FrancophonIA/ELRC3.0 huggingface dataset:
English: Two weeks after surgery, a topical corticosteroid treatment should be started with preservative-free dexamethasone 0.1% eye-drops, 1 drop three times per day for 2 weeks, then reduced to 1 drop twice daily for 1 week and 1 drop once daily for a further week.
Danish: To uger efter indgrebet skal en topisk kortikosteroid behandling påbegyndes med dexamethasonøjendråber uden konserveringsmiddel 0,1 %, 1 dråbe tre gange om dagen i 2 uger, som dernæst reduceres til 1 dråbe to gange dagligt i 1 uge og 1 dråbe én gang dagligt i yderligere en uge.
English: Keep Holoclar within the steel container in the plastic bag until surgery.
Danish: Opbevar Holoclar i stålbeholderen i plastposen indtil indgrebet.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: Fertility No clinical data on the effects of Holoclar on fertility are available.
Danish: Fertilitet: Der foreligger ingen kliniske data vedrørende Holoclars virkning på fertiliteten.
English: • Problems with cornea (erosion)
Danish: • Problemer med hornhinden (erosion)
English: Via Glauco Gottardi,100, Modena, 41100, Italy Name and address of the manufacturer responsible for batch release Holostem Terapie Avanzate S.R.L.
Danish: Via Glauco Gottardi,100, Modena, 41100, Italien Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Holostem Terapie Avanzate S.R.L.
English: Following implantation, an appropriate regimen of topical and systemic anti-inflammatory and prophylactic antibiotic treatment must be given.
Danish: Efter implantationen skal der gives en passende topisk og systemisk antiinflammatorisk- og profylaktisk antibiotisk behandling.
English: The container is put in a secondary plastic container which is then put in a sealed sterile plastic bag.
Danish: Beholderen placeres i en sekundær plastbeholder, som dernæst anbringes i en forseglet, steril plastpose.
English: On the day of surgery, the surgeon will anesthetise your eye and then will attach the edge of your new cornea with stitches to make sure that Holoclar stays in place.
Danish: På dagen for indgrebet vil kirurgen bedøve dit øje og vil dernæst fastgøre kanten af din nye hornhinde med sting for at sikre, at Holoclar bliver på plads.
English: • Scarring of the conjunctiva (the protective layer over the white of your eye) with damage where it joins to the inside of the eyelids (fornix shortening)
Danish: • Ardannelse på bindehinden (det beskyttende lag over det hvide i øjet) med beskadigelse, hvor den forbindes til indersiden af øjenlågene (fornix-forkortelse).
English: Via Palermo, 26/A, Parma, 43122, Italy Phone: +39 0521 2791
Danish: Via Palermo, 26/A, Parma, 43122, Italien Telefon: +39 0521 2791
English: Adverse reactions reported in patients implanted with Holoclar are provided in the table.
Danish: Bivirkninger indberettet hos patienter, der har fået implanteret Holoclar, er anført i tabellen.
English: Patients with a known hypersensitivity to mice or foetal bovine serum must not be treated (see section 4.3).
Danish: Patienter med kendt overfølsomhed over for mus eller føtaltbovint serum må ikke behandles (se pkt.
English: - There are two excipients: one is fibrin - a clear supportive layer used to keep Holoclar intact, the other one is a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial called Dulbecco's Modified Eagles Medium supplemented with L-glutamine.
Danish: - Øvrige indholdsstoffer: et er fibrin - et klart, understøttende lag, der anvendes til at holde Holoclar intakt, det andet er en væske, der indeholder aminosyrer, vitaminer, salte og kulhydrater, til at opbevare cellerne i hætteglasset kaldet Dulbecco's Modified Eagles-medium, suppleret med L-glutamin.
English: Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns.
Danish: Behandling af voksne patienter med moderat til alvorlig limbal stamcellemangel (defineret ved tilstedeværelsen af overfladisk neovaskularisering af cornea i mindst to corneakvadranter med implicering af den centrale del af cornea og alvorligt nedsat syn), unilateralt og bilateralt, forårsaget af fysiske eller kemiske okulære forbrændinger.
English: By taking some healthy limbal cells, a new layer of healthy tissue is grown in the laboratory on a supporting layer of fibrin, a protein scaffold.
Danish: Ved at tage nogle raskelimbale celler, dyrkes et nyt lag raskt væv i laboratoriet på et understøttende fibrinlag, som er en proteinstruktur.
