FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Obvestite zdravnika, kirurga ali fizioterapevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
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
Slovenian: Kirurg ali anestezist vam bosta razložila tveganja, povezana s postopki, ter morebitna dodatna tveganja, ki so pri vas možna zaradi vaše zdravstvene zgodovine ali trenutnega zdravstvenega stanja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
English: • the biopsy is of insufficient quality to produce MACI for you
Slovenian: • biopsija ni ustrezne kakovosti za izdelavo zdravila MACI za vas,
English: You may require more surgery to correct this
Slovenian: Morda bo potreben dodatni poseg, da se to popravi.
English: Return to sporting activity should be personalised in consultation with healthcare professionals.
Slovenian: Vrnitev k športnim aktivnostim je odvisna od vsakega posameznika v dogovoru z zdravstvenim osebjem.
English: There are no known risk groups or specific risk factors for graft hypertrophy in patients treated with MACI.
Slovenian: Ni znanih rizičnih skupin ali specifičnih dejavnikov tveganja za hipertofijo presadka pri bolnikih, zdravljenih z MACI.
English: Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic
Slovenian: Epinefrin ali fibrinsko lepilo (glejte poglavje 4.5), varčno naneseno neposredno na točke krvavitve, je primerno hemostatično
English: This should include specified or staged physical activity in order to minimise the likelihood of arthrofibrosis and graduated partial weight-bearing.
Slovenian: To naj vključuje specificirano ali vodeno fizično aktivnost, da se zmanjša verjetnost artrofibroze, in postopno delno obremenjevanje.
English: Keep MACI in the outer carton until ready to use.
Slovenian: Zdravilo MACI shranjujte v zunajni ovojnini, dokler ni pripravljeno na uporabo.
English: MACI N=72
Slovenian: Zdravilo MACI N = 72
English: • Patients with a femoral epiphyseal growth plate that is not fully closed.
Slovenian: • Bolniki s femoralno epifizo rastne ploščice, ki se še ni povsem zaprla.
English: • Educational material on the surgical procedures
Slovenian: • Izobraževalno gradivo o kirurških postopkih
English: Infective arthritis Wound infection Localised infection
Slovenian: Infekcijske in parazitske bolezni infekcijski artritis okužba rane lokalizirana okužba
English: • Cruciate ligament instability: the joint should not possess excessive laxity.
Slovenian: • Nestabilna križna vez: sklep ne sme biti pretirano ohlapen.
English: Please discuss with your doctor or physical therapist when to re-start specific physical activities.
Slovenian: Z zdravnikom ali fizioterapevtom se posvetujte, kdaj lahko ponovno začnete izvajati specifične fizične
English: Driving and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.
Slovenian: Vožnja in uporaba strojev sta lahko v obdobju rehabilitacije omejeni, v tem obdobju pa morate dosledno upoštevati nasvet zdravnika, kirurga ali fizioterapevta.
English: A small amount of blood (4 ml) will be taken by a qualified person for testing.
Slovenian: Usposobljena oseba vam bo odvzela majhno količino krvi (4 ml) za preiskave.
English: The use of MACI in this age group has not been studied.
Slovenian: Uporabe zdravila MACI v tej starostni skupini niso preučili.
English: In some cases, it may occur that source chondrocytes of the patient are not expandable or that the release criteria (see section 6.6) are not met due to poor biopsy quality, patient characteristics, or manufacturing failure.
Slovenian: V nekaterih primerih se lahko zgodi, da izvirnih hondrocitov bolnika ni mogoče razmnožiti, ali da kriteriji za sprostitev (glejte poglavje 6.6) niso izpolnjeni zaradi slabe kakovosti biopsije, značilnosti bolnika ali neuspelega postopka izdelave.
English: There are no data on possible effects of MACI treatment on fertility.
Slovenian: Podatkov o možnih učinkih zdravljenja z zdravilom MACI na plodnost ni.
English: What MACI is and what it is used for
Slovenian: Kaj je zdravilo MACI in za kaj ga uporabljamo
English: Complications may be related to MACI or to the surgical procedure, or both.
Slovenian: Zapleti so lahko povezani z zdravilom MACI ali s kirurškim postopkom ali z obema.
English: MACI should be used within 6 days after the date of release.
Slovenian: Zdravilo MACI morate porabiti v roku 6 dni od datuma sprostitve.
English: The use of MACI is not recommended in children and adolescents below 18 years.
