FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that at least 2 to 3 weeks before the administration day, preparatory surgery is performed comprising exploration (under anaesthesia) of fistula anatomy (number of existing fistulas and openings), topography (extent and relationship with the sphincters and other pelvic muscles), potential associated complications (such as abscesses) and whether local mucosal disease is mild or inactive.
Danish: Det anbefales, at der mindst 2-3 uger før dagen for administration, foretages forberedende kirurgi omfattende undersøgelse (under anæstesi) af fistlens anatomi (antal eksisterende fistler og åbninger), topografi (udbredelse og forbindelse til lukkemuskel og anden bækkenmuskulatur), mulige komplikationer forbundet dermed (såsom abscesser) og om den lokale mukosale inflammation kun er let aktiv eller inaktiv.
English: The product is checked at different stages during its manufacture to ensure that it is free of infection.
Danish: Produktet kontrolleres i forskellige faser af fremstilingsprocessen for at sikre, at stamcellerne ikke er inficeret.
English: *Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration.
Danish: * Reaktioner på forbehandling af fistel forekommer op til syv dage efter udskrabning af fistlen med henblik på behandling med stamceller.
English: For this, injection of a sodium chloride 9 mg/mL (0.9%) solution through the external openings until it gets out through the internal openings is recommended.
Danish: Det anbefales at gøre dette ved at injicere en 9 mg/ml (0,9 %) natriumkloridopløsning gennem de eksterne åbninger, indtil det passerer ud gennem de interne åbninger.
English: Keep the product within the outer carton.
Danish: Opbevar produktet i den ydre karton.
English: d) Replace the needle with a longer needle, also no thinner than 22G, in order to reach the intended sites of injection.
Danish: d) Erstat kanylen med en længere kanyle, også med minimumstørrelse 22G, for at kunne nå de tiltænkte områder for injektion.
English: • Instructions how to handle medication errors and transmission of infectious agents
Danish: • Instruktioner i, hvorledes medicineringsfejl og overførsel af infektiøse stoffer håndteres.
English: Inflammatory cytokines, in particular IFN-γ released by activated immune cells (i.e., lymphocytes), activate eASC.
Danish: Inflammatoriske cytokiner, i særdeleshed IFN-γ, der er frigivet af de aktiverede immunceller (dvs. lymfocytter), aktiverer eASC.
English: In vitro interaction studies have shown that the cell viability and immunomodulatory function of Alofisel is not affected by the presence of clinically-relevant concentrations of conventional therapies for Crohn's disease (infliximab, methotrexate and azathioprine).
Danish: In vitro interaktionsstudier med Alofisel har påvist, at stamcellernes levedygtighed samt den immunmodulerende funktion ikke er påvirket af tilstedeværelsen af klinisk relevante koncentrationer af konventionelle behandlinger for Crohns sygdom (infliximab, methotrexat og azathioprin).
English: The efficacy or safety of repeat administration of Alofisel has not been established.
Danish: Virkning sikkerhed ved gentagen administration af Alofisel er ikke fastlagt.
English: 2.2 Qualitative and quantitative composition Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
Danish: 2.2 Kvalitativ og kvantitativ sammensætning Hvert hætteglas indeholder en suspension med 30 millioner celler (eASC) i en 6 ml opløsning, svarende til en koncentration på 5 millioner celler/ml.
English: Alofisel is used when the fistulas have not responded sufficiently well to previous treatment.
Danish: Alofisel anvendes, når tidligere behandling ikke har virket tilstrækkeligt på fistler.
English: Reproductive and developmental toxicity studies have not been performed for darvadstrocel because preclinical biodistribution studies indicated no migration and integration of eASC into reproductive organs following administration of eASC via different routes.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet for darvadstrocel, da prækliniske undersøgelser af biodistribution ikke indikerede migration og integration af eASC ind i forplantningsorganerne efter administration af eASC ad forskellige veje.
English: Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses).
Danish: Perianale fistler beskrives som komplekse, hvis de har flere kanaler og åbninger og hvis de har gennemboret sig dybt ind i kroppen, eller hvis de har andre komplikationer, såsom ansamling af pus (som er betændt væske også kaldet bylder).
