FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3).
Danish: Samtidig indgivelse af andre potentielt fototoksiske stoffer (fx tetracykliner, sulfonamider, fluoroquinoloner, hypericin (perikon) ekstrakter) skal undgås (se også pkt.
English: The extent and frequency of procedure-related neurological side effects depends on the localisation of the brain tumour and the degree of resection of tumour tissue lying in eloquent brain areas (see section 4.4).
Danish: Omfanget og hyppigheden af procedurerelaterede neurologiske bivirkninger afhænger af hjernetumorens placering og graden af resektion af tumorvæv i elokvente hjerneområder (se pkt.
English: At least possibly related adverse reactions were reported in 2/201 (1.0 %) patients: mild vomiting 48 hours after surgery, and mild photosensitivity 48 hours after trial surgery.
Danish: Bivirkninger, der som et minimum muligvis var forbundet med lægemidlet, blev indberettet for 2/201 (1,0 %) patienter: mild opkastning 48 timer efter operationen og mild fotosensibilitet 48 timer efter operationen.
English: Four hours after oral administration of 20 mg/kg body weight 5-ALA HCl, the maximum PPIX plasma level is reached.
Danish: Fire timer efter oral indgift af 20 mg/kg legemsvægt 5-ALA HCl er det maksimale plasmaniveau af PPIX nået.
English: At the recommended oral dose of 20 mg/kg body weight, tumour to normal brain fluorescence ratios are usually high and offer lucid contrast for visual perception of tumour tissue under violet-blue light for at least 9 hours.
Danish: Ved den anbefalede orale dosis på 20 mg/kg legemsvægt er forholdet mellem fluorescensen af tumorvæv og normalt hjernevæv sædvanligvis høj og giver klar kontrast til visuel erkendelse af tumorvæv under violet-blå lys i mindst 9 timer.
English: photosensitivity reaction, photodermatosis
Danish: fotosensibilitetsreaktion, lysdermatose
English: Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Danish: Gliolan er indiceret til voksne til visualisering af malignt væv under kirurgisk indgreb for malignt gliom (WHO-grad III og IV).
English: Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles.
Danish: Gliolan fås i pakninger med 1, 2 og 10 flasker.
English: The excretion of 5-ALA or PPIX in milk has not been studied in animals.
Danish: Udskillelse af 5-ALA eller PPIX i mælken hos dyr er ikke undersøgt.
English: Gliolan should be used only by neurosurgeons who have attended a training course in accordance with the standards detailed below:
Danish: Gliolan må kun anvendes af neurokirurger, som har deltaget i et uddannelseskursus i henhold til nedenstående standarder:
English: Tell your doctor immediately if you experience any complaints.
Danish: Fortæl det straks til lægen, hvis du får det dårligt.
English: Phototoxicity observed after 5-ALA treatment in vitro and in vivo is obviously closely related to doseand time-dependent induction of PPIX synthesis in the irradiated cells or tissues.
Danish: Fototoksicitet, som blev observeret efter behandling med 5-ALA in vitro og in vivo, er tydeligvis tæt forbundet med den dosis- og tidsafhængige induktion af PPIX-syntese i de bestrålede celler eller væv.
English: In all patients with a tumour in the vicinity of an important neurological function, either pre- or intraoperative measures should be used to localise that function relative to the tumour in order to maintain safety distances.
Danish: Hos alle patienter med en tumor i umiddelbar nærhed af et område med en vigtig neurologisk funktion skal der træffes enten præoperative eller peroperative foranstaltninger for at lokalisere den pågældende funktion i forhold til tumoren og opretholde sikkerhedsafstandene.
English: The resulting fluorescence was used as an intraoperative marker for malignant glioma tissue with the aim of improving the surgical resection of these tumours.
Danish: Den deraf følgende fluorescens blev anvendt som en peroperativ markør for malignt gliomvæv med det formål at forbedre den kirurgiske resektion af disse tumorer.
English: After administration of this medicinal product, exposure of eyes and skin to strong light sources (e.g. operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours.
Danish: Efter indgivelse af dette lægemiddel skal udsættelse af øjnene og huden for kraftige lyskilder (fx operationslys, direkte sollys eller indendørsbelysning med kraftig fokus) undgås i 24 timer.
