FrancophonIA/ELRC3.0 huggingface dataset:
English: - You should resume physical activity according to the rehabilitation plan recommended by the physical therapist.
Danish: - Du bør genoptage din fysiske aktivitet i henhold til den genoptræningsplan, som fysioterapeuten anbefaler.
English: What you need to know before you use ChondroCelect
Danish: Det skal du vide, før du begynder at bruge ChondroCelect
English: In studies in goats, mild signs of synovitis were observed in the majority of the animals, including controls at 10 weeks post surgery.
Danish: I undersøgelser af geder sås milde tegn på synovitis hos størstedelen af dyrene, herunder kontroller 10 uger efter kirurgi.
English: EXP {DD month YYYY} at {hours} CET
Danish: UDLØBSDATO EXP {DD måned ÅÅÅÅ} kl. {tidspunkt}
English: • Autologous means that your own cells are used to make ChondroCelect.
Danish: • Autolog betyder, at dine egne celler bruges til at fremstille ChondroCelect.
English: This means that other knee problems such as lesions of the knee ligament or of the meniscus should be corrected before or during ChondroCelect implantation.
Danish: Dette betyder, at andre knæproblemer som f.eks. læsioner i knæets ligament eller menisken bør korrigeres inden eller under ChondroCelect implantationen.
English: The use of fibrin glue inside the cartilage defect bed is not recommended as this may result in a significantly poorer outcome (see section 5.3).
Danish: Anvendelse af fibrinforsegling inde i det defekte underlags brusk anbefales ikke, da dette kan resultere i et væsentligt dårligere resultat (se pkt.
English: ChondroCelect is an autologous product and should under no circumstances be administered to other patients.
Danish: ChondroCelect er et autologt lægemiddel og bør under ingen omstændigheder indgives i andre patienter.
English: The marketing authorisation holder shall submit the 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.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c(7) i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for
English: Warnings and precautions Talk to your doctor, surgeon or physiotherapist before using ChondroCelect.
Danish: Advarsler og forsigtighedsregler Kontakt lægen lægen, kirurgen eller fysioterapeuten, før du bruger ChondroCelect.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om
English: Marketing Authorisation Holder: TiGenix N.V.
Danish: Indehaver af markedsføringstilladelsen TiGenix N.V.
English: In general, these side effects are quite mild and disappear in the weeks following surgery.
Danish: Disse bivirkninger er generelt ret milde og forsvinder i ugerne efter operationen.
English: Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present.
Danish: Der kan forekomme ledsagende asymptomatiske brusklæsioner (ICRS grad I eller II).
English: Do not use this medicine after the expiry date which is stated on the container and vial after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på beholderen og hætteglasset efter
English: The cells are kept alive in a small sterile vial.
Danish: Cellerne holdes i live i et lille sterilt hætteglas.
English: Upon implantation, the patient should follow an appropriate rehabilitation schedule and physical activity should be resumed as recommended by the physician.
Danish: Efter implantationen bør patienten følge en passende genoptræningsplan, og den fysiske aktivitet bør genoptages som anbefalet af lægen.
English: The nature and intended clinical use of ChondroCelect are such that conventional studies on pharmacokinetics, absorption, distribution, metabolism and elimination are not applicable.
Danish: ChondroCelects karakter og dets tilsigtede kliniske anvendelse gør, at konventionelle undersøgelser af farmakokinetik, absorption, distribution, metabolisme og elimination ikke er
English: • The femoral condyle is the end of the thigh bone, which forms part of your knee.
Danish: • Femurkondylet er enden af lårbenet, der udgør en del af dit knæ.
English: ≥1/100 to <1/10
Danish: Almindelig ≥ 1/100 til < 1/10
English: In a randomized, controlled study in the target population, 51 patients were treated with ChondroCelect.
Danish: I en randomiseret, kontrolleret undersøgelse i målgruppen blev 51 patienter behandlet med ChondroCelect.
English: Elderly population The use of ChondroCelect has not been studied in this age group.
Danish: Ældre population Brug af ChondroCelect er ikke undersøgt for denne aldersgruppe.
English: In the majority of the 370 patients included in the Compassionate Use Program, a collagen membrane instead of a periosteal flap was used to seal the defect.