English: There have been no formal compatibility studies with Holoclar therefore this medicinal product should not be used with other medicinal products during the post-surgical period until the corneal epithelium integrity is fully restored.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder med Holoclar, må dette lægemiddel ikke blandes med andre lægemidler i perioden efter indgrebet, før corneaepitelets integritet er helt genoprettet.
English: The cells used to make Holoclar are known as autologous limbal cells:
Danish: Cellerne, der anvendes til at fremstille Holoclar, er kendt som autologe, limbale celler.
English: If you get any side effects, talk to your surgeon.
Danish: Hvis du oplever bivirkninger, bør du tale med kirurgen.
English: When categorical values for visual acuity were converted into the Logarithm of the Minimum Angle of Resolution (LogMAR), 47% of cases (40 over 85 with non-missing values) experienced an improvement equal or greater than 3 Snellen line equivalents.
Danish: Da kategoriske værdier for synsstyrke blev konverteret til LogMAR (logaritmen for den minimale opløsningsvinkel), oplevede 47 % patienter (40 over 85 med ikke-manglende værdier) en forbedring, der var lig med eller større end 3 Snellen-tavle-ækvivalenter.
English: A minimum of 1 - 2 mm2 of undamaged limbus is required for biopsy.
Danish: Mindst 1 - 2 mm2 af ubeskadiget limbus er nødvendig til en biopsi.
English: Do not use eye-drops containing benzalkonium chloride and/or other preservatives.
Danish: Brug ikke øjendråber, der indeholder benzalkoniumchlorid og/eller andre konserveringsmidler.
English: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italy
Danish: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italien
English: Do not irradiate (e.g. X-rays)
Danish: Må ikke bestråles (f.eks. med røntgen)
English: The proportion of patients with symptoms (pain, burning or photophobia) significantly decreased from pre-surgery (40 patients with at least one symptom; 38.5%) to one year after the procedure (12 patients; 11.5%).
Danish: Procentdelen af patienter med symptomer (smerter, brænden eller fotofobi) blev reduceret signifikant fra før indgrebet (40 patienter med mindst ét symptom; 38,5 %) til et år efter indgrebet (12 patienter;
English: Holoclar must not be sterilised.
Danish: Holoclar må ikke steriliseres.
English: The proportion of patients with improvement in visual acuity was higher among those without a scar of the corneal stroma (15/18 patients, 83.3%) than in those with scarring (36/81 patients, 44.4%).
Danish: Procentdelen af patienter med forbedring i synet var højere blandt dem uden ar på det cornealestroma (15/18 patienter; 83,3 %) end dem med ardannelser (36/81 patienter; 44,4 %).
English: Holoclar consists of a layer of your own cells which have been grown (ex vivo expanded) from a sample of limbal cells taken from your eye during a small surgical procedure called a biopsy.
Danish: Holoclar består af et lag af dine celler, som er blevet dyrket (ex vivo-ekspanderet) fra en prøve limbale celler, der blev taget fra dit øje ved et lille kirurgisk indgreb, som kaldes en biopsi.
English: • Anaesthetise your eye
Danish: • Bedøve dit øje
English: Holoclar is supplied as one individual treatment dose contained in a screw-cap container.
Danish: Holoclar leveres som en individuel behandlingsdosis indeholdt i en beholder med skruelåg.
English: Each preparation of Holoclar contains an individual treatment dose with sufficient number of cells to cover the entire corneal surface.
Danish: Hvert Holoclar-præparat indeholder en individuel behandlingsdosis med et tilstrækkeligt antal celler til at dække hele corneas overflade.
English: Warnings and precautions Talk to your surgeon before you are given Holoclar.
Danish: Advarsler og forsigtighedsregler Kontakt kirurgen, før du får Holoclar.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Holoclar in one or more subsets of the paediatric population in the treatment of limbal stem cell deficiency due to ocular burns (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Holoclar i en eller flere undergrupper af den pædiatriske population i behandlingen af limbal stamcellemangel på grund af okulære forbrændinger (se pkt.
English: • Additional risk minimisation measures
Danish: • Yderligererisikominimeringsforanstaltninger
English: After 2 weeks the systemic antibiotic administration should be stopped and the daily dose of prednisone should be tapered to 0.25 mg/kg (maximum 12.5 mg) per day for 1 week, to 0.125 mg/kg (maximum 5.0 mg) per day for the following week and then stopped.