English: Minimum requirements for a qualified trainer are: - Board-certification as neurosurgeon according to local, national requirements; - Previous successful participation at a training course, or equivalent course during the phase III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
Danish: Minimumskravene til en kompetent underviser er: - kommissionsgodkendelse som neurokirurg i henhold til lokale, nationale krav; - tidligere vellykket deltagelse i et uddannelseskursus eller tilsvarende kursus under fase III-forsøget; - erfaring med Gliolan-fluorescencs-ledt kirurgi i form af mindst 20 cases.
English: After surgery the patient also displayed facial erythema.
Danish: Efter operationen havde patienten desuden erythem i ansigtet.
English: Excessive single dose treatment of rats with 5-ALA reversibly impaired male fertility for two weeks after dosing.
Danish: Behandling af rotter med meget store enkeltdoser 5-ALA forringede reversibelt hannernes fertilitet i 2 uger efter indgiften.
English: One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract.
Danish: For en enkelt patient er der indberettet et enkelt tilfælde af svær solforbrænding, der varede i 5 dage, efter at denne medicin og et hypericin (perikon) ekstrakt blev taget samtidigt.
English: Plasma levels return to baseline values 24 hours after administration of an oral dose of 20 mg/kg body weight.
Danish: Plasmaværdierne vender tilbage til udgangsværdierne 24 timer efter indgivelse af en oral dosis på 20 mg/kg legemsvægt.
English: What you need to know before you take Gliolan Do not take Gliolan
Danish: Det skal du vide, før du begynder at tage Gliolan Tag ikke Gliolan
English: Package leaflet: Information for the user Gliolan 30 mg/ml powder for oral solution
Danish: Indlægsseddel: Information til brugeren Gliolan 30 mg/ml pulver til oral opløsning
English: Destruction of sebaceous cells, focal epidermal necrosis with a transient acute inflammation and diffuse reactive changes in the keratinocytes as well as transient secondary oedema and inflammation of dermis are observed.
Danish: Der er observeret ødelæggelse af talgkirtelceller, fokal epidermal nekrose med en forbigående akut inflammation og diffuse reaktive ændringer i keratinocytter samt forbigående sekundært ødem og inflammation i dermis.
English: Besides tumour tissue, faint fluorescence of the choroid plexus was reported.
Danish: Foruden tumorvæv er der rapporteret svag fluorescens af plexus chorioideus.
English: Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue.
Danish: Administration af overskydende eksogent 5-ALA forebygger den negative feedback-kontrol, og der sker en akkumulering af PPIX i målvævet.
English: In the event of overdose, supportive measures should be provided as necessary, including sufficient protection from strong light sources (e.g. direct sunlight).
Danish: I tilfælde af overdosering skal understøttendeforanstaltninger træffes efter behov, herunder beskyttelse mod kraftige lyskilder (fx direkte sollys).
English: The reconstituted solution is physically-chemically stable for 24 hours at 25 °C.
Danish: Den rekonstituerede opløsning er fysisk-kemisk stabil i 24 timer ved 25 ºC.
English: Other medicines and Gliolan
Danish: Brug af anden medicin sammen med Gliolan
English: Gliolan contains a substance called aminolevulinic acid (5-ALA).
Danish: Gliolan indeholder et stof, der hedder aminolevulinsyre (5-ALA).
English: Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism.
Danish: De alvorligste bivirkninger omfattede anæmi, trombocytopeni, leukocytose, neurologiske forstyrrelser og tromboemboli.
English: In a single-arm trial including 36 patients with malignant glioma, adverse drug reactions were reported in 4 patients (mild diarrhoea in one patient, moderate hypesthesia in another patient, moderate chills in another patient, and arterial hypotension 30 minutes after application of 5-ALA in another patient).
Danish: I et forsøg med en enkelt behandlingsarm og deltagelse af 36 patienter med malignt gliom blev der indberettet bivirkninger for 4 patienter (let diaré hos én patient; moderat hypæstesi hos en anden patient; moderate kulderystelser hos en tredje patient, og arteriel hypotension 30 minutter efter anvendelse af 5-ALA hos en fjerde patient).
English: Feeling sick (nausea), decrease of blood pressure (hypotension), skin reactions (for example rash, looking like sunburn).
Danish: kvalme, nedsat blodtryk (hypotension), hudreaktioner (for eksempel udslæt, som ligner en solforbrænding).
English: If the surgery is delayed by one or more days, another dose of this medicine can be taken 24 hours before anaesthesia.
Danish: Hvis operationen er forsinket en eller flere dage, kan en ny dosis af medicin gives 2-4 timer inden bedøvelsen.
