FrancophonIA/ELRC3.0 huggingface dataset:
English: • have severe osteoarthritis of the knee (disease of the joints with pain and swelling)
Danish: • hvis du har svær slidgigt i knæet (ledsygdom, der medfører smerter og hævelse)
English: A fibrin sealant is a type of glue that is made from human blood-clotting
Danish: En fibrinklæber er en slags lim, der er fremstillet af koagulerende proteiner fra
English: The length of time between your biopsy and the implantation of MACI can vary depending on the procedure date and the quality and number of cells in the biopsy.
Danish: Perioden mellem din biopsi og implantationen af MACI kan variere alt efter proceduredatoen og kvaliteten og antallet af celler i biopsien.
English: There are no data on the use of MACI during breast-feeding.
Danish: Der findes ingen data om brug af MACI under amning.
English: • The importance of explaining to the patients: o The risks asociated with the surgical procedures and MACI o The need for clinical follow-up o The need for rehabilitation following articular cartilage repair
Danish: • Vigtigheden af at forklare patienterne: o De risici, der er forbundet med de kirurgiske procedurer og MACI
English: Given the local nature of the medicinal product, adverse reactions of MACI on pregnancy are not anticipated.
Danish: I betragtning af den lokale anvendelse af lægemidlet forventes MACI ikke at have nogle skadelige virkninger på graviditet.
English: The following information is intended for medical or healthcare professionals only: During the first procedure a sample of healthy cartilage cells (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Under den første procedure tages en prøve af sundt bruskvæv (en biopsi) fra det berørte led under en
English: Ask your doctor or surgeon for more information as to which pain medicine you can safely use.
Danish: Bed din læge eller kirurg om yderligere oplysninger om, hvilken smertestillende medicin det er Indsprøjtning af smertestillende medicin i leddet anbefales ikke.
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Danish: Post-operativ blødning i leddet forekommer hovedsagelig hos patienter, som er prædisponerede for blødning eller ved insufficient kirurgisk blødningskontrol.
English: The implant is an opaque, off-white membrane, seeded with chondrocytes, supplied in 18 ml of colourless solution in a dish.
Danish: Implantatet er en uigennemsigtig, off-white membran med chondrocytter, leveret i 18 ml farveløs
English: The MACI implant will be secured in place using a fibrin sealant.
Danish: MACI-implantatet fastgøres ved hjælp af en fibrinklæber.
English: • Educational material on appropriate follow-up The educational material for surgeons and other healthcare professionals involved in the surgical treatment of patients receiving MACI shall include the following key messages:
Danish: Undervisningsmaterialet til kirurger og andet sundhedspersonale, som medvirker i den kirurgiske behandling af patienter, der får MACI, skal omfatte følgende vigtige oplysninger:
English: Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic
Danish: 4.5), appliceret sparsomt direkte på blødningsstedet, er egnede hæmostatika.
English: Please tell your doctor, surgeon or physical therapist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til din læge, kirurg eller fysioterapeut, hvis du tager anden medicin eller har gjort det for nylig.
English: The MACI will then be implanted into the cartilage defect in your joint by a second procedure.
Danish: MACI vil derpå blive implanteret i bruskdefekten i dit led ved en anden procedure.
English: On average this will be 6 weeks, however, cells can also be frozen and held in storage for up to 2 years until a convenient date for surgery is agreed between you and your surgeon.
Danish: Cellerne kan imidlertid også nedfryses og opbevares i op til 2 år, indtil du og din kirurg finder en passende dato til operationen.
English: Possible side effects
Danish: Disse bivirkninger vil
English: Any unused medicinal product or waste material should be disposed of as surgical waste in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for
English: Return to sporting activity should be personalised in consultation with healthcare professionals.
Danish: Genoptagelse af idrætsaktivitet skal foregå på et individuelt grundlag
English: • Hypersensitivity to any of the excipients listed in section 6.1, or porcine products, or any residual component carried over from manufacture of MACI, including bovine serum, and gentamicin.
Danish: 6.1, eller svineprodukter eller eventuelle reststoffer fra fremstillingen af MACI inklusive okseserum, samt gentamicin.
English: • have a growth plate of the knee that is not fully closed.
