FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid extravasation, a free-flowing intravenous line should be established before starting Visudyne infusion and the line should be monitored.
Danish: For at forhindre extravasation bør det sikres at infusionen løber frit inden infusion af Visudyne påbegyndes.
English: General symptoms can include headache, malaise, syncope, hyperhydrosis, dizziness, rash, urticaria, pruritus, dyspnoea, flushing, and changes in blood pressure and heart rate.
Danish: Generelle symptomer kan inkludere hovedpine, utilpashed, synkope, hyperhydrosis, svimmelhed, udslæt, urticaria, pruritus, dyspnø, ansigtsrødme og ændringer i blodtryk og hjerterytme.
English: No studies on the pharmacokinetics of verteporfin in patients with renal impairment are reported.
Danish: Der er ingen studier, hvor verteporfins farmakokinetik undersøges hos patienter med nedsat nyrefunktion.
English: Respiratory, thoracic and mediastinal disorders Common
Danish: Luftbeje, thorax og mediastinum Almindelig
English: What Visudyne looks like and contents of the pack Visudyne is supplied as a dark green to black powder in a clear glass vial.
Danish: Visudyne leveres som et mørkegrønt til sort pulver i et klart hætteglas.
English: The following adverse reactions were considered potentially related to Visudyne therapy.
Danish: Følgende bivirkninger er muligvis relateret til Visudynebehandling.
English: 7.5 ml of reconstituted solution contains 15 mg of verteporfin.
Danish: 7,5 ml rekonstitueret infusionsvæske indeholder 15 mg verteporfin.
English: • Infusion site side effects: as with other types of injections, some patients experienced pain,
Danish: • Bivirkninger på infusionsstedet: som ved andre injektioner oplever nogle patienter smerte,
English: • Eye disorders: bleeding of the retina or into the vitreous humour (the clear gel-like substance that fills the eyeball behind the lens), swelling or fluid retention in the retina and displacement of the retina in the treated eye.
Danish: • Øjensygdomme: Nethindeblødning eller blødning i glaslegemet (den klare gelelignende substans som fylder øjeæblet bag ved linsen), hævelse eller ophobning af væske i nethinden og forskydning af nethinden i det behandlede øje.
English: Visudyne should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia.
Danish: Visudyne bør kun administreres af øjenlæger, som har erfaring med behandling af patienter med aldersrelateret makuladegeneration eller patologisk myopi.
English: The VIP-AMD included patients with occult with no classic subfoveal CNV with a visual acuity score of >50 letters (20/100).
Danish: VIP-AMD-forsøgene omfattede patienter med okkult, ikke klassisk subfoveal CNV med en synsskarphed på >50 bogstaver (20/100).
English: Visudyne is used for the treatment of predominantly classic choroidal neovascularisation in adults with age-related macular degeneration, and also for the treatment of all types of choroidal neovascularisation in adults with pathological myopia.
Danish: Visudyne bruges overvejende til behandling af den klassiske choroidale neovaskularisering hos voksne med aldersrelateret makuladegeneration, og også til behandling af alle typer for choroidal neovaskularisering hos voksne med patologisk nærsynethed.
English: Other medicines and Visudyne
Danish: Brug af anden medicin sammen med Visudyne
English: During that time, avoid exposure to direct sunlight, bright indoor lights such as in tanning salons, bright halogen lighting, high power lighting as used by surgeons or dentists, or light from light-emitting medical devices such as pulse oximeters (used to measure oxygen in blood).
Danish: Indenfor de 48 timer, undgå at blive udsat for direkte sollys, kraftig indendørsbelysning såsom solarium, halogenlys, operationslys anvendt af læger og tandlæger eller lys fra medicinsk udstyr, f.eks. et pulsoximeter (bruges til at måle iltindholdet i blodet).
English: No clinical data on exposed pregnancies are available for verteporfin.
Danish: Der foreligger ikke kliniske data om eksponering for verteporfin under graviditet.
English: A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (88.1% versus 81.7%), associated adverse events (23.0% versus 7.5%), events leading to discontinuation (11.9% versus 3.3%) and events leading to death (n=10 [4.1%] versus n=1 [0.8%]).
Danish: En højere procentdel af de patienter, som modtog Visudyne sammenlignet med dem som fik placebo, oplevede bivirkninger (88,1% versus 81,7%), associerede bivirkninger (23,0% versus 7,5%), og hændelser som førte til seponering (11,9% versus 3,3%) og hændelser som medførte døden (n=10 [4,1%] versus n=1 [0,8%].
English: In sedated or anaesthetised pigs, a Visudyne dose significantly higher than the recommended dose in patients given as a bolus injection caused severe haemodynamic effects including death, probably as a result of complement activation.
