FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to implantation the patient's name should be carefully checked with the patient/donor identification on the shipment documentation and product container.
Danish: Før implantationen skal patientens navn omhyggeligt kontrolleres i forhold til patient-/donoridentifikationen på forsendelsesdokumenterne og produktbeholderen.
English: If the Holoclar primary container is damaged, the visual appearance of the product is affected, visual particulates are identified, the product must not be used and must be returned to the manufacturer.
Danish: Hvis Holoclars primære beholder er beskadiget, produktets visuelle udseende er påvirket eller synlige partikler identificeres, må produktet ikke anvendes og skal returneres til fremstilleren.
English: Any unused medicinal product or waste material must be returned to the manufacturer.
Danish: Ikke anvendt lægemiddel samt affald heraf skal returneres til fremstilleren.
English: Since this medicine will be used during your surgery, the hospital staff are responsible for the correct storage of the medicine before and during its use, as well as for the correct disposal.
Danish: Da lægemidlet vil blive anvendt under et indgreb, er hospitalspersonalet ansvarligt for den korrekte opbevaring af lægemidletfør og under dets anvendelse, samt for den korrekte bortskaffelse.
English: An incision of 2 x 2 mm is made to remove the biopsy.
Danish: Der laves en incision på 2 x 2 mm for at fjerne biopsien.
English: The container and closure should be carefully visually inspected for any derogation.
Danish: Beholderen og lukningen skal omhyggeligt inspiceres visuelt for tegn på afvigelser.
English: If the temperature monitored in the insulated box deviates from the storage conditions, contact the manufacturer.
Danish: Hvis den målte temperatur i den isolerede kasse afviger fra opbevaringsbetingelserne, kontaktes fremstilleren.
English: Do not store above 25°C or below 15°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C eller under 15 °C.
English: Most side effects affect the eye, some of which are caused by the surgery.
Danish: De fleste bivirkninger påvirker øjet, hvoraf nogle er forårsaget af indgrebet.
English: There is no information on the safety of Holoclar in children up to 7 years of age and only limited information in patients 8 - 17 years of age.
Danish: Der foreligger ingen oplysninger om Holoclars sikkerhed hos børn op til 7 år og kun begrænsede oplysninger hos patienter i alderen 8-17 år.
English: HOUR: (Time zone)
Danish: KLOKKESLÆT: (Tidszone)
English: Visit 1: Biopsy taken
Danish: Besøg 1: Biopsi tages
English: Full technical details on the procedures associated with the use of Holoclar are provided in the educational manual.
Danish: Udførlige, tekniske oplysninger om procedurerne, der er forbundet med anvendelsen af Holoclar, er at finde i undervisningsmanualen.
English: This ingredient can damage the cells of which Holoclar is made.
Danish: Dette indholdsstof kan beskadige cellerne, som Holoclar er fremstillet af.
English: The medicine is put in several layers of packaging which protect the medicine from bacteria and ensures that Holoclar is kept at a stable temperature for 36 hours, if stored at room temperature.
Danish: Lægemidlet anbringes i flere lag emballage, som beskytter lægemidlet mod bakterier og sikrer, at Holoclar opbevares ved en stabil temperatur i 36 timer, hvis det opbevares ved stuetemperatur.
English: For implantation.
Danish: Til implantation.
English: Holoclar is prepared individually from your own cells to match you, and must not be used for anyone other than yourself.
Danish: Holoclar fremstilles individuelt fra dine egne celler, så de matcher dig, og må ikke anvendes af andre end dig selv.
English: Other anaesthesiology procedures may be followed at the discretion of the surgeon.
Danish: Andre anæstesiologiske procedurer kan følges efter kirurgens skøn.
English: Special populations Elderly
Danish: Særlig population Ældre
English: Any shaking, inverting or other mechanical stress of the Holoclar container should be avoided.
Danish: Enhver rysten, invertering eller anden mekanisk belastning af Holoclar-beholderen skal undgås.
English: Name and address of the manufacturer of the biological active substance Holostem Terapie Avanzate S.R.L.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Holostem Terapie Avanzate S.R.L.
English: In some cases it may be possible that the source limbal stem cells of the patient are not expandable or that the release criteria are not met, due to poor biopsy quality, patient characteristics, or manufacturing failure.
