FrancophonIA/ELRC3.0 huggingface dataset:
English: Levels of ocular toxicity in healthy rabbits and monkeys, particularly on the retina/choroid, correlated with medicinal product dose, light dose, and time of light treatment.
Danish: Graden af okulær toksicitet, særligt vedrørende retina/choroidea, hos raske kaniner og aber korrelerede med lægemiddeldosis, lysdosis og varigheden af lysbehandling.
English: Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.
Danish: Brug af infusionsfilter med hydrofil membran (såsom polyethersulfon) med en porestørrelse af mindst 1,2 m anbefales.
English: Such reactions should be avoided by compliance with the photosensitivity protection instructions given in section 4.4.
Danish: Sådanne reaktioner bør undgås ved omhyggelig efterlevelse af instruktionen om beskyttelse mod lys jf. pkt.
English: Please tell your doctor if you are breastfeeding.
Danish: Fortæl det til din læge, hvis du ammer.
English: It is important to tell your doctor if you are pregnant, if you think you may be pregnant or if you plan to become pregnant.
Danish: Hvis du er gravid, har mistanke om du er gravid eller planlægger at blive gravid, er det vigtigt, at du informerer din læge.
English: The pharmacokinetics of verteporfin have been reported to be similar in healthy Caucasian and Japanese men after a dose of 6 mg/m2 by a 10-minute infusion.
Danish: Verteporfins farmakokinetik er rapporteret til at være ens hos raske, mandlige kaukasere og japanere efter en dosis på 6 mg/m indgivet som en 10-minutters infusion.
English: The acute and light-dependent toxicity of verteporfin was characterised by dose dependent localised deep-tissue damage as a consequence of the pharmacological effect of PDT with verteporfin.
Danish: Verteporfins akutte og lysafhængige toksicitet blev karakteriseret ved dosisafhængige, lokale skader i det dybtliggende væv som en konsekvens af den farmakologiske effekt af PDT med verteporfin.
English: Pathological myopia
Danish: Patologisk myopi
English: The following inclusion criteria were considered for the treatment: patients older than 50 years of age, presence of CNV secondary to AMD, presence of classic lesion components in the CNV (defined as a well-demarcated area of the fluorescence on angiography), CNV located subfoveally (involved the geometric centre of the foveal avascular zone), area of classic plus occult CNV 50% of the total lesion surface, greatest linear dimension of the entire lesion 9 Macular Photocoagulation Study (MPS) disc area, and a best-corrected visual acuity between 34 and 73 letters (i.e. approximately 20/40 and 20/200) in the treated eye.
Danish: Der var følgende inklusionskriterier: Ældre end 50 år, forekomst af CNV sekundært til AMD, forekomst af klassisk komponent af læsion i CNV (defineret som et velafgrænset område set ved fluorescensangiografi), CNV lokaliseret subfovealt (involverende det geometriske centrum af den avaskulære zone i fovea), arealet af klassisk plus + okkult CNV 50% af læsionens totale overflade, største lineære dimension af hele læsionen ≤ 9 Macular Photocoagulation (MPS) disc area, og bedst korrigeret syn mellem 34 og 73 bogstaver (~ ca 20/40 og 20/200) i det behandlede øje.
English: Visudyne is not indicated in this population.
Danish: Visudyne er ikke indiceret til denne patientgruppe.
English: For the light activation of Visudyne, a diode laser generating non-thermal red light (wavelength 689 nm  3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens.
Danish: Til lysaktivering af Visudyne anvendes en diodelaser, som genererer ikke-temiskrødt lys (der har en bølgelængde på 689 nm ± 3 nm) via fiberoptik og en spaltelampe med brug af en passende kontaktlinse.
English: A retinal toxicity study in healthy dogs with intravenous verteporfin and ambient light on the eye showed no treatment-related ocular toxicity.
Danish: Et retinalt toksicitetsstudie med raske hunde, der fik verteporfin intravenøst og blev udsat for normalt lys i øjet, viste ingen behandlingsrelateret okulær toksicitet.