Danish: Hos sederede eller bedøvede grise forårsagede en bolusinjektion af Visudyne givet under anæstesi alvorlige hæmodynamiske virkninger herunder dødsfald, i en dosis der var signifikant højere end den, der er anbefalet til mennesker.
English: At month 12, the study did not show statistically significant results on the primary efficacy parameter (responder rate 49.3% versus 45.6%, p=0.517).
Danish: Efter 12 måneder var der ingen statistisk signifikant forskel på hvad angår det primære effektkriterium (responderratio 49,3% versus 45,6%, p=0,517).
English: • General disorders: feeling sick (nausea), sunburn-like reactions, tiredness, infusion-related reaction, primarily presented as chest pain or back pain, and increased cholesterol levels.
Danish: • Almene symptomer: kvalme, reaktioner som ligner solskoldning, træthed, infusionsrelaterede reaktioner, først og fremmest brystsmerter eller rygsmerter, samt forhøjet kolesterol.
English: For a dose of 6 mg/m body surface (the dose recommended for the treatment) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5 %) solution for infusion to a final volume of 30 ml.
Danish: For at få en dosis på 6 mg/m² legemsoverflade (den anbefalede behandlingsdosis) fortyndes den nødvendige mængde Visudyneinfusionsvæske med glucoseinfusionsvæske 50 mg/ml (5%) til et endeligt volumen på 30 ml.
English: • Eye disorders: tear in the coloured layer of the retina, swelling or fluid retention in the macula.
Danish: • Øjensygdomme: Rift i det farvede lag af nethinden, hævelse eller ophobning af væske i makula.
English: A group of patients who had occult with no classic lesions (n=258) showed a statistically significant difference of 13.7% in favour of Visudyne compared to placebo (45.2% versus 31.5%, p=0.032).
Danish: For en gruppe af patienter med okkult uden klassisk komponent (n=258) var der en statistisk signifikant forskel på 13,7% til fordel for Visudyne sammenlignet med placebo (45,2% versus 31,5%, p=0,032).
English: During that period, patients should avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light such as tanning salons, bright halogen lighting, or high power lighting in surgery operating rooms or dental surgeries.
Danish: I denne periode, skal patienterne beskytte deres øjne, hud og andre organer mod direkte sollys, kraftig indendørsbelysning såsom solarium, halogenlys og operations- eller tandlægelamper.
English: Visudyne 15 mg powder for solution for infusion verteporfin
Danish: Visudyne 15 mg pulver til infusionsvæske, opløsning verteporfin
English: He/she will decide whether you should be given Visudyne.
Danish: Lægen vil beslutte, om du skal behandles med Visudyne.
English: The study did not show statistically significant results on the primary efficacy parameter at month 12 (15-letter responder rate 62.7% versus 55.0%, p=0.150; 30-letter responder rate 84.0% versus 83.3%, p=0.868) or at month 24 (15-letter responder rate 53.3% versus 47.5%, p=0.300; 30letter responder rate 77.5% versus 75.0%, p=0.602).
Danish: 30-bogstaver responsfrekvens 84,0% mod 83,3%, p=0,868) eller efter 24 måneder (15-bogstaver responsfrekvens 53,3% mod 47,5%, p=0,300; 30-bogstaver responsfrekvens 77,5% mod 75,0%, p=0,602).
English: The benefit of the product in the AMD patient population who have occult subfoveal CNV with evidence of recent or ongoing disease progression has not been demonstrated consistently.
Danish: Fordelen ved at give lægemidlet til personer med aldersrelateret makuladegeneration (AMD) med okkult subfoveal choroidal neovaskularisation med dokumenteret nylig eller pågående sygdomsforværring er ikke blevet tydeligt påvist.
English: How Visudyne is used
Danish: Hvad bruges Visudyne til
English: Following Visudyne treatment, patients may develop transient visual disturbances such as abnormal vision, vision decrease, or visual field defects that may interfere with their ability to drive or use machines.
Danish: Efter behandling med Visudyne, kan patienterne få kortvarige synsforstyrrelser, såsom begrænset synsfelt eller nedsat syn, som kan reducere evnen til at køre bil og eller betjene maskiner.
English: • General disorders: Hypersensitivity (allergic reactions), syncope (fainting), headache, lightheadedness, breathlessness.
Danish: • Almene symptomer: Overfølsomhed (allergiske reaktioner), besvimelse, hovedpine, svimmelhed, åndenød.
English: Both vasovagal and hypersensitivity reactions are associated with general symptoms such as syncope, sweating, dizziness, rash, dyspnoea, flushing, and changes in blood pressure and heart rate.