Slovenian: Zdravilo MACI se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Depending on your particular situation, your doctor or surgeon will advise you on whether or not to continue breast-feeding.
Slovenian: Glede na vašo individualno situacijo vam bo zdravnik ali kirurg svetoval, ali naj nadaljujete ali prekinete z dojenjem.
English: The Marketing Authorisation Holder (MAH) shall agree the content and the delivery of the Educational Program with the National Compentent Authority prior to the launch of MACI in that Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) se mora glede vsebine in razdeljevanja izobraževalnega programa dogovoriti z nacionalnim pristojnim organom (NPO) pred začetkom uporabe zdravila MACI v tej državi članici.
English: Peri-operative complications related to surgical intervention of the knee:
Slovenian: Peri-operativni zapleti, povezani s kirurškim posegom na kolenu:
English: Patient: (name - date of birth {DD.Mmm.YYYY}) Biopsy: {biopsy number} Matrix: 1/1
Slovenian: Bolnik: (ime - datum rojstva {DD mmm LLLL})
English: The following uncommon side effect may affect up to 1 in 100 people:
Slovenian: Naslednji občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
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.
Slovenian: Celotna razslojitev presadka je resen zaplet, pri katerem lahko bolnik doživi blokado, bolečino in oteklino po akutni deformaciji kolena.
English: Please inform your doctor or surgeon if you are pregnant or think you may be pregnant.
Slovenian: Obvestite zdravnika, če ste noseči, ali menite, da bi lahko bili noseči.
English: The following rare side effects may affect up to 1 in 1,000 people:
Slovenian: Naslednji redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
English: The biopsy will be sent to the cell processing facility.
Slovenian: Vzorec biopsije se nato pošlje v laboratorij za obdelavo celic.
English: Your doctor will discuss with you the specific rehabilitation programme that follows your surgery.
Slovenian: S kirurgom se boste posvetovali o posebnem rehabilitacijskem programu, ki sledi operaciji.
English: The defect bed should be debrided only down to the subchondral plate and not through it.
Slovenian: Debriment ležišča okvare naredimo do subhondralne plošče in ne skozi njo.
English: • The need for rehabilitation following articular cartilage repair
Slovenian: • Potreba po rehabilitaciji po popravilu sklepnega hrustanca.
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.
Slovenian: Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem
English: • Graft delamination (complete or partial, possibly leading to loose bodies in the joint or graft failure)
Slovenian: • razslojitev presadka (popolna ali delna, kar lahko povzroči prosta telesa v sklepu ali neuspeh
English: Ask your doctor or surgeon for more information as to which pain medicine you can safely use.
Slovenian: Svojega zdravnika ali kirurga vprašajte, katera protibolečinska zdravila lahko varno uporabljate.
English: • Guidance on the selection of suitable patients for MACI treatment and the importance of using MACI only in the approved indication
Slovenian: • Navodila za izbiro primernih bolnikov za zdravljenje z zdravilom MACI in pomen uporabe zdravila MACI samo v odobreni indikaciji.
English: The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect.
Slovenian: Količina uporabljenega zdravila MACI je odvisna od velikosti (površina v cm2) okvare hrustanca.
English: Non-clinical in vitro investigations have shown that the collagen membrane is non-cytotoxic, nonmutagenic, non-reactive (short- and long-term implantation), non-sensitising, a negligible irritant, and non-toxic (acute systemic).
Slovenian: Neklinične raziskave in vitro kažejo, da kolagenska membrana ni citotoksična, ni mutagena, ni reaktivna (kratkoročna in dolgoročna vsaditev), ne povzroča senzibilizacije, da povzroča zanemarljivo draženje in da ni toksična (akutna sistemska).
English: Each dish contains 1 implantation matrix, held in place by a green polycarbonate x-ring and closed with a green polycarbonate cover for shipment.
Slovenian: V vsaki posodi je 1 matriks za implantacijo, ki je pritrjen z zelenim x-obročkom iz polikarbonata, zaprta pa je z zelenim pokrovom iz polikarbonata za transport.
English: Following implantation, the patient should follow an appropriately controlled, phased rehabilitation programme as recommended by the treating physician based on the MACI Rehabilitation Manual.
Slovenian: Po vsaditvi se mora bolnik udeležiti ustrezno nadziranega rehabilitacijskega programa, razdeljenega v faze, kot priporoča lečeči zdravnik na podlagi rehabilitacijskega priročnika za zdravilo MACI.