Danish: • hvis dine epifyseskiver ved knæet endnu ikke er helt lukkede.
English: For information on preparation and handling of MACI, please refer to section 6.6.
Danish: For instruktioner om fremstilling og håndtering af MACI, se pkt.
English: At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile CE marked porcine derived type I/III collagen membrane, to make MACI.
Danish: På vævscentret dyrkes bruskcellerne aseptisk i kultur for at øge antallet af celler, og de anbringes på en CE-mærket type I/III kollagenmembran udvundet fra svin for at fremstille MACI.
English: The timing between the removal of the biopsy and MACI implantation can vary depending on logistical factors in addition to the quality and number of cells obtained from the biopsy.
Danish: Perioden mellem biopsitagning og MACI-implantation kan variere afhængigt af logistiske faktorer samt af kvaliteten og antallet af celler fra biopsien.
English: Vericel Denmark ApS Amaliegade 10
Danish: Amaliegade 10
English: Given the local nature of the product, adverse reactions of MACI on the nursing infant are not anticipated.
Danish: I betragtning af den lokale anvendelse af præparatet forventes MACI ikke at forårsage nogen uønskede virkninger hos det diende spædbarn.
English: • Clinical follow up details The training materials for healthcare professionals involved in the follow-up of patients treated with MACI shall include the following key messages:
Danish: Undervisningsmaterialet til sundhedspersonale, der er involveret i opfølgningen af patienter, som er behandlet med MACI, skal indeholde følgende vigtige oplysninger:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: Risks involved with arthrotomy or arthroscopy or MACI
Danish: Risici forbundet med artrotomi eller artroskopi eller MACI Alle kirurgiske procedurer indebærer en vis risiko.
English: At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile collagen membrane, to make MACI.
Danish: På vævscentret dyrkes bruskcellerne aseptisk i kultur for at øge antallet af celler, og de anbringes på en steril kollagenmembran for at fremstille MACI.
English: Fibrin sealants containing formaldehyde must not be used with MACI, since formaldehyde is cytotoxic to the chondrocytes.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Fibrinklæber, der indeholder formaldehyd, må ikke anvendes sammen med MACI, da formaldehyd er
English: Due to the surgical nature of the underlying procedure, implantation with MACI has a major influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Da MACI implanteres i forbindelse med kirurgi, påvirker implantation i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
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: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden
English: In some cases, it may occur that source chondrocytes of the patient are not expandable or that the release criteria (see section 6.6) are not met due to poor biopsy quality, patient characteristics, or manufacturing failure.
Danish: 6.6) ikke er opfyldt på grund af dårlig biopsikvalitet, patientkarakteristika eller produktionssvigt.
English: • Obligation to conduct post-authorisation measures
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Ikke relevant.
English: Patients may require debridement of the hypertrophic tissue
Danish: Debridering af hypertrofisk væv under artroskopi kan være nødvendig hos disse patienter.
English: At this time MACI will be implanted into the cartilage defect in the affected joint via a second procedure.
Danish: På dette tidspunkt implanteres MACI i bruskdefekten i det berørte led via en ny procedure.
English: Each implantation matrix consists of characterised autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of 500,000 to 1,000,000 cells per cm2, to be trimmed by the surgeon to the size and shape of the defect.
Danish: Hver implantationsmatrix består af karakteriserede autologe chondrocytter på en 14,5 cm² type I/III kollagenmembran med en tæthed på 500.000 til 1.000.000 celler per cm2.
English: MACI 500,000 to 1,000,000 cells/cm implantation matrix
Danish: LÆGEMIDLETS NAVN MACI 500.000 til 1.000.000 celler/cm implantationsmatrix
English: • Localised surgical site infection
Danish: • Lokaliseret inflammation på operationsstedet • Lokaliseret infektion på operationsstedet
English: At the surgeon's discretion, a few interrupted absorbable sutures may also be used to provide
Danish: Nogle få afbrudte absorberbare suturer kan også anvendes til at give ekstra sikkerhed, hvis kirurgen skønner det nødvendigt.
English: The timing between the removal of the biopsy and the implantation of the MACI implant can vary depending on logistics and the quality and number of cells in the biopsy.