Danish: Både vasovagale anfald og overfølsomhedsreaktioner ledsages af generelle symptomer som synkope, svedudbrud, svimmelhed, udslæt, dyspnø, ansigtsrødme og ændring af blodtryk og hjerterytme.
English: Rash, urticaria, pruritus
Danish: Udslæt, urticaria , pruritus1.
English: Do not use sodium chloride solution (see section 6.2).
Danish: Anvend ikke natriumchloridopløsning (se pkt.
English: Extravasation of Visudyne, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling, blistering or discoloration at the injection site.
Danish: Ektravasation af Visudyne, specielt hvis det affekterede areal bliver udsat for lys, kan forårsage stærk smerte, inflammation, ødem, blæredannelse eller misfarvning på injektionsstedet, som kan kræve smertebehandling.
English: A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (89.3% versus 82.5 %), associated adverse events (42.7% versus 18.4%) and events leading to discontinuation (6.2% versus 0.9%).
Danish: En højere procentdel af patienterne som fik Visudyne sammenlignet med dem som fik placebo, oplevede bivirkninger (89,3% versus 82,5%), associerede bivirkninger (42,7% versus 18,4%) og hændelser som førte til seponering (6,2% versus 0,9%).
English: Visudyne 15 mg powder for solution for infusion
Danish: Visudyne 15 mg pulver til infusionsvæske, opløsning
English: Hypercholesteraemia.
Danish: Hyperkolesterolæmi.
English: Two randomised, placebo-controlled, double-masked, multicentre, 24-month studies (BPD OCR 003 AMD, or Verteporfin in Photodynamic Therapy-AMD [VIP-AMD], and BPD OCR 013, or Visudyne in Occult Choroidal Neovascularisation [VIO]) were conducted in patients with AMD characterised by occult with no classic subfoveal CNV.
Danish: Der er udført to randomiserede dobbelt-blinde, placebokontrollerede multicenterforsøgene af 24 måneders varighed (BPD OCR 003 AMD eller Verteporfin in Photodynamic Therapy-AMD [VIPAMD] og BPD OCR 013 eller Visudyne in Occult Choroidal Neovascularization [VIO]) hos patienter med AMD karakteriseret ved okkult subfoveal CNV uden klassisk komponent.
English: Photosensitivity reaction
Danish: Fotosensibilisering
English: If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of Visudyne should be discontinued immediately and appropriate therapy initiated.
Danish: Administration af Visudyne skal straks seponeres, hvis anafylaktiske- eller alvorlige allergiske reaktioner forekommer under eller efter infusion og passende behandling skal initieres.
English: 1 vial of powder.
Danish: 1 hætteglas med pulver.
English: The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/m body surface area,
Danish: Det første trin er 10-minutters intravenøs infusion af Visudyne i en dosering af 6 mg/m legemsoverflade, fortyndet i 30 ml infusionsvæske (se pkt.
English: If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.
Danish: Hvis det er nødvendigt, kan behandlingen gentages hver 3.
English: At month 12, there was a benefit of Visudyne for the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity) - 86% for Visudyne versus 67% for placebo, p=0.011.
Danish: Efter 12 måneders behandling var der størst effekt af Visudyne med hensyn til det primære effektmål (andel af patienter som mister mindre end 3 linjer i synsstyrke) - 86% i Visudynegruppen mod 67% i placebogruppen, p=0,011.
English: The vial and any unused portion of reconstituted solution should be discarded after single use.
Danish: Hætteglasset og ethvert overskud af den rekonstituerede opløsning bør kasseres efter endt brug.
English: Visudyne is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Visudyne er kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
English: Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Danish: Laktosemonohydrat Ægphosphatidylglycerol Dimyristoylphosphatidylcholin Ascorbylpalmitat Butyleret hydroxytoluen (E321)
English: A total of 120 patients (81 Visudyne, 39 placebo) were enrolled in the study.
Danish: Der blev inkluderet ialt 120 patienter i afprøvningen (81 Visudyne, 39 placebo).
English: After reconstitution, 1 ml contains 2 mg of verteporfin.
Danish: Efter rekonstitution indeholder 1 ml 2 mg verteporfin.
English: In whole human blood, 90% of verteporfin is associated with plasma and 10 % associated with blood cells, of which very little was membrane associated.
Danish: I humant fuldblod findes 90% af verteporfin i plasma og 10% i blodlegemerne.
English: swelling, inflammation, and weeping from the infusion site.
Danish: hævelse, irritation og sivning af væske fra infusionsstedet.
