L-fenilalanin, L-serin, L-treonin, L-triptofan, L-tirozin dinatrij dihidrat, L-valin, D-kalcijev pantotenat, kolin klorid, folna kiselina, i-inozitol, niacinamid, riboflavin, tiaminklorid, piridoksinklorid) s natrijevom soli 4-(2-hidroksietil)-1-piperazinetansulfonske kiseline (HEPES), čiji se pH prilagođava pomoću kloridne kiseline ili natrijevog hidroksida, a osmolalnost pomoću
English: The majority of patients had undergone at least 1 prior orthopaedic knee surgery.
Croatian: Većina bolesnika prethodno je bila podvrgnuta najmanje jednom ortopedskom kirurškom zahvatu na koljenu.
English: • Patients with a femoral epiphyseal growth plate that is not fully closed.
Croatian: • Bolesnici s nepotpuno zatvorenom femoralnom epifiznom pločom rasta.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu
English: However as MACI will be implanted using invasive surgical techniques, it is not recommended during pregnancy.
Croatian: Međutim, budući da se MACI implantira invazivnim kirurškim tehnikama, ne preporučuje se za vrijeme trudnoće.
English: • Cruciate ligament instability: the joint should not possess excessive laxity.
Croatian: • Nestabilnost križnoga ligamenta: zglob ne smije biti prekomjerno labav.
English: • the increased cells do not meet all the quality requirements.
Croatian: • ako umnožene stanice ne zadovoljavaju sve zahtjeve kakvoće.
English: MACI will be sent back to the surgeon.
Croatian: MACI se šalje natrag kirurgu.
English: The use of MACI is not recommended in children and adolescents below 18 years.
Croatian: Primjena implantata MACI ne preporučuje se u djece i adolescenata mlađih od 18 godina.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Croatian: 13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA
English: Infective arthritis Wound infection Localised infection
Croatian: Infekcije i infestacije infektivni artritis infekcija rane lokalizirana infekcija
English: Non-clinical data based on implantation of MACI in rabbits and horses did not reveal any special hazard
Croatian: Neklinički podaci temeljeni na implantaciji MACI implantata u kunića i konja nisu ukazali ni na kakvu posebnu opasnost za ljude.
English: The following rare side effects may affect up to 1 in 1,000 people:
Croatian: Sljedeće rijetke nuspojave mogu se pojaviti u manje od 1 na 1000 osoba:
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseca nakon dobivanja odobrenja.
English: A total graft delamination is a serious complication and the patient may experience locking, pain, and swelling after an acute distortion of the knee.
Croatian: Potpuna delaminacija presatka ozbiljna je komplikacija kod koje bolesnik može osjetiti zakočenje, bol i oticanje nakon akutne distorzije koljena.
English: Cartilage is a tissue that is present in every joint in the body; it protects the ends of bones and allows joints to function smoothly.
Croatian: Hrskavica je tkivo koje postoji u svakom zglobu u tijelu; ona štiti završetke kostiju i omogućuje nesmetano pokretanje
English: A small amount of blood (4 ml) will be taken by a qualified person for testing.
Croatian: Kvalificirana osoba će Vam uzeti malu količinu krvi (4 ml) za potrebe provođenje pretraga.
English: The MAH shall ensure the traceability of each implant by using unique identification numbers assigned to each biopsy (Biopsy ID number), membrane and final MACI product (MAH ID number), as described in the Risk Management Plan.
Croatian: Nositelj odobrenja će osigurati praćenje svakog implantata pomoću jedinstvenih identifikacijskih brojeva dodijeljenih svakoj biopsiji (identifikacijski broj biopsije), membrani i završnom implantatu MACI (identifikacijski broj nositelja odobrenja), kao što je opisano u Planu upravljanja rizikom.
English: Return to sporting activity should be personalised in consultation with healthcare professionals.
Croatian: Odluka o povratku sportskim aktivnostima donosi se za svakoga bolesnika pojedinačno u dogovoru sa zdravstvenim djelatnicima.
English: The surgical procedure will have a major impact on your ability to drive and use machines.
Croatian: Kirurški zahvat značajno će utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: MACI is intended for autologous use only.
Croatian: MACI je namijenjen samo za autolognu primjenu.
English: There are no known risk groups or specific risk factors for graft hypertrophy in patients treated with MACI.
Croatian: Nema poznatih rizičnih skupina niti specifičnih faktora rizika za hipertrofiju presatka u bolesnika liječenih implantatom MACI.
English: By 6 months, these signals had subsided, resulting in a normal synovial appearance.
Croatian: Do 6. su se mjeseca ti pokazatelji povukli, što je za posljedicu imalo normalan izgled sinovije.
English: • have a growth plate of the knee that is not fully closed.
Croatian: • ako Vam ploča rasta koljena nije potpuno zatvorena.
English: Risk factors for graft delamination can include but are not limited to poor patient selection, poor adherence to recommended surgical technique, failure to address concomitant pathologies, poor compliance with the rehabilitation protocol or post-operative trauma to the knee.
Croatian: Faktori rizika za delaminaciju mogu uključivati, ali nisu ograničeni na: loš odabir bolesnika, slabo pridržavanje preporučenih kirurških tehnika, izostanak liječenja istodobno prisutnih patologija, slabo pridržavanje protokola rehabilitacije ili postoperativnu traumu koljena.
English: The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect.
Croatian: Količina primijenjenoga implantata MACI ovisi o veličini (površini u cm2) oštećenja hrskavice.
English: Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Denmark This leaflet was last revised in MM/YYYY
Croatian: Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Danska Ova uputa je zadnji puta revidirana u MM/GGGG Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:
English: • have a known, uncorrected bleeding disorder
Croatian: • ako imate poznat neliječen poremećaj krvarenja