FrancophonIA/ELRC3.0 huggingface dataset:
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: It can also be caused by repetitive trauma, as a result of overweight or due to incorrect weight-bearing on the knee as a result of a knee deformity.
Danish: Den kan også forårsages af gentagne traumer som følge af overvægt eller pga. ukorrekt vægtbelastning
English: Patients with lesions larger than 5 cm² have been treated under compassionate use only.
Danish: Patienter med læsioner på over 5 cm² blev kun behandlet under programmet med særlig udleveringstilladelse.
English: Fibrin glues are routinely used in ACI procedures to seal the outside margins and to improve the water-tightness of the compartment of the biological membrane used to cover the defect.
Danish: Fibrinlim anvendes rutinemæssigt ved ACI-procedurer til forsegling af de ydre grænser og til forbedring af vandtætheden af området under den biologiske membran, som anvendes til at dække læsionen.
English: ChondroCelect consists of autologous cultured cartilage cells.
Danish: ChondroCelect består af autologe dyrkede bruskceller.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot {lot number}
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: Pain in extremity, Peripheral neuropathy, Syncope,
Danish: Smerter i ekstremiteter Perifer neuropati Synkope
English: Therefore it can occur that ChondroCelect cannot be delivered.
Danish: Det kan derfor ske, at ChondroCelect ikke kan leveres.
English: • Obligation to conduct post-authorisation measures Not applicable.
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af
English: Cases in which ChondroCelect cannot be supplied
Danish: Tilfælde, hvor ChondroCelect ikke kan leveres
English: Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins.
Danish: Karakteriserede, levedygtige, autologe bruskceller, opformeret ex vivo, som udtrykker specifikke markørproteiner.
English: ChondroCelect is intended solely for autologous use.
Danish: ChondroCelect er udelukkende beregnet til autolog brug.
English: The MAH shall perform the pharmacovigilance activities as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: At this time point 41 patients were evaluated in the ChondroCelect arm and 49 were evaluated in the microfracture arm.
Danish: På dette tidspunkt blev 41 patienter evalueret i ChondroCelect-armen, og 49 blev evalueret i mikrofrakturarmen.
English: You can recognize most of the joint- related side effects if you have symptoms like pain, snapping, grinding, locking, swelling, bending limitations and stiffness in the knee.
Danish: De fleste af de ledrelaterede bivirkninger giver symptomer som smerter, knækken, knasen, fastlåsning, hævelse, bøjningsbegrænsninger og stivhed i knæet.
English: Common side effects ( affects in 1 to 10 users in 100) include: restriction of knee motion (arthrofibrosis, decreased joint range of motion, decreased mobility), excessive amount of joint fluid in the joint (joint effusion), joint lock, joint inflammation (arthritis, bursitis, synovitis), cavity filled with fluid in the knee (bone cyst, synovial cyst), bone swelling, cartilage disorder (chondropathy), benign bony growth (exostosis), blood in a joint (haemarthrosis), joint instability, joint stiffness, loose body in joint, weakening of muscle (muscle atrophy, Trendelenburg's sign), degenerative joint disorder (osteoarthritis), tendon disorder, inflammation of the tendon (tendonitis), impaired healing, treatment failure, gait disturbance, implant site hypersensitivity, peripheral edema, fever (pyrexia), postoperative wound complication (wound site reaction) ,wound infection (including erysipelas), redness, scar overgrowth, itching, scar pain, wound loosening, wound secretion loosening of the graft or membrane (graft complication, graft delamination), injury (cartilage injury, joint injury), blood clot in the deep vein of the leg (deep vein thrombosis), large bruise (haematoma), superficial vein inflammation (phlebitis), nausea, pain or nerve disorder (pain in extremity, peripheral neuropathy, complex regional pain syndrome, autonomic neuropathy), syncope, apnea, arthroscopy.