English: Marketing Authorisation Holder Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
Slovenian: Imetnik dovoljenja za promet z zdravilom Vericel Denmark ApS, Amaliegade 10, DK-1256 Kopenhagen K, Danska
English: Due to limited experience, the use of MACI in joints other than the knee is not recommended.
Slovenian: Zaradi omejenih izkušenj se uporaba zdravila MACI pri drugih sklepih, razen za koleno, ne priporoča.
English: Based on the exposure of more than 6,000 patients to MACI treatment in the knee, complications may be related to the arthrotomy procedure, general complications related to surgical intervention, other knee pathology (such as ligamentous or meniscal pathology), or the biopsy procurement.
Slovenian: Na podlagi izpostavljenosti zdravljenju kolena z zdravilom MACI pri več kot 6.000 bolnikih so lahko zapleti povezani s postopkom artrotomije, splošnimi zapleti, povezanimi s kirurškim posegom, drugimi patologijami kolena (kot je patologija vezi ali meniskusov) ali postopkom biopsije.
English: MACI is shipped following a validated rapid microbial sterility assay to determine absence of microbial growth.
Slovenian: Zdravilo MACI se pošlje po potrjenem hitrem testu mikrobne sterilnosti, s katerim se potrdi odsotnost mikrobne rasti.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti sledljivost vsakega vsadka s pomočjo edinstvene identifikacijske številke, dodeljene vsaki biopsiji (ID-številka biopsije), membrani in končnemu zdravilu MACI (ID-številka MAH), kot je opisano v načrtu obvladovanja tveganja.
English: The pharmacokinetic behaviour of MACI is related to the resorption of the collagen membrane, a proteolytic process performed by cells in the vicinity of the defects.
Slovenian: Farmakokinetično vedenje zdravila MACI je povezano z resorpcijo kolagenske membrane, kar je proteolitični proces, ki ga izvajajo celice v bližini okvare.
English: Details on the receipt, storage and handling of MACI and its preparation for implantation, including cross checks of patient details and Biopsy ID and MACI product ID numbers
Slovenian: Podrobnosti o prejemu, shranjevanju in ravnanju z zdravilom MACI in o njegovi pripravi za implantacijo, vključno z navzkrižnim preverjanjem podatkov bolnikov, IDštevilko biopsije in ID-številko zdravila MACI.
English: The median age of patients was 34 to 35 years (age range: 18 to 54), and the mean body mass index was 26.
Slovenian: Povprečna starost bolnikov je bila 34 do 35 let (razpon: 18 do 54), povprečni indeks telesne mase je bil 26.Večina bolnikov je imela vsaj 1 predhodno ortopedsko operacijo kolena.
English: Non-clinical data based on implantation of MACI in rabbits and horses did not reveal any special hazard
Slovenian: Neklinični podatki na osnovi vsaditve zdravila MACI kuncem in konjem ne kažejo posebnega
English: Like all medicines, MACI can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo MACI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The patient's haemostatic functions should be screened prior to surgery.
Slovenian: Bolnikove hemostatske funkcije je treba preveriti pred kirurškim posegom.
English: This means that other problems in the joint should be corrected before or during MACI implantation.
Slovenian: To pomeni, da je treba vse druge težave sklepa popraviti pred ali med vsaditvijo zdravila MACI.
English: • Malalignment: the tibio-femoral joint should be properly aligned.
Slovenian: • Neporavnanost: tibiofemoralni sklep mora biti pravilno poravnan.
English: By 6 months, these signals had subsided, resulting in a normal synovial appearance.
Slovenian: Pri 6 mesecih so ti znaki izzveneli, sinovija pa je dobila normalen videz.
English: Implantation of MACI is to be performed during arthrotomy under sterile conditions.
Slovenian: Vsaditev zdravila MACI se izvede med artrotomijo v sterilnih pogojih.
English: Your surgeon will organise the date for implantation.
Slovenian: Kirurg bo določil datum za
English: The safety and efficacy of MACI in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila MACI pri otrocih, starih do 18 let, nista bili dokazani.
English: • have a growth plate of the knee that is not fully closed.
Slovenian: • če rastna plošča v kolenu še ni povsem zaprta.
English: What MACI is and what it is used for What you need to know before you use MACI How to use MACI
Slovenian: Kaj je zdravilo MACI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo MACI
English: Your MACI implant has been manufactured specifically for you and cannot be administered to any other patient.
Slovenian: Zdravilo MACI je bilo izdelano posebej za vas, zato se ga ne sme dati drugim bolnikom.
