FrancophonIA/ELRC3.0 huggingface dataset:
English: Under these circumstances vision loss may be rapid and severe.
Danish: Under disse omstændigheder kan der komme et hurtigt og alvorligt synstab.
English: * Post-marketing experience; see “Description of selected adverse reactions”
Danish: * Erfaring efter markedsføring; se ”Beskrivelse af udvalgte bivirkninger”.
English: However, there was no consistent pattern among the different haemorrhages.
Danish: Der var dog ikke noget konsekvent mønster i de forskellige blødninger.
English: At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Danish: I slutningen af det 1. år (uge 54) var omkring 1053 patienter randomiseret igen til enten at forsætte samme behandling eller ophøre behandling efter uge 102.
English: Frequency of these side effects cannot be estimated from the data available.
Danish: Hyppigheden af disse bivirkninger kan ikke fastslås på baggrund af de tilgængelige data.
English: The plunger stopper should not be pulled back.
Danish: Stemplet må ikke trækkes tilbage.
English: Children and adolescents Macugen should not be used in children and adolescents under 18 years old.
Danish: Børn og unge Macugen bør ikke anvendes til børn og unge under 18 år.
English: Elderly No special considerations are needed.
Danish: Det er ikke nødvendigt at tage særlige forholdsregler.
English: MedDRA system organ class
Danish: MedDRA organklasse
English: Other possible side effects are as follows:
Danish: Der er følgende andre bivirkninger:
English: Mean Change in Visual Acuity Over Time; Year 1; ITT (LOCF)
Danish: Gennemsnitlig ændring i synsskarpheden over tid; År 1; ITT (LOCF)*
English: All injections of Macugen will be administered by your doctor.
Danish: Alle injektioner af Macugen vil blive givet af Deres læge.
English: Please do not forget to tell your doctor if you are known to be allergic to any substance.
Danish: Husk at fortælle det til lægen, hvis De ved, at De lider af nogen form for allergi.
English: Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Danish: Patienterne fik i gennemsnit mellem 8,4 - 8,6 behandlinger ud af 9 mulige på tværs af alle behandlingsarme i det første år.
English: This will reduce or prevent any pain you might have with the injection.
Danish: Dette vil nedsætte eller forebygge smerter i forbindelse med injektionen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/325/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/05/325/002
English: Read all of this leaflet carefully before you start your treatment with this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De bliver behandlet med dette lægemiddel, da den indeholder vigtige oplysninger.
English: • There is no experience of using Macugen in pregnant women.
Danish: • Der er ingen erfaring med brug af Macugen hos gravide kvinder.
English: Periodic Safety Update Reports
Danish: • Periodisk opdaterede sikkerhedsindberetninger
English: The adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er angivet efter klasse og frekvens: meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1000 til <1/100) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/40 and 20/320.
Danish: Patienterne havde haft op til 1 tidligere PDT behandling og baseline synsskarphed i forsøgsøjet på mellem 20/40 og 20/320.
English: The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.
Danish: Macula skaber det fine centrale syn, der er brug for ved aktiviteter såsom bilkørsel, læsning af lille skrift eller lignende.
English: There are no studies on the carcinogenic potential of pegaptanib.
Danish: Der er ingen studier af det karcinogenetiske potentiale for pegaptanib.
English: Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully.
Danish: Før behandlingen gives, kan Deres læge bede Dem om at bruge øjendråber der indeholder antibiotika eller at vaske Deres øjne omhyggeligt.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Ikke-kliniske data viser ingen særlig risiko for mennesker, baseret på traditionelle studier af sikkerhedsfarmakologi, gentagen dosistoksicitet og genotoksicitet.
English: Macugen should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Danish: Macugen bør ikke anvendes under graviditet, medmindre den potentielle fordel opvejer den potentielle risiko for det ufødte barn.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Danish: Inden markedsføring skal indehaveren af markedsføringstilladelsen (MAH) have undervisningsmateriale godkendt af de relevante myndigheder i det enkelte medlemsland.
