FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Gliolan in children and adolescents aged 0 to 18 years have not yet been established.
Danish: Gliolans sikkerhed og virkning hos børn i alderen 0-18 år er endnu ikke klarlagt.
English: The training course will take place at qualified training centres using qualified trainers.
Danish: Kurset vil blive afviklet i kompetente uddannelsescentre af kompetente undervisere.
English: However, considering the therapeutic indication, a single oral treatment with 5-ALA might not be related to any serious potential carcinogenic risk.
Danish: I betragtning af den terapeutiske indikation vil en enkelt oral behandling med 5-ALA dog næppe være forbundet med nogen alvorlig potentiel karcinogen risiko.
English: An adverse drug reaction of mild nausea was reported in 1 out of 21 volunteers.
Danish: Bivirkningen mild kvalme blev indberettet hos 1 ud af de 21 frivillige.
English: Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
Danish: Anvendelse af 5-ALA under andre betingelser end dem, der blev anvendt i de kliniske forsøg, medfører en ukendt risiko.
English: 2 bottles
Danish: 2 flasker
English: It is not known whether this medicine enters breast milk.
Danish: Det vides ikke, om denne medicin kan trænge over i modermælken.
English: There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
Danish: Der er dosisproportionalitet mellem AUC0-inf. af 5-ALA-værdier og forskellige orale doser af dette lægemiddel.
English: No significant increase in overall survival has been observed in this trial; however, it was not powered to detect such a difference.
Danish: Der blev ikke påvist nogen signifikant forbedring i den samlede overlevelse i dette forsøg, men forsøget var heller ikke dimensioneret til at påvise en sådan forskel.
English: A safe distance to eloquent cortical areas and subcortical structures of at least 1 cm should be maintained independent of the degree of fluorescence.
Danish: Der bør opretholdes en sikker afstand til elokvente kortikale områder og subkortikale strukturer på mindst 1 cm uafhængigt af fluorescensgraden.
English: Standard safety pharmacology experiments were performed under light protection in the mouse, rat and dog.
Danish: Almindelige farmakologiske sikkerhedsforsøg er udført under lysbeskyttelse på mus, rotter og hunde.
English: The influence of food has not been investigated because this medicinal product is generally given on empty stomach prior to induction of anaesthesia.
Danish: Betydningen af indtagelse af mad er ikke undersøgt, da dette lægemiddel normalt gives på tom mave inden induktion af anæstesi.
English: In this case, this medicine should be used with caution because your blood pressure may be decreased.
Danish: I så fald skal denne medicin bruges med forsigtighed, da blodtrykket kan blive nedsat.
English: There are no or limited amount of data from the use of 5-ALA in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelsen af 5-ALA til gravide kvinder.
English: Fertility There are no data available regarding the influence of 5-ALA on fertility.
Danish: Fertilitet Der er ingen tilgængelige data vedrørende indvirkningen af 5-ALA på fertiliteten.
English: Talk to your doctor or pharmacist before taking Gliolan.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Gliolan.
English: For oral use after reconstitution.
Danish: Til oral anvendelse efter fortynding.
English: Contrast-enhancing tumour was resected in 64 % of patients in the experimental group compared to 38 % in the controlgroup (p<0.0001).
Danish: Kontrastopladende tumor blev fjernet ved resektion hos 64% af patienterne i forsøgsgruppen sammenlignet med 38% i kontrolgruppen (p < 0,0001).
English: vomiting, nausea
Danish: opkastning, kvalme
English: A slight increase in saluresis cannot be excluded.
Danish: En svag stigning i saltudskillelsen i nyrerne kan ikke udelukkes.
English: Respiratory insufficiency and erythema completely resolved.
Danish: Den respiratoriske insufficiens og erythemet svandt fuldstændigt.
English: There are no special instructions for use in elderly patients with normal organ function.
Danish: Der er ingen særlige instruktioner for anvendelse til ældre patienter med normal organfunktion.
English: In this case, anaesthesia and surgery must be postponed for at least 2 hours, if possible.
Danish: I det tilfælde skal bedøvelsen og operationen om muligt udsættes i mindst 2 timer.
English: 22880 Wedel Germany
Danish: 22880 Wedel Tyskland
English: PPIX plasma levels rapidly decline during the subsequent 20 hours and are not detectable anymore 48 hours after administration.
Danish: Plasmaniveauerne af PPIX falder hurtigt i de efterfølgende 20 timer og kan ikke længere påvises 48 timer efter indgiften.
