FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: MACI frigives efter positive resultater af analyser, som vurderer chondrocytternes levedygtighed, identitet, potens, minimum-celleantal, endotoxin, sterilitet før frigivelse og
English: 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.
Danish: Abnorm varus- eller valgusbelastning af det tibio-femorale led kan kompromittere implantatet og bør håndteres med korrigerende osteotomi eller lignende procedure.
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.
Danish: Hvis du pludseligt får eller for nyligt har haft en knogle- eller ledinfektion, skal din behandling med MACI udsættes, indtil din læge skønner, at du er rask.
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.
Danish: Indehaveren af markedsføringstilladelsen skal sikre sporbarheden af hvert implantat ved hjælp af entydige identifikationsnumre, der tildeles hver biopsi (biopsi-id-nummer), membran og færdige MACI-præparat (MAH-id-nummer), som beskrevet i risikostyringsplanen.
English: MACI should be implanted in a reasonably healthy joint.
Danish: MACI skal implanteres i et forholdsvis sundt led.
English: C-reactive protein increased
Danish: Forhøjet C-reaktivt protein Tab af transplantat Bruskskade
English: Marketing Authorisation Holder Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
Danish: Vericel Denmark ApS, Amaliegade 10, DK-1256 København K, Danmark
English: 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.
Danish: Der blev ikke observeret nogen signifikante forskelle i de strukturelle markører for bruskreparation mellem de to behandlingsformer vurderet ud fra International Cartilage Repair Society (ICRS) II totalscore for histologisk biopsivurdering og defektfyldningsscore vurderet med MR.
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.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen (MAH) skal opnå accept af indholdet og leveringen af uddannelsesprogrammet hos den relevante nationale myndighed forud for lanceringen af MACI i den pågældende medlemsstat.
English: Thromboprophylaxis should be administered according to local guidelines.
Danish: Tromboseprofylakse skal administreres i henhold til lokale retningslinjer.
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.
Danish: Risikofaktorer for transplantatdelaminering kan omfatte, men er ikke begrænset til, dårlig patientudvælgelse, utilstrækkelig overholdelse af anbefalet kirurgisk teknik, mangelfuld håndtering af samtidige patologiske tilstande, mangelfuld overholdelse af genoptræningsprotokollen eller
English: 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.
Danish: Den korteste periode er 6 uger, men cellerne kan også kryopræserveres og oplagres i op til 24 måneder, indtil en operationsdato er fastsat.
English: Complications may be related to MACI or to the surgical procedure, or both.
Danish: Der kan være komplikationer forbundet med MACI, med det kirurgiske indgreb eller med begge dele.
English: • That MACI is an autologous product and should only be administered to the patient that the biopsy was taken from.
Danish: • At MACI er et autologt præparat og kun må administreres til den patient, som biopsien er taget fra.
English: In rare cases the MAH will not be able to produce a MACI implant from the available cells.
Danish: I sjældne tilfælde kan MAH ikke fremstille et MACI-implantat ud fra de tilgængelige celler.
English: 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.
Danish: Der er begrænset erfaring med applikation af MACI i knæet under artroskopi, men artroskopiske teknikker kan anvendes til at applicere MACI efter den behandlende læges skøn.
English: Please inform your doctor or surgeon if you are pregnant or think you may be pregnant.
Danish: Fortæl din læge eller kirurg, hvis du er gravid eller har mistanke om, at du er gravid.
English: 6.5 Nature and contents of container and special requirement for use, administration or
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse, administration eller implantation
English: MACI will be sent to the treatment facility.
Danish: MACI sendes til behandlingsstedet.
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
Danish: Oplysninger om modtagelse, opbevaring og håndtering af MACI og klargøring til implantation, inklusive krydstjek af patientoplysninger og biopsi-id- og MACI-id-numre
English: The safety and efficacy of MACI in children less than 18 years of age have not been established.
Danish: MACIs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Denmark This leaflet was last revised in MM/YYYY
Danish: Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Danmark
English: 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).
Danish: Komplikationer forbundet med knækirurgi generelt kan inkludere dyb venetrombose (blodprop i en dyb vene) og lungeemboli (blodprop i lungen forårsaget af en blokering af en lungearterie).
English: • the graft may detach completely or partially from the defect in the joint.
Danish: • transplantatet kan løsne sig helt eller delvist fra defekten i leddet.
