FrancophonIA/ELRC3.0 huggingface dataset:
English: Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Danish: Gliolan bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for 5-aminolevulinsyrehydrochlorid eller porfyriner.
English: The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light).
Danish: Resultatet af operationen blev sammenlignet for de patienter, der fik Gliolan (og blev opereret under blåt lys), og dem, der ikke fik nogen medicin til at synliggøre svulsten (og blev opereret under sædvanligt hvidt lys).
English: It concluded that Gliolan increases the ability of the tumour to be distinguished from healthy brain tissue during surgery, and that it increases the proportion of patients whose tumours are completely removed and extends the time that patients survive without progression.
Danish: Udvalget konkluderede, at Gliolan gør det lettere at skelne svulsten fra det sunde væv under operationen, og at det øger den andel af patienterne, hvis svulst bliver fuldstændig fjernet, og forlænger det tidsrum, hvori patienterne overlever uden fremadskriden af sygdommen.
English: When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue.
Danish: Når PPIX i svulstvævet belyses med blåt lys af en bestemt bølgelængde, lyser det kraftigt rødt, hvorimod det normale væv fremtræder blåt.
English: Why has Gliolan been approved?
Danish: Hvorfor blev Gliolan godkendt?
English: Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.
Danish: Gliolan bør kun anvendes af erfarne neurokirurger, der er fortrolige med operation af ondartet gliom, har indgående viden om hjernens anatomi og har gennemgået et kursus i fluorescens-vejledt kirurgi.
English: The active substance in Gliolan, 5-aminolevulinic acid, is a ‘sensitiser used in photodynamic therapy'.
Danish: Det aktive stof i Gliolan, 5-aminolevulinsyre, anvendes som fotosensitiser (lysfølsomhedsfremkaldende stof) ved fotodynamisk terapi.
English: Because the number of patients with malignant glioma is low, the disease is considered ‘rare', and Gliolan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 November
Danish: Da ondartet gliom er sjældent, blev Gliolan den 13. november 2002 udpeget som "lægemiddel til sjældne sygdomme".
English: At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
Danish: Ved scanning 72 timer efter operationen kunne der ikke ses svulstvæv hos 63,6 % af de patienter, der havde fået Gliolan, sammenholdt med 37,6 % af dem, der ikke havde fået Gliolan.
English: Before the medicine is launched, the company that makes Gliolan will set up training courses in all Member States for brain surgeons to inform them about how to use the medicine safely and effectively during surgery.
Danish: Det firma, der fremstiller Gliolan, vil inden markedsføringen i alle EU's medlemsstater afholde kurser for hjernekirurger, hvor de vil blive sat ind i risikofri og effektiv anvendelse af lægemidlet under operationer.
English: Removal of the brain tumour during surgery was more complete when Gliolan was used.
Danish: Hjernesvulsten blev mere fuldstændigt bortopereret, når der blev anvendt Gliolan.
English: Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Danish: Gliolan anvendes til behandling af voksne patienter med ondartet gliom (en art hjernesvulst).
English: The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger (‘progressing').
Danish: Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hos hvem der ikke kunne ses nogen svulst ved scanning 72 timer efter operationen, og den andel, der overlevede i seks måneder uden fremadskriden af sygdommen (dvs. tilbagevenden eller vækst af svulsten).
English: The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Danish: Udvalget fandt, at fordelene ved Gliolan opvejer risiciene til synliggørelse af ondartet væv ved operation for ondartet gliom.
English: Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour.
Danish: Gliolan blev anvendt i én hovedundersøgelse med 415 patienter, som havde ondartet gliom og skulle opereres i hjernen for at få fjernet svulsten.
English: What is Gliolan?
Danish: Hvad er Gliolan?
English: For the full list of all side effects reported with Gliolan, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Gliolan fremgår af indlægssedlen.
English: Gliolan is a powder to be made up into a solution to be taken by mouth.
Danish: Gliolan er et pulver, der er beregnet til at blive opløst og indtaget oralt.
English: This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.
Danish: Det får svulsten til at stå tydeligere frem under operationen, så kirurgen kan fjerne den med større præcision og samtidig skåne det raske hjernevæv.