English: In a limited number of patients followed up to Week 104, clinical remission at Week 104 was 56% in the Alofisel group and 40% in the control group.
Danish: Hos et begrænset antal patienter, som blev fulgt op indtil uge 104, var klinisk remission ved uge 104 56 % i Alofisel-gruppen og 40 % i kontrolgruppen.
English: • Guide for pharmacists with instructions on the appropriate reception and storage of Alofisel.
Danish: • Vejledning til farmaceuter/sygehusapotek med instruktioner i korrekt modtagelse og opbevaring af Alofisel.
English: In order to follow-up on the efficacy of Alofisel, the MAH should submit the results of a Phase III randomised double-blind, placebo-controlled study Cx601-0303 investigating a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients.
Danish: For at kunne følge op på effektiviteten af Alofisel, bør indehaveren af markedsføringstilladelsen fremsende resultaterne af et fase III, randomiseret, dobbeltblindet, placebokontrolleret forsøg Cx601-0303, der undersøger en enkelt administration af Cx601 til behandlingen af komplekse, perianale fistler hos patienter med Crohns sygdom.
English: Once you have been anaesthetised (general or regional anaesthesia), your surgeon will:
Danish: Efter, at du er blevet bedøvet (helbedøvelse eller lokalbedøvelse), vil din kirurg:
English: After inserting the needle tip into each intended injection site, perform a slight aspiration to avoid intravascular administration.
Danish: Efter indsætning af kanylespidsen i hvert af de tilsigtede injektionssteder aspireres let for at undgå intravaskulær administration.
English: The following information is related to the day when Alofisel is administered.
Danish: Informationen nedenfor er gældende for den dag, hvor Alofisel indgives.
English: Suspension for injection 1 dose consists of 4 vials of 6 mL (in total 24 mL)
Danish: Injektionsvæske, suspension 1 dosis består af 4 hætteglas af 6 ml (i alt 24 ml)
English: Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Danish: Darvadstrocel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: For example a needle for spinal anaesthesia measuring around 90 mm in length is required.
Danish: For eksempel er en kanyle til lumbalanæstesi, med en længde på cirka 90 mm påkrævet.
English: Pharmacodynamic effect
Danish: Farmakodynamisk virkning
English: The MAH shall ensure that in each Member State where Alofisel is marketed, all healthcare professionals who are expected to handle and administer Alofisel have access to the educational package for health professionals.
Danish: Indehaveren af markedsføringstilladelsen skal i hver medlemsstat, hvor Alofisel markedsføres, sikre at sundhedsprofessionelle, der forventes at ordinere og håndtere og administrere Alofisel, har adgang til undervisningsmaterialer for sundhedsprofessionelle.
English: Before treatment with Alofisel, you will be given an anaesthetic.
Danish: Inden behandling med Alofisel vil du blive bedøvet.
English: The most common treatment-emergent adverse events were anal abscess (Alofisel: 19.4% patients; control group: 13.7% patients), proctalgia (Alofisel: 14.6% patients; control group: 11.8% patients) and anal fistula (Alofisel: 10.7% patients; control group: 7.8% patients).
Danish: De mest almindelige uønskede hændelser opstået under behandling var anale abscesser (Alofisel: 19,4 % af patienter; kontrolgruppe: 13,7 % af patienter), proktalgi (Alofisel: 14,6 % af patienter; kontrolgruppe: 11,8 % af patienter) og anal fistel (Alofisel: 10,7 % af patienter; kontrolgruppe: 7,8 % af patienter).
English: Dulbecco's Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Danish: Dulbecco's Modified Eagle´s Medium (DMEM) (indeholder aminosyrer, vitaminer, salte og kulhydrater).
English: Half of the dose will be injected into the tissue around the inner openings of the fistulas, and half of the dose in the tissue walls along the fistulas.
Danish: Halvdelen af dosis vil blive injiceret i vævet omkring fistlernes indvendige åbninger og den anden halvdel af dosis i fistelkanelernes vægge.