English: Visudyne is available in packs containing 1 vial of powder.
Danish: Visudyne forhandles i pakninger indeholdende 1 hætteglas med pulver.
English: However, photodynamic therapy (PDT) induces the formation of reactive oxygen species and has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross links which may result in chromosomal aberrations, sister chromatid exchanges (SCE) and mutations.
Danish: Fotodynamisk terapi (PDT) inducerer imidlertid dannelsen af aktiverede oxygenmolekyler og er rapporteret at resultere i ødelæggelse af DNA, herunder brud på DNA-strenge, alkali-labile områder, DNA-nedbrydelse og DNA-protein-krydskobling, som kan resultere i kromosomale afvigelser, søster-kromatid-udveksling (SCE) og mutationer.
English: The reaction occurred mainly in patients with occult only (4.9 %) or minimally classic CNV lesions in patients with AMD and was not reported for placebo-treated patients.
Danish: Denne hændelse forekom fortrinsvis hos patienter udelukkende med okkult CNV (4,9%) eller AMDpatienter med kun en lille andel af klassisk CNV-læsion og blev ikke set hos placebobehandlede patienter.
English: Another efficacy parameter was also defined: the proportion of patients who lost less than 30 letters (equivalent to 6 lines) of visual acuity at months 12 and 24 relative to baseline.
Danish: En anden effektparameter var også defineret; andel af patienter, som mistede mindre end 30 bogstaver (tilsvarende 6 linjer) i synsskarphed efter 12 og 24 måneder i forhold til baseline.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, sundhedspersonalet eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: What you need to know before you are given Visudyne
Danish: Det skal du vide, før du får Visudyne
English: Vision loss is caused by new blood vessels (choroidal neovascularisation) that damage the retina (the light-sensitive membrane that lines the back of the eye).
Danish: Synstab skyldes nye blodkar (choroidal neovaskularisering), der beskadiger nethinden (den lysfølsomme membran bagerst i øjet).
English: Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended.
Danish: Det anbefales at benytte et funduskamera med en forstørrelse af størrelsesordenen 2,4 - 2,6 gange.
English: 5, infusion-related reaction primarily presented as back pain
Danish: 5, infusionsrelateret smerte, fortrinsvis som rygsmerter
English: Pack containing 1 vial.
Danish: Pakningen indeholder 1 hætteglas.
English: Cmax after a 10-minute infusion of 6 and 12 mg/m body surface area in the target population is approximately 1.5 and 3.5 µg/ml, respectively.
Danish: Cmax er efter 10-minutters infusion af hhv. 6 og 12 mg/m legemsoverflade i målgruppen af patienter ca. 1,5 og 3,5 µg/ml.
English: A total of 609 patients were enrolled (402 Visudyne, 207 placebo).
Danish: I alt 609 patienter blev inkluderet (402 på Visudyne og 207 på placebo).
English: Since blood vessel occlusion is the major mechanism of verteporfin action, there is a theoretical possibility that agents such as vasodilators and those which diminish clotting and platelet aggregation (e.g. thromboxane A2 inhibitors) can antagonise the action of verteporfin.
Danish: Da verteporfins primære virkningsmekanisme er okklusion af blodkar, er der en teoretisk mulighed for, at midler såsom vasodilatorer og midler, som reducerer koagulation og blodpladeaggregation (fx tromboxan-A2-hæmmere) kan hæmme virkningen af verteporfin.
