natgillin/translations-raw huggingface dataset:
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.
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.
• Øjensygdomme: Rift i det farvede lag af nethinden, hævelse eller ophobning af væske i makula.
• Eye disorders: tear in the coloured layer of the retina, swelling or fluid retention in the macula.
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).
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).
I denne periode, skal patienterne beskytte deres øjne, hud og andre organer mod direkte sollys, kraftig indendørsbelysning såsom solarium, halogenlys og operations- eller tandlægelamper.
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.
Visudyne 15 mg pulver til infusionsvæske, opløsning verteporfin
Visudyne 15 mg powder for solution for infusion verteporfin
Lægen vil beslutte, om du skal behandles med Visudyne.
He/she will decide whether you should be given Visudyne.
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).
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).
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.
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.
Hvad bruges Visudyne til
How Visudyne is used
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.
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.
• Almene symptomer: Overfølsomhed (allergiske reaktioner), besvimelse, hovedpine, svimmelhed, åndenød.
• General disorders: Hypersensitivity (allergic reactions), syncope (fainting), headache, lightheadedness, breathlessness.
Både vasovagale anfald og overfølsomhedsreaktioner ledsages af generelle symptomer som synkope, svedudbrud, svimmelhed, udslæt, dyspnø, ansigtsrødme og ændring af blodtryk og hjerterytme.
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.
Udslæt, urticaria , pruritus1.
Rash, urticaria, pruritus
Anvend ikke natriumchloridopløsning (se pkt.
Do not use sodium chloride solution (see section 6.2).
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.
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.
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%).
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%).
Visudyne 15 mg pulver til infusionsvæske, opløsning
Visudyne 15 mg powder for solution for infusion
Hyperkolesterolæmi.
Hypercholesteraemia.
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.
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.
Fotosensibilisering
Photosensitivity reaction
Administration af Visudyne skal straks seponeres, hvis anafylaktiske- eller alvorlige allergiske reaktioner forekommer under eller efter infusion og passende behandling skal initieres.
If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of Visudyne should be discontinued immediately and appropriate therapy initiated.
1 hætteglas med pulver.
1 vial of powder.
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.
The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/m body surface area,
Hvis det er nødvendigt, kan behandlingen gentages hver 3.
If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.
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.
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.
Hætteglasset og ethvert overskud af den rekonstituerede opløsning bør kasseres efter endt brug.
The vial and any unused portion of reconstituted solution should be discarded after single use.
Visudyne er kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
Visudyne is contraindicated in patients with severe hepatic impairment (see section 4.3).
Laktosemonohydrat Ægphosphatidylglycerol Dimyristoylphosphatidylcholin Ascorbylpalmitat Butyleret hydroxytoluen (E321)
Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Der blev inkluderet ialt 120 patienter i afprøvningen (81 Visudyne, 39 placebo).
A total of 120 patients (81 Visudyne, 39 placebo) were enrolled in the study.
Efter rekonstitution indeholder 1 ml 2 mg verteporfin.
After reconstitution, 1 ml contains 2 mg of verteporfin.
I humant fuldblod findes 90% af verteporfin i plasma og 10% i blodlegemerne.
In whole human blood, 90% of verteporfin is associated with plasma and 10 % associated with blood cells, of which very little was membrane associated.
hævelse, irritation og sivning af væske fra infusionsstedet.
swelling, inflammation, and weeping from the infusion site.
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.
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.
Visudyne er ikke undersøgt hos patienter med nyreforandringer.
Visudyne has not been studied in patients with renal impairment.
Midler som neutraliserer frie radikaler
Free radical scavengers
Overfølsomshedsreaktioner
Hypersensitivity reactions
Hjerte Ikke kendt
Cardiac disorders Not known
• Almene symptomer: Vasovagale reaktioner (besvimelse), svedudbrud, ansigtsrødme eller ændringer i blodtryk.
• General disorders: vasovagal reactions (fainting), sweating, flushing, or changes in blood pressure.