English: One multicentre, double-masked, placebo-controlled, randomised study (BPD OCR 003 PM [VIPPM]) was conducted in patients with subfoveal choroidal neovascularisation caused by pathological myopia.
Danish: Der er udført en dobbelt-maskeret, placebokontrolleret, randomiseret, multicenter, klinisk undersøgelse (BPD OCR 003 PM [VIP-PM]) hos patienter med subfoveal choroidal neovaskularisation forårsaget af patologisk myopi.
English: Visudyne has not been studied in patients with renal impairment.
Danish: Visudyne er ikke undersøgt hos patienter med nyreforandringer.
English: Free radical scavengers
Danish: Midler som neutraliserer frie radikaler
English: Hypersensitivity reactions
Danish: Overfølsomshedsreaktioner
English: Cardiac disorders Not known
Danish: Hjerte Ikke kendt
English: • General disorders: vasovagal reactions (fainting), sweating, flushing, or changes in blood pressure.
Danish: • Almene symptomer: Vasovagale reaktioner (besvimelse), svedudbrud, ansigtsrødme eller ændringer i blodtryk.
English: Therefore it must be washed off extensively with water in the event of direct contact.
Danish: Ved direkte kontakt med lægemidlet skal der skylles meget grundigt med vand.
English: 339 patients (225 verteporfin, 114 placebo) were enrolled in this study.
Danish: Der var inkluderet 339 patienter i dette forsøg (225 på verteporfin og 114 på placebo).
English: The two regioisomers of verteporfin exhibit similar pharmacokinetic properties of distribution and elimination and thus both isomers are considered verteporfin as a whole from the pharmacokinetic perspective.
Danish: Set fra et farmakokinetisk perspektiv anses begge isomerer derfor som værende verteporfin i sin helhed.
English: A lower percentage of Visudyne patients had events leading to death (n=4 [1.8%] versus n=3 [2.6%]); no death was considered to be related to treatment.
Danish: En lavere procentdel af patienterne, som fik Visudyne, oplevede hændelser, som medførte døden (n=4 [1,8%] versus n=3 [2,6%]).
English: If you have to go outdoors during daylight in the first 48 hours after treatment, you must protect your skin and eyes by wearing protective clothing and dark sunglasses.
Danish: Hvis du skal være ude i dagslys i denne periode skal du beskytte dine øjne og hud ved at bære mørke solbriller og dækkende tøj.
English: The subgroup of patients with predominantly classic CNV lesions (N=243; Visudyne 159, placebo 84) were more likely to exhibit a larger treatment benefit.
Danish: Der observeredes større behandlingseffekt i undergruppen af patienter med fortrinsvis klassisk CNV læsion (N=243; Visudyne 159 og placebo 84).
English: Do not use sodium chloride solution.
Danish: Anvend ikke natriumchloridinfusionsvæske.
English: - The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.
Danish: - Øvrige indholdsstoffer: dimyristoyl phosphatidylcholin, ægphosphatidylglycerol, ascorbylpalmitat, butylhydroxytoluen (E321) og laktosemonohydrat.
English: The percentage of patients who lost less than 1.5 lines was 72% for Visudyne and 44% for placebo (p=0.003).
Danish: Andelen af patienter som mistede mindre end 1,5 linje var 72% i Visudynegruppen mod 44% i placebogruppen, (p=0,003).
English: Verteporfin exposure is not significantly increased in patients with mild hepatic impairment (see “Biotransformation” and “Elimination” under section 5.2) and does not require any dose adjustment.
Danish: Udsættelse for verteporfin er ikke signifikant øget hos patienter med let nedsat nyrefunktion (se “Biotransformation” og “Elimination” i pkt.
English: Shelf-life after reconstitution and dilution
Danish: Opbevaringstid efter rekonstituering og fortynding
English: Injection site vesicles, injection site necrosis.
Danish: Vesikler ved infusionsstedet, nekrose ved injektionsstedet.
English: What Visudyne is and what it is used for What you need to know before you are given Visudyne How Visudyne is used
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Visudyne Sådan anvendes Visudyne Bivirkninger
English: Retinal pigment epithelial tear, macular oedema.
Danish: Læsion i retinalt pigmentepitel, maculaødem.
English: At month 24, 79% Visudyne patients versus 72% placebo patients had lost less than 3 lines of visual acuity (p=0.38).
Danish: Efter 24 måneder havde 79% af patienterne i Visudynegruppen mistet mindre end 3 linjer mod 72% i placebogruppen (p=0,38).
English: The largest possible arm vein, preferably the antecubital, should be used for the infusion and small veins in the back of the hand should be avoided.