English: What is Gliolan used for?
Danish: Hvad anvendes Gliolan til?
English: What benefit has Gliolan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Gliolan?
English: Since glioma cells take up more of the active substance and convert it more rapidly into PPIX, higher levels of PPIX accumulate in the cancer cells than in normal tissue.
Danish: Gliomceller optager mere af det aktive stof og omdanner det hurtigere til PPIX.
English: Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.
Danish: Gliolan får svulstvævet til at træde tydeligere frem under operationen til fjernelse af svulsten i hjernen.
English: How is Gliolan used?
Danish: Hvordan anvendes Gliolan?
English: How has Gliolan been studied?
Danish: Hvordan blev Gliolan undersøgt?
English: How does Gliolan work?
Danish: Hvordan virker Gliolan?
English: Gliolan should be used with caution in patients who have problems with their liver or kidneys.
Danish: Hos patienter med lever- eller nyreproblemer bør Gliolan anvendes med forsigtighed.
English: Treatment is continued for up to two weeks after the infection has been cured.
Danish: Behandlingen fortsættes i op til to uger, efter at infektionen er helbredt.
English: It is given once a day by infusion lasting about one hour.
Danish: Det gives én gang dagligt ved intravenøs infusion i løbet af ca. en time.
English: The name of the medicine was changed to Cancidas on 9 April
Danish: Lægemidlets navn blev ændret til Cancidas den 9. april
English: The full EPAR for Cancidas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cancidas findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effect in children is fever and this occurs in more than 1 patient in 10.
Danish: Den hyppigste bivirkning hos børn er feber, som forekommer hos mere end 1 ud af 10 patienter.
English: In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight.
Danish: Hos patienter i alderen 12 måneder til 17 år beregnes dosen ud fra barnets højde og vægt.
English: This is a summary of the European public assessment report (EPAR) for Cancidas.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cancidas.
English: Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group.
Danish: Cancidas bør anvendes med forsigtighed hos børn under 12 måneder, da lægemidlet endnu ikke er blevet tilstrækkeligt undersøgt hos denne aldersgruppe.
English: Other information about Cancidas
Danish: Andre oplysninger om Cancidas:
English: What measures are being taken to ensure the safe and effective use of Cancidas?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cancidas?
English: The Committee therefore recommended that Cancidas be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Cancidas.
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to continue living and growing.
Danish: Det virker ved at gribe ind i produktionen af et stof i svampens cellevæg kaldet polysaccharid af glucan, som er nødvendigt for at svampen fortsat kan leve og vokse.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cancidas den 24. oktober 2001.
English: • invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Danish: • invasiv aspergillose (en infektion forårsaget af Aspergillus), når patienten ikke reagerer på eller ikke kan tåle amphotericin B eller itraconazol (andre svampemidler)
English: In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.
Danish: Hos voksne begynder behandlingen med en startdosis på 70 mg efterfulgt af en daglig dosis på 50 mg eller en dosis på 70 mg, hvis patienten vejer over 80 kg. En lavere dosis kan være nødvendig hos voksne, som har moderate leverproblemer.
English: Studies show that Cancidas treatment can lead to favourable responses in patients with fungal infections, including improvement of symptoms and the clearing of fungus from patient's body.
Danish: Undersøgelser viser, at behandling med Cancidas kan give positive resultater hos patienter med svampeinfektioner, herunder forbedrede symptomer og fjernelse af svampen fra patientens krop.
English: Why is Cancidas approved?
Danish: Hvorfor blev Cancidas godkendt?
English: It is not intended to provide practical advice on how to use Cancidas.
Danish: Det er ikke en praktisk vejledning i, hvordan Cancidas skal anvendes.
English: Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Danish: Behandlingen med Cancidas bør indledes af en læge med erfaring i at behandle invasive svampeinfektioner.
English: What is Cancidas and what is it used for?
Danish: Hvad er Cancidas, og hvad anvendes det til?
English: This is known as ‘empirical treatment', which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection.
Danish: Denne måde at behandle på kaldes "empirisk behandling", dvs. at lægen indleder behandlingen alene ud fra de iagttagne symptomer, inden diagnosen er blevet bekræftet.