Ved direkte kontakt med lægemidlet skal der skylles meget grundigt med vand.
Therefore it must be washed off extensively with water in the event of direct contact.
Der var inkluderet 339 patienter i dette forsøg (225 på verteporfin og 114 på placebo).
339 patients (225 verteporfin, 114 placebo) were enrolled in this study.
Set fra et farmakokinetisk perspektiv anses begge isomerer derfor som værende verteporfin i sin helhed.
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.
En lavere procentdel af patienterne, som fik Visudyne, oplevede hændelser, som medførte døden (n=4 [1,8%] versus n=3 [2,6%]).
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.
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.
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.
Der observeredes større behandlingseffekt i undergruppen af patienter med fortrinsvis klassisk CNV læsion (N=243; Visudyne 159 og placebo 84).
The subgroup of patients with predominantly classic CNV lesions (N=243; Visudyne 159, placebo 84) were more likely to exhibit a larger treatment benefit.
Anvend ikke natriumchloridinfusionsvæske.
Do not use sodium chloride solution.
- Øvrige indholdsstoffer: dimyristoyl phosphatidylcholin, ægphosphatidylglycerol, ascorbylpalmitat, butylhydroxytoluen (E321) og laktosemonohydrat.
- The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.
Andelen af patienter som mistede mindre end 1,5 linje var 72% i Visudynegruppen mod 44% i placebogruppen, (p=0,003).
The percentage of patients who lost less than 1.5 lines was 72% for Visudyne and 44% for placebo (p=0.003).
Udsættelse for verteporfin er ikke signifikant øget hos patienter med let nedsat nyrefunktion (se “Biotransformation” og “Elimination” i pkt.
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.
Opbevaringstid efter rekonstituering og fortynding
Shelf-life after reconstitution and dilution
Vesikler ved infusionsstedet, nekrose ved injektionsstedet.
Injection site vesicles, injection site necrosis.
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Visudyne Sådan anvendes Visudyne Bivirkninger
What Visudyne is and what it is used for What you need to know before you are given Visudyne How Visudyne is used
Læsion i retinalt pigmentepitel, maculaødem.
Retinal pigment epithelial tear, macular oedema.
Efter 24 måneder havde 79% af patienterne i Visudynegruppen mistet mindre end 3 linjer mod 72% i placebogruppen (p=0,38).
At month 24, 79% Visudyne patients versus 72% placebo patients had lost less than 3 lines of visual acuity (p=0.38).
Infusionen bør overvåges, og man bør benytte den størst mulige armvene, helst vena intermedia cubiti.
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.
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
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).
Den renale udskillelse af verteporfin og dets metabolit er minimal (<1% af verteporfindosis).
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.
Laktosemonohydrat, dimyristoylphosphatidylcholin, ægphosphatidylglycerol, ascorbylpalmitat, butylhydroxytoluen (E321).
Lactose monohydrate, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321).
Visudynebehandling bør overvejes nøje til patienter med moderat nedsat leverfunktion eller galdevejsobstruktion.
Visudyne therapy should be considered carefully in patients with moderate hepatic dysfunction or biliary obstruction.
Må ikke opløses i natriumchloridinfusionsvæske.
Do not dissolve in sodium chloride solution.
• Bivirkninger på infusionsstedet: som ved andre injektioner får nogle patienter blæredannelse.
• Infusion site side effects: as with other types of injections, some patients experienced blistering.
Hvis dette sker, skal infusionen stoppes og huden afkøles med is.
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.
Det anbefales, at du ikke ammer i 48 timer efter en behandling med Visudyne.
It is recommended that, if you are given Visudyne, you do not breastfeed for 48 hours after administration.
Visudyne bruges til behandling af den våde form af aldersrelateret makuladegeneration og patologisk nærsynethed.
What Visudyne is used for Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.
Effektparametre var de samme som for TAP og VIO (se ovenfor) med yderligere et endepunkt ved 24 måneder.
The efficacy parameter was the same as in TAP and VIO (see above).