Danish: Hos størstedelen af de 370 patienter, der indgik i programmet med særlig udleveringstilladelse, blev der anvendt en collagenmembran i stedet for en periosteal flap til at forsegle læsionsområdet.
English: - The use of ChondroCelect is generally not recommended when you are overweight (i.e. a Body Mass Index over 30) because it could compromise the result of the treatment.
Danish: - Brug af ChondroCelect frarådes generelt, hvis du er overvægtig (dvs. et BMI på over 30) fordi det kan kompromittere resultatet af behandlingen.
English: Full technical details on the procedures associated with this implantation technique are provided in the ChondroCelect user manual.
Danish: De fuldstændige tekniske detaljer vedrørende procedurerne i forbindelse med denne implantationsteknik findes i brugermanualen for ChondroCelect.
English: However, the concomitant use of another type of fibrin glue with a synthetic fibrinolysis inhibitor (tranexamic acid) in the pivotal clinical trial did not reveal any safety signal.
Danish: Den samtidige brug af en anden type fibrinlim med en syntetisk fibrinolyseinhibitor (tranexamsyre) i det kliniske pivotale studie afdækkede dog ingen sikkerhedssignaler.
English: Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
Danish: Reparation af enkelte symptomatiske bruskdefekter i knæets femurkondyl hos voksne (International Cartilage Repair Society [ICRS] grad III eller IV).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: • Når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: No interaction studies with any other type of fibrin glues were performed.
Danish: Der er ikke udført interaktionsundersøgelser med andre typer fibrinlim.
English: This is called ‘autologous chondrocyte implantation' (ACI).
Danish: Dette kaldes "autolog chondrocyt implantation" (ACI).
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the cartilage defect.
Danish: Mængden af celler, der skal indgives, afhænger af brusklæsionens størrelse (overfladeareal i cm²).
English: No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.
Danish: På dette tidspunkt kunne der ikke observeres en statistisk signifikant forskel i den kliniske benefit mellem ChondroCelct og mikrofraktur.
English: Patients with patellofemoral cartilage lesion, OCD, depth of lesion >0.5 cm, prior meniscal transplant, prior mosaicplasty and prior microfracture within the last 12 month were excluded.
Danish: Patienter med patellafemoral brusklæsion, OCD, læsionsdybde >0,5 cm, tidligere menisk-transplantation, tidligere mosaikplastik og tidligere mikrofraktur inden for de seneste 12 måneder blev udelukket.
English: From a pre-clinical study in the orthotopic goat model it appeared that this technique provided comparable results as the Brittberg technique, on condition that a good fixation is established using stitches on the edges of the collagen membrane.
Danish: Fra et præklinisk forsøg efter den ortotopiske gedemodel fremgik det, at denne teknik gav resultater, der var sammenlignelige med Brittberg-teknikken, under forudsætning af, at der benyttes god fiksering ved hjælp af sting på kanten af kollagen-membranen.
English: Only 907 patients have been exposed up to now, including patients treated with ChondroCelect within the clinical trials conducted to support the MA of ChondroCelect.
Danish: Kun 907 patienter har været eksponeret op til nu, inklusive patienter behandlet med ChondroCelect inden for de kliniske afprøvninger gennemført som understøttelse for markedsføringstilladelsen for ChondroCelect.
English: The median time since onset of knee injury was slightly longer in the ChondroCelect group than in the microfracture group (2.0 years versus 1.6 years).
Danish: Mediantiden fra knælæsionens indtræden var lidt længere i ChondroCelect-gruppen end i mikrofrakturgruppen (2,0 år mod 1,6 år).
English: During the ACI procedure it is important to ensure that a good, direct contact of the implanted cells with the defect bed is obtained as such contact is of paramount importance for optimal tissue regeneration.
Danish: Under ACI-proceduren er det vigtigt at sikre, at der er etableret en god, direkte kontakt mellem de implanterede celler og underlaget, da en sådan kontakt er absolut nødvendig for en optimal vævsregeneration.
English: Each pack contains an individual treatment dose consisting of 1 to 3 vials, depending on the number of cells needed to treat the specific lesion size.
