FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not be given Visudyne - if you are allergic to verteporfin or any of the other ingredients of this medicine (listed in section 6).
Danish: Du bør ikke få Visudyne - hvis du er allergisk over for verteporfin eller et af de øvrige indholdsstoffer i Visudyne (angivet i punkt 6).
English: When you are given an infusion of Visudyne, it is distributed within your body through the blood vessels, including the blood vessels at the back of the eye.
Danish: Når du får en infusion af Visudyne, fordeles lægemidlet i din krop via blodårerne, herunder blodkarrene bagerst i øjet.
English: Studies in animals have shown teratogenic effects in one species (rat) (see section 5.3).
Danish: Forsøg på dyr har vist teratogene effekter hos en dyreart (rotter) (se pkt.
English: There are no clinical data to support concomitant treatment of the second eye.
Danish: Der findes ikke kliniske data, der understøtter samtidig behandling af begge øjne.
English: The posology and retreatments were the same as in the AMD studies.
Danish: Dosering og genbehandlingsregime var det samme som for AMD afprøvningerne.
English: Treatment with Visudyne is a two-step process
Danish: Behandling med Visudyne er en to-trins-proces.
English: No studies have been conducted to evaluate the carcinogenic potential of verteporfin.
Danish: Der er ikke udført studier, der vurderer verteporfins karcinogene potentiale.
English: - Do not stay in the dark because exposure to normal indoor lighting will help your body to eliminate Visudyne more quickly.
Danish: - Ophold dig ikke i mørke, da ophold i normal indendørsbelysning vil medvirke til at Visudyne hurtigere udskilles af kroppen.
English: You should not be given Visudyne.
Danish: I givet fald må du ikke få Visudyne.
English: Presence of occult CNV lesions (fluorescence not well demarcated on the angiogram) was allowed.
Danish: Tilstedeværelse af okkult CNV læsion (ikke velafgrænset fluorescens på angiogrammet) var tilladt.
English: When the laser light is shone into the eye, Visudyne is activated.
Danish: Når øjet belyses med laserlys, bliver Visudyne aktiveret.
English: Use in children Visudyne is a treatment for adults only and not indicated for the use in children.
Danish: Brug til børn Visudyne er en behandling til voksne og er ikke beregnet til børn.
English: In patients followed from month 24 onwards and treated with uncontrolled, open-label Visudyne treatment as needed, long-term extension data suggest that month-24 vision outcomes may be sustained for up to 60 months.
Danish: Hos patienter som blev fulgt fra måned 24 og frem, i et ukontrolleret, åbent/ublindet forsøg, hvor Visudynebehandling blev givet ved behov, tyder udvidet langtidsdata på at 24-måneders resultater for synet er vedvarende for op til 60 måneder.
English: Reconstituted Visudyne is an opaque dark green solution.
Danish: Rekonstitueret Visudyne er en uigennemsigtig mørkegrøn opløsning.
English: Adults, including the elderly (≥65 years old) Visudyne photodynamic therapy (PDT) is a two-step process:
Danish: Voksne inklusive ældre (≥65 år) Photodynamisk terapi med Visudyne (PDT) er en to-trinsprocedure.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du bruger nogen form for medicin.
English: There are no human fertility data for verteporfin.
Danish: Der er ingen humane fertilitetsdata for verteporfin.
English: Myocardial infarction has been reported, particularly in patients with previous cardiovascular history, sometimes within 48 hours after the infusion.
Danish: Myokardieinfarkt er blevet rapporteret, især hos patienter med tidligere kardiovaskulære tilfælde, nogle gange inden for 48 timer efter infusionen.
English: Single and repeated dose toxicity
Danish: Toksicitet ved enkelt- og gentaget dosis
English: Patients should be under close medical supervision during the Visudyne infusion.
Danish: Patienterne bør være under tæt medicinsk overvågning under Visudyneinfusionen.
English: Visudyne contains the active substance verteporfin, which is activated by light from a laser in a treatment called photodynamic therapy.
Danish: Visudyne indeholder det aktive stof verteporfin, som aktiveres af laserlys i en behandling som kaldes fotodynamisk terapi.
English: It produces cytotoxic agents only when activated by light in the presence of oxygen.
Danish: Der produceres kun cytotoksiske stoffer, når verteporfin aktiveres af lys i tilstedeværelse af oxygen.
English: If you come into direct contact with Visudyne, you must therefore wash it off thoroughly with water.