Danish: Perioden mellem biopsitagning og MACI-implantation kan variere afhængigt af logistiske faktorer og kvaliteten og antallet af celler fra biopsien.
English: Limited clinical data on exposed pregnancies are available.
Danish: Der er utilstrækkelige data fra graviditeter, hvor kvinden har været eksponeret for MACI.
English: MACI is an implant consisting of a porcine derived (derived from pigs) collagen membrane which contains your own cartilage cells (called autologous chondrocytes) and is implanted into your knee.
Danish: Membranen indeholder dine egne bruskceller (kaldet autologe chondrocytter) og implanteres i dit knæ.
English: At the cell processing facility, your cartilage cells will be grown aseptically (free from germs) in culture, to increase the number of cells, and placed onto a sterile collagen membrane to make MACI.
Danish: På vævscentret vil dine bruskceller blive dyrket aseptisk (fri for bakterier) i kultur for at øge antallet af celler.
English: • Haemarthrosis
Danish: Synovitis
English: Posology
Danish: Artrofibrose
English: The active substance of MACI consists of viable autologous human cartilage cells on a 14.5 cm² Type I/III collagen membrane, at a density of between 0.5 and 1 million cells per cm
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Autologe chondrocytter på en 14,5 cm² type I/III kollagenmembran, med en tæthed på mellem 500.000
English: C.
Danish: Anv.
English: • If you have any further questions, ask your doctor, surgeon or physical therapist.
Danish: • Spørg lægen, kirurgen eller fysioterapeuten, hvis der er mere, du vil vide.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs
English: Any spillage or waste material should be disposed of as surgical waste material in compliance with local practice.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for hospitalsaffald.
English: “Autologous” means that your own cells are used which have been taken from your knee (through a biopsy) and grown outside the body.
Danish: ”Autolog” betyder, at dine egne celler anvendes til fremstillingen.
English: 2.1 General description
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Responded
Danish: Ledblødning
English: • joint stiffness/numbness
Danish: • vævsirritation eller en betændelseslignende reaktion (inflammation)
English: EXP:
Danish: inden:
English: Matrix applied characterised autologous cultured chondrocytes This medicine is subject to additional monitoring.
Danish: Matrix-applicerede karakteriserede dyrkede autologe chondrocytter
English: Joint range-of-motion decreased
Danish: Mindsket bevægelighed af led
English: Investigations
Danish: Inflammation
English: Pregnancy and breast-feeding
Danish: Adrenalin eller fibrinklæber (se pkt.
English: • bleeding in the joint
Danish: Hævelse i led
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Danish: <{MM/ÅÅÅÅ}> <{DD/MM/ÅÅÅÅ}> <{DD måned ÅÅÅÅ}>
English: Avoid direct contact with the product.
Danish: Undgå direkte kontakt med produktet.
English: It is therefore recommended to treat the animal in the evening.
Danish: Det anbefales derfor at behandle dyret om aftenen.
English: It is not associated with clinical signs.
Danish: Det er ikke forbundet med kliniske tegn.
English: In these cases, the treatment should be immediately withdrawn.
Danish: I disse tilfælde bør behandlingen stoppes øjeblikkeligt.
English: Alternate the daily application between the left and right ears.
Danish: Skift hver dag mellem højre og venstre øre.
English: Read carefully the user safety warnings before use.
Danish: Læs omhyggeligt advarslerne vedrørende brugersikkerhed før anvendelse.
English: These adverse events, including local reactions, resolved at the end of treatment period with no specific treatment.
Danish: Disse bivirkninger, inklusive lokale reaktioner, forsvandt ved slutningen af behandlingsperioden uden specifik behandling.
English: In rare occasions, hypersensitivity reactions can occur.
Danish: I sjældne tilfælde kan overfølsomhedsreaktioner forekomme.
English: The product has an expected positive effect on feed intake by stimulating the appetite but this effect was not measured in the pivotal field trial.
Danish: Produktet har en forventet positiv virkning på fødeindtaget ved at stimulere appetitten, men denne virkning blev ikke målt i det pivotale feltstudie.
English: Treated animals should not be allowed to sleep with owners, especially children and pregnant women during all the period of the treatment.
Danish: Behandlede dyr bør ikke få lov til at sove sammen med ejeren, især ikke børn og gravide kvinder, i hele behandlingsperioden.
