FrancophonIA/ELRC3.0 huggingface dataset:
English: • Adverse drug reaction reporting forms
Danish: • Bivirkningsindberetningsskemaer
English: Your surgeon can explain these to you.
Danish: Din kirurg kan forklare dig disse.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Hyppigheder er defineret i henhold til følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000).
English: MACI should be used within 6 days after the date of release.
Danish: MACI skal anvendes inden for 6 dage efter frigivelsesdatoen.
English: Microfracture N=72
Danish: Mikrofraktur N=72
English: See responder rates in Table 1 below.
Danish: Se responshyppigheder i Tabel 1 nedenfor.
English: By 6 months, these signals had subsided, resulting in a normal synovial appearance.
Danish: Efter 6 måneder var disse signaler aftaget, hvilket resulterede i et normalt synovialt udseende.
English: • the increased cells do not meet all the quality requirements.
Danish: • hvis de dyrkede celle ikke opfylder alle kvalitetskravene.
English: • the cells cannot be grown in the laboratory
Danish: • hvis cellerne ikke kan dyrkes på laboratoriet
English: DK-1256 Copenhagen K Denmark
Danish: DK-1256 København K Danmark
English: If you notice any of the following, please contact your doctor immediately, since these may be symptoms of blood clotting:
Danish: Hvis du bemærker noget af følgende, skal du straks kontakte din læge, da det kan være symptomer på en blodprop:
English: There were no indications of gross inflammatory
Danish: Der var ingen indikationer på en kraftig inflammatorisk
English: The median age of patients was 34 to 35 years (age range: 18 to 54), and the mean body mass index was 26.
Danish: Den mediane patientalder var 34 til 35 år (interval: 18 til 54 år), og det gennemsnitlige body mass index var 26.
English: The following rare side effects may affect up to 1 in 1,000 people:
Danish: Følgende sjældne bivirkninger kan påvirke op til 1 ud af 1.000 personer:
English: The use of MACI in this age group has not been studied.
Danish: Brugen af MACI i denne aldersgruppe er ikke undersøgt.
English: • the biopsy is of insufficient quality to produce MACI for you
Danish: • hvis biopsien er af utilstrækkelig kvalitet til at fremstille MACI til dig
English: • Patients with a femoral epiphyseal growth plate that is not fully closed.
Danish: • Patienter med en femoral epifyseskive, der endnu ikke er helt lukket.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Danish: FREMSTILLERENS BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: MACI is not recommended for pregnant women.
Danish: MACI anbefales ikke til gravide kvinder.
English: In such situations, your surgeon will be informed and might have to select an alternative treatment for
Danish: I sådanne situationer vil din kirurg blive underrettet og vil muligvis være nødt til at vælge en alternativ
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige
English: Symptoms may include catching or pain.
Danish: Symptomer kan være låsning eller smerte.
English: Non-clinical data based on implantation of MACI in rabbits and horses did not reveal any special hazard
Danish: Ikke-kliniske data baseret på implantation af MACI hos kaniner og heste viser ingen speciel risiko for
English: SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares i køleskab eller nedfryses.
English: Peri-operative complications related to surgical intervention of the knee:
Danish: Peri-operative komplikationer relateret til kirurgisk indgreb i knæet:
English: Your surgeon will organise the date for implantation.
Danish: Din kirurg vil planlægge implantationsdatoen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 June 2013
Danish: Dato for første markedsføringstilladelse: 27. juni 2013
English: Adverse reactions are listed by System Organ Class and frequency.
Danish: Bivirkninger er angivet efter systemorganklasse og hyppighed.
English: Like all medicines, MACI can cause side effects, although not everybody gets them.
Danish: MACI kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Conventional reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the medicinal product.
Danish: Konventionelle studier af reproduktions- og udviklingstoksicitet anses ikke for at være relevante i betragtning af lægemidlets art og den påtænkte kliniske anvendelse.
English: Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
Danish: Da præparatet vil blive anvendt under din knæoperation, har hospitalspersonalet ansvaret for korrekt opbevaring af præparatet både før og under brug, såvel som for korrekt bortskaffelse.
English: Final sterility test results are not available at the time of shipping.
Danish: Endelige sterilitetstestresultater forefindes ikke på forsendelsestidspunktet.
