FrancophonIA/ELRC3.0 huggingface dataset:
English: Around a quarter of the patients in this study also had a reduction in tumour size.
Danish: Hos ca. en fjerdedel af patienterne i denne undersøgelse blev svulsten desuden mindre.
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 Foscan.
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 anvendelsesbetingelserne for Foscan.
English: This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Danish: Derved dræbes cellerne, fordi det ødelægger deres bestanddele, f.eks. proteiner og DNA.
English: However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom.
Danish: Men i den undersøgelse, der registrerede symptomlindringen ved fremskreden hoved-hals-kræft, fik 28 (22 %) af de 128 vurderede patienter en væsentlig bedring i de mest generende symptomer.
English: Therefore, the Committee decided that Foscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Foscan opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: For more information about treatment with Foscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Foscan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.
Danish: I alle undersøgelserne blev behandlingens virkning vurderet 12 til 16 uger efter den sidste behandling med Foscan, men Foscan blev ikke sammenlignet med andre behandlinger.
English: The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes.
Danish: Lægemidlet indgives gennem en fastliggende intravenøs sonde (et tyndt rør, der permanent er lagt ind i en vene) som en enkelt langsom indsprøjtning over mindst seks minutter.
English: During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour.
Danish: Under behandlingen skal de øvrige områder af kroppen beskyttes mod lyset, så lægemidlets aktivering begrænses til svulsten.
English: It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic' means that they are given as treatments throughout the body).
Danish: Det anvendes til patienter, for hvem anden behandling ikke længere virker, og som hverken er egnet til stråleterapi, operation eller systemisk kemoterapi (lægemidler, der anvendes til behandling af kræft; "systemisk" betyder, at de gives, så det virker i hele kroppen).
English: Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).
Danish: Foscan må kun gives på en specialafdeling for kræft, hvor patientens behandling kan vurderes af et team under opsyn af en læge med erfaring i brug af fotodynamisk behandling (behandling med anvendelse af lys).
English: Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml).
Danish: Foscan er en injektionsvæske (opløsning), der indeholder det aktive stof temoporfin (1 mg/ml).
English: The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients.
Danish: I de tre første undersøgelser blev det registreret, om svulsten var forsvundet efter indtil tre behandlinger med Foscan hos i alt 189 patienter.
English: When Foscan is injected, temoporfin is distributed within the body, including within the tumour.
Danish: Når indsprøjtningen af Foscan gives, fordeler temoporfin sig i hele kroppen, også i svulsten.
English: The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest.
Danish: The CHMP konkluderede, at Foscan's virkning på reduktion af symptomer forbundet med fremskreden hoved-hals-kræft var interessant.
English: The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light).
Danish: Det aktive stof i Foscan, temoporfin, er et fotosensibiliserende middel (dvs. et stof, der ændrer sig ved udsættelse for lys).
English: What is the risk associated with Foscan?
Danish: Hvilken risiko er der forbundet med Foscan?
English: The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy.
Danish: I den fjerde undersøgelse registreredes bedringen i symptomer hos 220 patienter, der havde fremskreden kræft i hoved eller hals, og som hverken kunne behandles med operation eller stråler.
English: Patients receiving Foscan should take care to avoid exposure to sun light or bright light for two weeks after injection to avoid skin burns.
Danish: Patienter, der får Foscan, bør undgå udsættelse for sollys eller andet stærkt lys i indtil to måneder efter indsprøjtningen for at undgå skoldning af huden.
English: Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a main blood vessel in or next to the area where the laser is to be shone.
Danish: Foscan må ikke anvendes til patienter med porfyri (manglende evne til at nedbryde porfyriner), andre sygdomme der forværres af lys, allergi over for porfyriner eller svulster, der har bredt sig til et hovedblodkar i eller tæt på det område, der skal belyses med laseren.
English: The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage (bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation.
Danish: De almindeligste bivirkninger af Foscan (der ses hos mere end 1 af 10 patienter) er smerter på det belyste område (såsom i ansigtet), hovedpine, smerter på injektionsstedet, blødning, ardannelse, nekrotiserende stomatitis, celle- eller vævsdød i munden, synkebesvær, hævet ansigt og tunge samt forstoppelse.
English: Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Danish: Foscan anvendes til at lindre symptomerne ved fremskreden pladecellekræft i hoved og hals (en kræftform, der udgår fra de celler, der indvendigt beklæder mund, næse, hals eller ører).
English: Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer.
Danish: Der er udført fire hovedundersøgelser af Foscan hos i alt 409 patienter med hoved-hals-kræft.
English: Foscan must not be used in people who are hypersensitive (allergic) to temoporfin or any of the other ingredients.
