FrancophonIA/ELRC3.0 huggingface dataset:
English: Further patient scores, e.g. the International Knee Documentation Committee (IKDC; subjective evaluation of the knee) and the Lysholm score showed after 12, 24, 36, 48 and 60 months also a significant improvement in comparison to the value before treatment.
Danish: Yderligere patientresultater, f.eks. International Knee Documentation Committee (IKDC, subjektiv vurdering af knæet) og Lysholm-score, viste efter 12, 24, 36, 48 og 60 måneder ligeledes signifikant bedring i forhold til værdien før behandling.
English: Ex vivo produced spheroids were implanted in mice (subcutaneous implantation of cartilage explants with human spheroids) or in minipigs (autologous spheroids implanted in cartilage defects).
Danish: Sfæroider fremstillet ex vivo blev implanteret i mus (subkutan implantation af bruskeksplantater med humane sfæroider) eller i minigrise (autologe sfæroider implanteret i bruskdefekter).
English: The objective of the study is to compare the efficacy and safety of the treatment of cartilage defects (1 to less than 4 cm2) at the femoral condyle of the knee joint with Spherox and microfracture treatment over a period of 5 years.
Danish: Formålet med undersøgelsen er at sammenligne virkning og sikkerhed af behandling af bruskdefekter (1 til under 4 cm2) på knæleddets femurkondyle dels med Spherox og dels med mikrofrakturer i en periode på 5 år.
English: Afterwards, the surgical wound can be closed without any additional cover of the treated area (e.g. periosteal flap), or any fixation of spheroids by using fibrin glue.
Danish: Derefter kan operationssåret lukkes uden yderligere dækning af det behandlede område (med f.eks. periostlap) og uden fastgørelse af sfæroiderne med fibrinlim.
English: No signs of inflammation, synovitis, infections, rejection, hypertrophy or immune toxicity, tumourigenicity or biodistribution were observed.
Danish: Der blev ikke iagttaget tegn på betændelse, synovitis, infektioner, afstødning, hypertrofi, immunotoksicitet, tumorigenicitet eller biodistribution.
English: Mainly, patients were treated with cartilage defects in knee.
Danish: De behandlede patienter havde hovedsagelig bruskdefekter i knæet.
English: No clinical data on exposed pregnancies are available for autologous chondrocytes or spheroids from autologous chondrocytes.
Danish: Der foreligger ikke kliniske data om graviditeter eksponeret for autologe chondrocytter eller sfæroider fra autologe chondrocytter.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER CO.DON AG, Warthestraße 21, 14513 Teltow, Germany Tel: +49 (0)3328 43 46 0, Fax: +49 (0)3328 43 46 43, Email: info@codon.de
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN CO.DON AG, Warthestraße 21, 14513 Teltow, Tyskland Tlf.: +49 (0)3328 43 46 0, fax: +49 (0)3328 43 46 43, e-mail: info@codon.de
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intraarticular use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intraartikulær anvendelse.
English: This is usually done as keyhole surgery through very small incisions (cuts), using a special instrument to look inside the knee (arthroscopy).
Danish: Dette gøres normalt ved en kikkertoperation gennem meget små snit ved hjælp af et særligt instrument, der giver mulighed for at se ind i knæet (artroskopi).
English: In a sheep study, also no biodistribution was observed after injection of spheroids into the knee joint.
Danish: I en undersøgelse hos får iagttoges heller ikke biodistribution efter injektion af sfæroider i knæleddet.
English: Spherox is an autologous medicinal product and must not be given to any other patient than the donor.
Danish: Spherox er et autologt lægemiddel, der ikke må administreres til nogen anden end donoren.
English: Application system co.fix 150 mm or
Danish: Applikationssystem co.fix 150 mm eller
English: The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side.
Danish: Applikatorens kateter er udført i termoplastisk polyurethan, Tætningsprop af akrylonitril-butadien-styren på den ene side og silikonelåg på den anden side.
English: The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap.
Danish: Den fyldte sprøjte består af en Luer Lock, en tætningsring og en kapsel.
English: Spherox can only be implanted by a specialist doctor in a medical facility and must only be used in the patient for whom it has been prepared.
Danish: Spherox kan kun implanteres af en speciallæge på en klinik og må kun anvendes hos den patient, som det er fremstillet til.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG ANSVARLIG FOR BATCHFRIGIVELSE
English: This may also be carried out by keyhole surgery.