Danish: Almindelige bivirkninger (påvirker 1 til 10 ud af 100 brugere) omfatter: begrænsning af knæets bevægelighed (artrofibrose, reduceret bevægelsesområde i leddet, nedsat mobilitet), stor mængde ledvæske i leddet (ledeffusion), fastlåsning af led, betændelse i leddet (artritis, bursitis, synovitis), hulrum fyldt med væske i knæet (knoglecyste, synovialiscyste), knoglehævelse, brusklæsion (chondropati), godartet gevækst på knoglen (exostose), blodudtrædning i leddet (hæmartrose), ustabilitet i leddet, ledstivhed, løs genstand i leddet, svækkelse af musklen (muskelatrofi, Trendelenburgs symptom), degenerativ ledlæsion (osteoartritis), senelæsion, senebetændelse (tendonitis), forsinket heling, fejlslagen behandling, gangforstyrrelse, overfølsomhed på implantationsstedet, perifert ødem, feber (pyreksi), sårkomplikation efter operation (reaktion i sårområdet), sårinfektion (inklusive rosen), rødme, ar-tilgroning, kløe, arsmerte, løsning af sår, sårsekretion, løsning af transplantatet eller membranen (transplantatkomplikation, transplantatløsning), læsion (brusklæsion, ledlæsion), blodprop i benets dybe vene (dyb venøs trombose), stor blodudtrædning (hæmatom), overfladisk årebetændelse (flebitis), kvalme, smerte eller nervelidelse (smerter i ekstremiteter, perifer neuropati, komplekst regionalt smertesyndrom, autonom neuropati), synkope, apnø, artroskopi.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og
English: Complete joint haemostasis must be achieved prior to membrane fixation and cell implantation.
Danish: Fuldstændig hæmostase i leddet skal sikres inden fastgørelse af membranen og implantation af celler.
English: Concomitant knee problems like early osteoarthritis, osteochondritis dissecans (OCD), instability of the knee, cartilage lesions at other locations than the femoral condyle, lesions of knee ligaments or of the meniscus, varus or valgus malalignment (abnormal weight distribution in the knee), and inflammatory joint disease are potential complicating factors.
Danish: Ledsagende knæproblemer som tidlig osteoartritis, osteochondritis dissecans (OCD), ustabilitet i knæet, brusklæsioner andre steder end i femurkondyl, læsioner i knæets ligament eller i menisken, varus eller valgus malalignmentsyndrom (unormal vægtfordeling i knæet) og inflammatoriske ledsygdomme er potentielle komplicerende faktorer.
English: ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only.
Danish: ChondroCelect skal indgives af en velkvalificeret kirurg og er udelukkende til hospitalsbrug.
English: This cartilage sample will be used to make ChondroCelect.
Danish: Denne bruskprøve vil blive brugt til fremstilling af ChondroCelect.
English: Using fibrin glue in the defect bed instead of stitches to secure the implant resulted in an overall poor outcome, suggesting the need for a direct contact of the implanted cells with the defect bed
Danish: Brug af fibrinklæber på det defekte underlag frem for sting til at fastgøre implantatet, gav generelt dårlige resultater, hvilket bekræfter behovet for direkte kontakt mellem de implanterede celler og det defekte underlag.
English: - ChondroCelect should be implanted in an otherwise healthy knee.
Danish: - ChondroCelect bør implanteres i et knæ, der på andre områder er rask.
English: ChondroCelect is therefore not recommended for use in children and adolescents below 18 years.
Danish: Derfor anbefales ChondroCelect ikke til børn og unge under 18 år.
English: If the ChondroCelect vial is damaged or its sterility has been compromised, the product must not be used and must be shipped back to TiGenix.
Danish: Hvis hætteglasset med ChondroCelect er beskadiget, eller det ikke længere er sterilt, må lægemidlet ikke anvendes, og det skal sendes tilbage til
English: Hypertrophic scar, Postoperative wound complication, Pruritus,
Danish: Hypertrofiske ar Postoperativ sårkomplikation Pruritus
English: After the 5 year follow-up period, 37 patients were evaluated in the ChondroCelect arm and 40 in the microfracture arm.
Danish: Efter en opfølgningsperiode på 5 år blev 37 patienter i ChondroCelect-armen og 40 i mikrofraktur-armen evalueret.
English: Autonomic neuropathy, Complex regional pain syndrome,
Danish: Autonom neuropati Komplekst regionalt smertesyndrom
English: - If you have an acute or recent history of bone or joint infections, you should be temporary deferred until documented recovery.