Danish: Foscan bør ikke anvendes hos patienter, der er overfølsomme (allergiske) over for temoporfin eller andre af indholdsstofferne.
English: Why has Foscan been approved?
Danish: Hvorfor blev Foscan godkendt?
English: Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘slit lamp' (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with a photosensitising agent.
Danish: Foscan må heller ikke anvendes til patienter, der skal opereres inden for de næste 30 dage, patienter med øjensygdomme, der inden for de næste 30 dage måtte have behov for en undersøgelse med en spaltelampe (et instrument, øjenlægen bruger til at se ind i øjet) eller patienter, der i forvejen behandles med et fotosensibiliserende middel.
English: Treatment with Foscan is a two-step process: the medicine is given first, and then it is activated using a laser.
Danish: Behandlingen med Foscan finder sted i to trin: Først gives lægemidlet.
English: For the full list of all side effects reported with Foscan, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Foscan fremgår af indlægssedlen.
English: The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours.
Danish: Resultaterne af de første tre undersøgelser var ikke tilstrækkelige til at vise, at Foscan kan fjerne svulster i hoved og hals.
English: Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable.
Danish: Fire dage senere belyses et område svarende til hele svulstens overflade samt 0,5 cm ind over det omgivende væv med laserlys.
English: Foscan temoporfin
Danish: EPAR - Sammendrag for offentligheden temoporfin
English: By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.
Danish: Kun svulstområdet belyses; derved bliver cellebeskadigelsen begrænset til svulstcellerne, hvorimod de øvrige områder af kroppen er upåvirkede.
English: When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Danish: Det reagerer derved med ilten i cellerne, så der dannes en meget reaktiv og giftig form for ilt.
English: What is Foscan?
Danish: Hvad er Foscan?
English: What is Foscan used for?
Danish: Hvad anvendes Foscan til?
English: What benefit has Foscan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Foscan?
English: How has Foscan been studied?
Danish: Hvordan blev Foscan undersøgt?
English: How is Foscan used?
Danish: Hvordan anvendes Foscan?
English: How does Foscan work?
Danish: Hvordan virker Foscan?
English: [Solution for injection (i.m.)]
Danish: [Injektionsvæske (i.m.)]
English: The CMDh therefore reworded this section, as follows:
Danish: CMDh omformulerede derfor er dette afsnit som følger:
English: Flupirtine-containing medicinal products are currently approved in 11 Member States (MSs) of the Union on prescription only: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovak Republic.
Danish: Lægemidler indeholdende flupirtin er på nuværende tidspunkt godkendt under receptpligt i 11 EUmedlemsstater: Bulgarien, Estland, Italien, Letland, Litauen, Polen, Portugal, Rumænien, Slovakiet, Tyskland og Ungarn.
English: This is particularly important with regards back pain model due to the expected high rate of spontaneous remission.
Danish: Dette er navnlig vigtigt ved rygsmertemodellen på grund af den forventede høje andel af spontan remission.
English: Patient exposure to flupirtine was greater in Germany and has increased steadily from 7,9 million DDD in 2001 to 28,1 million DDD in 2011.
Danish: Patienteksponeringen for flupirtin var større i Tyskland og er steget konstant fra 7,9 mio. DDD i 2001 til 28,1 mio. DDD i 2011.
English: Other dosages and pharmaceutical forms are available in Germany only.
Danish: Andre styrker og lægemiddelformer markedsføres kun i Tyskland.
English: The PRAC also recommended that Periodic Safety Update Reports should be submitted yearly.
Danish: PRAC anbefalede desuden, at periodiske opdaterede sikkerhedsindberetninger indsendes årligt.
English: Overall summary of the scientific evaluation of flupirtine containing medicinal products by PRAC
Danish: Samlet resumé af PRAC's videnskabelige vurdering af lægemidler indeholdende flupirtin
English: It also acts as functional N-methyl-Daspartate (NMDA) receptor antagonist.
Danish: Det virker desuden som en funktionel Nmethyl-D-aspartat (NMDA)-receptorantagonist.
English: The WHO defined daily dose (DDD) for flupirtine oral is 400 mg.
Danish: Den af WHO fastsatte døgndosis (DDD) ved oral anvendelse af flupirtin er 400 mg.
English: Overall, 11.8 million patients have been treated with flupirtine containing medicinal products since
Danish: Tilsammen er 11,8 mio. patienter siden 1999 blevet behandlet med produkter indeholdende flupirtin.
English: The 400 mg modified release tablets, although only authorised in Germany, is the most prescribed formulation in the Union since 2007.
Danish: 400 mg tabletten med modificeret udløsning har siden 2007 været den oftest ordinerede formulering i EU, skønt den kun er godkendt i Tyskland.