English: Store in a refrigerator (2ºC to 8ºC).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: The safety data described below summarise all procedure and adverse reactions in the 295 patients in the 0.3 mg treatment group.
Danish: De nedenfor beskrevne sikkerhedsdata opsummerer alle mulige procedure- og bivirkninger hos de 295 patienter, der var i 0,3 mg behandlingsgruppen.
English: The odds of increased IOP was increased by a factor of 1.128 for each additional injection (p= 0.0003).
Danish: Sandsynligheden for en stigning i det intraokulære tryk blev øget med en faktor 1,128 for hver yderligere injektion (p = 0,0003).
English: Investigations Uncommon increased gamma-glutamyltransferase activity
Danish: Undersøgelser Ikke almindelig øget gammaglutamyltransferase aktivitet
English: The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Danish: Den absolutte biotilgængelighed af pegaptanib efter intravitreal indgift er ikke vurderet hos mennesker, men er ca. 70-100% hos kaniner, hunde og aber.
English: An updated RMP should be submitted:
Danish: Desuden skal der fremsendes en opdateret RMP
English: Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Danish: Der ses reduceret kropsvægt (5%) og minimalt forsinket ossifikation i forpoteled; kun ved eksponeringsniveau baseret på AUC på over 300 gange større end det, der forventes hos mennesker.
English: Moreover patients should be closely monitored for vitreous haemorrhage and endophthalmitis in the two weeks following the injection.
Danish: Endvidere skal patienter nøje monitoreres for blødning i glaslegemet og endophthalmitis i 2 uger efter injektionen.
English: The medicine is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients.
Danish: Lægemidlet bruges til behandling af alle former for unormal vækst af blodkar hos voksne AMD-patienter.
English: These new blood vessels may bleed and leak fluid, causing the macula to bulge or lift up, thus distorting or destroying central vision.
Danish: Disse nye blodkar kan give blødning og væskeudsivning, der får macula til at bule ud eller løfte sig, og som følge heraf fordrejes eller ødelægges det centrale syn.
English: A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Danish: I alt blev 1190 patienter behandlet (892 med Macugen, 298 simuleret behandling (kontrol)) med en gennemsnitligs alder på 77 år.
English: The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure.
Danish: Størstedelen af de bivirkninger, der er indberettet efter administration af Macugen, er relateret til den intravitreale injektionsprocedure.
English: The systemic exposure is expected to be within a well tolerated range in patients with hepatic impairment, as a 10 fold higher dose (3 mg/eye) was well tolerated.
Danish: Den systemiske eksponering forventes at være indenfor et veltolereret niveau hos patienter med nedsat leverfunktion, da en 10 gange højere dosis (3 mg/øje) var veltolereret.
English: In some patients the pressure inside the treated eye may increase for a short period directly after the injection.
Danish: Hos nogle patienter kan trykket øges i det behandlede øje for en kort periode direkte efter injektion.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER
English: Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
Danish: I tilfælde af overdosering bør det intraokulære tryk derfor monitoreres, og hvis den behandlende læge vurderer, at det er nødvendigt, skal der iværksættes hensigtsmæssig behandling.
English: Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels (see section 5.3).
Danish: De udførte dyreforsøg er utilstrækkelige, men har vist reproduktionstoksicitet ved høj systemisk eksponering (se pkt.
English: Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored.
Danish: Derfor bør perfusionen af det optiske nervehoved og intraokulære tryk monitoreres.
English: Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.
Danish: Pegaptanib metaboliseres af nucleaser, og derfor er cytochrom P450 medierede lægemiddelinteraktioner usandsynlige.
English: The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye.
Danish: Injektionen gives i øjets glaslegeme, som er den geléagtige substans i øjet.
English: After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Danish: Efter hver injektion vil De måske blive bedt om at bruge øjendråber, der indeholder antibiotika (eller en anden type antibiotikabehandling) som beskyttelse mod øjeninfektion.
English: A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the medicinal product (see Figure 1, below).
Danish: En 27 eller 30 G x ½ inch nål sættes fast på luer lock adaptoren, så medicinen kan administreres (se figur 1 nedenfor).
