FrancophonIA/ELRC3.0 huggingface dataset:
English: None of the patients had received prior treatment with microfracture for their lesion less than one year before screening.
Danish: Ingen af patienterne havde fået forudgående behandling med mikrofrakturer for deres skade mindre end et år før screening.
English: It protects the bones and allows our joints to work smoothly.
Danish: Det beskytter knoglerne og gør, at vores led arbejder gnidningsfrit.
English: Hypersensitivity
Danish: Hypersensitivitet
English: Read all of this leaflet carefully before you are given with this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: In general, these side effects are quite mild and disappear during the weeks following surgery.
Danish: Sædvanligvis er disse bivirkninger ganske milde og forsvinder i ugerne efter operationen.
English: • reopening of a closed wound
Danish: • genåbning af et lukket sår
English: Additional statistical assessments were performed 24 and 36 months after treatment.
Danish: Ekstra statistiske vurderinger blev udført 24 og 36 måneder efter behandlingen.
English: Dispose of in accordance with local requirements.
Danish: Bortskaffes i henhold til lokale krav.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant.
English: How quickly this occurs depends for example on your body weight and the size of the cartilage defect.
Danish: Hvor hurtigt dette går, afhænger f.eks. af din vægt og bruskdefektens størrelse.
English: If you get any of the following serious side effects, you should immediately contact a doctor:
Danish: Hvis du får nogen af følgende alvorlige bivirkninger, skal du straks kontakte din læge:
English: A complete graft delamination is a serious complication which can be accompanied by pain.
Danish: Fuldstændig delaminering af implantatet er en alvorlig komplikation, som kan være ledsaget af smerter.
English: The treatment groups were balanced with respect to size, demography and disease background.
Danish: Behandlingsgrupperne var balancerede mht. størrelse, demografi og sygdomsbaggrund.
English: On the first visit, the doctor will evaluate your cartilage defect during an exploratory operation.
Danish: Ved det første besøg vil lægen vurdere din bruskdefekt ved en undersøgende operation.
English: This suggests that there are no risks for the use of spheroids in humans.
Danish: Dette tyder på, at der ikke er risici ved anvendelse af sfæroider hos mennesker.
English: • Periodic safety update reports (PSURs)
Danish: • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: • Primary (generalised) osteoarthritis.
Danish: • Primær (generaliseret) osteoartritis.
English: Further follow-up assessments of up to 5 years will be performed to generate long-term efficacy data on the treatment with Spherox.
Danish: Der vil blive udført yderligere opfølgende vurderinger i op til 5 år for at generere langvarige virkningsdata for behandlingen med Spherox.
English: These defects can be caused by acute injury, such as a fall.
Danish: Sådanne defekter kan forårsages af en akut skade, såsom et fald.
English: Therefore, patients should consult their treating physician and follow his/her advice strictly.
Danish: Patienterne bør derfor konsultere deres behandlende læge og følge dennes råd nøje.
English: The following adverse reactions considered surgery-related have been reported during the course of the clinical trials and/or from spontaneous sources:
Danish: De følgende bivirkninger, der anses for at være relateret til operationen, er blevet rapporteret i løbet af de kliniske studier og/eller fra spontane kilder:
English: In absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: After implantation, the patient should follow an appropriate rehabilitation schedule.
Danish: Efter implantationen bør patienten følge en passende rehabiliteringsplan.
English: They are transported in a clear colourless solution.
Danish: De transporteres i en klar, farveløs opløsning.
English: If the manufacturing of spheroids has failed or if the release criteria are not fulfilled, e.g. due to insufficient biopsy quality, the medicinal product cannot be delivered.
Danish: Hvis fremstillingen af sfæroider har slået fejl eller frigivelseskriterierne ikke er opfyldt, f.eks. som følge af utilstrækkelig biopsikvalitet, kan lægemidlet ikke leveres.
English: Rehabilitation program
Danish: Rehabiliteringsprogram
English: The subchondral plate should not be damaged.
Danish: Den subkondrale plade må ikke beskadiges.
English: Post-authorisation efficacy study (PAES): 60-month follow-up data for study cod 16 HS 13.