English: The German National Competent Authority (BfArM) identified a growing number of hepatotoxicity reactions (probably idiosyncratic) reported in association with flupirtine.
Danish: De tyske kompetente nationale myndigheder (BfArM) påpegede et stigende antal hepatotoksiske reaktioner (antagelig idiosynkratiske), der var indberettet i forbindelse med flupirtin.
English: What you need to know before you use < product name > [The wording below should be inserted in the relevant sections]
Danish: Det skal du vide, før du begynder at bruge <lægemidlets navn> [Nedenstående ordlyd indsættes i de pågældende afsnit]
English: Michel MC, Radziszewski P, Falconer C, Marschall-Kehrel D, Blot K. Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
Danish: Michel MC, Radziszewski P, Falconer C, Marschall-Kehrel D, Blot K. Unexpected frequent hepatotoxicity of a prescription drug, flupirtin, marketed for about 30 years.
English: The reporting rate for hepatic cases with flupirtine (regardless of causality) is of 15,2 cases/100 000 patients years (based on a patient exposure of 893, 000 patients year).
Danish: Indberetningsfrekvensen af hepatiske tilfælde med flupirtin (uanset årsagssammenhæng) er 15,2 tilfælde/100 000 patientår (baseret på en patienteksponering på 893 000 patientår).
English: Flupirtine is a ‘selective neuronal potassium channel opener' (SNEPCO) that acts by reducing the excessive electrical activity that leads to many pain states.
Danish: Flupirtin er en “selektiv kaliumkanalåbner” (SNEPCO), som virker ved at nedsætte den elektriske overaktivitet, der er årsag til mange smertetilstande.
English: Flupirtine is available as 100 mg immediate release capsules, 400 mg modified release tablet, 75 mg and 150 mg suppositories and as solution for injection (100 mg).
Danish: Flupirtin leveres som 100 mg kapsler med hurtig udløsning, 400 mg tabletter med modificeret udløsning, 75 mg og 150 mg suppositorier samt injektionsvæske (100 mg).
English: Another publication4 described six cases of flupirtine-induced liver injury, including one requiring liver transplantation.
Danish: Endnu en publikation4 beskrev seks tilfælde af flupirtin-induceret leverskade, hvoraf det ene krævede transplantation.
English: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below)
Danish: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below) Herrmann WM, Hiersemenzel R, Aigner M et al.: Die Langzeitverträglichkeit von Flupirtin.
English: As part of the risk minimisation measures the PRAC recommended amendments to the product information for all flupirtine containing medicinal products.
Danish: Som led i risikominimeringsforanstaltningerne anbefalede PRAC ændringer af produktinformationen for alle lægemidler indeholdende flupirtin.
English: Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
Danish: Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtin modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
English: 1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
Danish: 1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtin vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
English: However, the CMDh considered that changes were necessary to the wording proposed in section 2 of the PL, in order to accurately reflect the PRAC recommended amendments to the SmPC section 4.3 “contraindications”.
Danish: CMDh fandt det imidlertid nødvendigt at ændre den foreslåede ordlyd i indlægssedlens afsnit 2 for nøjagtigt at afspejle de af PRAC anbefalede ændringer af produktresuméets punkt 4.3 “kontraindikationer”.
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for flupirtine containing medicinal products.
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 107i i direktiv 2001/83/EF for lægemidler indeholdende flupirtin
English: It is authorised in the European Union since 1984 as an alternative analgesic to opioids and NonSteroidal Anti-Inflammatory Drugs (NSAIDs) for the treatment of acute and chronic pain (such as painful muscle tenseness, tension headaches, cancer pain, dysmenorrhoea and pain following trauma or orthopaedic surgery or injuries).
Danish: Det har været godkendt i Den Europæiske Union (EU) siden 1989 som et analgetisk alternativ til opioider og nonsteroide antiinflammatoriske lægemidler (NSAID) til behandling af akutte og kroniske smerter (såsom smertefuld muskelspænding, spændingshovedpine, cancersmerter, dysmenorré og smerter efter traumer og kirurgiske indgreb).
English: Cases possible related to flupirtine treatment, and with re-challenge reported, had reoccurrence or worsening of the symptoms in 93% of the cases.
Danish: I de tilfælde, hvor der var en mulig årsagssammenhæng med behandlingen med flupirtin, og hvor behandlingen blev genoptaget, medførte dette tilbagevenden eller forværring af symptomer i 93 % af tilfældene.
English: The two long term clinical studies presented (which became available since the granting of the initial Marketing Authorisation) were uncontrolled and regarded the use of flupirtine over a period of 2 - 6 months study5 and a one-year6,7.