Danish: Dette kan ligeledes udføres ved en kikkertoperation.
English: Visit 2: Spherox implantation
Danish: Besøg 2: Implantation af Spherox
English: • The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body.
Danish: • Det aktive stof i Spherox er sfæroider, der består af bruskceller og bruskmateriale udvundet fra din egen krop.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest revideret
English: The MAH shall ensure that in each Member State where Spherox is marketed, all surgeons and other health professionals who are expected to prescribe and administer the product have access to the educational materials including:
Danish: Indehaveren af markedsføringstilladelsen skal sørge for, at i hver medlemsstat, hvor Spherox markedsføres, har alle læger og andre sundhedspersoner, der forventes at ordinere og administrere produktet, adgang til uddannelsesmateriale, herunder:
English: Spherox is cultured and implanted as three-dimensional spheroids.
Danish: Spherox dyrkes og implanteres som tredimensionale sfæroider.
English: No suspicion of potential tumourigenesis or increased prevalence of tumours due to the implanted spheroids was observed.
Danish: Iagttagelserne gav ikke anledning til mistanke om potentiel tumorigenese eller øget prævalens af tumorer forårsaget af de implanterede sfæroider.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Application system co.fix 150 mm:
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Applikationssystem co.fix 150 mm:
English: Spherox is delivered to the doctor in a container ready for application.
Danish: Spherox leveres til lægen i en beholder klar til anvendelse.
English: Prior to launch of Spherox in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the training programme and the controlled distribution programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Danish: Før markedsføring af Spherox i hver medlemsstat skal indehaveren af markedsføringstilladelsen træffe aftale med de nationale kompetente myndigheder om indhold og format af uddannelsesprogrammet og programmet for kontrolleret distribution, herunder kommunikationsmedier, distributionsmåde og eventuelle andre aspekter.
English: Table 1: Undesirable Effects related to Spherox
Danish: Tabel 1: Bivirkninger relateret til Spherox
English: Spherox is used to treat defects up to 10 cm² in size.
Danish: Spherox anvendes til at behandle defekter op til 10 cm² i areal.
English: Any unused product or waste material should be disposed in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: In order to evaluate the long-term efficacy and safety of Spherox vs. microfracture in patients with cartilage defects of the knee with a defect size between 1 and < 4 cm2, the MAH should conduct and submit the results of the ongoing prospective, randomised, open label, multicentre study.
Danish: For at evaluere den langsigtede virkning og sikkerhed for Spherox vs mikrofraktur hos patienter med bruskskader i knæet med en defektstørrelse mellem 1 og <4 cm2 skal indehaveren af markedsføringstilladelsen gennemføre den igangværende prospektive, randomiserede, åbne multicenterundersøgelse og forelægge resultaterne.
English: One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
Danish: Én applikator har en maksimal kapacitet på 60 sfæroider i et volumen på op til 200 µl isotonisk natriumchloridopløsning.
English: CO.DON AG Warthestraße 21 14513 Teltow Germany
Danish: CO.DON AG Warthestraße 21 14513 Teltow Tyskland
English: • the bones in the joint have not finished growing
Danish: • hvis knoglerne i leddet ikke er udvokset
English: The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy).
Danish: Implantationen skal udføres under et operativt indgreb (fortrinsvis artroskopi eller miniartrotomi).
English: The applicator is delivered with an application device (sterile injection syringe).
Danish: Applikatoren leveres med en applikationsenhed (steril injektionssprøjte).
English: • Patients with not fully closed epiphyseal growth plate in the affected joint.
Danish: • Epifyseskive i det berørte led ikke helt lukket.
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Batch Number}
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER {Batchnummer}
English: Patients with local inflammations or acute as well as recent bone or joint infections should be temporarily deferred until the recovery from the infection is documented.
Danish: Ved lokal betændelse eller akutte eller nylige knogle- eller ledinfektioner bør behandlingen midlertidigt udsættes indtil det er dokumenteret, at patienten er restitueret efter infektionen.
English: If possible, concomitant joint problems should be corrected prior to or at the latest at the time of Spherox implantation.
Danish: Om muligt bør samtidige ledproblemer korrigeres før implantationen eller senest på tidspunktet for implantationen af Spherox.