English: Tell your doctor or pharmacist if you are taking any of the following medicines, as they may increase your sensitivity to light: - tetracyclines or sulphonamides (used to treat bacterial infection), - phenothiazines (used to treat psychiatric disorders, or nausea and vomiting), - sulfonylurea (used to treat diabetes), - medicines used to lower blood sugar, - thiazide diuretics (used to reduce high blood pressure), - griseofulvin (used to treat fungal infection), - calcium channel blockers (used to treat high blood pressure, angina and abnormal heart rhythms), - antioxidants such as beta-carotene or medicines that can remove or inactivate free radicals (such as dimethylsulfoxide (DMSO), formate, mannitol and alcohol), - vasodilators (used to widen blood vessels resulting from smooth muscle relaxation), - or, if you are undergoing radiation therapy,
Danish: Fortæl din læge eller apotekspersonalet, hvis du bruger nogen af følgende lægemidler, da de kan forøge din lysfølsomhed: - Tetracykliner eller sulfonamider (bruges til at behandle bakterielle infektioner), - Fenothiazider (bruges til at behandle psykiske lidelser eller kvalme og opkastning), - Sulfonylurinsyre (bruges til at behandle sukkersyge), - Lægemidler til at nedsætte blodsukkeret, - Thiaziddiuretika (bruges til at nedsætte højt blodtryk), - Griseofulvin (bruges til at behandle svampeinfektion), - Calciumantagonister (bruges til at behandle forhøjet blodtryk, hjertekrampe (angina) og unormal hjerterytme), - Antioxidanter såsom beta-caroten eller lægemidler, som kan fjerne eller inaktivere frie radikaler
English: Anaphylactic reaction.
Danish: Anafylaktisk reaktion.
English: It is possible that concomitant use of other photosensitising medicinal products (e.g. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, hypoglycaemic medicinal products, thiazide diuretics, and griseofulvin) could increase the potential for photosensitivity reactions.
Danish: Det er muligt at samtidig brug af andre fotosensibiliserende lægemidler (f.eks. tetracycliner, sulfonamider, phenothiaziner, sulfonylurinstof, hypoglykæmiske præparater, tiaziddiuretika og griseofulvin) kan forøge potentialet for lysfølsomhedsreaktioner.
English: • Infusion site side effects: as with other types of injections, some patients experienced bleeding at the infusion site, change in skin colour and hypersensitivity.
Danish: • Bivirkninger på infusionsstedet: Som med andre typer af infusioner oplever nogle patienter blødning på infusionsstedet, ændringer i hudfarve og overfølsomhed.
English: Since verteporfin is excreted primarily via the biliary (hepatic) route, increased verteporfin exposure is possible.
Danish: Da verteporfin udskilles primært via galden (hepatisk), er der en øget mulighed for eksponering for verteporfin.
English: It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration.
Danish: Det anbefales, at rekonstitueret Visudyne inspiceres visuelt for partikler og misfarvning umiddelbart før anvendelse.
English: Visudyne has been studied in two randomised, placebo-controlled, double-masked, multicentre studies (BPD OCR 002 A and B or Treatment of Age-related Macular Degeneration with Photodynamic Therapy [TAP]).
Danish: Visudyne er blevet testet i 2 randomiserede, placebokontrollerede, dobbelt-blinde, multicenterforsøg (BPD OCR 002 A og B eller Treatment of Age-related Macular Degeneration with Photodynamic Therapy [TAP]).
English: Treatment of the second eye with Visudyne
Danish: Behandling af begge øjne med Visudyne
English: The most frequently reported adverse reactions to Visudyne (verteporfin for infusion) are injection site reactions (including pain, oedema, inflammation, extravasation, rashes, haemorrhage, discolouration) and visual impairment (including blurred, fuzzy vision, photopsia, reduced visual acuity and visual field defects, including scotoma and black spots).
Danish: De hyppigst rapporterede bivirkninger ved Visudyne (verteporfin til infusion) er reaktioner på infusionsstedet (herunder smerter, ødemer, inflammation, ekstravasation, udslæt, blødning, misfarvning), og synsforstyrrelser (inklusive sløret, uklart syn, fotopsi, nedsat synsskarphed og synsfeltsdefekter, herunder skotom og sorte pletter).
English: Chest pain, vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported.
Danish: Brystsmerte, vasovagale anfald og overfølsomhedsreaktioner relateret til infusion af Visudyne er blevet rapporteret.
English: Although there is no clinical evidence, theoretical data suggest that antioxidants (e.g. beta-carotene) or medicinal products which scavenge free radicals (e.g. dimethylsulfoxide (DMSO), formate, mannitol or alcohol) might quench the activated oxygen species generated by verteporfin, resulting in decreased verteporfin activity.