Danish: I visse tilfælde kan det være muligt, at patientens limbalekildestamceller ikke ekspanderes eller at frigørelseskriterierne ikke opfyldes pga. ringe biopsikvalitet, patientkarakteristika eller fremstillingsfejl.
English: Please read the package leaflets for the individual medicines you are given for further information on these medicines.
Danish: Du bedes læse indlægssedlen for de enkelte lægemidler, du får, for yderligere information om disse lægemidler.
English: Store between 15 °C - 25 °C
Danish: Opbevares mellem 15 °C - 25 °C
English: If you are allergic to either of these ingredients, you will not be able to be given this medicine (see above under ‘You must not be given Holoclar').
Danish: Hvis du er allergisk over for et eller begge disse indholdsstoffer, vil du ikke få dette lægemiddel (se ovenfor under 'Du må ikke få Holoclar').
English: A total of 104 patients, aged between 13 and 79 years (mean 46.8 years) were included in the primary efficacy analysis.
Danish: Der var i alt 104 patienter mellem 13 og 79 år (gennemsnitsalder 46,8 år) inkluderet i den primære efficacyanalyse.
English: The treatment may be repeated if considered indicated by the treating physician.
Danish: Behandlingen kan gentages, hvis den behandlende læge anser det nødvendigt.
English: When the eye is badly damaged by physical or chemical burns, lots of scarring can occur and the limbus can be damaged.
Danish: Når øjet er svært beskadiget af fysiske eller kemiske forbrændinger, kan der opstå en hel del ardannelse, og limbus kan blive beskadiget.
English: These tests included cell karyotype, cell growth in soft agar and growth factor-dependent proliferation.
Danish: Disse tests omfattede cellekaryotype, cellevækst i blødt agar og vækstfaktorafhængig proliferation.
English: Follow their advice carefully.
Danish: Følg kirurgens råd nøje.
English: Holoclar can only be prescribed and given by an eye surgeon in a hospital.
Danish: Holoclar kan kun ordineres og gives af en øjenkirurg på et hospital.
English: If you have an acute eye infection or swollen, red (inflamed) eyes, your treatment should be delayed until you have recovered.
Danish: Hvis du har en akut øjeninfektion eller hævede, røde (betændte) øjne, skal din behandling udsættes, indtil du er blevet rask.
English: Damage to the limbus stops normal healing, which means that the damage to your eye is never properly repaired.
Danish: Beskadigelse af limbus standser normal heling, hvilket betyder, at beskadigelsen af dit øje aldrig helt kan repareres.
English: OTHER M.A.H: CHIESI FARMACEUTICI S.P.A
Danish: ANDET M.A.H: CHIESI FARMACEUTICI S.P.A
English: Patients with acute ocular inflammation or infections should be deferred until recovery has been documented since inflammation may compromise treatment success.
Danish: Implantation hos patienter med akut okulær inflammation eller infektioner skal udsættes, indtil der er blevet dokumenteret bedring, da inflammation kan kompromittere behandlingssuccesen.
English: Pregnancy There are no data for the use of Holoclar in pregnant women.
Danish: Graviditet Der er ingen data fra anvendelse af Holoclar til gravide kvinder.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2015
Danish: Dato for første markedsføringstilladelse: 17/02/2015
English: Holoclar must be administered by an appropriately trained and qualified surgeon and is restricted to hospital use only.
Danish: Holoclar skal administreres af en korrekt uddannet og kvalificeret kirurg og er begrænset til brug på hospitalet.
English: • Overgrowth around the implant (metaplasia)
Danish: • Overvækst rundt om implantatet (metaplasi)
English: Holoclar must not be irradiated or sterilised.
Danish: Holoclar må ikke bestråles eller steriliseres.
English: These results were confirmed in a sensitivity analysis where superficial neovascularisation was evaluated by an independent assessor from blinded photos of patients' eyes taken before and after Holoclar implantation.
Danish: Disse resultater blev bekræftet i en sensitivitetsanalyse, hvor overfladiskneovaskularisering blev evalueret af en uafhængig sagkyndig fra blindede fotografier af patientens øjne taget før og efter Holoclarimplantationen.
English: Data on the use of Holoclar in elderly populations are limited.
Danish: Data for anvendelsen af Holoclartil den ældre population er begrænsede.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Holoclar
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Holoclar
English: The biopsy must be received by the manufacturer within 24 hours from the procurement.