English: Biodistribution studies in preclinical models were conducted with the objective of evaluating the persistence of eASC at the site of injection and their potential migration into other tissues or organ systems.
Danish: Der er gennemført undersøgelser af biodistribution i prækliniske modeller med det formål at evaluere eASCs evne til at forblive ved injektionsstedet og deres potentielle migration ind i andet væv eller til andre organsystemer.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for biologisk materiale.
English: Alofisel must not be administered using a needle thinner than 22G.
Danish: Alofisel må ikke administreres ved brug af en kanyle, som er finere end 22G.
English: Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Danish: Kombineret remission ved uge 24 (% af patienter)
English: • clean the fistulas with salt water and remove any scar tissue.
Danish: • Rense fistlerne med saltvand og fjerne eventuelt arvæv.
English: The recommended dose is 120 million cells.
Danish: Den anbefalede dosis er 120 millioner stamceller i en behandling.
English: The procedure for injection along the walls of the fistula tracts should be performed based on prior knowledge of the anatomy and topology of the fistula tracts, as determined during the fistulas characterisation.
Danish: Proceduren for injektion langs fistelkanalernes væg skal foretages på grundlag af det forudgående kendskab til anatomien og topologien af fistelkanalerne som blev kortlagt under forbehandlingen af fistlerne.
English: Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites.
Danish: Darvadstrocel indeholder ekspanderede stamceller fra fedtvæv (eASC), som udviser immunmodulerende og antiinflammatorisk effekt på inflammerede områder.
English: Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Danish: Darvadstrocel er ekspanderede humane allogene mesenkymale voksne stamceller ekstraheret fra fedtvæv (expanded adipose stem cells - eASC).
English: This was a randomised, double blind, parallel group, placebo-controlled, multicentre clinical trial to assess efficacy and safety of Alofisel for the treatment of complex perianal fistulas in Crohn's disease patients.
Danish: Studiet er et randomiseret, dobbeltblindet, parallelgrupperet, placebokontrolleret, multicenter-studie med det formål at vurdere effekt og sikkerhed af Alofisel til behandling af komplekse perianale fistler hos patienter med Crohns sygdom.
English: Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyreforsøg er utilstrækkelige hvad angår reproduktionstoksicitet (se pkt.
English: Each vial should be used immediately after re-suspension to prevent the cells from re-sedimenting.
Danish: Hvert hætteglas anvendes umiddelbart efter resuspension for at undgå at cellerne bundfælder på ny.
English: Alofisel must not be irradiated or otherwise sterilised.
Danish: Alofisel må ikke bestråles eller steriliseres på anden vis.
English: Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Darvadstrocel bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
Danish: I det inflammerede område sker der infiltration af aktiverede lymfocytter og lokal frigivelse af inflammatoriske cytokiner.
English: Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal.
Danish: Hvert hætteglas indeholder 6 ml eASC suspension og er lukket med en gummiprop og en aftagelig forsegling.
English: This immunoregulatory activity reduces inflammation, which may allow the tissues around the fistula tract to heal.
Danish: Denne immunmodulerende aktivitet reducerer inflammation, hvilket kan give vævene omkring fistelkanalen mulighed for at hele.
English: When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.
Danish: Når Alofisel injiceres nær en perianal fistel, reducerer Alofisel inflammationen og øger derved sandsynligheden for, at fistlen heles.
English: Perianal fistulas are abnormal channels that connect parts of the lower bowel (rectum and anus) and the skin near the anus, so that one or more openings appear near the anus.
Danish: Perianale fistler er unormale kanaler, som forbinder dele af den nederste del af tarmene (endetarm og endetarmsåbning) med huden nær endetarmsåbningen, så der forekommer en eller flere åbninger nær endetarmsåbningen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alofisel in one or more subsets of the paediatric population in the treatment of anal fistula (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Alofisel til behandling af anale fistler i en eller flere undergrupper af den pædiatriske population (se pkt.
English: Alofisel is supplied as one treatment dose contained in 4 Type I glass vials.
Danish: Alofisel leveres som én behandlingsdosis indeholdt i 4 Type I-hætteglas.
English: Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.