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: 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)
English: This helps the surgeon to remove the tumour while sparing healthy tissue.
Danish: Dette hjælper kirurgen til at fjerne svulsten, samtidig med at det raske væv skånes.
English: The total number of bottles needed to achieve the intended dose for the individual patient can be determined according to the equation below (rounded up to the nearest whole bottle):
Danish: Det totale antal flasker, som er nødvendige for at opnå den tilsigtede dosis for den enkelte patient, kan bestemmes i henhold til den nedenstående ligning (rundet op til den nærmeste hele flaske):
English: and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Danish: og IV); - neurofysiologiske monitoreringsteknikker til kirurgiske indgreb i elokvente hjerneområder.
English: Therefore this medicine is not recommended in this age group.
Danish: Denne medicin frarådes derfor til denne aldersgruppe.
English: This value was defined as the percentage of patients with positive tumour cell identification in all biopsies taken from areas of weak and strong fluorescence.
Danish: Denne værdi blev defineret som procentdelen af patienter med positiv tumorcelleidentifikation i alle biopsier, der var taget fra områder med svag og kraftig fluorescens.
English: Gliolan is for single use only and any content remaining after first use must be discarded.
Danish: Gliolan er kun til engangsbrug, og eventuelt resterende indhold efter første brug skal kasseres.
English: Tissue surrounding the tumour and normal brain may also be affected.
Danish: Væv, der omgiver tumoren, og normalt hjernevæv kan også være berørt.
English: Light exposed skin recovered completely except for a persistent reduction in the number of hair follicles.
Danish: Lyseksponeret hud restitueredes fuldstændigt, bortset fra et vedvarende fald i antal hårfollikler.
English: Accordingly, general light protective measures of eyes and skin are recommended for at least 24 hours after administration of this medicinal product.
Danish: Derfor anbefales generelle foranstaltninger til beskyttelse af øjne og hud mod lys i mindst 24 timer efter indgift af dette lægemiddel.
English: 173 patients received standard resection without administration of the medicinal product and subsequent radiotherapy.
Danish: 173 patienter gennemgik standardresektion uden indgivelse af lægemidlet og med efterfølgende strålebehandling.
English: The Marketing Authorisation Holder in agreement with the competent authorities in the Member States shall implement, prior to launch:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med de kompetente myndigheder i medlemslandene inden lancering implementere:
English: This medicinal product shows good solubility in aqueous solutions.
Danish: Dette lægemiddel viser god opløselighed i vandholdige opløsninger.
English: This medicinal product should, therefore, not be administered to pregnant women.
Danish: Dette lægemiddel bør derfor ikke gives til gravide kvinder.
English: • Acute or chronic types of porphyria.
Danish: • Akut eller kronisk form for porfyri.
English: A positive predictive value of tissue fluorescence of 84.8 % (90 % CI: 70.7 %-93.8 %) was found.
Danish: Der blev fundet en positiv prædiktiv værdi af vævsfluorescens på 84,8% (90% CI: 70,7 %-93,8%).
English: • Hypersensitivity to the active substance or porphyrins.
Danish: • Overfølsomhed over for det aktive stof eller porfyriner.
English: 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance.
Danish: 5-ALA akkumuleres især i svulstceller, hvor det omdannes til et andet lignende stof.
English: These changes peak between 7 and 14 days after surgery.
Danish: Disse ændringer når deres maksimum mellem 7 og 14 dage efter det kirurgiske indgreb.
English: Tabulated summary of adverse reactions Very common (≥1/10)
Danish: Tabuleret oversigt over bivirkninger Meget almindelig (≥ 1/10)
English: Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories:
Danish: De bivirkninger, der er observeret efter anvendelse af dette lægemiddel til fluorescens-vejledt gliomresektion, er inddelt i følgende to kategorier:
English: If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).
Danish: Hvis du har taget mere Gliolan end du bør, vil din læge træffe foranstaltninger for at undgå eventuelle problemer, herunder sørge for tilstrækkelig beskyttelse mod stærkt lys (for eksempel direkte sollys).
English: Not relevant, the treatment itself will have an influence on the ability to drive and use machines.
Danish: Ikke relevant, behandlingen vil i sig selv påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Very rare side effects (may affect up to 1 in 10,000 people) or not known (frequency cannot be estimated from the available data):
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 behandlede) eller ikke kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data):
English: Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits.