Danish: De to forelagte kliniske undersøgelser med langtidsbehandling (som blev tilgængelige efter udstedelsen af den oprindelige markedsføringstilladelse) var ukontrollerede, og flupirtin blev her anvendt i henholdsvis 2-6 måneder5 og et år6,7.
English: The PRAC considers that there is sufficient evidence on efficacy in the acute (nociceptive) pain indication (mild, moderate and severe).
Danish: PRAC finder, at der er tilstrækkelig dokumentation for virkningen ved indikationen akutte (nociceptive) smerter (lette, moderate og svære).
English: There were no reports of liver failure from published clinical trials.
Danish: Der er ikke beskrevet leversvigt i de publicerede kliniske undersøgelser.
English: The PRAC considered that a Direct healthcare professional communication (DHPC) was needed to communicate the outcome of the present review.
Danish: PRAC fandt, at der bør udsendes en direkte meddelelse til fagfolk i sundhedssektoren (DHPC) for at formidle resultatet af denne gennemgang.
English: The amendments aim to reflect the restricted use of maximum of two weeks of treatment, consequently only for use in acute pain and when other analgesics are contraindicated.
Danish: Ændringerne har til formål at afspejle den indskrænkede behandlingsvarighed på to ugers behandling og den deraf følgende indskrænkning til akutte smerter, hvor andre analgetika er kontraindiceret.
English: The time to onset of liver failure observed in spontaneous reporting was 25 % for each of the cases after 2-3 weeks, after 3-8 weeks, after 8-13 weeks and after >13 weeks (information on time to onset was available in 35 cases of the total 49 cases).
Danish: Det iagttagne tidsrum til indsætten af leversvigt i de spontane indberetninger fordelte sig med 25 % i hver af kategorierne 2-3 uger, efter 3-8 uger, efter 8-13 uger og efter >13 uger (tiden til indsætten var oplyst i 35 af de i alt 49 tilfælde).
English: Finally educational materials are necessary in order to clearly inform prescribers and patients on the hepatotoxicity risk associated with flupirtine and on the measures necessary to minimise the risk.
Danish: Endelig er det nødvendigt med materiale, der klart oplyser de ordinerende læger og patienterne om den hepatotoksiske risiko ved flupirtin og om de foranstaltninger, der er nødvendige for at minimere risikoen.
English: Overall, the oral and suppositories formulations are indicated for the treatment of acute and chronic pain while the injectable is indicated for short-term use for acute pain such as post-operative pain.
Danish: De orale formuleringer og suppositorierne er hovedsagelig indiceret til behandling af akutte og kroniske smerter, mens injektionspræparatet er indiceret til korttidsbehandling af akutte smerter såsom postoperative smerter.
English: Most cases were reports of increased liver enzymes, jaundice, hepatitis or hepatic failure.
Danish: De fleste tilfælde var indberetninger om forhøjede leverenzymer, ikterus, hepatitis eller leversvigt.
English: Liver transplantation or fatal cases resulting from liver failure were seen after 3-5 weeks of treatment in 25% of the cases and the remaining after 60 days of treatment (information is only available from 8 cases of the total of 15 fatal cases).
Danish: De iagttagne transplantationskrævende eller fatale leversvigt indtrådte efter 3-5-ugers behandling i 25 % af tilfældene og efter 60 dages behandling i resten af tilfældene (oplysninger herom foreligger kun for 8 ud af de i alt 15 fatale tilfælde).
English: However, three published studies1,2,3 reported elevated transaminases in 3%, 31% and 58.6% respectively, of the patients treated with flupirtine.
Danish: Der blev dog beskrevet forhøjede transaminaser i tre publicerede undersøgelser1,2,3 hos henholdsvis 3 %, 31 % og 58,6 % af de patienter, der blev
English: In addition, the frequency of the observed increase in hepato-biliary markers in clinical studies lead to a higher frequency of occurrence of these adverse drug reactions and consequently amendments to the products information in this regard.
Danish: Den iagttagne stigning i hepatobiliære markører i de kliniske undersøgelser er desuden ensbetydende med en højere frekvens af sådanne bivirkninger, hvorfor produktinformationen må ændres i denne henseende.
English: During the period of 1999 to March 2013 a total of 136 reports of flupirtine drug induced liver injury (DILI, hepatic necrosis, liver failure including fatal cases) have been identified in spontaneous reporting and literature including 15 cases with fatal outcome.
Danish: I perioden fra 1999 til marts 2013 har der været i alt 136 indberetninger om leverskade forårsaget af flupirtin (lægemiddelforårsaget leverskade, levernekrose, leversvigt, herunder fatale tilfælde) i spontane indberetninger og i litteraturen, heraf 15 tilfælde med fatalt udfald.