English: Your surgeon will explain what arthrotomy and athroscopy
Slovenian: Kirurg vam bo razložil postopek artrotomije in atroskopije.
English: If positive sterility results are obtained, the treating physician will be contacted to discuss either cancellation of the implantation or a plan of action based on the patient-specific circumstances and risk assessment.
Slovenian: Če so rezultati sterilnost pozitivni, bo lečeči zdravnik o tem obveščen in se bo odločil za odpoved vsaditve ali za načrt ravnanja na podlagi okoliščin, specifičnih za bolnika, in ocene tveganj.
English: The following important risks have been identified related to either MACI or peri-operative complications:
Slovenian: Opredelili so naslednja pomembna tveganja, ki so povezana bodisi z zdravilom MACI bodisi z zapleti po operaciji:
English: • Details of appropriate disposal of MACI implant trimmings or unused MACI implants
Slovenian: • Podrobnosti o ustreznem odstranjevanju obrezlin vsadka MACI ali neuporabljenih vsadkov
English: You may also be given antibiotics or pain-killers to help reduce some of the side effects.
Slovenian: Morda boste prejeli antibiotike ali zdravila proti bolečinam, ki vam bodo pomagala lajšati nekatere neželene učinke.
English: Both anterior and posterior cruciate ligaments should be stable or undergo reconstruction to reduce shearing forces and rotation stresses across the joint.
Slovenian: Anteriorna in posteriorna križna vez morata biti stabilni ali pa ju je treba rekonstruirati, da se zmanjšajo strižne sile in napetost pri kroženju sklepa.
English: MACI is an implant consisting of a porcine derived (derived from pigs) collagen membrane which contains your own cartilage cells (called autologous chondrocytes) and is implanted into your knee.
Slovenian: Zdravilo MACI je vsadek, sestavljen iz kolagenske membrane (pridobljen iz prašičev), ki vsebuje vaše lastne hrustančne celice (imenovane avtologni hondrociti), ki se vsadi v vaše koleno.
English: During the rehabilitation period that follows MACI treatment patients should refer to their treating physician and follow their advice.
Slovenian: V obdobju rehabilitacije, ki sledi zdravljenju z zdravilom MACI, je treba bolnike napotiti k lečečemu zdravniku po nasvet, ki ga morajo upoštevati.
English: How to use MACI
Slovenian: Kako uporabljati zdravilo MACI
English: • the graft may detach completely or partially from the defect in the joint.
Slovenian: • vsadek se lahko povsem ali delno odcepi od okvare v sklepu.
English: Graft delamination refers to a loosening, either partial or total, of the graft from the subchondral bone and from the surrounding cartilage.
Slovenian: Razslojitev presadka pomeni zrahljanje, bodisi delno ali v celoti, presadka od subhondralne kosti in od okoliškega hrustanca.
English: Other complications have been identified as causally related to MACI.
Slovenian: Ugotovili so druge zaplete, ki so vzročno povezani z zdravilom MACI.
English: MACI is intended for autologous use only.
Slovenian: Zdravilo MACI je namenjeno samo za avtologno uporabo.
English: Visit 10 (Week 104) Unstratified
Slovenian: 10. obisk (104. teden) Stratificirano glede na center Odzivni Neodzivni Manjkajoči 10. obisk (104. teden)
English: MACI will be released following successful results from assays which assess chondrocyte viability, identity, potency, minimum cell number, endotoxin, pre-release sterility, and mycoplasma.
Slovenian: Zdravilo MACI sprostijo za uporabo po uspešnih rezultatih testov, ki ocenjujejo viabilnost hondrocitov, identiteto, zmožnost, minimalno število celic, endotoksine, sterilnost pred sprostitvijo in
English: Adverse reactions are listed by System Organ Class and frequency.
Slovenian: Neželeni učinki so našteti po organskih sistemih in pogostnosti.
English: MACI is not recommended for pregnant women.
Slovenian: Zdravilo MACI se ne priporoča za nosečnice.
English: However as MACI will be implanted using invasive surgical techniques, it is not recommended during pregnancy.
Slovenian: Vendar pa vsaditev zdravila MACI poteka z uporabo invazivne kirurške tehnike, zato se je med nosečnostjo ne priporoča.
English: If you have a sudden occurrence or recent history of bone or joint infections, your MACI treatment should be temporarily delayed until your doctor considers that you have recovered.