Danish: Alofisel er indiceret til behandling af komplekse perianale fistler hos voksne patienter med inaktiv eller let aktiv luminal Crohns sygdom, med utilstrækkeligt respons på mindst en konventionel eller biologisk behandling.
English: As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding.
Danish: Som en sikkerhedsforanstaltning anbefales administration af darvadstrocel ikke under amning.
English: Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Danish: Alofisel er en behandling med levende stamceller, derfor kan produktet ikke steriliseres.
English: Warnings and precautions Talk to your doctor or surgeon before youare given Alofisel.
Danish: Du skal tale med din læge eller kirurg inden du får Alofisel.
English: In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.
Danish: Ved tilstedeværelse af en absces foretages incision og drænage og, hvis relevant, anlæggelse af Seton-tråd i henhold til rutinemæssig kirurgisk procedure.
English: Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.
Danish: Sørg for, at stamcellerne ikke injiceres i fistelkanalernes lumen for at undgå stamcellelækage.
English: Vigorous curettage of all fistula tracts is recommended, with special emphasis in the internal openings area, using a metallic curette.
Danish: Der anbefales kraftig udskrabning (curettage) af alle fistelkanaler, med særligt fokus på de interne åbninger, ved brug af en metal curette.
English: - If there are two or three external openings, inject the content of the remaining two vials equally between the associated tracts.
Danish: - Hvis der er to eller tre eksterne åbninger, injiceres indholdet af de sidste to hætteglas ligeligt fordelt mellem de tilhørende kanaler.
English: The product is intended for local injection.
Danish: Produktet indgives ved injektion.
English: Alofisel may contain trace amounts of benzylpenicillin and streptomycin.
Danish: Alofisel kan indeholde spor af benzylpenicillin og streptomycin.
English: If you get any side effects, talk to your doctor or surgeon.
Danish: Hvis du oplever bivirkninger, bør du tale med lægen eller kirurgen.
English: Injection Two of the vials should be used for the internal openings and the remaining two for injection along the walls of the fistula tracts (via external openings).
Danish: Injektion To hætteglas benyttes til de interne åbninger og de andre to benyttes langs væggene af fistelkanalerne (via de eksterne åbninger).
English: Alofisel may contain traces of benzylpenicillin or streptomycin (antibiotics).
Danish: Alofisel kan indeholde sporstoffer af benzylpenicillin eller streptomycin (antibiotika).
English: Proctalgia*
Danish: Proktalgi*
English: After gentle re-suspension, the product is a white to yellowish homogeneous suspension.
Danish: Efter forsigtig resuspension ses produktet som en hvid til gullig homogen suspension.
English: d) Suture closed the internal openings.
Danish: d)De interne åbninger lukkes med sutur.
English: For further information on the use of Alofisel see section 4.2.
Danish: For mere information om brug af Alofisel, se pkt.
English: Injuring, poisoning and procedural complications
Danish: Traumer, forgiftninger og
English: Once activated, eASC impair proliferation of activated lymphocytes and reduce the release of pro-inflammatory cytokines.
Danish: Efter aktivering hæmmer eASC proliferation af aktiverede lymfocytter og reducerer frigivelsen af proinflammatoriske cytokiner.
English: Treatment with Alofisel is not recommended during pregnancy or while breast-feeding.
Danish: Behandling med Alofisel frarådes under graviditet eller amning.
English: c) Perform a vigorous curettage of all fistula tracts, with special emphasis in the internal openings areas, using a metallic curette.
Danish: c) Foretag en kraftig udskrabning (curettage) af alle fistelkanaler med særligt fokus på de interne åbninger og med anvendelse af en metalcurette.
English: Alofisel must not be filtered, or administered using a needle thinner than 22G (see section 4.4).
Danish: Alofisel må ikke filtreres eller administreres ved brug af en kanyle tyndere end 22G (se pkt.
English: There are two excipients used for storage of the cells: one is a liquid called Dulbecco's Modified Eagle´sMedium containing nutrients for the cells (amino acids, vitamins, salts and carbohydrates), and the other is human albumin, which is a natural protein found in the human body.