English: Other situations in which MACI cannot be given
Danish: Andre situationer, hvor MACI ikke kan gives
English: The implantation should be followed by an appropriate rehabilitation schedule (see section 4.4).
Danish: Implantationen skal efterfølges af en passende genoptræningsplan (se pkt.
English: • The need to screen donors using patient questionnaires and laboratory tests for hepatitis C, hepatitis B, HIV and syphilis
Danish: • Nødvendigheden af at screene donorer ved hjælp af patientspørgeskemaer og at udføre laboratorieundersøgelser for hepatitis C, hepatitis B, HIV og syfilis
English: You may require more surgery to correct this
Danish: Du vil muligvis få brug for yderligere en operation for at udbedre dette.
English: Bleeding through the subchondral plate should be avoided, but if it occurs, it must be controlled.
Danish: Blødning gennem den subkondrale knogleplade skal undgås, men hvis blødning forekommer, skal den bringes under kontrol.
English: Four patients were treatment failures in the microfracture treatment arm, versus one in the MACI treatment arm.
Danish: Fire patienter havde behandlingssvigt i mikrofraktur-armen versus en i MACI-armen.
English: When you receive MACI, you may experience side effects soon after the implantation.
Danish: Når du får MACI, kan du opleve bivirkninger hurtigt efter implantationen.
English: Your surgeon will explain what arthrotomy and athroscopy
Danish: Din kirurg vil forklare, hvad artrotomi og artroskopi er.
English: Therefore, it may occur that MACI cannot be delivered.
Danish: Det kan derfor ske, at MACI ikke kan leveres.
English: The educational pack for healthcare professionals shall contain the following components:
Danish: Undervisningsmaterialet for sundhedspersonalet skal indeholde følgende komponenter:
English: There are no known risk groups or specific risk factors for graft hypertrophy in patients treated with MACI.
Danish: Der er ingen kendte risikogrupper eller specifikke risikofaktorer for transplantathypertrofi hos patienter, der behandles med MACI.
English: Each dish contains 1 implantation matrix, held in place by a green polycarbonate x-ring and closed with a green polycarbonate cover for shipment.
Danish: Hver skål indeholder 1 implantationsmatrix, der holdes på plads af en grøn polycarbonat x-ring, og er lukket med et grønt polycarbonatlåg til forsendelse.
English: Seventy-two patients received MACI, and 72 were treated with microfracture.
Danish: MACI, og 72 blev behandlet med mikrofraktur.
English: A total graft delamination is a serious complication and the patient may experience locking, pain, and swelling after an acute distortion of the knee.
Danish: En total transplantatdelaminering er en alvorlig komplikation, og patienten kan opleve fastlåsning, smerte og hævelse efter en akut distorsion af knæet.
English: Store shipping box in an area below 37°C.
Danish: Opbevar forsendelsesboksen på et sted med temperatur under 37 °C.
English: Please discuss with your doctor or physical therapist when to re-start specific physical activities.
Danish: Du skal diskutere med din læge eller fysioterapeut, hvornår du kan genopstarte specifikke fysiske aktiviteter.
English: Dulbecco's Modified Eagles Medium (DMEM; Calcium Chloride anhydrous, Ferric Nitrate.9H2O, Potassium Chloride, Magnesium Sulphate anhydrous, Sodium Chloride, Sodium Bicarbonate, Potassium Phosphate Monobasic.H2O, D-Glucose, L-Arginine.HCl, L-Cystine.2HCl, L-Glutamine, Glycine, L-Histidine.HCl.H2O, L-Isoleucine, L-Leucine, L-Lysine.HCl, L-Methionine, L-Phenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine.2Na.2H2O, L-Valine, D-Calcium Pantothenate, Choline Chloride, Folic Acid, i-Inositol, Niacinamide, Riboflavin, Thiamine.HCl, Pyridoxine.HCl) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES) adjusted for pH with HCl or NaOH and osmality with NaCl.