English: The solution to be injected should reach room temperature (below 25°C) before injecting.
Danish: Injektionsvæsken bør nå stuetemperatur (under 25 °C) inden injektion.
English: The two trials enrolled patients, including all neovascular AMD lesion subtypes (25% predominantly classic, 39% occult with no classic and 36% minimally classic), lesion sizes up to 12 disc areas, of which up to 50% could be comprised of subretinal haemorrhage and/or up to 25% fibrotic scar or atrophic damage.
Danish: De 2 studier inkluderede patienter, af alle typer af neurovaskulære undergrupper af AMD læsioner 25% overvejende klassisk, 39% okkult, uden klassisk og 36% minimalt klassisk), læsionsstørrelser op til 12 disc områder, heraf kunne op til 50% bestå af subretinal blødning og/eller op til 25% med fibrotisk ar eller atropisk beskadigelse.
English: The rate of absorption from the eye is the rate-limiting step in the disposition of pegaptanib in animals and is likely to be in humans.
Danish: Absorptionshastigheden fra øjet er det hastighedsbegrænsende trin i dispositionen af pegaptanib hos dyr og sandsynligvis også hos mennesker.
English: Occasionally, an infection or bleeding in the eye can occur after Macugen injection (in the next two weeks).
Danish: Af og til kan der opstå infektion eller blødning i øjet efter injektion af Macugen (i de følgende 2 uger).
English: In advanced disease the initiation and continuation of Macugen therapy should consider the potential for useful vision in the eye.
Danish: Ved fremskreden sygdom bør initiering og fortsættelse med Macugen behandling overvejes i forhold til muligheden for bevaret syn på øjet.
English: • Macugen is not recommended during breastfeeding as it is not known whether Macugen passes into human milk.
Danish: • Macugen anbefales ikke til kvinder, der ammer, da det ikke vides, om Macugen går over i mælken hos mennesker.
English: At one year, pegaptanib 0.3 mg exhibited a statistically significant treatment benefit for the primary efficacy endpoint; proportion of patients losing less than 15 letters of visual acuity (prespecified pooled analysis, pegaptanib 0.3 mg 70% versus Sham 55%, p = 0.0001; EOP1003 pegaptanib 0.3 mg 73% versus Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% versus Sham 52%, p = 0.0031).
Danish: På ét år udviste 0,3 mg pegaptanib en statistisk signifikant behandlingsfordel for det primære effekt endepunkt, andelen af patienter der havde tabt mindre end 15 bogstaver i synsskarphed (prædefinerede samlede analyser, 0,3 mg pegaptanib 70% versus simuleret behandling 55%, p = 0,0001; EOP1003 pegaptanib 0,3 mg 73% versus simuleret behandling 59%, p = 0,0105; EOP1004 pegaptanib 0,3 mg 67% versus simuleret behandling 52%, p = 0,0031).
English: The safety and efficacy of Macugen beyond two years has not been demonstrated.
Danish: Macugens sikkerhed og effekt udover 2 år er ikke undersøgt.
English: Immune system disorders Not known anaphylactic reaction*
Danish: Immunsystemet Ikke kendt anafylaktisk reaktion*
English: Date of latest renewal: 19/11/2015
Danish: Dato for første markedsføringstilladelse: 31. januar 2006 Dato for seneste fornyelse: 19. november 2015
English: Your doctor will also give you some local anaesthetic (numbing medicine).
Danish: Deres læge vil også give Dem lokalbedøvende medicin.
English: Patients should be instructed not to drive or use machines until this has resolved.
Danish: Patienterne bør informeres om ikke at køre bil eller betjene maskiner, før denne virkning er aftaget.
English: On average, the treatment benefit was maintained at 102 weeks with continuing preservation of visual acuity for patients re-randomized to continue pegaptanib.
Danish: I gennemsnit bevaredes den positive behandlingseffekt i 102 uger med vedvarende opretholdelse af synsskarpheden hos patienter randomiseret igen til at fortsætte med pegabtanip.
