FrancophonIA/ELRC3.0 huggingface dataset:
English: As per the CHMP Guideline on Risk Management Systems for medicinal products of human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske sikkerhedsopdateringsrapport (PSUR).
English: The occurrence rate rose to 32% when a second course of therapy was given, especially in the areas where second treatment overlaps the first and amounted to 10% for those who received a third treatment course.
Danish: Forekomstfrekvensen steg til 32%, da der blev givet en ny behandlingskur, især hvor den ny behandlingskur overlappede den første, og beløb sig til 10% for dem, der modtog en tredje behandlingskur.
English: Check for the appearance of red marks, swelling or blistering after one day.
Danish: Kontrollér, om der kommer røde mærker, hævelse eller blisterdannelse efter én dag.
English: Whenever possible, the segment selected for the first light application should include all the areas of HGD.
Danish: Når det er muligt, skal det segment, der er valgt til den første lysbehandling, omfatte alle områderne med HGD.
English: If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er ibrugtagningens opbevaringstid og -forhold inden anvendelsen brugerens ansvar.
English: A second option (light intensity of 200 mW/cm) has also been included where necessary to accommodate lasers with a total capacity that does not exceed 2.5 W.
Danish: En anden mulighed (lysintensitet på 200 mW/cm) har også været inddraget, hvor det var nødvendigt at tilpasse sig lasere med en total kapacitet, der ikke overstiger 2,5 W.
English: If you miss the laser light treatment
Danish: Hvis De har glemt laserlysbehandlingen
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
Danish: − senest 60 dage efter en vigtig milepæl er nået (pharmacovigilance eller risikominimering)
English: Prophylactic use of corticosteroids to reduce stricture formation should be avoided during PDT as its use has shown not to reduce, and may worsen, stricture formation.
Danish: Profylaktisk brug af kortikosteroider for at reducere strikturdannelse bør undgås under PDT, da denne anvendelse har vist sig ikke at reducere, og kan forværre, strikturdannelse.
English: It is not known whether porfimer sodium is excreted into human breast milk.
Danish: Det vides ikke, om natriumporfimer udskilles i human brystmælk.
English: Such pain may be of sufficient intensity to warrant the shortterm prescription of opiate analgesics.
Danish: Disse smerter kan være så stærke, at de berettiger kortvarig ordination af opiater.
English: Light doses of two to three times the recommended dose have been administered to a few patients with superficial endobronchial tumours.
Danish: Lysdoser på to til tre gange den anbefalede dosis har været administreret til nogle få patienter med superficielle endobronchiale tumorer.
English: − Caution should be exercised if patients have moderate hepatic disease
Danish: − Der skal udvises forsigtighed, hvis patienterne har en moderat leversygdom.
English: Therefore, patients should not stay in a darkened room during this period and should be encouraged to expose their skin to ambient indoor light.
Danish: Derfor skal patienterne ikke opholde sig i et mørkelagt rum i denne periode, og de skal opfordres til at eksponere deres hud for omgivende indendørs lys.
English: The frequency and nature of the photosensitivity reactions experienced in this study are unlike the documented incidence seen in previous clinical studies in cancer patients (approx. 20%) or the spontaneously reported incidence from commercial use of PhotoBarr (< 20%).
Danish: Hyppigheden og naturen af de lysfølsomhedsreaktioner, der forekom i denne studie, er forskellig fra den dokumenterede incidens, der ses i tidligere kliniske studier på cancerpatienter (ca. 20%) eller den spontant rapporterede incidens fra kommerciel anvendelse af PhotoBarr (< 20%).
English: PhotoBarr is for single use only and any unused solution should be discarded.
Danish: PhotoBarr er kun til éngangsbrug, og eventuel ubrugt opløsning skal bortskaffes.
English: Other exclusion criteria were patients in whom omeprazole therapy was contraindicated.
Danish: Andre eksklusionskriterier var patienter hos hvem omeprazolterapi var kontraindiceret.