Hvert hætteglas indeholder 15 mg verteporfin.
Each vial contains 15 mg of verteporfin.
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.
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.
Patienter med moderat nedsat leverfunktion eller galdevejsobstruktion
Use in patients with moderate hepatic impairment or biliary obstruction
• Almene symptomer: general utilpashed.
in the treated eye. • General disorders: feeling unwell.
- Verteporfin udskilles i små mængder i modermælk.
- Verteporfin passes into human milk in low amounts.
Hvert hætteglas indeholder 15 mg verteporfin
Each vial contains 15 mg of verteporfin
Hyperæstesi.
Hyperesthesia.
Nethindeløsning, retinal blødning, blødning i glaslegemet, nethindeødem.
Retinal detachment, retinal haemorrhage, vitreous haemorrhage, retinal oedema.
Der er ikke rapporteret klinisk relevant komplementaktivering i kliniske forsøg,
No clinically relevant complement activation was reported in clinical trials but anaphylactic reactions have been reported during post-marketing surveillance.
Rekonstituer Visudyne i 7,0 ml vand til injektionsvæsker.
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution.
Hætteglasset og ethvert overskud af den rekonstituerede infusionsvæske skal kasseres efter endt brug i henhold til lokale retningslinjer.
After single use the vial and any unused portion of reconstituted solution should be disposed of after single use in accordance with local requirements.
Overfølsomhed på infusionsstedet, blødning på infusionsstedet, misfarvning på infusionstedet, feber, smerte.
Injection site pain, injection site oedema, injection site inflammation, injection site extravasation, asthenia.
Vasovagale reaktioner og overfølsomhedsreaktioner relateret til infusion af Visudyne, som i sjældne tilfælde kan være alvorlige, er blevet rapporteret.
Vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported.
4.2) og fortynd den med glucose 50 mg/ml (5%) infusionsvæske, opløsning, til et endeligt volumen på 30 ml.
For a dose of 6 mg/m body surface (see section 4.2) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5%) solution for infusion to a final volume of 30 ml.
Efter 12 måneder sås hos disse patienter en difference på 28% mellem behandlingsgrupperne (67% i gruppen af patienter behandlet med Visudyne mod 39%
After 12 months, these patients showed a difference of 28% between treatment groups (67% for Visudyne patients compared to 39% for placebo patients, p<0.001); the benefit was maintained at 24 months (59% versus 31%, p<0.001).
Anæstesi
Anaesthesia
Ekstravasation af infusionsvæsken, opløsningen
Extravasation of the solution for infusion
• Almene symptomer: ændringer i hjerterytmen (pulsen), infusionsrelaterede reaktioner, som kan stråle til andre steder, bl.a. men ikke begrænset til bækkenet, skuldrene eller brystkassen.
Infusion-related reaction, which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage.
Der er ingen erfaring vedrørende behandling med Visudyne hos patienter med moderat nedsat leverfunktion eller obstruktion af galdevejene.
Visudyne therapy should be considered carefully in patients with moderate hepatic impairment or biliary obstruction since no experience has been gained in these patients.
• Øjensygdomme: Manglende blodcirkulation til nethinden eller årehinden (øjets vaskulære lag)
Rare (may affect up to 1 in 1,000 people) • Eye disorders: lack of blood circulation to the retina or choroids (the vascular layer of the eye)
Fortæl det til din læge, hvis noget af det ovenstående passer på dig.
If any of these apply to you, tell your doctor.
Hvis du er under 18 år
If you are under 18 years of age
Der er ikke behov for yderligere monitorering.
No additional monitoring is required.
(Ukendt hyppighed)
(Frequency unknown)
4.4, 4.6 og 4.8).
(See sections 4.4, 4.6 and 4.8)
Der er imidlertid ikke rapporteret om reproduktionstoksicitet.
However, toxicity to reproduction has not been reported.
Formuleringsspecifikke advarsler tilføjes her, hvis relevant
Formulation specific warnings to be added here, if applicable
Det kan også anvendes til at kontrollere for højt blodtryk efter en operation.