Danish: Hjælpestoffer til opbevaring af stamcellerne: Dulbecco's Modified Eagle´s Medium som er en væske, derindeholder næringsstoffer til stamcellerne (aminosyrer, vitaminer, salte og kulhydrater), samt humant albumin, som er et protein, der findes naturligt i kroppen hos mennesker.
English: Anal fistula
Danish: Anal fistel
English: Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in elderly patients will differ from that observed in non-elderly patients.
Danish: Data vedrørende brug af darvadstrocel hos ældre er begrænsede, men da darvadstrocel består af stamceller og det er en lokal administrationsvej forventes det ikke, at benefit/risk-forholdet for darvadstrocel hos ældre patienter vil afvige fra det, som er set hos andre aldersgrupper.
English: At Week 12, 23/63 (36%) showed anti-donor antibody production.
Danish: (36 %) en produktion af anti-donor-antistof.
English: During shipment, the cells may have settled in the bottom of the vials forming a sediment and will need to be resuspended.
Danish: Under forsendelse kan stamcellerne have lagt sig som bundfald på bunden af hætteglassene og skal derfor resuspenderes.
English: c) Remove the cap from the vial, gently turn the vial upside down, and gently aspirate the whole content using a syringe with a conventional needle no thinner than 22G (see section 4.4).
Danish: c) Fjern hætten fra hætteglasset, vend hætteglasset forsigtigt på hovedet og træk forsigtigt hele indholdet op med en injektionssprøjte påsat en standardkanyle, som ikke må være finere end 22G (se pkt.
English: Takeda Pharma sp. z o.o tel. + 48 22 608 13 00
Danish: Takeda Polska Sp. z o.o tel. + 48 22 608 13 00
English: Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for produktet, bovint serum eller over for et eller flere af hjælpestofferne anført i pkt.
English: b) Injection along the walls of the fistula tracts: insert the needle through the external openings and, from within the fistulas lumen: - If there is a single external opening, inject separately the content of each of the remaining two vials superficially into the tissue walls along the length of the fistula tracts, making small deposits of the cell suspension.
Danish: b) Injektion langs fistelkanalernes vægge: Indfør kanylen gennem de eksterne åbninger og inde fra fistelens hulrum: - Hvis der er en enkelt ekstern åbning, injiceres indholdet af de to sidste hætteglas overfladisk i fistelkanalens væg langs hele fistelkanalen, ved at lave små depoter med stamcelleopløsningen.
English: An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Danish: En dosis med Alofisel består af 4 hætteglas, hver indeholdende 6 millimeter Alofisel, som er opbevaret i en ydre karton.
English: • procedural pain (pain after fistula cleaning)
Danish: • Smerter efter rensning af fistel (relateret til forberedelse til fistelbehandlingen)
English: - If there are two internal openings, inject the content of the first of two vials in small deposits into the tissue around one internal opening.
Danish: - Hvis der er to interne åbninger, injiceres indholdet af det første hætteglas i små depoter i vævet omkring den ene interne åbning.
English: A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
Danish: En behandling med Alofisel består i 120 millioner stamceller leveret i 4 hætteglas.
English: b) Re-suspend the cells by gently tapping the bottom of the vials until a homogeneous suspension is obtained, avoiding bubble formation.
Danish: b) Resuspendér stamcellerne ved forsigtigt at banke på bunden af hætteglassene, indtil suspensionen igen synes homogen, men undgå at danne bobler.
English: The vials are placed inside a cardboard box.
Danish: Hætteglassene er pakket i en karton.
English: Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Danish: Det er derfor ikke nødvendigt at justere dosis for patienter med nedsat lever- eller nyrefunktion.
English: Alofisel will be used after adequate preparation of the fistula, see section 3.
Danish: Alofisel anvendes efter passende klargøring af fistlen, se pkt.
English: Then inject the content of the second vial in small deposits into the tissue around the second internal opening.
Danish: Injicer derefter indholdet af det andet hætteglas i små depoter i vævet omkring den anden interne åbning.
English: • stitch up the inner openings of the fistulas.
Danish: • Sy fistlernes indvendige åbninger sammen.