English: Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
Danish: Pegaptanib blev undersøgt i 2 kontrollerede dobbeltblindede og identisk designede randomiserede studier (EOP1003, EOP1004) hos patienter med neovaskulær AMD.
English: In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
Danish: Hos kaniner elimineres pegaptanib som modersubstans og metabolitter primært i urinen.
English: There are no reproductive toxicity studies in rabbits.
Danish: Der er ingen reproduktionstoksicitetsforsøg med kaniner.
English: The pouch must not be opened until the patient has been prepared for injection.
Danish: Posen må ikke åbnes, før patienten er blevet gjort klar til injektion.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Macugen in all subsets of the paediatric population in age-related macular degeneration.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Macugen i alle undergrupper af den pædiatriske population for aldersbetinget maculadegeneration (se pkt.
English: If your doctor cannot be reached for any reason, an alternate doctor should be contacted immediately.
Danish: Hvis De af en eller anden grund ikke kan få fat i Deres læge, skal De straks søge lægehjælp et andet sted.
English: The mean area under the plasma concentration-time curve (AUC) is about 25 g·hr/ml at this dose.
Danish: Det gennemsnitlige område under plasmakoncentrationstidskurven (AUC) er ca. 25 µg t/ml ved denne dosis.
English: Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage.
Danish: Macugen virker ved at hæmme væksten af disse unormale blodkar og ved at hindre blødning og udsivning.
English: There is a small risk of a slight lasting increased pressure inside the eye after repeated injection in the eye.
Danish: Der er en lille risiko for permanent let forhøjet tryk i øjet efter gentagen injektion.
English: Mean Change in VA from Week 0 (Letters)
Danish: Gennemsnitlig ændring i synsskarpheden fra uge 0 (Bogstaver)
English: In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Danish: Hos mus, rotter, kaniner, hunde og aber, distribueres pegaptanib primært i plasmavolumen og distribueres ikke i udtalt grad til det perifere væv efter intravenøs indgift.
English: A decrease in creatinine clearance down to 20 ml/min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Danish: Et fald i kreatininclearance ned til 20 ml/min kan associeres med en op til 2,3 gange stigning i pegaptanib AUC.
English: (Actual air bubble formation may vary)
Danish: (Luftboblens faktiske udseende kan variere.)
English: Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
Danish: 2 tidlige kliniske studier udført på patienter, der fik Macugen alene og i kombination med PDT (fotodynamisk terapi) viste ingen synlige forskelle i plasmafarmakokinetikken for pegaptanib.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Kun til engangsbrug.
English: You may experience temporary visual blurring after receiving Macugen.
Danish: De kan opleve midlertidig sløring af synet efter at have fået Macugen.
English: Macugen is administered as a single injection (0.3 mg) into your eye at intervals of 6 weeks (i.e. 9 times per year).
Danish: Macugen gives som én enkelt injektion (0,3 mg) i øjet med et interval på 6 uger (dvs. 9 gange om året).
English: VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Danish: VEGF er et sekreret protein, som inducerer angiogenese, vaskulær permeabilitet og inflammation, der alle bidrager til progressionen af neovaskulær (våd) form for AMD.
English: Pegaptanib is metabolised by endo- and exonucleases.
Danish: Pegaptanib metaboliseres via endo- og exonuklease.
English: Pegaptanib 0.3 mg showed treatment benefit regardless of baseline lesion subtype, lesion size and visual acuity as well as age, gender, iris pigmentation and prior and/or baseline PDT usage.
Danish: 0,3 mg pegaptanib viser behandlingsfordele uanset baseline læsionsundergruppe, læsionsstørrelse og synsskarphed såvel som alder, køn, irispigmentering og tidligere og/eller baseline PDT behandling.
English: Verteporfin photodynamic therapy (PDT) was permitted in patients with predominantly classic lesions at the discretion of the investigators.
Danish: Verteporfin fotodynamisk terapi (PDT) var tilladt efter en vurdering fra investigatorerne hos patienter med overvejende klassiske læsioner.