Danish: Det er konstateret, at fluorescens-vejledt resektion hos disse patienter medfører en højere risiko for kritiske neurologiske defekter.
English: You should not drink or eat for at least 6 hours before anaesthesia.
Danish: Du må ikke indtage mad og drikkevarer i mindst 6 timer inden bedøvelsen.
English: Approximately 30 % of an orally administered dose of 20 mg/kg body weight is excreted unchanged in urine within 12 hours.
Danish: Cirka 30% af en oralt indgivet dosis på 20 mg/kg legemsvægt udskilles uændret i urinen inden for 12 timer.
English: The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:
Danish: Det administrerede volumen, som er nødvendigt for at opnå den tilsigtede dosis for den enkelte patient, kan beregnes i henhold til den nedenstående ligning:
English: Plasma protein binding of 5-ALA is unknown.
Danish: Plasmaproteinbindingen af 5-ALA kendes ikke.
English: It is unknown whether 5-ALA or its metabolite protoporphyrin IX (PPIX) is excreted in human milk.
Danish: Det er ukendt, om 5-ALA eller dets metabolit, protoporfyrin IX (PPIX), udskilles i human mælk.
English: The positive predictive value of strong fluorescence was higher (100.0 %; 90 % CI: 91.1 %-100.0 %) than of weak fluorescence (83.3 %; 90 % CI: 68.1 %-93.2 %).
Danish: Den positive prædiktive værdi af kraftig fluorescens var højere (100,0%; 90% CI: 91,1%-100,0%) end af svag fluorescens (83,3%; 90% CI: 68,1%-93,2%).
English: Patient body weight (kg) Number of bottles = -------------75 kg/bottle
Danish: Patientens legemsvægt (kg) Antal flasker = -------------75 kg/flaske
English: Respiratory insufficiency, which was reported in this patient, was managed by adaptation of ventilation and resolved completely.
Danish: Respiratorisk insufficiens, som blev indberettet for denne patient, blev behandlet med justering af ventilationen og forsvandt helt.
English: 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism.
Danish: 5-ALA-syntesen reguleres af den intracellulære mængdeaf frit hæm via en negativ feedback-mekanisme.
English: If the tumour is then exposed to blue light, this new substance emits a red-violet light which helps to better see what is normal tissue and what is tumour tissue.
Danish: Hvis svulsten derefter eksponeres for blåt lys, udstråler dette nye stof et rød-violet lys, som gør det nemmere at se, hvad der er normalt væv, og hvad der er svulstvæv.
English: In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis.
Danish: Ved tilstedeværelse af synligt lys kan fluorescens af PPIX (fotodynamisk virkning) i visse typer af målvæv anvendes til fotodynamisk diagnose.
English: Another patient accidentally received an overdose of the medicinal product (3000 mg instead of 1580 mg).
Danish: En anden patient fik ved en fejl en overdosis af lægemidlet (3000 mg i stedet for 1580 mg).
English: At the visit six months after tumour resection, 20.5 % of 5-ALA-treated-patients and 11 % of patients who underwent standard surgery were alive at the six-month visit without progression.
Danish: Ved kontrol 6 måneder efter tumorresektionen var 20,5% af de patienter, der blev behandlet med 5-ALA, og 11% af de patienter, der gennemgik det almindelige indgreb, i live uden progression.
English: Pharmacotherapeutic group: Antineoplastic agents, sensitisers used in photodynamic therapy, ATC code: L01XD04
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, sensibilatorer til fotodynamisk/stråle-terapi, ATC-kode: L01XD04
English: However, 5-ALA induced PPIX formation is significantly higher in malignant tissue than in normal brain.
Danish: 5-ALA-induceret PPIX-dannelse er dog betydeligt højere i malignt væv end i normalt hjernevæv.
English: The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
Danish: Medlemslandene skal inden lancering sammen med indehaveren af markedsføringstilladelse indvillige i foranstaltninger til implementering af følgende:
English: During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation.
Danish: Under operationen udviklede han respiratorisk insufficiens, som blev behandlet med justering af ventilationen.
English: The only adverse reaction reported in this trial was one case of mild sunburn occurring in a patient treated with the highest dose.
Danish: Den eneste bivirkning, der blev indberettet i dette forsøg, var et enkelt tilfælde af mild solforbrænding hos en patient, der blev behandlet med den højeste dosis.