English: In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and at greater frequency (daily) compared in the clinical use.
Danish: I disse studier forekom foetotoksicitet, men ikke teratogenicitet, hos rotter og kaniner kun ved evaluerede intravenøse doser (større end eller lig med 4 mg/kg) og ved større hyppighed (dagligt) i sammenligning med klinisk anvendelse.
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD01
Danish: Farmakoterapeutisk klassifikation: Sensibilisatorer til fotodynamisk/stråle-terapi, ATC-kode: L01XD01
English: Patients should not drive or use machines after the light treatment if they have been sedated for the procedure.
Danish: Patienterne bør ikke føre bil eller betjene maskiner efter lysbehandlingen, hvis de er blevet bedøvet under proceduren.
English: Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Danish: Samtidig administration af omeprazol (20 mg BID) begyndte mindst 2 dage før PhotoBarr-injektion.
English: As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Danish: Som resultat af PDT-behandling kan patienterne klage over substernale brystsmerter på grund af inflammatorisk respons i det behandlede område.
English: The medicinal product should only be administered when material and personnel experienced in evaluating and treating anaphylaxis are immediately available.
Danish: Lægemidlet må kun administreres, når udstyr til og personale med erfaring i at evaluere og behandle anafylaksi er umiddelbart tilgængeligt.
English: Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Danish: Sikkerhed og effektivitet hos patienter med behandlingssvigt af anden lokal mucosa-ablativ terapi er ikke evalueret.
English: Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Danish: Tumor- og dysplasivævs selektivitet i behandlingen kan til dels opstå gennem selektiv retention af natriumporfimer, men hovedsageligt gennem en selektiv tildeling af lys.
English: − The need to show this card to any doctor treating them
Danish: − Dette kort skal vises til alle læger, der måtte behandle patienterne.
English: Exposure of the skin to ambient indoor light is, however, beneficial because the remaining medicinal product will be inactivated gradually through a photobleaching reaction.
Danish: Eksposition af huden for omgivende indendørs lys er imidlertid gavnlig, fordi det resterende lægemiddel gradvist bliver inaktiveret gennem en fotoblegende reaktion.
English: Special care to ensure accurate PhotoBarr dosing and/or light dose is crucial, since miscalculation of either medicinal product or light dose may lead to a less effective treatment or cause detrimental effect to the patient.
Danish: Særlig omhu med at sikre præcis dosering af PhotoBarr og/eller lysdosis er afgørende, eftersom fejlberegning af enten medicinsk produkt eller lysdosis kan føre til en mindre effektiv behandling eller have en skadelig effekt på patienten.
English: The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
Danish: Serumhenfaldet var bi-eksponentielt med en langsom fordelingsfase og en meget lang eliminationsfase, der startede 24 timer efter injektion.
English: If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the patient can gradually resume normal outdoor activities, initially continuing to exercise caution and gradually allowing increased exposure.
Danish: Hvis der ikke forekommer nogen lysfølsomhedsreaktion (erythem, ødem, blisterdannelse) inden for 24 timer, kan patienten gradvist genoptage normale udendørs aktiviteter, idet han/hun i begyndelsen fortsætter med at udvise forsigtighed og gradvist tillader stigende eksposition.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/272/002
English: Skin and eye contact should be avoided due to the potential for photosensitivity reactions upon exposure to light; use of rubber gloves and eye protection is recommended.
Danish: Kontakt med hud og øjne skal undgås på grund af risikoen for lysfølsomhedsreaktioner efter eksponering for lys; det anbefales at anvende gummihandsker og beskyttelsesbriller.
English: The photosensitivity reactions occurred primarily on the face, hands, and neck regions, which are the areas of the skin that are most susceptible to accidental sunlight exposure.
Danish: Lysfølsomhedsreaktionerne optrådte primært i ansigtet, på hænderne og i halsregionerne, som er de hudområder, der er mest følsomme for tilfældig eksposition for sollys.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/272/001
English: Laser treatment should not be given if an overdose of PhotoBarr is administered.