English: Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF) EOP 1004
Danish: Opsummering af gennemsnitlige ændringer i synsskarpheden fra baseline til Uge 6, 12, 54 og 102 (LOCF)
English: • palpitations, high blood pressure, dilatation of the aorta (the main blood vessel)
Danish: • hjertebanken, højt blodtryk, udvidelse af aorta (de store blodkar)
English: The selective inhibition in animals with pegaptanib proved as effective at suppressing pathological neovascularisation as pan-VEGF inhibition, however pegaptanib spared the normal vasculature whereas pan-VEGF inhibition did not.
Danish: Den selektive hæmning hos dyr med pegaptanib viste sig at være ligeså effektiv til supprimering af patologisk neovaskularisering som pan-VEGF hæmning, dog skånede pegaptanib den normale vaskulære struktur, hvorimod pan-VEGF hæmning ikke gjorde.
English: • Physician safety brochure
Danish: • Sikkerhedsbrochure til lægen
English: Intravitreal use
Danish: Intravitreal brug
English: Pegaptanib does not accumulate in the plasma when administered intravitreally every 6 weeks.
Danish: Pegaptanib akkumulerer ikke i plasmaet, når det gives intravitrealt hver 6. uge.
English: Patients who were re-randomized to discontinue pegaptanib after one year, lost visual acuity during the second year.
Danish: Patienter randomiseret igen til at ophøre med pegabtanip efter 1 år fik nedsat synsskarpheden i løbet af det 2. år.
English: If the solution appears cloudy, particles are observed or if there is evidence of damage to the syringe, or if the plastic clip is missing or not attached to the syringe, that Macugen dose should not be used.
Danish: Hvis opløsningen er uklar, der observeres partikler, der er tegn på beskadigelse af injektionssprøjten eller hvis plastikklippen mangler eller ikke er fastgjort til sprøjten, må denne dosis Macugen ikke anvendes.
English: VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
Danish: VEGF165 er den VEGF isoform, der fortrinsvis indgår i patologisk okulær neovaskularisering.
English: Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or foetal mortality in mice at intravenous doses of 1 to 40 mg/kg/day.
Danish: Pegaptanib producerer ikke maternal toksicitet og der ses ikke tegn på toksicitet eller føtal mortalitet hos mus ved intravenøse doser på 1-40 mg/kg/døgn.
English: There are limited data on safety in patients with prior history of stroke or transient ischaemic attacks.
Danish: Der er begrænsede data vedrørende sikkerheden hos patienter med slagtilfælde eller transitorisk iskæmisk attak i anamnesen.
English: Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Danish: Farmakokinetikken af pegaptanibnatrium er ens hos kvinder og mænd i alderen 50 til 90 år.
English: If there are bubbles, the syringe should be gently tapped with a finger until the bubbles rise to the top of the syringe.
Danish: Hvis der er luftbobler, skal der forsigtigt bankes på sprøjten med en finger, indtil luftboblerne stiger til vejrs i sprøjten.
English: Ask your doctor or pharmacist for advice before starting Macugen treatment.
Danish: Spørg Deres læge eller apotek til råds, inden De starter behandling med Macugen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose: 0.3 mg/90 µl
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Enkeltdosis: 0,3 mg/90 µl
English: Prior to the administration, the syringe should be removed from the plastic clip and the tip cap removed.
Danish: Inden administration skal sprøjten fjernes fra plastikklippen og hætten fjernes.
English: Psychiatric disorders Uncommon nightmare, depression
Danish: Psykiske forstyrrelser Ikke almindelig mareridt, depression
English: No human data on the effect of Macugen on fertility are available.
Danish: Der er ingen tilgængelige data fra mennesker vedrørende Macugens indvirkning på fertiliteten.
English: • bleeding that occurs around the eye (periorbital bleeding)
Danish: • blødning der opstår rundt omkring øjet (periorbital blødning)
English: • small lump on your eyelid due to inflammation (chalazion)
Danish: • lille bule på øjenlåget på grund af betændelse (chalazion)
English: The pack is supplied without a needle.
Danish: Leveres uden nål.