English: Marketing Authorisation Holder and Manufacturer medac
Danish: Indehaveren af markedsføringstilladelsen og fremstiller medac
English: You should not take any such products up to 2 weeks after you have taken Gliolan.
Danish: Du bør ikke indtage sådanne stoffer, før der er gået 2 uger efter, at du har taget Gliolan.
English: Patient body weight (kg) x 20 mg/kg Administration volume (ml) = ------------------30 mg/ml
Danish: Patientens legemsvægt (kg) x 20 mg/kg Administrationsvolumen (ml) = ------------------30 mg/ml
English: This medicine itself has no influence on the ability to drive and use machines.
Danish: Denne medicin medfører i sig selv ingen påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: Brain metastases revealed inconsistent or no fluorescence.
Danish: Hjernemetastaser afslørede uensartet eller ingen fluorescens.
English: If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anaesthesia.
Danish: Hvis du har glemt at tage medicinen i denne periode, bør du ikke tage medicinen umiddelbart inden bedøvelsen.
English: The powder is a white to off-white cake.
Danish: Pulveret er en hvid til råhvid klump.
English: The highest dose (20 mg/kg body weight) was determined to be the most efficient.
Danish: Det blev fastlagt, at den højeste dosis (20 mg/kg legemsvægt) var den mest effektive.
English: Therefore, resection of fluorescing tissue should be weighed up carefully against the neurological function of fluorescing tissue.
Danish: Resektion af fluorescerende væv skal derfor opvejes nøje i forhold til den neurologiske funktion af det fluorescerende væv.
English: After excitation with blue light (λ=400-410 nm), PPIX is strongly fluorescent (peak at λ=635 nm) and can be visualised after appropriate modifications to a standard neurosurgical microscope.
Danish: Efter excitation med blåt lys (λ = 400-410 nm) er PPIX kraftigt fluorescerende (maksimum ved λ = 635 nm) og kan visualiseres efter passende modifikation af et neurokirurgisk mikroskop.
English: This medicinal product should only be used by experienced neurosurgeons conversant with surgery of malignant gliomas and in-depth knowledge of functional brain anatomy who have completed a training course in fluorescence-guided surgery.
Danish: Dette lægemiddel bør kun anvendes af erfarne neurokirurger, der er fortrolige med operation af maligne gliomer, og som har indgående viden om funktionel hjerneanatomi og gennemført et uddannelseforløb inden for fluorescens-vejledt kirurgi.
English: Minimum requirements for a qualified training centre are: - Microscope modified for fluorescence-guided resection; - Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III
Danish: Minimumskravene til et kompetent undervisningscenter er: - mikroskop, der er tilpasset fluorescens-ledt resektion; - tilstrækkelig casemængde (mindst 10 patienter pr. år) af maligne gliomer (WHO-grad III
English: Name and address of the manufacturer responsible for batch release medac
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse medac
English: • For 24 hours after administration of this medicine, protect your eyes and skin from strong light (for example direct sunlight or brightly focused indoor light).
Danish: • I 24 timer efter indgivelse af denne medicin skal du beskytte dine øjne og huden mod for kraftigt lys (for eksempel direkte sollys eller indendørsbelysning med kraftig fokus).
English: Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
Danish: Tlf.: + 49 4103 8006 0 Fax: + 49 4103 8006 100
English: In contrast, in low-grade tumours (WHO-grade I and II, e.g. medulloblastoma, oligodendroglioma) no fluorescence could be observed after application of the active substance.
Danish: Derimod kunne der i tumorer af lav grad (WHO-grad I og II, fx medulloblastoma, oligodendroglioma) ikke observeres nogen fluorescens efter indgift af det aktive stof.
English: If you forget to take Gliolan
Danish: Hvis du har glemt at tage Gliolan
English: Patients should not be exposed to any photosensitizing agent up to 2 weeks after administration of Gliolan.
Danish: Patienterne må ikke eksponeres for noget fotosensibiliserende middel i op til 2 uger efter indgivelse af Gliolan.
English: 5-ALA as drinking solution is rapidly and completely absorbed and peak plasma levels of 5-ALA are reached 0.5-2 hours after oral administration of 20 mg/kg body weight.
Danish: 5-ALA som drikkeopløsning absorberes hurtigt og fuldstændigt, og de maksimale plasmaværdier af 5-ALA nås 0,5-2 timer efter oral indgivelse af 20 mg/kg legemsvægt.