Danish: Undersøgelse af virkning efter markedsføring (PAES): 60-måneders opfølgningsdata for undersøgelse cod 16 HS 13.
English: ICRS grades were mostly IV A, followed by IIIB and IIIA (56, 23 and 10 patients respectively).
Danish: ICRS-graden var hovedsagelig IV A, efterfulgt af IIIB og IIIA (for henholdsvis 56, 23 og 10 patienter).
English: Side effects can occur with the following frequencies: Very common: may affect more than 1 in 10 people
Danish: Bivirkningerne kan optræde med følgende hyppigheder: Meget almindelig: (kan forekomme hos mere end 1 ud af 10 personer)
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 desuden indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale indberetningssystem, der er anført i Appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Prior to use, it must be verified if patient name matches the information of the patient/donor provided on the shipping documents and the product label.
Danish: Før brug skal det kontrolleres, om patientens navn svarer til de oplysninger om patienten/donoren, der er angivet på forsendelsesdokumenterne og på produktets etiket.
English: In cases where the recommended dose was significantly exceeded (up to 170 spheroids/cm² in an investigator-initiated trial with a follow-up period of 12 months), no negative effects were observed.
Danish: I tilfælde, hvor den anbefalede dosis blev overskredet væsentligt (op til 170 sfæroider/cm² i et investigatorinitieret forsøg med en opfølgningsperiode på 12 måneder), blev der ikke iagttaget negative følgevirkninger.
English: Pivotal efficacy data were based on an interim analysis at 12 months after treatment.
Danish: Pivotale virkningsdata var baseret på en interimanalyse 12 måneder efter behandling.
English: This can occur because the sample taken is not of sufficient quality to manufacture the product.
Danish: Dette kan skyldes, at den udtagne brusk ikke er af tilstrækkelig kvalitet til at produktet kan fremstilles.
English: Ask your doctor or physical therapist if you have any further questions about treatment with Spherox.
Danish: Spørg lægen eller fysioterapeuten, hvis du har flere spørgsmål om behandling med Spherox.
English: • Forms for documentation
Danish: • formularer til dokumentation
English: In order to allow your joint to recover well, you will have to follow an individual rehabilitation program.
Danish: For at dit led kan komme sig godt, skal du følge et individuelt rehabiliteringsprogram.
English: Be very careful when bending and putting weight on your treated joint.
Danish: Vær meget forsigtig, når du bøjer og belaster det behandlede led.
English: They are then expected to repair the defect with healthy and functional cartilage over time.
Danish: De forventes efterhånden at reparere defekten med sund og velfungerende brusk.
English: Summary of safety profile
Danish: Oversigt over sikkerhedsprofilen
English: 21 14513 Teltow GERMANY
Danish: 14513 Teltow TYSKLAND
English: • The other ingredient is sodium chloride used as transport solution.
Danish: • Det andet indholdsstof er natriumchlorid, der anvendes som transportvæske.
English: Store at temperatures between 1 °C and 10 °C.
Danish: Opbevares ved temperaturer mellem 1 °C og 10 °C.
English: 2.1 General description
Danish: 2.1 Generel beskrivelse
English: Follow the rehabilitation program, strictly, after implantation.
Danish: Følg rehabiliteringsprogrammet nøje efter implantationen.
English: Furthermore, a multicentre, prospective, randomised, controlled clinical Phase III study is ongoing.
Danish: Desuden pågår en prospektiv, randomiseret, kontrolleret klinisk fase III-multicenterundersøgelse.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: Compliance with an adequate rehabilitation programme after implantation (especially for patients with mental disorders or addiction) should be warranted.
Danish: Det anbefales at overholde et passende rehabiliteringsprogram efter implantation (især for patienter med psykiske lidelser eller afhængighed).
English: • The product will only be available to surgeons certified to prescribe and administer Spherox
Danish: • produktet må kun være tilgængeligt for læger, der er certificeret til at ordinere og administrere Spherox
English: Changes within each dose group were of similar magnitude, and the three between-group (pairwise) analyses did not reveal any statistically significant differences between the groups.
