FrancophonIA/ELRC3.0 huggingface dataset:
English: In a comparative, unblinded phase III trial (MC-ALS.3/GLI), 201 patients with malignant gliomas received 5-ALA HCl in a dose of 20 mg/kg body weight and 176 of these patients underwent fluorescence-guided resection with subsequent radiotherapy.
Danish: I et komparativt, ublindet fase-III-forsøg (MC-ALS.3/GLI) fik 201 patienter med malignt gliom 5-ALA HCl i en dosis på 20 mg/kg legemsvægt, og 176 af disse patienter gennemgik fluorescensvejledt resektion med efterfølgende strålebehandling.
English: Increased levels of amylase, total bilirubin, and leukocytes, but decreased levels of thrombocytes and erythrocytes were observed, however differences between treatment groups were not statistically significant.
Danish: Der blev observeret forhøjede værdier af amylase, total bilirubin og leukocytter, men nedsatte værdier af thrombocytter og erythrocytter.
English: - immediate reactions occurring after oral administration of the medicinal product before anaesthesia (= active substance-specific side effects) - combined effects of 5-ALA, anaesthesia, and tumour resection (= procedure-specific side effects).
Danish: - Umiddelbare reaktioner, der er opstået efter oral indgivelse af lægemidlet og inden anæstesi (= bivirkninger, der er specifikke for det aktive stof).
English: There is no experience with Gliolan in children and adolescents.
Danish: Der er ingen erfaring med anvendelse af denne medicin til børn og unge.
English: A more pronounced transient increase of liver enzymes without clinical symptoms was observed in the 5-ALA-treated patients.
Danish: En mere udtalt, forbigående stigning i leverenzymer uden kliniske symptomer blev observeret hos patienter, der blev behandlet med 5-ALA. Maksimumværdierne forekom mellem 7 og 14 dage efter indgivelsen.
English: This course shall consist of measures aiming to minimise adverse events associated with the Gliolan-fluorescence-guided surgery (in particular neurological serious adverse events) through adequate education about:
Danish: Dette kursus vil bestå af foranstaltninger, som har til formål at minimere bivirkninger (herunder især neurologiske alvorlige bivirkninger), som er forbundet med det Gliolan-fluorescens-ledte indgreb.
English: No trials have been performed in patients with clinically relevant hepatic or renal impairment.
Danish: Der er ikke gennemført studier af patienter med klinisk relevant nedsat lever- eller nyrefunktion.
English: Mild alterations of blood cell counts (red and white cells, platelets), and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Danish: mindre ændringer i blodværdier (røde og hvide blodlegemer, blodplader), svag stigning i nogle enzymer (transaminaser, γ-GT, amylase) eller bilirubin (et galdefarvestof, som produceres i leveren ved nedbrydning af rødt blodpigment) i blodet.
English: How to take Gliolan
Danish: Sådan skal du tage Gliolan
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDET
English: One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Danish: En ml fortyndet opløsning indeholder 23,4 mg 5-ALA svarende til 30 mg 5-ALA HCl.
English: The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
Danish: Dosering Den anbefalede dosis er 20 mg 5-ALA HCl pr. kilogram legemsvægt.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INHOLD (PAKNINGSSTØRRELSE)
English: No trials have been performed in patients with poor liver or kidney function.
Danish: Der er ikke lavet undersøgelser på patienter med nedsat lever- eller nyrefunktion.
English: General characteristics
Danish: Generelle egenskaber
English: Malignant glioma tissue (WHO-grade III and IV, e.g. glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma) has also been demonstrated to synthesise and accumulate porphyrins in response to 5-ALA administration.
Danish: Det er ogsåpåvist, at malignt gliomvæv (WHO-grad III og IV, fx glioblastoma multiforme, gliosarcoma eller anaplastisk astrocytoma) syntetiserer og akkumulerer porfyriner som reaktion på indgivelsen af 5-ALA. Koncentrationen af PPIX er markant lavere i hvid substans end i cortex og tumor.
English: hypesthesia
Danish: hypæstesi
English: thromboembolism
Danish: tromboemboli
English: One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Danish: En ml fortyndet opløsning indeholder 23,4 mg 5-aminolevulinsyre svarende til 30 mg 5-aminolevulinsyrehydrochlorid (5-ALA HCl).
English: Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.
Danish: Andre lægemidler, som kan beskadige leveren, skal undgås inden for 24 timer efter anvendelse af Gliolan.