Danish: Hvis du kommer i direkte kontakt med Visudyne, skal du sørge for at skylle grundigt efter med vand.
English: In non-clinical studies, no impairment of fertility and no genotoxicity have been observed (see section 5.3).
Danish: I ikke-kliniske undersøgelser, er der hverken observeret forringelse af fertilitet eller genotoksicitet (se pkt.
English: It should therefore not be administered to nursing mothers, or breastfeeding should be interrupted for 48 hours after administration.
Danish: Lægemidlet bør derfor ikke anvendes til ammende mødre, eller amning bør afbrydes i 48 timer efter behandlingen.
English: Overdose of Visudyne and light in the treated eye may result in severe vision decrease.
Danish: Overdosering af Visudyne og lys i det behandlede øje kan resultere i alvorlig synsnedsættelse.
English: Nausea.
Danish: Kvalme.
English: The powder is reconstituted in water prior to use to form an opaque dark green solution.
Danish: Pulveret rekonstitueres i vand umiddelbart før brug og danner en uigennemsigtig mørkegrøn opløsning.
English: Although mean plasma Cmax and AUC values in elderly patients who received verteporfin are higher than those in young volunteers or patients, these differences are not considered to be clinically significant.
Danish: Selvom de gennemsnitlige plasma-Cmax- og AUC-værdier er højere hos ældre verteporfin-behandlede patienter end hos unge raske frivillige eller unge patienter, anses disse forskelle ikke for at være klinisk signifikante.
English: The safety and efficacy of Visudyne in the paediatric population have not been established.
Danish: Visudynes sikkerhed og virkning hos den pædiatriske population er ikke klarlagt.
English: Photosensitivity reactions (in 2.2 % of patients and <1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
Danish: Lysoverfølsomhedsreaktioner (hos 2,2% af patienterne og ved <1% af Visudynebehandlingerne) skete i form af solskoldning efter eksponering med sollys normalt indenfor 24 timer efter behandlingen med Visudyne.
English: By itself, the clinically recommended dose of verteporfin is not cytotoxic.
Danish: Den klinisk anbefalede dosis af verteporfin er ikke cytotoksisk i sig selv.
English: If you are given more Visudyne than you should be Overdose of Visudyne may prolong the time during which you are sensitive to light and you may need to follow the protection instructions given in section 2 for longer than 48 hours.
Danish: Overdosering af Visudyne kan forlænge tiden, hvor du er lysfølsom, og du kan blive nødt til at følge instruktionerne om beskyttelse i punkt 2 ud over de påkrævede 48 timer.
English: Patients who experience a severe decrease of vision (equivalent to 4 lines or more) within one week after treatment should not be re-treated, at least until their vision has completely recovered to pretreatment level and the potential benefits and risks of subsequent treatment have been carefully considered by the treating physician.
Danish: Patienter, som får et alvorligt synstab (svarende til 4 linjer eller mere) indenfor en uge efter behandling, bør ikke behandles igen, i det mindste ikke før synet er som før behandlingen, og den mulige risk/benifit af efterfølgende behandling er overvejet nøje af den behandlende læge.
English: If material is spilled, it should be contained and wiped up with a damp cloth.
Danish: Hvis materialet spildes, skal det tørres op med en fugtig klud.
English: Name and address of manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m
Danish: Eksponeringsgraden og den maksimale plasmakoncentration er proportional med dosis i intervallet 6 til 20 mg/m2.
English: Caution should therefore be exercised when using Visudyne concomitantly with other photosensitising medicinal products (see “Photosensitivity and exposure to light” under section 4.4).
Danish: Forsigtighed bør derfor udvises ved anvendelse af Visudyne samtidig med andre fotosensibiliserende lægemidler (se “Fotosensitivitet og udsættelse for lys” under pkt.
English: In a study of patients with mild hepatic impairment (defined as having two abnormal hepatic function tests at enrolment), AUC and Cmax were not significantly different from the control group.
Danish: I et studie med patienter med let nedsat leverfunktion (defineret som to unormale leverfunktionsværdier ved inkluderingen) var AUC og Cmax ikke signifikant forskellige fra kontrolgruppen.
English: The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see “Method of administration”).
Danish: Andet trin er aktivering af Visudyne med lys 15 minutter efter infusionens start (se “Administration”).
English: For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion.
Danish: Ved behandling af læsioner, der er større end dette, skal lyset rettes mod det størst mulige aktive område af læsionen.