English: Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
Danish: Cancidas er et svampemiddel, der anvendes til at behandle følgende svampeinfektioner hos voksne og børn:
English: The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Danish: Det aktive stof i Cancidas, caspofungin, tilhører en gruppe svampemidler, der kaldes "echinocandiner".
English: The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
Danish: lavt kaliumniveau i blodet, hovedpine, betændelse i venerne, åndedrætsbesvær, kvalme, diarré, opkastning, forhøjet antal leverenzymer og bilirubin, (hvilket kan tyde på leverproblemer), udslæt, kløe, rødme på huden, kraftige svedeture, smerter i leddene, feber, kulderysten, kløe på injektionsstedet samt reduceret albuminniveau (et protein i blodet).
English: For the full list of all side effects reported with Cancidas in adults and children, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Cancidas hos voksne og børn fremgår af indlægssedlen.
English: What are the risks associated with Cancidas?
Danish: Hvilke risici er der forbundet med Cancidas?
English: Cancidas contains the active substance caspofungin
Danish: Cancidas indeholder det aktive stof caspofungin.
English: For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cancidas, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Cancidas is a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Cancidas er et pulver, der blandes til en opløsning til infusion (drop) i en vene.
English: Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years.
Danish: Endelig, i to undersøgelser af patienter med en formodet svampeinfektion, og som fik en "empirisk behandling", viste Cancidas sig at være lige så effektiv som amphotericin B. I en af de to undersøgelser, som omfattede omkring 1 000 voksne, responderede 34 % af patienterne positivt på enten Cancidas eller amphotericin B. Tilsvarende resultater sås i den anden undersøgelse, der omfattede 82 børn i alderen 2-17 år.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts.
Danish: • formodet svampeinfektion (f.eks. forårsaget af arterne Candida eller Aspergillus) hos patienter med feber og et lavt antal hvide blodlegemer.
English: Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow.
Danish: Ved behandling med Cancidas bliver svampecellernes cellevægge svækkede eller defekte, så cellerne bliver skrøbelige og ude af stand til at vokse.
English: The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cancidas opvejer risiciene ved behandling af invasiv candidiasis eller invasiv aspergillose og empirisk behandling af formodede svampeinfektioner hos voksne og/eller børn.
English: Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
Danish: Tilsvarende reaktioner sås i en undersøgelse af 49 børn og unge, der enten havde invasive candidiasis eller invasive aspergillose Behandlingen med Cancidas virkede hos 50 % af de, der havde invasiv candidiasis (5 af 10) og hos 81 % af de, der havde invasiv aspergillose (30 ud af 37).
English: In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Danish: I en undersøgelse af 239 voksne med invasiv candidiasis virkede behandlingen hos 73 % af de Cancidas-behandlede patienter, som kunne vurderes, (80 af 109), sammenlignet med 62 % hos voksne behandlet med amphotericin B (71 af 115).
English: What benefits of Cancidas have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cancidas?
English: Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Danish: For de, som ikke tålte andre midler, virkede behandlingen med Cancidas hos 70 % (7 ud af 10).
English: For practical information about using Cancidas, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cancidas, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de svampearter, som Cancidas virker mod, findes i produktresuméet, der også er en del af denne EPAR.
English: Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Danish: Af de voksne, hos hvem andre midler ikke virkede, virkede behandlingen med Cancidas hos 36 % (19 af 53).
English: How is Cancidas used?
Danish: Hvordan anvendes Cancidas?
English: In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63).
Danish: I en undersøgelse, der omfattede 69 voksne med invasiv aspergillose, virkede behandlingen med Cancidas hos 41 % ved undersøgelsens slutning (26 ud af 63).
English: • invasive candidiasis (an infection caused by Candida).
Danish: • invasiv candidiasis (en infektion forårsaget af Candida) "Invasiv" betyder, at infektionen har spredt sig til blodet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cancidas have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cancidas.
English: How does Cancidas work?
Danish: Hvordan virker Cancidas?