English: Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Danish: bivirkninger set hyppigt: opkastning, kvalme og let forhøjede enzymer (transaminase, gammaglutamyltransferase, amylase) eller bilirubin (et galdefarvestof, der produceres i leveren ved nedbrydning af rødt blodpigment) i blodet.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 behandlede):
English: diarrhoea
Danish: diaré
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede):
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos 1 ud af 10 behandlede):
English: hemiparesis, aphasia, convulsions, hemianopsia)
Danish: neurologiske sygdomme (fx hemiparese, afasi, kramper, hemianopsi)
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.
Danish: En flaske indeholder 1,17 g 5-aminolevulinsyre (5-ALA) svarende til 1,5 g 5-ALA HCl.
English: Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase.
Danish: Derudover forekommer følgende bivirkninger hyppigt: opkastning, kvalme og øgede niveauer af blodbilirubin, ALAT, ASAT, gammaglutamyltransferase og blodamylase.
English: After ingestion, 5-ALA itself is not fluorescent but is taken up by tumour tissue (see section 5.1) and is intracellularily metabolised to fluorescent porphyrins, predominantly PPIX.
Danish: Efter indtagelse er 5-ALA ikke fluorescerende i sig selv, men optages af tumorvæv (se pkt.
English: The compound potentially induces photogenotoxicity after subsequent irradiation or light exposure which is obviously related to the induction of porphyrin synthesis.
Danish: Størstedelen af de genotoksiske undersøgelser, som er gennemført i mørke, viser intet genotoksisk potentiale af 5-ALA. Præparatet inducerer potentielt fotogenotoksicitet ved efterfølgende bestråling eller lyseksponering, hvilket tydeligvis er forbundet med induktionen af porfyrinsyntese.
English: In combination with anaesthesia and tumour resection further side effects may occur:
Danish: Andre bivirkninger kan opstå efter kombination med bedøvelse og fjernelse af svulsten:
English: One bottle contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Danish: En flaske indeholder 1,17 g 5-aminolevulinsyre svarende til 1,5 g 5-aminolevulinsyrehydrochlorid (5-ALA HCl).
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Danish: En flaske indeholder 1,17 g 5-aminolevulinsyre (5-ALA) svarende til 1,5 g 5-aminolevulinsyrehydrochlorid (5-ALA HCl).
English: If the anaesthesia/surgery is delayed by some hours, additional doses of this medicine must not be given.
Danish: Der må ikke gives flere doser af denne medicin, selvom bedøvelsen/operationen er forsinket nogle timer.
English: After having taken Gliolan and before start of anaesthesia, the following side effects may occur:
Danish: Nedenstående bivirkninger kan opstå, efter at du har taget Gliolan og inden bedøvelsen:
English: What Gliolan is and what it is used for What you need to know before you take Gliolan How to take Gliolan
Danish: Det skal du vide, før du begynder at tage Gliolan Sådan skal du tage Gliolan Bivirkninger
English: If you take more Gliolan than you should
Danish: Hvis du har taget for meget Gliolan
English: brain oedema
Danish: Mave-tarm-kanalen
English: This medicine is a powder for oral solution.
Danish: Denne medicin er et pulver til opløsning, der skal drikkes.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: • If you get any side effects, talk to your doctor or pharmacist.
Danish: • Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viagra on 14 September 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Viagra den 14. september 1998.
English: Viagra was significantly more effective than placebo in all studies.
Danish: Viagra var væsentligt mere effektivt end placebo i alle undersøgelserne.
English: This is a summary of the European public assessment report (EPAR) for Viagra.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Viagra.
English: The full EPAR for Viagra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Viagra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on the ability of the men to get and maintain an erection.
Danish: Det primære effektmål blev baseret på mændenes evne til at få og opretholde en erektion.
English: Orodispersible tablets are tablets that dissolve in the mouth.
Danish: Smeltetabletter er tabletter, som opløses i munden.
English: For Viagra to be effective, sexual stimulation is required.
Danish: For at Viagra kan være effektivt, er seksuel stimulering nødvendig.
English: The recommended dose of Viagra is 50 mg taken as needed about one hour before sexual activity.
Danish: Den anbefalede dosis Viagra er 50 mg, som tages efter behov cirka en time før seksuel aktivitet.
English: A risk management plan has been developed to ensure that Viagra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Viagra anvendes så sikkert som muligt.
English: This was recorded in a special questionnaire completed at home using a scoring system on a five-point scale, where a score of 5 represents the best result.
Danish: Resultaterne blev opnået ved hjælp af et særligt spørgeskema, som deltagerne udfyldte hjemme, og hvori der blev anvendt en 5pointsskala med 5 som det bedste resultat.