Danish: Selvom der ikke er nogen klinisk evidens, tyder teoretiske data på, at antioxidanter (fx beta-caroten) eller lægemidler, som neutraliserer frie radikaler (fx dimethylsulfoxid (DMSO), formiat, mannitol eller alkohol), kan dæmpe de aktiverede oxygenmolekyler, som genereres af verteporfin.
English: • First your doctor or the pharmacist will prepare the Visudyne infusion solution.
Danish: • Først tilberedes infusionsopløsningen med Visudyne af din læge eller apotek.
English: Ophthalmic toxicity
Danish: Oftalmisk toksicitet
English: On rare occasions the vasovagal and hypersensitivity reactions may be severe and potentially include seizures.
Danish: I sjældne tilfælde kan disse vasovagale og overfølsomhedsreaktioner være alvorlige, og de kan muligvis omfatte krampeanfald.
English: Retinal ischaemia (retinal or choroidal vessel non-perfusion).
Danish: Retinal iskæmi (nedsat gennemblødning i retinale eller koroidale kar).
English: Other photosensitising agents
Danish: Andre fotosensibiliserende midler
English: Visudyne precipitates in sodium chloride solution.
Danish: Visudyne udfældes i natriumchloridinfusionsvæsker.
English: Visudyne is also contraindicated in patients with porphyria and in patients with severe hepatic impairment (see “Hepatic impairment” under section 4.2).
Danish: Visudyne er også kontraindiceret hos patienter med porphyri, og hos patienter med alvorlig leverdysfunktion (se “Nedsat leverfunktion” under pkt.
English: Visudyne is indicated for the treatment of - adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or - adults with subfoveal choroidal neovascularisation secondary to pathological myopia.
Danish: Visudyne er indiceret til behandling af - voksne med exudativ (våd) aldersrelateret makuladegeneration (AMD) med fortrinsvis klassisk subfoveal choroidal neovaskularisation (CNV), eller - voksne med subfoveal choroidal neovaskularisation sekundært til patologisk myopi.
English: In pregnant rats, intravenous verteporfin doses of 10 mg/kg/day (approximately 40-fold human exposure at 6 mg/m based on AUCinf in female rats) were associated with an increased incidence of anophthalmia/microphthalmia and doses of 25 mg/kg/day (approximately 125-fold the human exposure at 6 mg/m based on AUCinf in female rats) were associated with an increased incidence of wavy ribs and anophthalmia/microphthalmia.
Danish: Hos gravide rotter blev intravenøse doser af verteporfin på 10 mg/kg/døgn (ca. 40 gange human eksponering ved 6 mg/m baseret på AUCinf hos hunrotter) associeret med en øget forekomst af anoftalmi/mikroftalmi, og doser på 25 mg/kg/døgn (ca. 125 gange human eksponering ved 6 mg/m baseret på AUCinf hos hunrotter) blev associeret med en øget forekomst af bølgede ribben og anoftalmi/mikroftalmi.
English: • Heart attack has been reported, particularly in patients with a history of heart disease, sometimes within 48 hours after treatment with Visudyne.
Danish: • Hjerteanfald, særligt hos patienter med en sygehistorie med hjertesygdom, er blevet rapporteret indenfor 48 timer efter behandling med Visudyne.
English: The studies showed a difference of 15 % between treatment groups (61% for Visudyne-treated patients compared to 46% placebo-treated patients, p<0.001, ITT analysis).
Danish: Forsøgene viste en forskel på 15% mellem de behandlede grupper (61% for Visudynebehandlede mod 46% af de placebo-behandlede patienter, p<0,001, ITT analyse).
English: Age-related macular degeneration with occult with no classic lesions
Danish: Aldersrelateret makula degeneration med okkult læsion uden klassisk komponent
English: 15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap.
Danish: 15 mg pulver til infusionsvæske, opløsning, i engangshætteglas (type I), forseglet med brombutylgummiprop og aluminiumshætte til at tage af.