Danish: Fremstilleren skal modtage biopsien inden for 24 timer efter prøvetagningen.
English: • The limbus contains limbal cells which normally help to maintain the health of your eye and some of these are stem cells which can make new cells.
Danish: • Limbus indeholder limbale celler, som normalt hjælper med til at bevare øjets sundhed og nogle af disse er stamceller, som kan generere nye celler.
English: Therefore, do not drive or use machines after having Holoclar put in your eye until your surgeon tells you that it is safe to do so.
Danish: Derfor må du ikke føre motorkøretøj eller betjene maskiner, når du har fået Holoclar anbragt i øjet, indtil kirurgen fortæller dig, at det er sikkert at gøre dette.
English: Conventional non-clinical reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous product.
Danish: Konventionelle, ikke-kliniske, reproduktive og udviklingsmæssige toksicitetsstudier betragtes ikke som relevante på grund af typen af og den beregnede kliniske anvendelse af det autologe produkt.
English: Holoclar is implanted to repair the damaged surface of the eye in adults.
Danish: Holoclar implanteres for at reparere øjets beskadigede overflade hos voksne.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EUreferencedatoer(EURD list), som fastat i artikel 107c, tykke 7, i direktiv 2001/83/EF og alle efterfølgendeopdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The HLSTM01 study enrolled a total of seven patients (6.7% of the study population) with an age at baseline of 65 years or above, and seven additional patients (24.1%) were included in HLSTM02.
Danish: HLSTM01-studiet tilmeldte i alt syv patienter (6,7 % af studiepopulationen) med en alder ved baseline på 65 år eller derover, og syv yderligere patienter (24,1 %) blev inkluderet i HLSTM02.
English: Therefore, it can occur that Holoclar cannot be delivered.
Danish: Derfor kan det ske, at Holoclar ikke kan anvendes.
English: There is only limited information in elderly (n=12, >65 year old) and very elderly (n= 2, 75-84 year old) patients.
Danish: Ældre Der er kun begrænsede oplysninger om ældre (n=12, >65 år) og meget ældre (n= 2, 75-84 år) patienter.
English: Holoclar is generally implanted under topical retrobulbar or parabulbar anaesthesia.
Danish: Holoclar implanteres generelt under topisk retrobulbær eller parabulbær anæstesi.
English: The most serious side effects are problem with cornea (erosion) and perforation of the cornea, which may occur within the 3 months from Holoclar implantation.
Danish: De alvorligste bivirkninger er problemer med cornea (erosion) og perforation af cornea, hvilket kan forekomme inden for 3 måneder efter Holoclar implantation.
English: The cells are kept alive in a small sterile container.
Danish: Cellerne holdes i live i en lille, steril beholder.
English: Patient's Forename and Surname:
Danish: Patientens fornavn og efternavn:
English: Exceptions include non-topical antibiotics for prophylaxis and corticosteroids during the immediate post-operative period.
Danish: Undtagelser omfatter ikke-topiske antibiotika for profylakse og kortikosterioider i perioden umiddelbart efter indgrebet.
English: Moderate to severe LSCD was defined according to an invasion of at least two quadrants of the corneal surface by superficial neo vessels.
Danish: Moderat til alvorlig LSCD blev defineret i henhold til en invasion på mindst to kvadranter af corneaoverfladen af overfladiske nye kar.
English: In vitro studies have revealed no evidence of anchorage-independent growth indicative of tumorigenic potential.
Danish: In vitro-studier har ikke vist tegn på forankringsuafhængig vækst, der er indikativ for tumorigent potentiale.
English: In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
Danish: Hos de pædiatriske patienter, der var inkluderet i studierne HLSTM01 (13, 14 og 16 år) og HLSTM02 (8 og 14 år), var bivirkningsprofilen ikke anderledes end for den voksne population.
English: No interactions between Holoclar and the post-biopsy/post-operative treatment suggested in section 4.2 have been reported.
Danish: Der er ikke blevet indberettet om interaktioner mellem Holoclar og post-biopsi/post-operativ behandling anbefalet i pkt.
English: DATE:
Danish: DATO:
English: The following information is intended for healthcare professionals only: (The complete SmPC will be provided as a separate document in the medicine pack)
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: (Hele produktresuméet vil blive leveret som et særskilt dokument i emballagen med lægemidlet).