English: Risk of severe decrease of vision
Danish: Risiko for alvorligt synstab
English: Uncommon (may affect up to 1 in 100 people) • General disorders: pain, increased blood pressure, increased sensation, and fever.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) • Almene symptomer: smerte, forhøjet blodtryk, øget følsomhed, feber.
English: On rare occasions these reactions may be severe and potentially include convulsions.
Danish: I sjældne tilfælde kan disse reaktioner være alvorlige, og de kan potentielt omfatte krampeanfald.
English: The primary efficacy parameter was the same as in TAP (see above), with an additional endpoint of month 24 defined.
Danish: Den primære effektparameter var den samme som i TAP (se ovenfor), med et ekstra defineret endepunkt efter 24 måneder.
English: Toxicity observed following multiple doses of verteporfin without light was associated mainly with effects on the haematopoietic system.
Danish: Den toksicitet, som blev observeret efter flere doser af verteporfin uden lys, var hovedsageligt knyttet til påvirkninger af det hæmatopoietiske system.
English: In human plasma, 90% of verteporfin is associated with plasma lipoprotein fractions and approximately 6% are associated with albumin.
Danish: I humant plasma er 90% bundet til plasmalipoproteiner, og ca. 6% er bundet til albumin.
English: The higher incidence of back pain during infusion in the Visudyne group was not associated with any evidence of haemolysis or allergic reaction and usually resolved by the end of the infusion.
Danish: Den højere forekomst af rygsmerter under infusion i Visudyne-gruppen var ikke forbundet med tegn på hæmolyse eller allergisk reaktion og forsvandt normalt ved afslutningen af infusionen.
English: Syncope, headache, dizziness
Danish: Synkope, hovedpine, svimmelhed
English: Patients should not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help eliminate the medicinal product quickly through the skin by a process called photobleaching.
Danish: Patienter skal ikke opholde sig i mørke, men skal tilskyndes til at udsætte huden for normal indendørsbelysning, da det vil hjælpe med til at eliminere det aktive stof hurtigt gennem huden af en proces, der kaldes photobleaching.
English: Overdose of the medicinal product and/or light in the treated eye may result in non-selective nonperfusion of normal retinal vessels, with the possibility of severe vision decrease.
Danish: En overdosis af lægemidlet og/eller lys i det behandlede øje kan muligvis resultere i ikke-selektiv manglende perfusion af normale retinale kar med mulighed for alvorlig synsnedsættelse.
English: Singlet oxygen causes damage to biological structures within the diffusion range, leading to local vascular occlusion, cell damage and, under certain conditions, cell death.
Danish: Singlet oxygen forårsager skade på biologiske strukturer, der er indenfor diffusionsradius, førende til lokal vaskulær okklusion, celleskade og under særlige omstændigheder celledød.
English: The selectivity of PDT using verteporfin is based, in addition to the localised light exposure, on selective and rapid uptake and retention of verteporfin by rapidly proliferating cells including the endothelium of choroidal neovasculature.
Danish: PDTs selektivitet ved brug af verteporfin baseres, foruden på den lokaliserede lyseksponering, på selektiv og hurtig optagelse og retention af verteporfin i hurtigtdelende celler inklusiv endoteliet i choroidal neovaskulatur.
English: Do not use normal sodium chloride solutions or other parenteral solutions.
Danish: Brug derfor ikke standard natriumchloridinfusionsvæsker eller andre parenterale opløsninger.
English: A maximum 2-fold inter-individual variation in plasma concentrations at Cmax (immediately after end of the infusion) and at the time of light administration was found for each Visudyne dose administered.
Danish: Den maksimale inter-individuelle forskel i plasmakoncentrationer ved Cmax (umiddelbart efter afslutning af infusion) og på tidspunktet for lysbehandling var af en størrelsesorden 2 for hver af de administrerede Verteporfin doser.
English: Combined excretion of verteporfin and BPD-DA in human urine was less than 1%, suggesting biliary excretion.
Danish: Den samlede udskillelse af verteporfin og BPD-DA i human urin var mindre end 1% indikerende biliær ekskretion.
English: If you experience any of these, tell your doctor straight away.
Danish: Hvis du oplever nogen af disse bivirkninger, skal du kontakte din læge med det samme.
English: If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.