Danish: Efter 2 uger skal administrationen af det systemiske antibiotikum seponeres og den daglige dosis prednison nedtrappes til 0,25 mg/kg (maksimalt 12,5 mg) pr. dag i 1 uge, til 0,125 mg/kg (maksimalt 5,0 mg) pr. dag i den efterfølgende uge og dernæst seponeres.
English: Holoclar is intended solely for autologous use.
Danish: Holoclar er kun beregnet til autolog anvendelse.
English: • Periodic safety update reports
Danish: • Periodiske, opdateredesikkerhedsindberetninger (PSUR'er)
English: During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium.
Danish: Under den corneale reparationsproces er de administrerede stamceller beregnet til delvist at formere sig, differentiere og migrere for herved at regenerere corneaepitel og delvist at opbevare et reservoir af stamceller, der fortsat kan regenerere corneaepitelet.
English: Educational material for patients and/or carers to address the following key elements: - Contraindicated use of eye drops containing benzalkonium chloride - Side effects of post-transplant treatment with antibiotics and corticosteroids - Inform patients of the registry - Reporting suspected side effects
Danish: Undervisningsmaterialet for patienter og/eller plejere skal omfatte følgende væsentlige elementer: - Kontraindiceret brug af øjendråber, der indeholder benzalkoniumchlorid - Bivirkninger ved behandling efter transplantation med antibiotika og kortikosteroider - Informere patienter om registret - Indberetning af formodede bivirkninger
English: The biopsy is placed in the sterile test tube supplied containing transport medium.
Danish: Biopsien anbringes i det sterile prøveglas, der indeholder transportmediet.
English: The topical corticosteroid can be maintained in case of persistent ocular inflammation.
Danish: Det topiske kortikosteroid kan fortsættes ved persistentokulær inflammation.
English: Biopsy
Danish: Biopsi
English: Reports of glaucoma included adverse reactions of intraocular pressure.
Danish: Indberetninger af glaukom omfattede bivirkninger af intraokulært tryk.
English: Concomitant eyelids malposition, conjunctival scarring with fornix shortening, corneal anaesthesia and/or conjunctival anaesthesia or severe hypoaesthesia, pterygium and severe dry eye are potential complicating factors.
Danish: Samtidige fejlplacerede øjenlåg, ardannelse på conjunctiva med forkortelse af fornix, anæstetiskcornea og/eller conjunctiva eller alvorlig hypæstesi, pterygium og ekstremt tørre øjne er mulige komplikationsfaktorer.
English: Benzalkonium chloride (as well as other quaternary ammonium compounds) is cytotoxic and eyedrops containing this preservative may damage the newly-regenerated corneal epithelium.
Danish: Benzalkoniumchlorid (samt andre kvaternære ammoniumforbindelser) er cytotoksiske og øjendråber med dette konserveringsmiddel kan beskadige netop regenereret corneaepitel.
English: • Growth of the conjunctiva over the cornea (pterygium)
Danish: • Vækst af bindehinden over hornhinden (pterygium)
English: The eyelids are kept closed over the insert with a steri-strip band.
Danish: Øjenlågene holdes lukkede over implantatet med et steri-strip-tape.
English: Corneal infection
Danish: Corneainfektion
English: Each batch is shipped in a temperature-controlled thermally insulated box for organ transplant.
Danish: Hver batch sendes i en temperaturkontrolleret termisk isoleret transportkasse til organtransplantation.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italy
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italien
English: Even if the surgeon has already taken a small sample of limbal cells (a biopsy) needed to produce the medicine, it is possible that you will not be able to have treatment with Holoclar.
Danish: Andre tilfælde, hvor Holoclar ikke kan anvendes Selvom kirurgen allerede har taget en lille prøve limbale celler (en biopsi), der er nødvendig for at kunne fremstille lægemidlet, er det muligt, at du ikke vil kunne få behandling med Holoclar.
English: The following regimen is suggested: Doxycycline 100 mg tablets twice daily (or amoxicillin 500 mg twice daily) and prednisone orally at a daily dose of 0.5 mg/kg (to a maximum dose of 25 mg) per day should be administered from the day of surgery for 2 weeks.
Danish: Det følgende regime anbefales: Der skal administreres tablet doxycyclin 100 mg to gange dagligt (eller amoxicillin 500 mg to gange dagligt) og prednison oralt med en daglig dosis på 0,5 mg/kg (til en maksimal dosis på 25 mg) pr. dag fra dagen for indgrebet i 2 uger.
English: What Holoclar contains - The active substance consists of 300,000 - 1,200,000 of your living eye cells, on average 3.5% of which are stem cells.