Danish: Hver pakke indeholder en individuel behandlingsdosis bestående af 1 til 3 hætteglas afhængigt af det antal celler, der er nødvendigt til behandling af den pågældende læsionsstørrelse.
English: In the pivotal study of ChondroCelect, patients with these comorbidities of the knee were excluded from treatment.
Danish: I det pivotale studie af ChondroCelect blev patienter med disse co-morbiditeter i knæet udelukket fra behandling.
English: In the ChondroCelect group 77% of patients had a medial and 23% a lateral condyle defect.
Danish: I ChondroCelect-gruppen havde 77 % af patienterne en defekt i medial kondyl og 23 % en
English: More patients in the ChondroCelect treatment group, compared to patients in the microfracture group, had undergone previous knee surgery (88% versus 77%).
Danish: Flere patienter i ChondroCelect behandlingsgruppen end i mikrofrakturgruppen havde tidligere undergået knækirurgi (88 % mod 77 %).
English: In vitro interaction studies were performed with a commercially available fibrin glue containing aprotinin (a fibrinolysis inhibitor of bovine origin).
Danish: Der blev udført in vitrointeraktionsundersøgelser med fibrinlim, der er i handelen, som indeholder aprotinin (en fibrinolyseinhibitor af bovin oprindelse).
English: Overall, the clinically relevant benefit of ChondroCelect implantation observed over baseline after 36 months was maintained up to 60 months after treatment.
Danish: Generelt betragtet blev den klinisk relevante fordel i forhold til baseline ved ChondroCelect-implantationen, der var observeret efter 36 måneder, opretholdt i op til 60 måneder efter behandlingen.
English: When a collagen membrane was used to seal the lesion site after application of ChondroCelect, the incidence of cartilage hypertrophy was reported to be 1.8% compared to 25% in the randomized, controlled trial alone.
Danish: Når en collagenmembran blev anvendt til forsegling af læsionsområdet efter anvendelse af ChondroCelect, var den indberettede forekomst af bruskhypertrofi 1,8 % sammenlignet med 25 % i den randomiserede, kontrollerede undersøgelse alene.
English: Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Danish: For tidlig og for hård aktivitet kan bringe implantatet og varigheden af den kliniske fordel ved ChondroCelect i fare.
English: Conventional pharmacodynamic studies for ChondroCelect have not been performed.
Danish: Der er ikke udført konventionelle farmakodynamiske undersøgelser af ChondroCelect.
English: 51 patients were treated with ChondroCelect, 61 patients were treated with microfracture.
Danish: 51 patienter blev behandlet med ChondroCelect, 61 patienter blev behandlet med mikrofraktur.
English: However, ChondroCelect has not been evaluated in combination with collagen membranes in clinical studies, although a commercially available collagen membrane has been used in patients treated with ChondroCelect under compassionate use.
Danish: ChondroCelect er dog ikke blevet evalueret i kombination med collagenmembraner i kliniske undersøgelser, selv om en collagenmembran, der fås i handelen, er blevet anvendt til patienter behandlet med ChondroCelect i forbindelse med Compassionate Use.
English: In the subgroup of patients with recent symptom onset (< 3 years) the clinical benefit of ChondroCelect over microfracture was significantly larger, confirming the results at 36 months after treatment.
Danish: I undergruppen af patienter med nylig symptomdebut (< 3 år) var den kliniske benefit af ChondroCelect versus mikrofraktur signifikant større og bekræfter hermed resultaterne fra 36 måneder efter behandling.
English: Each product contains an individual treatment dose with sufficient number of cells to treat the predefined lesion size, as measured at biopsy procurement.
Danish: Hvert lægemiddel indeholder en individuel behandlingsdosis med et tilstrækkeligt antal celler til behandling af den på forhånd fastslåede læsionsstørrelse, som er målt ved en biopsi.
English: To keep the cartilage cells in place, a biological membrane is sewn over the defect.
Danish: For at holde bruskcellerne på plads indsys en biologisk membran over defekten.
English: In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
Danish: I kliniske undersøgelser med ChondroCelect blev der anvendt en periostflap som biologisk membran.
English: Where possible, concomitant knee problems should be corrected prior to or at the latest at the time of ChondroCelect implantation.