Danish: Dulbecco's Modified Eagles Medium (DMEM; vandfrit calciumchlorid, ferrinitratnonahydrat, kaliumchlorid, vandfrit magnesiumsulfat, natriumchlorid, natriumhydrogencarbonat, natriumdihydrogenphosphatmonohydrat, D-glucose, L-argininhydrochlorid, L-cystinhydrochlorid, Lglutamin, glycin, L-histidinhydrochloridmonohydrat, L-isoleucin, L-leucin, L-lysinhydrochlorid , Lmethionin, L-phenylalanin, L-serin, L-threonin, L-tryptophan, dinatrium-L-tyrosindihydrat, L-valin, D-calciumpantothenat, cholinchlorid, folinsyre, i-inositol, nicotinamid, riboflavin, thiaminhydrochlorid, pyridoxinhydrochlorid) med natriumsaltet af 4-(2-hydroxyethyl)piperazin-1ethansulfonsyre (HEPES), saltsyre eller natriumhydroxid til pH-justering og natriumchlorid til
English: The membrane is resorbed over the months following implantation.
Danish: Membranen resorberes i månederne efter implantationen.
English: The defect bed should be debrided only down to the subchondral plate and not through it.
Danish: Defekten skal kun debrideres ned til den subkondrale knogleplade og ikke gennem den.
English: Your surgeon or anaesthetist will explain to you the risks involved with the procedures as well as any additional specific risks that are applicable to you because of your medical history and current medical
Danish: Din kirurg eller narkoselæge vil forklare dig, hvilke risici der er forbundet med procedurerne, samt eventuelle yderligere risici, der gælder specielt for dig på grund af din sygehistorie og nuværende
English: It is important that you closely follow the rehabilitation programme recommended by your doctor.
Danish: Det er vigtigt, at du nøje følger det genoptræningsprogram, lægen har anvist.
English: Symptomatic graft hypertrophy is acomplication that may occur with MACI.
Danish: Symptomatisk transplantathypertrofi er en komplikation, der kan forekomme med MACI.
English: The final MACI implant will be sent back to your surgeon.
Danish: Det endelige MACI-implantat sendes tilbage til din kirurg.
English: • Guidance on the selection of suitable patients for MACI treatment and the importance of using MACI only in the approved indication
Danish: • Vejledning i udvælgelse af egnede patienter til MACI-behandling og vigtigheden af kun at bruge MACI til den godkendte indikation
English: Due to limited experience, the use of MACI in joints other than the knee is not recommended.
Danish: På grund af begrænset erfaring anbefales det ikke at bruge MACI i andre led end knæet.
English: You may also be given antibiotics or pain-killers to help reduce some of the side effects.
Danish: Du vil muligvis også få antibiotika eller smertestillende midler for at hjælpe med at reducere nogle af
English: Name and address of the manufacturer of the biological active substance Genzyme Biosurgery ApS
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Genzyme Biosurgery ApS
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med
English: MACI is shipped following a validated rapid microbial sterility assay to determine absence of microbial growth.
Danish: MACI afsendes efter en valideret hurtig mikrobiel sterilitetsanalyse for at bekræfte fravær af mikrobiel vækst.
English: If positive sterility results are obtained, the treating physician will be contacted to discuss either cancellation of the implantation or a plan of action based on the patient-specific circumstances and risk assessment.
Danish: Hvis der findes positive dyrkningsresultater, kontaktes den behandlende læge for at diskutere enten aflysning af implantationen eller en handlingsplan baseret på de patientspecifikke omstændigheder og en vurdering
English: This should include specified or staged physical activity in order to minimise the likelihood of arthrofibrosis and graduated partial weight-bearing.
Danish: Dette skal omfatte specificeret eller trinvis fysisk aktivitet for at mindske risikoen for artrofibrose og gradueret delvis vægtbelastning.
English: You will need to have two surgical procedures to receive this treatment:
Danish: Du skal gennemgå to kirurgiske procedurer for at kunne få denne behandling: 1.
English: Implantation of MACI is to be performed during arthrotomy under sterile conditions.
Danish: Implantation af MACI skal udføres under artrotomi under sterile forhold.
English: Both anterior and posterior cruciate ligaments should be stable or undergo reconstruction to reduce shearing forces and rotation stresses across the joint.
Danish: Både forreste og bageste korsbånd skal være stabile eller gennemgå rekonstruktion for at reducere forskydningskræfter og rotationsspændinger på tværs af leddet.
English: • Cruciate ligament instability: the joint should not possess excessive laxity.
Danish: • Manglende stabilitet af korsbånd: der må ikke være for stor løshed i leddet.
English: MACI will be sent back to the surgeon.
Danish: MACI sendes tilbage til kirurgen.