Danish: Holoclarindeholder: - Aktivt stof: 300.000-1.200.000 af dine levende øjenceller, af hvilket 3,5 % gennemsnitligt er stamceller.
English: Each preparation of Holoclar is intended as a single treatment.
Danish: Hvert Holoclar-præparat er beregnet til en enkelt behandling.
English: Chiesi Farmaceutici SPA, Via Palermo 26/A, 43122, Parma,
Danish: ChiesiFarmaceutici SPA, Via Palermo 26/A, 43122, Parma,
English: Eye-drops containing benzalkonium chloride, and/or other preservatives, must be avoided.
Danish: Øjendråber, der indeholder benzalkoniumchlorid og/eller andre konserveringsmidler, skal undgås.
English: Each square centimetre of Holoclar contains 79,000 - 316,000 cells.
Danish: Hver kvadratcentimeter af Holoclar indeholder 79.000-316.000 celler.
English: After biopsy has been taken, your surgeon will prescribe a course of antibiotics for you to reduce the chance of an infection.
Danish: Når biopsien er blevet taget, vil kirurgen ordinere en antibiotikakur til dig for at reducere risikoen for en infektion.
English: The eye is subjected to ocular surface lavage with sterile balanced salt solution for eye irrigation followed by detachment of the conjunctiva from the limbus to expose the sample collection site of the cornea.
Danish: Øjets overflade skylles med en steril, balanceret saltvandopløsning til øjenskylning efterfulgt af adskillelse af conjunctiva fra limbus for at eksponere corneas prøvetagningssted.
English: The excess of insert is trimmed and the edge covered with the conjunctiva applying 2 or 3 stitches (sutures) of vicryl or silk 8/0 in order to form a physical seal of the lesion and to secure the implant.
Danish: Implantatets overskydende stykke skæres væk og kanten dækkes med conjunctiva med 2 til 3 sting (suturer) af vikryl eller silke 8/0 for at kunne danne en fysisk lukning af læsionen og for at fastgøre implantatet.
English: Multinational, multicentre, prospective, open-label, uncontrolled interventional study (HLSTM03) to assess the efficacy and safety of autologous cultivated limbal stem cells grafting for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns
Danish: Multinationalt, multicenter, prospektivt, åbent, ukontrolleret interventionsstudie (HLSTM03), som vurderer virkningen og sikkerheden af transplantation af autologe, dyrkede limbal stamceller for regenerering af corneaepitel hos patienter med limbal stamcellemangel forårsaget af okulære forbrændinger
English: The safety and efficacy of Holoclar in children and adolescents aged 0 to 18 years has not yet been established.
Danish: Holoclars sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er endnu ikke klarlagt, men de nuværende data er beskrevet i pkt.
English: Finally, the thermally insulated box is put in a zipped sealable bag for transportation.
Danish: Endelig anbringes den termisk isolerede kasse i en lukket forseglet pose til transport.
English: This medicinal product is intended for autologous use only.
Danish: Dette lægemiddel er kun beregnet til autolog brug.
English: What you need to know before you are given Holoclar
Danish: Det skal du vide, før du begynder at få Holoclar
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC BAG (TERTIARY)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PLASTPOSE (TERTIÆR)
English: Holoclar is intended solely for use in autologous limbal stem cell regeneration in line with the approved therapeutic indication and should be administered under aseptic conditions in conjunction with limbal peritomy, undermining of the conjunctiva and excision of the corneal fibrovascular tissue in preparation of the defect bed.
Danish: Holoclar er kun beregnet til anvendelse ved autolog limbal stamcelleregenerering på linje med den godkendte terapeutiske indikation og skal administreres under aseptiske forhold i forbindelse med limbalperitomi, mobilisering af conjunctiva og ekscision af corneasfibrovaskulære væv ved klargøring af det defekte lag.
English: This layer of tissue is then implanted by a surgeon into the damaged cornea helping your eye to heal normally.
Danish: En kirurg implanterer dernæst dette vævslag i den beskadigede hornhinde, som hjælper dit øje med at hele normalt.
English: Hypersensitivity to any of the excipients listed in section 6.1 or to bovine serum and murine 3T3-J2 cells.
Danish: 6.1 eller over for bovint serum og murine 3T3-J2 celler.
English: Breast-feeding As a precautionary measure, Holoclar is not recommended for implant during breast-feeding.
Danish: Amning Som en sikkerhedsforanstaltning anbefales Holoclar ikke til implantation under amning.