Danish: Laserbehandling bør ikke gives, hvis der administreres en overdosis af PhotoBarr.
English: Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
Danish: Natriumporfimer er en blanding af porfyrinenheder, der er bundet sammen i kæder af to til otte enheder.
English: In the event of an overdose, patients should protect their eyes and skin from direct sunlight or bright indoor lights for 90 days.
Danish: I tilfælde af en overdosis skal patienterne beskytte deres øjne og hud mod direkte sollys eller stærkt indendørs lys i 90 dage.
English: They consist mainly of sunburn-like reactions, mild redness on exposed skin, usually the face and hands.
Danish: De består overvejende af solskoldningslignende reaktioner, let rødme på eksponeret hud, sædvanligvis i ansigtet og på hænderne.
English: Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen.
Danish: Spin-overførsel fra natriumporfimer til molekylært oxygen kan derpå generere singlet oxygen.
English: As with therapeutic overdose, any accidentally overexposed person must be protected from bright light.'
Danish: Som ved enhver terapeutisk overdosering skal utilsigtet overeksponerede personer beskyttes mod stærkt lys.
English: To calculate the light dose, the following specific light dosimetry equation applies for all fibre optic diffusers:
Danish: Til beregning af lysdosis gælder følgende specifikke ligning for lysdosimetri for alle fiberoptikdiffusorer:
English: Patients were followed every 3 months until 4 consecutive, quarterly follow-up endoscopic biopsy results were negative for HGD, and then biannually until the last enrolled patient had completed a minimum of 24 months of follow-up evaluations after randomisation.
Danish: Patienterne blev fulgt hver 3. måned, indtil 4 konsekutive, endoskopiske biopsiresultater ved kvartårlig opfølgning var negative for HGD, og derpå to gange om året, indtil den sidst indgåede patient havde fuldført et minimum på 24 måneders opfølgningsevalueringer efter randomisering.
English: Patients with BO > 7 cm, should have the remaining untreated length of Barrett's epithelium treated with a second PDT course at least 90 days later.
Danish: Patienter med BO > 7 cm skal have den resterende ubehandlede længde af Barretts epitel behandlet med en ny PDT-kur mindst 90 dage senere.
English: Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Danish: Clearance fra forskellige væv foregår i løbet af 40-72 timer, men tumorer, hud og organer i det retikuloendoteliale system (inklusive lever og milt) tilbageholder natriumporfimer i længere tid.
English: Conventional UV (ultraviolet) sunscreens are of no value in protecting against photosensitivity reactions because photoactivation is caused by visible light.
Danish: Konventionelle UV (ultraviolet) solbeskyttelsesmidler er uden værdi i beskyttelsen mod lysfølsomhedsreaktioner, fordi fotoaktivering forårsages af synligt lys.
English: Follow-up procedure
Danish: Opfølgningsprocedure
English: Therefore, patients should be advised to receive liquid food during the first days (up to 4 weeks) after the laser light application.
Danish: Derfor skal patienterne rådes til at indtage flydende kost i de første dage (indtil 4 uger) efter bestrålingen med laserlys.
English: Plasma samples were obtained out to 56 days (patients) or 36 days (volunteers) post-injection.
Danish: Plasmaprøver blev taget indtil 56 dage (patienter) eller 36 dage (frivillige) efter injektion.
English: Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/cm).
Danish: Tabel 2 leverer de indstillinger, der skal bruges for at levere dosen på den korteste tid (lysintensitet på 270 mW/cm).
English: In case of persistence of HGD, further treatment courses (up to a maximum of three courses) may be given (separated by a minimum of 90 days) to increase the response rate.
Danish: Hvis HGD persisterer, kan yderligere behandlingskure (indtil maksimalt tre kure) gives (adskilt af minimalt 90 dage) for at øge responsfrekvensen.
English: Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Danish: Mistænkt erosion af større blodkar på grund af risikoen for massiv, potentielt fatal blødning.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 2, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: If accidentally injected paravenously there may be damage to paravenous tissue.