Slovenian: Če se vam nenadno pojavi ali ste pred kratkim imeli okužbo kosti ali sklepa, bo zdravljenje z zdravilom MACI začasno preloženo, dokler zdravnik ne oceni, da ste okrevali.
English: The membrane is resorbed over the months following implantation.
Slovenian: Membrana se v nekaj mesecih po vsaditvi
English: For information on preparation and handling of MACI, please refer to section 6.6.
Slovenian: Za informacije o pripravi zdravila MACI in ravnanju z njim glejte poglavje 6.6.
English: Your surgeon will give you more information on any special considerations for your particular case.
Slovenian: Kirurg vam bo posredoval nadaljnje informacije o posebnih zadevah, ki se nanašajo na vas osebno.
English: Please consult the Surgical Technique Manual for further information.
Slovenian: Za nadaljnje informacije glejte priročnik s kirurškimi tehnikami.
English: Symptomatic graft hypertrophy is acomplication that may occur with MACI.
Slovenian: Simptomatska hipertrofija presadka je zaplet, ki se lahko pojavi pri uporabi zdravila MACI.
English: MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
Slovenian: Zdravilo MACI mora vsaditi kirurg, ki je posebej izurjen in usposobljen za uporabo zdravila MACI.
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.
Slovenian: Hrustanec je tkivo, ki ga najdemo v vsakem sklepu v telesu; ščiti skrajne dele kosti in omogoča gladko
English: MACI should be implanted in a reasonably healthy joint.
Slovenian: Zdravilo MACI se vsadi v sorazmerno zdrav sklep.
English: Four patients were treatment failures in the microfracture treatment arm, versus one in the MACI treatment arm.
Slovenian: Pri štirih bolnikih zdravljenje ni uspelo v kraku zdravljenja s postopkom mikrofrakture, v primerjavi z enim v kraku zdravljenja z zdravilom MACI.
English: The MAH shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of MACI or its components, as well as those involved in follow-up of patients treated with MACI in the Healthcare Establishment, receive the educational pack.
Slovenian: Imetnik dovoljenja za promet bo pred razdeljevanjem zdravila zdravstveni ustanovi zagotovil, da bodo vsi kirurgi in drugi strokovnjaki zdravstvene nege, ki uporabljajo zdravilo MACI in njegove sestavne dele, kot tudi vsi tisti, ki sodelujejo v postopku spremljanja bolnikov, ki so se zdravili z zdravilom MACI v zdravstveni ustanovi, prejeli ustrezen izobraževalni paket.
English: Tell your doctor or surgeon if you know you have a predisposition for bleeding or poor bleeding control following surgical procedures.
Slovenian: Povejte zdravniku ali kirurgu, če veste, da ste nagnjeni h krvavitvam ali se krvavitve po kirurškem posegu pri vas težko obvladajo.
English: • Details on biopsy procurement, and storage and handling of the biopsy harvest
Slovenian: • Podrobnosti o naročilu biopsije, skladiščenju in ravnanju z rezultati biopsije.
English: • bleeding in the joint
Slovenian: • krvavitev v sklepu,
English: “Autologous” means that your own cells are used which have been taken from your knee (through a biopsy) and grown outside the body.
Slovenian: »Avtologno« pomeni, da se uporabi vaše lastne celice, odvzete iz vašega kolena (z biopsijo).
English: Risks involved with implantation of MACI:
Slovenian: Tveganja, povezana z vsaditvijo zdravila MACI:
English: Due to the surgical nature of the underlying procedure, implantation with MACI has a major influence on the ability to drive and use machines.
Slovenian: Zaradi kirurške narave osnovnega procesa ima vsaditev zdravila MACI pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: • Meniscal pathology: unstable or torn meniscus requires repair, replacement, or partial meniscectomy.
Slovenian: • Patologija meniskusa: nestabilen ali strgan meniskus, ki ga je treba popraviti, zamenjati ali izvesti delno meniscektomijo.
English: Current clinical and nonclinical evidence suggests that delivery of autologous chondrocytes on the collagen membrane promotes proliferation and re-differentiation of seeded cells, and may result in synthesis of hyaline-like cartilage repair tissue.
Slovenian: Trenutni klinični in predklinični dokazi kažejo, da nanos avtolognih hondrocitov na kolagensko membrano spodbuja proliferacijo in ponovno diferenciacijo nacepljenih celic, in lahko povzroči sintezo hialinu podobnega tkiva, ki obnovi