English: Results were based on a phase II trial including 33 patients receiving 5-ALA HCl in a dose of 20 mg/kg body weight.
Danish: Resultaterne var baseret på et fase II-forsøg med deltagelse af 33 patienter, som fik 5-ALA HCl i en dosis på 20 mg/kg legemsvægt.
English: The solution should be administered orally three hours (range 2-4 hours) before anaesthesia.
Danish: Opløsningen skal indgives oralt 3 timer (inden for 2-4 timer) inden anæstesi.
English: Signs of systemic toxicity (cardiovascular and respiratory parameters) occurred at higher doses in the anaesthetised dog: at 45 mg/kg body weight intravenously a slight decrease in peripheral arterial blood pressure and systolic left ventricular pressure was recorded.
Danish: Tegn på systemisk toksicitet (kardiovaskulær og respiratorisk) forekom ved højere doser hos bedøvede hunde: Ved 45 mg/kg legemsvægt intravenøst blev et svagt fald i perifert arterielt blodtryk og systolisk tryk i venstre ventrikel registreret.
English: Breast-feeding should be interrupted for 24 hours after treatment with this medicinal product.
Danish: Amning skal afbrydes i 24 timer efter behandling med dette lægemiddel.
English: Some limited animal studies suggest an embryotoxic activity of 5-ALA plus light exposure (see section 5.3).
Danish: Nogle begrænsede dyreforsøg tyder på embryotoksisk aktivitet fra 5-ALA og lyseksponering (se pkt.
English: Systemic administration of 5-ALA results in an overload of the cellular porphyrin metabolism and accumulation of PPIX in various epithelia and cancer tissues.
Danish: Systemisk indgivelse af 5-ALA medfører en overbelastning af den cellulære porfyrin-metabolisme og en akkumulering af PPIX i diverse epitheler og cancervæv.
English: In patients with pre-existing cardiovascular disease, this medicinal product should be used with caution since literature reports have shown decreased systolic and diastolic blood pressure, pulmonary artery systolic and diastolic pressure as well as pulmonary vascular resistance.
Danish: Dette lægemiddel skal anvendes med forsigtighed til patienter med eksisterende hjerte-kar-sygdom, da offentliggjorte rapporter har vist reduceret systolisk og diastolisk blodtryk, reduceret systolisk og diastolisk lungearterietryk samt pulmonal vaskulær modstand.
English: • combined side effects of Gliolan, anaesthesia, and tumour resection.
Danish: • Kombinerede bivirkninger af Gliolan, anæstesi og fjernelse af svulsten.
English: 5-ALA is preferentially taken up by the liver, kidney, endothelials and skin as well as by malignant gliomas (WHO grade III and IV) and metabolised to fluorescent PPIX.
Danish: 5-ALA optages fortrinsvis af lever, nyrer, endothelier og hud og af maligne gliomer (WHO-grad III og IV) og metaboliseres til fluorescerende PPIX.
English: Decrease of blood pressure (hypotension), brain swelling (brain oedema).
Danish: nedsat blodtryk (hypotension), hævelse i hjernen (hjerneødem).
English: In a phase I/II trial including 21 patients, a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core was detected: higher doses of 5-ALA enhanced the fluorescence quality and the fluorescence extent of the tumour core compared to demarcation of the tumour core under standard white illumination in a monotone, non-falling fashion.
Danish: I et fase I/II-forsøg med deltagelse af 21 patienter blev der påvist en dosis/effekt-forbindelse mellem dosisniveauerne og udstrækningen og kvaliteten af fluorescens i tumorkernen: Højere doser 5-ALA øgede kvaliteten og udstrækningen af fluorescens i tumorkernen sammenlignet med afgrænsning af tumorkernen under almindelig hvid belysning på en monoton, ikke-faldende måde.
English: Five minutes after administration, the baseline values had been reached again.
Danish: Udgangsværdierne var nået igen 5 minutter efter indgiften.
English: Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.
Danish: Gliolan bruges til visualisering af visse hjernesvulster (som kaldes for malignt gliom) under kirurgisk fjernelse af svulsten.
English: Within a clinical trial, a 63-year old patient with known cardiovascular disease was accidentally given an overdose of 5-ALA HCl (3000 mg instead of 1580 mg).
Danish: I et klinisk forsøg fik en 63-årig patient med kendt hjerte-karsygdom ved en fejl en overdosis 5-ALA HCl (3000 mg i stedet for 1580 mg).