English: Patient: (name - date of birth {DD.Mmm.YYYY}) Biopsy: {biopsy number} Matrix: 1/1
Danish: Patient: (navn - fødselsdato {DD.Mmm.ÅÅÅÅ})
English: • Details of appropriate disposal of MACI implant trimmings or unused MACI implants
Danish: • Oplysninger om passende bortskaffelse af MACI-implantatoverskud eller ubrugte MACI
English: • Malalignment: the tibio-femoral joint should be properly aligned.
Danish: • Fejlstilling: det tibio-femorale led skal være i korrekt stilling.
English: The use of MACI is not recommended in children and adolescents below 18 years.
Danish: MACI anbefales ikke til børn og unge under 18 år.
English: Other complications have been identified as causally related to MACI.
Danish: Andre komplikationer er identificeret at have en årsagssammenhæng med MACI.
English: • have a known, uncorrected bleeding disorder
Danish: • hvis du har en kendt, ubehandlet blødersygdom
English: • Details on how to recognise the signs and symptoms of important identified or potential risks of the product
Danish: • Oplysninger om, hvordan man kan genkende tegn og symptomer på vigtige identificerede eller potentielle risici forbundet med præparatet
English: Depending on your particular situation, your doctor or surgeon will advise you on whether or not to continue breast-feeding.
Danish: Afhængigt af din særlige situation vil din læge eller kirurg rådgive dig om, hvorvidt du skal fortsætte med at amne eller stoppe.
English: The surgical procedure will have a major impact on your ability to drive and use machines.
Danish: Den kirurgiske procedure vil i væsentlig grad påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: The majority of patients had undergone at least 1 prior orthopaedic knee surgery.
Danish: Størstedelen af patienterne havde tidligere gennemgået mindst en ortopædisk knæoperation.
English: Your doctor will discuss with you the specific rehabilitation programme that follows your surgery.
Danish: Din læge vil diskutere det specifikke genoptræningsprogram, som du skal følge efter operationen.
English: This means that other problems in the joint should be corrected before or during MACI implantation.
Danish: Det betyder, at andre problemer i leddet skal udbedres før eller under MACI-implantationen.
English: MACI was superior compared to microfracture regarding the improvement of pain and function according to the KOOS scale (Knee Injury and Osteoarthritis Outcome Score).
Danish: MACI var superior til mikrofraktur med hensyn til forbedring af smerte og funktion i henhold til KOOS-skalaen (Knee Injury and Osteoarthritis Outcome Score).
English: The patient's haemostatic functions should be screened prior to surgery.
Danish: Patientens hæmostasefunktion skal screenes før operation.
English: Non-clinical in vitro investigations have shown that the collagen membrane is non-cytotoxic, nonmutagenic, non-reactive (short- and long-term implantation), non-sensitising, a negligible irritant, and non-toxic (acute systemic).
Danish: Ikke-kliniske in vitro studier har vist, at kollagenmembranen ikke er cytotoksisk, mutagen, reaktiv (kort- og langtidsimplantation), sensibiliserende og toksisk (akut systemisk), og at den har negligeable
English: Typical clinical pharmacokinetic (ADME) studies have not been performed on MACI.
Danish: Der er ikke udført typiske kliniske farmakokinetiske studier (ADME) med MACI.
English: The pharmacokinetic behaviour of MACI is related to the resorption of the collagen membrane, a proteolytic process performed by cells in the vicinity of the defects.
Danish: MACIs farmakokinetik er relateret til resorption af kollagenmembranen, en proteolytisk proces udført af celler i nærheden af defekterne.
English: MACI is supplied in 1 to 2 dishes, which are placed into a 95kPa pouch (outer bag) with absorbent material for transport.
Danish: MACI leveres i 1 til 2 skåle, som er placeret i en 95 kPa-pose (ydre pose) med absorberende materiale
English: MACI is intended for autologous use only.
Danish: MACI er kun beregnet til autolog anvendelse.
English: A small amount of blood (4 ml) will be taken by a qualified person for testing.
Danish: En person, som er kvalificeret til det, vil udtage en lille mængde blod (4 ml) med henblik på
English: Please consult the Surgical Technique Manual for further information.
Danish: Se vejledningen i operationsteknik for yderligere information.
English: Subsequently, the marketing authorisation holder shall submit 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 derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske
English: MACI must only be implanted by surgeons who have been specifically trained for this kind of surgery.