Danish: Anvendes infusionsvæsken ikke straks, har brugeren ansvar for opbevaringsbetingelser og holdbarhedstid, som ikke bør overskride 4 timer, opbevaret under 25C og beskyttet mod lys.
English: Verteporfin was not genotoxic in the absence or presence of light in the usual battery of genotoxic tests.
Danish: Verteporfin var ikke genotoksisk hverken sammen med eller uden lys i de sædvanlige genotoksicitetstest.
English: Protect the affected area thoroughly from bright direct light until swelling and discoloration have disappeared, and put cold compresses on the injection site.
Danish: Det afficerede område skal beskyttes omhyggeligt mod kraftigt direkte lys indtil hævelse og misfarvning er forsvundet, og der bør anbringes et koldt kompres på injektionsstedet.
English: If patients have to go outdoors in daylight during the first 48 hours after treatment, they must protect their skin and eyes by wearing protective clothing and dark sunglasses.
Danish: Hvis patienter ønsker at bevæge sig udendørs i dagslys de første 48 timer efter behandling, skal de beskytte deres hud og øjne med dækkende tøj og mørke solbriller.
English: Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
Danish: Indehaver af markedsføringstilladelsen CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
English: Based on theoretical data and despite the lack of clinical evidence these agents might result in enhanced verteporfin tissue-uptake when used concurrently.
Danish: Baseret på teoretiske data og til trods for manglende evidens kan disse midler muligvis medføre øget optagelse af verteporfin i vævet ved samtidig brug.
English: Prolonged exposure to light from light-emitting medical devices such as pulse oximeters should also be avoided for 48 hours following Visudyne administration.
Danish: Forlænget eksponering af lys fra medicinske lyskilder såsom pulse oximeter bør ligeledes undgås i de første 48 timer efter Visudynebehandlingen.
English: Age-related macular degeneration with predominantly classic subfoveal lesions
Danish: Aldersrelateret makula degeneration med fortrinsvis klassisk subfoveal læsion
English: In relation to TAP extension:
Danish: Angående TAP-ekstensionsforsøget:
English: It will be administered by your doctor or nurse into a vein using a drip (intravenous infusion).
Danish: Opløsningen vil blive givet af lægen eller sygeplejerskeren i et drop i en vene (intravenøs infusion).
English: At the recommended light intensity of 600 mW/cm2, it takes 83 seconds to deliver the required light dose of
Danish: Ved den anbefalede lysstyrke på 600 mW/cm2, tager det 83 sekunder at levere den nødvendige anbefalede lysdosis på 50 J/cm
English: The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography.
Danish: Den største diameter af den choroidale neovaskulære læsion bestemmes ved hjælp af fluoresceinangiografi og fotografering af fundus.
English: Infusion-related chest pain
Danish: Infusionsrelateret brystsmerte
English: However the pharmacological characteristics do not indicate any need to adjust the dose (see “Biotransformation” and “Elimination” under section 5.2).
Danish: De farmakologiske egenskaber antyder dog ingen grund til dosisjustering (se “Biotransformation” og “Elimination” i pkt.
English: The objective was to demonstrate the long-term efficacy and safety of photodynamic therapy with verteporfin in limiting the decrease in visual acuity in patients with subfoveal choroidal neovascularisation due to age-related macular degeneration.
Danish: Formålet var at vise langtidseffekt og sikkerhed af fotodynamisk behandling med verteporfin med hensyn til begrænsning i synstab hos patienter med subfoveal choroidal neovaskularisation på grund af aldersrelateret makuladegeneration.
English: Undesirable effects reported in patients with pathological myopia were similar to those reported in patients with AMD.
Danish: Bivirkningerne, som blev rapporteret hos patienter med patologisk nærsynethed, lignede de bivirkninger, der er rapporteret hos patienter med AMD.
English: Medicinal products which antagonise blood vessel occlusion
Danish: Lægemidler som hæmmer blodkar-okklusion
English: Overdose of the medicinal product may result in the prolongation of the period during which the patient remains photosensitive.
Danish: Overdosering af lægemidlet kan resultere i forlængelse af perioden for lysfølsomhed.
English: Pharmacotherapeutic group: Ophthalmologicals, Antineovascularisation agents, ATC code: S01LA01
Danish: Farmakoterapeutisk klassifikation: Ophthalmologica, antineovaskulære midler, ATC-kode: S01LA01
English: After Visudyne treatment you may have some vision problems, such as abnormal or decreased vision, which may be temporary.