English: • immediate side effects after having taken Gliolan and before anaesthesia
Danish: • Øjeblikkelige bivirkninger efter indtagelse af Gliolan og før anæstesi
English: Very common: anaemia, thrombocytopenia, leukocytosis
Danish: Meget almindelige: anæmi, trombocytopeni, leukocytose
English: 5-aminolevulinic acid hydrochloride
Danish: 5-aminolevulinsyrehydrochlorid
English: EXP Shelf life of the reconstituted solution: 24 hours at 25 °C.
Danish: EXP Opbevaringstid for den rekonstituerede opløsning: 24 timer ved 25 °C.
English: Single administration of high doses of 5-ALA to mice or rats leads to unspecific findings of intolerance without macroscopic abnormalities or signs of delayed toxicity.
Danish: En enkelt indgift af høje doser 5-ALA til mus eller rotter fører til uspecifikintolerance uden makroskopiske forandringer eller tegn på forsinket toksicitet.
English: Single use bottle - discard any content remaining after first use.
Danish: Engangsflaske - eventuelt resterende indhold skal kasseres efter første brug.
English: Therefore, this medicine should be used with caution in such patients.
Danish: Denne medicin skal derfor anvendes med forsigtighed til sådanne patienter.
English: 5-ALA-induced fluorescence of brain tissue does not provide information about the tissue's underlying neurological function.
Danish: 5-ALA-induceret fluorescens af hjernevæv giver ikke information om vævets tilgrundliggende neurologiske funktion.
English: All patients received the medicinal product in a dose of 20 mg/kg body weight and underwent fluorescence-guided resection.
Danish: Alle patienter fik lægemidlet i en dosis på 20 mg/kg legemsvægt og gennemgik fluorescens-vejledt resektion.
English: Contents of the pack and other information What Gliolan contains
Danish: Pakningsstørrelser og yderligere oplysninger Gliolan indeholder:
English: Repeat-dose toxicity studies performed in rats and dogs demonstrate dose-dependent adverse reactions affecting changes in bile duct histology (non-reversible within a 14 day recovery period), transient increase in transaminases, LDH, total bilirubin, total cholesterol, creatinine, urea and vomiting (only in dogs).
Danish: Undersøgelser af toksiciteten ved gentagne doser, som blev gennemført på rotter og hunde, viste dosisafhængige uønskede hændelser i form af ændringer i galdegangshistologien (ikke-reversible inden for en restitueringsperiode på 14 dage), forbigående stigning i transaminaser, LDH, total bilirubin, total kolesterol, kreatinin og urinstof samt opkastning (kun hos hunde).
English: Powder for oral solution 1 bottle
Danish: Pulver til oral opløsning 1 flaske
English: Therefore, this medicinal product should be used with caution in such patients.
Danish: Dette lægemiddel skal derfor anvendes med forsigtighed til sådanne patienter.
English: Fluorescence emission can be classified as intense (solid) red fluorescence (corresponds to vital, solid tumour tissue) and vague pink fluorescence (corresponds to infiltrating tumour cells), whereas normal brain tissue lacking enhanced PPIX levels reflects the violet-blue light and appears blue.
Danish: Fluorescensemission kan klassificeres som intens (massiv) rød fluorescens (svarer til vitalt, solidt tumorvæv) og svagt lyserød fluorescens (svarer til infiltrerende tumorceller), hvorimod normalt hjernevæv, der ikke har de øgede PPIX-niveauer, reflekterer det violet-blå lys og er blåt.
English: The oral solution is prepared by dissolving the amount of powder of one bottle in 50 ml of drinking water.
Danish: Den orale opløsning tilberedes ved at opløse pulvermængden i en flaske i 50 ml drikkevand.
English: Although pivotal studies on the reproductive and developmental behaviour of 5-ALA have not been performed, it can be concluded that 5-ALA induced porphyrin synthesis may lead to embryotoxic activity in mouse, rat and chick embryos only under the condition of direct concomitant light exposure.
Danish: Selvom der ikke er udført pivotale undersøgelser af 5-ALA's effekt på reproduktion og fosterudvikling, kan det konkluderes, at 5-ALA-induceret porfyrinsyntese kan føre til embryotoksisk aktivitet i embryoer hos mus, rotter og høns, men kun ved samtidig direkte lyseksponering.
English: This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma.
Danish: Denne medicin bruges normalt kun én gang, nemlig 2-4 timer inden bedøvelsen i forbindelse med et operation, hvor en type hjernesvulst, der kaldes for gliom, skal fjernes.