Danish: MACI må kun implanteres af kirurger, som er specialuddannet i denne type operation.
English: MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
Danish: MACI skal administreres af en kirurg, som er specialuddannet og kvalificeret i brugen af MACI.
English: Your doctor may give you other medicines to help reduce any side effects (see section 2 “Warnings and precautions”).
Danish: Din læge vil muligvis give dig anden medicin for at reducere eventuelle bivirkninger (se punkt 2
English: During the rehabilitation period that follows MACI treatment patients should refer to their treating physician and follow their advice.
Danish: I genoptræningsperioden, der følger efter behandlingen med MACI, skal patienterne rådspørge deres behandlende læge og følge dennes råd.
English: Missing * KOOS Response Rate: Responder is defined as an improvement of the Knee Injury and Osteoarthritis Outcome Score from baseline of minimal 10 points of a scale of 100.
Danish: * KOOS-responsrate: Responset defineres som en forbedring af Knee Injury and Osteoarthritis Outcome Score i forhold til baseline på mindst 10 point på en skala til 100.
English: There are no data on possible effects of MACI treatment on fertility.
Danish: Der findes ingen data på, hvilken indvirkning behandling med MACI kan have på fertilitet.
English: Your MACI implant has been manufactured specifically for you and cannot be administered to any other patient.
Danish: Dit MACI-implantat er specialfremstillet til dig og må ikke administreres til en anden patient.
English: MACI is used in adults to repair cartilage defects in your knee joint.
Danish: MACI anvendes til voksne til at reparere bruskskader i knæleddet.
English: Keep MACI in the outer carton until ready to use.
Danish: Behold MACI i den ydre emballage, indtil det skal bruges.
English: The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect.
Danish: Mængden af administreret MACI afhænger af bruskdefektens størrelse (overflade i cm2).
English: A rabbit study demonstrated that at 3 months post-implantation, minimal numbers of inflammatory cells were present in the vicinity of the defect, with variable chondrogenesis.
Danish: Et kaninstudium viste, at der 3 måneder efter implantation var et minimalt antal inflammatoriske celler til stede i nærheden af defekten, med variabel kondrogenese.
English: Based on the exposure of more than 6,000 patients to MACI treatment in the knee, complications may be related to the arthrotomy procedure, general complications related to surgical intervention, other knee pathology (such as ligamentous or meniscal pathology), or the biopsy procurement.
Danish: Baseret på eksponering af over 6.000 patienter for MACI-behandling i knæet kan der ses komplikationer i forbindelse med artrotomiproceduren, generelle komplikationer relateret til det kirurgiske indgreb, til andre patologiske tilstande i knæet (såsom ligament eller menisk) eller til biopsitagning.
English: Controlled physiotherapy, including early mobilisation, range-of-motion exercises, and partial weightbearing is recommended as soon as possible to promote graft maturation and to reduce the risk of postoperative thromboembolic events and joint stiffness.
Danish: Kontrolleret fysioterapi, herunder tidlig mobilisering, øvelser indenfor bevægeradius og delvis vægtbelastning anbefales så hurtigt som muligt for at fremme modning af transplantatet og for at mindske risikoen for postoperative tromboemboliske hændelser samt stivhed i leddet.
English: • Details on biopsy procurement, and storage and handling of the biopsy harvest
Danish: • Oplysninger om udtagning af biopsi og opbevaring og håndtering af den udtagne biopsi
English: • Meniscal pathology: unstable or torn meniscus requires repair, replacement, or partial meniscectomy.
Danish: • Meniskpatologi: ustabil eller overrevet menisk kræver reparation, udskiftning eller partiel meniskfjernelse.
English: Your surgeon will give you more information on any special considerations for your particular case.
Danish: Din kirurg vil give dig yderligere oplysninger om eventuelle særlige overvejelser, der gælder i dit
English: This package is enclosed in an outer carton insulated with ambient gel packs.
Danish: Denne pakke er indelukket i en ydre emballage, som er isoleret med omgivende gelpakker.
English: Patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.
Danish: Behandling af patienter med lokal inflammation eller aktiv infektion i knogle, led og omgivende bløddelsvæv skal midlertidigt udsættes, indtil dokumenteret sygdomsfrihed.
English: Infective arthritis Wound infection Localised infection
Danish: Infektiøs artritis Sårinfektion Lokaliseret infektion