English: In the case of overdose, the same effects as those observed at the recommended therapeutic dose were noted but with a higher incidence.
Danish: I tilfælde af en overdosis er der observeret samme bivirkninger som ved den anbefalede terapeutiske dosis, men med en højere forekomst.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Danish: Spis, drik, og ryg ikke under håndtering af veterinærlægemidlet.
English: People with known hypersensitivity to mirtazapine should not handle the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for mirtazapin bør ikke håndtere veterinærlægemidlet.
English: Each dose of 0.1 g contains:
Danish: En dosis på 0,1 g indeholder:
English: Avoid contact with the treated animal for the first 12 hours after each daily application and until the application site is dry.
Danish: Undgå kontakt med det behandlede dyr i de første 12 timer efter den daglige påføring, og indtil påføringsstedet er tørt.
English: In case of an overdose, symptomatic/supportive treatment should be instituted if needed.
Danish: I tilfælde af en overdosis bør symptomatisk/understøttende behandling om nødvendigt iværksættes.
English: Mirtazapine has been identified as potentially reprotoxic in rats and rabbits.
Danish: Mirtazapin er identificeret som potentielt reprotoksiske hos rotter og kaniner.
English: Care should be taken that other animals in the household do not come in contact with the application site until it is dry.
Danish: Der bør udvises forsigtighed, så andre dyr i husholdningen ikke kommer i kontakt med påføringsstedet, før det er tørt.
English: Step 1: Put on impermeable gloves.
Danish: Trin 1: Tag vandtætte handsker på.
English: Shelf life after first opening the immediate packaging: 30 days.
Danish: Opbevaringstid efter første åbning af den indre emballage: 30 dage.
English: The veterinary medicinal product should not be applied on damaged skin.
Danish: Veterinærlægemidlet bør ikke anvendes på beskadiget hud.
English: Date of first authorisation: 10/12/2019
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 10/12/2019
English: The efficacy of the product was only demonstrated with a 14-day administration corresponding to the current recommendations.
Danish: Virkningen af lægemidlet blev kun påvist ved 14 dages administration svarende til de aktuelle anbefalinger.
English: Pharmacotherapeutic Group: Psychoanaleptics, antidepressants ATCvet code: QN06AX11
Danish: Farmakoterapeutisk gruppe: Psychoanaleptica, antidepressiva ATCvet-kode: QN06AX11
English: Manufacturer responsible for batch release: Klifovet AG
Danish: Fremstiller ansvarlig for batchfrigivelse: Klifovet AG
English: Children must not be present when applying the treatment to the cat.
Danish: Børn må ikke være til stede, når produktet smøres på katten.
English: The plasma concentrations of mirtazapine may be also increased when used concomitantly with ketoconazole or cimetidine.
Danish: Plasmakoncentrationerne af mirtazapin kan også øges ved samtidig anvendelse af ketoconazol eller cimetidin.
English: The product can be absorbed via the cutaneous or oral route and can cause drowsiness or sedation.
Danish: Produktet kan absorberes kutant eller oralt og kan forårsage sløvhed eller sedation.
English: Repetition of the treatment has not been investigated and as such should only be done after benefit-risk balance assessment by the veterinarian.
Danish: Gentagelse af behandlingen er ikke undersøgt og bør derfor kun ske efter dyrlægens vurdering af benefit/risk-forholdet.
English: The exact mechanism by which mirtazapine induces weight gain appears to be multifactorial.
Danish: Den præcise mekanisme, hvorved mirtazapin inducerer vægtøgning, synes at være multifaktoriel.
English: Thoroughly wash hands immediately after administration of the veterinary medicinal product or in case of skin contact with the product or the treated cat.
Danish: Vask hænderne grundigt umiddelbart efter påføring af veterinærlægemidlet eller i tilfælde af, at huden kommer i kontakt med produktet eller den behandlede kat.
English: The therapy with mirtazapine should not replace necessary diagnostics and/or treatment regimens needed to manage the underlying disease(s) causing unintended weight loss.
Danish: Behandlingen med mirtazapin bør ikke erstatte nødvendig diagnosticering og/eller behandlingsregimer, som er påkrævet for at behandle den eller de underliggende sygdomme, der forårsager det uønskede vægttab.