English: Tell your doctor or surgeon if you know you have a predisposition for bleeding or poor bleeding control following surgical procedures.
Danish: Fortæl din læge eller kirurg, hvis du ved, at du er disponeret for blødning eller dårlig blødningskontrol efter operationer.
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.
Danish: Din evne til at føre motorkøretøj eller betjene maskiner vil muligvis være begrænset under genoptræningsperioden, og du skal nøje følge din læges, kirurgs eller fysioterapeuts råd i denne
English: Other medicines and MACI
Danish: Brug af anden medicin sammen med MACI
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.
Danish: Efter implantationen skal patienten følge et hensigtsmæssigt styret, trinvist genoptræningsprogram i henhold til anbefalinger fra den behandlende læge på grundlag af MACI-genoptræningsvejledningen.
English: MACI is an autologous implant and must only be administered to the patient for whom it was manufactured.
Danish: MACI er et autologt implantat og må kun administreres til den patient, som det er fremstillet til.
English: The surgeon will organise the date for MACI implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative.
Danish: Kirurgen planlægger datoen for MACI-implantation i samråd med indehaveren af markedsføringstilladelsen (MAH) eller dennes lokale repræsentant.
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.
Danish: Aktuel klinisk og ikke-klinisk evidens tyder på, at applikation af autologe chondrocytter på kollagenmembranen fremmer proliferation og gendifferentiering af de anbragte celler og kan resultere i syntese af hyalinlignende
English: If you get any side effects, talk to your doctor, surgeon or physical therapist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, kirurg eller fysioterapeut.
English: The surgeon will organise the date for implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative.
Danish: Kirurgen planlægger datoen for implantation i samråd med indehaveren af markedsføringstilladelsen (MAH) eller dennes repræsentant.
English: In the pivotal study of MACI, patients were excluded if they had a history of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee, or concomitant inflammatory disease.
Danish: I pivotalstudiet af MACI blev patienter ekskluderet, hvis de havde kendt osteoartrose (KellgrenLawrence grad 3 eller 4) i det pågældende knæ eller samtidig inflammatorisk sygdom.
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.
Danish: Indehaveren af markedsføringstilladelsen skal forud for distribution af præparatet til en/et bestemt klinik/hospital sikre, at alle kirurger og andet sundhedspersonale, der er involveret i håndteringen og administrationen af MACI eller dets komponenter, såvel som dem, der er involveret i opfølgningen af patienter, der er blevet behandlet med MACI på hospitalet/klinikken,
English: 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.
Danish: Den behandlende kirurg klipper implantationsmatrixen, så den svarer til defektens størrelse og form, for at sikre, at det beskadigede område er helt dækket, og den implanteres med cellesiden nedad.
English: However as MACI will be implanted using invasive surgical techniques, it is not recommended during pregnancy.
Danish: Da MACI imidlertid implanteres i forbindelse med invasive kirurgiske teknikker, anbefales det ikke under
English: Table 1: KOOS Response Rate*: Full Analysis Set n (%)
Danish: Tabel 1: KOOS-responsrate*: Fuldt analysesæt MACI N=72
English: The use of MACI in elderly with generalised degeneration of the cartilage or osteoarthritis is not recommended.
Danish: Anvendelse af MACI hos ældre patienter med generaliseret degeneration af brusken eller osteoartrose anbefales ikke.
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.
Danish: Brusk er væv, som findes i alle led i kroppen; det beskytter knogleenderne og bevirker, at leddene bevæger sig smidigere.
English: • are allergic to any of the ingredients of MACI (listed in section 6), or porcine products (derived from pigs), bovine serum (a protein derived from cows) or gentamicin (an antibiotic)
Danish: • hvis du er allergisk over for MACI eller et af de øvrige indholdsstoffer (angivet i punkt 6), svineprodukter (stammende fra grise), okseserum (et protein stammende fra køer) eller
English: Local treatment guidelines regarding the use of antibiotic prophylaxis around orthopaedic surgery should
Danish: Lokale retningslinjer for antibiotikaprofylakse i forbindelse med ortopædkirurgi skal følges.
English: While oral use of pain medication is recommended for post-surgical pain relief, intra-articular administration of analgesics is not recommended as studies have shown adverse effects on articular cartilage and chondrocytes with exposure.