Danish: Ændringerne inden for hver dosisgruppe var af samme størrelsesorden, og de tre (parvise) sammenligninger af grupperne viste ingen statistisk signifikante forskelle mellem grupperne.
English: The total MOCART scores 3, 12, 18, 24 and 36 months after treatment did not differ substantially between the two treatment groups.
Danish: De totale MOCART scoreværdier 3, 12, 18, 24 og 36 måneder efter behandlingen var ikke essentielt forskellige mellem de to behandlingsgrupper.
English: It must be administered by a specialised orthopedic surgeon and in a medical facility.
Danish: Det skal administreres af en specialiseret ortopædkirurg og på en klinik.
English: For intraarticular use.
Danish: Til intraartikulær brug.
English: The adverse reactions related to Spherox are displayed by system organ class and frequency in Table 1
Danish: Bivirkningerne relateret til Spherox er opstillet efter systemorganklasse og hyppighed i tabel 1
English: Implantation suspension.
Danish: Suspension til implantation.
English: The spheroids self-adhere within 20 minutes onto the defect ground.
Danish: Sfæroiderne klæber inden for 20 minutter af sig selv på defektområdet.
English: Depending on the treated joint, you may have to wear a brace.
Danish: Afhængigt af det behandlede led skal du muligvis have en skinne på.
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Danish: Farmakoterapeutisk klassifikation: Andre lægemidler til sygdomme i bevægeapparatet, ATC-kode: M09AX02
English: The spheroids look like small white to yellowish pearls.
Danish: Sfæroiderne ligner små hvide til let gullige perler.
English: Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4).
Danish: Patienter, der er behandlet med Spherox, skal gennemgå et særligt rehabiliteringsprogram (se pkt.
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Danish: < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000) og ikke kendt (kan ikke beregnes af de foreliggende data).
English: Also, during the rehabilitation period, the ability to drive and use machines may be restricted due to reduced mobility.
Danish: I rehabiliteringsperioden kan evnen til at føre motorkøretøj og betjene maskiner også være begrænset som følge af nedsat mobilitet.
English: Risk factors are in particular non-treatment of concomitant diseases, such as subchondral bone oedema.
Danish: Risikofaktorer er navnlig ubehandlede samtidige lidelser såsom subchondralt knogleødem.
English: Hypertrophy of the transplant
Danish: Hypertrofi af transplantatet
English: 14513 Teltow, Germany Tel.: +49 3328 43460 Fax: +49 3328 434643 E-mail: info@codon.de
Danish: 14513 Teltow, Tyskland Tlf.: +49 3328 43460 Fax: +49 3328 434643 E-mail: info@codon.de
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, har brugt det for nylig eller påtænker at gøre det.
English: There are no data on possible effects of Spherox treatment on fertility.
Danish: Der foreligger ingen data om mulig indvirkning af Spherox på fertiliteten.
English: below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Danish: nedenfor: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til
English: If Spherox is appropriate for you, the doctor takes a small cartilage sample from your joint.
Danish: Hvis Spherox er egnet til dig, tager lægen en lille bruskprøve fra dit led.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: • pain of the front knee or kneecap
Danish: • smerter forrest på knæet eller i knæskallen
English: They can also be caused by repetitive injury, such as long-term incorrect weight bearing on the joint.
Danish: De kan også skyldes gentagen beskadigelse såsom langvarig vægtbelastning af leddet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10th July 2017
Danish: Dato for første markedsføringstilladelse: 10. juli 2017
English: Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments.
Danish: Sfæroiderne påføres jævnt på defektområdet og spredes om nødvendigt over hele defektarealet ved hjælp af kirurgiske instrumenter.
English: • Training materials for surgeons and training materials for other health professionals
Danish: • kursusmaterialet til læger og kursusmaterialet til andre sundhedspersoner
English: The main objectives of the educational programme are to provide training to surgeons and other health professionals on proper procurement, storage, handling and administration of Spherox.
Danish: Hovedformålet med uddannelsesprogrammet er at instruere læger og andre sundhedspersoner i korrekt indkøb, opbevaring, håndtering og administration af Spherox.