English: 80689 Munich
Danish: 80689 München
English: Limited data are available on the reproductive toxicity of mirtazapine.
Danish: Der er kun begrænsede data tilgængelige om mirtazapins reproduktionstoksicitet.
English: If desired, the inner surface of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose.
Danish: Den indvendige side af kattens øre kan eventuelt rengøres med en tør serviet eller klud umiddelbart før den næste planlagte dosis.
English: Given that pregnant women are considered a more sensitive population, it is recommended that pregnant women or women trying to conceive should avoid handling the product and avoid contact with treated animals throughout the treatment period.
Danish: Da gravide kvinder anses som en mere følsom population, anbefales gravide og kvinder, der forsøger at blive gravide, at undgå håndtering af produktet og at undgå kontakt med behandlede dyr i hele behandlingsperioden.
English: In the case of use in cats with diabetes mellitus, glycaemia should be regularly monitored.
Danish: Ved brug hos katte med diabetes mellitus bør der regelmæssigt overvåges for glykæmi.
English: Mirtazapine may increase sedative properties of benzodiazepines and of other substances with sedative properties (antihistamines H1, opiates).
Danish: Mirtazapin kan øge de sedative egenskaber ved benzodiazepiner og andre stoffer med sedative egenskaber (antihistaminer H1, opiater).
English: Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product.
Danish: Vandtætte beskyttelseshandsker til engangsbrug bør udleveres ved salgsstedet sammen med produktet og skal anvendes ved håndtering og påføring af veterinærlægemidlet.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: Avoid hand to mouth and hand to eye contact until hands have been thoroughly washed.
Danish: Undgå hånd-til-mund- og hånd-til-øjekontakt, indtil du har vasket dine hænder grundigt.
English: Kidney disease may cause reduced clearance of mirtazapine, which may result in higher drug exposure.
Danish: Nyresygdom kan medføre reduceret clearance af mirtazapin, hvilket kan medføre højere eksponering for lægemidlet.
English: Non-greasy, homogeneous, white to off-white ointment.
Danish: Ikke-fedtet, homogen, hvid til råhvid salve.
English: Klifovet AG Geyerspergerstrasse 27 80689 Muenchen Germany
Danish: Klifovet AG Geyerspergerstrasse 27 80689 München Tyskland
English: The efficacy of the veterinary medicinal product has not been established in cats less than 3 years of age.
Danish: Virkningen af veterinærlægemidlet er ikke klarlagt hos katte under 3 år.
English: 27 80689 Munich Germany
Danish: 27 80689 München Tyskland
English: The efficacy and safety of the veterinary medicinal product has not been established in cats with severe renal disease and/or neoplasia.
Danish: Virkningen og sikkerheden ved veterinærlægemidlet er ikke klarlagt hos katte med svær nyresygdom og/eller neoplasi.
English: Depending on the severity of vomiting, dehydration or behavioural changes, administration of the product may be discontinued according to the benefit-risk assessment of the veterinarian.
Danish: Afhængigt af sværhedsgraden af opkastning, dehydrering eller adfærdsmæssige ændringer kan anvendelsen af produktet seponeres efter dyrlægens vurdering af benefit/risk-forholdet.
English: Proper diagnosis and treatment of the underlying disease is key to managing weight loss, and treatment options are dependent on the severity of weight loss and underlying disease(s).
Danish: Korrekt diagnose og behandling af den underliggende sygdom er vigtig for at behandle vægttab, og behandlingsmulighederne afhænger af sværhedsgraden af vægttabet og den eller de underliggende sygdomme.
English: The mean AUC0-24 was 100 ng*h/ml (± 51.7).
Danish: Den gennemsnitlige AUC0-24 var 100 ng*t/ml (± 51,7).
English: Bioavailability following topical administration was 34% (6.5 to 89%) compared to oral administration during the first 24 hours and 65% (40.1 to 128.0%) based on AUC0-∞.
Danish: Biotilgængeligheden efter topisk administration var 34 % (6,5-89 %) sammenholdt med oral administration efter de første 24 timer og 65 % (40,1-128,0 %) baseret på AUC0-∞.