English: Viagra has been studied in four main studies including 1,690 men aged 19 to 87 years, where it was compared with placebo (a dummy treatment) for between 12 and 26 weeks.
Danish: Viagra blev undersøgt i fire hovedundersøgelser, der omfattede 1 690 mænd i alderen 19 til 87 år, hvor det blev sammenlignet med placebo (en virkningsløs behandling) i en periode på mellem 12 og 26 uger.
English: Other information about Viagra
Danish: Andre oplysninger om Viagra
English: Patients with liver problems or severe kidney problems should start treatment with the 25 mg dose.
Danish: Patienter med leverproblemer eller svære nyreproblemer bør påbegynde behandlingen med en dosis på 25 mg.
English: Viagra is a medicine that contains the active substance sildenafil.
Danish: Viagra er et lægemiddel, der indeholder det aktive stof sildenafil.
English: By blocking the breakdown of cGMP, Viagra restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Viagra den erektile funktion.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Danish: Dosis kan øges til maksimalt 100 mg eller nedsættes til 25 mg afhængig af effekt og bivirkninger.
English: For more information about treatment with Viagra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Viagra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viagra.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Viagra skal anvendes.
English: The maximum recommended dosing frequency is once a day.
Danish: Den maksimalt anbefalede dosishyppighed er én tablet dagligt.
English: What measures are being taken to ensure the safe and effective use of Viagra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Viagra?
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Danish: Det må heller ikke indtages af patienter, som på noget tidspunkt har haft nedsat syn forårsaget af et problem med blodtilførslen til nerven i øjet (non-arteritis anterior iskæmisk opticusneuropati eller NAION).
English: In addition, there were studies in patients with spinal cord injury and with diabetes.
Danish: Derudover blev der foretaget undersøgelser hos patienter med rygmarvsskade og patienter med sukkersyge.
English: If Viagra is taken with food, the onset of activity may be delayed compared with taking it without food.
Danish: Hvis Viagra indtages i forbindelse med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis det indtages på tom mave.
English: Viagra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity.
Danish: Viagra anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), når de ikke kan få eller fastholde en tilstrækkelig stiv penis (erektion) til tilfredsstillende seksuel aktivitet.
English: It is available as tablets (25, 50 or 100 mg) and as orodispersible tablets (50 mg).
Danish: Det fås som tabletter (25, 50 eller 100 mg) og som smeltetabletter (50 mg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Viagra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Viagra, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere phosphodiesteraseenzymet, som normalt nedbryder et stof, der kaldes cyklisk guanosinmonofosfat (cGMP).
English: The CHMP decided that Viagra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Viagra opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Viagra.
English: The active ingredient in Viagra, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive indholdsstof i Viagra, sildenafil, tilhører en gruppe af lægemidler kaldet fosfodiesterase type 5 (PDE5)-hæmmere.
English: The orodispersible tablets should be placed on the tongue and left to disintegrate before swallowing.
Danish: Smeltetabletterne bør lægges under tungen, hvor de opløses, før de sluges.
English: The most common side effects with Viagra are headache, flushing, dyspepsia (indigestion), visual disorders, including visual colour distortion and blurred vision, nasal congestion (blocked nose), dizziness, nausea and hot flushes.
Danish: De hyppigste bivirkninger ved Viagra er hovedpine, rødmen, dyspepsi (fordøjelsesbesvær), synsforstyrrelser, herunder forvrænget farvesyn og sløret syn, nasal kongestion (stoppet næse), svimmelhed, kvalme og hedeture.
English: Viagra must not be taken with nitrates (medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Danish: Viagra må ikke tages sammen med nitrater (lægemidler til behandling af angina) eller lægemidler i klassen "guanylatcyklase-stimulatorer", såsom riociguat (til behandling af pulmonal hypertension [højt blodtryk i lungerne]).
English: What is the risk associated with Viagra?
Danish: Hvilken risiko er der forbundet med Viagra?
English: Because Viagra has not been studied in patients with severe liver disease, hypotension (low blood pressure), recent stroke or myocardial infarction (heart attack), or a hereditary eye disease, such as retinitis pigmentosa, these patients must not use it. For the full list of restrictions, see the package leaflet.
Danish: Eftersom Viagra ikke er blevet undersøgt hos patienter med alvorlige leversygdomme, hypotension (for lavt blodtryk), hos patienter, som for nyligt har haft et slagtilfælde eller et myokardieinfarkt (hjertetilfælde), eller hos patienter med en arvelig øjensygdom som f.eks. retinitis pigmentosa, må lægemidlet ikke anvendes til disse patienter.