English: • swelling due to obstructed flow of tissue fluid via the lymph vessels
Danish: • hævelse som følge af blokering af gennemstrømningen af vævsvæske via lymfekarrene
English: Your cartilage cells are extracted from this sample in a laboratory and are then grown to make the spheroids that constitute Spherox.
Danish: Fra denne prøve ekstraheres dine bruskceller i laboratoriet og dyrkes derefter til fremstilling af de sfæroider, som Spherox består af.
English: A tube may contain a maximum of two co.fix 150.
Danish: Et rør kan indeholde maksimalt 2 stk. co.fix 150.
English: • The Prescriber checklist shall contain the following key messages: o Corroboration that the patient receiving the product is the right patient receiving the appropriate product o Confirmation of the appropriate side of the implantation o A reference to the fact that the patient has been informed and understands the benefits and risks of the product and the associated procedures
Danish: • Tjeklisten for den ordinerende skal indeholde følgende hovedpunkter: o bekræftelse af, at den patient, der modtager produktet, er den rigtige patient og modtager det korrekte produkt o bekræftelse af, at implantationen foretages i den korrekte side o angivelse af, at patienten er blevet informeret og forstår fordele og risici ved produktet og de tilknyttede procedurer
English: Spherox is intended for autologous use only.
Danish: Spherox er kun til autolog brug.
English: Syringe: EXP {DD month YYYY} at {hours} CET
Danish: Sprøjte: EXP {DD måned ÅÅÅÅ} klokken {klokkeslæt} CET
English: Also it needs to be checked if the correct order number (lot number) is on the primary package.
Danish: Det skal ligeledes kontrolleres, at den indre emballage er mærket med det rigtige ordrenummer (batchnummer).
English: Spherox is used to repair cartilage defects of knee in adults.
Danish: Spherox anvendes til at reparere bruskdefekter i knæet hos voksne.
English: Spherox is not recommended in children or adolescents below 18 years.
Danish: Anvendelse af Spherox frarådes til børn eller unge under 18 år.
English: One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution.
Danish: Én fyldt sprøjte har en maksimal kapacitet på 100 sfæroider i et volumen på op til 1 000 µl isotonisk natriumchloridopløsning.
English: What you need to know before you are given Spherox 3.
Danish: Det skal du vide, før du får Spherox 3.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1181/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1181/001
English: The container may be a syringe or a special application system called co.fix that is a catheter with a stem length of 150 mm.
Danish: Beholderen kan være en sprøjte eller et særligt påføringssystem, der kaldes co.fix, som er et kateter med en skaftlængde på 150 mm.
English: Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution.
Danish: Sfæroider af humane autologe matrixassocierede chondrocytter til implantation, suspenderet i isotonisk natriumchloridopløsning.
English: Graft delamination describes the partial or complete detachment of the formed tissue from the subchondral bone and the surrounding cartilage.
Danish: Delaminering af et implantat vil sige partiel eller fuldstændig løsning af det dannede væv fra den subkondrale knogle og den omgivende brusk.
English: A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body.
Danish: En sfæroide ligner en lille perle og er dannet af bruskceller og bruskmateriale fra din egen krop.
English: • Measures to ensure the traceability of the product and guarantee the identification of: patient data; diagnosis leading to the treatment; information on biopsy including date of the operation, adverse events reported during the procedure and quality of the biopsy; information on the implant, including all in-process controls and final product controls.
Danish: • Foranstaltninger til at sikre sporbarheden af produktet og garantere identifikation af: patientdata, den diagnose, der har ført til behandlingen, oplysninger om biopsi, herunder operationsdatoen, bivirkninger indberettet under proceduren og kvaliteten af biopsien, oplysninger om implantatet, herunder alle proceskontroller og kontroller af det færdige produkt
English: Spheroids are spherical aggregates of ex vivo expanded human autologous chondrocytes and selfsynthesized extracellular matrix.
Danish: Sfæroider er sfæriske aggregater af ex vivo-ekspanderede humane autologe chondrocytter og selvsyntetiseret ekstracellulær matrix.
English: IKDC subscores as well as results from the IKDC Current Health Assessment Form and the modified Lysholm score also revealed overall improvements from baseline in both treatment groups with numerically slightly better results in the Spherox group but with no statistical significance.
Danish: IKDC-underscore og resultaterne fra IKDC Current Health Assessment Form og den modificerede Lysholm-score viste ligeledes overordnede forbedringer i forhold til baseline i begge behandlingsgrupper.