Danish: Efter behandling med Visudyne, kan du få nogle synsproblemer, såsom unormalt eller nedsat syn, som kan være forbigående.
English: What Visudyne is
Danish: Hvad er Visudyne
English: Vasovagal reactions
Danish: Vasovagale reaktioner
English: The volume of distribution of around 0.60 l/kg at steady state and clearance of around 101 ml/h/kg has been reported following a 10-minute infusion in dose range of 3-14 mg/m2.
Danish: Et distributionsvolumen på omkring 0,60 l/kg ved steady state og en clearance på omkring 101 ml/time/kg er blevet rapporteret efter en 10-minutters infusion i doseringsintervaller 3-14 mg/m2.
English: Agents which increase verteporfin uptake in the vascular endothelium
Danish: Midler som øger verteporfin-optagelsen i det vaskulære endotel
English: Agents such as calcium channel blockers, polymixin B, and radiation therapy are known to alter the vascular endothelium.
Danish: Midler såsom calciumantagonister og polymyxin B samt strålebehandling ændrer det vaskulære endotel.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion.
Danish: • Dernæst skal Visudyne aktiveres i øjet 15 minutter efter, at infusionen er begyndt.
English: Results indicate that, at 12 months, Visudyne was statistically superior to placebo in terms of the proportion of patients responding to the treatment.
Danish: Resultatet efter 12 måneder viser signifikant bedre effekt af Visudyne end af placebo med hensyn til den andel af patienterne, der har responderet på behandlingen.
English: What Visudyne contains - The active substance is verteporfin.
Danish: Visudyne indeholder: - Aktivt stof: verteporfin.
English: - If you have any liver problems or a blockage of your bile duct, please tell your doctor before starting Visudyne therapy.
Danish: - Hvis du lider af leverproblemer eller blokering af galdegangen, skal du fortælle det til din læge før behandling med Visudyne.
English: Plasma elimination half-life mean values ranged from approximately 5-6 hours for verteporfin.
Danish: Den gennemsnitlige halveringstid i plasma varierede fra 5-6 timer for verteporfin.
English: If this happens to you, there will be increased sensitivity to light in that part of the skin until the green discolouration disappears.
Danish: Hvis du oplever dette, vil du være ekstra lysoverfølsom på hudområdet, indtil den grønne misfarvning forsvinder.
English: The ester group of verteporfin is hydrolysed via plasma and hepatic esterases, leading to the formation of benzoporphyrin derivative diacid (BPD-DA).
Danish: Estergruppen af verteporfin hydrolyseres via plasma og leveresteraser, førende til dannelse af benzoporphyrin disyrederivat (BPD-DA).
English: Severely reduced visual acuity, equivalent to 4 lines or more, within seven days after treatment was reported in 2.1 % of the verteporfin-treated patients in the placebo-controlled ocular Phase III clinical studies and in less than 1 % of patients in uncontrolled clinical studies.
Danish: Der blev inden for 7 dage efter behandlingen observeret svært synstab, svarende til 4 linjer eller mere, hos 2,1% af de verteporfinbehandlede patienter i de placebokontrollerede fase IIIundersøgelser og hos mindre end 1% af patienterne i ukontrollerede kliniske forsøg.
English: In such cases, the patient should prolong skin and eye protection from direct sunlight or bright indoor light for a period proportionate with the overdose given.
Danish: I sådanne tilfælde bør patienten forlænge perioden for beskyttelse af hud og øjne mod direkte sollys og skarp indendørsbelysning proportionalt med den givne overdosis.
English: Patients should be under close medical supervision during the Visudyne infusion and caution should be exercised when Visudyne treatment under general anaesthesia is considered.
Danish: Patienterne bør være under tæt medicinsk overvågning under infusionen af Visudyne, og der bør iagttages forsigtighed, hvis det overvejes at foretage behandling med Visudyne under generel anæstesi.
English: Verteporfin and its diacid metabolic are excreted in human milk in low amounts.
Danish: Verteporfin og dens divalente syremetabolitter udskilles i human mælk i små mænger.
English: Cases of anaphylactic reactions have been observed in patients receiving Visudyne.
Danish: Tilfælde af anafylaktiske reaktioner er blevet observeret hos patienter som fik Visudyne.
English: - If you experience any eye problems after the treatment, such as a vision loss, talk to your doctor.
Danish: - Hvis du efter behandlingen får øjenproblemer, såsom synstab skal du kontakte din læge.