English: For the full list of all side effects reported with Viagra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Viagra fremgår af indlægssedlen.
English: Viagra must not be used where sexual activity is inadvisable (e.g. men with severe heart disease such as unstable angina or severe heart failure).
Danish: Viagra må ikke anvendes til personer, som er blevet frarådet seksuel aktivitet (f.eks. mænd med alvorlige hjertesygdomme såsom ustabile brystsmerter (angina) eller alvorlig hjerteinsufficiens).
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Danish: Stoffet cGMP produceres i penis ved normal seksuel stimulering og medfører en afslapning af musklerne i svulmelegemet (corpora cavernosa), hvorved blodstrømningen til corpora øges, og der således fremkaldes en erektion.
English: Two of these studies used fixed doses (patients allocated to 25, 50 or 100 mg) and two studies were flexible (patients started on 25 mg and could be moved to 50 or 100 mg depending on their response).
Danish: I to af disse undersøgelser blev der anvendt faste doseringer (på henholdsvis 25, 50 eller 100 mg), og i de to andre var doseringen fleksibel (dosis var ved behandlingens start på 25 mg og kunne øges til 50 eller 100 mg afhængigt af behandlingens effekt).
English: Why has Viagra been approved?
Danish: Hvorfor er Viagra blevet godkendt?
English: What is Viagra?
Danish: Hvad er Viagra?
English: In the fixed-dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg), compared with 25% on placebo.
Danish: Til spørgsmålet om, hvor tit patienten var i stand til at gennemføre samleje, lå resultatet på omkring 2 point uden behandling og på 3 eller 4 med behandling med Viagra 50 mg. I fastdosisundersøgelserne var den del af patienterne, som rapporterede, at behandlingen forbedrede deres erektioner, 62 % (25 mg), 74 % (50 mg) og 82 % (100 mg) sammenlignet med 25 % på placebo.
English: What is Viagra used for?
Danish: Hvad anvendes Viagra til?
English: What benefit has Viagra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Viagra?
English: How has Viagra been studied?
Danish: Hvordan blev Viagra blevet undersøgt?
English: How is Viagra used?
Danish: Hvordan anvendes Viagra?
English: How does Viagra work?
Danish: Hvordan virker Viagra?
English: Bioavailability after oral administration is about 60%.
Danish: Biotilgængeligheden efter oral administration er ca. 60 %.
English: White to off-white powder
Danish: Hvidt til off-white pulver
English: The active substance in Equisolon is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Equisolon er en godkendt substans, som beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
English: The correct dose should be mixed into a small amount of food.
Danish: Den korrekte dosis bør iblandes i en lille portion foder.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and the carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og på kartonen efter EXP.
English: Treatment may be repeated at 24 hour intervals during 10 consecutive days.
Danish: Behandlingen kan gentages med 24 timers intervaller i 10 på hinanden følgende dage.
English: SACHETS (3, 9 and 18 gram)
Danish: BREVE (3, 9 og 18 gram)
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser bliver nødvendigvis markedsført.
English: Excretion of prednisolone is complete within 3 days.
Danish: Prednisolon udskilles fuldstændigt inden for 3 dage.
English: Date of first authorisation: 12/03/2014 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 12/03/2014 Dato for seneste fornyelse af markedsføringstilladelse:
English: Each case should be assessed individually by the veterinarian and an appropriate treatment program determined.
Danish: Hvert tilfælde bør vurderes individuelt af dyrlægen, og der bør lægges en passende behandlingsplan.
English: T½ is 3.1 ±2.3 hours but is not meaningful from a therapy standpoint when evaluating systemic corticosteroids.
Danish: T½ er 3,1 ± 2,3 timer, men er ikke behandlingsmæssigt meningsfuld ved vurdering af systemiske kortikosteroider.
English: ATCvet code: QH02AB06
Danish: ATCvet-kode: QH02AB06
English: Opened sachets should not be stored.
Danish: Åbnede breve bør ikke gemmes.
English: Sachets of different pack size can be combined to achieve the correct dose, as per the table below:
Danish: Breve med forskellig pakningsstørrelse kan kombineres for at opnå den korrekte dosis, ifølge tabellen herunder:
English: Following oral administration in horses prednisolone is readily absorbed giving a prompt response which is maintained for approximately 24 hours.
Danish: Efter oral administration til heste absorberes prednisolon hurtigt og giver en hurtig respons, der holder sig i ca. 24 timer.
English: A significant increase in triglycerids occurs very commonly.
Danish: En betydelig stigning i triglycerider ses meget almindeligt.