English: Chondromalacia, Osteochondrosis, Osteonecrosis, Extraskeletal ossification
Danish: Chondromalaci, osteochondrose, osteonekrose, ekstraskeletal ossifikation
English: A GLP-compliant examination of biodistribution and tumourigenicity in NSG mice showed no signs of biodistribution and/or migration from implanted human spheroids.
Danish: En GLP-overensstemmende undersøgelse af biodistribution og tumorigenicitet i NSG-mus viste ingen tegn på biodistribution og/eller migration fra implanterede humane sfæroider.
English: Talk to your doctor before you are given Spherox, if you have any other joint problems or excess weight, as this may reduce the success of the procedure.
Danish: Tal med lægen, før du får Spherox, hvis du har andre ledproblemer eller er overvægtig, da det kan bevirke, at resultatet bliver mindre vellykket.
English: • Infection with the hepatitits B virus (HBV), hepatitis C virus (HCV) or HIV I/II viruses.
Danish: • Infektion med hepatitis B-virus (HBV), hepatitis C-virus (HCV) eller HIV I/II-virus.
English: Driving cars and using machines may be limited during the rehabilitation period.
Danish: Din mulighed for at føre motorkøretøj og betjene maskiner kan være begrænset i rehabiliteringsperioden.
English: Locally applied antibiotics or disinfectants may have potential toxicity on articular cartilage and it is not recommended that Spherox comes into direct contact with those substances.
Danish: Lokalt applicerede antibiotika eller desinfektionsmidler kan have potentiel toksisk virkning på ledbrusk, og det frarådes, at Spherox kommer i direkte kontakt med sådanne stoffer.
English: A symptomatic hypertrophy of the transplant may occur during treatment with Spherox resulting in pain.
Danish: Symptomatisk hypertrofi af transplantatet kan forekomme under behandling med Spherox, resulterende i smerter.
English: The patient's haemostatic functions should be screened prior to surgery.
Danish: Patientens hæmostasefunktioner bør screenes før operationen.
English: • you are infected with HIV (the virus that causes AIDS), hepatitits B virus or with hepatitis C
Danish: • hvis du er smittet med HIV (virusset der er årsag til AIDS), hepatitis B-virus eller hepatitis C
English: 2.2 Qualitative and quantitative composition
Danish: 2.2 Kvalitativ og kvantitativ sammensætning
English: For decision on treatment of facing defects (“kissing lesions” larger than ICRS grade II) the degree of overlap and location of the defects in the joint have to be taken into consideration.
Danish: Ved stillingtagen til behandling af i forhold til hinanden modstående defekter ("kissing lesions" større end ICRS klasse II) skal graden af overlapning og defekternes lokalisering i leddet tages i betragtning.
English: METHOD OF ADMINISTRATION For intraarticular use
Danish: ADMINISTRATIONSMETODE Til intraartikulær anvendelse
English: Do not open the outer packaging before use to prevent microbial contamination.
Danish: Åbn ikke den ydre emballage før brug for at forhindre mikrobiologisk kontaminering.
English: 6.5 Nature and contents of container and special equipment for use, administration or implantation
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse, administration eller implantation
English: • The patient should document the receipt and understanding of the information on the product
Danish: • patienten skal skriftligt bekræfte modtagelsen og at have forstået oplysningerne om produktet
English: Spherox consists of so-called spheroids.
Danish: Spherox består af såkaldte sfæroider.
English: Rehabilitation
Danish: Rehabilitering
English: Due to the nature and intended clinical use of Spherox, conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Danish: På grund af Spheroxs karakter og påtænkte kliniske anvendelse kan der ikke anvendes konventionelle undersøgelser af farmakokinetik, absorption, distribution, metabolisering og elimination.
English: 1 syringe in a sterile tube
Danish: 1 sprøjte i et sterilt rør
English: Very important: Carefully comply with the recommendations of your doctor and physical therapist.
Danish: Meget vigtigt: Overhold nøje lægens og fysioterapeutens anvisninger.
English: The treatment of defect sizes up to 10 cm2 is eligible for single as well as adjacent defects (combined area).