English: Colourless type I glass bottle with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.
Danish: Farveløst type I-flaske med butylgummiprop indeholdende 1,5 g pulver til rekonstitution i 50 ml drikkevand.
English: In a single-arm trial including 21 healthy male volunteers, erythema of the skin could be provoked by direct exposure to UVA light up to 24 hours after oral application of 20 mg/kg body weight 5-ALA HCl.
Danish: I et forsøg med en enkelt behandlingsarm og deltagelse af 21 raske mandlige frivillige kunne huderythem fremprovokeres ved direkte eksponering for UVA-lys i op til 24 timer efter oral administration af 20 mg/kg legemsvægt 5-ALA HCl.
English: Very common: blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, gamma glutamyltransferase increased, blood amylase increased
Danish: Meget almindelige: forhøjet bilirubin i blodet, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gammaglutamyltransferase, forhøjet amylase i blodet
English: The phenomenon of PPIX accumulation in WHO grade III and IV malignant gliomas may be explained by higher 5-ALA uptake into the tumour tissue or an altered pattern of expression or activity of enzymes (e.g. ferrochelatase) involved in haemoglobin biosynthesis in tumour cells.
Danish: Fænomenet med PPIX-akkumulering i maligne gliomer af WHO-grad III og IV kan muligvis forklares med en højere optagelse af 5-ALA ind i tumorvævet eller ændret mønster for ekspression eller aktivitet af enzymer (fx ferrokelatase), som er involveret i biosyntesen af hæmoglobin i tumorceller.
English: • Pregnancy (see sections 4.6 and 5.3).
Danish: 4.6 og 5.3).
English: Substance-specific side effects:
Danish: Bivirkninger, der er specifikke for det aktive stof:
English: Reconstituted solution The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.
Danish: Rekonstitueret opløsning Den rekonstituerede opløsning er fysisk-kemisk stabil i 24 timer ved 25 ºC.
English: Feeling sick (nausea), being sick (vomiting), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis), total or partial loss of ability to use or understand language (aphasia), seizures (convulsions) and blindness for half the field of vision in one or both eyes (hemianopsia), and blood clots that may obstruct blood vessels (thromboembolism).
Danish: kvalme, opkastning, forstyrrelser, der kan påvirke nervesystemet (neurologiske forstyrrelser) såsom delvis paralysering af den ene side af kroppen (hemiparese), hel eller delvis tab af evnen til at bruge eller forstå sprog (afasi), kramper og tab af synet i halvdelen af synsfeltet i det ene eller begge øjne (hemianopsi) og blodpropper, som kan blokere blodkarrene (tromboemboli).
English: Within 24 hours after administration, other potentially hepatotoxic medicinal products should be avoided.
Danish: Andre potentielt hepatotoksiske lægemidler skal undgås inden for 24 timer efter indgivelse.
English: Explanations for higher 5-ALA uptake include a disrupted blood-brain barrier, increased neo-vascularisation, and the overexpression of membrane transporters in glioma tissue.
Danish: De mulige forklaringer på højere optagelse af 5-ALA omfatter: nedbrudt blod-hjerne-barriere, øget neovaskularisering og overekspression af membrantransportører i gliomvæv.
English: The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Danish: Aktivt stof: 5-aminolevulinsyrehydrochlorid (5-ALA HCl).
English: Gliolan 30 mg/ml powder for oral solution 5-aminolevulinic acid hydrochloride
Danish: Gliolan 30 mg/ml pulver til oral opløsning 5-aminolevulinsyrehydrochlorid
English: You have to drink the prepared solution 2-4 hours before anaesthesia.
Danish: Du skal drikke den tilberedte opløsning 2-4 timer inden bedøvelsen.
English: Special care must be taken in patients with a tumour in the immediate vicinity of an important neurological function and pre-existing focal deficits (e.g. aphasia, vision disturbances and paresis) that do not improve on corticosteroid treatment.
Danish: Der skal udvises særlig forsigtighed i forbindelse med patienter med en tumor i umiddelbar nærhed af et område med en vigtig neurologisk funktion og hos patienter med allerede eksisterende fokale udfald (fx afasi, synsforstyrrelser og parese), som ikke bedres efter behandling med kortikosteroider.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre at alle betingelser eller begrænsningermed hensyn til en sikker og effektiv anvendelse af lægemidlet er implementeret:
English: Renal or hepatic impairment Pharmacokinetics of 5-ALA in patients with renal or liver impairment has not been investigated.