English: System / organ class
Danish: Systemorganklasse
English: Your eyelid will be taped closed for three days and your eye will be bandaged for 10 to 15 days after the implantation.
Danish: Dit øjenlåg vil blive lukket med plaster i tre dage, og du skal have en forbinding over øjet i 10 til 15 dage efter implantationen.
English: The most common adverse reactions are eye disorders.
Danish: De mest almindelige bivirkninger er øjenlidelser.
English: As a precautionary measure, and in light of the requirement of the post-operative pharmacological treatment, it is preferable to avoid the use of Holoclar during pregnancy.
Danish: Som en sikkerhedsforanstaltning,i betragtning af kravet til post-operativ farmakologisk behandling, bør Holoclar undgås under graviditeten.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Ikke relevant.>
English: Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige hvad angår reproduktionstoksicitet (se pkt 5.3).
English: You must not be given Holoclar: - if you are allergic to any of the ingredients of this medicine (listed in section 6) or to bovine serum and mouse cells
Danish: Du må ikke få Holoclar: - hvis du er allergisk over for et af de øvrige indholdsstoffer i Holoclar (angivet i punkt 6) eller over for bovint serum og museceller.
English: Blepharitis (10.5%), and corneal epithelium defect (3.5%) were the most common individual adverse reactions not related to the surgical procedure.
Danish: Blepharitis (10,5 %) og corneaepiteldefekt (3,5 %) var de mest almindelige, individuelle bivirkninger, der ikke var relateret til indgrebet.
English: Each preparation of Holoclar is made individually and is for a single treatment only, although treatments can be repeated.
Danish: Hvert Holoclarpræparat fremstilles individuelt og er kun beregnet til en enkelt behandling, selvom behandlinger kan gentages.
English: On the first visit, the surgeon will carry out a biopsy, which means removing a very small amount of tissue containing limbal cells (from your eye).
Danish: Ved det første besøg vil kirurgen udføre en biopsi, som betyder fjernelse af en meget lille mængde væv med limbale celler (fra øjet).
English: If you are pregnant, think you might be pregnant or you are breast-feeding, treatment with this medicine should be delayed.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, bør behandlingen med dette lægemiddel udsættes.
English: • The stitches break
Danish: • Stingene knækker
English: Fifty-seven patients underwent a keratoplasty after the use of the product with a success rate of 42.1% (N=24) one year after the corneal transplantation (i.e. with a stable corneal epithelium without significant recurrence of neovascularisation).
Danish: Syvoghalvtreds patienter fik keratoplastik efter anvendelsen af produktet med en succesrate på 42,1 % (N=24) ét år efter corneatransplantationen (dvs. med et stabilt corneaepitel uden signifikant recidiv af neovaskularisering).
English: One is foetal bovine serum which is from cows and is used to help grow your cells.
Danish: Et er føtaltbovint serum, som stammer fra køer, og som anvendes i dyrkningen af dine celler.
English: Non-clinical safety data were limited to in vitro testing of tumorigenicity of the human autologous cell cultures.
Danish: Præ-kliniske sikkerhedsdata var begrænset til in vitro-testning af tumorigenicitet af humane, autologe cellekulturer.
English: Handle with care, avoid any shaking, inverting or other mechanical stress.
Danish: Håndtér med forsigtighed og undgå enhver rysten, invertering eller anden mekanisk belastning.
English: The procedure of Holoclar administration include the use of antibiotics and corticosteroids (see section 4.2).
Danish: Proceduren med administration af Holoclar omfatter anvendelsen af antibiotika og kortikosteroider (se pkt.
English: • Bleeding from the eye lid skin
Danish: • Blødning fra øjenlågets hud
English: The most frequently occurring reaction related to the surgical procedure was conjunctival haemorrhage (5%) which appears mostly during the first day after surgery and tends to be mild in intensity and disappears within a few days without treatment.
Danish: Den hyppigst forekommende bivirkning relateret til indgrebet var blødning i conjunctiva (5 %), som oftest forekommer på den første dag efter indgrebet, og har en tendens til at være let i intensitet og forsvinder efter nogle få dage uden behandling.
English: The other ingredient is a special kind of inactivated mouse cell which is used to grow your limbal cells.
Danish: Det andet indholdsstof er en særlig slags inaktiveret musecelle, som anvendes til at dyrke dine limbale celler.