Danish: Behandling af defekter op til 10 cm2 er egnet til både enkelte og tilstødende defekter (kombineret areal).
English: If the primary or secondary packaging is damaged and therefore unsterile, Spherox must not be applied.
Danish: Hvis den indre eller den sekundære emballage er beskadiget og derfor usteril, må Spherox ikke anvendes.
English: Spherox contains so-called spheroids that consist of living cartilage cells with a non-cellular portion for the repair of cartilage defects.
Danish: Spherox indeholder såkaldte sfæroider, der består af levende bruskceller med en ikkecellulær del til reparation af bruskdefekter.
English: The assessment of the ‘overall KOOS' for the ITT population showed that both treatments yielded a statistically significant improvement relative to baseline (day before arthroscopy).
Danish: Vurderingen af det overordnede KOOS for ITT-populationen viste, at begge behandlinger resulterede i signifikant forbedring i forhold til baseline (dagen før atroskopi).
English: The MAH shall ensure that in each Member State where Spherox is marketed, a system aimed to control access to the product beyond the level of control ensured by routine risk minimisation measures.
Danish: Indehaveren af markedsføringstilladelsen sørger for, at der i hver medlemsstat, hvor Spherox markedsføres, findes et system beregnet til at kontrollere adgangen til produktet ud over det niveau af kontrol, der sikres ved rutinemæssige risikominimeringsforanstaltninger.
English: Since 2004, Spherox has been available on a named patient basis for the treatment of cartilage defects classified as Outerbridge grade 3 or 4 or ICRS grade III or IV (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000).
Danish: Siden 2004 har Spherox været tilgængeligt til navngivne patienter til behandling af bruskdefekter klassificeret som Outerbridge klasse 3 eller 4 eller ICRS klasse III eller IV (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000).
English: Pain, Gait disturbance
Danish: Smerter, gangforstyrrelser
English: Untreated bone oedema corresponding with the cartilage defect to be treated may adversely affect the success of the procedure.
Danish: Ubehandlet knogleødem svarende til den bruskdefekt, der skal behandles, kan have negativ indvirkning på resultatet af proceduren.
English: Even if the cartilage sample has already been taken, it may happen that you cannot be treated with Spherox.
Danish: Selv om du allerede har fået udtaget et stykke brusk, kan det ske, at du ikke kan behandles med Spherox.
English: The treatment of adults with Spherox is a two-step procedure:
Danish: Behandlingen med Spherox af voksne sker i to trin:
English: Defect sizes ranged from 0.5 to 4 cm2.
Danish: Defektstørrelserne var mellem 0,5 og 4 cm2.
English: Information on adverse reactions in 177 patients from pivotal clinical trials are available.
Danish: Der foreligger oplysninger om bivirkninger hos 177 patienter fra de pivotale kliniske studier.
English: All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene.
Danish: Alle dele af den fyldte sprøjte er af polypropylen, tætningsringen af isopren.
English: • Advanced osteoarthritis of the affected joint (exceeding grade II according to Kellgren and
Danish: • Fremskreden osteoartritis i det ramte led (overstigende klasse II efter Kellgren og Lawrence).
English: Twenty-five patients were treated with 10-30 spheroids/cm² defect, 25 with 40-70 spheroids/cm² defect and 25 with 3-7 spheroids/cm² defect.
Danish: 25 patienter blev behandlet med 10-30 sfæroider/cm² defekt, 25 med 40-70 sfæroider/cm² defekt og 25 med 3-7 sfæroider/cm² defekt.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Autologous chondrocyte implantation (ACI) is based on the extraction of the patient's own chondrocytes isolated from healthy cartilage, their culture in vitro and their subsequent implantation into the cartilage defect.
Danish: Implantation af autologe chondrocytter (ACI) er baseret på ekstraktion af patientens egne chondrocytter isoleret fra sund brusk, dyrkning af dem in vitro og efterfølgende implantation af dem i bruskdefekten.
English: Visit 1: Evaluation of the cartilage defect, sample and blood taking
Danish: Besøg 1: Vurdering af bruskdefekten, prøvetagning og blodprøvetagning