Danish: Hvis det ved et uheld injiceres paravenøst, kan der komme beskadigelse af paravenøst væv.
English: The most frequently reported treatment-associated serious adverse reaction (SAR) was dehydration (4%), experienced by 5 patients.
Danish: Den mest hyppigt rapporterede behandlingsassocierede alvorlige bivirkning var dehydrering (4%) oplevet af 5 patienter.
English: If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
Danish: Hvis PDT skal anvendes før eller efter radioterapi, skal der være tilstrækkelig tid mellem terapierne til at sikre, at inflammationsreaktionen, der er fremkaldt af den første behandling, er svundet, inden den nye behandling påbegyndes.
English: What PhotoBarr contains
Danish: PhotoBarr indeholder
English: However, to speed up the natural process of inactivating the medicine in your body, it is good to expose the skin to normal levels of indoor light.
Danish: Imidlertid er det godt at fremskynde den naturlige proces med inaktivering af medicinen i Deres krop ved at udsætte huden for normalt indendørs lys.
English: Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than nonmelanoma skin cancer or if they had received prior PDT to the oesophagus.
Danish: Patienter blev udelukket fra undersøgelsen, hvis der forekom invasiv øsofaguscancer, hvis de havde cancer i sygehistorien udover ikke-melanomisk hudcancer, eller hvis de tidligere havde fået PDT på øsofagus.
English: A study investigating pharmacodynamic interactions has demonstrated that corticosteroids given before or concomitant with PDT to decrease formation of strictures may decrease the safety of treatment.
Danish: En studie, der undersøgte farmakodynamiske interaktioner har vist, at kortikosteroider indgivet før eller samtidig med PDT for at mindske strikturdannelse kan mindske behandlingssikkerheden.
English: Photodynamic therapy with PhotoBarr has exclusively been studied in patients not suffering from severe medical conditions, such as congestive heart failure of advanced stage or serious pulmonary conditions that might impair the eligibility of patients for surgical procedures.
Danish: Fotodynamisk terapi med PhotoBarr er udelukkende undersøgt på patienter, som ikke lider af alvorlige medicinske tilstande såsom kongestiv hjerteinsufficiens i fremskredent stadium eller alvorlige lungetilstande, der kunne vanskeliggøre patientudvælgelsen til kirurgiske procedurer.
English: How to use PhotoBarr 4.
Danish: Sådan skal De bruge PhotoBarr 4.
English: The recommended dose of PhotoBarr is 2 mg/kg body weight.
Danish: Den anbefalede dosis PhotoBarr er 2 mg/kg legemsvægt.
English: If patients travel to a different geographical area with greater sunshine, they should retest their level of photosensitivity.
Danish: Hvis patienter rejser til et andet geografisk område med kraftigere solskin, bør de foretage en ny test af deres grad af lysfølsomhed.
English: It is possible that prolonged exposure to light at the clinical research unit or accidental sunlight exposure after discharge may be responsible for the high frequency of photosensitivity reactions.
Danish: Det er muligt, at længerevarende eksposition for lys på den kliniske forskningsenhed eller tilfældig eksposition for sollys efter udskrivelsen kan være ansvarlig for den høje frekvens af lysfølsomhedsreaktioner.
English: Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Danish: Enogfyrre procent af patienterne fremviste normalt pladeepitel, og 49% havde fravær af dysplasi.
English: The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity (92%).
Danish: Hovedparten af behandlingsassocieret øsofagusstenose (som omfatter øsofagusforsnævring og øsofagusstrikturer) rapporteret i PhotoBarr PDT + OM-gruppen var af mild eller moderat intensitet (92%).
English: Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Danish: Cellebeskadigelsen forårsaget af natriumporfimer PDT er en følge af formeringen af frie radikal-reaktioner.
English: Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both medicinal product and light.
Danish: Fotodynamisk terapi med PhotoBarr er en totrinsproces, der kræver administration af både lægemiddel og lys.