English: The spheroids are provided in a pre-filled syringe or an applicator (stem length 150 mm (co.fix 150)).
Danish: Sfæroiderne leveres i en fyldt sprøjte eller en applikator (skaftlængde 150 mm (co.fix 150)).
English: • cracking sounds in the joint
Danish: • knirkende lyde i leddet
English: OTHER For autologous use only.
Danish: ANDET Udelukkende til autolog anvendelse.
English: In case of application system co.fix 150 mm as primary packaging unit: EU/1/17/1181/001
Danish: Hvis applikationssystemet co.fix 150 mm er indre emballage: EU/1/17/1181/001
English: Concomitant joint problems like early osteoarthritis, subchondral bone defects, instability of the joint, lesions of ligaments or of the meniscus, abnormal weight distribution in the joint, varus or valgus malalignment, patellar malalignment or instability, and metabolic, inflammatory, immunological or neoplastic diseases of the affected joint are potential complicating factors.
Danish: Samtidige ledproblemer som tidlig osteoartritis, subchondrale knogledefekter, ustabilitet af leddet, læsioner af ledbånd eller menisk, unormal vægtfordeling i leddet, varus- eller valgusfejlstilling, fejlstilling eller ustabilitet af patella og metaboliske, betændelseslignende, immunologiske eller neoplastiske sygdomme i det berørte led er potentielle komplicerende faktorer.
English: Spherox has been analysed in a prospective, randomized, uncontrolled open-label, multicentre Phase II clinical study including 75 patients with focal cartilage defects (ICRS grade III or IV) in the knee with a defect size of 4-10 cm2.
Danish: Spherox er analyseret i en prospektiv, randomiseret, ukontrolleret, åben, klinisk fase IImulticenterundersøgelse, der omfattede 75 patienter med fokale bruskdefekter (ICRS klasse III eller IV) i knæet med en defektstørrelse på 4-10 cm2.
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from Spherox.
Danish: For tidlig og for kraftig aktivitet kan vanskeliggøre implantationen af Spherox og bevarelse af den kliniske fordel.
English: Other cases in which Spherox cannot be supplied
Danish: Andre tilfælde, hvor Spherox ikke kan leveres
English: The number of primary packaging units delivered depends on the type of the primary packaging unit and the number of spheroids necessary for the specific defect size (10-70 spheroids/cm²).
Danish: Hvor mange indre emballageenheder, der leveres, afhænger af typen af den indre emballage og af, hvor mange sfæroider, der er nødvendige til størrelsen af den pågældende defekt (10-70 sfæroider/cm²).
English: 01-Mar-2021
Danish: Indsendes årligt Endelig undersøgelsesrapport: 01-mar-2021
English: Thromboprophylaxis should be administered according to local guidelines.
Danish: Der bør gives tromboseprofylakse i overensstemmelse med lokale retningslinjer.
English: Spherox should preferably be implanted into an otherwise healthy joint.
Danish: Spherox bør fortrinsvis implanteres i et ellers raskt led.
English: Magnetic resonance imaging (MRI) results according to the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system (0 = worst result; 100 = best result) showed an improvement within the first 60 months from 59.8 at Visit 2 (3 months after treatment) up to 75.0 points in the group of patients treated with 3-7 spheroids/cm² defect, from 64.5 at Visit 2 up to 76.4 points in the dose group of 10-30 spheroids/cm² defect, and from 64.7 at Visit 2 up to 73.6 points in the dose group of 40-70 spheroids/cm² defect.
Danish: Resultaterne af magnetisk resonans-billeddannelse (MRI) i henhold til scoresystemet Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) (0 = værste resultat; 100 = bedste resultat) viste en bedring inden for de første 60 måneder fra 59,8 ved besøg 2 (3 måneder efter behandlingen) op til 75,0 point i den gruppe patienter, der var behandlet med 3-7 sfæroider/cm² defekt, fra 64,5 ved besøg 2 op til 76,4 point i dosisgruppen 10-30 sfæroider/cm² defekt, og fra 64,7 ved besøg 2 op til 73,6 point i dosisgruppen 40-70 sfæroider/cm² defekt.
English: Common: may affect up to 1 in 10 people
Danish: Almindelig: (kan forekomme hos op til 1 ud af 10 personer)
English: The spheroids are provided in an applicator or a pre-filled syringe as primary packaging unit.