English: • are under 18 years Talk to a pharmacist or your doctor before taking if you:
Danish: • er under 18 år Tal med apoteket eller lægen inden du tager det, hvis du:
English: The active substance ibuprofen shows an environmental risk for the aquatic environment especially to fish.
Danish: Det aktive stof, ibuprofen, viser en miljørisiko for vandmiljøet, især for fisk.
English: Dose reduction is recommended in patients showing signs of worsening hepatic function.
Danish: Reduktion af dosis anbefales hos patienter, som udviser tegn på forværring af deres leverfunktion.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Præparatoplysningerne kan efterfølgende opdateres efter behov af medlemsstatens myndighed i samarbejde med referencemedlemsstaten, hvor det er passende, i overensstemmelse med procedurerne, som er beskrevet i kapitel 4 titel III i direktiv 2001/83/EU.
English: [The following AEs are described as follows:] ‘Paraesthesia' to frequency Rare (moved from Very Rare) ‘Oedema' to frequency Common (moved from Very Rare)
Danish: [Følgende bivirkninger er beskrevet som følger:] "Paræstesi" til hyppigheden Sjælden (flyttet fra Meget sjælden) "Ødem" til hyppigheden Almindelig (flyttet fra Meget sjælden)
English: Do not take for more than 3 days.
Danish: Må ikke tages i mere end 3 dage.
English: [The following wording should be amended as follows] If your symptoms do not get better after 3 days, if they get worse or if you get new symptoms, talk to your doctor.
Danish: Hvis dine symptomer ikke bliver bedre efter 3 dage, hvis de bliver værre, eller hvis du får nye symptomer, skal du tale med din læge.
English: [The following phrase is deleted as it was duplication]
Danish: [Følgende udtryk er slettet, da den var duplikeret]
English: B. Labelling Carton
Danish: B. Etikettering Karton
English: The valid product information is the final version achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below:
Danish: Den gyldige produktinformation er den endelige version udarbejdet i løbet af koordineringsgruppeproceduren med følgende ændringer (indsætning, udskiftning eller slettelse af tekst som det er passende) for at afspejle den aftalte ordlyd, som fremsat nedenfor: A. Produktresumé
English: The exact mechanism of action of ibuprofen is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthesise inhibition.
Danish: Den nøjagtige virkningsmekanisme af ibuprofen menes at være gennem perifer hæmning af cyclooxygenaser og efterfølgende hæmning af syntesen af prostaglandin.
English: Section 4.8 Undesirable effects
Danish: Afsnit 4.8 Bivirkninger
English: Children under18 years: [The following wording should be amended as follows] This product is not recommended forDo not give to children under 18 years.
Danish: Børn under 18 år: [Følgende ordlyd skal ændres som følger] Produktet anbefales ikke tilMå ikke gives til børn under 18 år.
English: [The following wording should be amended as follows] This medicinal product should not be taken with other medicinal products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates or with any other anti-inflammatory drugs (NSAIDs) unless under a doctor's instruction.
Danish: Lægemidlet må ikke tages sammen med andre lægemidler, der indeholder paracetamol, ibuprofen, acetylsalicylsyre, salicylater eller med andre non-steroide anti-inflammatoriske lægemidler (NSAID'er), medmindre en læge har instrueret dig derom.
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section]
Danish: Afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Nedenstående ordlyd skal indsættes i dette afsnit]
English: What {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}contain macrogol/PEG 4000
Danish: {Paracetamol/Ibuprofen 500 mg/150 mg filmovertrukne tabletter}{Novogesic 500 mg/150 mg filmovertrukne tabletter} indeholder macrogol/PEG 4000
English: Amendments to the relevant sections of the product information
Danish: Ændringer i de relevante punkter i produktresumeet
English: Treatment should be stopped in those patients who develop severe liver failure (see section 4.3).
Danish: Behandling skal seponeres hos patienter, som udvikler alvorligt leversvigt (se afsnit 4,3).
English: [The wording below should be inserted in this section] Treatment should be stopped in those patients who develop severe renal failure (see section 4.3).
Danish: [Nedenstående ordlyd skal indsættes i dette afsnit] Behandling skal seponeres hos patienter, som udvikler alvorligt nyresvigt (se afsnit 4,3).