English: In the TAP study in all lesion types, the average number of treatments per year were 3.5 in the first year after diagnosis and 2.4 in the second for the randomised placebo-controlled phase and 1.3 in the third year, 0.4 in the fourth and 0.1 in the fifth year for the open-label extension phase.
Danish: I TAP-forsøget ved samtlige læsionstyper, var det årlige antal af gennemsnitlige behandlinger 3,5 i det første år efter diagnostisering, 2,4 i det andet år for den placebokontrolleret fase, 1,3 i det tredje år, 0,4 i det fjerde år og 0,1 i det femte år ved den åbne/ublindede ekstensionsfase.
English: - If, during the infusion, Visudyne goes outside the vein, and especially if the affected area is exposed to light, this can cause pain, swelling, blistering and a change in skin colour in the area of the leakage.
Danish: - Hvis Visudyne kommer udenfor venen under infusionen, og især hvis det berørte område udsættes for lys, kan der opstå smerte, hævelse, blærer og misfarvning af huden omkring injektionsstedet.
English: In the VIP-PM study in pathological myopia, the average number of treatments per year were 3.5 in the first year after diagnosis and 1.8 in the second for the randomised placebo-controlled phase and 0.4 in the third year, 0.2 in the fourth and 0.1 in the fifth year for the open-label extension phase.
Danish: I VIP-PM-forsøget ved patologisk myopi, var det årlige antal af gennemsnitlige behandlinger 3,5 i det første år efter diagnosticering, 1,8 i det andet år for den placebokontrolleret fase, 0,4 i det tredje år, 0,2 i det fjerde år og 0,1 i det femte år ved den åbne/ublindede ekstensionsfase.
English: Infusion-related back and chest pain, which may radiate to other areas, including, but not limited to, the pelvis, shoulder girdle or rib cage.
Danish: Infusionsrelateret ryg- og brystsmerte, som kan brede sig til andre områder, men ikke begrænset til at inkludere bækkenet, skuldre eller brystkasse.
English: 364 patients (244 verteporfin, 120 placebo) were enrolled in this study.
Danish: 364 patienter (244 verteporfin, 120 placebo) deltog i dette forsøg.
English: Patients should not drive or use machines as long as these symptoms persist.
Danish: Patienter skal undlade bilkørsel eller betjening af maskiner, indtil synet er normaliseret.
English: Visudyne contains small amounts of butylated hydroxytoluene (E321) This ingredient is irritant to eyes, skin and mucous membranes.
Danish: Visudyne indeholder små mængder af butylhydroxytoluen (E321) Dette indholdsstof virker irriterende på øjne, hud og slimhinder.
English: Visudyne contains small amounts of butylated hydroxytoluene (E321), which may be irritant to eyes, skin and mucous membranes.
Danish: Visudyne indeholder små mængder af butyleret hydroxytoluen (E321), som kan irritere øjnene, huden og slimhinderne.
English: Severe reduced visual acuity
Danish: Svær nedsat synsskarphed
English: The primary efficacy variable was responder rate, defined as the proportion of patients who lost less than 15 letters (equivalent to 3 lines) of visual acuity (measured with the ETDRS charts) at month 12 relative to baseline.
Danish: Det primære effektkriterie var responderratio, defineret som andelen af patienter, som havde mistet mindre end 15 bogstaver (svarende til 3 linjer målt med ETDRS kort) efter 12 måneder relateret til basistidspunkt.
English: There were no teratogenic effects observed in rabbits at doses up to 10 mg/kg/day (approximately 20-fold human exposure at 6 mg/m based on body surface area).
Danish: Der blev ikke påvist teratogen virkning hos kaniner ved doser på op til 10 mg/kg/døgn (ca. 20 gange human eksponering ved 6 mg/m baseret på legemsoverfladeareal).
English: Partial recovery of vision was observed in some patients.
Danish: Hos nogle patienter er der set delvis normalisering af synet.