English: Holoclar is a medicine used for replacing damaged cells of the cornea (the clear layer that covers the coloured iris at the front of the eye) including limbal cells which normally help to maintain the health of your eye.
Danish: Holoclar er et lægemiddel, der anvendes til at udskifte beskadigede celler i hornhinden (det klare lag, der dækker den farvede iris foran i øjet), herunder limbale celler, som normalt hjælper med at holde dit øje raskt.
English: Most side effects are mild and disappear in the weeks after surgery.
Danish: De fleste bivirkninger er lette og forsvinder nogle uger efter indgrebet.
English: At the time of product administration, the mean duration of the condition since the injury was 18 years (median 10 years), 99% of patients had corneal opacity and 90% of them had a severe impairment in visus (1/10th or less at Snellen chart).
Danish: På tidspunktet for produktadministrationen var middelvarigheden for tilstanden siden skaden 18 år (median 10 år), 99 % af patienterne havde corneauklarhed og 90 % af dem havde en alvorlig synssvækkelse (1/10 eller mindre på Snellen-tavlen).
English: Holoclar contains lethally-irradiated murine 3T3 fibroblast cells and may contain traces of foetal bovine serum.
Danish: Holoclar indeholder letalt bestrålede murine 3T3-fibroblastceller og kan indeholde spor af føtaltbovint serum.
English: Fibrin support.
Danish: Understøttende fibrinlag.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Potentially infected biological material.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Potentielt inficeret biologisk materiale.
English: For the manufacture of Holoclar, a biopsy of 1 - 2 mm2 of undamaged limbus is required.
Danish: Til fremstillingen af Holoclar er en biopsi på 1 - 2 mm2 ubeskadiget limbus nødvendig.
English: The administration should be followed by an appropriate antibiotic and anti-inflammatory treatment schedule, as recommended by the physician (see section 4.4).
Danish: Administrationen skal efterfølges af en passende antibiotika- og antiinflammatorisk behandlingsplan, som anbefalet af lægen (se pkt.
English: Each package contains an individual treatment dose which is large enough to cover your cornea.
Danish: Hver pakke indeholder en individuel behandlingsdosis, som er stor nok til at dække din hornhinde.
English: Via Glauco Gottardi,100, Modena, 41100, Italy
Danish: Via Glauco Gottardi,100, Modena, 41100, Italien
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dubegynder at fådette lægemiddel, da den indeholder vigtige oplysninger.
English: Therefore, following treatment with Holoclar, driving and using machines must be limited and patients should follow the advice of their treating physician.
Danish: Derfor skal det at føre motorkøretøj og betjene maskiner efter behandling med Holoclar begrænses, og patienterne skal følge deres behandlende læges råd.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparatinden for 6 måneder efter godkendelen.
English: Holoclar is given by surgery on your eye and this will impact on your ability to drive and use machines.
Danish: Holoclar gives til dig via et indgreb i øjet og dette vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: • Increased pressure in the eye (glaucoma)
Danish: • Øget tryk i øjet (glaukom)
English: Other medicines and Holoclar Some eye-drops contain a preservative called ‘benzalkonium chloride'.
Danish: Brug af anden medicin sammen med Holoclar Nogle øjendråber indeholder et konserveringsmiddel kaldet "benzalkoniumchlorid".
English: Do not sterilise
Danish: Må ikke steriliseres
English: Success of the procedure was evaluated based on the presence of a stable corneal epithelium (i.e. absence of epithelial defects) without significant recurrence of neovascularisation (no more than one quadrant without central corneal involvement) at 12 months post-intervention.
Danish: Indgrebets succes blev evalueret baseret på tilstedeværelsen af et stabilt corneaepitel (dvs. fravær af epiteldefekter) uden signifikant recidiv af neovaskularisering (højst en kvadrant uden implicering af den centrale del af cornea) 12 måneder efter indgrebet.
English: The efficacy of the medicinal product was evaluated in a multi-centre, case-series, non-controlled, retrospective cohort study in 106 patients (HLSTM01 study) of both genders, treated for the presence of a moderate to severe limbal stem cell deficiency (LSCD).
Danish: Lægemidlets virkning blev evalueret i et multi-center, case-serie, ikke-kontrolleret, retrospekt cohortestudie hos 106 patienter (HLSTM01-studiet) af begge køn, der blev behandlet for tilstedeværelsen af en moderat til alvorlig limbal stamcellemangel (LSCD).