Danish: Nedsat nyre- eller leverfunktion Farmakokinetikken for 5-ALA hos patienter med nedsat nyre- eller leverfunktion er ikke undersøgt.
English: The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Danish: Den fortyndede opløsning er en klar og farveløs til lysegul væske.
English: Gliolan 30 mg/ml powder for oral solution.
Danish: Gliolan 30 mg/ml pulver til oral opløsning.
English: 5-ALA is also taken up and metabolised to PPIX by other tissues, e.g. liver, kidneys or skin (see section 4.4).
Danish: 5-ALA optages og metaboliseres også til PPIX af andre væv, fx lever, nyrer eller hud (se pkt.
English: nausea
Danish: kvalme
English: • in case of known or suspected pregnancy.
Danish: • hvis du er gravid eller har formodning om, at du er gravid
English: • in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
Danish: • hvis du er allergisk over for 5-ALA eller porfyriner i tilfælde af kendte eller mistænkte akutte eller kroniske former for porfyri (dvs. nedarvede eller erhvervede defekter i visse enzymer i syntesen af rødt blodpigment)
English: 5-ALA is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX.
Danish: 5-ALA, det aktive stof i Gliolan, er et naturligt, biokemisk forstadie til hæm, som metaboliseres i en række enzymatiske reaktioner til fluorescerende porfyriner, især PPIX.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John's wort extracts).
Danish: Dette gælder især medicin, som kan give hudproblemer, når huden udsættes for kraftigt lys (for eksempel nogle typer medicin, der kaldes for antibiotika), men det gælder også medicin, som ikke er købt på recept (for eksempel hypericinekstrakter eller perikon).
English: This medicine is given once only at the day of surgery, 2 - 4 hours before start of anaesthesia.
Danish: Denne medicin gives kun én gang på dagen for operationen 2-4 timer inden bedøvelsen.
English: 5-ALA administration does not influence the function of the gastrointestinal and central nervous system.
Danish: Indgift af 5-ALA påvirker ikke mave-tarmkanalens og centralnervesystemets funktion.
English: The usual dose is 20 mg 5-ALA HCl per kilogram body weight.
Danish: Den normale dosis er 20 mg 5-ALA HCl pr. kilogram legemsvægt.
English: Procedure-related side effects
Danish: Bivirkninger, der er specifikke for proceduren
English: In a phase III trial with 349 patients with suspected malignant glioma amenable to complete resection of contrast-enhancing tumour were randomised to fluorescence-guided resection after administration of 20 mg/kg body weight 5-ALA HCl or conventional resection under white light.
Danish: I et fase III-forsøg blev 349 patienter med mistænkt malignt gliom, som var egnet til komplet resektion af kontrastopladendetumor, randomiseret til fluorescens-vejledt resektion efter indgivelse af 20 mg/kg legemsvægt 5-ALA HCl eller konventionel resektion under hvidt lys.
English: Most serious side effects include mild alterations of blood cell counts (red and white cells, platelets), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis) and blood clots that may obstruct blood vessels (thromboembolism).
Danish: De alvorligste bivirkninger omfatter milde forstyrrelser af blodlegemetallene (røde og hvide blodlegemer, blodplader), forstyrrelser, der kan påvirke nervesystemet (neurologiske forstyrrelser) såsom delvis paralysering af den ene side af kroppen (hemiparese) og blodpropper, der kan sætte sig fast i blodkarrene (tromboemboli).
English: In another single-centre trial, 21 patients with malignant glioma received 0.2, 2, or 20 mg/kg body weight 5-ALA HCl followed by fluorescence-guided tumour resection.
Danish: I et andet forsøg, udført på et enkelt center, fik 21 patienter med malignt gliom 0,2, 2 eller 20 mg/kg legemsvægt 5-ALA HCl efterfulgt af fluorescens-vejledt tumorresektion.
English: One bottle of Gliolan 30 mg/ml powder for oral solution reconstituted in 50 ml of drinking water corresponds to a total dose of 1500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Danish: En flaske med Gliolan 30 mg/ml pulver til oral opløsning, rekonstitueret i 50 ml drikkevand, svarer til en total dosis på 1500 mg 5-aminolevulinsyrehydrochlorid (5-ALA HCl).
English: Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.
Danish: Ammende mødre skal afbryde amningen i 24 timer efter behandling med denne medicin.