English: Data on the use of Holoclar in patients with hepatic and renal impairment are not available.
Danish: Der foreligger ingen data vedrørende brugen af Holoclar hos patienter med nedsat lever- og nyrefunktion.
English: • Eye disorders - stickiness of the eyelid, bloodshot eyes, swelling of the eye, perforation of the cornea and eye irritation
Danish: • Øjenlidelser - klæbrighed af øjenlåget, blodskudte øjne, hævelse af øjet, perforation af hornhinden og øjenirritation.
English: The most serious adverse reactions are corneal perforation and ulcerative keratitis, which may occur within the 3 months from Holoclar implantation and are related to the corneal epithelial instability, and syncope vasovagal occurring in the first day after surgery due to eye pain.
Danish: De mest alvorlige bivirkninger er perforering af cornea og ulcerativkeratitis, som kan opstå inden for 3 måneder fra implantationen med Holoclar og er relateret tilinstabilitet af corneaepitelet og vasovagal synkope, der opstår på første dag efter indgrebet pga. smerter i øjet.
English: This biopsy will then be used to make
Danish: Denne biopsi vil dernæst blive anvendt til at fremstille Holoclar.
English: Glaucoma (3.5%) was the most frequent adverse reaction considered related to the corticosteroid treatment (see sections 4.2 and 4.4).
Danish: Glaukom (3,5 %) var den hyppigste bivirkning forbundet med kortikosteroidbehandlingen (se pkt.
English: Fifty-one patients (49.0%) had an improvement in visual acuity of at least one full line on a Snellen chart (or one category for the severely impaired cases).
Danish: Enoghalvtreds patienter (49,0 %) fik en forbedring af synet på mindst én hellinje på Snellen-tavlen (eller én kategori i de alvorligt svækkede tilfælde).
English: • Infection of the cornea
Danish: • Infektion i cornea
English: Next, the insert is fitted under the undermined conjunctiva.
Danish: Dernæst tilpasses implantatet under den mobiliseredeconjunctiva.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SCREW-CAP CONTAINER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BEHOLDER MED SKRUELÅG
English: Method of administration For implantation.
Danish: Administration Til implantation.
English: Transport medium (Dulbecco's Modified Eagles Medium supplemented with L-glutamine).
Danish: Transportmedium (Dulbecco's Modified Eagles Medium suppleret med L-glutamin).
English: Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 - 316,000 cells/cm2), including on average 3.5% (0.4 to 16%) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium.
Danish: Holoclar består af en gennemsigtigt, rund skive med 300.000 til 1.200.000 levedygtige, autologe, humane corneaepitelceller (79.000-316.000 celler/cm2), herunder gennemsnitligt 3,5 % (0,4-16 %) limbale stamceller, og stamcelleafledte forbigående forstærkende og terminalt differentierede celler, fæstnet til et understøttende fibrinlag på 2,2 cm i diameter og opbevaret i transportmediet.
English: Following the biopsy, an appropriate regimen of prophylaxis with an antibiotic treatment must be given.
Danish: Behandling efter biopsien Efter biopsien skal der gives en passende profylakse i form af en antibiotisk behandling.
English: The biopsy is performed using topical anaesthesia.
Danish: Biopsien udføres vha. topisk anæstesi.
English: Haemorrhage subcutaneous
Danish: Hudogsubkutanevæv
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftningerogbehandlingskomplikationer Suturruptur
English: Conventional pharmacodynamic studies for Holoclar have not been performed Clinical efficacy and safety
Danish: Der er ikke blevet udført konventionelle farmakodynamiske studier for Holoclar.
English: Before the biopsy, the surgeon will give you eyedrops to anaesthetise your eye and surgically take the biopsy.
Danish: Før biopsien vil kirurgen give dig øjendråber til at bedøve dit øje og udtage biopsien ved et lille indgreb.
English: • Inability for your eye to sense pain (anaesthesia of the cornea or conjunctiva or hypoaesthia)
Danish: • Øjnenes manglende evne til at mærke smerte (følelsesløs hornhinde eller bindehinde eller nedsat følelse)
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch
Danish: FREMSTILLERENS BATCHNUMMER, DONATIONS- OG PRODUKTKODER Batch
English: Ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Danish: Ex vivo-ekspanderede autologe, humane corneaepitelceller indeholdende stamceller.
English: • Remove the scarred surface of the cornea
Danish: • Fjerne hornhindens arrede overflade