English: At month 24, a statistically significant difference of 12.9% in favour of Visudyne compared to placebo was observed (46.2% versus 33.3%, p=0.023).
Danish: Efter 24 måneder sås en statistisk signifikant forskel på 12,9% til fordel for Visudyne sammenlignet med placebo (46,2% mod 33,3%, p=0,023).
English: Patients who receive Visudyne will become photosensitive for 48 hours after the infusion.
Danish: Patienter i behandling med Visudyne bliver lysfølsomme i 48 timer efter behandlingen.
English: There are no clinical data on the use of Visudyne in anaesthetised patients.
Danish: Der eksisterer ingen data vedrørende brug af Visudyne hos anæsteserede patienter.
English: Talk to your doctor, pharmacist or nurse before you are given Visudyne - If you experience any infusion-related problems or symptoms during or following the treatment such as chest pain, sweating, dizziness, rash, breathlessness, flushing, irregular heart beat or seizure, please tell your doctor or nurse immediately, as the infusion may need to be stopped and your condition may need to be treated urgently.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Visudyne - Hvis du oplever nogle infusions-relaterede problemer eller symptomer under eller efter behandlingen såsom brystsmerter, svedudbrud, svimmelhed, udslæt, åndenød, ansigtsrødme, uregelmæssig hjerterytme eller anfald, skal du straks fortælle det til din læge eller sygeplejerske.
English: 2, visual impairment such as reduced visual acuity, blurred, fuzzy vision, or photopsia, visual field defect such as scotoma, grey or dark haloes and black spots.
Danish: 2, synsforstyrrelser såsom reduceret synsskarphed, sløret, sløret syn, eller fotopsi, defekter i synsfeltet som scotoma, grå eller mørke ringe og sorte pletter.
English: This 15% difference between treatment groups was confirmed at 24 months (53% Visudyne versus 38% placebo, p<0.001).
Danish: Denne 15% difference mellem de behandlede grupper blev bekræftet efter 24 måneder (53% for Visudyne mod 38% for placebo, p<0,001).
English: The VIO study included patients with occult with no classic subfoveal CNV with a visual acuity score of 73-34 letters (20/40-20/200), and patients with lesions >4 MPS disc areas were to have baseline visual acuity <65 letters (<20/50).
Danish: VIO-forsøget omfattede patienter med okkult, ikke klassisk, subfoveal CNV med en synsskarphed på 73-34 bogstaver (20/40-20/200), og patienter med læsioner >4 MPS diskområder skulle have en baseline ved synsskarphed <65 bogstaver (<20/50).
English: The percentage of patients who lost less than 1.5 lines was 64% for Visudyne and 49% for placebo (p=0.106).
Danish: Andelen af patienter som mistede mindre end 1,5 linje var 64% i Visudynegruppen og 49% i den placebobehandlede gruppe (p=0,106).
English: • Eye disorders: severe decrease of vision (loss of 4 lines or more within 7 days of treatment), visual disturbances such as blurred, hazy or fuzzy vision, flashes of light, decreased vision, and a change in the field of vision in the treated eye such as grey or dark shadows, blind spots or black spots.
Danish: • Øjensygdomme: Alvorligt synstab (tab af 4 linier eller mere indenfor 7 dage efter behandling), synsforstyrrelser i det behandlede øje, såsom sløret, tåget eller uklart syn, lysglimt, nedsat syn og ændringer i synsfeltet såsom grå eller sorte skygger, blinde eller sorte pletter.
English: The treatment spot should cover all neovasculature, blood and/or blocked fluorescence.
Danish: Alle nydannede kar, alt blod og/eller blokeret fluorescens skal dækkes af pletten, der behandles.
English: This study also included patients with classic containing CNV with a visual acuity score >70 letters (20/40).
Danish: Dette forsøg inkluderede også patienter med klassisk CNV med en synsskarphed på >70 bogstaver (20/40).
English: Shelf-life after reconstitution and dilution: see package leaflet.
Danish: Holdbarhed efter rekonstitution og fortyndning: Se indlægsseddel.