It can also be used to control high blood pressure after an operation.
I disse tilfælde bør kun den laveste dosis anvendes.
In this case, only the lowest posology should be used.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Udfyldes nationalt
QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
Din læge vil være ekstra forsigtig:
Your doctor will take special care:
Den antihypertensive virkning afhænger af den administrerede dosis.
The antihypertensive effect will depend on the administered dose.
Hyppighedskategorierne er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
4.5 Interaktion med andre lægemidler og andre former for interaktion Forøgelse af negativ inotrop virkning
4.5 Interaction with other medicinal products and other forms of interaction Enhancement of negative inotropic effect
Inden for 8 dage efter myokardieinfarkt
Within 8 days after myocardial infarction
Kompetitive neuromuskulære blokkere
Competitive neuromuscular blockers
Patienter med portal hypertension
Patients with portal hypertension
Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Andre almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede):
Other common side effects (these may affect up to 1 in 10 people) are:
I tilfælde af overdosering anbefales det at anvende rutinemæssige tiltag, inklusive monitorering af hjertefunktion og respiration.
In case of an overdose it is recommended to use routine measures including monitoring of cardiac and respiratory function.
Den renale vaskulære modstand er nedsat.
Renal vascular resistance is decreased.
Doseringsregimet til opnåelse af det ønskede blodtryk kan variere afhængigt af målblodtrykket, patientens respons og patientens alder eller status.
The dosage regimen to achieve the desired blood pressure can vary depending on the targeted blood pressure, the response of the patient, and the age or status of the patient.
Hvis du for nylig har haft et slagtilfælde
If you have suffered a recent stroke
Dette lægemiddel vil blive indsprøjtet langsomt i en blodåre.
The medicine will be injected slowly into a vein.
Dets virkning foregår primært på arterielle glatte muskler.
Its action is produced mainly on arterial smooth muscle.
Potentiel additiv antihypertensiv virkning
Potential additive antihypertensive effect
Blodtryk og hjertefrekvens skal monitoreres mindst hver 5. minut under infusionen og herefter, indtil de vitale tegn er stabile, dog i mindst 12 timer efter afsluttet nicardipinadministrationen.
Blood pressure and heart rate must be monitored at least every 5 minutes during the infusion, and then until vital signs are stable, but at least for 12 hours after the end of the administration of nicardipine.
Det er særligt vigtigt, at du fortæller det til lægen, hvis du tager et eller flere af følgende lægemidler:
In particular, tell your doctor if you are taking any of the following medicines:
Dette genspejles i relativt store og hurtige ændringer i blodtrykket med minimale inotrope ændringer i hjertefunktionen (barorefleksvirkning).
This is reflected in relatively large and rapid changes in blood pressure, with minimal inotropic changes in cardiac function (baroreflex effect).
Der er utilstrækkelig information om nicardipins virkninger hos nyfødte/spædbørn.
There is insufficient information on the effects of nicardipine in newborns/infants.
Hvis dit høje blodtryk skyldes forsnævring ved hjerteklappen eller andre hjertefejl Hvis du har haft et hjerteanfald inden for de sidste otte dage
If your high blood pressure is because of narrowing of a heart valve or other defects in the heart If you have had a heart attack in the last eight days
I meget lave koncentrationer hæmmer det tilløbet af calcium i cellen.
At very low concentrations it inhibits the influx of calcium into the cell.
I studier med enten en enkeltdosis eller administration 3 gange dagligt i 3 dage har vist, at mindre end 0,03 % uomdannet nicardipin genfindes i urinen hos mennesker efter oral eller intravenøs administration.
Studies involving either a single dose, or administration 3 times daily for 3 days, have shown that less than 0.03% of unchanged nicardipine is recovered in the urine in humans after oral or intravenous administration.
[Advarsler vedrørende produktspecifikke formuleringer udfyldes nationalt]
[Product specific formulation warnings to be completed nationally ]