Danish: Infusionen bør overvåges, og man bør benytte den størst mulige armvene, helst vena intermedia cubiti.
English: No effect on male or female fertility has been observed in rats following intravenous verteporfin doses of up to 10 mg/kg/day (approximately 60 and 40-fold human exposure at 6 mg/m based on AUCinf in male and female rats, respectively).
Danish: Der er ikke observeret påvirkning af fertiliteten hos han- og hunrotter efter intravenøse verteporfindoser på op til 10 mg/kg/døgn (ca. 60 og 40 gange den humane eksponering ved 6 mg/m baseret på
English: The renal excretion of verteporfin and its metabolite is minimal (<1% of the verteporfin dose) and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
Danish: Den renale udskillelse af verteporfin og dets metabolit er minimal (<1% af verteporfindosis).
English: Lactose monohydrate, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321).
Danish: Laktosemonohydrat, dimyristoylphosphatidylcholin, ægphosphatidylglycerol, ascorbylpalmitat, butylhydroxytoluen (E321).
English: Visudyne therapy should be considered carefully in patients with moderate hepatic dysfunction or biliary obstruction.
Danish: Visudynebehandling bør overvejes nøje til patienter med moderat nedsat leverfunktion eller galdevejsobstruktion.
English: Do not dissolve in sodium chloride solution.
Danish: Må ikke opløses i natriumchloridinfusionsvæske.
English: • Infusion site side effects: as with other types of injections, some patients experienced blistering.
Danish: • Bivirkninger på infusionsstedet: som ved andre injektioner får nogle patienter blæredannelse.
English: If this happens, the infusion needs to be stopped and the skin treated with cold compresses and thoroughly protected from light until the skin colour returns to normal.
Danish: Hvis dette sker, skal infusionen stoppes og huden afkøles med is.
English: It is recommended that, if you are given Visudyne, you do not breastfeed for 48 hours after administration.
Danish: Det anbefales, at du ikke ammer i 48 timer efter en behandling med Visudyne.
English: What Visudyne is used for Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.
Danish: Visudyne bruges til behandling af den våde form af aldersrelateret makuladegeneration og patologisk nærsynethed.
English: The efficacy parameter was the same as in TAP and VIO (see above).
Danish: Effektparametre var de samme som for TAP og VIO (se ovenfor) med yderligere et endepunkt ved 24 måneder.
English: Each vial contains 15 mg of verteporfin.
Danish: Hvert hætteglas indeholder 15 mg verteporfin.
English: This effect was not observed in conscious non-sedated pigs, or in any other species, including man. Verteporfin at more than 5 times the expected maximum plasma concentration in treated patients, caused a low level of complement activation in human blood in vitro.
Danish: In vitro har verteporfin forårsaget et lavt niveau af komplementaktivering i humant blod ved koncentrationer, der var 5 gange den forventede maksimale plasmakoncentration hos behandlede patienter.
English: Use in patients with moderate hepatic impairment or biliary obstruction
Danish: Patienter med moderat nedsat leverfunktion eller galdevejsobstruktion
English: in the treated eye. • General disorders: feeling unwell.
Danish: • Almene symptomer: general utilpashed.
English: - Verteporfin passes into human milk in low amounts.
Danish: - Verteporfin udskilles i små mængder i modermælk.
English: Each vial contains 15 mg of verteporfin
Danish: Hvert hætteglas indeholder 15 mg verteporfin
English: Hyperesthesia.
Danish: Hyperæstesi.
English: Retinal detachment, retinal haemorrhage, vitreous haemorrhage, retinal oedema.
Danish: Nethindeløsning, retinal blødning, blødning i glaslegemet, nethindeødem.
English: No clinically relevant complement activation was reported in clinical trials but anaphylactic reactions have been reported during post-marketing surveillance.
Danish: Der er ikke rapporteret klinisk relevant komplementaktivering i kliniske forsøg,
English: Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution.
Danish: Rekonstituer Visudyne i 7,0 ml vand til injektionsvæsker.
English: After single use the vial and any unused portion of reconstituted solution should be disposed of after single use in accordance with local requirements.
Danish: Hætteglasset og ethvert overskud af den rekonstituerede infusionsvæske skal kasseres efter endt brug i henhold til lokale retningslinjer.
English: Injection site pain, injection site oedema, injection site inflammation, injection site extravasation, asthenia.
Danish: Overfølsomhed på infusionsstedet, blødning på infusionsstedet, misfarvning på infusionstedet, feber, smerte.
English: Vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported.
Danish: Vasovagale reaktioner og overfølsomhedsreaktioner relateret til infusion af Visudyne, som i sjældne tilfælde kan være alvorlige, er blevet rapporteret.