Danish: - Hvis du har en akut knogle- og ledinfektion eller har haft en sådan infektion for nylig, bør du vente, indtil det er dokumenteret, at du rask.
English: Limited clinical data on exposed pregnancies are available.
Danish: Der foreligger kun begrænsede kliniske data om eksponeringen for autologe bruskceller under graviditet.
English: It protects the ends of our bones and allows our joints to function smoothly.
Danish: Det beskytter knogleenderne og gør det muligt for
English: Tendon disorder, Tendonitis
Danish: Senelidelser Tendonitis
English: There are no data on possible effects of ChondroCelect treatment on fertility.
Danish: Der foreligger ingen data om eventuel påvirkning af fertilitet ved ChondroCelect-behandling.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING White screw top container
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Beholder med hvidt skruelåg
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikat ioner
English: In this technique, a good fixation using stitches on the edges of the collagen membrane is required, in order to assure a direct contact of the implanted cells with the defect bed.
Danish: Der kræves ved denne teknik god fiksering ved hjælp af sting på kanten af kollagen-membranen for at sikre direkte kontakt mellem de implanterede celler og det defekte underlag.
English: Before re-suspension the cells are settled to the bottom of the container forming an off-white layer and the excipient is a clear colourless liquid.
Danish: Før resuspension ligger cellerne på bunden af beholderen og danner et råhvidt lag, og hjælpestoffet er en klar, farveløs væske.
English: ChondroCelect 10,000 cells/microlitre implantation suspension.
Danish: ChondroCelect 10.000 celler/mikroliter suspension til implantation.
English: Details and information on the appropriate rehabilitation schedule is provided in the ChondroCelect user manual.
Danish: Nærmere oplysninger om den tilpassede genoptræningsplan findes i brugermanualen for
English: During open-knee surgery, the cartilage cells are implanted into the cartilage defect.
Danish: Under åben knækirurgi implanteres bruskcellerne i bruskdefekten.
English: - The other ingredient is sterile, buffered Dulbecco's Modified Eagles Medium (DMEM), a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial.
Danish: Det andet indholdsstof er steril Dulbecco's Modified Eagles Medium (DMEM) behandlet med buffer, en væske indeholdende aminosyrer, vitaminer, salte og kulhydrater til opbevaring af cellerne i hætteglasset.
English: Visit 2: ChondroCelect implantation
Danish: Besøg 2: implantering af ChondroCelect
English: Treatment failure in the ChondroCelect group was generally related to delamination of the graft.
Danish: Behandlingssvigt i ChondroCelect-gruppen skyldtes hovedsagelig delaminering af transplantatet.
English: In a study in sheep, the majority of animals showed penetration of the transplanted cells in subchondral bone; in two of these cases complete penetration of underlying bone marrow was observed.
Danish: I en undersøgelse forekom der hos størstedelen af dyrene penetration af de transplanterede celler i den subchondrale knogle.
English: Due to the surgical nature of the underlying procedure, implantation with ChondroCelect has a major influence on the ability to drive and use machines.
Danish: På grund af procedurens kirurgiske karakter har ChondroCelect stor indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the product, it is possible that you will not be eligible for treatment with ChondroCelect.
Danish: Andre tilfælde, hvor ChondroCelect ikke kan leveres Selv om kirurgen allerede har udtaget en lille prøve af bruskcellerne (en biopsi), der er nødvendig for at kunne fremstille medicinen, er det muligt, at du ikke vil kunne behandles med ChondroCelect.
English: The Marketing Authorisation Holder (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 ChondroCelect or its components, as well as those involved in followup of patients treated with ChondroCelect in the healthcare establishment, receive training as per the educational programme described in the risk management plan.
Danish: • Yderligere risikominimeringsforanstaltninger Forud for udleveringen af lægemidlet til en bestemt sundhedsinstitution skal indehaveren af markedsføringstilladelsen sikre, at følgende personer modtager uddannelse som anført i uddannelsesprogrammet, der er beskrevet i risikostyringsplanen: Alle kirurger og andet sundhedspersonale, som er inddraget i håndteringen og administrationen af ChondroCelect og komponenterne heri, samt de personer, som er inddraget i opfølgningen af de patienter, der er blevet behandlet med ChondroCelect i sundhedsinstitutionen.