Danish: Sfæroiderne leveres i en applikator eller en fyldt sprøjte som indre emballage.
English: During the rehabilitation period, the amount of weight you can put on the joint will increase gradually.
Danish: I løbet af rehabiliteringsperioden kan du efterhånden belaste leddet mere og mere.
English: Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery.
Danish: Anvendelse af Spherox frarådes til gravide eller ammende kvinder, da det anvendes ved operation.
English: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.
Danish: Reparation af symptomatiske leddbruskdefekter på op til 10 cm2 (International Cartilage Regeneration & Joint Preservation Society [ICRS] klasse III eller IV) i femurkondylen og patella i knæet hos voksne.
English: During treatment with Spherox surgery-related (implantation) or Spherox-related adverse reactions may occur.
Danish: Under behandling med Spherox kan der forekomme operativt relaterede (implantationen) eller Spheroxrelaterede bivirkninger.
English: • partial or complete detachment of the tissue beneath the bone and surrounding cartilage
Danish: • hel eller delvis løsning af vævet under knoglen og den omgivende brusk
English: The analysis population comprised 102 patients (41 women, 61 men) aged 37 years on average (range from 18 to 49 years) with a mean body mass index (BMI) of 25.8.
Danish: Analysepopulationen omfattede 102 patienter (41 kvinder og 61 mænd) i gennemsnitsalderen 37 år (variationsbredde 18 til 49 år) med et gennemsnitligt BMI på 25,8.
English: By surgery the spheroids are implanted to the defected cartilage area and stick to the defect site.
Danish: Sfæroiderne implanteres kirurgisk i det defekte bruskområde og sætter sig fast på det defekte sted.
English: • blood clot in a deep vein (symptoms: e.g. swelling, pain, increased warmth in the affected area)
Danish: • blodprop i en dyb vene (symptomer: f.eks. hævelse, smerter og varmefornemmelse i det berørte område)
English: Adverse reactions related to the surgical procedure:
Danish: Bivirkninger relateret til det operative indgreb:
English: 10-70 spheroids are applied per square centimetre defect.
Danish: Der påføres 10-70 sfæroider pr. kvadratcentimeter defekt.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Danish: • Forpligtelse til foranstaltninger efter markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Precautions for use
Danish: Forsigtighedsregler vedrørende brugen
English: • hypersensitivity (allergy) (symptoms: e.g. skin reactions, low blood pressure, constriction of airways, swollen tongue or throat, weak and rapid pulse, sickness, vomiting, diarrhoea, dizziness, fainting, fever)
Danish: • allergi (hypersensitivitet) (symptomer: f.eks. hudreaktioner, lavt blodtryk, indsnævring af luftvejene, hævet tunge eller hals, svag, hurtig puls, kvalme, opkastning, diarré, svimmelhed, besvimelse og feber)
English: The safety and efficacy of Spherox in patients with cartilage defects outside the femoral condyle and the patella of the knee have not been established.
Danish: Sikkerheden og virkningen af Spherox hos patienter med bruskdefekter uden for femurkondylen og patella er ikke fastlagt.
English: • you have advanced joint and bone inflammation with degeneration in the affected joint
Danish: • hvis du har fremskreden betændelse af led og knogler med nedbrydning af det berørte led
English: Application system co.fix 150 mm: EXP {DD month YYYY} at {hours} CET
Danish: Applikationssystem co.fix 150 mm: EXP {DD måned ÅÅÅÅ} klokken {klokkeslæt} CET
English: General
Danish: Generelle
English: The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem).
Danish: Den fyldte sprøjte leveres med en applikationsanordning (fastliggende kanyle eller filterskaft).
English: For information on preparation and handling of Spherox, please refer to section 6.6.
Danish: For oplysninger om klargøring og håndtering af Spherox henvises til pkt.
English: Cartilage tissue is present in every joint as a hard smooth layer on the surface of bone ends.
Danish: Bruskvæv findes i alle led som et hårdt, glat lag på knoglernes endeflade.
English: In case of syringe as primary packaging unit: 1 syringe containing {Number of Spheroids} spheroids in a sterile tube
Danish: Hvis sprøjte er indre emballage: 1 sprøjte indeholdende {antal sfæroider} sfæroider i et sterilt rør