English: If some photosensitivity reaction occurs with the limited skin test, the patient should continue exercising precautions for another 2 weeks before retesting.
Danish: Hvis der forekommer en vis lysfølsomhedsreaktion ved den begrænsede hudtest, bør patienten fortsat udvise forsigtighed i 2 uger inden fornyet test.
English: Tumour cell death also occurs through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release.
Danish: Tumorcelledød opstår også via iskæmisk nekrose sekundært til vaskulær okklusion, der viser sig at være delvist medieret af thromboxan A2frigørelse.
English: o Patients should be aware of potential risk factors (skin phototype and hepatic impairment).
Danish: o Patienterne skal kende til potentielle risikofaktorer (hudfølsomhedstype og nedsat leverfunktion).
English: Manufacturer Axcan Pharma SAS, Route de Bû, 78550 Houdan, France
Danish: Fremstiller Axcan Pharma SAS, Route de Bû, 78550 Houdan, Frankrig
English: One single-use vial per pack.
Danish: Ét hætteglas pr. pakke til éngangsbrug.
English: Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight
Danish: Rekonstitueret PhotoBarr-opløsning (ml) = patientens vægt (kg) x 2 mg/kg = 0,8 x patientens vægt
English: Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light.
Danish: Natriumporfimer var ikke mutagent i standard genotoksicitetstests i fravær af lys.
English: PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
Danish: PhotoBarr PDT forårsager direkte intracellulær beskadigelse ved at initiere radikalkæde-reaktioner, der beskadiger intracellulære membraner og mitokondrier.
English: Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to three courses of PDT (each injection separated by a minimum of 90 days) should be given to a previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment was >7 cm in length.
Danish: Patienterne kan modtage en ny PDT-kur efter mindst 90 dages forløb efter den initiale behandling; der bør gives indtil tre PDT-kure (med et mellemrum på mindst 90 dage mellem hver injektion) til et tidligere behandlet segment, der stadig frembyder HGD eller til et nyt segment, hvis det initiale Barretts segment var >7 cm langt.
English: These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria).
Danish: Disse manifestationer kan muligvis skyldes en pseudoporfyri-tilstand (forbigående lægemiddelinduceret kutan porfyri).
English: Women of child-bearing potential should use effective contraception before, during and for at least 90 days after treatment.
Danish: Kvinder i fertil alder bør anvende effektiv antikonception før, under og mindst 90 dage efter behandling.
English: In an open label pharmacokinetic study, all 24 healthy subjects experienced photosensitivity reactions, which were characteristically represented by erythematous rash and oedema and were mild to moderate in intensity.
Danish: I en open-label farmakokinetisk studie oplevede alle 24 raske personer lysfølsomhedsreaktioner, der var karakteristisk repræsenteret ved erythematøst udslet og ødem og var af mild til moderat intensitet.
English: No pharmacokinetic and safety data in patients with hepatic impairment are available.
Danish: Der er ingen tilgængelige farmakokinetiske data og sikkerhedsdata for patienter med leverfunktionsnedsættelse.
English: No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic interactions with other medicinal products.
Danish: Der er ikke udført interaktionsundersøgelser med PhotoBarr til undersøgelse af farmakokinetiske interaktioner med andre lægemidler.
English: Nutrition in Patients
Danish: Patienternes ernæring
English: Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
Danish: Toksikologistudier vedrørende reproduktion var utilstrækkelige til at understøtte sikkerheden af natriumporfimer under graviditet, da der ikke var blevet anvendt lysaktivering.
English: If intake of food and/or drink becomes impossible or repeated vomiting occurs, patients should be advised to return to the clinic for evaluation and to receive intravenous fluids if needed.
Danish: Hvis indtagelse af mad og/eller drikke bliver umulig, eller der kommer gentagne opkastninger, skal patienten tilrådes at vende tilbage til klinikken for evaluering og for, om nødvendigt, at få intravenøs væske.