Danish: Orale analgetika anbefales til postkirurgisk smertelindring, hvorimod intraartikulær indgift af analgetika ikke kan anbefales, da studier har påvist skadelige virkninger på ledbrusk og chondrocytter
English: Clinical pharmacology studies have not been conducted on MACI.
Danish: Der er ikke foretaget kliniske farmakologiske studier med MACI.
English: MACI is shipped in custom-designed, sterile, sealed, clear polystyrene dishes.
Danish: MACI sendes i specialfremstillede, sterile, forseglede skåle af klar polystyren.
English: • currently suffer from inflammatory arthritis or inflammatory joint disease of the knee
Danish: • hvis du i øjeblikket lider af inflammatorisk artritis eller inflammatorisk ledsygdom i knæet
English: In rare cases the cell processing facility will not be able to produce MACI from your cells.
Danish: I sjældne tilfælde kan vævscentret ikke fremstille MACI ud fra dine celler.
English: 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.
Danish: Implantation af MACI udføres under anvendelse af sterile kirurgiske teknikker og kræver både klargøring af defekten og anvendelse af fibrinklæber på defektens bund og kant for at sikre, at implantatet sidder godt fast.
English: MACI is not recommended in patients with a total menisectomy unless the meniscal deficiency can be addressed with a staged or concurrent meniscal graft.
Danish: MACI anbefales ikke til patienter med total menisektomi, medmindre en ny menisk kan indopereres ved en planlagt eller samtidig menisktransplantation.
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.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med MACI hos pædiatriske patienter under 18 år til reparation af symptomatiske bruskdefekter i knæet (se pkt.
English: Store below 37°C in the outer carton until ready to use.
Danish: Skal opbevares ved temperaturer under 37 °C i yderemballagen, indtil det skal bruges.
English: 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
Danish: MACI er undersøgt i et parallelt, randomiseret, åbent studium hos 144 patienter med Outerbridge grad III eller IV fokale bruskdefekter på 3-20 cm2) i knæet.
English: The safe use of MACI has not been demonstrated during pregnancy or breast-feeding.
Danish: Det er ikke blevet vist, at det er sikkert at bruge MACI under graviditet og amning.
English: 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.
Danish: Brug ikke MACI efter den udløbsdato, der står på yderemballagen og skålen efter Anv.
English: Rehabilitation
Danish: Genoptræning
English: Dulbecco's Modified Eagles Medium (DMEM) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES)
Danish: Dulbecco's Modified Eagles Medium (DMEM) med natriumsaltet af 4-(2-hydroxyethyl)piperazin-1
English: Characterised viable autologous chondrocytes expanded ex vivo expressing chondrocyte-specific marker genes, seeded onto a CE marked porcine derived Type I/III collagen membrane.
Danish: Karakteriserede levedygtige autologe chondrocytter dyrket ex vivo, som udtrykker chondrocytspecifikke genmarkører, anbragt på en CE-mærket type I/III-kollagenmembran, udvundet fra svin.
English: Complications related to knee surgery in general may also include deep vein thrombosis and pulmonary embolism.
Danish: Komplikationer relateret til knæoperationer generelt kan desuden omfatte dyb venetrombose og lungeemboli.
English: 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.
Danish: MACI er indiceret til reparation af symptomatiske bruskdefekter i knæet, der går helt igennem brusken (grad III og IV på Modified Outerbridge Scale), på 3-20 cm hos voksne patienter med et fuldt
English: • Graft delamination (complete or partial, possibly leading to loose bodies in the joint or graft failure)
Danish: • Delaminering af transplantatet (komplet eller partiel, kan muligvis føre til løse dele i leddet
English: 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.
Danish: I et hestestudium observeredes der efter 3 måneder tegn på et mindre inflammatorisk respons, kendetegnet ved et let øget synovialvæskevolumen og en mindre lymfeansamling i synovium.
English: 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.
Danish: Det vil dog i gennemsnit være 6 uger, idet celler dog også kan kryopræserveres og opbevares i op til 2 år, indtil patient og kirurg har aftalt en passende
English: • difficulty breathing, chest pain and palpitations • leg swelling, leg pain and redness
Danish: • Vejrtrækningsbesvær, smerter i brystet og hjertebanken • Hævede ben, smerter i benene og rødme
English: The implant is an opaque, off-white membrane supplied in 18 ml of colourless solution in a dish.
Danish: Implantatet er en uigennemsigtig, off-white membran, der leveres i 18 ml farveløs opløsning i en skål.