English: The vials are placed in a sterile falcon tube with a plastic screw top.
Danish: Hætteglassene anbringes i et sterilt falconglas med et plastikskruelåg.
English: Most of the reported adverse reactions were expected as related to the open-knee surgical procedure..
Danish: De fleste af de indberettede bivirkninger var forventede, da de er forbundet med åben knækirurgi.
English: ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.
Danish: ChondroCelect er kun beregnet til autolog anvendelse og bør administreres i forbindelse med debridement, en fysisk forsegling af læsionen (anbringelse af en biologisk membran, helst en
English: For information on preparation and handling of ChondroCelect, please refer to section 6.6.
Danish: I afsnit 6.6 findes der oplysninger om forberedelse og håndtering af ChondroCelect.
English: 6.5 Nature and contents of container and special equipment for use, administration or
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse,
English: Each vial contains 0.4 ml of autologous human cartilage cells suspension and is closed with a chlorobutyl stopper and aluminium seal.
Danish: Hvert hætteglas indeholder 0,4 ml autologe humane bruskceller i en cellesuspension og er lukket med en chlorbutylprop og en aluminiumsforsegling.
English: ChondroCelect was compared to the procedure of microfracture in the repair of symptomatic single cartilage lesions of the femoral condyles of the knee.
Danish: ChondroCelect blev sammenlignet med proceduren mikrofraktur i forhold til reparation af enkelte symptomatiske brusklæsioner i knæets femurkondyl.
English: Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
Danish: Før indgivelse bør ChondroCelect resuspenderes ved forsigtigt at banke på hætteglasset for at
English: Very common side effects (affects more than 1 user in 10) include: joint pain (arthralgia), overgrowth of cartilage cells (cartilage hypertrophy), crackling or clicking sensation when articulating the knee (joint crepitation), and joint swelling.
Danish: Meget almindelige bivirkninger (påvirker mere end 1 ud af 10brugere) omfatter: ledsmerte (artralgi), for kraftig vækst af bruskceller (bruskhypertrofi), knasende eller klikkende fornemmelse, når knæet bøjes (krepitation) og hævelse af led.
English: The falcon tube is placed in a plastic screw top container together with surgery materials (one sterile syringe of 1 ml, one 18G intravenous catheter and two pieces of Vicryl 6.0) and a temperature monitor.
Danish: Falconglasset anbringes i en beholder med plastikskruelåg sammen med det kirurgiske materiale (en steril sprøjte på 1 ml, et 18G intravenøst kateter og to stykker Vicryl 6.0 sutur)
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER
English: Patients with acute or recent history of bone or joint infections should be temporary deferred until documented recovery.
Danish: Behandling med ChondroCelect af patienter med akutte knogle- og ledinfektioner eller patienter, som har haft sådanne infektioner for nylig, bør udsættes midlertidigt, indtil patienterne er dokumenteret raske.
English: Treatment with ChondroCelect: a two-step procedure.
Danish: Behandling med ChondroCelect foregår ad to omgange
English: Do not use ChondroCelect if you: are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
Danish: Er allergisk over for nogen af indholdsstofferne i ChondroCelect (angivet i punkt 6) Lider af fremskreden osteoartritis (degenerativ ledsygdom) i knæet.
English: Given the local nature of ChondroCelect adverse reactions on the nursing infant are not anticipated.
Danish: I betragtning af ChondroCelects lokale karakter, forventes der ingen bivirkninger for det ammende barn.
English: Arthrofibrosis
Danish: • Artrofibrose
English: The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding.
Danish: Sikker brug af ChondroCelect under graviditet og amning er ikke blevet undersøgt.
English: Driving cars and using machines may be limited during the rehabilitation period.
Danish: Evnen til at føre motorkøretøj eller betjene maskiner kan være begrænset i
English: Depending on the location, the size of the lesion and the patient's profile, appropriate rehabilitation instructions have been developed.
Danish: Der er udarbejdet passende genoptræningsinstrukser afhængigt af læsionens placering og størrelse samt patientens profil.
English: - ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
Danish: - ChondroCelect anbefales ikke til reparation af bruskdefekter andre steder end i knæets femurkondyl.