Danish: Hvor det er muligt, bør ledsagende knæproblemer korrigeres inden eller senest på tidspunktet for ChondroCelect-implantationen.
English: ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital.
Danish: ChondroCelect kan kun ordineres og implanteres af en ortopædkirurg på et hospital.
English: Therefore, based upon the safety profile of ChondroCelect, which requires the submission of 1yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years' time.
Danish: Baseret på sikkerhedsprofilen for ChondroCelect, der kræver indsendelse af 1-årlige PSUR'er, at indehaveren af markedsføringstilladelsen bør indsende én yderligere ansøgning om fornyelse i løbet af 5 år.
English: Prior to implantation match the patient name to the patient/donor identification on the shipment documentation and product vial.
Danish: Forud for implantationen kontrolleres patientens navn i forhold til patient-/donor-identifikationen på forsendelsespapirerne og hætteglasset med ChondroCelect.
English: Most side effects of ChondroCelect implantation are side effects related to open-knee surgery.
Danish: De fleste bivirkninger ved implantation af ChondroCelect er bivirkninger forbundet med åben knækirurgi.
English: ChondroCelect is supplied as one individual treatment dose (falcon tube) contained in 1 to 3 Type I glass vials of 1 ml.
Danish: ChondroCelect leveres som en individuel behandlingsdosis (falconglas) opbevaret i 1-3 type hætteglas på 1 ml.
English: Histological examination of the repair biopsy at 12 months showed superior structural repair in the ChondroCelect arm compared to the microfracture arm.
Danish: En histologisk undersøgelse af reparationsbiopsien efter 12 måneder viste en bedre strukturel forbedring i ChondroCelect-armen sammenlignet med mikrofrakturarmen.
English: The surgical procedure will have a major influence on your ability to drive and use machines.
Danish: Det kirurgiske indgreb vil have stor indflydelse på din evne til at føre bil eller betjene maskiner.
English: There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
Danish: Der blev konstateret en fortsat forbedring af de kliniske resultatmål KOOS (Knee Injury and Osteoarthritis Outcome Score) i op til 36 måneder i begge behandlingsarme.
English: Seven patients treated with ChondroCelect needed re-intervention, compared to 10 patients in the microfracture group.
Danish: Syv patienter, der var behandlet med ChondroCelect, havde behov for nyt indgreb sammenlignet med 10 patienter fra mikrofrakturgruppen.
English: Driving cars 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 bil eller betjene maskiner kan være begrænset i genoptræningsperioden, og du bør altid nøje følge din læges, kirurgens eller fysioterapeutens
English: Re-intervention on the treated lesion for graft delamination or periost loosening occurred in 2 of 51 patients within 36 months after ChondroCelect implantation, compared to 7 of 61 patients treated with microfracture having generally insufficient or inadequate cartilage repair.
Danish: Et nyt indgreb i læsionen, som var behandlet for transplantatløsning eller periostløsning, var nødvendig hos 2 ud af 51 patienter inden for 36 måneder efter ChondroCelect-implantationen sammenlignet med 7 ud af 61 patienter behandlet med mikrofraktur, der generelt havde en utilstrækkelig eller
English: Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1-5cm².
Danish: Dokumentationen for virkningen er baseret på en randomiseret, kontrolleret undersøgelse, der vurderede virkningen af ChondroCelect hos patienter med læsioner på mellem 1 og 5 cm2.
English: ChondroCelect must not be used in case of advanced osteoarthritis of the knee.
Danish: ChondroCelect må ikke anvendes i tilfælde af fremskreden osteoartrit i knæet.
English: The product is made from a small sample of cartilage cells (a biopsy) taken from your knee.
Danish: Lægemidlet fremstilles af en lille prøve af bruskceller (en biopsi), som tages fra dit knæ.
English: In the compassionate use patients, a higher incidence of arthrofibrosis and decreased joint range of motion was observed in a subgroup of patients with a patellar lesion (8.2% and 13.1% respectively) compared to non-patellar lesions (0.6% and 2.6% respectively).
Danish: Hos patienter omfattet af programmer med særlig udleveringstilladelse sås en højere forekomst af artrofibrose og nedsat ledbevægelighed i en undergruppe af patienter med patella-læsion (henholdsvis 8,2 % og 13,1 %) sammenlignet med læsioner, som ikke forekommer i patella (henholdsvis 0,6 % og 2,6 %).