English: The following important risks have been identified related to either MACI or peri-operative complications:
Danish: Følgende vigtige risici er identificeret som værende relateret til enten MACI eller
English: 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).
Danish: MACI anbefales ikke til ældre patienter over 65 år med generel nedbrydning af brusken eller osteoartritis (sygdom i leddene med smerte og hævelse).
English: The following uncommon side effect may affect up to 1 in 100 people:
Danish: Risici forbundet med implantation af MACI: Følgende ikke almindelige bivirkninger kan påvirke op til 1 ud af 100 personer:
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SKÅL
English: • The need for rehabilitation following articular cartilage repair
Danish: • Nødvendigheden af genoptræning efter ledbruskreparation
English: • Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation
Danish: • Inflammatorisk artritis, inflammatorisk ledsygdom eller medfødte koagulationsforstyrrelser,
English: When treating trochlear and patellar defects, abnormal patellar tracking must be corrected, prior to or concurrent with MACI implantation.
Danish: Ved behandling af defekter i trochlea og patella skal abnorm patellasporing korrigeres før eller samtidig med MACI-implantationen.
English: • Educational material on the surgical procedures
Danish: • Undervisningsmateriale om kirurgiske procedurer • Undervisningsmateriale om passende opfølgning
English: Each dish is sealed in a gamma-irradiated clear plastic bag.
Danish: Hver skål er forseglet i en gammabestrålet, klar plastpose.
English: Pharmacotherapeutic group: Other Medicines for Disorders of the Musculo-Skeletal system, ATC code: M09AX02
Danish: Farmakoterapeutisk klassifikation: Andre lægemidler til sygdomme i bevægeapparatet, ATC-kode:
English: The biopsy will be sent to the cell processing facility.
Danish: Biopsien sendes til vævscentret.
English: Package leaflet: Information for the user MACI 500,000 to 1,000,000 cells/cm2 for implantation
Danish: Indlægsseddel: Information til brugeren MACI 500.000 til 1.000.000 celler/cm til implantation
English: For implantation.
Danish: Ødem på implantationsstedet
English: The administered dose corresponds to 500,000 to 1,000,000 autologous cells/cm of implantation matrix.
Danish: Den administrerede dosis svarer til 500.000 til 1.000.000 autologe celler/cm implantationsmatrix.
English: Each implant contains matrix applied characterised autologous cultured chondrocytes.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert implantat indeholder matrix-applicerede karakteriserede dyrkede autologe chondrocytter.
English: During the first procedure, a sample of healthy cartilage tissue (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Danish: Under den første procedure tages en prøve af sundt bruskvæv (en biopsi) fra det berørte led under artrotomi eller artroskopi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, OUTER BAG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDEREMBALLAGE, YDERPOSE
English: Graft delamination refers to a loosening, either partial or total, of the graft from the subchondral bone and from the surrounding cartilage.
Danish: Transplantatdelaminering er en hel eller delvis løsning af transplantatet fra den subkondrale knogle og den omgivende brusk.
English: Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the
Danish: Selv hvis kirurgen allerede har taget en lille prøve af bruskceller (en biopsi), som er nødvendig for at fremstille MACI-implantatet, er det muligt, at du ikke vil være kvalificeret til behandling med
English: To create a favourable environment for healing, concomitant pathologies must be addressed prior to or concurrent with implantation of MACI.
Danish: For at skabe gunstige forhold for heling skal samtidige patologiske tilstande klarlægges før eller samtidig med implantationen af MACI.
English: 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.
Danish: Da MACI imidlertid implanteres i forbindelse med invasive kirurgiske teknikker, skal der træffes beslutning om, hvorvidt amning skal afbrydes under hensyn til de behandlingsmæssige fordele for
English: If this occurs, the surgeon will advise the patient on the best course of action.
Danish: Hvis det sker, vil kirurgen rådgive patienten om, hvad der bedst kan gøres.
English: If this happens, your surgeon will advise you on the best course of action.
Danish: Hvis det sker, vil din kirurg rådgive dig om, hvad der er den bedste løsning for dig.
English: Talk to your doctor or surgeon if you are breast-feeding.
Danish: Tal med din læge eller kirurg, hvis du ammer.
English: Medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe, og er forbeholdt brug på særlige, specialiserede afdelinger (se bilag I: Produktresumé, pkt.