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect
Danish: LÆGEMIDLETS NAVN ChondroCelect
English: ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
Danish: ChondroCelect anvendes til reparation af enkelte symptomatiske bruskdefekter i knæets femurkondyl hos voksne.
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension
Danish: LÆGEMIDLETS NAVN ChondroCelect 10.000 celler/mikroliter suspension til implantation
English: Sixteen patients below 18 years have been treated with ChondroCelect under compassionate use.
Danish: 16 patienter under 18 år er blevet behandlet med ChondroCelect under programmet med særlig udleveringstilladelse.
English: Method of administration For implantation.
Danish: Administration Til implantation
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Danish: 2.1 Generel beskrivelse
English: Wound dehiscence, Wound secretion
Danish: Arsmerte Sårruptur Sårsekretion
English: Wound infection, Erysipelas, Erythema,
Danish: Sårinfektion Erysipelas Erytem
English: Reporting of side effect
Danish: Tabel over bivirkninger
English: If the surgeon decides that treatment with ChondroCelect is appropriate for you, he/she will take a small sample of cartilage cells (a biopsy) from your knee.
Danish: ChondroCelect er egnet til dig, vil han/hun udtage en lille prøve af bruskcellerne (en biopsi) fra dit knæ.
English: Uncommon side effects (affects in 1 to 10 users in 1,000 include: anxiety, dermal and visual hypersensitivity ), migraine, mini stroke (transient ischaemic attack), fat entering the circulatory system (fat embolism), vein blockage and inflammation (thrombophlebitis), blockage in a lung artery (lung embolism), itching scar, pain at the front of the knee (chondromalacia), breakdown of knee tissue (gonartrhosis, atrophy), discomfort, chronic inflammation (granulomatous lesion).
Danish: Ikke almindelige bivirkninger (påvirker 1 til 10 ud af 1.000 brugere) omfatter: angst, dermal og visuel overfølsomhed, migræne, mindre slagtilfælde (forbigående iskæmisk anfald), fedt, der kommer ind i kredsløbet (fedtemboli), åreblokering og -betændelse (tromboflebitis), blokering af lungearterien (lungeemboli), kløende ar, smerte foran på knæet (chondromalaci), nedbrydning af knævæv (gonartrose, atrofi), ubehag, kronisk betændelse (granulomatøs læsion).
English: There are no data on the use of ChondroCelect during breast-feeding.
Danish: Der foreligger ingen data om brugen af ChondroCelect under amning.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Danish: ATC kode: M09AX02
English: Impaired healing, Implant site hypersensitivity, Peripheral edema, Pyrexia
Danish: Ineffektivt lægemiddel Gangforstyrrelser Helingsvanskeligheder Overfølsomhed på implantationsstedet Perifert ødem Pyreksi
English: Keep the product vial(s) within the falcon tube in the plastic screw top container in order to protect from light and bacterial/fungal contamination.
Danish: Opbevar produkthætteglasset i falconglasset i beholderen med plastikskruelåg for at beskytte det mod lys og bakterie/svampekontaminering.
English: Arthroscopy
Danish: Artroskopi
English: Keep the product vial(s) within the falcon tube in the outer plastic screw top container in order to protect from light and bacterial/fungal contamination.
Danish: Opbevar produkthætteglasset/-ene i falconglasset i den ydre beholder med plastikskruelåg for at beskytte det mod lys og bakterie/svampekontaminering.
English: This finding might be related to the inability to perform a progressive loading under nonweight bearing conditions post-surgery in these models and therefore cannot be fully extrapolated as such to the human situation.
Danish: Dette resultat kan hænge sammen med den manglende mulighed for at udføre en gradvis belastning under ikke-vægtbærende forhold efter kirurgi i disse modeller og kan derfor ikke ekstrapoleres fuldstændigt til at gælde for mennesker.En teknisk variant af ACI-proceduren er cellepodningsmetoden, hvor cellerne podes på en kollagen-membran inden implantation.
English: ChondroCelect is intended solely for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI).
Danish: ChondroCelect er udelukkende beregnet til autolog bruskreparation og indgives ved hjælp af en ACI (Autolog Chondrocyt Implantation)-teknik.