English: In patients with a longer time since onset of symptoms, both treatments performed equally.
Danish: Hos patienter med længere tidsinterval efter symptomdebut var de 2 behandlinger lige gode.
English: During the rehabilitation period that follows treatment with ChondroCelect, patients should refer to their treating physician and follow their advice strictly.
Danish: I genoptræningsperioden efter behandlingen med ChondroCelect bør patienterne rådføre sig med den behandlende læge og nøje følge lægens
English: A technical variant of the ACI procedure is the cell seeding method, whereby the cells are seeded onto a collagen membrane prior to implantation.
Danish: En teknisk variant af ACI-proceduren er celle-injiceringsmetoden, hvor celler injiceres i en kollagen-membran forud for implantationen.
English: Tabulated list of adverse reactions They are listed by System Organ Class and frequency.
Danish: De er angivet efter systemorganklasse og hyppighed.
English: ChondroCelect is not recommended for pregnant and breast-feeding women.
Danish: ChondroCelect anbefales ikke til gravide eller ammende kvinder.
English: The adverse reactions listed are those that occurred most frequently, with treatment failure and delamination being the most serious.
Danish: De anførte bivirkninger er de hyppigst forekommende, hvoraf behandlingssvigt og
English: As ChondroCelect is used to repair a cartilage defect of the knee and is implanted with the ACI procedure using open-knee surgery, it is not recommended during pregnancy.
Danish: Da ChondroCelect anvendes til reparation af brusklæsioner i knæet og implanteres ved hjælp af ACI-teknikken under åben knækirurgi, anbefales det ikke under graviditet.
English: The training materials for surgeons shall include the following key messages and components:
Danish: Undervisningsmaterialerne for kirurger skal omfatte følgende centrale budskaber og
English: Implantation of ChondroCelect is to be performed during arthrotomy under sterile conditions and requires both preparation of the defect bed and a seal (biological membrane) to secure the implant.
Danish: Implantation af ChondroCelect foretages ved artrotomi under sterile forhold og kræver både forberedelse af det defekte leje og en forsegling (biologisk membran) til at sikre implantatet.
English: Dulbecco's Modified Eagles Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Danish: Dulbecco's Modified Eagles Medium (DMEM) (indeholdende aminosyrer, vitaminer, salte og kulhydrater).
English: Scientific publications have shown that commercially available collagen membranes can be used as an alternative to the periost in ACI procedures.
Danish: Det fremgår af faglitteraturen, at collagenmembraner, der fås i handelen, kan anvendes som alternativ til periost under ACIprocedurer.
English: An arthroscopy is performed through very small incisions in the skin, using a narrow telescope (arthroscope) to look at the inside of the knee.
Danish: En artroskopi udføres gennem et meget lille snit i huden, og en smal kikkert (artroskop) anvendes til at se ind i knæet.
English: The recommended dose of ChondroCelect is 0.8 to 1 million cells/cm², corresponding with 80 to 100 microlitre of product/cm² of defect.
Danish: Den anbefalede dosis ChondroCelect er 0,8 til 1 millioner celler/cm² svarende til 80 til 100 mikroliter af lægemidlet/cm² læsion.
English: Patients with less than 3 years since onset of symptoms (n=27 in the ChondroCelect arm and n=32 in the microfracture arm) benefited most from ChondroCelect.
Danish: Patienter, hvor der var gået mindre end 3 år siden symptomernes indtræden (n=27 i ChondroCelect-armen og n=32 i mikrofrakturarmen), havde størst effekt af ChondroCelect.
English: Fibrin sealant products differ significantly in their quantitative and qualitative composition.
Danish: Der er stor forskel på fibrin-vævsklæberes kvantitative og kvalitative sammensætning.
English: ≥1/1,000 to <1/100
Danish: Ikke almindelig ≥ 1/1.000 til < 1/100
English: ChondroCelect 10,000 cells/microlitre implantation suspension Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Danish: ChondroCelect 10.000 celler/mikroliter suspension til implantation Karakteriserede levedygtige autologe bruskceller, opformeret ex vivo, som udtrykker specifikke markørproteiner